Q4 2019 Earnings Call

Good day and welcome to the course up Therapeutics Conference call. Today's conference is being recorded if you would like to ask a question. Please signal by pressing star one on your telephone keypad at this time I'd like to turn the conference over to Charlie Robb. Please go ahead Sir.

Operator: Corcept Therapeutics conference call. Today's conference is being recorded. If you would like to ask a question, please signal by pressing star one on your telephone keypad. At this time, I'd like to turn the conference over to Charlie Robb. Please go ahead, sir.

Unknown Executive: Good afternoon. Thank you for joining us.

Good afternoon. Thank you for joining us I'm of course, that's chief Financial Officer earlier today, we issued a press release announcing our financial results for the fourth quarter and full year and reviewing our research and development programs.

Gary Charles Robb: I'm Corcept's Chief Financial Officer. Earlier today, we issued a press release announcing our financial results for the fourth quarter and full year and reviewing our research and development programs. A copy is available at Corcept.com. Complete results will be available when we file our Form 10-K with the SEC. This call is being recorded. A replay will be available through March 5th at 888-203-1112 from the United States and 719-457-0820 internationally. The passcode will be 708-5899.

Copy is available at <unk> Dot com complete results will be available when we file our form 10-K with the FCC.

Today's call is being recorded a replay will be available [noise].

[noise] through March fit at 8882, 03111, too from the United States in 7194, or 570 820 internationally. The pass code will be seven no wait 5899.

Gary Charles Robb: Statements during this call, other than statements of historical fact, are forward-looking statements based on our plans and expectations that are necessarily 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 generate sufficient revenue to fully fund our commercial operations and development programs, the availability and competitive viability of competing treatments for Cushing's Syndrome, including generic versions of Corleum, the initiation or outcome of litigation, our ability to obtain acceptable prices or adequate insurance reimbursement for Corleum, and risks related to the development of our product candidates, including clinical outcomes, regulatory approvals, mandates, oversight, and These and other risks are set forth in our SEC filings, which are available on our website, during this call.

Statements. During this call I didn't statements of historical fact are forward looking statements based on our plans and expectations that are necessarily subject to risks and uncertainties, which might cause actual results to differ materially from those such statements expressed or implied these risks and uncertainties include but are not limited to our ability.

To generate sufficient revenue to fully fund, our commercial operations and development programs, the availability and competitive viability of competing treatments for Cushing syndrome, including generic versions of Korlym, the initiation or outcome of litigation our ability to obtain acceptable prices are adequate insurance reimbursement for korlym and risks related to the device.

One of our product candidates, including clinical outcomes regulatory approvals mandates oversight and other requirements. These and other risks are set forth interests, you see filings, which are available at our website and the Fccs website.

This call.

Gary Charles Robb: Forward-looking statements include those concerning our revenue guidance and our expected growth and financial performance in future years. Physician awareness of hypercortisolism and the selection of corallum is the optimum medical treatment. Timing, cost, and outcome of litigation, including our lawsuits against Teva Pharmaceuticals and Sun Pharmaceuticals, and the challenges to our intellectual property before the Patent, Trial, and Appeals Board, the scope and protective power of our intellectual property, and the benefits of our

Forward looking statements include those concerning our revenue guidance and our expected growth and financial performance in future years physician awareness of hyper cortisol Ism and the selection Korlym is the optimum medical treatment.

I mean cost an outcome of litigation, including our lawsuits against have a pharmaceuticals, and Sun pharmaceuticals, and the challenges to our intellectual property before the patent trial and Appeals board.

Scope and protect your power of our intellectual property the benefits of orphan drug designation, the clinical attributes of relic Cortland, Mirick Orland and exit correlate the progress timing design and results of our development programs, including the Grace gradient and gratitude trials and our other current and planned clinical trials.

Unknown Attendee: Unknown Attendee, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Our revenue in the fourth quarter was $87.9 million, a 32% increase from the fourth quarter of 2018. For the full year, our revenue was $306.5 million, an increase of 22% from 2018. We have reiterated our 2020 revenue guidance of between $355 and $367 million.

We disclaim any intention or duty to update forward looking statements.

Our revenue in the fourth quarter was $87.9 million, a 32% increase from the fourth quarter of 2018.

For the full year, our revenue was $306.5 million an increase of 22% from 2018, we have reiterated our twentytwenty revenue guidance of between 355 and $375 million.

Gary Charles Robb: Our Gap Net Income was $94.2 million for the year and $29.4 million in the fourth quarter of 2019, compared to $75.4 million for the year and $22 million in the fourth quarter of 2018. Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income was $133.3 million for the year and $40.3 million in the fourth quarter of 2019, compared to $108.2 million for the year and $30.4 million in the fourth quarter of 2018. A reconciliation of gap to non-gap net income is included in our press release. Our cash and investments increased to $48.4 million in the fourth quarter, to a balance of $315.3 million at December 31, 2019. We believe our revenue, together with our cash on hand, will be sufficient to fully fund our commercial business and complete our planned development program.

Our GAAP net income was $94.2 million for the year and $29.4 million in the fourth quarter of 2019 compared to 75.4 million for the year and 22 million in the fourth quarter of 2018.

Excluding noncash expenses related to stock based compensation in the utilization of deferred tax assets together with related income tax effects non-GAAP net income was $133.3 million for the year and $40.3 million in the fourth quarter of 2019 compared to 108.2 million dollar.

For the year and 30 $430.4 million in the fourth quarter of 2018.

A reconciliation of GAAP to non-GAAP net income is in our press release.

Our cash and investments increased $48.4 million in the fourth quarter, two a balance of $315.3 million at December 30, Onest. Two 2019, we believe air revenue together with our cash on hand will be sufficient to fully fund our commercial business and complete our plan development programs now brief legal.

Gary Charles Robb: Now, a brief legal update. As most of you know, we are currently prosecuting two lawsuits against Teva Pharmaceuticals. In February of 2018, Teva gave notice it was seeking to market a generic version of Coraline. In March of 2018, we sued Teva for patent infringement, thereby delaying FDA approval of its proposed generic product until August of 2020. In December 2019, the Patent Office issued us a patent covering methods of improving Mifepristone absorption, which we have asserted against Teva in a second lawsuit. The District Court has not yet decided whether these two lawsuits should be consolidated. In addition, TEVA is challenging the validity of another of our patents, known as the 214 patent, before the Patent Office Trial and Appeals Board, or PTAB, in a proceeding known as Post-Grant Review, or PGR for short. As we have said repeatedly, patent litigation is complex and takes a long time to resolve. Our dispute with Teva is no exception. The Markman hearing and the first lawsuit we filed against Teva.

Update.

As most of you know we are currently prosecuting to lawsuits against Teva Pharmaceuticals in February of 2018, Teva gave notice it was seeking to market a generic version of Korlym in March of 2018, we suit Teva for patent infringement, thereby stain FDA approval of Tevas proposed generic product until.

Oh, I guess of Twentytwenty.

In December 2019, the patent office issued <unk> patent covering methods of improving if a person absorption, which we have asserted against have a in a second lawsuit. The district court has not yet decided whether these two lost lawsuits should be consolidated.

Separately Teva is challenging the validity of another of our patents known as the two one for patent but for the patent office trial in Appeals board or P. tab in the preceding known as post Grant review PG our for short.

As we've said repeatedly patent litigation is complex and takes a long time to resolve our dispute with Teva is no exception. The markman hearing in the first law suit we filed against habit is scheduled for March bet. As a reminder, a markman hearing is where the court decides the meaning of any disputed patent claims we expect.

Gary Charles Robb: [inaudible] We expect the court will set a schedule for the balance of the litigation, including a tentative trial date and whether or not to consolidate our two lawsuits sometime in the next few weeks. We are also drafting briefs and conducting expert discovery in the PGR of our 214 patent. Oral argument before the PTAB will take place in August of this year, followed by a decision in November. The losing party in a PGR proceeding may appeal an adverse decision to the Federal Circuit Court of Appeals, which takes about one year to resolve. The soonest we expect definitive resolution of the PGR is the fourth quarter of 2021. As many of you know, Sun Pharmaceuticals is also seeking FDA approval to market Generic Coraline.

The court will set of schedule for the balance of litigation, including attended trial date, and whether or not to consolidate our two lawsuits sometime in the next few weeks.

We're also drafting briefs and conducting expert discovery in the P.G. our of our two one for patent oral argument before the pizza I will take place in August of this year, followed by a decision in November losing party in a PDR proceeding may appealing adverse decision to the federal Circuit Court of Appeals, which takes about one year to reserve.

Oh, the soonest, we expect definitive resolution of the P.G.R. is the fourth quarter of 2021.

As many of you know Sun Pharmaceuticals is also seeking FDA approval to market generic Korlym, we have sued sun for patent infringement stain FDA approval of SUNS proposed generic product until the earlier of December 820, 21, and a decision by the district court. The patents, we have asserted against son or invalid and.

Gary Charles Robb: We have sued Sun for patent infringement, and we are awaiting FDA approval of Sun's proposed generic product until the earlier of December 8, 2021, and a decision by the district court that the patents we have asserted against Sun are invalid, unenforceable, or not infringed. Despite overlapping subject matter and legal issues with our lawsuits against Teva and the fact that the same judge is presiding over both cases, our dispute with Sun is separate and is following its own timeline. A Markman Hearing

Forcible, we're not in French despite overlap in subject matter and legal issues with our law suit against Teva and the fact that the same judges provide is presiding over both cases are dispute with Sun is separate this following its own timeline.

A markman hearing in the case is set for November of this year the timing of events after that is still to be determined.

Gary Charles Robb: The case is set for November of this year, but the timing of events after that is still to be determined.

Gary Charles Robb: I will conclude by reviewing a recent positive development. One year ago, the PTAB agreed to review the validity of the 348 patent, one of the patents underlying our 30-month stays against Teva and Sun. The challenge was initiated by Neptune Generics, a subsidiary of the litigation finance firm Burford Capital. Neptune had threatened to attack the 348 patent unless we paid it a substantial fee to leave us alone. We refused, and Neptune asked the PTAB to institute a proceeding known as Interparts Review, IPR for short, in which they challenged the 348 patent's validity. I'm pleased to report that the PTAB has decided Neptune's IPR in our favor. The decision, which is available on the Patent Office's website, found every claim of the 348 patent to be valid. Put simply, we won.

I will conclude by reviewing a recent positive development one year ago. The P type agreed to review the validity of the 348 Patton one of the patents underlying our 30 months days against habit and Sun. The challenge was initiated by Neptune generics subsidiary of the litigation Finance from Burford capital.

Neptune had threatened to attack the three for a patent unless we paid it a substantial feed to leave US alone we refused and Neptune asked the P. PTAB instituted proceeding noticed inter Partes review I PR for short in which they challenged the 348 patents validity.

I'm pleased to report that the P. tab has decided Neptune IP are in our favor the decision which is available at the patent offices web site found every claim of the three four patent to be valid put simply we won Neptune has until mid March to ask the P. tab to reconsider his decision and it didn't until mid April.

Gary Charles Robb: Neptune has until mid-March to ask the PTAB to reconsider its decision and until mid-April to file a Notice of Appeal to the Federal Circuit. Whatever Neptune decides to do next, if anything, we remain confident in our ability to protect our patent. This victory is significant. As a matter of principle, it is important to defend one's rights when they are attacked. We have done so, and without paying Neptune a nickel

To file a notice of appealed to the federal circuit, whatever Neptune decides to do next if anything we remain confident in our ability to protect our patent.

This victory is significant as a matter of principal it is important to defends ones right. When they are attached we've done so and without pain Neptune a nickel as a practical matter. It is helpful. The three foray Pat will continue to play its partner lawsuits against have and son, it's validity bolstered by the P. tabs positive decision.

Gary Charles Robb: As a practical matter, it is helpful that the 348 patent will continue to play its part in our lawsuits against Teva and Sun, its validity bolstered by the PTAB's positive decision. However, although the district court is not bound by the PTAB decision, Teva & Son can, and undoubtedly will, continue to challenge the 348 patent's validity. The PTAB's positive ruling makes their positions more difficult. Although this result is not surprising to us, it is nonetheless good news. I will now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Joe?

Ian.

Although the district court is not bound by the P type decision to evidence on can and undoubtedly will continue to challenge. The three four patents validity. The p. tabs positive ruling makes their positions more difficult. Although this result is not surprising to us. It is nonetheless good news.

I'll now turn the call over to Dr., Joseph Belanoff, Our Chief Executive Officer, Joe.

Joseph K. Belanoff: Thank you, Charlie. 2019 was an excellent year for Corcept. Thanks to the skill and dedication of our commercial team, the number of patients receiving Coralim increased each quarter, as did the number of first-time and repeat prescribers of the medication. Our revenue grew 22 percent to $306.5 million, and we expect growth to continue. As Charlie mentioned, we have reaffirmed our 2020 revenue guidance of between $355 and $375 million. At year-end, we had $315 million in cash and investments.

Thank you Charlie.

2019 was an excellent year for course up thanks to the skill and dedication of our commercial team the number of patients receiving korlym increased each quarter as to the number of first time and repeat prescribers of the medication.

<unk> revenue grew 22% to 306.5 million and we expect growth to continue as Charlie mentioned, we've reaffirmed our 2020 revenue guidance of between 355 and $375 million a year end, we had $315 million in cash and investments our strong financial position.

Joseph K. Belanoff: Our strong financial position allows us to pursue the optimal development of a proprietary selective cortisol modulator. Our programs in Cushing Syndrome, Solid Tumors, Antipsychotic Induced Weight Gain, and NASH are advanced. These programs represent Corcept's future.

<unk> allows us to pursue the optimal development of our proprietary selective cortisol modulators our programs in Cushing syndrome solid tumors anti psychotic induced weight gain and Nash are advancing.

These programs represent forceps future success in any of them could produce a medication of great benefit to many patients.

Joseph K. Belanoff: Success in any of them could produce a medication of great benefit to many patients. As most of you know, we are actively enrolling patients in our phase three trial of Vrela Quarrelent, our planned successor to Quarrelom, to treat patients with Cushing syndrome. We call the study GRACE. It is now open at 54 sites in the United States, Europe, and Israel. The trial has two parts. In its initial open-label phase, patients received Ruprella Quarrelent for 22 weeks. Those who exhibit pre-specified improvements in glucose metabolism or hypertension are randomized to a double-blind, placebo-controlled second phase, in which half continue receiving Reliquorilent and the rest are switched to placebo. Grace's primary endpoints are the rate and degree of relapse in patients receiving Reliquorilent compared to those receiving placebo during this randomized withdrawal phase. The expected enrollment is 130 patients.

As most of you know we are actively enrolling patients in our phase three trial umbrella correlate our plants et cetera, the korlym to treat patients with Cushing syndrome. We call. This study Grace Grace is now open at 54 sites in the United States Europe, and Israel. The trial has two parts in it so.

Initial open label phase patients receive coral Frelick Korlym for 22 weeks.

Those who exhibit pre specified improvements in glucose metabolism core hypertension are randomized double blind placebo controlled second phase in which have continue receiving relamorelin and the rest are switched to placebo.

Grace's primary endpoints are the rate and degree of relapse in patients receiving relic orland compared to those receiving placebo. During this randomized withdrawal phase expected enrollment is 130 patients.

We plan to submit in India for railcar Ireland to treat patients with Cushing syndrome in the fourth quarter 2021.

Joseph K. Belanoff: We plan to submit an NDA for Rellych-Loreland to treat patients with Cushing syndrome in the fourth quarter of 2021. Later this quarter, we plan to open a second Phase 3 trial, which we have named Grady. Gradient will be a double-blind placebo-controlled trial of Relacorland to treat patients whose Cushing syndrome is caused by an adrenal adenoma. Patients with this etiology of Cushing syndrome have not been rigorously studied. Although they usually have a more indolent course of disease, their health outcomes are poor.

Later this quarter, we plan to open a second phase three trial, which we have named gradient gradient will be a double blind placebo controlled trial umbrella cortland to treat patients, whose cushing syndrome is caused by an adrenal adenomas.

Patients with this etiology of Cushing Cushing syndrome have not been rigorously studied although they usually have a more indolent course of disease their health outcomes are poor.

Gradient has a plans enrollment of 130 patients at sites in the United States and Europe.

Patients will receive either relic Orlando or placebo for six months with the primary endpoints being improvement in glucose metabolism and hypertension.

Joseph K. Belanoff: Gradian has a planned enrollment of 130 patients at sites in the United States and Europe. Patients will receive either Relaquarelent or placebo for six months, with the primary endpoints being improvement in glucose metabolism and hypertension. Many of the investigators for GRACE will also participate in Grady.

Many of the investigators for Grace will also participate ingredient.

With Grace actively enrolling patients in gradient about to begin I'd like to comment briefly on the contribution we expect these trials to make to the long term development of our Cushing syndrome business.

The purpose of the Grace trial, it's you definitively demonstrate the efficacy and safety umbrella correlate relic korlyms efficacy data have been very encouraging its phase two results were comparable to what we observed at similar time points in Korlyms pivotal study.

Joseph K. Belanoff: With GRACE actively enrolling patients and Gradient about to begin, I'd like to comment briefly on the contribution we expect these trials to make to the long-term development of our Cushing syndrome business. The purpose of the GRACE trial is to definitively demonstrate the efficacy and safety of Reliquoril. Reliquorlin's efficacy data have been very encouraging. For example, phase II results were comparable to what we observed at similar time points in Quorlum's pivotal study. Our poster presenting ReliCorrelance Phase II data at the American Association of Clinical Endocrinologists Annual Congress is available on the Investors Past Events tab of our website. Another of GRACE's important objectives is to confirm Reliquoriline's promising safety profile. As effective as it is for many patients, coraline causes major side effects that limit its effectiveness and require that its distribution be tightly controlled.

Our post are presenting relic Orleans phase two data at the American Association of clinical Endocrinologist annual Congress is available at the investors past events tab of our website.

Another Grace is important objectives objectives is to confirm umbrella carlin's promising safety profile.

Fective is as it is for many patients korlym causes major side effects limit its use and require that its distribution be tightly controlled korlym.

Potently to the progesterone receptor PR for short, which makes it isn't aboard a fashion.

Willems active ingredient and if a person down is the same as the abortion pills, which is why Korlyms label includes a black box warning. The most serious medication wanting required by the FDA for termination of pregnancy.

Joseph K. Belanoff: finds potently to the progesterone receptor, PR for short, which makes it an abortifacient. Corallum's active ingredient, Mipipristone, is the same as abortion pills, which is why its label includes a black box warning, the most serious medication warning required by the FDA for termination of pregnancy. In addition to terminating pregnancy, Coraline's PR affinity causes endometrial thickening and vaginal bleeding in approximately a quarter of the women who take it, regardless of their age. These adverse effects can result in hospitalization and treatment discontinuation. Approximately 70% of patients with Cushing syndrome are women. By a different mechanism, coral also causes potassium to become dangerously low in many patients, a condition known as hypokalemia. Hypokalemia affects men and women equally. For example, more than 40% of the patients in Quorum's Pivotal trial experienced low potassium. Hypokalemia is manageable, but it requires close and continued monitoring. It is one of the leading causes of coralline discontinuation. Relic Horolent does not cause...

In addition to terminating pregnancy, korlyms PR affinity causes endometrial thickening and vegetable eating in approximately a quarter of the women who take it regardless of their age. These adverse effects can result in hospitalization and Korlym discontinuation.

Approximately 70% of patients with Cushing syndrome are women.

By different mechanism Korlym also causes potassium to become dangerously low and many patients a condition known as hyperkalemia.

I don't believe me affects men and women equally more than 40% of the patients and korlyms pivotal trial experienced low potassium.

Okay EMEA is manageable, but requires close and continued monitoring it is one of the leading causes of Korlym discontinuation.

Well look orland does not cause these off target effects. Unlike korlym relamorelin does not bind to PR. It is not the abortion pill and does not cause the other adverse effects arising from PR affinity such as endometrial thickening and fashionable bleeding.

It also does not appear to cause hyperkalemia.

Joseph K. Belanoff: Unlike Coraline, Relacoraline does not bind to PR. It is not an abortion pill and does not cause the other adverse effects arising from PR affinities, such as endometrial thickening and vaginal bleeding.

If the efficacy and safety characteristic gorilla Carlin has demonstrated its development through base to our confirm bike race relic Corlanor will constitute a major medical advance and effective cortisol modulator that does not cause korlyms most significant off target effects.

Joseph K. Belanoff: It also does not appear to cause hypokalemia. If the efficacy and safety characteristics Rellocorrelant has demonstrated in its development through Phase II are confirmed by GRACE, Rellocorrelant will constitute a major medical advance, an effective cortisol modulator that does not cause its most significant off-target effect. Although GRADIENT will study patients with the same indication as GRACE, Cushing Syndrome, and test the same drug candidate, Relacorrelant, GRADIENT serves a different purpose, and it is not a required part of Relacorrelant's NDA.

Although gradient will study patients with the same indication as Grace Cushing syndrome, and test the same drug candidate relic coral and gradient serves a different purpose gradient is not required particle relamorelin, India, rather our expectation is that gradients findings will lead to better care for patients with a serious.

But not yet rigorously studied etiology of Cushing syndrome, Cushing syndrome caused by adrenal adenomas or adrenal hyperplasia, where grace has what might be characterized as a narrow purpose securing approval for a successor to korlym Grady as part of our long term investment and development of cortisol modulation as a treatment for patients.

Joseph K. Belanoff: Rather, our expectation is that GRADIENT's findings will lead to better care for patients with a serious but not yet rigorously studied etiology of Cushing Syndrome, Cushing Syndrome caused by adrenal adenomas or adrenal hyperplasia, where grace has what might be characterized as a narrow, Securing Approval for a Successor to Corallum, Gradient is part of our long-term investment in the development of I'll now provide a brief update on our program in metabolic. Preclinical and clinical data show that cortisol modulation has the potential to treat both weight gain caused by antipsychotic medications and non-alcoholic steatohepatitis, or NASH, serious disorders that affect millions of people and for which there are few good treatment options. Millions of people depend on antipsychotic medications such as olanzapine and risperidone to treat schizophrenia, bipolar disorder, and other serious conditions. Unfortunately, these life-saving drugs cause serious metabolic side effects, including rapid and sustained weight gain, hyperglycemia, and hyperlipidemia. Cardiovascular disease, not suicide, is the leading cause of death in patients with schizophrenia.

Yes, with hyper cortisol lesson.

I'll now provide a brief update of our program and metabolic disorders.

Preclinical and clinical data showed the cortisol modulation has the potential to treat both weight gain caused by antipsychotic medications and non alcoholic Seattle hepatitis or Nash serious disorders that affect millions of people and for which there are few good treatment options.

Millions of people depend on anti psychotic medication, such as Lan subpoena and risperidone to treat schizophrenia bipolar disorder and other serious conditions. Unfortunately, these life saving drugs cause serious metabolic side effects, including rapid and sustained weight gain hyperglycemia and hyperlipidemia cardiovascular.

Disease, not suicide is the leading cause of death in patients with schizophrenia.

In addition to the medical morbidity is caused by these needed medications. There ill effects are seen in felt by patients who then often stopped taking them.

We demonstrated in double blind placebo controlled trials that middle pressed down significantly reduce the weight gain and other adverse effects of land subpoena and risperidone in healthy subjects. The results were published in the journals advances in therapy in October 2009 entered obesity in December 2010. Unfortunately.

We could not advancement of pressed down as a treatment for such a common disorder because Mr personality active ingredient any abortion pill and for that reason cannot be widely distributed.

Joseph K. Belanoff: In addition to the medical morbidities caused by these needed medications, their ill effects are seen and felt by patients, who then often stop taking them. We demonstrated in double-blind placebo-controlled trials that mifepristone significantly reduced the weight gain and other adverse effects of olanzapine and risperidone in healthy subjects. The results were published in the journals Advances in Therapy in October 2009 and In Obesity in December 2010. Unfortunately, we could not advance mifepristone as a treatment for such a common disorder because mifepristone is the active ingredient in the abortion pill and, for that reason, cannot be widely distributed.

Our proprietary selective cortisol receptor modulator Mira correlate can be widely distributed and is therefore suitable for development what's more in animal models. It is even more potent on a per milligram basis to mr., Chris down in preventing and reversing a land subpoena risperidone induced weight gain.

Our first clinical study of mirror correlate produced highly encouraging results. Each of 66 healthy subjects received 10 milligrams of Elanzapine any their 600 milligrams of mirror Cortland or placebo daily for 14 days.

Joseph K. Belanoff: Our proprietary selective cortisol receptor modulator, miracorrelant, can be widely distributed and is therefore suitable for development. What's more, in animal models, it is even more potent on a per milligram basis than mifepristone in preventing and reversing olanzapine and risperidone-induced weight gain. Our first clinical study of miraclorelant produced highly encouraging results. Each of 66 healthy subjects received 10 milligrams of olanzapine and either 600 milligrams of miracorrelant or placebo daily for 14 days. With clear statistical significance, subjects who receive miracorrelant gain less weight measured at both day 8 and day 15 than those who receive placebo. In addition, enzymes ALT and AST, markers of liver damage that temporarily increase at the onset of lansipine therapy, increase less markedly in subjects receiving miracorrelant, which suggests that miracorrelant may have protective effects in the liver. These results demonstrating miracloralance activity. Full results from this study will be presented this April at the annual meeting of the American Psychiatric Association in Philadelphia. Last year, we began a Phase II trial of miracloralant in patients with schizophrenia who have gained weight rapidly after starting antipsychotic medication. This study is called Gratitude.

Clear statistical significance subjects received mirror correlate gain less weight measured at both they ate and day 15 than those who received placebo.

In addition, enzymes LT and Asap markers of limited liver damage the temporarily increase at the onset of Elanzapine therapy increased less markedly in subjects, receiving mirror correlate which is just that mirror correlate me a protective effects in the liver.

These results demonstrating mirror correlates activity, our especially encouraging given the short duration of treatment and look.

Full results from this study will be presented this April at the annual meeting at the American Psychiatric Association in Philadelphia.

Late last year, we began a phase two trial Americorp, Ireland in patients with schizophrenia, who have gained weight rapidly after starting anti psychotic medication.

This study is called gratitude.

Study participants received either 600 milligrams of mirror core Ireland or placebo in addition to their existing anti psychotic medication.

Planned enrollment is 100 patients. The studies primary endpoint is weight loss, while maintaining or improving the patients psychiatric condition.

As I have mentioned on prior calls we've been developing a formulation of miracle arland suitable for use in phase three and commercially.

Greatly increases the drugs bioavailability, we expect that formulation to be available by the fourth quarter of this year at which point, we plan to open a double blind placebo controlled phase two trial in patients with longstanding anti psychotic induced weight gain. We also we will also add a cohort of patients receiving a significantly higher dose of mirror.

Joseph K. Belanoff: Study participants received either 600mg of miraquirulent or placebo in addition to their existing antipsychotic medication. Planned enrollment is 100 patients. The study's primary endpoint is weight loss while maintaining or improving the patient's psychiatric condition. As I have mentioned on prior calls, we've been developing a formulation of miracloraline suitable for use in phase three and commercially that greatly increases the drug's bioavailability. We expect that formulation to be available by the fourth quarter of this year, at which point we plan to open a double-blind placebo-controlled phase two trial in patients with longstanding antipsychotic-induced weight gain. We will also add a cohort of patients receiving a significantly higher dose of miracloraline to gratitude. Finally, we plan to open a double-blind, placebo-controlled Phase II trial of miracloraline to treat patients with NASH by year-end.

Core led to gratitude.

Finally, we plan to open a double blind placebo controlled phase two trial, a miracle Orlando to treat patients with Nash by year end in animal models Miracle Merrill Lynch prevents and repurchases, both fatty liver and liver fibrosis mirror korlyms potential benefit to patients with a serious widespread disorder merits clinic.

We'll study.

I will now turn to our oncology program.

Many solid tumors express the glucocorticoid receptor or GR.

Unfortunately.

Cortisol activation of GR inhibits apoptosis programmed cell death, which is the mechanism by which chemotherapy achieves its intended effect.

We are testing the hypothesis that co administering cortisol modulator may allow chemotherapy to achieve its maximum benefit.

Joseph K. Belanoff: In animal models, miracloralant prevents and reverses both fatty liver and liver fibrosis. Miracloralant's potential benefit to patients with a serious widespread disorder merits clinical study. I will now turn to our oncology program. Many solid tumors express the glucocorticoid receptor, or GR. Unfortunately... Cortisol activation of GR inhibits apoptosis, programmed cell death, which is the mechanism by which chemotherapy achieves its intended effect. We are testing the hypothesis that co-administering a cortisol modulator may allow chemotherapy to achieve its goal.

At the ASCO conference last year, we presented data from a phase one slash two study umbrella core.

In combination with Nab Paclitaxel Celgenes Taxane based drug abraxane in patients with a variety of solid tumors. The results were striking seven up 25 patients with metastatic pancreatic cancer and five of 11 patients with metastatic ovarian cancer achieved durable disease control, meaning they.

Tumors, either shrank, where ses growing for 16 weeks or longer a particular note with the duration of benefit tumor shrinkage in two patients with metastatic pancreatic cancer lasted longer than 52 weeks, a patient with ovarian cancer exhibited tumor shrinkage for 65 weeks all of these patients tumors had progressed during multiple.

Joseph K. Belanoff: At the ASCO Conference last year, we presented data from our Phase 1-2 study of Reliquorin in combination with NAP-Haquatex. Cell Genes Taxane-Based Drug Abraxane in patients with a variety of solid tumors. The results were striking. Seven of 25 patients with metastatic pancreatic cancer and five of 11 patients with metastatic ovarian cancer achieved durable disease control, meaning their tumors either shrank or ceased growing for 16 weeks or longer. Of particular note was the duration of benefit. Tumor shrinkage in two patients with metastatic pancreatic cancer lasted longer than 50 weeks. A patient with ovarian cancer exhibited tumor shrinkage for 65, Transcript by Transcription Outsourcing, LLC. Including Treatments with Tax, that some responded when brellachorlin was added to their treatment was surprising and heartening. Our ASCO poster presenting these data is available at the...

All lines of prior therapy, including treatments with Taxanes that some responded when reliv korlym was added to their treatment, what's surprising and heartening.

Our ASCO poster presenting these data is available at the investors past events tab of our web site.

We are conducting a 180 patient controlled phase two trial umbrella chlorella, plus Nab paclitaxel in patients with metastatic or unresectable ovarian cancer at sites in the United States in Europe. The primary endpoint is progression free survival with secondary endpoints, including overall survival and duration of benefit.

We expect to report results of this study in the first half of next year.

We're also preparing to start phase three trial umbrella coral and plus Nab paclitaxel in patients with metastatic pancreatic cancer disease with a very poor prognosis and no. Good treatment options. Following discussions with the FDA. We have identified a trial design that could support accelerated approval for those.

You not familiar with it accelerated approval as an FDA program that permits faster approval of drugs that treat serious conditions and fill in unmet medical need provided one or more confirmatory trials are initiated prior to approval being granted.

Joseph K. Belanoff: We are conducting a 180 patient-controlled phase 2 trial of relacorrelant plus nabpaclitaxel in patients with metastatic or unresectable ovarian cancer at sites in the United States and Europe. The primary endpoint is progression-free survival, with secondary endpoints including overall survival and duration of benefit.

We expect to begin enrolling patients in this trial next quarter.

[noise] cortisol is the Bodys natural immunosuppressant, although this effect can be beneficial by reducing the prevalence in severity of auto immune disorders. It also makes it easier for tumor cells to survive and proliferate.

Joseph K. Belanoff: We expect to report the results of this study in the first half of next year. We are also preparing to start a Phase III trial of brella-correlant plus nab-paclitaxel in patients with metastatic pancreatic cancer, a disease with a very poor prognosis and no good treatment options. Following discussions with the FDA, we have identified a trial design that could support accelerated approval. For those of you not familiar with it, accelerated approval is an FDA program that permits faster approval of drugs that treat serious conditions and fill an unmet medical need, provided one or more confirmatory trials are initiated prior to approval being granted.

In the second quarter, we plan to launch phase one be trial of relic Orland plus the PD one checkpoint inhibitor Pembro was a mab merck's drug keytruda and 20 patients with metastatic or Unresectable adrenal cancer, we know that cortisol modulation with Korlym treats the symptoms of Cushing syndrome.

These patients frequently experience.

Our trial will examine whether relamorelin can by reducing the immune suppression caused by these patients excess cortisol bull treat the symptoms of quotas Cushing syndrome and help the immunotherapy achieved its maximum effect.

Finally, cortisol modulation may help treat castration resistant prostate cancer.

Joseph K. Belanoff: We expect to begin enrolling patients in this trial next quarter. Cortisol is the body's natural immunosuppressant, and although this effect can be beneficial by reducing the prevalence and severity of autoimmune disorders, it also makes it easier for tumor cells to survive and proliferate.

Stimulation of the androgen receptor causes prostate cancer cells to proliferate, which is why androgen receptor antagonism with medications such as Enzalutamide Pfizer's drug standpoint, it's a standard therapy.

Unfortunately, when prostate tumor cells are exposed to enzalutamide side their growth often ships to being stimulated by cortisol, adding a cortisol antagonists to androgen deprivation therapy may block this tumor escape route.

Joseph K. Belanoff: In the second quarter, we plan to launch a Phase 1b trial of Relacoralant plus the PD-1 checkpoint inhibitor Pembrolizumab, Merck's drug Keytruda, in 20 patients with metastatic or unresectable adrenal cancer. We know that cortisol modulation with corallum treats the symptoms of Cushing syndrome these patients frequently experience. Our trial will examine whether Relacloriline can, by reducing the immune suppression caused by these patients' excess cortisol, both treat the symptoms of Cushing syndrome and help the immunotherapy achieve its maximum effect. Finally, cortisol modulation may help treat castration-resistant prostate cancer. Stimulation of the androgen receptor causes prostate cancer cells to proliferate, which is why androgen receptor antagonism with medications such as enzalutamide, Pfizer's drug Xtandi, is a standard therapy. Unfortunately, when prostate tumor cells are exposed to..., their growth often shifts to being stimulated by cortisol. Adding a cortisol antagonist to androgen deprivation therapy may block this tumor escape route.

This year, we expect to conclude a dose finding trial of our selective cortisol modulator execute garland combined with enzalutamide in patients with castration resistant prostate cancer.

Investigators at the University of Chicago are also leading a trial of relic Orland plus enzalutamide in patients with this disease.

Of course has had an excellent 2019, our Cushing syndrome business added physicians and patients we expect more growth in 2020 and have reaffirmed our revenue guidance of $355 million to $375 million with $315 million cash investments that you're in a balance that will grow this year.

We are able to fully fund the development of our proprietary compounds as potential treatments for a variety of serious disorders.

Our Grace trial is actively enrolling patients as previously stated we plan to submit an anda for Relamorelin in Cushing syndrome in the fourth quarter of next year.

This quarter, we will open our phase three gradient trial, a double blind placebo controlled study examining relic korlyms activity in an understudied etiology of Cushing syndrome, Cushing syndrome caused by adrenal adenomas or adrenal hyperplasia.

Joseph K. Belanoff: This year, we expect to conclude a dose-finding trial of our selective cortisol modulator, hexachloraline, combined with enzalutamide in patients with castration-resistant prostate cancer. Investigators at the University of Chicago are also leading a trial of relacorlin plus enzalutamide in patients with this disease. Corcept had an excellent 2019.

Our controlled phase two trial umbrella, Carla plus Nab Paclitaxel and advanced ovarian cancer is actively accruing patients. We expect to report results in the first half 2021.

Next quarter, we plan to start a phase three trial umbrella correlate plus Nab paclitaxel in patients with metastatic pancreatic cancer that may provide the basis for accelerated approval.

Joseph K. Belanoff: Our Cushing Syndrome business added physicians and patients. We expect more growth in 2020 and have reaffirmed our revenue guidance of $355 to $375 million. We had $315 million of cash and investments at year end, a balance that will grow this year.

Also in the second quarter, we plan to open a phase one be study umbrella correlate in combination with checkpoint inhibitor in patients with metastatic or Unresectable adrenal cancer. Finally, we expect our dose finding trial of extra korlym in combination with absolute might in patients with metastatic castration resistant prostate cancer.

Joseph K. Belanoff: We are able to fully fund the development of our proprietary compounds as potential treatments for a variety of serious disorders. For example, our GRACE trial is actively enrolling patients. As previously stated, we plan to submit an NDA for Rella-Correlant and Cushing Syndrome in the fourth quarter of next year. This quarter, we will open our Phase 3 Gradient Trial, a double-blind, placebo-controlled study examining relucorelance activity in an understudied etiology of Cushing syndrome, Cushing syndrome caused by adrenal adenomas or adrenal hyperplasia. Our controlled Phase 2 trial of relacorrelant plus nabpaclitaxel in advanced ovarian cancer is actively accruing patients, and we expect to report results in the first half of 2021. Next quarter, we plan to start a Phase 3 trial of relacorrelant plus nabpaclitaxel in patients with metastatic pancreatic cancer that may provide the basis for accelerated approval.

To conclude by year end.

Mirror Chloroquins phase two trial for the treatment of recent anti psychotic induced weight gain is actively enrolling patients and by year end, we plan to use and improve formulation of mirror correlate into double blind placebo controlled phase two trials one in patients with longstanding anti psychotic induced weight gain and the other in patients with Nash.

I'll stop here for questions.

Thank you you would like to ask your question. Please signal by pressing star one on your telephone keypad, if you're using a speakerphone. Please make sure. Your mute function is turned off the louder signal to reach our equipment again press star one to ask your question well pause for just a moment to allow everyone an opportunity to signal progressed.

The first question will come from Charles Duncan with Cantor Fitzgerald. Please go ahead.

[noise] good afternoon.

Selling and team thanks for taking our questions and congratulations on a good your gross and.

Revenue generation with Korlym, sorry for the back thanks, nice harmonic too.

Joseph K. Belanoff: Also, in the second quarter, we plan to open a Phase I-B study of relacorrelant in combination with a checkpoint inhibitor in patients with metastatic or unresectable adrenal cancer. Finally, we expect our dose-finding trial of exacorrelant in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer to conclude by year end. Miracloralin's Phase II trial for the treatment of recent antipsychotic-induced weight gain is actively enrolling patients, and by year-end, we plan to use an improved formulation of Miracloralin in two double-blind placebo-controlled Phase II trials, one in patients with long-standing antipsychotic-induced weight gain and the other in patients with NASH. I'll stop here for questions.

Thanks.

So why did ask a couple of questions just really related to core loans.

Franchise I mean, when you think about guidance what are the key kinda triggers between the 355.

Level and the upper end.

And can you give us some sense of.

Kind of thoughts behind new patients or new prescribers and then of course.

Any impact on pricing.

I said in those cards.

Those guidelines well I'll.

S answer the second part of your question first.

I think.

As you know Chaz, we had a 5% price increase at the beginning of the year and what we do with pricing is every quarter really since we've been commercial we look at where pricing is and go from there, but you know at this point in time, we really have a substantial franchise and approximately inflation based price growth is where.

Operator: Thank you. If you would like to ask a question, please signal by pressing star 1 on your telephone keypad. If you're using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment.

We're probably going to be that's about as much really guidance I can give you at this point.

Operator: Again, press star 1 to ask a question. We'll pause for just a moment to allow everyone an opportunity to signal for questions. The first question will come from Charles Duncan with Cancer Fitzgerald. Please go ahead with your question. Good afternoon, Joe and team. Thanks for taking our questions and congratulations on a good year of growth and revenue generation with Coralim. Sorry for the background noise.

And yes, you know in terms of weather, where we fall in the range. It is just a question about how many new patients are added and as you know with the <unk> I guess, we probably answer midyear last year, we're beginning the process of adding new clinical specialists to our group there.

A significant number of doctors, we had not yet been able to reach with the number that we had we been in the process in the second half of the year of bringing those people onboard that process continues and also it's you know as chat as soon as Paul for the company for long time is an extensive training period, we don't expect those clinical specialists to really be productive until the second half of this year.

Charles Duncan: I wanted to ask you a couple of questions just related to Coralim's franchise. I mean, when you think about guidance, what are the key kind of triggers between the 355 level and the upper end? And can you give us some sense of the thoughts behind, you know, new patients or new prescribers? And then, of course, any impact on pricing expected in those guides?

And how productive they are we'll obviously influence where we end the year.

Okay, and then one additional question on Korlym and down one on relic Korlym. If I may quickly on Korlym I'm wondering if you could you know fast forward to couple of years from now assuming or maybe three or assuming rella korlym is approved but it seems like.

Joseph K. Belanoff: Well, I'll answer the second part of your question first. I think, as you know, Chas, we had a 5% price increase at the beginning of the year. And what we do with pricing is, every quarter, you know, really, since we've been commercial, we look at where pricing is and go from there. But, you know, at this point in time, we have a substantial franchise, and, you know, approximately inflation-based price growth is where we're probably going to be. That's about as much real guidance I can give you at this point.

The profile of Korlym is such that its adequate given the lack of.

Kind of alternatives right now, but if relic Korlym has approved would would you continue to market.

Korlym or would that be something that you think that that the profile just doesn't make sense given given that.

Chris Pasquale a better drug.

You know I can really answered that question more medically then commercially.

If relamorelin continues to produce the results that it's produced so far it's my opinion my personal opinion that it will entirely replace Carla.

Joseph K. Belanoff: And, yes, you know, in terms of where we fall in the range, it is just a question of how many new patients are added. And as you know, I guess we probably announced mid-year last year, we're beginning the process of adding new clinical specialists to our group. There are a significant number of doctors we had not yet been able to reach with the number that we had. We've been in the process of bringing those people on board, and that process continues. And also, as you know, Chas, as someone who's followed the company for a long time, it's an extensive training period. We don't expect those clinical specialists to really be productive until the second half of this year. And how productive they are will obviously influence where we end the year.

I think that the efficacy and added benefits, particularly in safety the ease of distribution.

We'll we'll make it just a superior trial he does not simply another purple pill, and it's really a meaningful advance so cross our fingers, we'll see if our results can replicate but that's where it is I I haven't really considered the commercial question that you're talking about so far but I really do think that rental correlate will be far superior drug if it replicates its results.

As we've seen.

[laughter] EM relative to relic Korlyms results and then I'll hop back in the Q.

Joseph K. Belanoff: Okay, and then one additional question on Coraline and then one on Relic Coraline. If I may, quickly on Coraline. I'm wondering if you could, you know, fast forward to a couple of years from now, assuming, or maybe three, assuming Relic Coraline is approved. It seems like the profile of Coraline is such that it's adequate, given the lack of any kind of alternatives right now. But if Relic Coraline is approved, would you continue to market Coraline? Or would that be something where you think that the profile just doesn't make sense, given that the first, possibly a better drug?

You know you mentioned, possibly filing by the end of next year, but I'm wondering if he could provide any additional granularity on one when you would expect clinical results from that trial.

And if you you pointed out press release those aircraft at that time. Thanks.

Yes, just to answer your question.

As you and the other half so do you know sort of count back.

And you'll know and the results are but I think we've really since so much goes into a Andy a submission not just the efficacy studies were really hard at work and preparing all of those things. So we really can be on target to send our NDS and by the end of 2021.

Joseph K. Belanoff: You know, I can really answer that question more medically than commercially. If roach chloraline continues to produce the results that it's produced so far, it's my opinion, my personal opinion, that it will entirely replace chloraline. I think that the efficacy and added benefits, particularly safety and ease of distribution, will make it just a superior drug. It is not simply another purple pill. It is really a meaningful advance. So, we cross our fingers. We'll see if our results can replicate, but that's where it is. I haven't really considered the commercial question that you're talking about so far, but I really do think that roach chloraline will be a far superior drug if it replicates its results as we've seen.

Thanks for the added color.

Okay.

Thank you for the question. The next question will come from its went back a little rock with H.C. Wainwright. Please go ahead with your question.

Thank you ZAR came from had CW.

Congratulations on that 2019.

And going into 200 trend to.

Can you give us a little bit of an idea.

So.

Oh, how we should think about the cost lines for 2020 [noise].

Yes, I'm going to get turned that question over to Charlie.

Yeah, Hi, RK I can we don't provide earnings guidance, but I think I can give you sort of a general sense of things and if you look back folks look back at sort of the history of our revenue growth in our and our you know our expense increases over the years. There's you can see sort of a pretty predictable pattern, which is we have a sort of a.

Joseph K. Belanoff: Relative to correlates results, and then I'll hop back in the queue, you know, you mentioned possibly filing by the end of next year, but I'm wondering if you could provide any additional granularity on when you'd expect clinical results from that trial and if you plan to press release those at that time. Thanks.

A marginal increase every year and are sort of SGN. A spending is you know Sean add some salespeople and we know the marketing team grows a bit and we add on the administrative side and those then tend to be pretty flat across the year, just sort of the accident the calendar in the way our business works.

Joseph K. Belanoff: Yeah, just to answer your question, you know, as you and the other analysts will do, you know, sort of count back, and you'll know when the results are, but I think we really, since so much goes into an NDA submission, not just the efficacy studies, we're really hard at work at preparing all of those. So we can really be on target to send our NDA in by the end of 2020.

And I think I don't see any reason why that wont continue and I think it will certainly continue this year research and development. Obviously, you've heard you know Joe go over the list of programs, which are expanding considerably and I think the yes. The we expect to spend more this year and.

In research and development as our trials open and accrue patients exactly how much we spend will depend on how fast those things go but I think that a.

Swayampakula Ramakanth: Thanks for the added color. Thank you for the question. The next question will come from Swayampakula Ramakanth with H.C. Wainwright. Please go ahead with your question. Thank you. This is RK from HCW.

A fair step up in R&D expending is to be expected.

I mean that behind that I think.

The other thing I'd add is we you know we expect to remain significantly cash flow positive across the year.

Hi, Thank you Charlie for that.

Swayampakula Ramakanth: Congratulations on a great 2019 and going into 2020. Can you give us a little bit of an idea in terms of how we should think about the cost lines for 2020?

Then I'll see multiple oncology studies.

Either being conducted this year or being planned for Joe what are the water.

<unk>, either one or two of those studies, which you think could be could end up as a low hanging fruit are all Richmond is exciting in your mind.

Swayampakula Ramakanth: Yeah, I'm going to turn that question over to Charlie.

Gary Charles Robb: Yeah, hi RK. I can, you know, we don't provide earnings guidance, but I think I can give you sort of a general sense of things. And if you look back at sort of the history of our, you know, revenue growth and our, you know, our expense increases over the years, I think you can see sort of a pretty predictable pattern, which is we have a sort of a marginal increase every year in our sort of SG&A spending as, you know, Sean adds some salespeople, and we, you know, the marketing team grows a bit, and we add on the administrative And those then tend to be pretty flat across the year, just sort of the accents of the calendar and the way our business works.

You know I don't think theres any low hanging fruit and any of the metastatic disease is that we're studying.

Ill someone over already gotten there in those patients would have a much better outcome than they currently do today. So they're all high bars, but you know look whether you met metastatic pancreatic cancer metastatic ovarian cancer metastatic adrenal cancer, all terrible diseases, and I'd love to be able to bring a treatment forward for any one.

One of them.

Obviously at this point, we have data and small amount of data, but good data in pancreatic in ovarian cancer and our next studies will really tell us where we are.

Gary Charles Robb: And I don't see any reason why that, you know, won't continue, and I think it'll certainly continue this year. Research and development, obviously, you've heard Joe go over the list of programs which are, you know, expanding considerably. And I think we expect to spend more this year on research and development as our trials open and accrue patients. Exactly how much we spend will depend on how fast those things go. A fair step up in R&D spending is to be expected. I mean, that being said, I think the other thing I'd add is that we, you know, we expect to remain significantly cash flow positive across the year.

And last question for me is regarding this matter Korlym for Nash.

As we know there are multiple drugs in development and how should we think about the competitiveness of this drug or carlen arguments are those which are out there in the early discovery I suppose.

The RK I'm going to I, just have one introduced reintroduce Andreas Grauer, our chief Medical Officer, who is going to answer that question.

Okay that that's an excellent question and I think we'll we'll find that out right. We are planning to do a proof of concept study.

Swayampakula Ramakanth: Thank you, Charlie, for that. Now, of the multiple oncology studies that are either being conducted this year or being planned for, Joe, what are either one or two of those studies that you think could end up as a low-hanging fruit or which one is exciting in your mind?

Study with imaging endpoints and I think at that point, we will get a much better idea on how are the preclinical data translate into clinical benefit and.

Joseph K. Belanoff: You know, I don't think there's any low-hanging fruit in any of the metastatic diseases that we're studying, or else someone would have already gotten there, and those patients would have a much better outcome than they currently do today. So they're all high. But, you know, look, metastatic pancreatic cancer, metastatic ovarian cancer, metastatic adrenal cancer are all terrible diseases, and I'd love to be able to bring a treatment forward for any one of them. Obviously, at this point, we have data, you know, a small amount of data, but good data in pancreatic and ovarian cancer, and our next studies will really tell us where we are.

We'll take it from there.

[noise]. Thank you. Thank you for protection all my questions.

Thanks Saket.

Thank you. The next question will come from disease Ahmed with Bank of America. Please go ahead with your question.

Hi, good afternoon. Thank so much for taking my questions, maybe if I could ask the pipeline.

Joe or Charlie as far as the Grey study.

You talked about that target of enrolling 130 patients.

You've given us the Guy mine of when you plan to apply for approval, but can you talk to US about you know the cadence with which the study has been enrolling so far how do you feel about the piece of enrollment I know, it's not exactly apples to apples, but can you compare it to the pace of enrollment of your fees to setting for example, which of course.

Swayampakula Ramakanth: The last question for me is regarding miracorrelant for NASH. As we know, there are multiple drugs in development, and how should we think about the competitiveness of this drug, miracorrelant, against others which are out there in the various development pathways?

It was much smaller and then I've a couple of questions on somebody other program.

Yeah, you know, obviously, we're not going to comment really on where we are in that study and enrollment until it's done and hopefully that will be a with a within sight I think an interesting thing with the phase two study was that the first half, which we use lower doses of reliv coral and really to quite a bit longer to enrolled in the second half.

Andreas Grauer: Hey RK, I just want to reintroduce Andreas Grauer, our Chief Medical Officer, who's going to answer that question.

Andreas Grauer: Well, okay, that's an excellent question, and I think we'll find that out, right? We are planning to do a proof-of-concept study as a first study with imaging endpoints, and I think at that point, we will get a much better idea of how the preclinical data translate into clinical benefit, and we'll take it from there. Thank you. Thank you, folks, for taking all my questions.

Which had higher doses because I think the people who were in the high the doctors who work in that.

Enrolling patients in the higher dose cohorts saw how the patients in the lower cohort lower dose cohort of done and I'm, hoping that those positive results will really be meaningful to the investigators currently enrolling in our study. We're just now really at the point of almost getting all of our sites up we're very close to that and as.

Gary Charles Robb: Thanks, RK.

Tazeem Ahmed: Thank you. The next question will come from Tazeem Ahmed with Bank of America. Please go ahead with your question. Hi, good afternoon.

And I guess the only other thing I would tell you is that because you know as you know we never introduced coral on in Europe, It's our expectation that like the phase two study the bulk maybe 70% of the enrollment will actually come from European sites.

Tazeem Ahmed: Thanks so much for taking my questions. Maybe I could ask a couple on the pipeline. Joe or Charlie, as far as the GRACE study is concerned, you talked about the target of enrolling 130 patients. You've given us a guideline of when you plan to apply for approval, but can you talk to us about the pace with which the study has been enrolling so far? How do you feel about the pace of enrollment? I know it's not exactly apples to apples, but can you compare it to the pace of enrollment in your phase two study, for example, which, of course, was much smaller? And then I have a couple of questions on some of the other programs.

Okay.

And maybe a question on Rolla Cortlandt on your phase two study, where you're looking at rather korlym snap half attack. So can you give us an idea of what you would consider to be clinically meaningful data when that reads out I think you said, you're expecting results, but that in the first half of 21.

Anyway, and you'll be hearing in cancer. So yes. It seems okay I'm going to pass you back to Andreas.

Can you. Please clarify the question I mean, we've we as a Joe was.

Joseph K. Belanoff: Yeah, you know, Kazim, we're not going to comment really on where we are in that study and enrollment until it's done, and hopefully that will be within sight. I think an interesting thing with the Phase 2 study was that the first half, which used lower doses of Rellocorrel, and really took quite a bit longer to enroll than the second half, which had higher doses. The doctors who were enrolling patients in the Higher Dose Cohort saw how the, I'm hoping that those positive results will really be meaningful to the investigators currently enrolling in our study. We're just now really at the point of almost getting all of our sites up. We're very close to that, and I guess the only other thing I would tell you is that because, as you know, we never introduced Quorulum in Europe, it's our expectation that, like the Phase II study, the bulk, maybe 70% of the enrollment will actually come from European sites.

Saying in his words that the endpoint would be progression free survival. So an improvement in that would obviously be clinically very meaningful.

And than any around 11% I guess I'm looking for particular level of improvement and I guess, how would you compare that so what might currently <unk> and that.

Well the the overall study to scene is statistically significant improvement in Relamorelin, plus Nab paclitaxel relative to NAV packs with Paclitaxel alone and I don't have in front of me the number of months that actually generates for decides patient, but we'll be very glad to get back.

To you at that.

After the call.

Okay, that's fine and maybe the third one if I could squeeze in I think in your prepared remarks, you talked about I'm a study that you're doing in metastatic prostate with Orlando, but there was also I believe a physician sponsored study with Raila coral and is that in the scene indication I just wanted to clarify.

Joseph K. Belanoff: Okay, and maybe a question on rilocorrelant in your phase two study where you're looking at rilocorrelant plus nabpacotaxel. Can you give us an idea of what you would consider to be clinically meaningful data when that reads out? I think you said you were expecting results for that.

Tazeem Ahmed: In the opioid and cancer study, yes.

It is dizzying, yes, they're both studies in metastatic.

Andreas Grauer: Yeah, can you please clarify the question? I mean, as Joe was saying in his words, that the endpoint would be progression-free survival. So an improvement in that would obviously be clinically very meaningful. So is it any level of improvement, I guess? Are you looking for a particular level of improvement? And, I guess, how would you compare that to what might currently be used in that setting?

Castration resistant prostate cancer, if that's correct and they're running in parallel and you had it exactly right extra correlate the company is doing relic coral and an investigator group led by a lead investigator at the University of Chicago is doing and we'll obviously look at the results of both of those.

Okay is there any reason to think that one might perform better than the other.

Well the only reason you know we're doing exit corlanor, absolutely and in some sense. We got first pick was that in the animal models exit Corlanor you know both performed well, but extra color on outperform relet korlym in that in the animal study, but as you know there's a great distance between treating.

Andreas Grauer: Well, the overall study, Tizine, is a statistically significant improvement in Relacloralin plus Nalpaclitaxel relative to Nalpaclitaxel alone. And I don't have in front of me the number of months that that actually generates for this size patient, but we'll be very glad to get back to you with that, you know, after the call.

Cancer in rats as there is in people so having two shots on goal. We think really is beneficial in terms of gaining information.

Okay. Thank you so much appreciate it well sure.

Tazeem Ahmed: Okay, that's fine. And maybe the third one, if I could squeeze in, I think in your prepared remarks, you talked about a study that you're doing in metastatic prostate cancer with exocorrelins, but there's also, I believe, a physician-sponsored study with relacorrelins. Is that in the same indication? I just wanted to clarify.

Thank you for the question. The next question will come from Adam Walsh with Stifel. Please go ahead with your question.

Okay.

Hi, Thank for taking the question if I had one zone or Adam.

My first question.

Okay. Great study it seems to me that a U.S. fuel you Rolling Peterson now well my question here what are the limiting factors.

Joseph K. Belanoff: It is Tizine, yes, they're both studies in metastatic castration-resistant prostate cancer, if that's correct, and they're running in parallel, and you had it exactly right. ExaQuirulent, the company is doing, ReliQuirulent, an investigator group led by a lead investigator at the University of Chicago is doing, and we'll obviously look at the results of both of those.

So the ruling pays its not as far as you expect so let my first question.

I'm not sure exactly understand your question, but the enrolling.

The made the major thing for Rolling is really just the number of patients with the disease and the number of sites that are open to treat them.

I recall on in the last year, you expect the enrollment to be finished by you and plenty of 19.

Joseph K. Belanoff: Okay, is there any reason to think that one might perform better than the other?

Joseph K. Belanoff: Well, the only reason, you know, we're doing exochloraline is that, in the animal models, exochloraline, you know, both perform well, but exochloraline outperformed ralochloraline in the animal study, but as you know, there's a great distance between treating cancer in rats as there is in people, so having two shots on goal is really beneficial in terms of gaining information.

That's a right.

I think we we talked about that at one of the earlier earnings calls, where we said that EM.

Like look like in the the last quarter of last year, we were able to better assess the enrollments be because one of the key factors was the opening of the.

Adam Walsh: Okay, thank you so much; I appreciate it. You're welcome, sure. Thank you for the question. The next question will come from Adam Walsh with Stiefel. Please go ahead with your question. Hi, thanks for taking the question. This is Adam and John.

Clinical studies, so, it's a which cannot today with all the contracting and all these.

These administrative hurdles takes longer and longer and you can recruit until you have your sites open and now that we have the vast majority of the sites opened nearly all of them, we have a clearer picture of of our enrollment expectation.

Adam Walsh: For Adam, my first question is a quick one on the GREASE study. It seems to me that you are still enrolling patients now. So my question is, what are the limiting factors? The enrollment pace is not as fast as you expect. So that's my first question.

And then listen this is a this is not a frequent DVS, there's not a surprise right, but on the other hand, we're I think we were well set up we're in the study is enrolling and and well will yeah, we'll see what the what the future brings there right.

Unknown Executive: Unknown Speaker Thank you for those questions. I'm not sure I exactly understand your question, but the enrollment, the major thing for enrollment is really just the number of patients with the disease and the number of sites that are open to treat them.

Fair enough.

Or my second question on the every quarter lands on mass.

I would talk to the FDA on the trial design.

Do you plan to target on early or late stage not station.

Andreas Grauer: I recall in the last year you expected enrollment to be finished by year end 2019. Is that right?

You also exclusion of them, what kind of move them off action.

Andreas Grauer: I think we talked about that on one of the earlier earnings calls where we said that, in the last quarter of last year, we were able to better assess enrollment speed because one of the key factors was the opening of the clinical study sites, which today, with all the contracting and all these administrative hurdles, takes longer and longer, and you can't recruit until you have your sites open. And now that we have the vast majority of the sites open, nearly all of them, we have a clearer picture of our enrollment expectations. And in addition, you know, this is not a common disease. It's not a surprise, right? But on the other hand, we're, I think we were well set up, we're in, the study is enrolling, and we'll, we'll, you know, we'll see what the future brings there, right? Yeah, it's very nice.

For your mass for example of the.

Cortisol modulator impact.

Liver fibrosis. Thank you.

I'm going to answer this the second question then I'll pass it back Andres for the first question. It's interesting because one of the things that you see frequently with patients with Cushing syndrome is fatty liver and as you know fatty liver is really the prerequisite for that.

A percentage of those patients go on to have Nash and of course, Unfortunately, a percentage of the patients who want to have Nashville and to have cirrhosis.

And essentially I think really fatty liver disease is really perceived as the liver manifestation of metabolic syndrome, and metabolic syndrome is often driven by excess cortisol activity. So modulating cortisol <unk>.

It is really a treatment first for fatty liver and we've certainly seen you know in anecdotal ways that improved with patients who take korlym for Cushing syndrome, but I think that in the animal models, where you can really accelerate that would testing for fibrosis. You also see a benefit there as well now but coming up to our first study in piece.

Adam Walsh: Um, my second question on that. Have you talked to the FDA about the trial design? Do you plan to target early or late stage NASH patients? Can you also explain the mechanism of action? In us, for example, how does a cortisol modulator impact liver fibrosis?

Well, obviously not everything again as I said before in animals translates to people, but we have some sense. If this really might translate and that is the mechanism and asked for your question. Your regulatory question I'll pass back to entrees and there. The onset is pretty straight forward no. We have not talk to the FDA yet that would be premature we won two.

Joseph K. Belanoff: Thank you.

Joseph K. Belanoff: I'm going to answer the second question, then I'll pass it back to Andres for the first question. It's interesting because one of the things that you see frequently with patients with Cushing syndrome is a fatty liver, and as you know, fatty liver is really the prerequisite for a percentage of those patients going on to have NASH, and, unfortunately, a percentage of the patients who go on to have NASH go on to have cirrhosis. And essentially, I think really fatty liver disease is really perceived as the liver manifestation of metabolism. Atabolic syndrome is often driven by excessive cortisol activity. So modulating cortisol is really a treatment first for fatty liver. And we've certainly seen, you know, in anecdotal ways, that it improved with patient.

Reduce clinical data first so that we have a have something in hand to talk to the FDA about.

The the most appropriate development program on the other had I think the the or whatever phrase into clinical development in Nash is sort of fairly well organized and a in a moment follows.

Relatively.

Relatively predictable endpoints, so I don't expect that too many surprises once we see the results of our early studies I think we'll be able to position and design, our future trials and interact with the F. day.

Joseph K. Belanoff: Syndrome, but I think that in the animal models where you can really accelerate that with testing for fibrosis, you also see a benefit there as well. Now we're coming up to our first study in people. Obviously, not everything again, as I said before, in animals translates to people, but we have some sense that this really might translate, and that is the mechanism. Now as for your question, your regulatory question, I'll pass it back to Andreas.

Thank you.

You're welcome.

Thank you. The next question will come from Adam long with Biowatch News. Please go ahead with your question.

Yeah, congratulations to the quarter and even brighter outlook.

I think the first one would be [laughter] first when we might be for your Joe and also maybe Andrew you know the pancreatic cancer trial will include from fairly desperate cases, and I recognize that the usual research designs habits difficulties could you provide any color at this point on the pancreatic trial design.

Andreas Grauer: Yeah, and there the answer is pretty straightforward. No, we have not talked to the FDA yet. That would be premature. We want to produce clinical data first so that we have something in hand to talk to the FDA about the most appropriate development program. On the other hand, I think the, how would I phrase that, clinical development in NASH is sort of fairly well organized and, at the moment, follows relatively predictable endpoints, so I don't expect too many surprises once we see the results of our early studies. I think we'll be able to position and design our future trials and interact with the FDA. Thank you. You're welcome. Thank you. The next question will come from Adam Long with BioWatch. Please go ahead with your question. Yeah, congratulations on the quarter and an even brighter outlook.

[music].

Yes, you're absolutely right. This is a patient population that is in desperate need off.

A treatment that improves that that creates some clinical responses.

And which is why after seeing the results and our early study that that's been presented at ASCO. We decided that this is something that we should pursue because we might be able to give a pancreatic cancer patients.

Exactly that so we're going to do is we're going to.

Execute the study in two phases, the first phase will be a single arm.

Phase.

With approximately 40 patients after which we will do an interim analysis and then.

Adam Walsh: I think this first one might be for you, Joe, and also maybe Andreas. You know, the pancreatic cancer trial will include some fairly desperate cases, and I recognize that the usual research designs have their difficulties. Could you provide any color at this point on the pancreatic cancer trial design? Yeah, you're absolutely right.

Continue with a two arm design, adding a nab paclitaxel arm.

To this study and the prospective randomized fashion.

I think the difficulty thing and I think Alan you know you're alluding to it is no. This is a group of patients for whom really nothing works very well and there really are difficult issues around running a placebo controlled study you know as we've mentioned before this is this is a program where we have met from the FDA.

Andreas Grauer: This is a patient population that is in desperate need of a treatment that improves, that creates some clinical responses, which is why, after seeing the results of our early study that was presented at ASCO, we decided that, you know, this is something that we should pursue because we might be able to give pancreatic cancer patients exactly that. So what we're going to do is we're going to conduct the study in two phases. The first phase will be a single-arm phase with approximately 40 patients, after which we will do an interim analysis and then continue with a two-arm design, adding a NAPPAC-to-Taxel arm to the study in a prospective randomized fashion.

We've taken their feedback seriously and we hope we designed to stage really optimize our chances obviously to both show the medicine works and to achieve regulatory benefit.

Yeah, I would really be groundbreaking their add something into a a traditional therapy and giving an improvement in that area.

If I mean can I ask you about adrenal cancer 'cause, it's rare and there isn't a lot of medical commentary on it and its apparent your work with Cushing syndrome gives you unusual access well the trial would be using just keytruda in real a korlym or will the dual will be added to the ongoing or any current therapy and just.

Joseph K. Belanoff: I think the difficulty thing, and I think Alan, you know, you're alluding to it, is that this is a group of patients for whom really nothing works very well. And there really are difficult issues around running a placebo-controlled study. You know, as we've mentioned before, this is a program where we have met with the FDA, we've taken their feedback seriously, and we hope we've designed a study to really optimize our chances, obviously, to both show the medicine works and to achieve regulatory benefit.

Add onto it. Furthermore, you could have paired with abraxane or another therapy, rather than a checkpoint inhibitor.

Can you provide any color on these things.

Yeah, I think it's sort of the other way round right. We [laughter] d. So first of all we feel that these patients with adrenocortical cancer like we've shown Mismeasure Princeton will benefit from Google quote unquote receptor manipulation. After all they have Cushing syndrome, we're focusing this trial in patients with good quarter quit.

Yes, so that.

Adam Walsh: Yeah, it would really be groundbreaking to add something to a traditional therapy and get an improvement in that area. If I may, can I ask you about adrenal cancer because it's rare and there isn't a lot of medical commentary on it, and it's apparent your work with Coasting Syndrome gives you unusual access.

Determined our initial patient selection, but the philosophy behind doing that trial as show was explaining in his remarks was that we want to look at the effect of credit quick receptor modulation on the effect of a checkpoint inhibitor.

And this this patient population that has.

Andreas Grauer: Will the trial be using just Keytruda and Rilocorlant, or will the dual be added to the ongoing or any current therapy? And just to add on to it, furthermore, you could pair it with Braxine or another therapy rather than a checkpoint inhibitor. Can you provide any color on these things?

Even measurable ubiquity could access one can easily imagine that a checkpoint inhibitor that needs the immune effect will not work as well in this patient population and that the published data.

The support that assumption so the idea of unleashing the effect of a checkpoint inhibitor by inhibiting glucocorticoid action seem particularly worthy of study that's why we picked that particular approach.

Joseph K. Belanoff: Yeah, I think it's sort of the other way around, right? We, so first of all, we feel that these patients with adrenocortical cancer, like we've shown with mifepristone, will benefit from glucocorticoid receptor modulation. After all, they have Cushing's syndrome, and we're focusing this trial on patients with glucocorticoid access. So that determined our initial patient selection. But the philosophy behind doing that trial, as Joe was explaining in his remarks, was that we wanted to look at the effect of glucocorticoid receptor modulation on the effect of a checkpoint inhibitor. You know, and in this patient population that has even measurable glucocorticoid access, one can easily imagine that a checkpoint inhibitor that needs an immune effect will not work as well in this patient population, and the published data support So the idea of unleashing the effect of a checkpoint inhibitor by inhibiting glucocorticoid action seemed particularly worthy of study. That's why we picked that particular approach. Yeah, it'd certainly be the acid test. Yeah, and just, no, Alex, I know you've followed the story for a long time, and I just, I just want to, uh...

Yeah, certainly be passed the test.

Yeah, and then just laugh and no I know you follow the story for a long time and I just I just want to.

Underscore one of the things that Andreas at.

Yeah, we had patients in our both in our pivotal trial with Korlym and of course you.

You know many patients since then I would say quorum spin commercial who have adrenal cancer and their Cushing syndrome is well treated by Mr., Chris don't but it doesn't in isolation do much for their cancer care cancer still progress is now they're very pleased because they don't have diabetes anymore in their quality of life is better, but we really want to now.

If we can do both things we want to see if we can really <unk>.

And to use Andres has turned to unleash the the checkpoint inhibitor, which to date in the absence of cortisol modulation has very limited effect. So it's very interesting study, there's a lot of academic interest and we'll see how it pans out.

Yeah.

Last question, you're there are new anti psychotics coming in the market with less impact on metabolic metrics do you see any meaningful impact introduction onto the market or what you will remain a large unmet need can you provide any any color on that.

Joseph K. Belanoff: underscore one of the things that Andrea said, you know, we had patients in our pivotal trial with Corallum and, of course, many patients since then when Corallum became commercial, who have adrenal cancer, and their Cushing syndrome is well treated by mifepristone, but it doesn't, in isolation, do much for their cancer. Their cancer still progresses. Now, they're very pleased because they don't have diabetes anymore, and their quality of life is better, but we really want to see if we can do both things. We want to see if we can really, to use Andrea's term, unleash the checkpoint inhibitor, which to date, in the absence of cortisol modulation, has a very limited effect. So it's very interesting.

Well, you know us as a psychiatrist prescribing these medications for now almost 30 years I'm always waiting for the one which is again neutral of side effects related to metabolic things I you know I'm. So me I'm, hoping that that'll happen.

But it hasn't been my experience so far that that's the actual case at least at the degree that was hope for before before it was released commercially but even even that being said, what's what's what's very true is that not every anti psychotic medication works, where every patient as the big studies have shown there's wrapped switching between.

Medications often related to different side effects and so my I'm confident that there's no world in front of US that's very soon to occur where one medication is going to be the most effective medication for every single patient and I think that the metabolic demands that are placed on patients with almost all of the medications.

Adam Walsh: Last question. There are new antipsychotics coming to the market with less impact on metabolic metrics. Do you see any meaningful impacts from their introduction onto the market, or will it still remain a large unmet need? Can you provide any color on that?

We have to date are really very substantial and alleviating that would have great utility and I say that as a as as a practitioner.

Joseph K. Belanoff: Well, you know, as a psychiatrist prescribing these medications for now almost 30 years, I'm always waiting for the one which is, again, neutral in side effects related to metabolic things. I, you know, I'm so, I'm hoping that that'll happen, but it hasn't been my experience so far that that's the actual case, at least to the degree that was hoped for before it was released commercially.

Well. Thank you were really excited about how the course of train as a gathering momentum.

Thank you Alan.

Thank you for the question. The next question will come from Matt Kaplan with Ladenburg Thalmann. Please go ahead.

Oh, Hi, this is ramin in for Matt. Thanks for taking my question. Congrats on the 29. So yeah. So thanks for the overview on the litigation, but perhaps is there any additional details on how the recent <unk> on.

Joseph K. Belanoff: But even that being said, what's very true is that not every antipsychotic medication works for every patient, as big studies have shown. There's rapid switching between medications, often related to different side effects. And so my, I'm confident that there is no world in front of us that is, you know, very soon to occur where one medication is going to be the most effective medication for every single patient. And I think that the metabolic demands that are placed on patients with almost all the medications we have to date are really very substantial, and alleviating that would have great utility. And I say that as a practitioner.

Neptune generics, my providing insight or probabilities and how we should think about the PCR Keith can step up going for perhaps.

Yeah, Chuck Charlie is going to answer that question. Yeah. Sure you know as it is a natural question to ask and I mean to and I think there are a couple of points that are important to keep in mind, but but one thing is just unrest served as a technical matter a the decision yeah with respect to the three for 348 patent in the IP are.

It doesn't binds the patent tribe, you'll in any respect with <unk> with regards to the P.G.R. or the district court. They really are separate they're separate disputes separate proceedings that being said I think the the the thing to really are really two points that I think are important to keep in mind one of them is very simple.

Adam Walsh: Well, thank you. We're really excited about how the corset train is gathering momentum.

Adam Walsh: Thanks.

Matthew Lee Kaplan: Thank you for the question. The next question will come from Matt Kaplan with Ladenburg-Tolman. Please go ahead. Oh, hi. This is Raymond speaking on behalf of Matt. Thanks for taking my question, and congrats on the 2019 results. Yeah, so thanks for the overview on the litigation, but perhaps there is any additional detail on how the recent IPR ruling on Neptune Generics might provide any insight or probability on how we should think about the PCR case against Teva going forward?

But very important and it's it's that we want we won this patent was very important to US we have asserted against both Teva and son, it's one of the patents that underlies our 30 months day against both those companies and this is the first time that our intellectual property has been.

Before an impartial tribunals, then adversarial proceeding where Neptune was poking as many holes in it as it could and the P. tab decided in our favor on every count and I think that that is just an unequivocal win and should not be interpreted in any other way.

Matthew Lee Kaplan: Yeah, Chuck Charlie's going to answer.

Gary Charles Robb: It's a natural question to ask, and I think there are a couple of points that are important to keep in mind. But one thing, just as a technical matter, the decision with respect to the 348 patent and the IPR doesn't bind the patent tribunal in any respect with regard to the PGR or the district court. They really are separate. They're separate disputes, and separate proceedings. That being said, I think there are really two points that I think are important to keep in mind. One of them is very simple but very important, and that's that we won. We won. This patent was very important to us. We have asserted it against both Teva and Sun. It's one of the patents that underlies our 30-month stay against both those companies.

Just good news now my second point really relates to my first point, which is that I think.

My hope is that the victory in this proceeding will cause people to perhaps reexamined their assumptions about our prospects for success in other proceedings, you know I think there as a prevailing understanding in the market now that we're going to lose to Teva, That's just and if you look back at the history.

Got it when Teva filed its first motion to dismiss against our lawsuit in 2018. The market immediately assumed that have would would win and we wouldn't lose when in fact haven't lost and we want it wouldn't have a file that second motion to dismiss the assumption was that tepid would win and we would lose and in fact, we won and pebble lost.

Gary Charles Robb: And this is the first time that our intellectual property has been put before an impartial tribunal in an adversarial proceeding where Neptune was poking as many holes in it as it could, and the PTAB decided in our favor on every count. And I think that that is just an unequivocal win and should not be interpreted in any other way. It's just good news.

Now there are obviously important large decisions and disputes that are going to kind of starting to come onto the horizon, where the PG. Our decision in November a district court trial at some point in the future that will have a better sense of soon and [noise].

Gary Charles Robb: Now, my second point really relates to my first, which is that I think and my hope is that the victory in this proceeding will cause people to perhaps re-examine their assumptions about our prospects for success in other areas. You know, I think that there is a prevailing understanding in the market now that we are going to lose to Teva. That's just, and if you look back at the history of it, when Teva filed its first motion to dismiss against our lawsuit in 2018, the market immediately assumed that Teva would win and we would lose. When, in fact, Teva lost, and we won, and when Teva filed its second motion. The assumption was that Teva would win, and we would lose. And, in fact, we won, and Teva lost.

We have said at every point that we have confidence in our intellectual property and so far we've been right, but I think the market assumes that every point that our chance of success is zero and I think that is a and inaccurate assumptions and that everyone needs to decide for themselves what the proper risk calculation is obviously I can't do that.

Anyone in my opinion is simply my opinion, but I think our confidence is something that should be taken seriously as people evaluate what they think is going to happen next.

Not yet thanks for providing that added detail and I guess, perhaps your follow quickly would not push on the clinical and pipeline kind timeline. So I was wondering I'm just following up the previous question. The comments would you David deep provide on layout potential deal announcement for the upcoming year, perhaps in medical conferences with regard to mirror korlym and metabolic disorders.

Gary Charles Robb: Now, there are obviously important, large decisions and disputes that are kind of starting to come onto the horizon, with the PGR decision in November, and a district court trial at some point in the future that we'll have a better sense of soon. We have said at every point that we have confidence in our intellectual property, and so far, we've been right. But I think the market assumes at every point that our chance of success is zero. And I think that is an inaccurate assumption and that everyone needs to decide for themselves what the proper risk calculation is. Obviously, I can't do that for anyone, and my opinion is simply my opinion. But I think our confidence is something that should be taken seriously. People evaluate what they think is going to happen next.

And recorded on college.

Yeah. So.

Liver Cortland.

Joe had had introduced we are planning to share the results from Weve submitted and.

The results of our placebo controlled study and prevention in healthy volunteers to the Americans I can't take society.

Matthew Lee Kaplan: No, yeah, thanks for providing that added detail.

So that is do you currently planned or you have a date yeah. So that's an April I think that's the currently planned presentation of results from ever Coral and we're not expecting data.

Matthew Lee Kaplan: Timeline. So I'll see you guys next time.

Matthew Lee Kaplan: So, I was wondering, just following up on the previous question and comments, would you be able to provide a layout of potential data announcements for the upcoming years, perhaps at medical conferences, with regard to mirror correlate and metabolic disorders and relative correlation and oncology? Yeah, so from Miracoreland, as Joe had introduced, we are planning to share the results, and we've submitted the results of our placebo-controlled study and prevention and healthy volunteers to the American Psychiatric Society. So that is what is currently planned.

No we're not expecting data read out from the phase two next year.

So.

Yeah, No no no further expert at no further releases are there to be expected yeah. Just I'm just I'm just going to repeat that so the the phase one study in did that I was alluding to in my comments will be.

You will see much of the results, but well data will be released in April American Psychiatric Association meeting, but the larger phase two studies will not produce results in 2020 not until 2021.

Andreas Grauer: We have a date.

Okay no.

Joseph K. Belanoff: Yeah, so that's in April, I think. That's the currently planned presentation of results from Miracorland. We're not expecting data. We're not expecting data readout from Phase 2 next year. So, yeah, no further releases there are to be expected.

That's definitely thanks for the detail and that's it for me I'll hop back in I think <unk>. Thank you Sir.

Thank you. The next question will come from Chris Howerton with Jefferies. Please go ahead.

Hey are one moment hey.

Questions coming from Rogers phone with Jefferies. Please go ahead.

Andreas Grauer: Yeah, I'm just going to repeat that. So the phase one study that I was alluding to in my comments, you've seen much of the results, but the full data will be released in April at the American Psychiatric Association meeting, but the larger phase two studies will not produce results in 2020, not until 2021.

Okay go ahead, Roger we can hear Hey, Hey try to I think I'd, just say Roger fall for Chris.

Yes, so a Muslim question is or how to do now right.

First off congrats for the Oh, well Q and Ah I, just maybe you have one quick kind of follow up question for the.

Matthew Lee Kaplan: Okay, no, that's definitely, thanks for the detail, and that's it for me; I'll hop back in the queue. Thanks a lot. Thank you.

Colin Litigation then obviously this mastery 40, a waiting is there kind of a important when a company and a at the Master Ah. We also want to play kind of do different kind of scenario and the in your mind on your model.

Chris Howerton: The next question will come from Chris Howerton with Jefferies. Please go ahead. Hey, one moment please. Questions coming from Roger Song with Jefferies. Please go ahead.

Roger Song: Okay. Go ahead, Roger. We can hear you.

If you have this kinda for generic coming into the market whenever a it becomes a reality how you can maximize I ran up heartland matter apparent on demand in the case of the both Harlan and the generic column is available.

Roger Song: Hey Charlie, thank you, this is Roger for Chris. So most of the questions have been answered. First of all, congrats on the 4Q. And I just maybe have one quick kind of follow-up question for the... Unknown Attendee, Swayampakula Ramakanth, Gary Robb, Joseph Belanoff, Unknown Attendee, Swayampakula Ramakanth, Unknown Attendee, Sean Maduck, William Guyer, Alan Leong, Unknown [inaudible]

Well I mean, I would say two things first it is not our estimate that there will be generic product available certainly this year. That's you know ever our revenue guidance. For example is our best estimate revenue and our best estimate of revenue includes our our opinions that there will not be a generic.

Gary Charles Robb: Well, I mean, I would say two things. First, it is not our estimate that there will be, you know, generic products available, certainly this year. That's, you know, our revenue guidance, for example, is our best estimate of revenue. And our best estimate of revenue includes our opinion that there will not be a generic quorum, no matter what, in 2020, certainly. And, you know, everyone needs to come to their own conclusions about that, but that is our belief. Now, as to what we would do if there ever were to be. That is something that we plan for, along with many other scenarios, and I think that's really all I can say is that we think hard about that possibility, even though we're confident in our position. We always hope for the best and prepare for the worst, and we give that a lot of thought. And that's really, I think, all I can tell you.

Korlym no matter what in 2020, certainly and you know everything you know everyone needs to come to their own conclusions about that but that's our that is our our belief now as to what we would do if there ever were to be generic korlym that is something a scenario that we plan for along with many other scenario.

Yes, and you know I think that's really all I can say is that we think hard about that possibility. Even though you know we're confident in our position, it's always you'd hope for the best and prepare for the worst and and we give that a lot of thought and that's really I think all I can tell you.

Yeah, Yeah, yeah understood. Thank you yeah. That's a that's on him that when of course, you have not been out. Thank you.

Sure well listen thank you everybody for listening I'm really appreciate it look forward to talking to you next quarter.

Right.

This concludes todays call. Thank you for your participation you may now disconnect.

Gary Charles Robb: Yeah, yeah, understood. Thank you. Yeah, that's the only question I have right now. Thank you.

[noise].

Joseph K. Belanoff: Well, listen, thank you everybody for listening. I really appreciate it and look forward to talking to you next quarter. Bye. Bye

This concludes today's call. Thank you for your participation. You may now disconnect.