Corcept Therapeutics Incorporated
Q3 2016 Earnings Call Transcript

Published: 2 Nov 2016

[Operator:]

Welcome to the Corcept Therapeutics Conference Call. My name is Nathan 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'll now turn the call over to CFO, Charlie Robb. You may begin.

[Charlie Robb:]

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 third quarter 2016 financial results, and then for an adjustment of our 2016 revenue guidance and a 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-Q with the SEC. Today's call is being recorded. A replay will be available through August 15th, at 888-843-7419 from the United States and 630-652-3042 internationally. The passcode will be 43632675. This information is also contained in our press release. 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 anticipated contributions of our sales organization, the cost, timing and results of preclinical and clinical trials, whether conducted by us or by independent investigators, the clinical attributes and advancement of our selective cortisol modulators, including CORT125134, CORT118335, CORT125281 and CORT122928, the protections afforded by Korlym's orphan drug designation for Cushing's syndrome or our other intellectual property rights, including the composition of matter patents covering our selective cortisol modulators and patents concerning the use of cortisol modulators to treat triple negative breast cancer, castration-resistant prostate cancer and other indications. These and other risks are set forth in our SEC filings, which are available at our website, or from the SEC's website. We disclaim any intention or duty to update any forward-looking statement made during this call. Now, I’ll review our third quarter financial results. Corcept’s net revenue in the third quarter of 2016 was $21.7 million compared to $13.3 million in the second quarter of - I’m sorry, in the third quarter of 2015, a 64% increase. We expect growth to continue with 2016 revenue of between $79 million and $82 million, which is an increase from our initial guidance range of $76 million to $81 million. In the third quarter, we recorded GAAP net income of $2.6 million or $0.02 per share, compared to a net loss of $600,000 in the third quarter of last year. Excluding non-cash expenses related to stock-based compensation and accreted interest on our capped royalty financing agreement, we generated non-GAAP net income of $4.9 million or $0.04 per share, compared to non-GAAP net income of $1.6 million or $0.02 a share in the third quarter of last year. A reconciliation of our GAAP and non-GAAP calculations of net income and net loss is contained in our press release and Form 10-Q. Our cash balance at quarter end increased to $47.9 million, up from $41.8 million at June 30, 2016. Our increase in cash is after payment of $4 million in principal and interest under our capped royalty financing arrangement. We expect to make our final payment under that obligation in 2017. As we have said in past calls, we believe revenue from our Cushing’s syndrome business together with our cash on hand will be sufficient to fund our planned activities, which include fully funding our Cushing's syndrome franchise, Completing our Phase 1/2 study of Korlym for the treatment of triple negative breast cancer, in combination with eribulin and if that produces sufficiently positive results, conducting a Phase 3 study, conducting Phase 2 studies of our proprietary selective cortisol modulator CORT125134 in both Cushing’s syndrome and solid tumor cancers, advancing to the clinic at least three more of our next generation cortisol modulators and repaying the balance of our capped royalty financing obligation. I will now turn the call over to Dr. Belanoff. Joe?

[Joseph Belanoff:]

Thank you Charlie and thank you all for joining us. I'll begin by reviewing the third quarter results of our Cushing’s syndrome franchise and then briefly discuss the development of our cortisol modulation platform. Our first product of cortisol modulator Korlym treats patients with endogenous Cushing’s syndrome, a serious disease caused by a tumor that produces either excess cortisol or ACTH, a hormone that causes the body to produce cortisol. It is a serious, sometimes lethal disorder. There are about 20,000 patients diagnosed with Cushing's syndrome in the United States, approximately half of whom have been cured by surgery. The rest are candidates for treatment with Korlym. Our Cushing's syndrome franchise has delivered another strong quarter. Revenue grew to $21.7 million, 64% more than in the third quarter of last year. We have increased our estimate of 2016 revenues to between $79 million and $82 million. As I’ve said on prior calls, we see no leveling off in this growth. There are many physicians who have not yet prescribed Korlym and there are many patients who could benefit from the medication, but have yet to receive it. As I’ve also noted on prior calls, our Cushing’s syndrome business continues to fund all of the company's activities, including our advancing development programs. In the third quarter, we earned a GAAP profit of $2.6 million. Excluding non-cash expenses, our profit on a non-GAAP basis was $4.9 million. Our cash balance rose as it has for the last five quarters. As Charlie mentioned, we do not need to raise funds or finance our current or planned activity to finance our current or planned activities. In a nutshell, we performed well in the third quarter for the same reason we performed well in the second quarter. The clinical specialists we hired mid-year last year have become productive - are becoming productive. The productivity of the clinical specialists we hired at the beginning of this year is beginning to be felt. I will add that we recently added several more top quality representatives who have just begun their training. We look forward to their contribution next year. Cushing’s syndrome is a complex rare disease. In addition to extensive training, even a highly skilled clinical specialist must spend significant time interacting with a physician, often, five to seven visits before that physician writes their first Korlym prescription. I also want to emphasize the importance of our support for physicians and patients and effort which is fundamental to our success. With a rare disorder such as Cushing’s syndrome, giving doctors and patients the information and logistical support they need to diagnose and treat the disease is essential. Since Korlym’s approval in 2012, we have invested heavily in developing the infrastructure and skills required to do this. Our staff of patient advocates for example work closely with patients and physicians to manage a wide range of issues. We make sure that physicians with questions about Korlym are able to consult if they request it, with both a skilled medical science liaison and often an experience Korlym prescriber. Our specialty pharmacy reimbursement specialists and operations teams make sure patients receive their prescribed medication and that insurance coverage issues, should any arise, are managed efficiently. We have a serious commitment to ensuring that our patients get the optimum care for their illness. Korlym is a very effective treatment for Cushing's syndrome, but it has the drawback of modulating activity of the progesterone receptor, abbreviated as PR as well as the cortisol receptor. In some women, Korlym’s affinity for PR causes endometrial thickening and irregular vaginal bleeding. These side effects are not life threatening and are manageable, but they are annoying and patients and physicians would prefer to avoid them. One of the key elements of our plan for protecting and expanding our Cushing's syndrome franchise is developing a next generation medication that modulates cortisol, but does not cause the side effects associated with Korlym’s affinity for PR. As many of you know, our lead proprietary molecule with these qualities, CORT125134, has entered Phase 2. Early preclinical and our Phase 1 clinical data showed that CORT125134, like Korlym, potently modulates the effects of cortisol, the essential quality in a treatment for Cushing's syndrome. Unlike Korlym, it does not bind to PR and so will not cause the side effects associated with PR activity. For these reasons, we believe CORT125134 may prove superior to Korlym for many patients. We expect to have results of this study by this time next year. I will now turn from Cushing’s syndrome to oncology. Before I discuss our program, let me briefly explain why cortisol modulation may prove to be an effective therapy for certain solid tumor cancers. In some cancers, such as triple negative breast, ovarian and pancreatic cancer, cortisol stimulates genes that retard apoptosis, the programmed cell death that many chemotherapies are meant to provoke. Preventing the stimulation of these apoptosis suppressing genes by adding a cortisol modulator to a chemotherapy regimen should allow the chemotherapeutic regimen to achieve its optimal effect. Cortisol modulation also appears to work through a second more systemic mechanism. As you know, there is much current interest in therapies that stimulate the body's immune system to fight cancer. Cortisol suppresses the immune system and the physiological and psychological stress of cancer and its treatment raise cortisol activity. Cortisol modulators may counter this effect, making immunotherapy more potent. In cancers that are particularly susceptible to the body's immune response, such as melanoma, cortisol modulation may be useful even without a companion agent. I will now summarize recent developments on our oncology program. We are concluding an open label trial of Korlym in combination with eribulin on to treat metastatic triple negative breast cancer. Eribulin is the generic name for e-sized drug, Halaven. Enrolment in the trial is complete and we expect to present final results at the San Antonio Breast Cancer Symposium this December. A few months ago, we presented encouraging preliminary data for this trial at the annual meeting of the American Society of Clinical Oncology. In particular, we noted that 5 of 22 patients achieved progression free survival, longer than the upper bound for progression free survival in a very similar population of patients receiving eribulin monotherapy as reported by Aogi et al in the annual oncology in 2012. We and our expert consultants already believe that the results of our open label trial merit study in a more controlled setting. We are gratified that investigators at the University of Chicago have initiated with funding provided by Celgene Corporation and Korlym provided by us, a 64-patient controlled multisite trial of Korlym in combination with Abraxane to treat patients with triple negative breast cancer. This trial would provide a definitive test of cortisol modulation’s efficacy in treating this serious disease. Korlym is also being studied to treat patients with castration resistant prostate cancer. Researchers at the University of Chicago are leading an 84-patient multicenter controlled study of Korlym in combination with enzalutamide, Astellas and soon to be Pfizer’s drug standing to treat patients with this serious disease. We are providing Korlym for the trial, which is being funded by the Prostate Cancer Foundation and the Department of Defense. In addition to the trials I have described utilizing Korlym, we've begun a trial of CORT125134 to treat patients with a range of solid tumor cancers. The first trial in this program combines 125134 with Abraxane. We are now enrolling patients in the trial’s dose finding portion. Once we determine the optimum dose of CORT125134 and Abraxane, we will open expansion cohorts of 20 patients to test efficacy and specific solid tumor cancers. Possible target indications include triple negative breast cancer, ovarian cancer, pancreatic cancer and sarcoma. We are also considering testing CORT125134 in combination with additional therapeutic agents, including checkpoint inhibitors and have begun animal testing to inform our next steps. I've spoken before of our large portfolio of proprietary selective cortisol modulators, all of which modulate cortisol and none of which affect progesterone. In addition to achieving this important fundamental medical benefit, these compounds also appear to have an important additional commercial value, because they are not entirely identical to each other. For example, CORT118335 has shown great promise as a treatment for fatty liver disease and anti-psychotic induced weight gain, but it is not particularly potent in models of Cushing's syndrome. Differences such as these will allow us to develop different medications for both relatively common disorders and orphan diseases such as Cushing’s syndrome. Currently, we are working to advance three more of these molecules, CORT118335, CORT122928 and CORT125281 and expect them to enter the clinic next year. In addition to my comments about CORT118335, let me briefly discuss CORT125281. Preclinical data suggests that CORT125281 potentially could be a potent part of the treatment regimen for castration resistant prostate cancer. We plan to advance CORT125281 to the clinic next year as a treatment for that indication in combination with enzalutamide. Our efforts complement those of investigators, led by the University of Chicago who, as I mentioned before, are studying Korlym in combination with enzalutamide to treat patients with this disease. Data from both trials will inform our future development decisions. To sum up, Corcept had a very good third quarter. Revenue from our Cushing’s syndrome business reached $21.7 million, a 64% increase from the same period last year. Cash generated by our Cushing’s syndrome business has and will continue to fully fund our planned development programs. Our cash balance increased. Our development programs are advancing. The Phase 2 trial of CORT125134, a compound which may offer Korlym’s benefits, but without some of its side effects, is now enrolling patients. Successful development of this proprietary compound will, in our view, significantly expand the Cushing’s syndrome market and extend our hold on it for years to come. Our oncology program broadened significantly with more growth planned for next year. We will present final results of our trial of Korlym combined with eribulin to treat patients with triple negative breast cancer this December. This trial’s promising preliminary results are being followed up by a Celgene financed multi-centric controlled study of Korlym and Abraxane. We're also enrolling patients in our own trial of CORT125134 in combination with Abraxane to treat solid tumor cancers and are investigating opportunities to broaden that program to include other companion therapeutic agents. Separately, a controlled multisite trial of Korlym in combination with Xtandi to treat patients with castration resistant prostate cancer has begun, led by University of Chicago investigators. We plan to begin our own Phase 1/2 trial of CORT125281 in combination with Xtandi in castration resistant prostate cancer soon. Finally, additional next generation cortisol modulator should enter the clinic early next year. We are particularly excited about CORT118335, which is extremely potent in treating fatty liver disease and anti-psychotic induced weight gain in animal models and we hope will produce similar results in human studies. Thank you. I'll stop here and answer questions.

[Operator:]

Thank you. [Operator Instructions] And our first question comes from Roy Buchanan. Roy, go ahead.

[Roy Buchanan:]

Hi. Thanks for taking the question. I just had a really quick one I guess on protecting the Cushing’s franchise and Joe, you kind of, I think, alluded to this at the end, but do you think 125134 is going to be sufficient to protect that? Korlym’s orphan exclusivity runs down in 2019, do you plan to extend that lifespan, can you envision a scenario where Korlym might be the better drug in Cushing versus the 125134, I know 125134 needs to be proven, but maybe just theorize on that? Thanks.

[Joseph Belanoff:]

Sure, Roy. Thank you for the question. I just really want to sort of broaden it, because I obviously, Roy, you know the story well, but I want to make sure all of our audience does. I think really important characteristics of our commercial program with Korlym include that it’s not just the pill that we provide, it’s not just the tablet we provide. We provide an extensive amount of support and we’ve spent a lot of time frankly with trial and error, really figuring out how to make that work well. Patients who sign up for what we call our SPARK program, who enroll in that and consent to it and that's really, most of the patients are put in regular contact at Corcept with nurses who we have here and payment specialists to really make sure their entire care is taken care of. Remember this is a chronically used drug and for patients to really get the optimum benefit which is very important. They really have to have their needs dealt with on an ongoing basis and often for a very long period of time. The second thing to really understand is that although the orphan indication for this drug doesn't back run out in 2019, we have intellectual property and our developing more intellectual property which I think highlight important characteristics of the use of the drug around things like how it's to be administered, how it's to be distributed and so forth, which I think actually are very important pieces of intellectual property which potentially extend the drugs exclusivity. But as you said and I really want to return to it by far the most important thing is that I think the CORT125134 now entering phase 2 is because of its lack of progesterone receptor antagonists and it's simply a better drug if it works. I think that many you are probably aware how Korlym to some people still carries the moniker of the abortion pill, this is the drug which used to be known as RU-486 and even aside from its political notoriety if progesterone receptor antagonist and portion of it really does prevent some patients and some doctors, some patients from using the drug and some doctors from prescribing it. Just an example, in one of trips east a few weeks ago I was visiting with a doctor in Connecticut who is very enamored with the drugs used it four patients, all men, and does not plan to use it for any women. Now there are doctors of course you do use it for women but the doctor Rod mentioned basically just doesn't want to deal with the potential progesterone receptor antagonist [indiscernible]. Not to your final question, I can tell you in the pre-clinical studies and the Phase 1 study, CORT125134 showed equal or greater potency in terms of cortisol modulation then Korlym. Obviously we're beginning the Phase 2 study; we don't know its results until we're done. But unlike most development programs including some of our own, we have I think a significantly higher degree of confidence based on what we've seen already that this drug will actually be a potent drug for Cushing's syndrome and it will eliminate the progesterone receptor activity certainly. I can tell you just as a point of example of how confident we are. We are anticipating having to do a Phase 3 study, we will of course talk to FDA after our Phase 2 study and that planning is already starting because we really don't want to waste a minute should we have to begin a Phase 3 program as our expectation.

[Roy Buchanan:]

And then a question, let's review that and quantify this, but do you have a sense of - do you have more patients by finding a physician who has patients and they don't maybe know what the patient has and discovered that they have Cushing or there are more patients coming on where the patient discovers that this drug is available through whatever means that make sense.

[Joseph Belanoff:]

Not sure exactly I know what you mean but I think we actually - I think that in many cases we have right now been treating patients who are already know to have Cushing's syndrome and their doctor has come to learn about our medications from a variety of different places and the doctor has treated. I think an interesting point that you're making though and it is an important one I think for many years to come because I think that as a viable medication like Korlym exist in the market there are more and more patients who are being screened for Cushing’s syndrome who openly I think can get to treatment.

[Operator:]

And our next question comes from Christopher James. Go ahead. Chris, are you on the line? Chris your phone might be muted. And our next question comes from Charles Duncan. Charles, go ahead.

[Charles Duncan:]

First of all congrats on a good quarter and for managing the issues around the August timeframe of last year. I have a couple of questions, one is on the second generation compound in terms of the study in Cushing’s disease, which is ongoing, what do anticipate to be the key point of value creation with regard to derisking and being able to compare that drug to Korlym, would it be the ongoing Phase 2 or would you have to wait until you get exposure out of Phase 3 to be able to really believe that you derisk that program?

[Joseph Belanoff:]

Well first, Charles, thanks for calling in and I can hear you loud and clear. I think I understand your question. It’s interesting, as you know I've been involved with drug development for quite a while at this point and I think that in many cases you really do have to see a definitive Phase 3 result before you can say for certain whether a drug works or not. And that's a portion of every program but I think what makes this program a little bit different is that really even starting from Phase 1 we could see this the pharmacodynamic effects of CORT125134 in human subjects as you would remember, Charles, we actually were able to give people prednisone which is essentially a synthetic cortisol and see if we can reverse its effects and Korlym of course does that and CORT125134 does that equally well. So we think we're in an unusual situation where I believe that if you know successful Phase 2 study. I think is really going to prove the concept in a very serious way and at that point in time and of course fingers crossed for ultimate results and sides and so forth. I think the point really will have been proven that this is in effect of cortisol modulator. I think we can already state that it does not - this drug does not antagonize the progesterone receptor and that portion is taken care of. So hopefully if our dose finding gets us to the right place, unlike most development programs we will have largely proved our concept of at the end of Phase 2

[Charles Duncan:]

That’s helpful kind of consistent with what we had anticipated as well. The other question I had is on Korlym specifically, what do you see as the biggest driver to growth in the quarter and it is possible that you would see that continue over the next year or so in terms of driving your guidance. Thanks.

[Joseph Belanoff:]

Thanks, Charles. I'm going to reintroduce you and our group to Sean Maduck who is our Senior Vice President, who runs all our commercial area I think we can - he just came in the room from his hard work on our commercial business and I think we can answer that question well.

[Sean Maduck:]

Charles thanks for the question. We've talked over the last few quarters of how we work to expand our field force and bring in top quality talent and then of course train them appropriately to be as effective as quickly as possible in the field. We on the last call announced that we had gone from 25 to 30 clinical specialists and that we expanded this quarter actually to two more. So we have 32 clinical specialists and we have five regions in place as well as a national sales sector in place that are really all helping to drive performance. I mean ultimately all of our clinical specialists are becoming more productive and more quickly in the field are engaging in lots of great conversations with physicians which is driving of more patients being diagnosed and then more patients being on product. Ultimately in terms of his growth continuing on I mean over the last many quarters we've seen new physicians and new multi-prescribers being added consistently quarter upon quarter, we have not seen a plateau of that. And as Joe announced in the notes at the beginning of the call, I mean ultimately we believe there are many physicians who have yet to prescribe Korlym and many patients who will be eligible to receive it. So we do believe that this growth will continue into the future.

[Joseph Belanoff:]

And really, Charles, I just want to kind of underscore that, we have both many new prescribers each quarter and we actually have many multiple prescribers who are single prescribers in the past, so the growth actually comes from both of those areas.

[Charles Duncan:]

A good high quality growth, Sarah is on the line, I’m wondering if she had any additional questions and I appreciate you taking my questions.

[Unidentified Analyst:]

I just had one more specific question about the dosing paradigm you're using in the Phase 2 study and 134 in Cushing’s. And if you could explain what the two different dosing arms and dose escalation paradigm it's designed to demonstrate? Thanks.

[Joseph Belanoff:]

Sure. Sarah thanks very much for the question. I'd like to again introduce our group to Bob Fishman who is our Chief Medical Officer, who I think can answer that question quite succinctly. Thanks.

[Bob Fishman:]

Sure. Thanks very much for the question. So just as a reminder this is - it's a Phase 2 open label study and we're examining six dose levels and the way we are doing that is that we have low and high dose groups with 15 patients per group and each patient gets to escalate twice during a 12-week treatment period. So therefore we will see the - we expect to see or our set up to detect a whole range of effects across the six dose levels. And beyond that we’ll hopefully be able to see the effects of dose escalation within individual patients, so we expect it to result in a very rich data set.

[Joseph Belanoff:]

Thanks Sarah, next question.

[Operator:]

And our next question comes from Chris James. Chris, go ahead.

[Chris James:]

Can you hear me now?

[Joseph Belanoff:]

Yes, can hear you well.

[Chris James:]

Thanks, sorry for the technical difficulties. So just I guess most of them have been answered at this point but just on 125281, Joe, what gives you - so what are the properties that give you confidence that this could be used in combination with enzalutamide in prostate, in castration resistant of prostate cancer. What are you seeing specifically that versus 125134 or even Korlym or mifepristone rather.

[Joseph Belanoff:]

Chris, I'm very glad to answer questions but just let me provide a little context for my answer. I think most of you and you Chris follow the company for a long period of time, know it was a real mission for us to see frankly that we could come up Korlym with our progesterone receptor antagonist I mean that was actually a real medicinal chemistry feat and we were very proud to have done it but what was very interesting about that is we began to test the next generation of compounds in a lab, first in cell culture and then in animal models, really prove that these compounds were not identical. As I've mentioned before in previous calls some were better at for instance creating insulin sensitivity. Some were better at creating weight loss, some got into the brain, some didn't get into the brain and we started to test them in the oncologic models, some were more potent than Mifepristone and some were less potent. That’s a long scientific explanation I think we have a pretty good handle on why that's happening but just take it as a given that that is in fact the case and it turns out that CORT125281 is particularly potent in the animal model of castration resistant prostate cancer. In fact we've now replicated that several times now. In truth you - the initial tests are actually with actual castration which is something which is more palatable I think for a rodent than it is for a person but ultimately I think we think it's a good representation of what's going to happen with enzalutamide and that actual animal testing is going on right now. So it's simply an empirical result Chris, it was not something we necessarily would have predicted beforehand but as we run all of our compounds to these various models, 125281 was a real standout in a castration resistant prostate cancer model.

[Operator:]

And our next question comes from Alan Leong, Alan go ahead.

[Alan Leong:]

I have a question from a little bit different area. You have a number of important clinical trials coming from and preclinical trials coming from independent investigators especially in alcohol withdrawal, metabolic disease like you’ve already outlined in cancer. And we have patient and waiting and almost seems like there is a bullish of trial completions on your results due to come in during the near term. Could you present a broad brush of what these trials look like and generally ballpark around their arrival?

[Joseph Belanoff:]

Yeah, Alan, thank you for your question, it really gives me an opportunity to talk about one of the things that I'm most proud of at Corcept, which is a different tack we've taken for a very long time. At the beginning of Corcept, we had more ideas than money but we thought this was a very important platform cortisol modulation in that it really might be appropriate to study it in many, many different disease states. So we took it, we really took a position I think somewhat different than many pharmaceutical companies that we would really collaborate extensively with academic researchers. At any given point in time, we probably have thirty different academic collaborations both in the United States and abroad to test cortisol modulation platform in a wide range of diseases ranging as you know you point out from psychiatric diseases like post-traumatic stress disorder or alcohol abuse to metabolic disorders like fatty liver disease even to an ophthalmologic disorder called central serous retinopathy. And you were also correct that these are investigator who run studies where we have donated our medication and our expertise for whatever that's worth but highly motivated academic investigators are really working on this project. And you're also correct that some of these important studies are now coming to a conclusion now. Again, I always have to give the caveat these are studies which are not in our hands and so we're a little bit at arm's length as to exactly when they will conclude. But just as an example, the post-traumatic stress disorder which is being run by the VA System led with investigators at the Bronx VA has now completed its enrolment and we expect to actually have results of that study within the next six months. So that's a good example of something which is going to come forward, very important disease, really good, you know reason why this would - why this form of treatment might actually be effective. Well obviously turn that card over and see where it is and it's pretty soon. Other diseases are marching along the same way as an example the ophthalmologic disease that I mentioned to you central serous retinopathy, we expect to conclude enrollment by the first quarter of next year and have results shortly after. So I tend not to emphasize these because they are a little distance from us in terms of time but we do keep score of all of them and I know Alan I've always appreciated that you particularly follow this because I really do think it's potentially an important part of our own development program. We really consider this tonight, might be, I hope not for Chicago fans the last night of the World Series but for baseball fans out there this is a very, very important farm system to us that allows us to bring us we did with the oncology programs very productive and positive programs that run in academic centers in-house for us to complete.

[Operator:]

And our next question comes from Tazeen Ahmad. Tazeen you may begin.

[Unidentified Analyst:]

Hi, guys this is Peter on for Tazeen, congrats on a good quarter and thanks to my question. So you indicated for 125134, you fully expect the Phase 3 trial. Does not mean that there's potential for the Phase 2 being a pivotal trial and what kind of results would you expect from the Phase 2 that might expedite an approval process. Thank you.

[Joseph Belanoff:]

I think, as I said I don't want to repeat my answer in full before but this is a clinical program where cross our fingers we have a high degree of confidence that this drug works the way we think it works. On the other hand, unlike when we brought Korlym forward when there was no drug approved for Cushing's syndrome we actually now have quite an effective drug available for Cushing’s syndrome. Now, of course as I talked about Korlym does have progesterone antagonist and it does have the notoriety as the abortion pill and I think that CORT125134, again fingers crossed is going to prove to be a significant advance beyond Korlym. On the other hand, I don't want any investors counting on sort of the minimal program to approval, although of course we will make our best case to the FDA. So I think you just have to sort of keep both of those things in mind at the same time is that we think this drug has great promise but we don't want anyone to really get ahead of their ourselves because we think that the fact that Korlym is in the market and works so well, it gives in some sense reduces the need for an immediate approval and so we'll just have to play that as it goes along.

[Unidentified Analyst:]

Well, thank you.

[Joseph Belanoff:]

Well thank you very much for all of your questions and really look forward to talking to you next quarter and really hope the rest of the year is very productive for you. Thanks.

[Operator:]

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