Corcept Therapeutics Inc (CORT) 2015 Q4 法說會逐字稿

Welcome to the Corcept Therapeutics conference call. My name is Anna, and I'll be your operator for today's call.

(Operator Instructions)

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 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-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 contributions of our sales organization; the cost and timing of pre-clinical 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 statement made during this call.

Now I will review our preliminary financial results. Corcept's net revenue in the fourth quarter was $15 million compared to $9 million in the fourth quarter of 2014, a 66% increase. For the full year, revenue was $50.3 million compared to $26.6 million in 2014, an 89% increase. We expect growth to continue, with full-year 2016 revenue of between $76 million and $81 million.

In the fourth quarter, Corcept earned its first GAAP profit. Preliminary GAAP net income for the fourth quarter of 2015 was $0.01 per share compared to a loss of $0.04 per share in the fourth quarter of 2014. For the full year, the Company's GAAP net loss was $0.06 per share compared to a GAAP net loss of $0.31 per share in 2014.

It is important to note that our 2015 audit is ongoing, and our figures for 2015 our preliminary. Our complete and final financial results will be available when we file our annual report on Form 10-K with the SEC.

Our cash balance at year end was $40.4 million compared to $36.5 million at the end of the third quarter. The $4 million increase in our cash balance is after the payment of $2.8 million in principle and interest under our capped royalty financing arrangements. We expect to make our final payment under that obligation in 2017.

As we have said in past calls, based on our current plans, 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, and if that study produces positive results, conducting a Phase 3 study, conducting Phase 2 studies in both Cushing's syndrome and solid tumor cancers with our proprietary compound CORT125134, advancing to the clinic at least two more of our next-generation compounds, and repaying the balance of our capped royalty financing obligation, we believe revenue from our Cushing's syndrome business, together with our cash on hand, will be sufficient to fund our expected activities.

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

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 castration-resistant prostate cancer; psychiatric indications, such as post-traumatic stress disorder, and alcohol and cocaine dependence; metabolic diseases, such as anti-psychotic-induced weight gain and non-alcoholic 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 treatment.

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 are also about to begin a Phase 2 study of CORT125134 to treat patients with Cushing's 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 a large library of next-generation cortisol modulators. CORT125134 is our lead next-generation compound, but others are progressing towards the clinic. One of them, CORT118335, has shown promise in animal models of fatty liver disease and other metabolic disorders. Another, CORT122928, appears to be active in animal models of alcohol withdrawal.

I've mentioned a third compound, CORT125281, on past calls. It is a candidate for treating certain solid-tumor cancers, such as castration-resistant prostate cancer, ovarian cancer, and triple-negative breast cancer. As these compounds undergo pre-clinical testing, we will be looking to the results of our own research and that of our academic collaborators to pick their optimum therapeutic targets.

Before I give more detail about our key programs, I want to pause for a moment to note that Corcept recently achieved an important financial result. In the fourth quarter of 2015, we earned our first GAAP profit. We plan to invest a substantial portion of our increasing revenue, continuing the development of proprietary selective cortisol modulators.

While our financial results will vary a bit from quarter to quarter, we have become, and expect to remain, a fundamentally self-funding business. Our Cushing's syndrome franchise now supports our entire Business, even as we expand our development activities and retire our royalty debt, which we expect to extinguish completely in 2017.

I'll briefly review our key programs, then stop to answer your questions. As I've mentioned, our sales of Korlym grew substantially in 2015, and we are expecting significant growth in 2016. But I do not want the focus on our recent results and our near-term forecast to cause us to lose sight of the long-term potential of the Cushing's syndrome market.

We added new prescribers and new patients in the fourth quarter of 2015, just as we have in every quarter since Korlym's launch. Nonetheless, the vast majority of the 10,000 or more patients who could benefit from Korlym have yet to use the drug. We believe Korlym has many years of growth ahead of it.

Korlym is a very effective treatment. This has always been its most important quality, both as a medication and as a commercial product. But the mere fact of its efficacy is not sufficient to get Korlym to every patient it could help.

Endocrinologists are particularly busy clinicians, and conservative prescribers of new treatments. It can take as many as seven visits from a Corcept clinical specialist before an endocrinologist who is not familiar with Korlym writes that first prescription.

After the prescription is written, both patient and physician often require significant support from Corcept's patient advocates, clinical specialists and medical science liaisons as they begin treatment and arrive at an appropriate dose. We have learned that there is predictability to this process, which has helped us fine-tune the support we offer. We have also learned that it takes time.

The clinical specialists we hired in 2015 have been doing the hard work of educating physicians about Korlym and the benefits cortisol modulation can provide their patients. We are just beginning to see their efforts result in new prescriptions. We expect all of our clinical specialists to contribute significantly to our growth this year.

The advancement of our lead next-generation cortisol modulator, CORT125134, to Phase 2 is an important step in the development of our Cushing's syndrome franchise. For all of its power as a treatment for Cushing's syndrome, Korlym has certain drawbacks, the chief being that it blocks the progesterone receptor, and terminates pregnancy. In some non-pregnant women, progesterone receptor blockade also causes endometrial thickening and irregular vaginal bleeding, non-life-threatening, manageable side effects, but ones that patients and their physicians would prefer to avoid.

Data from CORT125134's Phase 1 trial shows that it appears to share Korlym's ability to potently reverse the effects of excess cortisol activity, the essential quality in treating Cushing's syndrome. But unlike Korlym, CORT125134 does not act at the progesterone receptor, and should not cause the progesterone blocking side effects I've just described. For some patients, CORT125134 may prove to be even better than Korlym. The trial's first clinical sites are expected to open by the end of this quarter.

Before I discuss the particulars of our oncology program, I would like to explain why we believe cortisol modulation, whether using Korlym, CORT125134 or another of our next-generation compounds, may prove to be useful in treating certain types of cancer. In some cancers, such as triple-negative breast cancer, cortisol activity at the tumor's glucocorticoid receptors, GR for short, promotes tumor growth.

To simplify, after binding to the tumor's GR, cortisol stimulates genes which retards cellular apoptosis. Modulating cortisol's activities with a GR antagonist such as Korlym or one of our next-generation compounds should increase tumor apoptosis.

There is also another, more systemic mechanism at work. Cortisol suppresses the body's immune response. This is often beneficial, as it lessens the frequency of autoimmune diseases.

However, it is now clear that activating, not suppressing, the body's immune system is beneficial in fighting certain cancers. When a patient undergoes chemotherapy that is designed to promote apoptosis in tumor cells, cortisol's immunosuppressive anti-apoptotic effect is counterproductive. Modulating cortisol should help cancer patients' own immune system combat their disease.

Our research has shown that a large range of tumor types express GR and potential targets for cortisol modulation therapy, among them triple-negative breast cancer, ovarian, prostate and pancreatic cancer, as well as melanoma. As many of you know, we are conducting our own oncologic clinical trials, and closely monitoring the work of our academic collaborators.

In December at the San Antonio breast cancer symposium, we presented preliminary efficacy results from our Phase 1/2 trial of Korlym in combination with the drug, eribulin, to treat metastatic triple-negative breast cancer. As a reminder, eribulin is the generic name for Eisai's drug, Halaven. Enrollment in this portion of the trial is ongoing, and will eventually total 20 women, each of whom will receive 300 mg of Korlym every day, and 1.1 mg per meter squared of Halaven on a 21-day cycle.

Patients with triple-negative breast cancer have tumors that do not express the three receptors -- estrogen, progesterone and HER2 -- to which medications like tamoxifen or Herceptin bind, which means that these medications cannot treat their disease. The great majority of triple-negative breast cancer tumors do, however, express GR, the receptor to which cortisol binds.

40,000 women in the United States are diagnosed with this disease every year. There is no FDA-approved treatment, and patients with metastatic disease have a dire course.

In December, we presented preliminary efficacy data for 13 patients. These results were encouraging, and we look forward to completing the trial.

By the end of the first quarter, we plan to open the first clinical sites in a Phase 1/2 trial of CORT125134 in combination with chemotherapy to treat solid-tumor cancers. The trial's design will be similar to our current Phase 1/2 trial, with an initial dose-binding portion, followed by an expansion cohort in one or more cancers, testing the efficacy of the recommended dose. Another of our compounds, CORT125281, is a candidate treatment for a number of cancers, including castration-resistant prostate cancer, triple-negative breast cancer and ovarian cancer, and is now being tested in pre-IND toxicology studies.

I want to close with a brief discussion of Corcept's portfolio of more than 300 next-generation compounds. We and our academic collaborators have explored the possible use of these novel molecules in a wide range of indications besides Cushing's syndrome and oncology, including non-alcoholic fatty liver disease, anti-psychotic-induced weight gain, alcohol and cocaine dependence, ALS and Alzheimer's disease.

An important fact is that these compounds are all cortisol modulators, and none are selective -- non are active at the progesterone receptor, but they behave differently from one another in important respects. Some appear to be tissue-specific, for instance. This variability should allow us to develop different compounds for different indications. For instance, CORT118335 appears particularly active in fatty liver disease, an illness suffered by millions of Americans, but not as active as CORT125134 in Cushing's syndrome, a disease with widely disseminated symptoms.

2016 should be a year of substantial advancement for our next-generation cortisol modulators. We are about to start two Phase 2 trials with CORT125134. CORT125281, CORT118335 and CORT122928 are all in pre-IND testing. We hope to have them in human testing early next year.

To sum up, our Cushing's syndrome business grew 89% last year, and we expect significant growth in 2016 and beyond. We earned our first GAAP profit in the fourth quarter, and are confident that our cash flow, together with our cash reserves, will be sufficient to fund our planned activities, including repayment of our royalty obligation, without having to raise additional funds.

Our lead next-generation compound, CORT125134, will enter Phase 2 study for the treatment of patients with Cushing's syndrome at the end of this quarter. Preliminary pre-clinical and clinical data suggest that this compound may offer patients the benefits of cortisol modulation, as Korlym does, but without the side effects associated with Korlym's activity at the progesterone receptor.

Our oncology program also continues to advance. Preliminary efficacy results in our Phase 1/2 trial of Korlym to treat triple-negative breast cancer show promise. We look forward to sharing additional results at the ASCO conference in June.

CORT125134 will begin its own Phase 1/2 trial for patients with solid-tumor cancers by the end of this quarter. Our next-generation compounds continue their development, and we hope to advance one or more of them to the clinic by this time next year.

I'll stop here and answer any questions.

(Operator Instructions)

Charles Duncan, Piper Jaffray.

This is Sarah Weber on for Charles. Congrats on a strong quarter. My first question is, is there anything strategic about the site selection for the Cushing's trial of 134 and could you see that trail helping to raise awareness of the mechanism in Cushing's?

Sarah, nice to hear from you and thank you for the question. I just want to repeat it. The question was site selection for CORT125134 Cushing's syndrome study.

That was a very important question because I think it's really worth knowing while we will have some sites of in the United States, including, for example, the NIH, we will also have multiple sites in Europe for this particular trial. I think that will really help awareness of therapeutic modality of GR modulation or Cushing's syndrome in that group.

As you know, mifepristoned Korlym is approved in the United States and we hope to have CORT125 approved in a worldwide setting. So yes, in fact, site selection is very consequential and thank you for letting me address it.

Great.

Roy Buchanan, Janney Montgomery.

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

I'd like to just -- you have my colleagues sitting around the table I would like to now introduce you to Bob Fishman, who's our Chief Medical Officer. Bob, would you like to handle that question?

Yes, sure. 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 we will be looking at the trial at a variety of clinical parameters.

As before, we will focus on glucose control, blood pressure control. But yes, we hope by virtue of that evidence based to have a broader label and perhaps most importantly, because of the lack of effect on progesterone receptor, we would expect a label without the current black-box warning.

In short, we are 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 patient who could potentially use it.

Do these compounds have any impact on cortisol synthesis or are you looking for compounds that might have an impact on that?

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

Okay. Great. 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 may see data from that?

Your right. You've raised the key issue. It is an academic study being done at the University of Chicago and at that sort of arm's length, we don't have as full insight into the timetable but we know that study is really progressing and fingers crossed, we actually will see data within the next 12 months from that study.

Okay, great. One last question, I'll jump back into the queue. I had a question about the heterogeneity of GR expression in certain tumor types. 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 have used and it really started with, I think, really closely looking at what was done herceptin was that tumors that have greater than 10% expression of the GR receptor within them. There is variation. They run 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 has been the cutoff for our data. So greater than 10% expression within the tumor.

Great.

Christopher James, FBR Inc.

Good afternoon, guys. Thanks for taking my questions. Let me congratulate you on an excellent quarter and generating your first GAAP profitable quarter. Starting on Cushing's, could you provide a little bit of commentary around what you are 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'd like to -- Chris, thank you for the question. I would like to introduce our two senior commercial officers, Sean Maduck, who's here and Dave Penake. Sean, just for those who may meet him in the future, is responsible sort of broadly for patient acquisition and Dave for areas around patient retention. Dave, you'd like to handle this question?

Yes, thank you. Thank you, Joe. Christopher, thanks for the question. I think to start with, one thing we have talked about in the past is our average dose commercially was lower than what we had seen in the seismic study.

One of the things that we've taken into account try and manage that and improve that is we've implemented what we call retention programs here. What we are trying to do is follow every patient, help every patient, help make sure that the patient and physician are having the right discussions where they can find the optical benefit of the drug.

What that's led to is patients are on longer, more of our enrolled patients become chronic and when they do so it's because they are getting a very effective dose -- or a very effective treatment and a lot of that has to do dose. We have continued to see rising dose of 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 of where the seismic study landed would be appropriate.

The other thing I would 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 a maximum effect that they 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 were in the range of the seismic study. We think that is going to continue over time and those two things are really inexorably tied together, good retention is because of good dosing and good dosing causes good retention.

Got it. Remind me what that dose -- it was 750 mgs?

It was -- yes. And just really for the whole audience, the mean dose was about 750. The median dose was about 900.

Moving to the competitive landscape, one question we are getting a particular from investors is on a competitive drug COR-003. It's -- I think you are familiar with it, levoketoconazole. We are aware that levoketoconazole had some issues with LFTs. I guess maybe in broad strokes maybe give your thoughts on a similar agent and do you think it would have a different profile?

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. This was an underserved group for many, many years and it wasn't much to offer them at all. I am glad that perhaps we've been the ones who have sparked interest in treating this group. That in itself is a good thing.

You are correct. This really is a completely different mechanism of action. The drug that you are describing is a cortisol synthesis inhibitor. It basically lowers the level of cortisol generally. That is a very different mechanism than Korlym or of any of our follow-on compounds which modulate activity at the endpoint, at the receptor.

I guess maybe an analogy to draw from it is basically that cortisol synthesis inhibitors 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.

I'm very anxious to see everyone else's data as it comes out. 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 having now passed through phase 1 and entering phase 2 has an opportunity to really show the same mechanism and potentially actually take away one of the side effects of Korlym that has kept probably some patients from using it.

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

Chris, the first and most thing I can tell you is that we will present all the data we can at ASCO. It's our expectation that the study is going to be over about midyear and I don't know exactly when that's going to be. If it's not at ASCO it will be soon after and we will present all that we can.

You're hitting on something very important. Glad to inform the whole group which is that the feedback we have received from the regulatory agencies is that progression-free survival is the endpoint they would want to see for a pivotal study for approval and we, of course, are keeping track of that as we are going on. As you know, in the ASCO poster while patients were still active it was certainly something 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. It's very unfortunate. It really is a dire illness and frankly we feel like every month of progression-free survival is a month of close to overall survival because for many of these patients, unfortunately, the next place after our trial is hospice care.

I don't know exactly where that's going 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 is really going to be the acid test of whether we are showing an improvement. We feel optimistic about moving to a trial like that, but we really have to analyze all our results we are currently going to see before we make the decisions to exactly what's going to happen after that.

Boris Peaker, Cowen.

I would want to add my congratulations to the excellent results.

Thank you, Boris. It's good to hear from you.

I just want to follow more on Chris's question in terms of the breast cancer study. Specifically, were these patients selected for GR receptors and was any correlation of response in GR receptor expression?

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 -- whose tumors were GR positive and some whose were not.

The responders in their small study clearly showed that the GR positive patients were the responders and 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. Is there a correlation, is there different levels of GR expression that you could look at correlation to efficacy or is it just binary yes or no?

We are starting with the binary criteria of greater than 10% of the tumors have to be GR positive. You're asking a prescient question. That is data we will look at as we get results from this study. I don't have a result for it yet.

I can tell you that in University of Chicago study, there was a patient, for instance, was less than 10% was not a responder in the greatest responders were across the board. They did not necessarily have the highest degree of GR density.

Got you. When looking at the solid tumors that you plan to pursue with your second-generation molecule, I guess, are you also going to be screening for GR receptors as an enrollment criteria and that's just going to be kind of the standard going forward?

Initially, I think in the dose finding portion will take all comers but observe what the GR status is. I think going forward, it's highly likely we will use GR positivity as a criteria.

Keep in mind one thing, which is interesting and we have 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. In the literature it was estimated that maybe 25% to 30% of the tumors were in fact GR positive.

We have now done by far the largest tumor bank screening and the GR positivity rate is much higher than that, certainly above 80% and I can tell you in our clinical trials so far I think it's 100%. For triple-negative breast cancer at least, it looks as if it matches up. For other cancers, I do think that GR positivity is going to be an entry criteria.

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

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

Got you. Okay. Thank you very much for the details and we look forward to the additional --

Glad to speak with you, Boris. Please keep us in mind with any other questions.

[Alan Leong from Senior Analyst]

I have two sets of questions. There's was an earlier person who asked about the prostate cancer trial at the University of Chicago. I wonder if you could do the same except with the -- see if you have any commentary on the breast and ovarian cancer trial as well.

There's a non-University of Chicago trial with lung cancer, as I understand it. Comment on whatever milestones but also the importance of these trials to your overall clinical program.

Let me sort that out for all the listeners. I think a really a unique thing about Corcept is that really from the beginning, we thought that academic collaborations were very, very important part of our plan. Sort of joke and said at the beginning, we really had a lot more ideas than money but we really wanted to keep our research going.

We extensively collaborated over a period of years. At any given point in time, we probably have 30 different academic collaborations going on in the United States and abroad. It really stands as a very nice -- to use a sports analogy, farm system, the kind of programs we went to eventually bring in house.

At University of Chicago -- now to your question, there are more than one oncology study going on with mifepristone with Korlym. One is in castrate-resistant prostate cancer. Another one is in triple-negative breast cancer and ovarian cancer. In some sense they are in similar places. They've enrolled a fair number patients at this point. They are not complete but I get the progress report every week and progress is being made.

I can't give you a specific read-out date at this point but I can tell you these our passion investigators who have actually originated the science and I know that their adjusted in putting out their results as soon as they feel they have gelled.

The last point you made was about non-small cell lung cancer. Yes, in the last, I guess, month a trial has opened with that disease at a site in Philadelphia. It is interesting trial because this investigator is using the drug as monotherapy. He has published some on this before we will see what his results are. But I know at least the patient has entered that study.

I have a philosophical question. It's really for you and Charlie. You are trying to live within your means and you have this wonderful IP that can be applied to a number of different indications. If I look at 2016 and early 2017, a lot of the playing cards get turned over.

I wonder if you can provide kind of commentary or some color. On the one hand, you're living within your means, but on the other hand, even within cancer you have a number of direction you can forge ahead.

I think you raise an interesting question which is we are very pleased. Sean and Dave have run a great commercial business. It's really at this point it's funding everything that we do. We are budgeted for all the things we describe.

It is possible that a significant positive result could cause us to want to expand what we are currently doing and that would be a nice moment to have to deal with. We'll is have to -- as you said, a lot of cards get turned over in the next 12 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 are going to emerge as positive enough results for us to take forward, but we have many possibilities.

Thanks. I look forward to seeing you soon.

Good, Alan. Thank you.

Roy Buchanan, Janney Montgomery.

Just a couple quick follow ups. I had a question on future combo studies, if you had any plans with abraxane and/or checkpoint inhibitors, if you could comment on that?

First on the topic of checkpoint inhibitors, for sure that's an area of great interest to us and we can tell you 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 tumors, so that's an exciting update.

In terms of abraxane, yes, we are considering other possibilities. We noted, as 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.

Just let me elaborate one thing. Roy, of course checkpoint inhibitors have been for good reason in the press a great deal. Checkpoint inhibitors are a form of immunomodulation and promising. Very nice results.

GR antagonism is the core immunomodulation. It's your natural immune system. There's scientific reason to think that in combination this could be an effective strategy. The data will tell us what the data is going tell us but I 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 are hoping by the next time we have a conference call we will have early animal data to share with you.

Great. Okay, thanks. I had a question about I think you were completing a ketoconazole interaction study. Is that done? Is there any reason --

It is done.

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

The answer to the question is, there's really is no reason to combine the two treatments and it's an important kind of medical expiration. There's really no amount of the cortisol activity which can't be modulated by Korlym.

I can tell you the doses vary a great deal. There people with more modest Cushing's syndrome -- no Cushing syndrome is good, who require a lower dose and people with more severe Cushing's syndrome, which require a much higher dose, but all of those forms of the disease can be modulated with Korlym.

So there really is no additive value of using a drug like ketoconazole with Korlym. The answer to your second question, no, we are not seeing people use them together.

Okay, great. Thank you, guys.

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.