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Corcept Therapeutics Inc
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Good day and welcome to the Corcept Therapeutics Conference Call. Today’s conference is being recorded. [Operator Instructions]
At this time, I would like to turn the conference over to Charlie Robb. Please go ahead, sir.
Good afternoon. I’m Charlie Robb, Corcept’s Chief Financial Officer. Thank you all for joining us. Earlier today, we issued a press release giving our second quarter financial results, announcing a stock repurchase program and providing a clinical development. A copy is available at corcept.com. Complete financial results are available in our Form 10-Q. Today’s call is being recorded. A replay will be available through August 23, 2018 at 888-203-1112 from the United States and 719-457-0820 internationally. The passcode will be 6703650.
Statements during this call other than statements of historical fact are forward-looking statements based on our plans and expectations and are subject to risks and uncertainties that might cause actual results to differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to generate sufficient revenue to fund our commercial operations and development programs, the protections afforded by Korlym’s Orphan Drug designation and our intellectual property; the availability of competing treatments, including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; and the scientific regulatory management and financial risks related to the development of our product candidates. These and other risks are set forth in our SEC filings, which are available at our website and the SEC’s website.
On this call, forward looking statements will include those concerning our 2018 revenue guidance and expected growth in 2019 and beyond; our stock repurchase program and its intended funding sources; physician awareness of hypercortisolism and selection of Korlym as the best medical treatment for many patients and continued shifts in medical practice; the clinical attributes of relacorilant; data from the dose-finding portion of our Phase1/2 study of relacorilant plus Abraxane as justification for expanding our oncology program; and the progress and results of our development programs, including our current and planned clinical trials of relacorilant CORT125281 and CORT118335. We disclaim any intention or duty to update forward-looking statements made in this press release or on this call.
Now I will review our financial results. Corcept’s revenue in the second quarter was $62.3 million, 75% increase from the second quarter of 2017. This increase was primarily due to broad-based organic growth, more physicians prescribing Korlym to more patients. There was no price increase in the quarter.
We have reduced our 2018 revenue guidance from a range of $275 million to $300 million to a range of $250 million to $270 million, which constitutes growth of between 57% and 70%, compared to our revenue last year. We expect significant growth in 2019 and beyond.
Our fully diluted net income in the second quarter was $0.14 per share, compared to $0.10 per share in the second quarter of 2017. Excluding non-cash expenses related to the stock compensation and use of our deferred tax assets, second quarter non-GAAP net income was $25.4 million, compared to $16 million in the second quarter of 2017.
Cash and investments at June 30 were $159.9 million, up from $140.4 million at March 31. We announced today that our Board of Directors upon consideration of our strong financial position and prospects has approved a program running through June 30, 2019 to repurchase up to $100 million of our common stock. We will determine timing and size of any repurchases based on market conditions, our stock price and other factors.
We believe revenue from our Cushing’s syndrome franchise together with our cash on hand will be sufficient to fully fund our commercial business, conduct Phase 2 and Phase 3 trials of relacorilant in both Cushing’s syndrome and solid tumors, conduct Phase 1, 2, and 3 trials of CORT125281 for castration-resistant prostate cancer and CORT118335 for antipsychotic-induced weight gain and NASH, advance to the clinic additional proprietary selective cortisol modulators and fund our plan to repurchase up to $100 million of our common stock.
I will now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Joe?
Thank you, Charlie. Thank you, everyone, for joining us today. Corcept had another strong quarter. Revenue grew to $62.3 million, 75% more than our revenue in the second quarter last year. Excluding significant non-cash items, our non-GAAP net income was $25.4 million, 59% increase over the second quarter last year.
Our cash and investments grew by $19.6 million to $159.9 million. The second quarter growth in our Cushing’s syndrome franchise was driven by the factors I described on previous calls. Korlym, our first-generation cortisol modulator works very well and practically all patients with hypercortisolism. At the same time, physicians are increasingly aware that every instance of hypercortisolism is serious and merits treatment.
As they screen more thoroughly for the disorder, physicians are again to find more patients, and in many cases, choosing cortisol modulation with Korlym as the best medical treatment. This shift in medical practice is not slowing down. We’re reducing our revenue guidance for the year, because we do not think we will see revenue growth accelerate past the 60% to 65% growth rate we are currently seeing. An important reason for confidence in the future of our hypercortisolism franchise is our proprietary selective cortisol modulator, relacorilant. We released positive interim data from relacorilant’s Phase 2 trial.
To understand the promise, relacorilant holds for our business, I need to explain how relacorilant’s clinical data suggest it would benefit patients. As many of you know, Korlym competes with cortisol at the glucocorticoid receptor, GR, for short. The receptor, which is activated when cortisol levels are high.
Patients with hypercortisolism have too much cortisol activity at GR, which is what causes their symptoms. By reducing excess cortisol activity, Korlym makes patients better. Unfortunately, Korlym also binds the progesterone receptor, or PR. Korlym’s affinity for PR makes it an [aboard of] [ph] fashion and causes in many women endometrial thickening and vaginal bleeding. A cortisol modulator does not cause these adverse events or constitute a major clinical and commercial advance. This is why our objective when we set out to design relacorilant years ago was simple. Create Korlym without PR affinity, we succeeded.
Preclinical and clinical studies demonstrate that relacorilant does not bind to PR and so does not cause Korlym’s progesterone-related off-target effects. But relacorilant’s clinical data demonstrates another important benefit, one we did not fully anticipate. By reducing cortisol’s negative feedback in the hypothalamus and pituitary gland, Korlym usually causes a patient’s cortisol levels to rise even if their hypercortisolism symptoms abate.
Unfortunately, to the activation of an off-target receptor elevated cortisol often causes the patient’s potassium levels to drop, potentially life-threatening condition known as hyperkalemia. Physicians prescribing Korlym must monitor patients closely for hyperkalemia for as long as their patients take Korlym since this condition can develop at any time.
The Korlym label has a section expressly directed to this risk. Despite their physicians diligence, hyperkalemia remains common in patients taking Korlym. 44% of the subjects in Korlym’s pivotal trial develop hyperkalemia. It’s one of the most frequently reported adverse events and causes a discontinuation in patients taking Korlym today.
Our clinical data shows that relacorilant does not cause this off-target effect. It modulates cortisol activity at GR, which is why patients in its Phase 2 trial experience clinical benefit. But unlike Korlym, relacorilantdoes not cause cortisol levels to rise very much. As a result, it did not cause hyperkalemia. This is very good news for patients and for Corcept.
Now I will briefly describe the results we released today. Relacorilant’s Phase 2 trial is a 35 patient open-label study conducted at sites in the United States and Europe. Its purpose is to evaluate the efficacy and safety of relacorilantover a range of potential doses, so the optimum range can be advanced to Phase 3.
The trial consists of two cohorts, an initial low-dose cohort received a daily dose of 100 milligrams of relacorilant for four weeks, then four weeks of 150 milligrams and finally, four weeks of 200 milligrams. This group has completed the study.
The trial’s second high-dose cohort filed the same four-week titration protocol with doses of 250 milligrams per day, followed by 300 milligrams and 350 milligrams and finally, 400 milligrams per day. We have data from this group to eight weeks of treatment, which includes completion of the 250 milligram and 300 milligram dose levels.
Based on feedback from the FDA, we have applied to this Phase 2 data, the response criteria we plan to use in relacorilant’s Phase 3 trial. These endpoints mark clinically meaningful improvements in glucose control and hypertension to a hypercortisolism’s most prominent and pernicious symptoms.
As measured against these endpoints, the response of patients in the high-dose cohort after eight weeks was impressive. 58% of patients with hyperglycemia achieved improved glucose control, as shown by either 0.5% or greater reduction in Hemoglobin A1C or a 50 milligram per deciliter or greater reduction or normalization into our glucose as measured in the oral glucose tolerance test, or a meaningful decrease in anti-diabetic medications.
By comparison, 48% had met this endpoint after 10 weeks of treatment in Korlym’s pivotal trial and 23% had done so with the conclusion of 12 weeks of treatment in the relacorilant low-dose cohort. In addition, 55% of patients in the relacorilant high-dose cohort with uncontrolled hypertension achieved a 5 millimeter or greater drop in either systolic or diestop blood pressure as measured by 24-hour ambulatory monitoring.
The comparable figure for Korlym’s pivotal trial was 44%. For the relacorilant, low-dose cohort was 45%. These positive interim data frame well our clinical and commercial expectations for relacorilant. It has the potential to provide clinically meaningful benefits to patients with hypercortisolism without the two off-target effects that cause Korlym’s most frequent and potentially serious adverse events. We look forward to confirming these findings in a Phase 3 trial, which we plan to start this year.
I’ll turn now to our oncology program, which is about to expand significantly. Some of you know, cortisol modulators may help treat solid tumors through several mechanisms. In cancers, where the tumors express GR, such as ovarian pancreatic and triple negative breast cancer, cortisol stimulates genes that prevent apoptosis. The program sell that chemotherapies are meant to provoke.
Preventing the stimulation of apoptosis suppressing genes by adding a cortisol modulator to a chemotherapy regimen should allow that regimen to achieve its optimal effect Cortisol modulators may also help the body’s immune system by cancer. A healthy body produces cancer cells all the time, but the immune system identifies and destroys them.
Cortisol suppresses the immune system. The stress of cancer and its treatment increase cortisol activity, creating even greater immunosuppression. Cortisol modulators administered either as monotherapy or in combination with immunotherapy medications may counter this effect, allowing the immune system to act more potently.
At the ASCO meeting this May, we reported positive data from our Phase 1/2 study of relacorilant plus Abraxane to treat patients with solid tumors. At the minimum therapeutic dose, four of seven patients with metastatic ovarian cancer and four of nine patients of metastatic pancreatic cancer demonstrated durable disease control. These patients all had aggressive metastatic disease and had progressed on one or more prior taxane-based treatments and yet they benefited when a cortisol modulatorwas added to their taxane treatment.
Based on these findings and compelling preclinical data, we plan to initiate a placebo-controlled Phase 2 trial of relacorilant plus Abraxane in metastatic ovarian cancer by year-end. By year-end, we also expect to have collected sufficient data from patients with metastatic pancreatic cancer to determine if we can proceed to a pivotal study for that indication.
As we advanced relacorilant to Phase 2, our collaboration with the University of Chicago are conducting their own clinical trial using Korlym to treat solid tumors. With financial support from Celgene, they continue to enroll patients in their 64-patient double-blind, placebo-controlled, multicenter Phase 2 trial of Korlym plus Abraxane to treat patients with triple negative breast cancer.
They’re also enrolling patients in a 74-patient open-label Phase 2 trial of Korlym in conjunction with Merck’s immunotherapy agent, KEYTRUDA, to treat patients with triple negative breast and HER-2 negative breast cancer. Merck is providing financial support for that trial. We are providing Korlym to both trials and possessed the intellectual property covering the use of these combinations of medications for these indications.
As some of you know, our oncology program is pursuing an additional lethal disease, castration resistant prostate cancer. Androgen stimulate growth in tumors of the prostate, which is why androgen deprivation known as chemical castration is a common treatment.
Unfortunately, patients treated with an androgen receptor blocker, such as Pfizer’s drug XTANDI, often quickly develop tumors, where cortisol is the primary growth factor. Combining a cortisolmodulator with an androgen modulator, such as XTANDI from the outset of treatment may block this cancer escape route.
We are currently in the dose ranging portion of our clinical program testing our proprietary selective cortisol modulator, CORT125281 plus XTANDI, to treat patients with metastatic castration resistant prostate cancer. At the same time, University of Chicago investigators continue to advance their 84-patient controlled multicenter Phase 2 trial of Korlym plus XTANDI.
Department of Defense and the Prostate Cancer Foundation are funding this trial. Pfizer is providing XTANDI, we are providing Korlym and possess the intellectual property for the use of this combination of medications.
I will close with a brief discussion of one of our most promising selective cortisol modulators, CORT118335, which is currently undergoing Phase 1 testing. CORT118335 has particularly potent effects in the liver, which makes it a promising candidate to treat two serious disorders. The weight gain and other metabolic ill effects experienced by patients taking antipsychotic medications and non-alcoholics steatotic hepatitis commonly referred to as NASH.
Millions of people rely on antipsychotic medications, such as ZYPREXA and Risperdal to treat psychosis. These drugs work well, because serious metabolic side effects, including weight gain, hyperglycemia and hyperlipidemia. There are no good treatment options for the millions of patients suffering these ill effects.
We have demonstrated in placebo-controlled clinical trials that in healthy human subjects, Korlym significantly mitigates the metabolic side effects caused by ZYPREXA and Risperdal. The study results were published in the journals, Advances in Therapy in October 2009 and in Obesity in December 2010. Unfortunately, Korlym’s PR affinity to be blunt its status as the abortion pill, prevented us from developing it for this important use.
In animal models, CORT118335 prevents and reverses antipsychotic-induced weight gain more potently than Korlym does. And because it is a selective cortisol modulator with no infinity for PR where 118335 can be developed and potentially distributed to the millions of patients with this disorder.
Many of you are already familiar with NASH, a form of liver inflammation that is often a precursor to cirrhosis. NASH affects millions of people in the United States and there are no good treatment options. We know that cortisol modulation may offer a treatment for NASH, because we have observed Korlym reversing fatty liver disease in patients with Cushing’s syndrome.
In animal models, CORT118335 is more potent than Korlym in preventing and reversing fatty liver disease. These preclinical results are compelling. They’re made even more compelling by our positive clinical findings with Korlym. If CORT118335 Phase 1 trial is successful, we plan to advance it to Phase 2 for both antipsychotic-induced weight gain NASH by year-end.
To recap, Corcept had another strong commercial quarter. Revenue increase by 75% over the same period last year. We expect 2018 revenue of between $250 million and $270 million with significant growth in 2019 and beyond. Excluding significant non-cash items, our non-GAAP net income increased by 59% over the second quarter last year. Our cash and investments grew by $19.5 million in the first quarter to $159.9 million. We have no debt.
Our Phase 2 trial of relacorilant is fully enrolled and continues to generate positive data, including surprising and very important finding that relacorilant does not cause hypokalemia, one of Korlym most common adverse events. We are on track to begin relacorilant’s Phase 3 trial this year.
Our oncology program is taking significant steps forward. By year-end, we plan to file the positive data we released in May with placebo-controlled Phase 2 trial of relacorilant plus Abraxane in patience with metastatic ovarian cancer. We also expect to collect by year-end sufficient data to decide whether a registrational study of relacorilant plus Abraxane is warranted in patients with metastatic pancreatic cancer.
Our Phase 1 trial of CORT118335 is nearing completion, and we plan to advance the compound to Phase 2 for both antipsychotic-induced weight gain and NASH by year-end. Serious disorders suffer by millions of people for which there are no good treatment options.
I’ll stop now to answer questions.
Thank you. [Operator Instructions] We’ll go first to Adam Walsh with Stifel.
Hey, guys, this is Neil Carnahan on for Adam. Would you guys mind providing some detail on the number of patients that ended up making it to the 350 milligram and 400 milligram cohorts? And then just any more detail you can provide around the discontinuation, what dose that occurred at? Thanks.
I’m not sure I exactly follow your question. I apologize, Neil. Please again tell?
Like what percentage of patients made it to in the dose-escalation made it to the 350 milligram, 450 milligram dose? And then on the SAE, do you have any detail around what dose that occurred at?
Yes. Okay. I think, I can get there. We have data now through 300 milligrams, that – that’s what we presented to date and will present the rest of the data as we actually have it in completion. And I want to just turn over for a second to Bob Fishman, who I think can answer the question about the adverse event.
Yes.
By the way, for those of you who don’t know, I’ve been on oncology for Bob is our Chief Medical Officer.
Right. The – well, to clarify the one serious adverse event was a pilonidal abscess and this is a complication of a congenital defect. It starts out as a pilonidal system, it simply became infected. So I don’t recall the exact dose at which occurred, but it was clearly by the investigator judgments and and ours unrelated.
And the second question was about the person who discontinued, which dose was that?
All right. It was on a – go ahead, sorry.
Yes, I believe it was at the 300 milligram.
At 300 milligram dose, Adam. Okay.
Okay. Thank you. I’ll get back in queue.
We’ll go next to Tazeen Ahmad with Bank of America.
Hi, guys, thanks for taking my questions.
Sure.
Would you mind us giving us an update on, I guess, where the Teva situation is with the patent litigation in terms of when we should expect the next update either from you or for Teva – from Teva or just from the CORT in Teva?
Yes, very glad to do so. I’m just turning the call back over to Charlie Robb, our Chief Financial Officer.
Yes. Hi, Tazeen. I’m sure, I’m happy to answer. Let me just stop by giving just a – I’ve got to give a little bit of background for – others on the call who might not be as up to speed on that as you are. So you understand, I can’t – for others, I really can’t comment on the substance of our legal positions or Teva’s legal position, our strategy and so forth. What all that we have, as you referred to our publicly available documents and those to date are just very, very few.
But with that understood for everyone, I – Tazeen, I can answer your question. In broad terms, what we’re seeing now is, what we believe you should get used to seeing for quite sometimes complex legal process and argument, paperwork exchanges pushing us and Teva that we think is going to go on for – in one form or another for quite a while.
Now with that sort of bit of context, I can answer your question directly. As most of you know, in February, we received notice that Teva had filed an Abbreviated New Drug Application, or ANDA, with the FDA, seeking approval to sell a generic version of Korlym. Under the statute that governs these things Hatch-Waxman Act, we then had 45 days to sue to have an infringement of what are called our Orange Book patents.
These are the patents that the owner of a branded product, such as Korlym believes that generic would infringe. So on March 15, we sued Teva for infringement of what is the time where our two Orange Book patents. Under Hatch-Waxman, our lawsuit automatically stayed or on nonlegal terms prevented the FDA’s approval of Teva’s proposed generic product for 30 months for the resolution of our lawsuit with respect to those patents, whichever comes first.
So in June, Teva moved to dismiss our complaint. In July, we amended our complaint. And among other things, our new complaint added allegations of infringement of a third newly issued Orange Book patent. So now we’re suing three patents against Teva. As we expected, later in July, Teva moved to dismiss our new complaint, and that’s where we are right now.
Our response to Teva’s new motion is due later this month, I think, August 21st or thereabouts. Teva will have a chance to reply to that response. And sometime in the fall, we expect to be arguing the issue in front of the judge. So that’s where we are with the back and forth. And I think, yes there’s no more – cannot be more descriptive than that.
Okay. Thanks for that color.
Sure.
We’ll go next to Corey Davis with Seaport.
Corey?
Good afternoon. Thanks. I’m sorry, jumped on the call late if you answered this. But in general, how enthusiastic would you say you are in the relacorilant data in terms of these lower doses continuing to show a higher response in the last two doses that you have yet to report on?
Well, I’m going to again turn this over to Bob [Technical Difficulty]. A general answer to your question is very enthusiastic. I mean, these are significant clinical effects in the absence of, as expected, progesterone receptor antagonism. But again, we commented on it when we presented on the low-dose group in a minor way, because we weren’t sure whether that would continue as we increase the dose.
But the striking lack of hyperglycemia is a very, very meaningful events and one that makes the medication in some respects much easier to use for many practitioners than Korlym. But I’ll turn over to Bob if you have any additional comment.
I would just add that the investigators impression of the benefit that they’re seeing in their individual patients was reflected in the acceleration of the pace of enrollment this year. So we – that was a strong indicator that the investigators were seeing the benefit that adds up to the data displays that we showed you.
And then, again, I apologize if you answered this already. But how quickly can you start enrollment of the Phase 3? And do you need to wrap certain things up before you can finalize the protocol, get the sights onboard, et cetera, et cetera?
Bob?
We had – yes, thanks for your question. Just to provide some context, we had the very unusual and enormously helpful position of being able to ask FDA for guidance for Phase 2 was ongoing, because we have an open-label trial. And so we submitted interim data and a proposal for our Phase 2 plan to FDA they took our request seriously and gave meaningful guidance. So that we’re confident we settled on endpoints that are going to meet their expectations. And so we have the design, we’ve shown you in our press release, our plan response criteria by which we will measure clinical benefit in these patients.
And what it all really funnels down to, I think, to answer your question, Corey is, we we are fully expecting to be able to start the study this year.
So is there anything left to do that is contingent upon completion of the ongoing study?
Again, we are in active planning for the Phase 3 study and expect to begin it in sometime in the near future. I don’t really have any more detail for you than that. In some sense, you’ve seen all the important data that we’ve seen.
All right. And then lastly, just safe to assume then that in its guidance to you that the FDA agrees that the endpoints as presented in this press release are going to be sufficient for endpoints in your Phase 3 program?
Bob?
Well, first just to clarify, we don’t have a special protocol assessment. So they haven’t officially approved them. But the guidance, as I mentioned, was very meaningful. So, yes, we have a high confidence in some of these endpoints. We’ll need FDA’s expectations and we’re confident that we’re the – collecting the data necessary to show the clinical improvement in the patients with Cushing’s syndrome.
Okay. That’s all I had for now. Thank you.
We’ll go next to Matt Kaplan with Ladenburg Thalmann.
Good afternoon. Just want to focus a little bit more on the Phase 3 plan for relacorilant. Can you give us a little bit more detail in terms of what the Phase 3 will look like the timeline? And I guess, will you have to go head to head versus Korlym in the study?
Yes, happy to do so. So we plan a Phase 3 that will be about 120 patients, it will be an international study. And it will be a placebo-controlled, randomized withdrawal study, and I’ll be back to that in just a moment. We will enroll patients who have endogenous Cushing’s syndrome, who as you heard, also have hyperglycemia and/or uncontrolled hypertension. And the patients will enter a six-month open label phase that starts with dose escalation, and this remind many on the call of the structure of the seismic trial.
And then patients who meet the response criteria, which you’ve seen laid out and are the basis for data displays in the press release, those patients who meet response criteria will then enter a randomized withdrawal phase. And in the randomized withdrawal phase, patients either stay on medicine or they switch to placebo, and that’s done in a blinded fashion.
And once they randomize, we expect patients on medicine to maintain their response in the patients on placebo to start to lose some of the benefit that they had gained previously. And then we compare the differences in glucose control and in blood pressure between the medicine group and the placebo group.
One of the benefits of this is that it helps minimize the amount of time that these really sick patients spend on placebo. And in all of these trials as well as in ours, there will be enrolled than anyone with a significant relapse of their disease can go right back on drug.
Great. And potential timeline for study like that?
Well, as Joe mentioned, planning to start this year assume the two years end-to-end, which brings us to mid-2020.
So I just want to repeat that that’s two years first patient in to last patient out. But I think there was a little confusion in the past call about the glucose, I think, was a mistake two years in enrollment, that’s not what we mean. Two years from first patient into last patient out.
Got it. Thank you for that detail. And then just going back to the interim Phase 2 results that you reported. Initially, you showed a dose response in terms of glucose control at the lower dose. Are you continuing to see that at the higher-dose cohort?
We’re certainly seeing it and the best display of that is the point in particular to the graph on the number of responders for improvements in glucose control which was three in the low-dose group and seven in the high-dose group. So, yes, we’re seeing continued benefit in terms of that increased number of respondents.
Okay. And I guess, this is – you’re – the study you’re just going to need a single study for the approval actually?
Bob?
Yes, that’s our expectation. We have no indication of anything otherwise.
And how many patients do you need to get into the withdrawal phase randomized withdrawal?
Into the what?
How many patients you need to make it through the dose-escalation six-month open-label dose escalation to get to?
Rough numbers, out of the 120 open-label phase, we’ll need about 60 completer responders, meaning people who both complete in our responders and therefore, both qualify and are available to enter the randomized withdrawal phase.
Thanks a lot for the added detail.
You’re welcome.
Thanks, Matt.
And we’ll take a follow-up from Adam Walsh with Stifel.
Hi, guys. Can you just walk us through on the rationale behind, you guys obviously had kind of track record of being raised. Can you just talk to us about what’s changed since you originally issued guidance back in February? And then just the rationale behind the buyback program? Thank you.
Yes, very good. So two questions in there and I’m going to sort them in a different way. First, again, I want to reintroduce you to Sean Maduck, he is our senior Commercial Officer, who runs the Cushing’s syndrome franchise for the commercial question. And then I think, Charlie will answer the second question.
Hi, Neil, thanks for the question. Our business is rapidly growing. And in the orphan drug space, I think, as many people know, the law of small numbers exist, which can make it very difficult to predict future revenues. I definitely don’t say this as an excuse, as we as an organization always trying to be as accurate as we possibly can. But that being said, predicting whether we’re going to grow at 60% or 80% is not perfect science.
As a reminder to everybody on the call, we raised our guidance multiple times last year, because we underestimated the accelerated uptake that occurred and we were lowering our projections. If you look back historically, our revenues have grown by approximately 60% to 90% annually over the last two years, and we have definitely seeing fluctuations in that growth over that window of a time.
For this year – remainder of this year further acceleration off of our current 60% to 68% growth rate doesn’t seem likely, as Joe has previously mentioned, which is why we adjusted our revenue range down. Again, as an organization, we strive to be as accurate as possible on our estimates and this guidance shift does not change our belief in the longer-term size and value of this market.
In terms of our actual business this year, we continue to experience revenue growth from both new and existing prescribers and we expect that to continue through this year and into next and beyond. Our prescriber base is growing. And in the first six months of 2018, we actually added more new prescribers and saw more active prescribers, which as any physician that has written one or more prescription than in any equivalent window of time since launch.
In fact, over half of our prescriptions this year in 2018 have come from physicians that prescribe Korlym for the first time over the last 12 months, and we believe this bodes very well for the future. And we said this many times before, but there are many naive – Korlym naive physicians have yet to write their first prescription. And we believe there are many more hypercortisolism patients who could benefit from a GIR receptor antagonism.
Thanks, Sean.
Okay. Thank you. And then just on the buyback?
Yes. Hey, Neil, this is Charlie. The reason – the rationale for the buyback is really very straightforward, as I said in my introductory remarks. Looking at our cash reserves, our prospects and our planned development activities, we felt that we would be able to do all of those things and return money in this sort of tax efficient way to shareholders and we got that sort of as our company that’s our obligation to do that. So that’s why we’ve announced the program.
Thank you, guys.
Thank you.
Adam.
We’ll go next to Alan Leong with BioWatch News.
Thanks for taking my questions, Joe, Charlie, Sean, and Bob.
Sure.
First set of question really goes back to the recent results, but really I want to take a different tact on it. I wanted to talk – see if I get a discussion on the impact on labeling, because Korlym didn’t earn a blood pressure label. But what can you say now about the FDA’s approach for earning such a way within Cushing’s? And then as you – and then the follow-up on that is, as you sit back and look at your results, what were major lessons learned or carryovers into your general metabolic program?
Okay. Let me see if I can really sort those questions out. I mean, I think, really the first thing to begin with Alan is that, GR modulator like relacorilant, that’s the one you asked about. What’s really the point of approval is for the treatment of Cushing’s syndrome. We’ve highlighted two symptoms, glycaemic control and hypertension as a kind of lead symptoms for Cushing’s syndrome, but there are many others.
I believe that we actually test for 24, because cortisol goes everywhere in the body. When you have aberrant cortisol activity, you have many other things which are wrong as well people get, and I think, you know this. But they gain weight. They gain weight particularly around their middle, they have cognitive issues, they have thin skin, they are immunosuppressive, they get infections, so there are many, many things that we measure.
But ultimately, what we want is the broadest label and most appropriate label, which is for the treatment of Cushing’s syndrome. And there isn’t at this point in time just in the field a validated index for the treatment of Cushing’s syndrome.
So in sense that you’re obligated to prove improvements sort of a symptom at a time and obviously, hyperglycemia and hypertension are two particularly pernicious symptoms, so that they’re easy to measure, you do see when improvement occurs and certainly, people were 100% agreement that if you improve those, you can prove something significantly. So I think that’s really the – I hope that’s addressed your question. I think that’s really how we’re looking at it.
And the second question, I think was – you are asking about how this reads over to metabolic diseases? Well, at the core of it, Cushing’s syndrome is a metabolic disease. Many of the symptoms you see are metabolic iterations not all of the symptoms obviously, as I just talked about, but many in fact actually are.
And so we feel like that relacorilant because of the way it penetrates all the organs of the body and so forth, it’s a very good medicine, it’s already proving for the treatment of Cushing’s syndrome, because it is – it can affect both the metabolic symptoms and other symptoms that are involved with Cushing’s syndrome.
Now we centered in on CORT118335, because it is a particularly potent drug in the liver and it isn’t particularly active throughout all of the organs of the body. And this is one of those things, I think, I’ve mentioned many times during calls. But it’s very clear to us that although all of our cortisol modulators do just that modulate cortisol and none of them touch progesterone, they are not identical. And we really started to see that in preclinical testing and now we’re beginning to see that in clinical testing as well.
So we think the CORT118335 where we aimed it is particularly useful, because we think that an antipsychotic-induced weight gain as an example, it has particularly potent effects on a milligram per kilogram basis. As we said, the direct comparison has been through Korlym, which was clearly effective in the preclinical models when 118335 is even more effective. But the important extra fact is that, Korlym was very effective in the clinical models we could test. But just because if it’s aboard of fashion qualities, could not go any further in development.
What can you tell us about the Phase 1 results with 118335 and your special interest is really the prednisone challenge, what can you say at this point about the anti-inflammatory versus metabolic outcomes?
We’ll give you all the results when they’re filed. That study is still in progress, Alan, and I don’t want to really get ahead of ourselves. But I can – I guess, the one thing I’ll comment to you, because I’ve already made that comment is in terms of tolerability, which really is what Phase 1 is about so far so good.
Thank you.
At this time, I would like to hand the call back over to Charlie Robb for any additional or closing remarks.
That’s all. Thank you very much, everyone, for joining us, and we’ll be speaking to you again next quarter. Thanks.
That does conclude today’s conference. We thank you for your participation.