Earnings Labs

Corcept Therapeutics Incorporated (CORT)

Q2 2015 Earnings Call· Wed, Aug 5, 2015

$46.73

+1.10%

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Transcript

Operator

Operator

Welcome to the Corcept Therapeutics Conference Call. My name is Cathilda, and I will be your operator for today. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session. Please note that this conference is being recorded. I will now turn the call over to Charlie Robb, Chief Financial Officer. Mr. Robb, you may begin.

Charles Robb

Management

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 second quarter 2015 summary financial results and a corporate update. To get a copy of this release, go to corcept.com and click on 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 19th at 1-888-843-7419 in the United States and 1-630-652-3042 internationally. The pass code will be 40261436. Before we begin, I want to remind you that any statements during this call other than the 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 operating expenses for 2015 and beyond, the timing of preclinical trials and clinical trial and results of such trials, the pace of Korlym’s acceptance by physicians and patients, the anticipated contribution of our sales organization to our revenue growth and net income, the pace of enrollment and or the outcome of our clinical trial in the advancement of our next generation selected GR modulators, the effects of rapid technological change in competition, the protections offered by Korlym’s orphan drug designation for Cushing syndrome or our other intellectual property rights or the costs, pace and success of our other product development efforts. These and other risks are set forth in our SEC filings, which are available at our website and corcept.com or from the SEC's website SEC.gov. We disclaim any intention or duty to update…

Joseph Belanoff

Management

Thank you, Charlie, and thank you all for joining us. Corcept develops and commercializes medications that modulate the effects of cortisol widely known as the stress hormone. We market our first generation cortisol modulator, Korlym for the treatment of Cushing syndrome, a life threatening disease that affects approximately 20,000 patients in the United States. We are conducting a Phase 1/2 trial Korlym as a treatment for triple negative breast cancer, a deadly disease with no FDA approved treatment. We have developed a large portfolio of next generation cortisol modulators which we hope to develop into approved treatments for a wide range of serious diseases. Our lead next generation compound CORT 125134 has completed Phase 1 and will begin two Phase 2 trials, one for the treatment of Cushing syndrome and another for the treatment of yet to be chosen oncologic indication in the first quarter of 2016. Before I discuss these topics in more detail, I want to take a minute to observe that last quarter Corcept passed an important milestone. Excluding non-cash expenses, we are under profit. Our non-GAAP net income of $369,000 was small, but it demonstrated a very important fact, not only as our Cushing syndrome business profitable on a standalone basis, it has the potential now that demonstrate a potential if on the rest of our activities including development of the next generation treatments in our product pipeline, very few biotech companies can make that claim. I’ll briefly review our key programs and start to answer your questions. With again offering Korlym to patients with Cushing syndrome in April 2012, since then our business is growing steadily. We expect that it will continue to do so. As you’ve just heard, we’re revising our revenue guidance for 2015 to between $49 and $53 million, which roughly double…

Operator

Operator

We will now begin the question-and-answer session. [Operator Instructions]. Our first question comes from Charles Duncan from Piper Jaffray.

Charles Duncan

Analyst

I had a question on the current Korlym business and then on the pipeline, and the question on the current business is, you raised guidance to lower end which make sense to me. What do you think is the biggest input to revenue growth? Is it increasing the prescriber base? Is it increasing the number of patients? Or is it increasing the duration or the dosing the patients are exposed to?

Joseph Belanoff

Management

Hey Chuck we’ll first thank you for calling in on an August day; i'ts very nice of you, particularly in the late afternoon. I’d like reintroduce you onto Sean Maduck, who is our Vice President of sales and marketing at Corcept. You heard from Sean at the last call, but I think he really is in a very good position to answer your question.

Sean Maduck

Analyst

Hi Joe, thank you and thanks for the question. I think I’ll start-up by reiterating what Joe said during the call, I mean mainly Korlym sales grew last quarter, because more physicians prescribe Korlym, and the number of patients -- with an increase in the number of patients taking the medication increased as well. In terms of what are the main drivers of that in the market, we've learned a lot about our market since launch and we've become far more effective I think in telling that Korlym story. Endocrinologists are becoming far more familiar with our product. I am sure that we are getting extended base time with them, but then I am not able to get into a much deeper conversions about all the etiologies of Cushing center including pituitary, ectopic and adrenal. And because of that they’re now far more receptive with that, and how far it could benefit their patients, and are becoming increasingly more confident in treating medically with our products. And through that we’re now actively looking forward and testing more patients who could benefit from the product. So it’s a factor of more physicians prescribing, more patients being prescribed the product, and all our effort is around them.

Charles Duncan

Analyst

So you feel like physicians are getting a better handle on using Korlym relative to some of the other approaches that have been used to treat Cushing’s in the past?

Joseph Belanoff

Management

Yes, I just want to underscore Sean’s point. I think that it is really -- Charles, I know you follow the story for a very long time. It was really -- but those who haven’t, just to highlight some of the history of it; Korlym was approved on a 50-patient open label study; on it's PDUFA day without an advisory panel with 17 doctors participating, because the efficacy was very-very high. In terms of clinical global response virtually every patient responded. You know it's is a great advantage. But at the beginning hardly any physicians had used Korlym, this new mechanism hadn’t understood prior to that point. Our commercial team has worked very-very hard to increase the awareness of the medication how it works and so forth. And I think that we are still early even though in adoption oriented launch, we’re still relatively early in that process. We're not seeing a level letting off of the increase of interest. And we know that this is a sale that requires some sophistication. So, really as I think just moving along in the same way that it has just with the broader and broader base every single month.

Charles Duncan

Analyst

And now as you mentioned we've covered this -[indiscernible] some time and I’ve always been primarily driven by the broad potential applicability of the platform. So I wanted to ask you about that, clearly you are starting to articulate that aspect of the story and I appreciate that. I wanted to -- however you mentioned the triple negative breast cancer trial, then would you anticipate and update at the San Antonio breast cancer meeting coming up here in December?

Joseph Belanoff

Management

Yes, it's a terrific venue, and it will be great to be able to present information at that point. I can't promise that, because we’ll have to see how the study is going. But certainly that would be a nice venue for us, if we could because that’s a conference which is very well covered.

Charles Duncan

Analyst

And should you see some favorable responses in TNBC, it was seen that given the completely unmet clinical need there would makes sense to file for breakthrough therapy designation. Would you anticipate that possibly be the case?

Joseph Belanoff

Management

Well as with everything else we do Charles, really it's going to be driven by the data and we will look at every opportunity to advance the treatment as quickly as we can if it looks like the results are warranted.

Charles Duncan

Analyst

And then final question, then I'll hop back in the queue, you mentioned something interesting that about 50% or so triple negative breast cancer tumors or tumors in women with triple negative breast cancer express, highly express GR. I’m wondering if you are considering that as a potential stratification strategy for future studies.

Joseph Belanoff

Management

Let me just give a little context to answer. I know you know the story well, but others may not. It has not been a standard screening to look for the cortisol receptor on triple negative tumors. University of Chicago first developed and academic assay, but if you go to the older academic literature it was very sparse and it basically said that about a quarter of these tumors perhaps had the GR receptor on it, you just can’t see - the largest tumor bag screening for GR that had ever been done and as I mentioned we are covering academics, we publish and we will publish this soon but what it showed that it was not 25% nor was it 100% but it was considered more than 50% which really says that this is a very worldwide target for substantial group of women who have this disease. But really I think is moving along in that way. Now in that context Charles, can I have your question again?

Charles Duncan

Analyst

Yes, is that possible factor that you look at two stratify patients with and study in phase 3 or is it even possible that in the future that you could use that in the commercial setting?

Joseph Belanoff

Management

Okay. Now I fully understand your question. And the answer is that we anticipate that we will use GR positivity as a way for patient with triple negative breast cancer to enter or not enter our study we really feel very strongly that patients do not have, sadly if they do not have a GR target we will not actually bring that forward. But at this point in time it really is our first thought that this will be, we will have developed and bring along through phase 3 into commercialization a companion diagnostic and would anticipate at this point that that it would in fact be part of our label. Obviously we will have to see what the data share is and I will make decisions along that way, but that's how we are looking at the situation right now.

Operator

Operator

Our next question comes from Christopher James from FBR & Company.

Christopher James

Analyst

Alright guys, good afternoon and let me also add my congratulations on a really good quarter and thanks for taking my question as well. Joe, what can you tell us, what have you seen in terms of new patients that are coming aboard with respect to disease severity of relative to your initial launch. And are you also seeing an increase in average dose?

Joseph Belanoff

Management

Yes. So two different questions, but first good to hear from you Chris. The first question is it really very interesting when just as we about it. In our study we saw in some sense that doctor's biggest trainer act, the patients willing to study have really had no other treatment and so entered in. I think what was really very heartening is that those are very, very sick patients did quite well and I think overtime patients with more moderate Cushing Syndrome have again to get treated with Korlym. Now it's our strong opinion that nobody there does not have a mild case of Cushing Syndrome, it is a bad disease but there are patients who have got really severe and there are patients who have the more chronic, but also powerful illness. And yes we have actually seen more and more treatment of patients who have more moderate disease as opposed to the most of your patients. Now the titration question is an interesting one and a little bit more complex than you might think. I have mentioned before in the conference calls that the average dose in the clinical trial is about 750 milligrams and what we actually had, it will work to do is explain endocrinologist, how the initial dose 300 milligrams was probably not going to be the most effective dose for many of their patients. Now what was actually pulse in the publication at this point come forward and I think the people will really understand that better as our sales force is explained and that the literature comes out. So on the one hand you have patients who do have somewhat more mild -- on the other hand you have patients who probably have not been fully traded to our optimum dose in the past and I think those two forces kind of involve with each other in combination. I can tell you that overtime we have seen a modest increase in dose and if you are asking my personal opinion I think that that will probably continue to increase overtime even as patients with more moderate disease and there are patients of group.

Christopher James

Analyst

Great. That's helpful. And then on the expanded salesforce. When do you think we will see the full incremental effect of that expanded salesforce. Do you think we should think about this as a 3Q event or a 4Q event?

Sean Maduck

Analyst

That's a great question. I will touch on that, but before I go into discussion space I want to add an increase of or highlight another relevant field point that did have a an impact in Q2 that will also carry forward, we have announced historically that we did increase the size of the sales force account specialist organization to 25 in Q1, but we also expanded our sales leadership team and we now have four active regional managers who are seeing this group. So their leadership has really benefited both our veteran as well as new hired clinical specialist and has helped our increase affecting this other field in Q2. So now onto your question about new hires, in terms of have we seen activity to date the only answer I will be know, I mean our new specialist are really recently completed all their training and we expect to see some of contribution coming from them in Q3 with that really ramping up in Q4. We have a very extensive training program here at Corcept, Korlym is a complicate in sale and CS is clinical specialist, need to have [indiscernible] and be very well versed in both the disease and our mechanism of action more to be a factor than and it take some time to build relationships and be productive in territory, so just to reiterate, we will see some activity in Q3 with ramping up in Q4.

Christopher James

Analyst

Great that's really helpful. And I guess on to triple negative, the UC data as you pointed out you will see in phenomenal, I guess what response rate are you targeting, I don't know if you can say that publically, but what response rate are you targeting to really think about going directly into a pivotal and do you think you need to replicate those phenomenal results seen at University of Chicago?

Joseph Belanoff

Management

Well, I think it would be wonderful but highly unexpected if we unless any trial of micro [indiscernible] agent had an 80% response rate, and so we don't expect to replicate that result although it was wonderful for that smaller group of patients. On the other hand, just for a basis of comparison, of course we filed the space with medication recently did a study in triple negative breast cancer, and the response rate would have been 7% and they were not terribly unenthusiastic about that. So the question you raises is a complicate one, I’m not sure exactly what response rate is going to excite us, certainly 80% will excite us, but this, I guess I have to again pull back to context this is an enormously sick group patients. These are patients who have failed every other therapy and sadly we’ve had already in our clinical patients who passed away between when consensus it and they got their first dose of medication. It is shows you how acutely ill these patients are, so in some sense any response rates that so reasonable is worthy of bringing the medication forward, I don't have a specific percentage for you and luckily have to carefully as we get the data because as you know the data is not just response rate, but things very increasing survival plan and so forth.

Christopher James

Analyst

Right, okay and then maybe just two more on pipeline. And then I’ll jump back in the queue, you mentioned Core 125, going into tumor type getting specify which type, I guess it is safe to assume that it will be one of those three tumor types to discuss or are you potentially thinking about other tumor types?

Joseph Belanoff

Management

Well, we’re trying to think more broadly at this point, because just recently completed a screening of other solid tumors and found that there was GR represented in a fair group of them, not all of them, which actually give me contents of how it work, but in a fair group of them, now we do actually have in vitro data the 125, and 134 in triple negative breast cancer, castration- resistant prostate cancer and ovarian cancer and we actually in vivo data in both triple negative breast cancer and castration-resistant prostate cancer at this point in time. So they certainly are headed the line, but we are really taking a careful look to see if we want to promise because we feel like the strategy might have a real legs in other forms of solid tumors, so it's a series top of the consideration, it’s probably going to take another two months of thinking, two three months of thinking to get through it, but by the latter part of the year we know where we are going.

Christopher James

Analyst

Great that's helpful and then finally on prostate, just wondering, just given the biology and the papers that have come out, how should we think about the potential of mifepristone, should this be is something. You something think about in combination with enzalutamide or in enzalutamide failures?

Joseph Belanoff

Management

Yes, important question, as far as we can see mifepristone by itself does not have particular oncologic benefits it really is in combination with other treatments and. And I’ll speak to you specifically. What really appears and this is a topic of a [indiscernible] journal editorial, I guess about a year ago. It's that enzalutamide which is a terrific medication, and shortly after it as given and you know it's a powerful androgen receptor antagonist; colonies of cells which are GR positive and where GR is the growth factor, begins to develop. Broadly one could say that eventually enzalutamide resistance, a fair portion of that is its GR positivity. So what we’re looking for is blocking another exit route for the tumor and the combination is really what’s been tested. So the study of University of Chicago is enzalutamide versus enzalutamide plus mifepristone

Operator

Operator

Thank you. We have no further questions at this time. We will like to thank you. Please go ahead.

Joseph Belanoff

Management

Yes. Thank you very much and we’ll talk to you next quarter.