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Executives

Dr. Joseph Belanoff - Chief Executive Officer

Charlie Robb - Chief Financial Officer

Analysts

Kim Lee - Janney Capital

Roy Buchanan - Piper Jaffray

Koon Ching - Credit Suisse

Annabel Samimy - Stifel

Corcept Therapeutics Inc. (CORT) Q1 2013 Earnings Conference Call May 2, 2013 5:00 PM ET

Operator

Welcome to the Corcept Therapeutics’ First Quarter 2013 Financial Results Conference Call. My name is Adrianne 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, Chief Financial Officer. Charlie Robb, you may begin.

Charlie Robb

Thank you. Good afternoon. I am 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 setting forth our first quarter summary financial results. Complete results will be available when we file our first quarter report on Form 10-Q with the Securities and Exchange Commission. To obtain a copy of this release, please go to our website at www.corcept.com and click on News & Events. Today’s call is being recorded. A replay maybe heard through May 16, by dialing 1-888-843-7419 from the United States and 1-630-652-3042, internationally. The pass code will be 34774024.

I would like to remind you that we will be making forward-looking statements. Such statements might include statements related to the pace of Korlym’s acceptance by physicians and patients, the reimbursement decisions of government or private insurers, the pace of enrollment in and the outcome of the company’s Phase 3 trial of mifepristone for the treatment of psychotic depression, the effects of rapid technological change and competition, or the cost, pace and success of our selective GR-II antagonists. These statements are only predictions and involve known and unknown risks and uncertainties, including the risks outlined under Risk Factors and elsewhere in our filings with the Securities and Exchange Commission, which can be accessed at www.corcept.com or the SEC’s website, sec.gov.

Although we believe the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee future results, events, levels of activity, performance or achievement. We are not under any duty to update forward-looking statements, unless required by law.

Before I turn the call over to Dr. Belanoff, I’ll recap our financial results for the quarter. Our revenue in the first quarter of 2013 was $1.7 million compared to $1.4 million in the fourth quarter of 2012. Our net loss for the quarter was $12.1 million for the first quarter 2013 compared to a net loss of $11 million in the first quarter of 2012. Our net loss for the first quarter of 2013 and the same period in 2012 included significant non-cash expenses of $2.4 million in each quarter. After adjusting for these non-cash expenses, our net loss on a non-GAAP basis was $9.7 million in the first quarter of this year and $8.6 million in the first quarter of 2012.

A reconciliation from GAAP net loss to non-GAAP net loss is included in our press release. The company’s cash balance as of March 31 was $81.5 million compared to $93.1 million at December 31, 2012.

I will now turn the call over to Dr. Belanoff. Joe?

Dr. Joseph Belanoff

Thank you, Charlie and thank you for joining the call this afternoon. Most of you are familiar with Corcept and our first product Korlym, but for those of you who are not, I will provide some background.

As many of you know, the FDA approved Korlym for the treatment of endogenous Cushing’s syndrome in February 2012. As the FDA stated in its news release, prior to FDA’s approval of Korlym, there were no approved medical therapies for the treatment of endogenous Cushing’s syndrome. Cushing’s syndrome is a devastating life threatening illness. It’s usually caused by a single tumor that produces too much cortisol provide tumor that produces too much ACTAs, which in turn stimulates the body to produce too much cortisol.

Cortisol is often referred to in the late press as the stress hormone and is essential for life. Unfortunately, in excess it causes severe and sometimes lethal illness. Korlym works by competitively blocking one of the body’s receptors for cortisol with powerful results in many patients. As you may recall, Korlym was approved on its PDUFA date. Prior to Korlym’s approval, we took the steps we could within our financial needs to prepare for commercialization. These steps allowed us to make Korlym available to patients in April 2012 with both private and public insurers promptly covering the cost of the drug.

However, to conserve funds, we postponed building much of our commercial infrastructure and promotional capabilities until after Korlym’s approval. For instance, we did not begin hiring and trading medical science liaisons until late spring and summer of last year. When we learned that a significant number of patients suffering from Cushing’s syndrome are treated in non-academic centers by community endocrinologist. We’ve hired a team of experienced sales representatives now 18 in number, they began calling on doctors in the fourth quarter of 2012.

Our Phase 3 trial for Cushing’s syndrome let us to expect that our biggest challenge will be getting endocrinologist to write their first prescriptions for Korlym and then positive outcomes with their patients would lead them to write prescriptions for the second, third and fourth patients. This has been the case, our most powerful promotional tool is simple Korlym works.

Now I want to address briefly of Corcept’s two other strategic priorities. Our ongoing Phase 3 study of mifepristone for the treatment of psychotic depression and the development of our next-generation selective cortisol antagonists, as the names suggests, psychotic depression consists of major depression coupled with psychosis which means delusions and/or hallucinations. It is a severe episodic illness that flicks approximately 2 million to 3 million people in the United States. Patient suffering from that are 70 times more likely to commit suicide and those who do not have the disease. It is a severe illness. There is no FDA approved treatment.

Our current Phase 3 trials are investigating with a Korlym-administered a dose of 1,200 milligrams per day for seven days will lead to a rapid and sustained improvement in the psychotic symptoms of these patients. Our goal is to enroll sufficient patients by the end of this year to permit a successful interim analysis of the study with an NDA submission leading to an NDA filing shortly thereafter. I’d also like to update you on our progress in our drug discovery program. Evidenced in the scientific literature increasingly suggest that modulating cortisol activity may have utility in treating many diseases psychiatric, metabolic and oncologic. Specific diseases that are stayed at this point include posttraumatic stress disorder, early Alzheimer’s disease, alcoholism, breast and ovarian cancer.

We have produced more than 300 proprietary next generation selective GR-II antagonists. Drugs that blocked cortisol receptor that like Korlym potently block cortisol that do not block the progesterone receptor and therefore do not terminate pregnancy. If shown to be safe and effective, these molecules could be marketed for indications for which Korlym is not a yield. Although the outcome of this work is in the future, we hope our efforts will yield several new and important medications.

To sum up, we’re pleased to see how well patients taking Korlym are doing and with the number of physicians issuing prescriptions for Korlym continues to increase as a number of physicians issuing prescriptions for the second, third and fourth patients. Insurance coverage for Korlym has been prompt and universal. In addition and importantly, we are working to complete our Phase 3 trial of Korlym for psychotic depression and to advance to the clinic several of our next generation compounds.

I’ll be glad to stop here and answer any questions.

Question-and-Answer Session

Operator

Thank you. We will now begin the question-and-answer session. (Operator Instructions) And we have Kim Lee from Janney Capital on line with the question. Please go ahead.

Kim Lee - Janney Capital

Good afternoon. Thanks for taking the question. I jumped in a little late so excuse me if you had covered this, but as far as Korlym goes, can you give us some additional launch metrics that you are seeing so far such as a number of docs issuing prescriptions, how many repeat prescriptions are being written and then how many patients are on drug currently? Thank you.

Dr. Joseph Belanoff

Yeah, I am sorry, go ahead.

Kim Lee - Janney Capital

That’s it, thanks.

Dr. Joseph Belanoff

That’s it. The categories that you have mentioned we have not disclosed at this point. And I think it’s important for people to understand that we really do consider each of this metrics as we go forward. And at the point in time we feel we can present that information in a way to help people understand what’s going to happen prospectively we’ll do so. So, that’s an analysis we will do every quarter, but to-date we have not revealed those specific categories and numbers.

Kim Lee - Janney Capital

Okay. And it’s been I guess a little over a year since Korlym was launched and what point in time would you feel comfortable getting that information to us?

Dr. Joseph Belanoff

I think the point in time we will be comfortable as I said is when we feel like it can be used in a way to more accurately predict what’s going to happen in front of that as it goes forward and I think we’re not at that point yet but we look at that each quarter.

Kim Lee - Janney Capital

Okay. Thanks for that clarity. And one other question, how are you seeing the success of competition on Korlym sales?

Dr. Joseph Belanoff

I think that you probably just for the audience referring to Signifor is that what you’re talking about?

Kim Lee - Janney Capital

Yes.

Dr. Joseph Belanoff

Okay. So, for those of you who are unfamiliar with it, Signifor is a drug the Novartis has now released for the treatment of Cushing’s disease which is a subset of Cushing syndrome. It’s a twice a day injectable drug that is used for ACTH-producing tumors, which again is a subset of those tumors that are seen in Cushing’s syndrome. We actually don’t have very much information about it at all. It’s been very hard to figure out publicly kind of where they are. And frankly I think sometimes the analyst on the call have a better ability to gauge where they are than we do. But it’s a medication with a very different mechanism of action, a very different mode of delivery and very different profile on its clinical trials than Korlym.

Kim Lee - Janney Capital

Thanks.

Operator

And we have Charles Duncan from Piper Jaffray on line with question. Please go ahead.

Roy Buchanan - Piper Jaffray

Hi guys. This is Roy in for Charles. Thanks for taking my question.

Dr. Joseph Belanoff

Hi Roy.

Roy Buchanan - Piper Jaffray

Couple of quick ones, hi. I guess do you characterize maybe the biggest challenge that you guys are having has it been IDing patients or is it educating the physicians into the paradigm that you’re using to treat that disease?

Dr. Joseph Belanoff

Thanks Roy. I would like to use it clearly to address for those questions it’s sort of what’s going on in the quarter. In many respects we don’t really have any earth shaking milestones this quarter. It was really just a quarter of hard work. But your questions really helped me address the few of things that we’ve been working so hard on. One other things that I think we really got a much better handle on it as the quarter progressed was where the patients are. And as I said in my introductory comments I think that our finding really have shifted from what we had initially thought that these patients who are mainly at academic centers they are fact or not mainly at academic centers when their surgery that’s done as often at academic centers, but then when they return to the community and their surgery in fact unfortunately fails they begin treated by community endocrinologists of an interesting Cushing’s syndrome. The important really point there is that targeting the patients and targeting the doctors that treat those patients is something that we made great progress on during the quarter. Those results don’t necessarily show up instantly, but I think will show up over time as we go forward. So, I think that’s one important thing.

The other thing is that our marketing researchers really told us that there are many physicians who really did not fully understand or completely understand the mechanism of action of the drug and even our clinical results. And what we really worked hard in the quarter to do is to figure out how to explain that story in a way which resonates with those physicians and it’s clear. And I think we made a lot of progress in doing that as well. I think that’s a very long, very important long run benefit that they are needed to happen for us to really maximize our outcome. So, I think that Roy really it comes from two – I think those were two different challenges we’re identifying the doctors and the patients where they were and really making sure the people understood the medicine, because I think what’s interesting is we now have a coterie of physicians who are in fact writing second, third and fourth prescriptions for the drug, but it’s a relatively limited group, relative with what we think that can be and essentially getting to those other physicians and getting them into that group I think is really our challenge over the remainder of the year.

Roy Buchanan - Piper Jaffray

My next question I guess how long do you think it will take you to reach those physicians or the majority of those physicians…?

Dr. Joseph Belanoff

Well, it’s really one physician in one day at a time and I think that we do it in a variety of different forms mainly it’s really shoe leather and knocking on doors and explaining to doctors exactly where our results are and how the medicine works. But there are larger group events as you may know there is the Endocrine Society meeting is coming up in June is a good way to capture people. There are tension after doctors and there are tension just this week, there is a meeting that’s we did the ACE meeting we have a group of our people down there. So, really is sort of I hate to use kind of hold expression by the 24/7 activity and making sure that we get this medication on two patients and we get their doctors to understand it how it works in order to do so.

Roy Buchanan - Piper Jaffray

Okay, thank you.

Dr. Joseph Belanoff

Sure.

Operator

Now, we have (Boris Parker) from Oppenheimer online with a question. Please go ahead.

Dr. Joseph Belanoff

Are you related to Boris Peaker?

Unidentified Analyst

Yeah, it’s very close.

Dr. Joseph Belanoff

Okay.

Unidentified Analyst

Thank you, Joe. So, my question is going back to Korlym, you haven’t mentioned on European strategy, could you give us an update there any developments?

Dr. Joseph Belanoff

Yeah, I would like to actually turn this question over. We didn’t introduce them before, but my partner, Bob Roe, President and he runs all development is also in the room, and he is specifically working on that project among others, so Bob?

Bob Roe

Yeah, thanks very much. So, we are pursuing registration in Europe. And as many of you probably know, it’s somewhat more sequential and complicated process than it is in the U.S. And so we have finished developing the pediatric investigational plan. We have had one round of review with the regulatory authorities in Europe. And it’s back with them. We expect that to be approved in June and that’s a step essential before we put together and make the actual submission, which we plan to do in the fall.

Dr. Joseph Belanoff

And Boris in terms of I take your question also encompass commercial activities, there is really several developments in that area, one as you know, this is a orphan market, and one where our company of our size really can consider going alone. We also on the other hand have entertained bids for partnership in Europe and continued to do so and have not yet made a decision as to which way we will go there. We are also investigating new patients use in the interim in Europe.

Unidentified Analyst

Now, you are learning more about that sales dynamics in United States and you just alluded to more patients seeing outside of the academic centers, let’s say, than you previously thought. What did you know about the – under treatment dynamics in Europe for this indication, how different or how similar would it be to the U.S.?

Dr. Joseph Belanoff

It’s interesting. I think that in Europe, it genuinely is a disease, Cushing’s syndrome is a disease treated at academic center, because there are central, national health systems really funnel patients to specific places. For instance, in the Netherlands, there is really two centers, which three all the patients. Now, in terms of how the treatment is used, it actually does differ from country to country, for instance, just as an example. In England – in the United States, just to put it at one end on surgery, which I think most of us believe is the optimum first choice for many patients. It’s usually done relatively quickly, whereas in England sometimes it’s delayed over a longer period of time and piece of patients are kind of maintained before surgery takes place. But I think as a general statement, what I would say, is that the market there, physician market will turn out to be more concentrated than it has been in the United States, because their systems really mandate that to be the case.

Unidentified Analyst

Okay, well thank you very much for taking my questions.

Dr. Joseph Belanoff

Thank you, Boris.

Operator

And we have Ravi Mehrotra from Credit Suisse on line with a question. Please go ahead.

Koon Ching - Credit Suisse

Hi, thanks.

Dr. Joseph Belanoff

Hi, Ravi.

Koon Ching - Credit Suisse

Hi, this is actually Koon asking a question on behalf of Ravi.

Dr. Joseph Belanoff

Okay, good.

Koon Ching - Credit Suisse

I just wondered you give me any color on whether how physicians are using column in terms of whether they are using it to treat for the whole disease or is it really just, they are really focused on the label, in particular, for glucose intolerance?

Dr. Joseph Belanoff

So, yes, I don’t want to make sure everyone understands the questions in order to really do that, it’s yet to understand this mechanism first disease and the mechanism of action of the drug. So, Cushing’s syndrome is truly a syndrome. It’s the issue is that cortisol, the hormone cortisol is in excess, and that (indiscernible) with all the tissues in the body have receptors for cortisol. So, when someone is sick with Cushing’s syndrome, they don’t have a single symptom, they have many symptoms. In fact in our clinical trial – in our pivotal clinical trial, which is now published, we actually measured 24 different symptoms throughout the body ranging from psychiatric to metabolic to dermatologic. So, many, many things can go on as Cushing’s syndrome goes on. Cortisol, as it goes everywhere and mifepristone goes everywhere in the body as well and it actually has a relatively simple mechanism of action and blocked one of the recepetors for cortisol, an important one in controlling the disease state.

So, now to your question, yes, the labels for patients who have glucose intolerance or diabetes, but it also in our label points up that other symptoms should be observed as the patient is treated with the drug, because they tend to improve over a timescale. For instance, glucose intolerance and psychiatric symptoms improved quickly. Body shape and weight gain improved over time. And those are things that need to be modulated as the treatment goes on. So, I think again I can’t speak, the physicians, you will have to speak to them directly, but the feedback we certainly receive is they understand the full mechanism of action of the drug and the full symptomatology of the illness and their expectation is that it will treat Cushing’s syndrome, a symptom that exist in addition to simply glucose intolerance.

Koon Ching - Credit Suisse

Thank you.

Operator

And we have Annabel Samimy from Stifel on line with question. Please go ahead.

Annabel Samimy - Stifel

Hi, thanks for taking my question. I just wanted to go back to one of the things that you are mentioning how a lot of the patients turns out, it’s there in the community setting. So, I guess to that point, is the size and sales and structure that you have right now with the 10 medical liaisons, and I guess you have an additional number of sales reps, is that enough to reach these community physicians and how are you going to get the message out there to get patients on drug and find the patients for that matter?

Dr. Joseph Belanoff

Yeah. So, again, the question is do we have broader enough coverage with the people we have right now. And the answer is that’s really still a work in progress. I think the answer to that might be yes, or I think the answer might be that we may end up meeting a few more. But one of the things and it’s sort of the wonder of being able to get diagnostic information in a terrific guy – we have a terrific analyst who is able to look at kind of what patients are treated and where they are treated. We now have a much better sense in fact of where the individual patients are and who are their doctors. And we feel that with modern transportation, we can’t get to those patients with the people that we have on board. Now, I can’t promise you that, that won’t mean that we won’t have another 10 sales reps if we feel like that, our sales reps are fully occupied and we need more. It’s really – this is a high profit margin business. It’s really a simple thing for us to do. So, that’s really an evaluation that we do on an ongoing basis, but at this moment in time, we feel pretty equipped to handle the demand of where we see it.

Annabel Samimy - Stifel

Okay. Is it worse thinking of any kind of broader partnership with someone to be able to reach those patients more rapidly?

Dr. Joseph Belanoff

In the United States, we really think we can handle this efficiently by ourselves, and I think we had really generated the information in the last quarter to push its flow on that direction.

Annabel Samimy - Stifel

Okay. And then I guess separately in terms of the treating physicians, you must have had a dialogue with them already in terms of how their patients are responding. So, what is the feedback that you are getting from those physicians and are those physicians communicating at all to their communities to their physician community regarding that they are seeing and are using any of them as keep thought leaders for sales or marketing efforts?

Dr. Joseph Belanoff

Well, I have to say that’s part of my job. You said the patients who are – have been treated commercially have done just as well as the patients who are in the studies, and patients from the studies as you know did very well. So, that’s really been gratifying to see. Now, I think we really do have a base of people right now, base of prescribers and had actually within the last, I think four weeks brought together our first speakers bureau meeting for doctors who are interested in fact going out and addressing that colleagues, and that is something that’s going to happen over the remainder of the year. And again, I will just point you to something that I said before. We have a group of most important satisfied patients, but also of course satisfied doctors. It is not the group that we hope to have a year from now. We hope that we are building much larger and we think we know where those doctors are and we hope that the doctor to doctor communication that we are going to foster will be a good way to get there.

Annabel Samimy - Stifel

Okay, great, thank you.

Operator

And we have (indiscernible) online with a question from Bank of America. Please go ahead.

Unidentified Analyst

Hi, thanks for taking my question, I’m on for Steve Burns. I just wanted to ask regarding some trends that you noted in the last call, specifically you have mentioned that the patients that were up titrating have been slower than what you had seen on Phase 3, is that still the case and if those or anything else that you heard about has been different from history?

Dr. Joseph Belanoff

I can’t actually speak of that, because that has changed a bit since the last call. Yes, we are now finding as change the distance from the last call. We’re not finding as the patients who are on the medicine and I think this is some expectation took them five to six months as opposed to 2.5 or 3 months that they have been in the study now are getting to the doses that we saw in the clinical trial get those – I have actually looked at those lines recently and they are now beginning to cross. So, I think it really was just the question of time and understanding when I think that will happen as – I know I can say with more confidence that’s likely to happen over time.

Unidentified Analyst

And would you have any idea of how long that would be is this going to be kind of an extended process?

Dr. Joseph Belanoff

Well, I think two points, one I think the titration rate is slower than it was in the clinical trial and part of that is just that endocrinologist do an active practice don’t see their patients as often as patients in clinical trial. So, I think that’s really a portion of it. And I think you should also question on you guys again also very good at the math understand that at the beginning of treatment dose is lower and so the patients in some sense that you had at the beginning or always pulling that number down, but I think remember at this time, it has utility to assets in the company is that when you have a patient on the medicine for the fifth or sixth refill of their dose at that point and that’s what I can tell you really is now approaching the business that we have in the clinical trial.

Unidentified Analyst

Okay another comment that we got from a few of the specialists that we spoke with before was that maybe some challenge system during the mechanism of Korlym to assesses directly with the impact it has on cortisol levels. Have you noted that has there – sales force noted that to be the case from doctors that has used the drug so far?

Dr. Joseph Belanoff

Well, it’s definitely true for doctors who haven’t used the medicine so far because I think that everyone kind of knows this well knows that one of the ways to figure out the progress of the patients and how they are doing with the medicine it’s not possible is their actual cortisol level. As one of our investigator said during the meeting for the trial doctors to actually use this medicine you have to be real doctor, you have to measure things like blood glucose and blood pressure and clinical symptoms and I have to say for some of you who know me better as a psychiatrist that’s about all we have. We don’t have blood test for things so that’s actually something we are quite used to. For endocrinologists it actually takes initially a little bit of only to say that they can do it, what’s encouraging is that once they do it a single time they really do recognize that they can do it going forward. And as I said its really getting the people to that single time use and they will understand that this is a medication that they can manage, but I think it makes all the difference. So, yes, it is a real point, it’s something that we address on a regular basis and I think that is the difference between zero and one for many doctors.

Unidentified Analyst

Okay and the last question I have is can you give us an idea when we might be able to see some data for your early stage data – sorry for your early stage pipeline?

Dr. Joseph Belanoff

Yeah, I think that we on this, yes. So, just to begin backup so everyone understands what you are talking about and this is really a promising, promising area for Corcept and perhaps to understand because it is there already we don’t get much credit for that. We have a variety of specific cortisol antagonists and these are compounds which are not board of fashion don’t block progesterone which are in early stages. And one other things again it was sort of hard working quarter without lot of visible milestones, what we are really working to do is to get those compounds a lead edge of those compounds into the clinic and then into eventually patients where we can see it. Now these compounds are in their early stages of testing and we’re not going to emphasize results on that until we really know exactly which disease we are going to take them in and so forth we are really characterizing, but the other part characterizing this medication. But I think it is interesting that we have taken a strategy of supporting the work many different academic investigators. I think we have 28 different collaborations at this point.

And as a recovering academic myself one of the things that we actually acquire from those groups is that they publish that information and they can. And so just as an example one of our lead compounds called CORT 108297, we don’t have the fancier name for it yet, very interesting article was written and published last week in the proceedings of the National Academy of Science, the PNAS journal and I suggest that if you are interested in it access that journal, but my point really is that sort of information is going to emerge on a continual basis has emerged over the last year will continue to emerge over the year. And as we have meaningful information as to where these compounds kind of go in clinical development as we begin to treat patients, we will also give out that information.

Unidentified Analyst

Okay. Thank you.

Dr. Joseph Belanoff

Thank you.

Dr. Joseph Belanoff

Yeah, it looks like we have gone through our questions. So, I just wanted to say thank you for everyone who has attended. And we will be talking to you next quarter and if anything interesting happens in the interim.

Operator

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

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