Earnings Labs

Corcept Therapeutics Incorporated (CORT)

Q2 2017 Earnings Call· Tue, Aug 1, 2017

$46.73

+1.10%

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Transcript

Operator

Operator

Welcome to the Corcept Therapeutics Conference. My name is Brandon and I will be your operator for today. At this time, all participants are in a listen-only mode. [Operator Instructions] Please note this conference is being recorded. And I will now turn it over to Charlie Robb. Charlie, you may begin.

Charlie Robb

Analyst

Good afternoon. My name is Charlie Robb. I am Corcept’s Chief Financial Officer. With 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 second quarter financial results, a corporate update and an upward revision of our 2017 revenue guidance. For 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. Today’s call is being recorded. A replay will be available through August 14 at 1888-843-7419 from the United States and 1630-652-3042 internationally. The pass code will be 45276605. Any statements made during this call that are not 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 financial results including our revenue guidance and expense estimates for 2017 and beyond, the anticipated contributions of our sales organization, the cost, timing and results of preclinical and clinical trials, including the trials of CORT125134 in Cushing’s syndrome and solid tumor cancers; CORT125281 in castration resistant prostate cancer; and CORT118335 for fatty liver disease and other disorders; the utility of our FKBP5 gene expression assay; the protections afforded by Korlym’s orphan drug designation for Cushing’s syndrome and 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 patients with Cushing’s syndrome, 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…

Joseph Belanoff

Analyst

Thank you, Charlie and thank you everyone on the phone for joining us. Corcept has never had a better quarter. Our revenue grew to $35.6 million, an increase of 80% from the second quarter of 2016 and 29% more than the first quarter of this year. We generated $12.6 million in GAAP net income. Excluding non-cash expenses, our non-GAAP net income was $16 million. Our cash and investments increased by $10.4 million even as our clinical development programs progressed and we paid down our royalty debt, which in July we retired completely. We have raised our 2017 revenue guidance to between $145 million and $155 million, an increase of $20 million. And we anticipate significant revenue growth in 2018, 2019 and beyond. At a superficial level, it’s easy to explain how we achieved these results. More doctors are writing the first prescriptions for Korlym and when the CLL, the medicine works writing second, third and fourth prescriptions, but I wanted to discuss the trends in medical practice that are driving this change in physician behavior. First and foremost, Korlym is effective. For almost all patients, Korlym works very well. In our pivotal trial, 87% of the patients as adjudicated by independent outside experts experienced significant clinical improvement. The positive outcomes of patients who have received Korlym since its commercial launch have been consistent with these clinical findings. Cortisol is the stress hormone. It’s secreted by the adrenal glands with a rhythm that is essential for health. It peaks just after we wake up and then falls through the day rising again just before dawn. Cushing’s syndrome is caused by a tumor that produces either excess cortisol, or ACTH, a hormone that causes the body to produce cortisol. Cortisol in patients with Cushing’s syndrome does not follow a healthy diurnal rhythm.…

Operator

Operator

Thank you. [Operator Instructions] And from Ladenburg Thalmann we have Christopher James. Please go ahead.

ChristopherJames

Analyst

Hi, Joe and Charlie. First congrats on the excellent execution this quarter. The increase is really impressive. Regarding mifepristone, could you help us maybe understand the drivers behind the surge in revenue? Is this a function of your sales force perhaps better education of endocrinologist and then maybe can you comment on the use that you are seeing in outside of Cushing’s patients, particularly in severe diabetic patients? Thanks.

Joseph Belanoff

Analyst

Yes, I am going to turn over the question – the bulk of your questions to Sean Maduck who runs our whole commercial area and our Korlym franchise. But I can answer your last question first we basically see very, very, very little use in anything except for Cushing’s syndrome. Sean, please go ahead.

Sean Maduck

Analyst

Thanks, Joe and thanks Chris for the question. I mean as Joe stated in the opening remarks, this really was organic growth driven by increased Korlym volume. We have 35 highly trained, highly skilled clinical sales specialists in the field that really are reaching more physicians on a daily basis. Because of that, there has been an increased testing as Joe referenced, which has really led to more patients being prescribed Korlym. And Korlym is a efficacious product and when physicians see the benefit that the drug has for their patients, they end up looking for more patients within their practice that could benefit. So ultimately, our first time prescribers become multi prescribers. Again ultimately, organic growth really we are seeing prescriptions from all over the country from all regions and for all patients across all geologies of Cushing’s syndrome. It really was a strong Q2 on a lot of different fronts and we don’t expect that growth to level off.

ChristopherJames

Analyst

Great. And then secondly, the CLIA-validated test, how do you plan to use this test commercially with either Korlym or second gen 125134?

Joseph Belanoff

Analyst

Chris, at this point, just the audience really understands entirely, we really are stood still figuring this out. I mean this is a very, very interesting area of science. As I said before, I think this is really an important understanding, pretty up to now, the measurements for cortisol have really had to do with the level of cortisol and bodily fluids, who cares what’s in your urine, what really matters is what’s going on at the cellular level where activity is really taking place. And our real hope for this assay is we can get a much closer measure of what’s actually going on which causes the symptoms of this really bad disease. Now, where we are really is still roughly a few steps beyond the beginning. We have really been able to validate the concept of normal people who are given prednisone and we are now in the process of testing people who actually have Cushing’s syndrome both before and after treatment. So we will see where that goes. Ultimately, where that goes commercially, we really can’t say at this point. We really are still figuring it out. It’s important to see what the science is and so forth. But I think at this point, our main focus is really getting the science right, because we think that if this really does come to pass, it’s not only breakthrough the Cushing’s syndrome, but provide some insight into how to provide a better way of diagnosis and treatment for all other endocrinologic diseases even things that Corcept itself is not working on.

ChristopherJames

Analyst

Got it. And then and finally, you pushed out the data for second gen to the first quarter, was this more about patient enrollment, what sort of was the logic behind that?

Joseph Belanoff

Analyst

I’d like to introduce the group, I think some of you know him, but maybe not all to Dr. Bob Fishman, who is our Chief Medical Officer and runs all of our clinical programs. Bob?

Bob Fishman

Analyst

Hi, Chris, Bob Fishman here. Thanks a lot for the questions. So yes, it is about enrollment and these are all academic sites and it took longer than expected for sites to open and get up and running and that was particularly the case in Europe. And we meet face-to-face with our investigators frequently and there are two key points that come as a result of these meetings. One is that we have a good sense of site productivity and the other is that these meetings have helped our recruiting efforts to gain traction. And in addition a number of additional sites that expressed interest in joining the study and we are adding at least 4 in the U.S.

ChristopherJames

Analyst

Got it. Thanks for the questions, guys and congrats again really, really impressive quarter.

Joseph Belanoff

Analyst

Thank you.

Operator

Operator

From Bank of America we have Tazeen Ahmad. Please go ahead.

Tazeen Ahmad

Analyst

Hi, thanks for taking my question. So, thanks first of all for all that color on how you think the market is evolving. I just wanted to get more clarification. So are you able to potentially let us know how many docs are prescribing Korlym now, if you can’t give us the number itself, can you give us the percent change at least versus let’s say what you were seeing this time last year, in terms of your growth you definitely said it’s volume related but how much of that potentially could be from new patient growth versus patients that are already on Korlym and potentially titrating to a higher dose? And then I have a couple of follow-ups.

Joseph Belanoff

Analyst

Well, the answers that we have not provided specific number of doctors who have prescribed the medication as you know we think we have said in previous calls we targeted about 1,500 doctors. And certainly a greater percentage from last year of them are prescribing, but we by no means have all of them prescribe, so there are many doctors to we still expect as they begin to screen their patients more carefully that they will become prescribers in the future as well. And as for your second question, virtually all of the growth is due to new patients, almost none of it is due to titration.

Tazeen Ahmad

Analyst

Okay. I guess intra-quarter is there a way for us to really kind of be more aware of what your trends are, because it is very difficult to tackle a lot of these things and as you said for example, you have even been on a learning curve for some of these items one of which you said was that surgery rates aren’t as successful as we might have thought they were, I mean how are you coming to the conclusion or what do you think is the actual success rate of surgeries?

Joseph Belanoff

Analyst

Well, I think we have said actually from the time the Korlym was launched that we thought this would be – surgery success rate was about 50%. And I think the interesting thing is that for reasons that weren’t always clear to us that was what was believed out in the world. And I think some of it was publication bias doctors, the best doctors provided their best results and the weaker doctors didn’t publish them. But I thought what was very interesting is that as we have been out there, for the last 5 years, our original concept that was about half the patients has played out, we have never really felt like it was any different as we actually saw patients. And the interesting thing is as I said there is a very recent publication with all academic investigators which basically says, yes it is about 50% and that adds to the literature which previously show that it was about 50%, so I think there was just a real disconnect between what people were saying and what was really going on and it’s not anything new.

Tazeen Ahmad

Analyst

Okay. So in terms of how the differences you are seeing and uses of KOLs versus community docs, so could it be the case that community docs because they might have to treat a larger volume of patients might, when they have a patient put on Korlym immediately, put them on the higher dose, rather than titrate them up over longer periods of time, do you have any kind of feedback on that?

Joseph Belanoff

Analyst

Yes, I do, that’s definitely not the case. The community physician started the same dose and we actually do track that. There is – their titration curve is actually very similar to anybody else is.

Tazeen Ahmad

Analyst

Okay, alright. Thanks for the time.

Joseph Belanoff

Analyst

Sure. Thank you, Tazeen.

Charlie Robb

Analyst

Yes. Thanks.

Operator

Operator

From Piper Jaffray, we have Charles Duncan. Please go ahead.

Charles Duncan

Analyst

Hi guys. First of all, thanks for taking my question and congratulations on a nice commercial quarter, also thanks for the reminder of some of the nuance differences between the cortisol modulator and synthesis inhibitor earlier in the call. I did have a couple of questions, one on Korlym 134 second generation compound, regarding Korlym, some of the questions were already asked, but I am – it looks like nice numbers, I am wondering what are some of the assumptions behind your guidance range and specifically some of the goals behind call at the lower end of the range versus the higher end of the range, what needs to happen for a good – super good performance?

Charlie Robb

Analyst

I am Charles, I think I just want to emphasize an important point that both Charlie and Sean made. I mean I think the language you use is the growth is entirely organic it’s just more patients. And I have said before that this is a group of physicians who unlike other physicians in other fields, oncologists as an example tend to be a little bit more cautious before they change their treatment practices, but we are actually seeing and we have seen it all year is that in some sense when herd starts to move, it really does begin to move. And our guidance to you is just that it’s guidance it has a range, because it’s unclear to us exactly where the year is going to end up. But what I can tell you and I will just use the same phrase that Sean did, it’s just not leveling off, I mean we continue to see more physicians and more – and physicians who are satisfied to write more prescriptions. And it’s a little bit hard at this point in the curve to know exactly kind of where that is and so really in some sense the difference between the low end of our range and the high end of our range really does express our uncertainty about how positive the outcome is going to be over the course of this year. But if current trend is really indicative we are just getting going.

Charles Duncan

Analyst

And then do you anticipate any additional price increases yet this year and can you – do you have any information on persistence or dose average dosing that you can share with us at this point?

Joseph Belanoff

Analyst

Well, I will give you to Charlie to ask the question about pricing.

Charlie Robb

Analyst

Yes. So we – pricing is something we look at every quarter. We haven’t taken a price increases since January 1, this year and we will continue to look at it. However, in formulating our guidance for the rest of the year we have not assumed any price increase.

Joseph Belanoff

Analyst

And I just didn’t catch, could you please repeat your second question?

Charles Duncan

Analyst

Do you have any information broadly on average persistence or average dosing levels for Korlym?

Joseph Belanoff

Analyst

I can give you sort of two different questions and I will give you some guidance to it. In the clinical study that we did, the average does at the end was about 730 milligrams. And I think at this point in time, we still run below that. Part of that is a function of more new patients and so they will start at a lower dose before they titrate up and so forth. But we worked actually very hard because we really felt that the beginning of the launch because doctors really weren’t used to this titration model that we had doctors who put people on the first dose of medication saw some modest improvement and then really didn’t do the titration, one of the real efforts that we have made as to at least titrate to the level where we saw the most efficacy and in the clinical study. and just as a reminder to you only about 20% of the patients who are on 300 milligrams in the clinical study saw that as their optimum dose. The optimum dose really range between as I have said between 600 milligrams and 900 milligrams. So that really is a portion of what we say. And again, I am sorry, Charles. I just want to make I get your next question exactly right, could you repeat it again?

Charles Duncan

Analyst

I think you kind of answered it, it was regarding dosing or persist?

Joseph Belanoff

Analyst

Okay. Yes. And the only other thing I really wanted to talk about persistence and this is important, because it’s really one of the efforts that Sean’s team made that I thought was so terrific. And it is an important medical thing, but since you have asked, I will speak to it is that we really find that the time that we have to really focus on helping patients with their medicines is in the first four months on treatment. Patients who have had high cortisol levels for long period of time when you bring those levels down, actually feel what I really describes as cortisol withdrawal, that body is not used to it. When they have surgery they feel absolutely terrible, but they can’t reverse it, surgery is just done. With medicine you can always stop taking your medicine. And we really work hard with physicians to make sure that their patient understand that that’s going to happen and in some sense it’s a sign that the medicine is really working for them, because we know that once the patient begins to see clinical improvement out in the 3-month, 4-month period, particularly they really are then reaping its benefits and stay on the medicine without an early drop off.

Charles Duncan

Analyst

Okay, that’s helpful. And then just shifting over to 134 quickly, you already answered a question regarding enrollment, but I am just kind of wondering if the enrollment and I think your guy mentioned that he has been meeting with people, a fair amount investigators, I am wondering if he get a sense for how the study is going and I appreciate you got to do the studies before you can really say how it’s – what the outcome is, but what’s your sense of how the piece, how enrollment is going in terms of the quality of patients and in breadth [ph] of patients. And then is it possible that the push out could do something positive for you in terms of enrolling patients that may enhance your ability to draw some conclusions from this study?

Joseph Belanoff

Analyst

Well. Charles, I sort of say with a smile on face, but first the most important thing I can tell you is the trial is really being conducted to its highest standards. And I think that that’s a very important thing. But I also say on the flip side of it, we have very experienced investigators. We are really convinced that of course with the inclusion criteria their following it very carefully. They are enrolling the patients who they should enroll. And so that’s not a surprise to us, that’s going on sort of as we are going along. So all I can really tell you is we are very confident. Study is being conducted appropriately and that the medicine has the effect that we anticipate that will happen, you will be able to see that.

Charles Duncan

Analyst

Okay. Thanks for the added information.

Joseph Belanoff

Analyst

Thank you. Charles. Thank you very much.

Operator

Operator

[Operator Instructions] And from BioWatch News we have Alan Leong. Please go ahead.

Alan Leong

Analyst

So Charlie congratulations.

Charlie Robb

Analyst

Thanks Alan.

Alan Leong

Analyst

Joe you brought up the problem with ketoconazole, which is actually true with a lot of the competitive medication, they don’t allow the natural [Technical Difficulty] for cortisol levels, I am wondering if you can provide some color, the term that might present to some patients exactly in terms of the emotional well being or whatever I wonder if you can comment on that?

Joseph Belanoff

Analyst

Yes, I can. Thank you Alan for giving the opportunity just to expand that a little bit. I introduced this because it’s just an important scientific concept. Cortisol has a diurnal rhythm, meaning high in the morning, it falls through the day and it rises through the night and that’s very important to well-being, particularly to psychiatric well being as you know you Alan that’s the prime interest of mine. So for instance one of the symptoms that you really see in patients who have Cushing’s syndrome is very poor sleep, because their stress axis really doesn’t turn off at night. And it’s very important for one’s mental health well being to have a real needer of cortisol. And so I just think that’s a very, very important concept that if you just simply lower the level of cortisol, but it doesn’t have a diurnal rhythm you can improve some things, but there a lots of things that you don’t improve, because I think that that rhythm is actually very meaningful. And that’s really what I wanted to highlight.

Alan Leong

Analyst

I also want to allow you to talk about the next things in broad stroke, how much money does that take to fund your clinical trial program for the next 18 months against all the increase in revenues and working capital I guess what do you guys do with all this money?

Joseph Belanoff

Analyst

Okay. Well, it’s a broader question that you’re asking and I think it is actually worthwhile for the whole audience. What we have said is in some sense we are very fortunate. Our revenue growth really meets or exceeds all the things that we wanted from a clinical program at this point. And I joke about it we are not planning on paying any dividends, because we do think that as our studies get further along they become more expensive, they have larger patients. But as Charlie mentioned in his comments all the things that we will plan right now are fully covered by all the revenues that we think we are going to produce in the cash that we have on hand. So I think the broad answer to your question is expect increasing costs as we get deeper into the studies, but feel confident same degree of discipline that we provided so far on to the financial of the company, we will be providing in the future as well.

Alan Leong

Analyst

Thank you.

Joseph Belanoff

Analyst

Thank you, Alan. Well, it looks like we are out of questions here. So I really appreciate for the whole audience their time on a summer afternoon. Thank you. And we look forward to bringing you our progress next quarter.

Operator

Operator

Thank you. Ladies and gentlemen, we will now conclude today’s conference. Thank you for joining. You may now disconnect.