Preliminary Q4 2020 Corcept Therapeutics Inc Earnings Call and Corporate Update

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Ladies and gentlemen, thank you for standing by and welcome to the course Yep Therapeutics Conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask the question on the session you will need to press Star then one on your telephone.

Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Corcept Therapeutics conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star then 1 on your telephone. If you require any further assistance, please press star then zero. I will now hand the conference over to your speaker for today, Charlie Robb. You may begin.

If you require any further assistance. Please press Star then zero I'm on.

Now like to hand, the conference over to your speaker for today, Charlie Robb you may begin.

Good afternoon, My name is Charlie Robb on course.

Gary Charles Robb: Good afternoon. My name is Charlie Robb.

Gary Charles Robb: I'm Corcept's Chief Financial Officer. Today we issued a press release announcing our fourth quarter and full year preliminary selected financial results and providing a corporate update. A copy is available at Corcept.com. Complete results will be available when we file our Form 10-K with the SBC. This call is being recorded.

<unk> Chief Financial Officer.

We issued a press release announcing our fourth quarter and full year preliminary selected financial results and providing a corporate update.

A copy is available at <unk> Dot com.

Results will be available when we file our form 10-K with the SEC.

Today's call is being recorded a replay will be available at the investors past events tab on our website.

Gary Charles Robb: A replay will be available on the Investors 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 differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals during the COVID-19 pandemic and thereafter, including our ability to generate revenue and cash reserves sufficient to fund our commercial operations and development.

Statements. During this call other than statements of historical fact are forward looking statements based on our plans and expectations.

Subject to risks and uncertainties, which may cause actual results to differ materially from those such statements expressed or imply.

These risks and uncertainties include but are not limited to our ability to operate our business and achieve our goals during the COVID-19, pandemic and thereafter, including our ability to generate revenue and cash reserves sufficient to fund our commercial operations and development programs the availability of competing treatments, including generic versions of Korlym. The.

Gary Charles Robb: The availability of competing treatments, including generic versions of Coraline, the initiation or outcome of litigation, our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for, and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversight, and other requirements, and the impact of the COVID-19 pandemic on our employees, consultants, and vendors, as well as on physicians, patients, insurers, regulators, and These and other risks are set forth in our SEC filings, which are available on our website and the SEC's website.

Shneur outcome of litigation, our ability to obtain acceptable prices are adequate insurance coverage and reimbursement for korlym and risks related to the development of our product candidates, including their clinical attributes regulatory approvals mandates oversight and other requirements and the impact of the COVID-19 pandemic on our employees consultants and vendors as well.

It was on physicians patients insurers regulators in the practice of medicine in general.

These and other risks are set forth in our SEC filings, which are available on our website and the SEC's website.

On this call forward looking statements include those concerning on our revenue guidance cash flow unexpected growth our stock repurchase program the impact of the COVID-19 pandemic on our commercial operations financial performance clinical development programs physicians payers and patients and expectations regarding our financial performance and clinical development program.

Gary Charles Robb: Forward-looking statements include those concerning our revenue guidance, cash flow, unexpected growth, our stock repurchase program, the impact of the COVID-19 pandemic on our commercial operations, financial performance, clinical development programs, physicians, payers, and patients, as well as expectations regarding our financial performance and clinical development programs after the COVID-19 pandemic is brought under control. Physician awareness of hyper cortisolism and the selection of corallum is the optimum medical treatment.

After the COVID-19 pandemic.

Under control physician awareness of hyper cortisol Lisbon, the selection on Korlym as the optimum medical treatment timing cost and outcome on litigation, including our lawsuits against Teva Pharmaceuticals, and Sun Pharmaceuticals have his challenge to the validity of one of our patents for the patent trial and Appeals board and any legal action that may arise with Hikma pharmaceuticals.

Gary Charles Robb: Timing, cost, and outcome of litigation, including our lawsuits against Teva Pharmaceuticals and its fund pharmaceuticals. Tevis Challenge to the validity of one of our patents before the Patent Trial and Appeals Board and any legal action that may arise with Hikma Pharmaceuticals USA, the scope and protective power of our intellectual property, progress, enrollment, timing, design, and results of our clinical trials, and the clinical and commercial attributes of Relacorrelant, Exacorrelant, Miracorrelant, and our other selective cortisol modulators.

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Nope and protective power of our intellectual property progress enrollment timing design and results of our clinical trials and the clinical and commercial attributes relative Orleans extra Cortlandt mirror Berlin, and our other selective cortisol modulators, we disclaim any intention on duty to update forward looking statements.

Gary Charles Robb: We disclaim any intention or duty to update forward-looking statements. I will now share with you some preliminary financial information. Please keep in mind these results are prior to the completion of our annual independent audit and are subject to adjustment.

I will now share with you some preliminary financial information keep in mind. These results are prior to the completion of our annual independent audit and are subject to adjustment final figures will be available when we file our 10-K later this month.

Gary Charles Robb: Final features will be available when we file our 10-K later this month. Our revenue in 2020 was $353.9 million, compared to $306.5 million in 2019. Our fourth-quarter revenue was $85.7 million, and our fourth-quarter 2019 revenue was $87.9 million. Our fully diluted GAAP net income was $0.85 per share in 2020, compared to $0.77 per share in 2019. In the fourth quarter of 2020, our fully diluted GAAP net income was $0.20 per share.

Our revenue in 2020 was $353 9 million compared to $306 $5 million in 2019 on.

Our current fourth quarter revenue was $85 7 million in the fourth.

The fourth quarter of 2019 was $87 $9 million on.

Our fully diluted GAAP net income was <unk> 85 per share in 2020 compared to 77 per share in 2019, and the fourth quarter of 2020, our fully diluted GAAP net income was <unk> 20 per share was 24 cents per share in the fourth quarter of 2019.

Gary Charles Robb: Twenty-four cents per share in the fourth quarter of 2019. We expect revenue growth to resume as the COVID-19 pandemic is brought under control, with our 2021 revenue being between $375 and $405 million. In the fourth quarter, our cash and investments increased by $32.7 million to $476.9 million at December 31st. On December 31st, 2019, it was 315.3 million.

We expect revenue growth to resume as the COVID-19 pandemic is brought under control with our 2021 revenue been between 375 and $405 million.

On the fourth quarter, our cash and investments increased by $32 7 million to $476 $9 million at December 31.

On December 31, 2019, it was $315 $3 million.

We repurchased just under 460000 shares of our common stock on the fourth quarter at an average price of $21.08 per share and is currently authorized terms of our program of $193 million remains available for the repurchase of shares we will determine the timing and size of any future repurchases based on.

Gary Charles Robb: We repurchased just under 460,000 shares of our common stock in the fourth quarter at an average price of $21.08 per share. Under the currently authorized terms of our program, $190.3 million remains available for the repurchase of shares. We will determine the timing and size of any future repurchases based on market conditions, our stock price, and other factors.

Market conditions, our stock price and other factors.

Gary Charles Robb: Now, a brief legal update. As most of you know, in March 2018, we sued Teva Pharmaceuticals and the Federal District Court to prevent it from marketing a generic version of Coraline in violation of our patent. Originally, the trial was set for February 2, 2021. Last quarter, however, the court vacated that date and ordered the parties to be ready for trial by March 17. That date is no longer realistic, although a new one has not been set.

Now brief legal update.

As most of you know in March 2018, we sued Teva Pharmaceuticals in Federal District court to prevent it from marketing each generic version of Korlym in violation of our patents.

Originally trial was set for February 2021.

Last quarter, the court vacated that day and ordered the parties to be ready for trial by March 17th.

Good day, just no longer realistic, although a new one has not been set on.

New trial ready day, most likely be in the second or third quarter of this year, although that is for the court to decide whenever that day, we will be ready.

Gary Charles Robb: Our new trial-ready date will most likely be in the second or third quarter of this year, although that is for the court to decide. Whatever the date, we will be ready. As many of you know, in 2019, Teva challenged the validity of our 214 patent in a post-grant review, or PGR, at the U.S. Patent Office's Patent Trial and Appeals Board. Peace out.

As many of you know in 2019 Covid challenged the validity of our two one for patent and a post Grant review where P. G are for the U S patent Office's patent trial and Appeals board feedback on.

Remember on November 18th Pizza have announced his decision affirming the validity of every claim for the two one for patents.

Kevin has filed notice that it plans to appeal its losses.

Circuit Court of Appeals and Hasnt on March 12, five.

Appeals to the federal circuit take about 12 to 16 months to resolve this as soon as we expect definitive resolution on the P. GR is the first quarter of 2022 and.

Gary Charles Robb: On November 18th, the PTAB announced its decision, affirming the validity of every claim of the 214 patent. Teva has filed notice that it plans to appeal its loss at the PTAB to the Federal Circuit Court of Appeals and has until March 12th to file its appeal. Appeals to the Federal Circuit take about 12-16 months to resolve.

Unless and until Teva prevail on appeal and outcome, we think unlikely to 14 patent is and will remain valid. Furthermore, Teva is barred from challenging the two went for patents validity and our district court action using any arguments raised or could have raised for the pizza.

Gary Charles Robb: The soonest we expect definitive resolution of the PGR is the first quarter of 2022, unless and until Teva prevails on appeal, an outcome we think is unlikely. 214 patent is and will remain valid. Furthermore, TEVA is barred from challenging the 214 patent's validity in our district court action using any arguments it raised or could have had for the P-TECH. Sun Pharmaceuticals is also seeking to market generic versions of its product. Our lawsuit against Sun has stayed final FDA approval of Sun's proposed product until the earlier of December 8, 2021, or a decision by the district court that our patents are invalid, unenforceable, or not in print. Our dispute with Sun is separate from our litigation against Teva and is following its own, more indolent timeline. There are, at present, no trial dates or discovery deadlines in this action.

So part of Sun Pharmaceuticals is also seeking to market generic korlym.

Our lawsuit against Sun State has stayed final FDA approval of Sun's proposed product. So the earlier on December eight 2021, or a decision by the district court that our patents are invalid unenforceable or not infringed on us.

People with Sun is separate from our litigation against Teva and is following its own more indolent timeline. There are present no trial date on discovery deadlines and dissection.

Finally on February one we received notice of another Anda Filer Hikma Pharmaceuticals USA.

And then other generics manufacturer, we seek to enter the Korlym market is not surprising.

Attractive market. The important point is this as is true with respect to our disputes with Teva and Sun. We are confident in the strength and validity of our intellectual property, which we will assert vigorously.

I will now turn the call over to Dr. Joseph Belanoff, Our Chief Executive Officer, Jim.

Gary Charles Robb: Finally, on February 1st, we received notice of another antifiler, Hikma Pharmaceuticals USA, and another generics manufacturer would seek to enter the core limit market is not surprising. It's an attractive market. The important point is this. As regards our disputes with Teva and Sun, we are confident in the strength and validity of our intellectual property, which we will assert vigorously. I will now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer.

Thank you Charlie.

<unk> life is unknowable, but one thing I am sure last January No company has the words to COVID-19, and its business plan.

The virus itself the challenges posed by the pandemic have been unprecedented and persistent and.

In such a difficult environment of course have stable commercial business and lean operating model are specially value.

We did not achieve all of the goals that we set for ourselves.

<unk> started but we accomplished a lot.

Joseph K. Belanoff: Joe?

<unk> more revenue more net income and more cash in 2020.

Joseph K. Belanoff: Thank you, Charlie. Much in life is unknowable, but of one thing I am sure. Last January, no company had the words COVID-19 in its business plan. Like the virus itself, the challenges posed by the pandemic have been unprecedented and persistent. In such a difficult environment, Corcept's stable commercial business and lean operating model are especially valuable. We did not achieve all of the goals that we set for ourselves before the pandemic started, but we accomplished a lot. We generated more revenue, more net income, and more cash in 2020. The Patent Office ruled against Teva in full in its challenge to our 214 patent, which runs to 2037.

Patent office ruled against Teva in full and tennis challenge to our two one for Pat which runs to 2037.

We are more confident than ever in our intellectual property and added several more orange for patents over the course of the year.

Our commercial team has adapted to pandemic conditions creatively the obstacles they face and have faced since last March are significant.

Diagnosis of Cushing syndrome requires extensive examination and repeated testing. This is obviously hampered by patients being reluctant to leave their homes, but physicians understandable concern that necessary follow up.

In addition, many medical practices have sharply limited in person visits by commercial representatives, reducing educational opportunities for physicians, who have yet not yet prescribed korlym.

Joseph K. Belanoff: We are more confident than ever in our intellectual property and added several more orange book patents over the course of the year. Our commercial team has adapted to pandemic conditions creatively. The obstacles they face, and have faced since last March, are significant.

The challenges posed by remote medicine by growing our business extremely difficult for 2020.

Continue to enroll new patients and added to our roster of Korlym prescribers are more slowly there.

Confident the pace of enrollment will click on S pandemic conditions improve.

Signs, we see now are encouraging many physicians have begun to resume seeing patients in person.

Joseph K. Belanoff: This is obviously hampered by patients being reluctant to leave their homes and by physicians' understandable concern about necessary follow-up. In addition, many medical practices have sharply limited in-person visits by commercial representatives, reducing educational opportunities for physicians who have not yet prescribed Coraline. The challenges posed by remote medicine made growing our business extremely difficult in 2020. We continued to enroll new patients and added to our roster of core loan prescribers, but more slowly.

As for becoming more comfortable leaving their homes to seek care.

These visible shifts if they are sustained bode well for our results.

Foundation of our business and effective lifesaving saving medication promoted by a dedicated commercial team that puts the interest of patients first remains rock solid and is placed to support significant growth once conditions improve.

Hope not but there may be setbacks on temporary reversals on a brighter future is in sight, we are confident in our commercial prospects for 2021 and beyond.

Joseph K. Belanoff: We are confident the pace of enrollment will quicken as pandemic conditions improve, and the signs we see now are encouraging. Many physicians have begun to resume seeing patients in person, and patients are becoming more comfortable leaving their homes to seek care. These visible shifts, if they are sustained, bode well for our results. The foundation of our business, an effective, life-saving medication promoted by a dedicated commercial team that puts the interests of patients first, remains rock-solid and is poised to support significant growth once conditions improve. We hope not, but there may be setbacks and temporary reversals, but a brighter future is in sight.

The pandemic impact on our development activities has been variable and has significantly slowed the pace of studies and illnesses that are less rapidly progressing.

It's been frustrating to watch our trials in patients with Cushings syndrome, castration resistant prostate cancer antipsychotic induced weight gain and non alcoholic Seattle hepatitis or Nash.

Patients more slowly than they would've been a world without COVID-19.

During the slowdown we are working to ensure that our clinical trial sites are ready to make rapid progress once conditions improve.

Contrast studies in patients with acutely life threatening diseases have been largely unaffected.

Trials in patients with metastatic pancreatic cancer and platinum resistant ovarian cancer severe diseases for which there are no. Good treatments enrolled briskly and will produce data in the first half of this year as we expected before the pandemic set in.

Joseph K. Belanoff: We are confident in our commercial prospects in 2021 and beyond. The pandemic's impact on our development activities has been variable. It has significantly slowed the pace of studies in illnesses that are less rapidly progressing. It has been frustrating to watch our trials in patients with Cushing's syndrome, castration-resistant prostate cancer, antipsychotic-induced weight gain, and non-alcoholic steatohepatitis or NASH accrue patients more slowly than they would have in a world without COVID.

We're also excited about the progress last year in new clinical development efforts. Despite pandemic related obstacles. We opened an important trials phase III trial in patients with metastatic pancreatic cancer phase one b trial in patients with advanced adrenal cancer.

Second phase II trial in patients with anti psychotic induced weight gain and a phase II trial in patients with Nash.

Also to continue to advance new selective cortisol modulators.

One such compound core 113176 as shown promise in animal models on a L. S. We plan to evaluate it in the phase two trial beginning in the fourth quarter of 2021.

Joseph K. Belanoff: During this slowdown, we are working to ensure that our clinical trial sites are ready to make rapid progress once conditions improve. By contrast, studies in patients with acutely life-threatening diseases have been largely unaffected; trials in patients with metastatic pancreatic cancer and platinum-resistant ovarian cancer, severe diseases for which there are no good treatments, enrolled briskly, and will produce data in the first half of this year, as we expected before the We're also excited about the progress made last year in new clinical development efforts.

As I've said before I do not know any company of course emphasize the combined commercial success with such diverse and promising clinical activities.

As many of you know we are evaluating realm of correlate our planned successor to Korlym for the treatment of hyper for a solid two phase III trials rubber Carlin is a selective cortisol modulator like karla and achieves its effect by competing with cortisol at the glucocorticoid receptor on.

Unlike korlym it does not bind to the progesterone receptor PR for short, which means it does not cause PR effects, including termination of pregnancy, endometrial thickening and vaginal bleeding.

Joseph K. Belanoff: Despite pandemic-related obstacles, we opened important trials, a Phase III trial in patients with metastatic pancreatic cancer, a Phase I-B trial in patients with advanced adrenal cancer, a second Phase II trial in patients with antipsychotic-induced weight gain, and a Phase II trial in patients with NASH. We also continue to advance new selective cortisol modulators. One such compound, CORT 113176, has shown promise in animal models of ALS.

On a different mechanism Bella Korlym also does not appear to cause hypokalemia low potassium.

Serious side effects experienced by 44% of patients in carloads pivotal trial.

We love induced hypokalemia is a leading cause of korlym discontinuation.

We expect relative launch phase III reach trial serve as the basis for our NDA submission in Cushing syndrome.

Grace continues to enroll patients although the pandemic has significantly slowed the rate of addition.

Surge in Covid infections scene in the United States and Europe in the third and fourth quarters of last year, coupled with the slow pace of vaccinations.

Joseph K. Belanoff: We plan to evaluate it in a Phase 2 trial beginning in the fourth quarter of 2021. As I've said before, I do not know any company of Corcept's size that combines commercial success with such diverse and promising clinical activities. As many of you know, we are evaluating Relacorrelant, our planned successor to Corallim, for the treatment of hypercorazolism in two phase three trials. Runle Coralline is a selective cortisol modulator. Like Coralline, it achieves its effect by competing with cortisol at the glucocorticoid receptor.

We are unlikely to meet our target of submitting an NDA in the second quarter of next year.

The day, we ultimately achieve will depend in large part on the virulence and duration of the pandemic.

To know how long the current pandemic conditions will persist.

Slow to abate, our NDA submission can be delayed as much as a year. We are working to ensure that our sites are ready to resume aggressive effective enrollment as soon as conditions permit.

The delay in Grace is separately frustrating rella Cortland as two results were strong patients experienced meaningful improvements in hypertension, and glucose control as well as in a variety of other signs and symptoms of Cushing syndrome.

Joseph K. Belanoff: Unlike horlim, it does not bind to the progesterone receptor, PR for short, which means it does not cause PR effects, including termination of pregnancy, endometrial thickening, and vaginal bleaching. By a different mechanism, Brella Chloralent also does not appear to cause hypokalemia, low potassium, a serious side effect experienced by 44% of patients in Chloralent's pivotal trials.

No real correlate induced incidence of endometrial thickening or vaginal bleeding and also no drug induced hypokalemia.

And our investigators are anxious to take race to the finish line.

Our second phase III trial, Rella Cortland in patients with Cushings syndrome gradient studying relative Orleans effects in patients, whose cushings syndrome is caused by an adrenal adenoma or adrenal hyperplasia.

Joseph K. Belanoff: Corleone-induced hypokalemia is a leading cause of corleone discontinuation. We expect Relich-Lorelin's Phase 3 GRACE trial to serve as the basis for our NDA submission in- Grades continues to enroll patients, although the pandemic has significantly slowed the rate of addition. The surge in COVID infections seen in the United States and Europe in the third and fourth quarters of last year, coupled with the slow pace of vaccinations, mean we are unlikely to meet our target of submitting an NDA in the second quarter of next year.

Patients with this etiology of Cushing syndrome, often experienced a less rapid decline, but ultimately their health outcomes are poor.

<unk> is the first controlled study in patients with this type of Cushing syndrome.

Expect its findings will.

<unk> the optimal treatment of these patients.

As I mentioned, our trials in metastatic ovarian in metastatic pancreatic cancer will produce at it in the first half of this year.

Joseph K. Belanoff: The date we ultimately achieve will depend in large part on the virulence and duration of the pandemic. It is difficult to know how long the current pandemic conditions will persist. If they are slow to abate, our NDA submission could be delayed as much as a year. We are working to ensure that our sites are ready to resume aggressive, effective enrollment as soon as conditions permit. The delay in grace.

Before I go further let me provide some background.

Our oncology program is testing three mechanisms postulated by investigators at the University of Chicago more than 10 years ago for.

First mechanism, which we were evaluating in our study in ovarian and pancreatic cancer concerns a pop ptosis programmed cell death chemotherapy is intended to induce cordis.

Joseph K. Belanoff: Rella-Correlan's Phase II results were strong. Patients experienced meaningful improvements in hypertension and glucose control, as well as in a variety of other signs and symptoms of Cushing syndrome. There were no relic correlant-induced instances of endometrial thickening or vaginal bleeding, and also no drug-induced hypokalemia. We and our investigators are anxious to take Grace to the finish line.

Cortisol suppresses E pop ptosis, there's compelling preclinical and clinical data, suggesting that rella correlate blood cortisol anti apoptotic effect, helping chemotherapy reach its full potential.

Our study in ovarian cancer is a controlled as two trial and 178 patients with platinum resistant disease.

Trial has three arms patients receive either continuous or intermittent doses of rella, Cortland, plus Nab paclitaxel or Nab Paclitaxel alone.

Joseph K. Belanoff: Our second phase three trial of Rella-Correlant in patients with Cushing Syndrome, Gradient. Studying Rella-Correlant's effects in patients whose Cushing Syndrome is caused by an adrenal adenoma or adrenal hyperplasia. Patients with this etiology of Cushing syndrome often experience a less rapid decline, but ultimately, their health outcomes are poor.

Trial's primary endpoint is progression free survival with secondary endpoints, including objective response rate duration of response and overall survival.

We hope data from this trial will guide us to design a phase III study that will lead to a successful NDA.

We'll have top line results from this study in the second quarter.

Our study in pancreatic cancer reliant as a planned enrollment of 80 patients with metastatic disease with each patient receiving relative orland plus Nab paclitaxel.

Joseph K. Belanoff: Grading is the first controlled study in patients with this type of Cushing's, and we expect its findings will contribute to the optimal treatment of these patients. As I mentioned, our trials in metastatic ovarian and metastatic pancreatic cancer will produce data in the first half of this year. Before I go further, let me provide some background.

Trial's primary endpoint is objective response rate with secondary endpoints, including progression free survival duration of response and overall survival.

While design includes an analysis of data for the first 40 patients. We will also have topline results from this cohort in the second quarter.

In addition to blunting, a pop ptosis cortisol activation reduces inflammation and suppresses the immune system, which is why synthetic cortisol are used to treat inflammatory and autoimmune disorders.

Joseph K. Belanoff: Our oncology program is testing three mechanisms postulated by investigators at the University of Chicago more than 10 years ago. The first mechanism, which we are evaluating in our study of ovarian and pancreatic cancer, concerns apoptosis. Programmed cell death chemotherapy is intended to induce apoptosis, but cortisol suppresses apoptosis. There is compelling preclinical and clinical data suggesting that relacorrelate can blunt cortisol's anti-apoptotic effect, helping chemotherapy reach its full potential. Our study in ovarian cancer is a controlled Phase II trial in 178 patients with platinum-resistant disease. The trial has three arms.

Fortunately by suppressing the immune system cortisol also diminishes the effectiveness of immunotherapy in patients with solid tumors.

September we initiated an open label phase one b trial umbrella Cortland, plus the PD, one checkpoint inhibitor <unk> merck's drug keytruda in patients with advanced adrenal cancer, whose tumors produced excess cortisol. These.

And these patients suffered the effects of adrenal cancer and Cushings syndrome, a usually quickly lethal combination.

We believe that cortisol excess may also count counteract the intended effects of Pembroke Elisa map, which is rarely effective as monotherapy in these patients.

Joseph K. Belanoff: Patients received either continuous or intermittent doses of Relic Oraline plus NAB haplotaxil or NAB haplotaxil alone. The primary endpoint of the trial is progression-free survival, with secondary endpoints including objective response rate, duration of response, and overall survival. We hope data from this trial will guide us to design a phase 3 study that will lead to a successful NDA. We will have top-line results from this study in the second quarter. Our study in pancreatic cancer, Reliant, has a planned enrollment of 80 patients with metastatic disease, with each patient receiving Relic Horlant plus NAP Paclitaxel.

Our trial is evaluating whether <unk> can treat these patients cushings syndrome by reducing the effects of excess cortisol activity and by reversing cortisol induced immune suppression also cloud embolism map to achieve its full cancer, killing effect.

Our posters at this year's ESCO and ACR meetings present, preclinical and clinical biomarker data supporting her hypothesis you can review them at the research and pipeline Slash publications tab of our website.

We plan to enroll 20 patients in this trial at five sites in the United States primary endpoint was objective response rate with secondary endpoints, including progression free survival duration of response and overall survival.

Joseph K. Belanoff: The trial's primary endpoint is objective response rate, with secondary endpoints including progression-free survival, duration of response, and overall survival. The trial design includes an analysis of data from the first 40 patients, so we will also have top-line results from this cohort.

The third mechanism, we are studying concerns cortisol its ability to stimulate tumor growth in patients with castration resistant prostate cancer.

Joseph K. Belanoff: In addition to blunting apoptosis, cortisol activation reduces inflammation and suppresses the immune system, which is why synthetic cortisols are used to treat inflammatory and autoimmune disorders. Unfortunately, by suppressing the immune system, cortisol also diminishes the effectiveness of immunotherapy in patients with solid tumors. In September, we initiated an open-label Phase 1b trial of Relocoralin plus the PD-1 checkpoint inhibitor Pembrolizumab, Merck's drug Keytruda, in patients with advanced adrenal cancer whose tumors produced excess cortisol.

Zelle stimulation is a major reason patients treated with a widely prescribed androgen receptor antagonist and <unk> eventually experienced resurgent disease.

Price of androgen stimulation their tumor switched to cortisol activity as a growth pathway.

Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route.

For conducting a phase one b trial, our selective cortisol modulator korlym combined with <unk> in patients with castration resistant prostate cancer and expect to identify a dose regimen suitable for advancing to a larger controlled study in the second or third quarter of this year.

Joseph K. Belanoff: These patients suffer the effects of adrenal cancer and Cushing's syndrome. A Usually Quickly Lethal Combination, We believe that cortisol excess may also counteract the intended effects of pembrolizumab, which is rarely effective as monotherapy in these patients. Our trial is evaluating whether Reliquorolin can treat these patients' Cushing syndrome by reducing the effects of excess cortisol activity and, by reversing cortisol-induced immune suppression, also allow Pembrolizumab to achieve its full cancer-killing effect. Our posters at this year's ASCO and AACR meetings present preclinical and clinical biomarker data supporting our hypothesis. You can review them at the research and pipeline slash publications tab of our website.

I will conclude with a brief update on our program in metabolic diseases, where our selective cortisol modulator mirror for Linde has shown promise in preclinical and clinical studies in.

In animal models mirror, coral and prevents and reverses fatty liver disease and liver fibrosis to precursors of Nash serious disorder that affects five per cent of the U S population.

In December we opened a double blind placebo controlled phase two trial mirror korlym as a treatment for patients with Nash trial has a planned enrollment of 120 patients at 15 sites in the United States study participants will receive a daily dose of either 600 milligrams on mirror correlate 900 milligrams with mirror Portland or placebo.

For 12 weeks.

We're also evaluating New York Korlym as a treatment for anti psychotic induced weight gain a serious and widespread disorder.

Joseph K. Belanoff: We plan to enroll 20 patients in this trial at five sites in the United States. The primary endpoint is objective response rate, with secondary endpoints including progression-free survival, duration of response, and overall survival. The third mechanism we are studying concerns cortisol's ability to stimulate tumor growth in patients with castration-resistant prostate cancer. Cortisol stimulation is a major reason patients treated with the widely prescribed androgen receptor antagonist enzalutamide eventually experience resurgent disease; deprived of androgen stimulation, their tumors switched to cortisol activity as a growth pathway. Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route.

In the United States 6 million people take antipsychotic medications, such as Olanzapine you out of the lease trucks, Zyprexa and Risperdal J&J risk for Dol to treat illnesses, such as schizophrenia bipolar disorder and depression.

While these drugs are very effective the exact steep price in the form of rapid and sustained weight gain cardiovascular disease and other metabolic disturbances.

On skin gained more than 50 pounds and their life expectancy is decreased on average by 20 years due in part to excess cardiovascular events, such as heart attacks and strokes.

We have completed three double blind placebo controlled clinical trials in healthy subjects in which co administration of a cortisol modulator reduces these dangerous adverse effects.

Joseph K. Belanoff: We are conducting a Phase 1b trial of our Selective Cortisol Modulator, X-Chloraline, combined with Enzalutamide in patients with castration-resistant prostate cancer, and we expect to identify a dose regimen suitable for advancing to a large and controlled study in the second or third quarter of this year. I will conclude with a brief update on our program in metabolic disease, where our Selective Cortisol Modulator, Miracoraline, has shown promise in preclinical and clinical studies. In animal models, mirocoagulant prevents and reverses fatty liver disease and liver fibrosis, two precursors of NASH, a serious disorder that affects 5% of the U.S. population. In December, we opened a double-blind, placebo-controlled Phase II trial of Miracorlin as a treatment for patients with NASH. The trial has a planned enrollment of 120 patients at 15 sites in the United States.

Two of these trials used mifepristone the active ingredient in korlym.

Positive results were published on the journal's advances in therapy and obesity in 2009 and 2010.

Unfortunately, korlym would share active ingredient with the abortion pill cannot be advanced for such a prevalent disorder.

Mirror Korlym is not the abortion pill and can be advanced for this use.

Sales for Mira Orleans first trial in this disorder, we are promising and that trial 99 healthy subjects received olanzapine and either 600 milligrams of mirror correlate 900 milligrams of mirror correlate or placebo for 14 days.

Study participants who receive mirror cortland in statistically less and statistically significantly less weight than those who received placebo.

In addition, the exhibited a smaller increase in triglyceride and in the liver enzymes, a S T and ALG markers of liver damage that price at the onset of Olanzapine therapy.

Joseph K. Belanoff: Study participants will receive a daily dose of either 600mg of miraclorelin, 900mg of miraclorelin, or placebo for 12 weeks. We're also evaluating miraclorelin as a treatment for antipsychotic-induced weight gain, a serious and widespread disorder. In the United States, 6 million people take antipsychotic medications such as olanzapine, Eli Lilly's drug Cyprexa, and Risperdal, J&J's Risperdal, to treat illnesses such as schizophrenia, bipolar disorder, and depression. While these drugs are very effective, they exact a steep price in the form of rapid and sustained weight gain, cardiovascular disease, and other metabolic disturbances.

We plan to publish a paper presenting the results of this study later this year.

Hello, Blind placebo controlled phase II trials of mirror Orland in anti psychotic induced weight gain continued to enroll patients.

Our gratitude trial is evaluating whether mirror correlate can reverse recent antipsychotic induced weight gain.

Patients with schizophrenia or bipolar disorder, we will receive in addition to their established Joseph anti psychotic medication, either 600 milligrams of mirror correlate or placebo for 12 weeks.

<unk> is being conducted at 30 centers in the United States.

Gratitude two study is testing mirror korlym as a treatment for long standing antipsychotic induced weight gain on.

Joseph K. Belanoff: Patients can gain more than 50 pounds, and their life expectancy is decreased on average by 20 years due in part to excess cardiovascular events such as heart attacks and strokes. We have completed three double-blind, placebo-controlled clinical trials in healthy subjects in which co-administration of a cortisol modulator reduces these dangerous adverse effects. Two of these trials used Mifepristone, the active ingredient in chlorella. Our positive results were published in the journals Advances in Therapy and Obesity in 2009 and 2010. Unfortunately, CORLA, which shares its active ingredient with the abortion pill, cannot be advanced for such a prevalent disorder. However, miracalline is not an abortion pill and can be advanced for this use.

150 patients with schizophrenia will receive in addition to their established Joseph anti psychotic medication.

600 milligrams or 900 milligrams of mirror correlate or placebo for 26 weeks.

Our attitude to who will be conducted at 35 centers in the United States. The primary endpoint in both studies is reduction in body weight. Other important measures metabolic activity will also be examined.

And 'twenty 'twenty, the Covid pandemic had a real effect on core step as a day on most companies. Nonetheless, we entered 'twenty 'twenty one stronger in every respect financially legally and clinically.

Although our financial results were affected by the pandemic, our revenue net income and cash balance increased significantly for Ya.

Joseph K. Belanoff: Results from Miracoralline's first trial in this disorder were promising. In that trial, 99 healthy subjects received elanzapine and either 600mg of Miracoralline, 900mg of Miracoralline, or placebo for 14 days. [inaudible] gained statistically significantly less weight than those who received lansipine. In addition, they exhibited a smaller increase in triglycerides and in the liver enzymes AST and ALT, markers of liver damage that rise at the onset of lansipine therapy. We plan to publish a paper presenting the results of the study later this year.

Spect further growth S pandemic conditions improve.

Our revenue guidance for 2021 $375 million to $405 million.

Our clinical programs also made substantial progress five existing trials advance and important new trials were started.

The pandemic slowed enrollment in some of our trials significantly, especially those studying diseases that are not acutely life threatening.

This slowdown has laid our target date for submitting relative Orleans NDA as a treatment for Cushings syndrome that being said all of our trials continue to add patients and collect valuable data and we expect the pace of enrollment in all of them to accelerate once conditions improve.

We completed enrollment in both our phase two trial umbrella Korlym plus Nab paclitaxel in patients with metastatic ovarian cancer and short time ago in the first 40 patient cohort of reliant our phase III trial in patients with metastatic pancreatic cancer.

Joseph K. Belanoff: Our double-blind placebo-controlled phase 2 trials of Miracoraline in antipsychotic-induced weight gain continue to enroll patients. The GRATITUDE trial is evaluating whether mirror-correlant can reverse recent weight gain. About 100 patients with schizophrenia or bipolar disorder will receive, in addition to their established dose of antipsychotic medication, either 600 mg of miracoraline or placebo for 12 weeks. Gratitude is being conducted at 30 centers in the United States. Our Gratitude II study is testing miracloraline as a treatment for long-standing antipsychotic-induced weight gain.

We will have data from both these trials for the first half of this year as planned.

Enrollment is underway in our phase one b trial umbrella correlate combined with a PD one checkpoint inhibitor <unk> is a map to treat patients with advanced adrenal cancer and cortisol excess.

And the second or third quarter of this year, we expect to select the optimum dose of extra correlate to advance in combination with <unk> in a controlled phase II trial in patients with castration resistant prostate cancer.

Joseph K. Belanoff: 150 patients with schizophrenia will receive, in addition to their established dose of antipsychotic medication, either 600 mg or 900 mg of miracorrelant or placebo for 26 weeks. Gratitude II will be conducted at 35 centers in the United States. The primary endpoint in both studies is reduction in body weight, although other important measures of metabolic activity will also be examined.

Finally enrollment is underway in three double blind placebo controlled phase two study in patients with metabolic disorders, one in patients with Nash and to credit and gratitude two in patients with anti psychotic induced weight gain.

I'll stop here for questions.

Thank you.

Ladies and gentlemen, as a reminder to ask the question you will need to press Star then one on your telephone.

To withdraw your question press the pound key.

Joseph K. Belanoff: In 2020, the COVID pandemic had a real effect on Corcept, as it did on most companies. Nonetheless, we enter 2021 stronger in every respect, financially, legally, and clinically. Although our financial results were affected by the pandemic, our revenue, net income, and cash-back were affected.

Again, Thats star one to ask the question.

Please standby, while we compile the Q&A roster.

Our first question comes from.

And on that bank.

<unk> of America. Your line is open.

Hi, good afternoon, and thank you so much for taking my question.

One question on Korlym, if I may I wanted to get your thoughts.

And how you're thinking about the ramp in sales for this year.

Joseph K. Belanoff: We expect further growth as pandemic conditions improve. Our revenue guidance for 2021 is $375 to $405 million.

Did talk extensively about a potential headwind from COVID-19 and slower than expected vaccination rates as part of your prepared statement, but are you thinking that the.

Joseph K. Belanoff: Our clinical programs also made substantial progress. Five existing trials, bands, and important new trials were started. However, the pandemic slowed enrollment in some of our trials significantly, especially those studying diseases that are not acutely life threatening. This slowdown has delayed our target date for submitting Reliquorla's NDA as a treatment for Cushing's syndrome.

The pace of growth this year could accelerate more so in the second half of the year.

And I guess next on that you can talk about how you made your internal calculations about what you think the lower end of the range would be this year on.

Joseph K. Belanoff: That being said, all of our trials continue to add patients and collect valuable data, and we expect the pace of enrollment in all of them to accelerate once conditions improve. We completed enrollment in both our phase two trial of Rellocorlin plus NAPAQUATAXEL in patients with metastatic ovarian cancer and, a short time ago, in the first 40-patient cohort of Reliant, our phase three trial in patients with metastatic pancreatic cancer. We will have data from both these trials in the first half of this year, as planned.

That would be helpful. Thank you.

Could you talk to <unk> I'm, just going to switch you over to Shama, Duke who you've all heard from income before Sean as our Chief commercial officer and runs all of our commercial business.

Hydrazine thanks for the question.

So in terms of 2021 revenue and scale up I mean, obviously.

January 1st there's not a lot different than the December 31st of all last year, but region by region. We are starting to see light at the end of the tunnel and conditions around the country have improved over the last few weeks Covid cases are declining and based on our own research and expertise patients are less careful to visit their doctors and burst on it for the most part.

Joseph K. Belanoff: Enrollment is underway in our Phase 1b trial of relocorlin combined with a PD-1 checkpoint inhibitor, pembrolizumab, to treat patients with advanced adrenal cancer and cortisol extremes. In the second or third quarter of this year, we expect to select the optimum dose of hexaquareline to advance in combination with enzalutamide in a controlled phase two trial in patients with castration Finally, enrollment is underway in three double-blind, placebo-controlled Phase II studies in patients with metabolic disorders. 1 in patients with NASH and 2, gratitude and gratitude 2, in patients with antipsychotic-induced weight. I'll stop here for questions.

Patient case loads have returned to pre pandemic levels and we've seen it on on earlier calls and Joe mentioned in his statement. This is a disease that takes multiple physician visits in multiple test to actually diagnose. So this increase patient visits bodes well for testing on diagnosis, which we believe will lead to more prescriptions.

One other point just for core sales specifically as it seems like a long time ago now, but as a reminder for everybody we.

Executing on our sales force expansion at the end of 2019, which was completed at the beginning of last year.

And then the pandemic started so we've never really had the opportunity to experience the full effect of our expanded field. So they've been doing their best over the last year to meet with both for physicians, both in person and virtually a they've been training and getting ready to hit the ground running when when things open up and I expect.

Operator: Thank you. Ladies and gentlemen, as a reminder to ask a question, you will need to press star and then one on your telephone. To withdraw your question, press the power key. Again, that's star one to ask the question.

As the country opens up more and more of an in person interactions increase.

We'll see an increase in productivity. So things are definitely not going to change overnight, but again conditions really have started to improve and we are optimistic for return on some return to a semblance of normalcy this year.

Operator: Please stand by while we compile the Q&A roster. Our first question comes from Tazeen Ahmed, Bank of America. Your line is open. Hi, good afternoon, and thank you so much for taking my questions. One question on Coralim, if I may, I wanted to get your thoughts on how you're thinking about the ramp in sales for this year. You did talk extensively about potential headwinds from COVID and slower-than-expected vaccination rates as part of your prepared statements, but are you thinking that the pace of growth this year could accelerate more so in the second half of the year? And I guess to the extent that you can talk about how you made your internal calculations about what you think the lower end of the range would be this year, that would be helpful. Thank you.

Okay. That's helpful.

Paul.

And maybe a related question on <unk>, so as it relates to enrollment in your current studies are you, making the assumption that.

The delay of up to one year, what does that assume.

On your internal assumptions about when when you think that people are going to be vaccinated and I know there are estimates about when.

When the U S can achieve herd immunity is that on major factor in determining.

On the enrollment rate on your study or are there other things that that you're also taking into account.

Sean Maduck: Good to talk to you, Suzeen. I'm just going to switch you over to Sean Maduck, who you've all heard from before. Sean is our Chief Commercial Officer and runs all of our commercial businesses.

Two things.

First I want to do.

One chance to hear from Andreas Grauer again on Andreas as our Chief Medical Officer and.

I reserve the right, but on <unk>.

Sean Maduck: Hi Tazine, thanks for the question. So, you know, in terms of 2021, revenue and scale up, I mean, obviously, January 1 is not a lot different than than December 31, the last year, but region by region, we are starting to see light at the end of the tunnel, and conditions around the country have improved over the last few weeks, COVID cases are declining, and based on our own research and expertise, patients are less fearful to visit their doctors in person, and for the most part, patient caseloads have returned to normal.

<unk> made me add a comment or two when youre done.

Yeah.

Thank you for the question. That's obviously the millions of other question for all of US These days.

How do we assume.

Assumptions, we make for the pandemic and keep in mind for physical trial, we haven't gone on Western Canada and in the number of European countries and the dynamics of the.

Vaccination is different.

All of those.

So.

There is no one fixed fee.

We base, our assumption on where we're actually working with each individual site there is pockets.

Some of the countries that show signs of improvement just like as a specific example, the city of Rome in Italy.

Sean Maduck: And we've stated on earlier calls, and Joe mentioned in his statement, this is a disease that takes multiple physician visits and multiple tests to actually diagnose. So, this increased patient visit bodes well for testing and diagnosis, which we believe will lead to more core limit prescriptions. One other point, just for Corcept specifically, is that it seems like a long time ago now, but as a reminder for everybody, we executed on a Salesforce expansion at the end of 2019, which was completed at the beginning of last year, and then the pandemic started.

They seem to be ahead on the curve in Italy, the rest of Italy, not so much. So we're looking at this at a very granular level.

<unk> made sort of a site by site assessment on.

Inc will.

We'll be able to pick things up again on that has led us.

With that assessment and also with the remaining uncertainty.

Okay. Thank you.

Thank you to see.

Interest.

Thank you.

Our next question comes from the line of Chris Howerton with Jefferies. Your line is open.

Hey, there. Thanks, so much for for taking the questions I appreciate it.

So I guess, maybe just to follow up on the previous question in terms of revenue guidance for this year.

Sean Maduck: So, you know, we've never really had the opportunity to experience the full effect of our expanded field. So they've been doing their best over the last year to meet with both positions, both in person and virtually. They've been training and getting ready to hit the ground running when things open up. And I expect that as the country opens up more and more, and in-person interactions increase. Creation, CREATED by J.J. T. A. M. R. M. B. H. T. J. T. M. H. T. M. R. M. D. M. N. M. M. M. N. M. M. M. Okay, that's helpful.

So what I heard you say Shawn was that essentially you're expecting an increase in some point in this year and certainly in the impact of your sales force expansion, but.

Like what is there any more color that you can give us with respect to.

Specific factors that went into the revenue guidance and maybe some things might specifically could be like Inc.

Kris compliance new patient adds and price increase might be some things that investors could be interested in.

Joseph K. Belanoff: Maybe a related question on reluctance. So as it relates to enrollment in your current studies, are you making the assumption that the delay of up to one year, what does that assume, I guess, in your internal assumptions about when you think that people are going to be vaccinated? I know there are estimates about when the US can achieve herd immunity, but is that a major factor in determining the enrollment rate in your study? Or are there other things that you're also taking into account?

Yes.

Hey, Chris This is Joe Belanoff ill answer at least part of your question here.

Look we would really like.

Like everyone else in the world to know how soon this is going to be.

From this point forward I just have to reiterate what Andreas as Sean said, we are seeing things that werent happening two months ago happening right now I don't know if thats going to continue but certainly at this point the trend at least however, slight really it looks like it's in it.

Andreas Grauer: Two things, Suzeen. First, I want to give everyone a chance to hear from Andreas Grauer again. Andreas is our Chief Medical Officer, and I reserve the right to ask him to add a comment or two when you're done.

Moving zone.

And I think that the major thing I'll just repeat from my comments earlier is that patients who are already on the medicine, we're doing fine on the medicine. They remain on the medicine early asset group. The heart thing has been adding new patients and so patient enrollment is really what we think is going to pick up.

Andreas Grauer: Yeah, thank you for the question. That's obviously the million-dollar question for all of us these days: what, how do we assume Unknown Attendee, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Alan Leong, Corcept Therapeutics Inc.

Over the course of the year new patient enrollment.

For the year and.

Andreas Grauer: The vaccination is different than all of those, so there is no one fixed date that we base our assumption on. We're actually working with each individual site. There are pockets in some of the countries that show signs of improvement, just like, as a specific example, the city of Rome in Italy. They seem to be ahead of the curve in Italy. The rest of Italy, not so much. So we're looking at this at a very granular level, and we have made sort of a site-by-site assessment on when we think they will be able to pick things up again, and that has led us to that assessment and also to the remaining uncertainty. Okay, thank you.

Obviously, we'll see what happens as time goes on but we have good reason to think that actually will be ending 2021 in a very different place than we ended 2020 and so of all other things that you've mentioned I think that's probably the single biggest thing that will lead to growth over time and how quickly that is possible is really going to be the biggest back.

And how our revenue increased over the next year.

Basically based on what we saw sort of in the worst of the pandemic that was the issue and so that's we're looking forward to I wish we could give you kind of better timing I will say because it's not really something that you wouldn't assume we are assuming improvement over the course of the year, although in some sense not for awhile because it really is not.

Joseph K. Belanoff: Unknown Attendee, Swayampakula Ramakanth, Gary Robb, Joseph Belanoff, Gregory Fraser

Going to go all the way at once but I think we'll be looking at a different world.

Joseph K. Belanoff: Our next question comes from the line of Chris Howerton with Jefferies. Your line is open. Hey there. Thanks so much for taking the questions. Appreciate it. So I guess maybe just to follow up on the previous question in terms of revenue guidance for this year, you know, so what I heard you say, Sean, was that essentially you're expecting an increase at some point this year and certainly an impact from your Salesforce expansion. Specific factors that went into the Revenue Guidance and maybe some things might specifically be like increased compliance, new patient ads, and price increase might be some things that investors could be interested in.

Nine months from now six months from now.

Right.

Well I mean, I I don't think I speak alone that I I completely agree with your sentiment and I truly hope and believe that it to be the case not only for of course, it but mark Bradley absolutely.

Well, maybe just another quick question on the ovarian cancer trial, I guess, you know as we're getting closer to those data what do you what are the expectations or possibilities of.

Attaining accelerated approval based upon the outcome of this trial in the end.

Joseph K. Belanoff: Joe Belanoff, Co-Founder & CEO, Swayampakula Ramakanth, Atabak Mokari, Swayampakula Ramakanth, Atabak Mokari, Swayampakula Ramakanth, Atabak Mokari,

If that were to be the case what are the specific learnings that you think you can achieve from this trial too to design a successful phase III.

Yeah exactly on the question I think about.

Joseph K. Belanoff: I don't know how soon this is going to be.

Very good.

Joseph K. Belanoff: are in, you know, from this point forward. I just have to reiterate what Andreas and Sean said. We are seeing things that weren't happening two months ago happening right now. I don't know if that's going to continue, but certainly at this point, the trend, at least, however slight, really looks like it's in an improving zone. And I think that the major thing, I'll just repeat from my comments earlier, is that patients who are already on the medicine are doing fine on the medicine. They remain. And so patient enrollment is really what we think is going to pick up over the course of the year, new patient enrollment. Unknown Attendee, Swayampakula Ramakanth, Gary Robb, Joseph Belanoff, Gregory Fraser, Unknown Attendee, Swayampakula Ramakanth, Alan Leong, Corcept Therapists Inc.

This trial just to give everyone a little bit of background, who maybe has Paul.

Of course.

For La is that this is a phase two study based on a relatively small group of patients in phase. One. So we look at this study as a really great opportunity to learn.

For the disease works and which patients that's better.

And really is set up as a design.

Help us design, what we very much anticipate will be phase III program I think the probability of the ovarian cancer study leading to an accelerated approval really is pretty small and I don't think anybody should really go in with that kind of expectation now.

That said fingers crossed on rooting for it and so forth, but really our internal thinking is this was our first opportunity studies serious group of patients and number on 180 patients and we really think we will.

We'll extend on the promise we saw on the phase one study and learn a lot. So they can really design a program that will take us to the.

Joseph K. Belanoff: Well, I mean, I don't think I speak alone in saying that I completely agree with your sentiment, and I truly hope and believe that this will be the case, not only for Corset, but more broadly, absolutely. Well, maybe just another quick question on the ovarian cancer trial. I guess, you know, as we're getting closer to those data, what are the expectations or possibilities of attaining accelerated approval based upon the outcome of this trial and, you know, if that weren't to be the case, what are the specific learnings that you think you can achieve from this trial to design a successful phase three?

Finish line, but you should anticipate that a large phase III study is still to come.

Okay Alright.

Well, that's very clear. Thank you I appreciate the comments, Joe and thanks for your debt.

Okay.

Thank you.

Our next question comes from the line of sway Apple Colo Raw Mccann with H C. Wainwright.

Line is open.

Thank you this is RK from H C Wainwright.

Good afternoon, Joe.

Charlie.

So just to start off.

I understand.

Try to help us.

You now have a sudden idea of 2021 in terms of Korlym revenues.

I just want to see if you can give us a little bit if on the idea of what happened in the fourth quarter.

Joseph K. Belanoff: Yeah, exactly the question I'm thinking about. So very good.

Suddenly you walked into fourth quarter with the lower guy at lower of the guidance moving off the guidance.

Joseph K. Belanoff: You know, this trial, just to give everyone a little bit of background who maybe has to follow up, of course, for a long time, is that this is a phase two study based on a relatively small group of patients in phase one. So we look at this study as a really great opportunity to learn where the disease works and which patients it does better in, and really is set up as a designed study to help us design what we very much anticipate will be a phase three program.

And still there was an impact on.

Is that a way for you to give us an idea of what sort of an impact that was and maybe that's kind of that'll give us an idea of what.

What you're concerned about for 2021.

I apologize I had a little.

Trouble hearing you, but I think I got the gist of your question and in some ways.

Probably a pretty simple unsatisfying answer which was simply that these got worse in a lot of parts of the United States in <unk>.

Joseph K. Belanoff: I think the probability of the ovarian cancer study leading to an accelerated approval is really pretty small, and I don't think anybody should really go in with that kind of expectation. Now, you know, that said, fingers crossed and rooting for it, and so forth. But really, our internal thinking is this was the first opportunity to study a serious group of patients in number, about 180 patients. And we really think we will both extend the promise we saw in the phase one study and learn a lot so that we can really design a program that will take us to the finish line. But you should anticipate that a large phase three study is still to come.

Thanksgiving and everyone kind of experienced that and it really.

Allow for much less opportunity for.

Doctors to be seen for patients for doctors to see their patients and so that's really.

The single biggest factor and I think that as we move forward and that begins to abate.

Will.

That trend will reverse.

And again I wish I could give you more detail on sort of exactly how that's going to become but really in some sense. The answer. Your question is simple and our progress to be made it's going to be simple and it's going to be completely related to how much how much sort of the world opens up because as I said before our existing patients taking the medicine really remain.

Joseph K. Belanoff: Well, that's very clear. Thank you. I appreciate the comments, Joe, and thanks for your time. Thank you. Our next question comes from the line of Swayampakula Ramakanth with HC Wainwright.

Well treated and so forth but.

Joseph K. Belanoff: Your line is open. Thank you. This is R.K. from Hits Eventright. Good afternoon, Joe and Charlie.

Getting the information to doctors and having the doctors be able to care of their patients optimally, it's very difficult for new patients in the Covid environment.

Joseph K. Belanoff: So to start off, I understand you have tried to help us have a certain idea of 2021 in terms of core and revenues. And I just want to see if you can give us a little bit of an idea of what happened in the fourth quarter. You know, certainly you walked into the fourth quarter with a lower level of guidance, a lowering of the guidance. And still, there was an impact. And, Is there a way for you to give us an idea of what sort of an impact that was? And maybe that's kind of, that'll give us an idea of what you're concerned about for 2021.

Okay. Thank you for that.

Regarding the Hikma challenge.

How different is it from what Tara on Sun.

What problems for them on some challenging or is it is it the same set of patents.

I'm going to pass you to Charlie for that question RK.

Okay.

Just because this is really so arcane, let me just take a minute to give folks some background as to everyone's oriented here.

The way.

These these challenges work is that there is a.

Legal illegal scheme whereby.

Would be generic manufacturer provides us notice that they plan to seek approval to be a generic manufacturer.

Joseph K. Belanoff: I apologize, RK, because I had a little trouble hearing you, but I think I got the gist of your question. And in some ways, you know, it's probably a pretty simple, unsatisfactory answer, which is simply that the disease got worse in a lot of parts of the United States after Thanksgiving, and everyone kind of experienced that, and it really allowed for much less opportunity for doctors to be seen, for doctors to see their patients.

And that.

That gives us time to decide to sue them in district court for violation of our patents and then litigation goes from there. If we soon there will be a 30 months stay on any FDA approval of their proposed medication, while we litigate the issues and that's what happened with Teva, So what happens on and we'll see.

See how things exactly proceed with Hikma, but we received their notice for a week ago.

Joseph K. Belanoff: And so that's really, you know, the single biggest factor. And I think that as we move forward, and that begins to fade, we will, you know, that trend will reverse. And again, I wish I could give you more detail on sort of exactly how that's going to be, but really, in some sense, the answer to your question is simple, and if progress is to be made, it's going to be simple. It's going to be completely related to how much the world opens up.

For.

From what we received in the notice there is theres not theres really nothing new nothing about this is any different.

Then than anything we've seen before with respect to our other litigants and I guess I would say that.

The other thing to appreciate is this is very standard course of events events for disputes like this and initial generic manufacturers steps forward. In this case it was Teva litigation with them ensues, and it's very common for second and third and fourth would be manufacturers to hang back.

Joseph K. Belanoff: Because, as I said before, our existing patients taking the medicine really remain well-treated and so forth, but getting the information to doctors and having the doctors be able to care for their patients optimally is very difficult for new patients in the COVID environment.

File attempt to seek approval later just in the hope that if the initial mover Teva is able to secure anything there'll be able to secure something in form of a settlement.

Joseph K. Belanoff: Okay, thank you for that. Regarding the HIKMO challenge, how different is it from what Tava and Sun are challenging, I mean what patterns Tava and Sun are challenging, or is it the same set of patterns?

Not as good as that for the initial filer secures, but something's secured at a much lower cost. They just kind of tag along I don't know exactly what Hikma is strategy is going to be it's obviously much too early to know, but this is exactly the course with Vince you would expect to see so I think the important point really is.

Gary Charles Robb: I'm going to pass you to Charlie for that question, RK.

Gary Charles Robb: Okay, just because this is really so arcane, let me just take a minute to give folks some background, just so everyone's oriented here. The way these challenges work is there's a legal scheme whereby a would-be generic manufacturer provides us notice that they plan to seek approval to be a generic manufacturer, and that gives us time to decide if we, you know, sue them in district court for violation of our patents, and then litigation goes from there.

Our two as you asked nothing really new and secondly, certainly nothing that makes us any less confident in the protective power of our intellectual property. So we will see exactly what happens but.

Nothing on settling or unusual.

Thank you and then regarding the clinical data that is anticipated in the first half of this year.

Gary Charles Robb: If we sue them, there will be a 30-month stay on any FDA approval of their proposed medication while we litigate the issues. And that's what happened with Teva, that's what happened with Sun, and, you know, we'll see how things exactly proceed with Hikma, but we received their notice a week later.

Is that a venue that debt.

Sure.

Thinking of are.

Is this going to be just a press when theres over that time.

Yes, My guess is that it will initially be a press release, because it will in all likelihood can't imagine it not being material information and then we will do.

Gary Charles Robb: Um, from what we received in the notice, there's really nothing new, nothing about this is any different. Unknown Attendee, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, The other thing to appreciate is this is a very standard course of events, events for

<unk> presentations I don't know if on tranches any color on that yet but over time, we will.

We're all sort of recovering academic so.

I'll be more than one.

Yes.

Exactly the plan that we're going to like pipeline was we're going to Miss the ESCO deadlines.

Gary Charles Robb: Disputes like this.

Gary Charles Robb: and Initial Generic Manufacturer Steps Forward; in this case, it was.

And so therefore.

Gary Charles Robb: [inaudible]

It'll be exactly as Joe.

Gary Charles Robb: Litigation with them ensues, and it's very common for second and third and fourth would-be manufacturers to hang back, file on, you know, attempt to seek approval later, just in the hope that if the initial mover, Teva, is able to secure anything, they'll be able to secure something in the form of a settlement. Not as good as that that the initial filer secures, but some things secured at a much They just kind of tag along.

<unk>.

Okay perfect.

Waiting to see it.

Thank you very much gentlemen.

Good day.

To talk to you.

Thank you. Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Your line is open.

Thank you hi, guys. Thanks for taking my questions.

I just wanted to dig in a little bit more in terms of the.

The implications of the P T I D.

On affirmation of what are the two one for patents.

With with I guess term out to 2037, what other implications for the Teva.

Gary Charles Robb: I don't know exactly what HICMA's strategy is going to be. It's obviously much too early to know, but this is exactly the course of events you'd expect. So I think the important point really is, or two, as you asked, nothing really new. And secondly, certainly nothing that makes us any less confident in the protective power of our intellectual property. So, you know, we'll see exactly what happens, but it is nothing unsettling or unusual.

Litigation and potentially I guess Sun pharma and Hikma.

Sure, Matt happy to answer that and again.

Just to give everybody a little bit of a brief Ted talk on legal process before I answer your question directly.

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These patent litigation in United States, and the sort of hatch Waxman litigation.

Under involved in now.

Can follow a parallel course, meaning 2018, whichever announced they wanted to enter the market we sued them in Federal District Court.

Joseph K. Belanoff: Thank you. And then regarding the clinical data that is anticipated in the first half of this year, you know, is there a venue that you're thinking of, or is this going to be just a press release at the time?

And a year after that when Sun.

Joseph K. Belanoff: My guess is that it will initially be a press release because, in all likelihood, I can't imagine it not being material information. And then we will do conference presentations. I don't know if Andreas has any color on that yet, but over time, we will, you know, we're all sort of recovering academics, so we'll be at more than one.

So they wanted to the market we sued them in Federal District Court in those cases have been proceeding, especially the Teva case doing all the normal things you are doing litigation with discovery in motion and expert testimony on all that stuff. Its just been moving along ever since now in parallel.

You can also litigate patents in front of the patent office and a sort of quasi judicial administrative type of procedure and so after we asserted our patents against Teva, including eventually this two one for patent.

Joseph K. Belanoff: ..

Andreas Grauer: Yeah, that's exactly the plan. We're going to, like, timeline-wise, we're going to miss the ESCO deadlines.

Teva went to the patent office and said look with respect to this two one for patent we think it is invalid never should have been issued and we want you to look at it again.

Andreas Grauer: And so, therefore, it'll be exactly as Joe has outlined it. Okay, perfect. I'm waiting to see it.

Joseph K. Belanoff: Thank you very much, gentlemen. Thank you. Our next question comes from the line of Matt Kaplan with Lindenburg-Solomon. Your line is open. Thank you.

Obviously agreed to do that in a procedure called a post grant review and after a year of back and forth in front of the patent office, where we presented our arguments and evidence and witnesses and have presented their arguments and evidence on witnesses the patent office decided in our favor. They rule that every claim of the two one for patent was valid.

Joseph K. Belanoff: Thanks for taking the questions. I just wanted to dig in a little bit more in terms of the implications of the PTAB affirmation on the validity of the 214 patent with, I guess, term out to 2037. What are the implications for the TEVA litigation and, potentially, I guess, Suncom and HICMA?

And that's where we stand right now so the question yet, but we have a valid patent challenge failed.

They by the way have a.

The right to appeal that loss, which they have filed notice saying they plan to do.

Gary Charles Robb: Sure, Matt, happy to answer that. And again, I'll just give everybody a little bit of my brief TED Talk on the legal process before I answer your question directly. Patent litigation in the United States, and you know, these sort of hatch, waxman litigations we're under, under, involved in now, can follow a parallel course. Meaning, in 2018, when Teva announced they wanted to enter the corporate market, we sued them in federal district court.

And they're filing is due no later than March 12, So we'll see what happens.

If they do file an appeal it will be to the federal Circuit Court of Appeals.

Those take about a year to 16 months to resolve which is why we say the issue won't be fully settled until this time next year basically on a little bit after that but until then the patent is valid and in place and the <unk>.

Gary Charles Robb: And a year after that, when Sun Microsystems went into the market, we sued them in federal district court, and those cases have been proceeding, especially as a case doing all the normal things you do in litigation with discovery and motion and expert testimony and all that stuff. It's just been moving along ever since.

That is what does that mean for the parallel district court dispute that litigation and the answer is that the law is designed to keep politicans from having sort of day one more bite.

Gary Charles Robb: Now, in parallel, you can also litigate patents in front of the patent office in a sort of quasi-judicial administrative process. And so after we asserted our patents against Teva, including eventually this 214 patent, Teva went to the patent office. Unknown Attendee, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, And that's where we stand right now.

So having chosen to challenge the validity of our two one for patent for the patent office and lost Teva is now barred from challenge and the ability of that patent is there any argument. It raised for could've raised at the patent office, which I think in this case is a pretty comprehensive list of arguments so.

For all intents and purposes Teva is now barred from challenging the validity of that patent in district Court.

Gary Charles Robb: So the question that we have a valid patent has failed. They, by the way, have the right to appeal that loss, which they have filed notice saying they plan to do, and their filing is due no later than March 12th, so we'll see what happens with that. If they do file an appeal, it will be to the Federal Circuit Court of Appeals. Those take about a year to 16 months to resolve, which is why we say the issue won't be fully settled until this time next year, basically, or a little bit after that.

As this dispute goes along they are faced with a conceded leave valid patent.

And there are only recourse with respect to witness to argue that they would not their product we're not infringing.

Some difficult argument for them to make.

So the consequences.

Net <unk> options are drastically narrowed with respect to that patent and a recall on these cases the patent owner has the only prevail on one patents prevail overall, so teva has really put themselves in a very very tough spot as implication for Teva.

Gary Charles Robb: But until then, the patent is valid and in place. And the question then is, what does that mean for the parallel district court? Atabak Mokari, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Alan Leong, and Lost, HEVA is now barred from challenging the validity of that patent using any argument it raised or could have raised at the patent, which I think in this case is a pretty comprehensive list of arguments. So, for all intents and purposes, TEVA is now barred from challenging As this dispute goes along, they are faced with a conceivable...

Every litigant is different Sun would have the rights challenged patent.

Hikma if we it gives into litigation with them would have the right to challenge the patents validity.

But they will all face difficulty.

Difficult fact patent offices now both issued the patent and examined as essentially a second time in a quasi judicial proceeding and reaffirmed the validity of it. So all of our challenges are in a tough spot specially teva.

Which is.

Not to lose the import of all this in mind sort of exposition of legal process very good news for us.

That's that's very helpful. Charlie Thank you for additional color on clarity.

Gary Charles Robb: valid patent. And their only recourse with respect to it is to argue that they would not not infringe it. Unknown Attendee, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Every litigant is different.

Another question in terms of.

Your clinical development programs, there seems to be a bit of a dichotomy at least for me.

Gary Charles Robb: Sun would have the right to challenge the patent. Hickman, if we get into litigation with them, would have the right to challenge the patent's validity, but they will all face difficulty, sort of difficult facts. The Patent Office has now both issued the patent and examined it essentially a second time in a quasi-judicial proceeding and reaffirmed the validity of it. So all of our challengers are in a tough spot, especially TEVA, which is, you know, not to lose the import of all this in my sort of exposition of the legal process. It is very good news for us.

Terms of what Youre, saying about the return to growth for Korlym later this year.

And we.

Extension potentially for at least another year.

The timing for.

Grace results and filing our NDA potentially up to second quarter two.

2000 to now help me understand maybe you guys can give us for more detail in terms of the current status.

The great study on where that is.

Why are you thinking.

Joseph K. Belanoff: That's very helpful, Charlie; thank you for the additional color and clarity. Another question in terms of your clinical development programs. There seems to be a bit of a dichotomy, at least for me, in terms of what you're saying about the return to growth for Coralin later this year and the extension, potentially, for at least another year of the timing for the GRACE results and filing of the NDA, potentially out too.

Based on based on the other inputs that debt it could be delayed price once a year.

Well.

Matt.

Really understand the nuance of the question and.

Kind of walk you through as best they can but I think the most important thing to understand is debt.

While the pandemic affected almost everything didn't affect everything identically. So for instance, I'll give you. An example of that doctors who work in.

Joseph K. Belanoff: , and the second quarter of 2022 now. Help me understand. Maybe you guys can give us some more detail in terms of the current status of the GRACE study and where that is and why you're thinking, based on the other inputs, that it could be delayed by as much as you can.

On their own office and the community as an example.

They're living depends on what I'm seeing patients, particularly patients in.

Person and as consequence day I think they have been more we see it in the last weeks or so more aggressive in sort of getting back to work. So that's an effect, which we see primarily in our commercial business on the other hand major medical centers, particularly those medical centers, which are in their countries.

Joseph K. Belanoff: Well, you know, Matt, I really understand the nuance of the question and will try to kind of walk you through as best I can. But I think the most important thing to understand is that while the pandemic affected almost everything, it didn't affect everything identically. So, for instance, I'll give you an example of that. Doctors who work in their own office, in the community, as an example, their living depends on them seeing patients, particularly patients in person.

Treating COVID-19 have basically said for non acute purposes on our resources are really diverted to that business and so when things get better you're going to get better all around but not necessarily at the same pace and so we don't have a great prediction S.

Joseph K. Belanoff: And as a consequence, I think they have been more, we've seen it in the last, you know, weeks or so, more aggressive in sort of getting back to work. So that's an effect which we see primarily in our commercial business. On the other hand, major medical centers, particularly those medical centers which are in their countries treating COVID, have basically said, for non-acute purposes, their resources are really diverted to that business.

Two particularly the latter because that's what you're really asking about in terms of trial enrollment a little bit harder for us to really visualize since we've never been in this circumstance how fast those places reopen.

We are absolutely helping deal for us.

Quickly as they can so we can really get moving on it but I just want to point out that the situations are not exactly the same in commercial than they are in clinical and even within the clinical development program as I pointed out they're not identical either for instance, the pancreatic and ovarian cancer studies actually came in a couple of months ahead.

Joseph K. Belanoff: And so when things get better, they're going to get better all around, but not necessarily at the same pace. And so we don't have a great prediction as to the latter, because that's what you're really asking about in terms of trial enrollment. It's a little bit harder for us to really visualize, since we've never been in this situation, how fast those places will reopen. So we hope they will open as quickly as they can, so we can really get moving on it. But I just want to point out that these situations are not exactly the same in commercial as they are in clinical. And even within the clinical development program, as I pointed out, they're not identical.

Where they thought they would those are very youll patients. They have to go to the hospital anyway. So to continue them in a clinical trial into them in a clinical trial didn't wasn't distracted much by the pandemic on the other hand, you have diseases, where.

Tomorrow or the next day for the next week don't seem to be as critical.

It's more easy for patients to avoid those studies were for doctors too.

Not be as active in this study so I just point this out because it's obviously a new learning for all of US as we went through the pandemic.

Joseph K. Belanoff: Neither.

Joseph K. Belanoff: For instance, the pancreatic and ovarian cancer studies actually came in a couple of months ahead of where they thought they would. Those are very ill patients. They have to go to the hospital anyway, so to continue them in a clinical trial, or even injure them in a clinical trial, wasn't much distracted by the pandemic. On the other hand, you have diseases where tomorrow or the next day or the next week don't seem to be as critical.

Just sort of repeat where I started the pandemic affected everybody or almost everybody with just to different degrees and we'll see how it plays out obviously if in fact major medical centers open quicker to clinical trials like ours.

We will get done quicker, it's really as simple as that and if they go slowly.

There's not much we can do except continued to be ready for when they move less flow.

Joseph K. Belanoff: It's easier for patients to avoid those studies or for doctors to not be as active in those studies. So I just point this out because it's obviously a new learning for all of us as we went through the pandemic. I'll just sort of repeat where I started. The pandemic affected everybody, or almost everybody, but just to different degrees.

Got it.

Good color. Thank you for walking on again.

Sure.

Thank you.

Our next question comes from the line of Alan Leon with buy on watch news.

Okay.

Congratulations for a team that may be moving slower, but the story looks like it's unfolding.

Joseph K. Belanoff: And we'll see how it plays out. Obviously, if major medical centers actually open quicker to clinical trials like ours, we'll get done quicker. It's really as simple as that. And if they go slowly, then there's not much we can do except continue to be ready for when they move less slowly.

As you outlined before so congratulations.

First we noticed the bipolar patients were added cubic gratitude trial can we hear your thinking on this slide for example are you setting for potentially adding bipolar patients.

For a label or.

Joseph K. Belanoff: That's a good added color. Thank you for walking us through that. Our next question comes from Alan Leong of BioWatch News. Kalani, congratulations to the team. It may be moving slower, but the story looks like it's unfolding as you outlined before.

Strengthening the argument for any non short term use of anti psychotics on weight gain.

That's a great question on a great observation, yes, indeed, we have added.

Polar patients for the original gratitude study.

First of all we believe that the nature of weight gain anti psychotic induced weight gain is very similar and schizophrenics on bipolar patients.

Joseph K. Belanoff: So congratulations. First, we noticed that bipolar patients were added to the gratitude trial. Can we hear your thinking on this? Like, for example, are you preparing the setting for potentially adding bipolar patients to the eventual label, or are you strengthening the argument for any non-short-term use of anti-psychotics on weight gain? That's a great question and a great observation. Yeah, indeed we have added Unknown Attendee, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, and William Guyer, which allows us to broaden our base. of Label Implications Downstream. Let me remind you, we're still in phase two. Whatever we find will have to be confirmed. Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Alan Leong, Corcept Therapeutics Inc.

Therefore.

Allows us to broaden our base hopefully facilitate enrollment on the other hand.

No.

See consistent results for homes that.

It may have label applications downstream, let me remind you were still in phase two at this point whatever we find we will have to be confirmed in a phase III trial, but.

We learn as much as we can and that's certainly important insight debt that will.

We're looking forward to have interest in.

Let me sort of sum it up.

In a sense.

For you Alan.

I agree with everything that Entre is set the bottom line is this what causes the weight gain is not the diagnosis medicine.

So patients with bipolar disorder, and schizophrenia can be equally prone to having the metabolic issues from these medications is important to study them because they are both very large groups of people.

Joseph K. Belanoff: And just let me sort of sum it up for you, Alan, because I agree with everything that Andrea said. The bottom line is this: what causes the weight gain is not the diagnosis; it's the medicine. And so patients with bipolar disorder and schizophrenia can be equally prone to having metabolic issues from these medications, and it's important to study them because they're both very large groups of people.

Congratulations on the CYP inhibition publication.

<unk> profile for drug drug interactions isn't as bad as perhaps one once feared can you provide any light it seems that only mild dose adjustments are required with the practicing and perhaps also within the <unk>. So any day.

Joseph K. Belanoff: Congratulations on the CYP inhibition publication. Well, the correlance profile for drug-drug interactions isn't as bad as perhaps once feared. Can you provide any light? It seems that only mild dose adjustments are required with Abraxane and perhaps also with Enzalutamide. So, anything you could provide would be helpful.

If you could provide would be helpful.

Well as you often do al when you actually read our papers.

Yes.

We don't even pay you to do that so.

More people on read them, but you're absolutely right the drug drug interactions related to relative orland when.

Joseph K. Belanoff: Well, as you often do, Alan, you actually read our papers, and we don't even pay you to do that, so I wish more people would read them, but you're absolutely right. The drug-drug interactions related to relacoralin, we actually tested them in people in rigorous drug-drug interaction studies, proved to be much more limited than some people thought they might be. It's really as simple as that, and it really makes it very, you know, the interaction, for instance, with napaqlitaxel is really quite manageable with a relatively small dose reduction of napaqlitaxel getting to the right dose.

When we actually tested them and people in and rigorous drug drug interaction studies proved to be much more limited than some people thought they might be it's really as simple as that in it.

It really makes it.

The interaction for instance, with Nab Paclitaxel is really quite quite manageable.

Relatively small at this reduction in Nab paclitaxel for getting getting to be ranked debt. So in some sense no surprise to us we have that data talked about it is we want to do but now it's been peer reviewed published and for people, who really do want to read about detail. Please come to our website you can find out the site.

Joseph K. Belanoff: So in some sense, no surprise to us, we've had that data, you know, talked about it as we wanted to do, but now it's been peer-reviewed and published, and for people who really do want to read about it in detail, please come to our website, and you can find out the site.

And a real quick bonus question I noticed there's a new drug in clinical trials.

Within our liquid capsule form can you provide any additional light on the matter at this time.

Yes, Alan on I'm not positive we often use.

Joseph K. Belanoff: And a real quick bonus question. I noticed there is a new drug in clinical trials, and I noticed it's in liquid capsule form. Can you provide any additional light on the matter at this time?

Think maybe you're referring to the soft gel capsules for relative Cortland, we've switched that because we felt like it was.

Easier to manufacturer and it was going to produce more reliable plasma levels.

Joseph K. Belanoff: Yeah, Alan, I'm not positive. We often use, I think maybe you're referring to the soft gel capsules for relacoralin. We switched that because we felt like it was easier to manufacture and was going to produce more reliable plasma levels. We're not the only people who have actually done that earlier in development. It was just easier to do those hard gel capsules, and we just think this is better. So I think that's what you're referring to. And that's the reason we did it. We found a really sound manufacturer to produce very reproducible levels when they tested it.

We're not the only people who have actually done that earlier in development. It was just easier to do this hard gel capsules and we just think this is better so I think that's what you're referring to.

And that's the reason we did it we found a really sound manufactured produce.

On a reproducible levels when they tested the drug.

So you just re labelled as Cort one to $5 32 nine.

Oh different question.

But for 125329 is a compound in phase one studies, where that is also the case that's right.

Joseph K. Belanoff: So you just relabelled it as Court 125329? Oh.

Awesome.

Thanks.

In general that's a direction that we would choose to move when manufacturing makes it possible.

Joseph K. Belanoff: Oh, different question; Court 125-329 is a compound in Phase 1 studies where that is also the case. Thank you.

All right well this has very much post Super Bowl and on a KOL day in New York. Thanks for listening in and we'll be back to you next quarter and fingers crossed that there'll be a lighter pandemic conversation by that period of time.

Joseph K. Belanoff: But in general, that's a direction that we would choose to move when manufacturing makes it possible. All right, well listen, thank you guys very much. Post-Super Bowl and on a cold day in New York, thanks for listening in, and we'll be back to you next quarter, fingers crossed that there'll be a lighter pandemic conversation by that period of time.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.

Okay.

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Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation.

Yes.

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Gross.

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