Corcept Therapeutics' CEO Discusses Q3 2012 Results - Earnings Call Transcript

Nov. 1.12 | About: Corcept Therapeutics (CORT)

Corcept Therapeutics, Inc. (NASDAQ:CORT)

Q3 2012 Earnings Call

October 31, 2012 5:00 PM ET

Executives

Charlie Robb – CFO

Joe Belanoff – CEO

Analysts

Boris Peaker – Oppenheimer

Annabel Samimy – Stifel Nicolaus

Koon Ching – Credit Suisse

Operator

Welcome to the Corcept Therapeutics Third Quarter Results and Corporate Update Conference Call. My name is Christine and I will be your operator for today’s call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note that this conference is being recorded.

I will now turn the call over to Charlie Robb. You may begin.

Charlie Robb

Thank you. Good afternoon, everyone. I am Charlie Robb, Corcept Therapeutics’ Chief Financial Officer. Joining me today is Dr. Joseph Belanoff, our Chief Executive Officer.

Thank you for participating in this call. Earlier today we issued a news release setting forth our third quarter financial results and providing an update of our recent corporate activities. To obtain a copy of this release, please go to our website at www.corcept.com and click on News & Events. Today’s call is being recorded. A replay maybe heard through November 13, by dialing 1-888-843-7419 from the United States and 1-630-652-3042, internationally. The passcode is 33645011.

Before we proceed, I would like to remind you that we will be making forward-looking statements, such statements might include statements related to the magnitude or timing of Corcept’s future revenues, the pace of Korlym’s acceptance by physicians and patients, the reimbursement decisions of government or private insurers, the outcome of the company’s Phase 3 trial of mifepristone for the treatment of psychotic depression, the effects of rapid technological change and competition, or the cost, pace and success of Corcept’s product development efforts. These statements are only predictions and involve known and unknown risks and uncertainties, including the risks outlined under Risk Factors and elsewhere in our filings with the Securities and Exchange Commission, which can be accessed at www.corcept.com or the SEC’s website at SEC.gov.

Although we believe that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee future results, events, levels of activity, performance or achievement. We are not under any duty to update forward-looking statements, unless required by law.

Before I turn the call over to Dr. Belanoff, I’ll recap our financial results for the third quarter and first nine months of the year. Corcept reported a net loss of $8.3 million or $0.08 per share for the third quarter of 2012, compared to a net loss of $6.4 million for the third quarter of 2011.

For the third quarter of 2012, which was the first full quarter in which Korlym was available, Corcept recognized approximately $1.1 million in net product sales, after deducting associated government rebates, chargebacks and other allowances. Cost of sales for the period was $24,000, which consisted primarily of the cost of stability testing.

Operating expenses for the quarter were $8.7 million, compared to $6.4 million for the third quarter of 2011. Selling, general and administrative expenses were $5.7 million, compared to $3.2 million for the comparable period in 2011. This increase was primarily due to increased staffing, consultancy and other professional services costs related to the commercialization of Korlym.

Research and development expenses were $3 million, compared to $3.2 million for the comparable period in 2011. The decrease was primarily due to lower consultancy costs, which fell when we finished prosecuting our new drug application for Korlym and decreased clinical trial costs, which were lower because we had completed our Phase 3 study of Korlym for Cushing’s syndrome.

These decreases were partially offset by the cost of expanding our Phase 3 trial of mifepristone for the treatment of psychotic depression and discovery and development of our next-generation selective GR-II antagonists.

Corcept’s cash balance as of September 30, was $101.6 million, as compared to $39.6 million as of at June, pardon me, at December 31, 2011, and includes net proceeds of $13.3 million from our March 2012 warrant exchange and other warrant and option exercises; $46.1 million from our July 2012 sale of common stock; and $30 million from our August 2012 capped royalty financing transaction; less approximately $27.4 million spent on operations during the first nine months of 2012.

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

Joe Belanoff

Thank you, Charlie, and thank all of you for joining the call this afternoon, particularly those of you in New York. I know what a difficult week it’s been and glad that you’re able to participate.

I’d like to provide some background to help everyone understand both our progress with the launch of our first product, Korlym, and our work toward the company’s longer-term objectives. As many of you know, the FDA approved Korlym for the treatment of endogenous Cushing’s syndrome in February. As the FDA stated in its news release, and I quote “prior to FDA’s approval of Korlym, there were no approved medical therapies for the treatment of endogenous Cushing’s syndrome.”

Cushing’s syndrome is the archetypal illness of cortisol excess. It is usually caused by a solitary tumor that produces too much cortisol or by a tumor that produces too much ACTH, which in turn stimulates the body to produce too much cortisol.

Cortisol is often referred to as the stress hormone and is essential for life. Unfortunately, in excess it causes severe and sometimes lethal illness. The morbidity and mortality of the condition almost always stems not from the tumor per se, but from the cortisol it produces.

It is estimated that at least 80% of the tissue in the body has receptors for cortisol, which is why patients with Cushing’s syndrome have so many different symptoms. Because excess cortisol affects their metabolism, Cushing’s patients often gain large amounts of fat, usually around their middle. Even as they gain weight, their bodies lose muscle mass and strength. These patients often develop moon-shaped faces and fat deposits on their upper backs.

Cortisol gets into their brain and so psychiatric symptoms, depression, anxiety and psychosis are common. In fact, psychiatric changes are often the first thing patients notice when they develop Cushing’s syndrome. Excess cortisol causes insensitivity to insulin, so about 80% of patients with Cushing’s syndrome have frank diabetes or glucose intolerance and eventually all the problems one sees with those conditions. Korlym works by blocking the therapeutic results in many patients.

Because we felt confident that Korlym would be approved by the FDA, we took the steps we prudently could to prepare for Korlym’s commercialization before the PDUFA date, including manufacturing the supply of Korlym tablets, establishing our specialty distribution network, and maybe most important, helping ensure that payers understood the benefits of Korlym and would cover its use. Having taken these steps, we were able to offer Korlym to patients in April, just seven weeks after approval with both private and public insurers covering patients’ use of the medication promptly.

To conserve funds, we postponed building much of our commercial infrastructure until after Korlym’s approval. For instance, we did not begin hiring and training our team of medical science liaisons or MSLs until after approval.

Our Phase 3 trial had led us to expect that our biggest challenge would be helping endocrinologists to write their first prescriptions for Korlym. By blocking the cortisol receptor, Korlym treats a complex life-threatening illness in a fundamentally new way. Some of its potential side effects, such as endometrial thickening and irregular vaginal bleeding, although manageable, are not ones endocrinologists typically face.

Just as we have seen in the clinical trial, we expected doctors to take a conservative approach, putting their sickest patients on the medication and then waiting for results. As was the case in the study, we expected that positive outcomes would lead to prescriptions from the same doctors for less ill patients.

We assumed that success would be measured one patient and one doctor at a time. Although it is early, our commercial experience has validated this assumption. In coming months you’ll hear from patients yourself on our website.

We also knew that launching Korlym success later will require us adapt our plans to new information. For instance, almost from the beginning we have received prescriptions from both specialist with extensive Cushing’s syndrome practices and community endocrinologists that – who treat just a few Cushing’s syndrome patients.

To reach a geographically diverse group of community endocrinologists, we added a team of 11 experienced sale representatives in October. These sales reps are working with our MSLs to reach our larger-than-anticipated prescriber base. As the launch continues, we know that we will learn more and will continue to adapt.

I want to address briefly Corcept’s two other strategic priorities, our ongoing Phase 3 study of mifepristone for the treatment of psychotic depression and the development of our next-generation selective cortisol antagonists. This summer we raised $76 million to fund these priorities fully, even as we commercialize Korlym.

Evidence in the scientific literature shows that cortisol antagonism, blocking the cortisol receptor may have utility in treating many conditions, including weight gain caused by atypical antipsychotic medications, post-traumatic stress disorder, mild cognitive impairment, early Alzheimer’s disease, alcoholism, breast and ovarian cancer and psychotic depression. Of course, much work must be done before we can know if the effects of cortisol receptor antagonism in these indications shows promise in early models will result in effective human treatments. But we are excited to be the leading company in this field.

Other than endogenous Cushing’s syndrome, the indication on which we have most focused is psychotic depression. As its name suggests, psychotic depression consists of major depression, coupled with psychosis, delusions or – and/or hallucinations. Unlike in disease, for instance, like schizophrenia, the patients develop psychosis only when depressed, but when they develop this psychosis it’s a highly morbid condition.

Psychotic depression affects approximately 3 million people in the United States and it is particularly morbid, sometimes unfortunately lethal. Sufferers of this serious illness are 70 times more likely to commit suicide than those who do not have this disease. There is no FDA approved treatment.

We are studying whether a Korlym-administered dose of 1,200 milligrams per day for seven days will lead to a rapid and sustained improvement in these patients’ psychoses. As allowed by these summer’s financings, we have begun increasing the number of clinical sites in the study and what we hope will be our final clinical trial, with the goal of completing patient enrollment by the end of 2013.

Our financings also allowed us to accelerate development of the lead candidates in a proprietary portfolio of 300 selective cortisol antagonists. Like Korlym, these molecules potently block the cortisol receptor, but unlike Korlym, they do not block the progesterone receptor and they do not terminate pregnancy. If shown to be safe and effective, it could be marketed for indications for which Korlym, still called by some, the abortion pill, is not ideal.

With the funds raised this summer, we’ve begun advancing several of the most promising of these compounds to the clinic in parallel. Our first objective is to find a follow-on compound for Korlym for Cushing’s syndrome. Interestingly, some of our next-generation compounds behave differently from both Korlym and from one another in important ways. For instance, some get into the brain, some do not, some appear better at preventing anti-psychotic induced weight gain, some are better in increasing insulin sensitivity. We hope that our efforts will yield several new and important medications.

To sum up, we are pleased to see how well patients taking Korlym are doing and with how the launch of Korlym for endogenous Cushing’s syndrome has progressed. Coverage for Korlym has been prompt and universal. We have received prescriptions from an even more diverse group of physicians than we expected and they include our study investigator, other Cushing’s syndrome specialists and community endocrinologists, and we have adopted our plans accordingly.

In addition, and importantly, we’re effectively using the funds we raised this summer to complete our Phase 3 trial of Korlym for psychotic depression and to advance to the clinic in parallel, several of our next-generation compounds. I’ll stop here and answer any questions.

Question-and-Answer Session

Operator

Thank you. We will now begin the question-and-answer session. (Operator Instructions) And our first question is from Boris Peaker of Oppenheimer. Please go ahead.

Boris Peaker – Oppenheimer

Hello. Can you hear me?

Joe Belanoff

Yes, Boris. I can hear you.

Boris Peaker – Oppenheimer

Hi, Joe. How are you?

Joe Belanoff

Very well, thanks. Thanks for calling.

Boris Peaker – Oppenheimer

I have a few questions and maybe I’ll start with commercial questions. What fraction of clinical trial patients rolled over from that clinical trial to the commercial supply of drug, do you have that?

Joe Belanoff

That is correct. Yes.

Boris Peaker – Oppenheimer

Yeah, but can you tell me what fraction? Is it all of them have rolled over, or is it just?

Joe Belanoff

I can answer your question, generally, yes. Of the patients who are in the clinical trial, almost every patient who was still on the medicine at the point of that – of the extension study became a commercial user of the drug.

Boris Peaker – Oppenheimer

Got it. Okay. So that’s helpful. Now in terms of the competitive developments, or could you just give us some comments on – as this being the first drug approved and then no prior drugs available for these patients, what is this drug competing with in the marketplace? Is it surgical procedures? Is it other drug use off-labels? Can you just position it competitively for us?

Joe Belanoff

Sure. And so, Boris yes, first just to remind everyone who’s on the call, the medication is approved for patients who either have failed surgery or surgery has failed them, I really should say, or who are ineligible for surgery. So, we really recommend – and I say this both personally and professionally – that if a patient’s tumor can be found and it can be removed, that’s great. That’s a cure and that would certainly be medically what we would recommend.

And so patients who are in that sphere kind of go in two directions, either they do get cured, but unfortunately about half of them either are not cured right from the get-go or their tumor comes back. And the sort of the metaphor I kind of use for it over time is I think that it’s wrong to think of these tumors as if they were sort of a walnut you could grab; they’re not. They’re more like a spider and unfortunately if you leave half a leg, a year-and-a-half later you have another tumor, often deep in the tissue.

So, I wouldn’t really say that’s a competitive treatment. That’s a treatment we would actually ourselves recommend for patients as a first line piece of therapy. However, there’s a large group of patients for whom that is unfortunately not curative and that is really where Korlym fits in.

Now there in terms of what other medications are used – and I think that many on the call may know – that for years it was discovered, in fact, I guess probably in the mid to late 1980s it was discovered that an unfortunate side effect of the medication ketoconazole, which was an anti-fungal was that it was essentially a poison to the process of producing cortisol. And in fact shortly after that in patients who failed surgery, it began to be used as a medical treatment for Cushing’s syndrome.

And I think that for doctors who have been around for a while, it is a familiar treatment. So in some respects, it’s a difficult medication to use. It has to be used multiple times a day. There’s a liver toxicity associated with it, but it is what has been used off-label now for many, many years. So that really is basically the active competitive landscape at the current time.

There are another medications used much less infrequently that are like ketoconazole but really they operate essentially with the same mechanism of action, which is just poisoning the process to produce cortisol.

Boris Peaker – Oppenheimer

Could you then maybe just in the same context in terms of competitive landscape, could you give us some – I don’t know if you can give quantitative or then if not, then maybe qualitative guidance of some sort, what to expect and when from the commercial adoption of Korlym?

Joe Belanoff

I’m not sure I really can answer your question, exactly. I can maybe answer it a bit more subjectively. As I said, most endocrinologists in the field know that ketoconazole is a drug they would have tried before Korlym and some will still try it now. I think there are others who, as they begin to use Korlym, will use it first as opposed to using ketoconazole first. It’s just difficult to know how that transition will take place.

What we’ve really said to our commercial team and really throughout the company is our biggest hurdle and our biggest objective is to get a doctor to use Korlym once. Because once they’ve used it a single time, it’s very clear to them how well it works and I think it makes it much easier for them to write the second prescription. And I will tell you that some of those second prescriptions are now starting to come in.

Boris Peaker – Oppenheimer

Okay. Well, my last question is any updates on European strategy?

Joe Belanoff

Yes, I’m glad to give it. I think as you can imagine, that Cushing’s syndrome is just as common an illness in Europe as it is in United States. We have in recent months worked very hard to put together our MAA, our equivalent of the NDA for the European theater, and that has actually moved along quite well.

We recently, in fact, had preliminary meetings with the European regulatory authorities and we’ll be moving forward as the year progresses. And we’ve looked very hard and still have not made a decision as to whether or not we want to partner the medication or go it alone. I think again, as many of you on the call know, the European healthcare system is a system that really centralizes care.

So for instance as an example, in the Netherlands there really are only two centers that treat Cushing’s syndrome, the patients all end up there. What’s been interesting, one of the things we’ve learned in the United States is that while there are Cushing’s specialists, a bit of a surprise to us is that there are, in fact, what may be many doctors out there who have one, two, three or four patients who they also treat with Cushing’s syndrome, even though their large part of their practice is really diabetologic practice.

So where it sort of goes to, Boris, is that in Europe it is possible for a small company to market the drug on its own and to keep all the economics for itself. I’m not saying that we’re going in that direction, we may still partner the drug and certainly have consider partnering bids even to this date, we just haven’t made a decision yet.

Boris Peaker – Oppenheimer

Okay. Well thank you very much for taking my questions.

Joe Belanoff

No, not at all.

Operator

Thank you. The next question is from Annabel Samimy from Stifel, Nicolaus. Please go ahead.

Annabel Samimy – Stifel Nicolaus

Hi, can you hear me?

Joe Belanoff

I can Annabel. Please go ahead.

Annabel Samimy – Stifel Nicolaus

Hi, thanks for taking my question then...

Joe Belanoff

Sure.

Annabel Samimy – Stifel Nicolaus

Can you just, in the same vein as the last question, can you tell us what you think the biggest hurdles are for these patients to initiate therapy, given that really they’re without option, they’ve failed surgery or they’ve – they’re not eligible for surgery? So what do you think the biggest hurdles are to initiating therapy for some of these patients?

Joe Belanoff

I think the biggest hurdle is that this is a new mechanism of action for the treatment of Cushing’s syndrome and I think that as a group and in taking this group among doctors, endocrinologists are fairly conservative. They’re slow to try new treatments, at least as a group. And I think that really – the thing which really moves that along is, again, the first treatment. And we have several things in place to really enhance that.

For instance, we now have people who were investigators in our clinical trial actively talking to other physicians, both one-on-one in the form of webinars, in terms of direct communication at meetings, to let them know that this is a medication maybe they can be comfortable to using and that it is, in fact – has been in fact very effective for their patients.

We present at conferences. We’re sort of recovering academics. We publish all the information we have. But I think the single biggest hurdle is simply the hurdle of conservative use with a new medication. This is not like we’re the seventh medication into this field. This is a disease that really hasn’t had an approved treatment and I think we really have to do the hard work to get that going.

And so what I’d also add to that is in our strategy, yes, we really did not have the money to hire MSLs or sales force before approval. But we decided to hire medical science liaisons first because we really wanted to seed the practitioners with the scientific knowledge they would need to begin to consider use of the drug. And now as time as gone along, we can now return to them a second or third time with a more sales-oriented call.

So I think, again, just to really repeat myself, but I think it’s an important thing to repeat: the single biggest thing is getting doctors to write their first prescription, after that I think the medicine takes care of itself.

Annabel Samimy – Stifel Nicolaus

Okay. And could you talk how many of the 300 target endocrinologists that your medical liaison reps have reached already?

Joe Belanoff

I don’t know the exact number of that and it’s not all of them, but it’s a percentage that’s greater than half at this point.

Annabel Samimy – Stifel Nicolaus

Okay. And if I can just go more towards the actual treatment, do you have a sense of what the average dose is for the patients who are on treatment right now?

Joe Belanoff

We haven’t disclosed that piece of information. But I’ll give you two things that may be helpful for you, I don’t know. In the trial, the average dose was about 750 milligrams, but it’s a little bit misleading because, as you know, this is a medication which needs to be titrated, and so you capture people both at the low end and then above that.

And if you also remember, in the trial, the mode group, so the group with the largest number of people at the end of the trial were actually on 1,200 milligrams. But there were people who responded at 300, 600, 900, 1,200 and there were people who actually took more than that. An interesting thing is that of the patients who have actually transitioned from the clinical trial, so those who’ve been now on the medicine for two, three years in many cases, the average dose is about 850 milligrams.

Annabel Samimy – Stifel Nicolaus

Okay. Great. And can you just give us one more sense of the speed of enrollment and the PMD indication? I know you just got some more funds to speed up that trial. How do you think that getting those sites on board, how is that going to progress in terms of helping enrollment?

Joe Belanoff

Well now, I’m really glad you asked about that. I was hoping someone would because that’s such an important priority for us. So Annabel, I know you’ve followed the story for a long time and you know basically as a money-saving technique and it turned out to be the correct one, we really focused our financial resources on getting the Cushing’s syndrome program completed and pared down the number of sites in our clinical trial to about eight, which was basically just kind of a low simmer.

As a result of the financings that we did over the summer, we’ve now began to gear up. Our goal is to have 20 sites online by the end of the year and realistically certainly into the first – by the end of the first quarter or into the first quarter. And we think that will change enrollment a lot. But as you may know, there’s just a time lag to getting – making the decision to putting a site online and actually getting them online.

So that’s just now starting to happen. It really hasn’t changed the pace of enrollment at all at this point. But to kind of get to the end of the story, we are hoping that we will be able to conclude enrollment in the study by the end of 2013 and – cross our fingers with a successful result – be able to send in our NDA in 2014.

Annabel Samimy – Stifel Nicolaus

Okay. Thank you.

Operator

Thank you. Our next question is from Ravi Mehrotra from Credit Suisse. Please go ahead.

Koon Ching – Credit Suisse

Hi, this is Koon Ching actually asking question on behalf of Ravi, just a couple, if I may.

Joe Belanoff

Sure.

Koon Ching – Credit Suisse

So one of the things you mentioned was that your physician base, your anticipated physician base actually is a little bit different, right? You have more community endocrinologists.

Joe Belanoff

Yes.

Koon Ching – Credit Suisse

I guess as opposed to the central – as opposed endocrinologists in the center. I just wanted to know why has that been the case? I just want to know why, you would think that the endocrinologists at the centers would sort of be the primary users of your drug. Just curious as to why that’s the case.

Joe Belanoff

Koon, that’s a good question. And it’s one I’ve actually given a lot of thought to. I think that we really and part of this like with all of us is sort of the prejudice of your own background and I came from major medical centers, so I just figured that that’s where all patients ended up. But in fact, that’s not the case. What we really found and it started right from the beginnings, we were getting prescriptions from doctors who we didn’t even know their name. We had no idea who they actually were.

And what we found is that there were doctors all throughout America who are endocrinologists, whose primary practice is diabetes, which is unfortunately the epidemic that it is. But who’ve managed over the time to maintain an interest in what they’d learned in their training and feel comfortable treating patients with Cushing’s syndrome, and have one, two, three or four patients in their practice who need treatment. And in some sense they never gave those patients up to the major medical centers.

And so now, having gotten that information and not just in a single place, but actually quite a few places, we’ve really decided that every patient is worth our time. And that was really behind the incentive to – that was really our incentive and what was behind adding the clinical special sales reps who we’ve added now in October. Because we want to really be able to geographically get to those doctors and help them with their needs. Every patient frankly to us is so valuable that it’s worth it.

Koon Ching – Credit Suisse

Thanks. And what has limited the use of Korlym by the academic centers then?

Joe Belanoff

No. I don’t think anything has particularly limited it, it’s just that we expected that – and I think this is something that we announced – we talked about before the medication was even approved, that it was really our assumption, which we’ve had to modify. That essentially, like Europe for instance, all the patients got to the medical centers, and they don’t. I mean, a lot of them do not get there. Sometimes they’ll get their surgery in a major medical center, but when they’re actually – their surgery does not work, they don’t necessarily turn to that major medical center to get retreated. They go to their community endocrinologist who is willing to take their care.

Koon Ching – Credit Suisse

Okay. And just one more question if I may. How many patients, how many eligible patients have you actually identified if you spanned the community endocrinologists that you’ve seen prescriptions from, as well as the academic centers?

Joe Belanoff

We don’t have an exact number of patients who we have identified and really what I’ll just sort of return to is, originally, what we learned was – what we’ve learned from the literature that there was about 20,000 patients with Cushing’s syndrome and about half of them were cured with surgery and we haven’t really seen anything from any of the data which has come in or from what others are doing to really make us change our mind about the overall market size.

So, we’re really in a process of identifying patients in some sense one-by-one and doctors, one-by-one, as they prescribe.

Koon Ching – Credit Suisse

Okay, all right. Thank you very much.

Joe Belanoff

All right. I think that concludes all the questioners. I hope everyone on the East Coast goes out and enjoys Halloween and recovers from the storm. And we will be talking to you as we have more information. Thank you very much.

Operator

Thank you, ladies and gentlemen. This concludes today’s conference. Thank you for participating. You may now disconnect.

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