Earnings Labs

Corcept Therapeutics Incorporated (CORT)

Q3 2017 Earnings Call· Thu, Nov 2, 2017

$46.73

+1.10%

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Transcript

Operator

Operator

Welcome to the Corcept Therapeutics' Conference Call. At this time, all participants are in a listen-only mode and later we will conduct a question-and-answer session. Please note this conference is being recorded. And I will now turn it over to Charlie Robb. Charlie, you may begin.

Charlie Robb

Management

Thank you. Good afternoon. I am Charlie Robb, Corcept's Chief Financial Officer. Thank you all for participating in the call. Earlier today, we issued a news release giving our third quarter financial results, a corporate update and an upward revision of our 2017 revenue guidance. For a copy, 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 November 16 at 1888-843-7419 from the United States and 1630-652-3042 internationally. The pass code will be 45799161. 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, revenue guidance and expense estimates for 2017 and beyond, the anticipated performance of our sales organization, the cost, timing and results of preclinical and clinical trials, including the trials of relacorilant the generic name for CORT125134 in Cushing's syndrome and solid tumor; CORT125281 in castration resistant prostate cancer; and CORT118335 for antipsychotic induced weight gain, 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 or duty to update any forward-looking statements made during…

Joseph Belanoff

Management

Thank you, Charlie, and thank you to everyone on the phone for joining us. Corcept had an excellent quarter. Our revenue grew to $42.8 million, an increase of 97% from the third quarter of 2016 and 20% more than the second quarter of this year. We generated $13.8 million in GAAP net income. Excluding non-cash expenses, our non-GAAP net income was $17.4 million. Cash and investments increased by $9 million even as our clinical development programs progressed and we've retired our royalty debt, we are now debt free. Our revenue growth is not slowing. We have raised our 2017 revenue guidance to between $157 million and $162 million. We anticipate significant revenue growth in 2018, 2019 and beyond. It is worth pausing here to note, how one common it is for a biotech company to be in Corcept's position. Our Cushing's syndrome business generates enough cash to fund both itself and the development of our rich portfolio, proprietary selective coritsol modulators, our cash reserves have increased, we have no debt. These attributes give us the freedom and resources we need to build our business and optimally advance coritsol modulation as a treatment for a wide range of serious disorders. With strong growth in Korlym revenue in the third quarter was sustained by the same trends in medical practice that we have described in previous calls. Growing awareness among physicians of Korlym's efficacy, the increasing frequency with which physicians are screening for and treating patients with hypercortisolism, and our commercial organization is focused on the endocrinologists who treat most patients with hypercortisolism. Before I discuss the first of these two trends in more detail, I need to make an important point about terminology. We use the terms hypercortisolism and Cushing's syndrome interchangeably because they are the same thing. When Harvey Cushing…

Operator

Operator

[Operator Instructions] Our first question comes from Charles Duncan from Piper Jaffray. Please go ahead.

Charles Duncan

Analyst

Hi guys. First of all congratulations on very nice quarter and thanks for taking my questions. One of the questions that I've heard recently is whether or not you could characterize where the growth is coming from in the quarter or perhaps more importantly as you look out towards the end of this year and next year and look at maybe five different kind of contributors one of them being new patients another being new doctors writing scripts and now there is increasing persistence for patients on the drug and perhaps dose for those patients. And then the last is price, and I guess if you look at those five contributors which one is most important to you? Could you provide us any even semi quantitative metrics around them?

Joseph Belanoff

Management

Yes. Charles, thanks very much for the question. And what I'd like to do is reintroduce all of you out there to Sean Maduck. Sean is our Senior Commercial Officer and runs the whole Cushing's syndrome franchise and I think he'd like to answer this question.

Sean Maduck

Analyst

Thanks Joe, and thanks Charles for the question. And the answer really is a simple one and that's that more patients are being prescribed Korlym of all the metrics that you described. As I previously said on earlier calls, I mean our greatest challenge in the commercialization of Korlym has really been to get endocrinologist to write their first prescription. Once they do, they see the efficacy of the product and then they look for more eligible patients. And we've had many new physicians prescribed for the first time this year, and in fact, so far in 2017 the prescriptions from this group of physicians have exceeded those of our legacy prescribes. And we expect this group of physicians to perform similar to the earlier cohort and become multi prescribes as well and we expect to continue to add new prescribes as we move forward. Again, our growth is due entirely in the quarter to more Korlym prescriptions and not price or titration which are two of the other metrics that you mentioned. We took a price increase at the beginning of this year and we have not taken a price increase sense. And in terms of titration, we do continue to see a slight rise in our average dose and we do believe over time at some point we will come close to the average dose that we saw in our pivotal study seismic which was approximately 730 milligrams, but we are not there yet. I mean as a reminder to everybody, when new patients are initially prescribed Korlym, they prescribed 300 milligrams and it does take some time for their physicians to titrate them to the dose that is most efficacious for that specific patient. So the more patients that we have coming on a 300 milligrams and the longer it takes for our overall average dose to rise.

Charles Duncan

Analyst

Good, thank you Sean.

Operator

Operator

Our next question comes from Tazeen Ahmad from Bank of America. Please go ahead.

Peter Stapor

Analyst

Hi, guys. This is Peter Stapor on for Tazeen. Thanks for taking my question. First question, I'm on the FDA adverse events report system order right now. See the Korlym has 91 that case associated with it. You could you talk about whether those are drug related and what the cost might be?

Joseph Belanoff

Management

I'm not sure exactly what you're looking at. So I can't really refer to what's specifically, but patients with Cushing's syndrome are a very ill group of patients, some of them have cancer and some of them die in their own, but to say, be more specific on that, I can't really refer to it, I'm not sure. I'm not sure what exactly what you're referring to.

Peter Stapor

Analyst

Okay, it's publicly available FDA website?

Joseph Belanoff

Management

Yes.

Peter Stapor

Analyst

So my next question is whether - why the relacorilant [indiscernible] pushed and so it's going to be 1Q, but it was previously fourth quarter?

Joseph Belanoff

Management

We actually have revised that, I believe a quarter or two ago to be on the first quarter of next year.

Peter Stapor

Analyst

Right, I'm wondering why that was the case?

Joseph Belanoff

Management

Yes, I'm glad to address that question again. The reason that really occurred was the start-up time for many sites, particularly academic sites has grown over time and that's equally true in Europe as it is in the United States. This is a Phase II study that's taking place really at all academic sites. And unfortunately, I can tell you as an academic investigator myself many years ago that used to go much more quickly what used to take two or three months to get going is now taking 10, 11, 12 months to get on. So that was really the cause of the initial delay.

Peter Stapor

Analyst

Gotcha, that makes sense. And do you have an expectation for Phase III whether you'll need one or two studies?

Joseph Belanoff

Management

Yes, our expectation although I want to really put an important caveat on that. Our expectation is that we will do one Phase III study as we did previously. But the real caveat is we haven't yet filed to the FDA. So we can't really say with any certainty, exactly what's going to happen. But that is our expectation at the current time.

Peter Stapor

Analyst

Gotcha, okay. And another one that's come up a few times for us, but our sales continue to increase if the trend continues, what are your expectations for generic challenger entering the market when you lose exclusivity in early 2019?

Joseph Belanoff

Management

I apologize, because I'm still seeing Tazeen name on the screen, I apologize. I didn't catch your first name Peter. Peter, I'd like to reintroduce Charlie to - who really manages all of our lifecycle management to answer that question.

Charlie Robb

Management

Sure. Well I think there are a couple of things important facts to keep in mind as you think about this. On the one hand there are facts about Korlym and Corcept. The active ingredient in Korlym is the abortion pill and while I think that's often glossed over, it's an important fact that I think really needs to be weighed. I don't hear anyone clamoring for broad distribution of generic abortion pill in the United States. So that's one fact. Another factor as you've heard us talk about the importance of our sort of high touch business model, or the close support we provide patients and physicians and that our pharmacy provides to patients and physicians, really been central to our the success of our commercial business. That a generic company could replicate that model, but it would be off the ordinary - the beaten path for them. And then finally and most importantly, got to remember we have a what we believe will prove to be a superior successor molecule in development and when I say superior in this context, I mean something very specific. Relacorilant as Joe mentioned, does not have affinity for the progesterone receptor and that means it will not be the abortion pill. And furthermore it won't cause the side effects such as endometrial thickening in a regular vaginal bleeding that caused some patients and the patients and physicians would both strongly prefer to avoid and cause some to avoid Korlym of them right now. So yes set those considerations to one side and keep those in your head. And then take a look at you know the path that any generic company would need to walk to get approval for generic Korlym. The first they would need to obtain Korlym tablets so they…

Operator

Operator

Our next question comes from Adam Walsh for Stifel. Please go ahead.

Neil Carnahan

Analyst

Hi, guys, Neil Carnahan on for Adam. Congratulations on a good quarter. Just a couple questions, upon the possible approval your second generation relacorilant. How would you expect transition of patients from Korlym on to that second generation cortisol modulator to go and would there be any reason for patients to remain on Korlym even with the second generation approved drug out there with a better safety profile?

Joseph Belanoff

Management

I'll just give you my opinion obviously we don't know that with certainty. But I think the Korlym sales will essentially go to zero. I think that this drug really is superior and extremely important ways not the least of which is that it will be - potentially much more easy to obtain. There really is a serious process to getting it Korlym at this point in time. It's intended so that there will be very tight control of where Korlym tablets are we know where they all essentially every single tablet goes and because relacorilant is not the abortion pill I think that portion of the equation really changes tremendously. In addition to that while we're not expecting relacorilant have any better efficacy than Korlym because Korlym has super efficacy taking away the protest around side effects particularly for women who are the majority of patients with Cushing's syndrome things get much, much easier for them and for their doctors and prescribing the medication. So I'll just some up to say I think the transition will be rapid and approach complete. I can't really think of any particular reason why anyone would stay at Korlym, if CORT125134 or relacorilant actually proves to be as efficacious as we think it is.

Neil Carnahan

Analyst

Okay. And then on the FKBP5 gene assay, if you guys were to pursue FDA approval for that, what would that mean for physicians, what would that mean for patients, and what would that mean for you guys overall?

Joseph Belanoff

Management

I'd like to introduce another member of our senior team, so thank you for the question. That speaker is Bob Fishman, who is a Medical Doctor and our Chief Medical Officer and he will address your FKBP5 question.

Robert Fishman

Analyst

Hi, Neil. Thanks very much for your question. First to say, that we think the FKBP5 is a useful tool and we plan to help build the literature that will enable eventual interpretation of the meaning of results et cetera. So this we hope will be a major innovation for the diagnosis and management of Cushing's syndrome in future years helpful both in the diagnosis and monitoring of patients. So a complement to everything else that we're doing.

Neil Carnahan

Analyst

Thanks guys.

Joseph Belanoff

Management

Thank you.

Operator

Operator

Our last question comes from Matt Kaplan from Ladenburg Thalmann. Please go ahead.

Matthew Kaplan

Analyst

Hi, guys. With respect to the Phase II study that's coming up in the first quarter. Help us understand what we should be looking for from a safety and efficacy point of view in that 30 patient open-label study?

Joseph Belanoff

Management

Yes. So let me just review an important thing. I alluded to it in my opening comments, but I sometimes think that it's a little hard for people to kind of integrated all once I'm going to - I'm going to say something that in some sense, again maybe in a slightly different way. Cushing's syndrome is just that. It is a syndrome. Cortisol goes everywhere in the body and when it is in excess it has symptoms that are across all organ systems of the body, so it causes psychiatric issues, it causes metabolic issues, it causes cardiovascular issues, it causes issues related to immunosuppression and infection, it causes issues related to fat deposition. So many, many different things going on. And just to get some sense of this, in our registration trial for Korlym, we actually measured 24 different endpoints because all of them had meaning in patients with Cushing's syndrome. And essentially we're going to be doing the same thing in the Phase II study. We're really looking to see whether Cushing's syndrome, all the symptoms of Cushing's syndrome improve as they do with cortisol modulation with Korlym. Now prominent symptoms you'll be familiar with will be things like improvements in glucose tolerance and improvements in blood pressure, but the other symptoms are also very meaningful to like improvement in mood, improvement in weight, improvement in waist circumference. So all of those things will be read out and obviously with 30 patients, we will be looking at each individual patient to see how they did in terms of each of those broad effects.

Operator

Operator

And there are no further questions at this time.

Joseph Belanoff

Management

Thank you very much and really looking forward to talking to you in 2018.