Corcept Therapeutics (CORT) Q2 2026 earnings call transcript

And now I'd like to introduce your host for today's program, Adepak Mulkari, CFO. Please go ahead, sir. Hello, everyone. Good afternoon, and thank you for joining us. Today we issued a press release announcing our financial results for the second quarter and providing a corporate update. The copy is available at CORCEPT. com. Our complete financial results will be available when we file our 401k with the SEC. Today's call is being recorded. A replay will be available at the Investor's Past Events tab of our website. Statements during this call, other than statements of historical fact, are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties which might cause actual results to be materially different from those such statements expressed or implied.

The risks and uncertainties that may affect our forward-looking statements are described in our annual report on Form 10-K and our quarterly reports on Form 10-Q, which are available at the SEC's website. Please refer to those documents for more information. Please claim any intention or duty to update forward-looking statements. Our revenue in the second quarter of 2026 was $256.1 million, a 32% increase over the prior year period. Coralum and authorized generic product revenue was $208.6 million. The Fiori product revenue was $47.6 million in its first quarter of availability. We expect growth to continue and have increased our 2026 revenue guidance to a range of $1.1 to $1.2 billion. Net income was $43 million in the second quarter of 2026 compared to net income of $35 million in the prior year period.

Please note that our operating expenses in the second quarter were flat to the first quarter of 2026. Our cash and investments at June 30 were $545 million.

I will now turn the call over to Sean Madouk, president of our endocrinology division. Sean? Thanks, Ottobach. Our Cushing Center business continues to experience strong demand. The second quarter saw a record number of new prescriptions and first-time prescribers. We have never had more patients receiving our medications or more active prescribers. Our growth is due to physicians' increasing awareness that hypercortisolism is a serious disease that is more prevalent than Hipercortisolism is underdiagnosed because its signs and symptoms, such as difficult to treat diabetes or resistant hypertension, are the same as those of other more common conditions. Tens of millions of people have diabetes or hypertension or both, but those patients whose conditions are being driven by hypercortisolism have often been missed.

That is especially important because hypercortisolism-induced hyperglycemia or hypertension responds poorly, if at all, to conventional pharmacotherapy. A drug that reduces excess cortisol activity is required to treat these patients. As clinical practice adapts to this critical insight, screening for and treatment of Cushing syndrome will continue to increase, as will the number of patients receiving our medications. Our landmark catalysts and momentum trials are driving increased physician awareness of hypercortisolism. Catalysts showed that 24% of patients with difficult-to-treat diabetes had hypercortisolism, and that treatment with Corlin led to substantial reductions in hemoglobin A1C, excess body weight, and waist circumference. Momentum screened more than 1,000 patients with high blood pressure that was not controlled despite concurrent use of three or more antihypertension medications, a condition known as resistant hypertension, and found that 27% of these patients had hypercortisolism.

Patients with both resistant diabetes and resistant hypertension, the prevalence of hypercortisolism was even higher, 39.7% in catalyst and 32.6% in Momentum. These paradigm-shifting findings will take time to be fully incorporated into medical practice, a process that is only just beginning. Atlas results were published in the field's leading journal, Diabetes Care, in 2025, and were referenced in the American Association of Clinical Endocrinology, or ACE, guidance documents for the management of diabetes in March of this year.

Momentum's results are also recent. We first presented them at the annual conference of the American College of Cardiology, or ACC, in March, and again at the American Diabetes Association, or ADA, annual scientific sessions in June. The results will be published in a major medical journal later this year. That being said, the catalyst and momentum results are becoming more widely known, and doctors are acting upon them. Screening for and treatment of Cushing syndrome is increasing, and with it the number of patients being treated with our medications. We expect this trend to continue, propelling our current Cushing syndrome business to at least $2 billion in annual revenue by the end of this decade. RELA-CORLANT's availability, which should occur shortly after the December 17th PDUFA date assigned to its resubmission, will accelerate this growth.

With the addition of RELACORALENT, we expect that our Cushing Syndrome annual revenue will grow to between $3 and $5 billion in 2020.

I will now turn the call over to Roberto Vieira, President of our Oncology Division. Roberto? Thanks, Sean. Liffioli's launch is one of the strongest ever for an oncology medication. The FDA approved Liffioli on March 25th, nearly four months ahead of its PDUFA date. A few dates after that, on April 1st, we sold our first lithium-ion capsules. Revenue for the first quarter was $47.6 million. Our success has been driven in large part by lithium-ion's compelling clinical characteristics. Patients with ovarian cancer have few good treatment options. This is especially true for those with platinum-resistant ovarian cancer. They and their physicians are excited to have a new treatment, backed by strong efficacy data, a very manageable safety profile, convenient oral administration, and no biomarker requirement.

Accordingly, LeFioli is on its way to becoming a new standard of care. Payer coverage for LeFioli has been excellent. The National Comprehensive Cancer Network, or NCCM guidelines, listed LeFioli as a preferred regimen just 15 days after approval, an unusually quick action that has supported broad insurance coverage and accelerated physician adoption. As of today more than 70 of the combined Medicare Medicaid and commercial lives have formal coverage policy for leafiole in place More than 1 patients have now started treatment with leafiole a number that continues to grow every day Demand has come from gynecology, medical and hematology oncologists, in academic and non-teaching hospitals, as well as community oncology clinics across the country. As of today, more than 1,000 doctors have prescribed lithium-ion to at least one patient, and an increasing number of physicians have written prescriptions for multiple patients.

While we are extremely pleased with lithium-ion's rapid uptake, we are just getting started. In the year term, we expect to reach more physicians at more oncology practices, large and small. We also expect physicians to prescribe lithium-ion more frequently as they gain experience with the drug. Those efforts alone should grow lithium-ion's annual revenue in the United States to more than $1 billion.

I will now turn the call over to Joel Belenov, our Chief Executive Officer. Joel? Thank you, Berto, for your oncology update, and thank you, everyone, for joining us. Since our founding, CORCEPT has worked to discover and develop molecules that harness glucocorticoid receptor, GR antagonists, to treat serious diseases. We have made important progress. It has now established that hypercortisolism is much more prevalent than previously believed, and that modulating cortisol's activity can help many patients.

But Viori's unprecedented uptake as a treatment for platinum-resistant ovarian cancer is eye-catching, and it's an important step to proving that GR antagonism can help treat many types of solid tumors. And our plans go well beyond Cushing syndrome and oncology.

Reliquoralant's new drug application, NDA, in Cushing syndrome is based on the positive outcome of our pivotal phase 3 GRACE trial, With confirmatory evidence from our double-blind, placebo-controlled, phase 3 gradient trial, our long-term extension study, and our earlier stage development data. Collectively, these results show that patients treated with relicloralant experience meaningful, durable improvements in the signs and symptoms of Cushing syndrome. And without the serious adverse events associated with the currently approved medications, hypokalemia, endometrial hypertrophy, vaginal bleeding, adrenal insufficiency, or QT prolongation.

To say that we were disappointed when we received a complete response letter at the end of last year is an understatement. At our meeting with the FDA in April, the agency requested additional analyses of the data in our original NDA submission. We completed those analyses, and based on their results, we resubmitted our NDA on June 17. The FDA accepted our resubmission and has assigned it a PDUPA date of December 17, 2026.

It is important to make relicloralant available as soon as possible. As Sean said, the catalyst and momentum studies are changing medicine. As screening for hypercortisolism becomes the norm rather than the exception in patients with resistant diabetes and hypertension, many patients whose health has been damaged by previously undiagnosed hypercortisolism will be able to receive more effective targeted care. Better treatments are greatly needed. The approval of Lipiorle was enormously gratifying. It is wonderful to be able to offer patients with platinum-resistant ovarian cancer, one of the most challenging forms of cancer, a safe and effective treatment option. We presented complete results from Lipiorle's pivotal trial, Rosella, in April at the Society of Gynecologic Oncology, SGO's, annual meeting with their simultaneous publication in The Lancet.

In Rosella, Lipiorli met both primary endpoints, significantly delaying disease progression, and even more important, significantly extending overall survival. Patients treated with Lipiorli and NAPAClitaxel chemotherapy experienced a 35% reduction in their risk of death, a hazard ratio of 0.65, compared to patients treated with NAPAClitaxel alone. The p-value was . 0004. Notably, the survival benefits were achieved in all patients with platinum-resistant ovarian cancer, not just those selected based on a specific biomarker.

But Biorle's approval is just the first step toward advancing GR antagonisms with full potential to treat solid tumors. Many tumors exploit GR signaling to drive treatment resistance. Beyond platinum-resistant ovarian cancer, GR antaginam has the potential to treat any solid tumor expressing the GR in combination with any anti-cancer agent. Our oncology development program aims to provide the evidence needed to realize the potential.

We are evaluating relicloraline combined with chemotherapy in a variety of solid tumors. One of the arms of our BELLA trial is studying the effect of relicloraline plus snap-paclitaxel and bevacizumab in women with platinum-resistant ovarian cancer. This arm will produce results this year. Our BELLA trial has two other arms, one which is studying the treatment of patients with platinum-sensitive ovarian cancer and earlier stage of the disease, and one which is studying endometrial cancer. Our STELA trial in cervical cancer and our TRIDEN trial as a first-line treatment for pancreatic cancer are also underway.

These trials will all produce results by the end of next year. We expect data from these studies to be NCCN guideline enabling and to inform our future development decisions. Successful results would immediately increase the number of patients that relicoralant may help by five-fold. Also, very important, GR antagonism may augment the effects of immunotherapy. Cortisol suppresses the immune system, blunting the effectiveness of therapies that stimulated an immune response. A treatment regimen combining an immunotherapy agent with a GR antagonist may stimulate a stronger, more effective immune response. We have initiated Synergy, a Phase 1b study of our proprietary selective GR antagonist, Nena Coralant, in combination with Nivolumab, a PD-1 directed immunotherapy, across a broad range of solid tumors.

We expect results from Synergy by the end of next year Finally cortisol activity at the GR stimulates the growth of prostate cancer tumors helping them escape the effects of androgen deprivation therapy Our collaborators at the University of Chicago are enrolling a randomized placebo-controlled Phase II trial of relicorolant plus the androgen receptor blocker enzalutamide in patients with early-stage prostate cancer to see if adding a GR antagonist can block cortisol-mediated tumor escape routes.

Cortisol activity is involved in the development and progression of metabolic dysfunction associated with the adohapetitis, or MASH. This serious liver disorder afflicts millions of patients worldwide and is a significant and rapidly growing cause of liver and cardiometabolic morbidity and mortality. Our proprietary selective cortisol modulator, mirichloralant, is very potent in the liver. In our Phase 1B study, it rapidly reduced liver fat and improved other elements of important markers of liver health, including fibrosis.

Mirichloralant was well-tolerated without the gastrointestinal side effects commonly seen in patients being treated for MASH. Our 175-patient double-blind placebo-controlled Phase IIb MONARCH study has completed enrollment and will produce data later this year. Positive results would support advancement to Phase III.

Patients with ALS frequently have elevated cortisol levels, which is why we believe cortisol modulation may help them. Results from DAZLs, the Phase II trial of a proprietary selective cortisol modulator DAZI-CORRALANT, have been very encouraging. Patients who received 300 mg of DAZI-CORRALANT exhibited an 84% reduction in risk of death at the one-year mark compared to patients who received placebo.

The p-value for this finding was . 0009. This survival benefit persisted into the study's second year, with an 87% reduction in risk of death with a p-value of less than . 0001. There is a common misperception that death from ALS is always coterminous with severe functional decline. It isn't. Many patients die from complications such as pneumonia or cardiovascular events arising well before they have lost significant function and quality of life.

Cortisol modulation could prevent such complications or help patients to survive them. It would provide a significant benefit. We are currently conducting a study to see if dose titration can improve dazochirilin's gastrointestinal tolerability. Non-serious GI distress caused most of the discontinuations in Dazzles. The findings from the study will inform the design of the pivotal trial that we plan to start early next year. To sum up, our Cushing syndrome business is growing and is poised for accelerated growth, driven by increasing awareness of hypercortisolism's true prevalence and the increasing evidence of the importance of treating it. Our landmark catalyst and momentum studies are leading to much wider screening for and treatment of Cushing syndrome. Approval of relicorolent would lead to even faster growth.

The launch of lithioreli in platinum-resistant ovarian cancer is off to a very strong start. We believe that GR antagonism has a broad utility in oncology. We look forward to helping many more patients with cancer in the near future. Our BELLA, STELLA, and TRIDEN studies will produce results by the end of next year and have the potential to increase the number of patients LeFiori could benefit by a factor of five.

We are also evaluating the treatment of other solid tumors and other treatment combinations to fully realize our potential in oncology. Following up on our positive Phase II Dazzles findings, we are conducting a dose titration study to inform the design of our planned Phase III trial in patients with ALS. By year-end, we will have results from our Phase II Monarch trial in patients with MASH. If those results are sufficiently positive, we will proceed to Phase III. The potential of cortisol modulation is immense.

Developing that potential into safe and effective medications is important work. We thank the patients who participate in our trials, our employees, our clinical investigators, and our academic collaborators who make it possible.

Okay, thank you, David. And several questions. I'll try to sort them out.

First question, I think, will go to Roberto, our president of oncology. So thank you, Joe. Thank you, David. So, David, we spoke about the 1,300 patients that we have initiated on therapy since we have launched. As you can see from what we discussed in the previous quarter as well, we have really accelerated the adoption of patients there. We are very happy. We see a very broad range of patients. We see patients very early lines of therapy, but also patients across the entire spectrum, late lines as well. And we have maintained actually a very strong pace of edging patients every week We are on our way to become market leaders as well as to realize the potential of billion just for platinum ovarian cancer in itself So I think that you can derive from there where we are headed We are very happy with market access as we discussed.

So overall, this story holds together as significant growth is ahead of us. Now, talking about this rate of acceleration of demand, we have, of course, as I said, very strong uptakes so far, and we are actually working very hard to educate a much broader group of physicians that expand across new clinics. We think we have meaningful opportunity ahead. So our goal is to really go early and go broad. And when I say go early, we think that lithium-ion is a drug that belongs early in the intervention. We think that the overall survival benefit, especially the fact that the drug has the opportunity to impact the disease, that the disease modification effect. You look at the overall survival curve, you see that those curves separate over time.

So there's an increasingly positive benefit to patients. And all those things together points to this drug really belonging into early lines of platinum-resistant ovarian cancer. So when you put all this together, the profile of the drug, the outcome of the opportunity, you should be looking to continue to grow for the brand for the quarters to come.

Very good. Thank you, Roberto.

And Sean, why don't you take the next question about where things stand with the pharmacy? Yeah, no, happy to take that. So in terms of just how the quarter ended up, I want to just set the stage. I mean, we had record enrollments. We had a record number of new prescribers, a record number of patients on medicine, which, of course, led to the highest tablets we've seen. The market is growing, and, of course, that was evidenced in our business in the second quarter, but we expect that to continue to grow and, of course, to continue to benefit our business. Now, in terms of the pharmacy specifically, we saw continuous improvement every single day, and we expect that continued improvement to move forward.

As I just mentioned, the market is growing, our business is growing, and we expect them to continue to improve and continue to keep up.

And, Audubon, perhaps you can respond to the guidance question. Sure. Yeah, so our new guidance range reflects strength across both of our businesses, across both endocrinology and oncology, and so both of those are reflected in the updated guidance range. Okay.

Please. Thank you, David.

Okay, thank you, RK. I think we got both of those questions.

Roberto, would you like to answer the first question on oncology growth? Yeah, so, RK, as you said, 1,300 patients initiated therapy and 1,000 unique prescribers since we have launched. So that is, I think, the answer to your question. You asked about the duration of therapy. It's kind of early for us to assess the duration of therapy. As you can imagine, most of our patients, we have followed them through for a couple of months or weeks. And we think that the Rosella data is a very good benchmark for us. So think about our PFS data. That's what we think that we will have that reflect the patient population.

Thank you, Roberto.

And Sean? I had a question on inventory.

Oh, yes. Okay. I'm sorry. Yes. The question was related to inventory.

That's for you, Audubon. I'll take that one. So your question on that In our case, the simple answer is no, there's not much inventory contribution in the quarter results. And so what do I mean by that? So the background is that we sell through both specialty pharmacies and specialty distributors. Revenues through the specialty pharmacy are direct to patient, so there is no inventory at the channel level. It's all direct to patient and realized when the patient received the medicine. So through the specialty distribution, and just to be clear, in our Cushing syndrome business, almost 100% of our business goes through the specialty pharmacy.

On the oncology side, about 30% goes through the specialty pharmacy, and the rest goes through specialty distributors, which do hold inventory to then ultimately provide to hospital pharmacies and so forth. Within that, I mean, ultimately, this is given the cost of the medication, the distributors want to hold minimal inventory. So you're talking about roughly about a week of demand that they keep on hand. So like I started at the beginning, very little of inventory dynamics in the quarter results.

Thank you. Okay.

And Sean, you have a couple of questions here. Yeah, so thanks, Arke. So your question, I think, was the $44 million growth we saw from Q2 over Q1 driven by sort of catch-up associated with the pharmacy transition? And the answer to that is no. The transition is behind us. The number was driven by continued servicing of our existing patient base, and as I shared earlier, a record number of new enrollments coming in. So the servicing of new patients coming in. We've had a record number of patients every single month, and we expect that to continue to grow.

Thank you, John. Thank you. Okay. Thank you. Well, thank you, everyone. It was a very exciting quarter for us. It's really wonderful to be able to help this new group of patients. We really hope to enlarge that as we go forward and really have great expectations that we will. So we'll talk to you next quarter. Thank you very much, and enjoy the rest of your summer. Bye-bye.