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. Charlie, you may begin.

Thank you. Good afternoon. My name is Charles 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 fourth quarter 2015 and full-year preliminary financial results, 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 February 12 at 888-843-7419 from the United States and 630-652-3042 internationally. The passcode is 41568920. 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 preliminary financial results for the fourth quarter of 2015, our anticipated revenues and expenses for 2016 and beyond, the pace of Korlym’s acceptance by physicians and patients, the anticipated contribution of our sales organization. The cost and timing of preclinical and clinical trials and the results of such trials, the clinical attributes and advancement of our next-generation selective cortisol modulators, the protections afforded by Korlym’s orphan drug designation for Cushing’s syndrome or our other intellectual property rights including our patent concerning the use of glucocorticoid receptor antagonists to treat triple negative breast cancer. These and other risks are set forth in our SEC filings, which are available at our website, corcept.com, or from the SEC’s website, sec.gov. We disclaim any intention or duty to update any forward-looking statements made during this call. Now, I’ll…

Thank you, Charlie, and thank you all for joining us. Corcept seeks to help patients by developing and commercializing medications that modulate the effects of cortisol, widely known as the stress hormone. Our research and research by the dozens of academic investigators with whom we collaborate has shown that cortisol modulation has therapeutic potential in many serious illnesses including oncologic disorders such as triple negative breast cancer, ovarian cancer, and castrate resistant prostate cancer, psychiatric indications such as post-traumatic stress disorder and alcohol and cocaine dependence, metabolic diseases such as antipsychotic induced weight gain and non-alcohol fatty liver disease and Cushing’s syndrome which our first medication Korlym has been approved to treat. Let me briefly recap our recent results. As Charlie mentioned, our Cushing’s syndrome business grew strongly in 2015. Revenue increased 89% to $50.3 million. We expect significant growth in 2016 with revenue reaching between $76 million and $81 million. Our oncology program continues to progress in December at the San Antonio breast Cancer Symposium, we announced preliminary efficacy results of our Phase 1/2 trial of Korlym in combination with the chemotherapy drug eribulin to treat women with triple negative breast cancer, a severe form of the disease with a poor prognosis and no FDA approved treatments. We are about to begin a Phase 2 trial of our lead next-generation cortisol modulator, CORT125134, to treat patients with one or more types of solid tumor cancer. The first clinical sites in this trial are expected to open by the end of this quarter. We’re also about to begin a Phase 2 study at CORT125134 to treat patients with Cushing syndrome. Our hope is that CORT125134 will share Korlym’s effectiveness without causing the side effects associated with Korlym’s affinity for the progesterone receptor. As many of you know, we have created…

[Operator Instructions] And we have a question from Charles Duncan from Piper Jaffray. Please go ahead.

Hi, this is Sarah Weber on for Charles. Well, congrats on a strong quarter. My first question is [indiscernible] anything strategic about the site selection for the Cushing’s trial of 134 and could you see that trial helping to raise awareness of the mechanism in Cushing’s?

Yes, Sarah, nice to hear from you and thank you for the question. I just want to repeat it. The question was site selection for the CORT125134 Cushing’s syndrome study. And that’s a very important question because I think that it’s really worth knowing that well we will have some sites in the United States, including for example the NIH, we will also have multiple sites in Europe for this to this particular trial. And I think that that will really help awareness of the therapeutic modality of GR modulation or Cushing’s syndrome in that group. As you know mifepristone Korlym is approved in the United States and we hope to have CORT125134 approved in worldwide setting. So, yes, in fact site selection is very consequential and thank you for letting me address it.

Great.

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

Hi, guys. Thanks for taking the questions. I had a question about a potential label for 125134 in Cushing’s. Would you expect that to look similar to the Korlym label or different?

I like just – but my colleagues sitting around the table and I’d like to now introduce you to Bob Fishman, who is our Chief Medical Officer. Bob would you like to handle that question?

Yes, sure, and thanks very much for the question. Yes, it is our hope that we will have a broader label. As you know Cushing’s syndrome has a variety of manifestations. And so, we will be looking in the trial at a variety of clinical parameters as before we’ll focus on glucose control, blood pressure control. But, yes, we hope by virtue of that evidence base to have a broader label. And perhaps most importantly because of the lack of effect on the progesterone receptor, we would expect to label without the current black-box warning.

Yes. And in short, Roy, we’re putting together a series of trials, which we think will allow for the broadest possible label for 125134 in Cushing’s syndrome and really hope to have it available to any patients, who could potentially use it.

Okay, great. Is it – these compounds have any impact on cortisol synthesis or are you looking for compounds that might have an impact on that?

No, our real mechanism of action that we’re looking for is competitive antagonist at the glucocorticoid receptor, not cortisol synthesis inhibition.

Okay, all right, great. And then I had a question about the IST, the Phase 1/2 of Korlym plus Xtandi. I know it’s not your study, but do you guys have any idea when we might see data from that?

Well, you’re right. You’ve raised kind of the key issue. It is an academic study being done at the University of Chicago and that sort of arms length that we don’t have this space, full insight into the timetable. But we noticed that study is really progressing and fingers-crossed we actually will see data within the next 12 months from that study.

Okay, great. And one last question, I’ll jump back in the queue. I had a question about the heterogeneity of GR expression in certain tumor types. So, when you say 75% expression level, is that 75% of cells in pretty much all the tumors or is it 75% of tumors with a high level of expression?

The standard that we’ve used and it really started with I think really closely looking at what was done with Herceptin was that tumors that have a greater than 10% expression of the GR receptor within them. And so, there is variation that runs from 10% all the way to 100%. And I could tell you looking at our own tumor samples they tend to be on the high side, but that’s been the cutoff for our data, so greater than 10% expression within the tumor.

Okay, great.

Our next question is from Christopher James from FBR Inc. Please go ahead.

Hi, good afternoon guys and thanks for taking my questions. And let me congratulate you on an excellent quarter and generating your first GAAP profitable quarter.

Thanks, Chris.

I guess – yes, thanks, Joe. So just starting I guess on Cushing’s maybe could you provide a little bit of commentary around what you’re seeing with respect to the average dose of Korlym. And do you see any room for upside in the daily dose currently being used?

I would like to – Chris, thank you for the question. I’d like to introduce our two Senior Commercial Officers, Sean Maduck is here and Dave Penake. Sean just for those of you who may need him in the future is really responsible sort of broadly for patient acquisition and Dave Penake is around patient retention. And Dave, do you like to handle this question?

Yes, thank you, thank you Joe. Well, Christopher thanks for the question. I think to start with one thing we have talked about it in the past is that our average dose commercially was lower than what we have seen in the seismic study. And one of the things that we’ve taken into account to try and manage that and improve that is we’ve implemented what we call retention programs here. What we’re really trying to do is follow every patient, help every patient, help make sure that the patient and the physician are having the right discussions, where they can find the optimal benefit of the drug. What that’s led to is patients who are on longer, patients – more of our enrolled patients become chronic. And when they do so, it’s because they’re getting a very effective dose and or very effective treatment. And a lot of that has to dose. So we’ve continued to see rising dose over the last couple of quarters. We expect that to continue, we do not know where it tapers off. But we think somewhere in the range where the seismic study landed would be appropriate.

And the other thing I’d like to add to that Chris just to Dave’s point, which I think was well expressed, is that, yes, it was a little frustrating because we felt like patients early on were being under dosed and weren’t really getting the maximum effect that they might get from the drug. That has been less and less of an issue with Dave’s retention programs and we are now seeing doses that we’re in the range of the seismic study. And we think that that’s going to continue over time and those two things are really sort of inexorably tied together. Good retention is because of good dosing and good dosing causes good retention.

Got it. And remind me what the dose 750 mg?

It was 750 – yes, and just it was the whole lot, the mean dose was about 750, the medium dose was about 900.

Got it, okay. And then just moving to the competitive landscape, one question we’re getting in particular from investors. Is on a competitive drug COR-003 levo, I think you’re familiar with it levo ketoconazole. We are aware that ketoconazole had some issues with LFTs. I guess, may be in broad strokes, maybe give your thoughts on a similar agent and do you think it would have a different profile?

Well I mean the first thing I’d really like to say is, I think it’s terrific for these patients that people are doing research in this area. I mean this was a really an underserved group for many, many years. And there wasn’t much to offer them at all. And I’m glad that perhaps we’ve been the ones who really sparked interest in treating this group. So that that itself is a good thing. You are correct this really is a completely different mechanism of action. The drug that you’re describing is of cortisol synthesis inhibitor. So it basically lowers the level of cortisol generally. It’s a very different mechanism than Korlym of any of our follow-on compounds, which modulate activity at the end point – at the receptor. And I guess the – maybe an analogy to drop them is basically that cortisol synthesis inhibitor sort of lowers the water in the pool in a very leveling way, whereas a cortisol receptor antagonist allows for the normal diurnal variation to take place. And really in some sense causes a different qualitative result, I think in the group of patients. But I’m very anxious to see everyone else’s data as it comes out. I think that we’re – we think mechanistically we have something which is really very special and I think one of the things that’s exciting about this call is that CORT125134 once before having now passed through Phase 1, and entering Phase 2 as an opportunity to really show the same mechanism. And potentially actually take away one of the side effects of Korlym that has kept probably certain patients from using it.

Great. Thanks for the color on that. And then my last question with respect to the pipeline, I think you mentioned data at ASCO. Do you expect to present PFS data by mid-year and or will this be objective response data only? And then maybe sort of comment on your view of the necessary bar on PFS in metastatic triple-negative breast from your, I guess understanding of historical data.

So Chris, the first and most important thing I can tell you is that we’ll present all the data we candid ASCO. So it’s our expectation that this study is going to be over about mid-year and I don’t know exactly when that’s going to be, but if it’s not at ASCO it will be soon after and we’ll present all that we can. Now you’re hitting on something which is very important and glad to inform, excuse me, the whole group, which is that the feedback we’ve received from the regulatory agencies is that progression free survival is the end point they would want to see for pivotal study for approval. And we of course are keeping track of that as we’re going along. And as you know in the ASCO poster, while patients were still active it was something that we would measure. We don’t know exactly what the bar for improvement in progression free survival is going to be. Unfortunately, for this disease progression free survival is slight and it’s really, it’s very unfortunate very is a dire illness and frankly we feel like every month the progression free survival is really a month very close to overall survival, because for many of these patients unfortunately the next place after our trial is hospice care. So I don’t know exactly where that’s going to be. I would actually make sure everyone understands that in the end we’re going to have to do a trial, which measures standard therapy plus our medicine versus standard therapy that’s really going to be the acid test of whether we’re filling an improvement. We feel optimistic about moving to a trial like that but we really have to analyze all our results that we’re currently going to see before we make the decisions that exactly what’s going to happen after that.

Our next question is from Boris Peaker from Cowen. Please go ahead.

Good evening and I want to add my congratulations to the excellent results.

Thank you, Boris. And it’s good to hear from you.

So, I just want to follow-up more on Chris’s question in terms of breast cancer study. So…

Yes.

Particularly where these patients selected for GR receptors and was there any kind of correlation of response, correlation with any response in GR receptor expression?

So, I just want to – I know you have some of the background, but I just want to give it for the whole group. In the original University of Chicago study, they took patients who had tumors with GR-positive and some whose were not. And the responders in their small study, clearly showed that the GR-positive patients were the responders, they had longer progression-free survival and greater objective response and so forth. In our current study, I can tell you that all of our patients are in fact GR-positive.

Got you. And is there a correlation, I mean if there are different levels of GR expression that that you could look at correlation to efficacy or is it just kind of binary yes or no?

We’re starting with the binary criteria of greater than 10% of the tumors have to be GR-positive, but you’re asking an oppression question, that data we will look at as we get results from the study. I don’t have the results for it yet. I can tell you that in the University of Chicago study, there was a patient for instance, who was less than 10%, who was non-responder, and the greatest responders were across the board. They did not necessarily have the highest degree of GR density.

Got you. And when looking at the solid tumors that you plan to pursue with your second generation also, I guess.

Yes.

Are you also going to be screening for GR receptors as enrollment criteria, there is just going to be kind of – at the end of going forward?

Initially, I think in the dose-finding question we will take all covers, but observe what the GR status is. I think, it going forward it’s highly likely that we will use GR positivity as a criteria, but keep in mind one thing, which is really interesting and we’ve now published is that, there wasn’t much of the scientific literature about GR positivity in triple negative breast cancer before we really began to examine the disease. And in the literature, it was estimated that maybe 25% to 30% of the tumors were in fact GR-positive. We’ve now done by far the largest tumor event screening, and the GR positivity rate is much higher than that. Certainly about 80% and I can tell you in our clinical trials so far, I think it’s 100%. So this is, for triple negative breast cancer at least, it looks as if it sort of matches up. For other cancers I do think that you GR positivity is going to be an entry criteria.

And in general, in these cancer patients, is cortisol level consistent with a healthy patient or do they have aberration in cortisol level as well?

There is a nice literature around this, and the answer is they tend to be higher and they tend to use their diurnal rhythm and if they lose their diurnal rhythm, their outcome is worse.

Got you. Okay. Well, thank you very much for the details and we look forward to the additional…

Yes. And glad to speak with you Boris. Please keep us in mind with any other questions.

Sure.

Our next question is from Alan Leon from Senior Analyst. Please go ahead.

Thank you very much. Good to hear from you guys.

Hi, Alan.

I have two sets of questions. But there was an earlier question asked about the prostate cancer trials the University of Chicago. I wonder if you could do the same, except but, if you have any commentary on the breast and ovarian cancer trial as well, as there is a non- University of Chicago trial with lung cancer as I understand it. Comment on what are the milestones, but also the importance of these trials, clinical program?

Yes. So let me just sort that out for all the listeners. I think really a unique thing about Corcept is that really from the beginning we thought the academic collaborations were very, very important part of our plan. Sort of Joseph said at the beginning, we really had a lot more ideas than money. But we really wanted to keep our research going and so we extensively collaborated over a period of the year I said at any given point in time, we probably have 30 different academic collaborations going on in the United States and abroad. And it really stands a very nice, how to use a sport analogy form system for the kind of programs we want to eventually bring in-house. Now at University of Chicago, now to your question, there are more than one oncology study going on with the mifepristone with Korlym. One is in castration-resistant prostate cancer, another one is in triple-negative breast cancer and ovarian cancer and in some – in similar places they’ve enrolled a fair number of patients at this point, they’re not complete. But I guess the progress report every week and progress is being made. So I can’t give you a specific read-out data at this point, but I can tell you these are passionate investigators who’ve actually originated the science and I know that they’re interested in putting out the results as soon as they feel like they have gel. The last point you made was about non-small cell lung cancer, yes in the last, if I guess, a month. A trial has opened with that disease, at a site in Philadelphia it’s an interesting trial, because this investigators actually using the drug as monotherapy, it’s published on this before and we’ll see what is results are. But I know at least the first patient has entered that study.

I have a philosophical question seriously; even Charlie, just trying to [indiscernible] and you have this wonderful IP that applies on number of different indications. And if I look at 2016, I know in 2017, a lot of playing cards get turned over. So I wonder if you can provide a kind of commentary or some color on – on one hand, they’re living within their needs, on the other hand even within camps you have a number of directions you can afford to have.

Yes, and I think you raise an interesting question, which is we have – we’re very pleased that Sean and Dave run a great commercial business. It really at this point is funding everything that we do. And we’re budgeted for all the things that we described, it is possible that a significant positive result would want – could cause us to or want to expand what we’re currently doing. And that would be a nice moment to have to deal with. We’ll just have to – as you said, a lot of cards gets turned over in the next 12 months to 18 months, we’ll have to see where we are we’re feeling more and more confident that the scientific underpinnings for this area are growing and are strong. I don’t know where they’re going emerge as positive and net results for us to take forward. But we have many possibilities.

Well, thanks. I look forward to seeing you soon.

Good Alan, thank you.

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

Hi guys, just a couple of quick follow-up. I have a question on future combo studies if you had any plans with Abraxane or checkpoint inhibitors if you comment on that.

Bob, would you like to handle that question?

Sure. First on the topic of checkpoint inhibitors, for sure that’s an area of great interest to us and we can tell you that it’s an active research program. And in fact our research colleagues have completed the original study of tolerability in animals. And so now we move on to actual studies of the tumor, so that’s an exciting update. In terms of Abraxane, yes, we are considering other possibilities, we noted as a – I’m sure you have the approval just today in liposarcoma. We had been thinking about sarcoma. So, yes, we don’t have the final list, but are considering additional tumors as possibilities for investigation.

Yes. And just let me elaborate one thing. Roy, of course checkpoint inhibitors had been for good reason in the press a great deal. Checkpoint inhibitors are a form of immunomodulation and promising, very nice results. GR antagonist is sort of a core immunomodulation, it’s your natural immune system, I think. And you know there’s scientific reason to think that in combination this could be an effective strategy. Now the data will tell us what the data is going to tell us, but I just want to amplify what Bob said, this is something we’ve thought about for a while. The first animal study is now complete. And we’re hoping by the next time we have a conference call, we’ll have early animal data to share with you.

Great, okay, thanks. And then I had a question about, could you guys were completing a ketoconazole interaction study, has that done? And is there any reason…

It is done. Yes.

Okay. Is there any reason physicians couldn’t combine Korlym with ketoconazole and are you getting any – are they doing that?

The answer to that question is there really is no reason to combine the two treatments and its important kind of medical explanation. There’s really no amount of cortisol activity, which can’t be modulated by Korlym and I can tell you the dose is very great deal. There are people with more modest Cushing’s syndrome, no Cushing’s syndrome is good, who require a lower dose; and people with more severe Cushing’s syndrome, which require a much higher dose. And all of those forms of the disease can be modulated with Korlym. So there really is no additive value of using the drug like ketoconazole with Korlym. And the answer to your second question is no. No, we are not seeing people use them together.

Okay, great. Thank you, guys.

Okay. Well, thank you very much everybody and really look forward to talking to you next quarter.

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