Q4 2021 Corcept Therapeutics Inc Earnings Call

February 15, 2022

Hello, Thank you for standing by and welcome to the course of Therapeutics Conference call. At this time all participants are in a listen only mode. After the speaker presentation. There will be a question and answer session basket question. During the session you will need to press star one on your telephone please be advised that today's conference may be.

Recorded if you require any further assistance. Please press star zero I would now like to hand, the conference over to your speaker today at the Bank Macquarie. Please.

Please go ahead.

Good afternoon, and thank you for joining us I'm Outback Mccarthy <unk> Chief Financial Officer.

Today, we issued a press release announcing our financial results for the fourth quarter and providing a corporate update copies available.

Oh of course dot com or.

Our complete financial results will be available when we file our Form 10-K with the SEC.

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

Statements. During this call other than statements of historical fact are forward looking statements based on our plans and expectations that are subject to risks and uncertainties, which may cause actual results to differ materially from those such results.

Those statements expressed or implied.

These forward looking statements are described in today's press release, and the risk and uncertainties that may affect them are described in our annual report on Form 10-K , and our quarterly reports on Form 10-Q .

Refer to those documents for additional information regarding these forward looking statements and the factors that may affect them.

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

Our revenue in the fourth quarter 2021, with $98 8 million, an increase of 15% compared to the prior year period.

Our growth to continue and have provided 2022 revenue guidance of $400 million to $430 million compared.

Compared to 2021 revenue of 366 million.

GAAP net income was $32 1 million in the fourth quarter and $112 5 million for the full year 2021.

non-GAAP net income, which excludes noncash expenses related to stock based compensation and the utilization of deferred tax assets together with related income tax effects was $42 6 million in the fourth quarter and $149 $5 million for the full year.

Our cash and investments of $335 8 million at December 31 reflects the purchase of $10 million of course of shares or about 9% of our shares outstanding for $207 5 million in the fourth quarter.

Now Charlie Robb, our Chief business Officer, who will provide a legal update Charlie.

Thank you Adam I'll begin by reminding everyone that in December of last year. There was an important positive development in our history.

Susan.

As many of you know in March 2018, we suit in Federal District Court to prevent it from marketing and generic version of Korlym violation of our patents.

Two years ago in the midst of our Federal Court litigation have a challenged one of our patents 214 patent before.

The patent trial and Appeals board in a procedure known as post Grant review Board PR.

Remember of 2020 have rejected this argument.

Holding the $2 14 to one important patent entire.

Hello appeal of its loss to the Federal Circuit Court of Appeals, where in December this past December at loss again.

The deadline for Teva to file further appeals or seek reconsideration of its claims.

This matter is closed.

This now final determination by the.

It is barred from challenging the two important patents validity in district court and so has reduced arguing that it's proposed product. We're not infringe position. We believe has no legal or factual support.

So where do things stand.

Last April the district court granted us permission to file for summary judgment based on service infringement of the <unk> <unk>.

<unk> responded by filing a summary judgment motion.

Judgment as a reminder, this procedure whereby of course can decided case without holding trial.

We believe the court has all it needs to decide this case in our favor.

Granted our motion we will have one turbine would be barred from marketing generic korlym until 214 patent expires in 2037.

If the court rules in Teva stable, we will proceed to trial, perhaps sometime this year.

There is at present no timetable for the court's summary judgment ruling no trial date and no scheduled for any trial related activities.

In March 2021, we see another Anda filer, Hikma Pharmaceuticals, and same federal District Court hearing our case against.

This matter accordance that effects discovery deadline of July one.

Nothing is scheduled after that.

With respect to both Kevin Hikma, we are confidence in the strength of our legal position.

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

Thank you Charlie.

The past two years have shown how sensitive the growth of our commercial business is to pandemic conditions.

Look health restriction and precautions taken by patients and physicians make it more difficult for physicians to identify diagnose and optimally treat all of their patients and especially those with complex disorders, such as Cushings syndrome.

Having acknowledged the challenges posed by the pandemic I want to stress how optimistic we are about the present and the future of our Cushing syndrome business.

Our <unk> syndrome business is built on a strong foundation and effective lifesaving medication promoted by a dedicated commercial team puts the interest of patients first.

Leading endocrinologist increasingly believe that there are substantially more patients with Cushings syndrome was once assume.

Any of these patients Korlym is an excellent treatment.

As pandemic conditions and fears recede as they already have in certain locations. We expect our growth to continue and we are providing 2022 revenue guidance of $400 million to $430 million.

We're also extremely optimistic about our clinical development programs. We have said for years that cortisol modulation has the potential to help treat many serious diseases in 2021 data generated by our ovarian cancer and Nash programs provide an evidence of cortisol modulations broad application and <unk>.

22, you will see important results for many of our ongoing clinical programs.

These programs are examining lead candidates from our portfolio of more than 1000 proprietary cortisol modulators, many of which are attractive candidates for development.

Like Korlym these compounds buying strongly to the glucocorticoid receptor GR.

Unlike korlym is no affinity for the progesterone receptor and so don't cause some problems from a series of off target effects.

Beyond sharing the qualities of strong cortisol modulation and not perturbing, the progesterone receptor preclinical and clinical testing have shown that our molecules behave differently from one another in important ways.

Cross the blood brain barrier, others do not some performed best in models of solid tumors, others are more potent in models of metabolic disease still appear to be tissue specific others have more global effects.

These diverse qualities and allowed us to initiate clinical trials in a wide variety of disorders, including ovarian adrenal in prostate cancer anti psychotic induced weight gain Nash and of course Cushings syndrome.

To start a phase II trial in patients with ALS in the second quarter and have additional compounds in phase one in preclinical development.

Heartlands commercial success has provided the funds to advance all of these programs.

Our oncology program is testing three anti cancer mechanisms first postulated by investigators at the University of Chicago and confirmed by other prominent researchers.

One mechanism is increasing a pop ptosis.

Graham cell death, and chemotherapy is meant to induce in solid tumors cordis.

Cortisol suppresses epoch, tennis's, meaning cortisol works against the beneficial effects of chemotherapy.

And our successful trial in women with advanced ovarian cancer. The addition of our selective cortisol modulator MELA cortland enhance the effects of chemotherapy likely by blunting cortisol anti apoptotic effect.

These patients disease had progressed on two or more previous lines of treatment <unk> appeared to re sensitize. Some of these patients to the beneficial effects of chemotherapy.

As a reminder, our phase two trial is it controlled multicenter study of 178 women with platinum resistant ovarian cancer, who were randomized to one of three treatment arms 60 women received a higher dose umbrella carlin on the day before.

And the day after they received Nab Paclitaxel, we call this the intermittent arm.

58 women receive a lower daily dose in combination with Nab Paclitaxel, we call. This the continue with Xyrem and.

60 women received Nab Paclitaxel loan called this the comparator arm.

<unk> primary endpoint was progression free survival or PFS.

The women, who participated in our study were very ill and including those with platinum refractory disease, all had experienced disease progression. Despite prior lines of therapy their.

Median number of prior treatments was three.

As the results we presented at the European Society for medical oncology ESMO.

Congress clearly showed.

<unk> orland, providing benefits to many of these women.

Those who received <unk> intermittently exhibited a statistically significant improvement in PFS PFS compared to the group that received Nab Paclitaxel monotherapy.

Their hazard ratio was <unk> 66, with a P value of 0.38.

The median PFS was $5 six months, one eight months longer into the Nab Paclitaxel monotherapy groups, which is three eight months.

Women in the intermittent arm also experienced a statistically significant improvement in their duration of response relative to those in the comparator arm five six months versus three seven months with a hazard ratio of <unk>, three six and a P value of 0.006.

The overall survival or less data collection had accumulated only 63% of the target 120 events at the time of the database cut off on the progression free survival result.

At that time, the women in the intermittent arm exhibited a median OS of 12 nine months compared to $10 four months in the comparator arm safety and Tolerability data from the two groups were comparable.

We had expected that we would be able to present final overall survival results from this study last quarter. We currently expect that the primary analysis of the overall survival data will be available later this quarter.

We are quite heartened that women in our study on the longer and we and our investigators anticipated.

We have received very positive feedback from leading gynecological oncologist regarding the promise of rella Cortland as a potential treatment.

This entire disease in their view railcar ones potential benefit.

Disease progression without increased side effect burden constitute an important medical advance we plan to meet with the FDA in the coming months to discuss the optimal path forward.

Our second Ms mechanisms by which cortisol modulation may prove useful so by blocking an important tumor growth pathway.

Cortisol stimulation is a major reason why.

My patients with metastatic prostate cancer treated with widely prescribed androgen receptor antagonist and dilutive might eventually experienced resurgent disease.

Prior to the androgen stimulation or tumor switched to cortisol activity stimulate growth.

Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy.

Does this tumor escape route.

We recently completed enrollment in our dose finding study of our selective cortisol modulator <unk> lines combined with <unk> in men with castration resistant prostate cancer.

Investigators at the University of Chicago are conducting a similar study a relative Ireland combined with <unk> in the same patient population.

We expect to select an optimum dose of either another korlym or exit wireline to take forward in the second quarter of this year.

A third therapeutic mechanism seeks to reduce cortisol suppression of the immune system quad.

Quality of cortisol that likely launch the effectiveness of immunotherapy.

We are conducting an open label phase one b trial umbrella Cortland, plus the PD, one checkpoint inhibitor and ruled isn't that.

Merck's drug keytruda in patients with advanced adrenal cancer, whose tumors produce excess cortisol.

These patients suffered the effects of adrenal cancer and Cushing syndrome are usually quickly lethal combination Kim.

<unk> is a map is rarely effective as monotherapy in these patients. We believe that these patients cortisol excess maybe counteracting the intended effects in burleson map, which is to stimulate the immune system.

Our trial is evaluating with the relic Portland can treat these patients cushings syndrome by reducing cortisol activity and by reversing cortisol induced immune suppression.

Allowing <unk> to achieve its full cancer, killing effect.

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

I'll now turn to our programs in metabolic disease and the recent findings of our selective cortisol modulator mirror correlate in patients with Nash are serious liver disorder.

Patients, who received mirror Cortland and our phase II trial exhibited large rapid reductions in liver fat, but also substantial transient elevations of liver enzymes LT and ESG.

The improvement in liver fat in these patients with greater than occurred much more rapidly than we had expected and are rarely seen over any period of treatment.

As a reminder, the trial's primary endpoint was a 30% reduction in liver fat after 12 weeks of treatment and.

In fact patients exhibited reductions ranging from 38, 5% to 73, 8% after receiving mirror correlate for just a month.

It may be that the rapidity of mirror correlates fat reducing effect caused the patients <unk> to rise.

One way to liver shed status by metabolized metabolizing into fatty acid, which an excessive amount <unk> deliver.

Interestingly lipids in the blood of these patients did not increase providing support to the idea that mirror orland caused the excess fat.

Metabolized in the liver.

The goal of our phase <unk> dosing dose finding trial in patients with presumed Nash is to identify a dosing regimen that significantly reduces fat without causing an access of liberty irritation.

We're also evaluating mirror Portland, as a potential treatment for patients with another serious and widespread disorder anti psychotic induced weight gain.

In the United States 6 million people take antipsychotic medications, such as Olanzapine and risperidone to treat illnesses, including schizophrenia bipolar disorder and depression.

While these drugs are very effective the exact steep price in the form of rapid and sustained weak which leads to cardiovascular and metabolic disease.

The average life expectancy of patients in the United States to chronically take antipsychotic medications decreased by 20 years frequently due to increased cardiovascular events, such as heart attacks and strokes.

We are conducting two double blind placebo controlled phase II trials of urine correlate in patients with this disorder.

Gratitude and gratitude.

I'm pleased to say that enrollment and gratitude two is complete and we expect gratitude to be fully enrolled by mid year.

These trials seek to build on the positive data from our study of <unk> in healthy subjects. In 2020, we completed trial, which 96 healthy subjects received Olanzapine and either 600 milligrams of York Orleans, 900 milligrams or.

Or placebo for 14 days.

Subjects, who received mirror <unk> significantly less wheat, and those who received placebo. They also exhibited a smaller increase in triglycerides and in <unk>, which typically exhibited sharp transient increases at the start of Olanzapine therapy.

A paper describing these results was published in the journal of clinical Psychopharmacology.

The gratitude trial has a planned enrollment of 100 patients and is evaluating with the mirror Orland can reverse recent antipsychotic induced weight gain.

Agents with schizophrenia or bipolar disorder. We received in addition to their established dose of anti psychotic medication, either 600 milligrams in euro korlym or placebo for 12 weeks.

Gratitude is being conducted at 30 centers in the United States.

Our gratitude to study enrolled 150 patients and is testing mirror korlym as a treatment for long standing antipsychotic induced weight gain.

<unk> with schizophrenia receive in addition to their established disappear anti psychotic medication, either 600 milligrams or 900 milligrams.

Or placebo for 26 weeks gratitude two is being conducted 35 centers in the United States.

The primary endpoint in both studies is reduction in body weight. Other important measures of metabolic activity will also be examined.

Look forward to the data Readouts for both trials, which we expect in the fourth quarter.

As most of you know <unk> is our planned successor to Korlym for the treatment of hyper cortisol.

We are evaluating in two phase III trials Grace ingredients like.

Like all of our proprietary molecules rella Cortland is a selective cortisol modulator.

<unk> core loan achieves its efficacy its effect by competing with cortisol at the glucocorticoid receptor.

Unlike korlym it does not bind to the progesterone receptor PR for short.

It is not the abortion pill and it does not cause other PR related side effects, including endometrial thickening and vaginal bleeding.

By a different mechanism rella Korlym also does not appear to cause hypokalemia low potassium.

Serious side effects experienced by 44% of patients in <unk> pivotal trial.

Harlem induced hypokalemia is a leading cause of korlym discontinuation.

Well look Orleans as two efficacy and safety data was strong patients experienced meaningful improvements in hypertension, and glucose control as well as in a variety of other signs and symptoms Cushing syndrome.

There were no rolla correlate induced instances of endometrial thickening or vaginal bleeding and no drug induced hypokalemia.

While results were published in frontier and endocrinology.

Our Grace trial has a planned enrollment of 130 patients with any etiology of Cushing syndrome. As a reminder, grace has a randomized withdrawal trial design.

All patients receive <unk> for 22 weeks in an open label phase those in need response criteria are prudently glucose control hypertension or bulk are randomized to continue treatment with <unk> or placebo for 12 weeks.

While the pandemic has and continues to impact the execution of this trial, we and our and our investigators are eager to take race to the finish line.

We expect rates to serve as the basis for our NDA submission and Cushing syndrome, which we plan to submit in the second quarter of 2023.

Our second phase III trial gradient is studying <unk> in patients, whose cushings syndrome is caused by an adrenal adenomas or adrenal hyperplasia.

Patients with this etiology of Cushing syndrome, often experience on that rapid decline, but ultimately their health outcomes are poor.

<unk> has a planned enrollment of 130 patients and is being conducted at many of the sites participating in grace.

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

Do not expect our NDA Cushing syndrome depend on data from gradient, we do expect that its findings will help improve the pair these increasingly recognized patients.

Finally, a brief word about Gaza correlate previously known as Cort 113 hundred 76, which has shown promise in animal models of ALS, we have been refining our development plans with leading clinicians and regulators in the United States and Europe and plan to initiate a phase II trial in the second quarter.

Sure.

We expect our commercial growth to continue as pandemic conditions improve remember even in the most challenging periods of the pandemic, our commercial business generated more than enough cash under our advancing development activities.

We believe cortisol modulation can treat many serious disorders, I believe for which our development programs that provided a growing body of evidence.

Portland for patients with Cushings syndrome is one example.

Cortisol modulations benefit.

In 2021.

Data generated by our ovarian cancer and Nash programs provided evidence of cortisol modulations broad applications.

In 2022, we expect to see very important clinical results. Our oncology program is evaluating two of our proprietary cortisol modulators in three tumor types ovarian prostate and injury.

Our metabolic program is following up encouraging clinical data in Nash and anti psychotic induced weak.

We continue to enroll patients in our phase III trials with Korlym and Cushing syndrome.

Next quarter, we will start a phase II trial using another of our proprietary compounds task of Cortland to treat patients with ALS.

Additional proprietary compounds are advancing towards the clinic.

This is an exciting time at <unk> I'd like to thank our employees for their tremendous effort and dedication.

We're expanding our team to support what we believe is a substantial commercial opportunity and an incredibly broad and strong pipeline.

I'll stop here for questions.

Yeah.

Thank you as a reminder is that a question you will need to press star one on your telephone to withdraw your question press the pound key.

First question comes from Matt Kaplan with Ladenburg Thalmann, you May proceed with your question.

Hi, good afternoon, and congrats on the progress.

Just wanted to I guess, one for one for Charlie just to follow up on.

Hey.

We will update.

What's your sense in terms of the potential timing for.

Summary judgment motion decision.

Hi, Matt.

The answer to that is as simple as it is satisfying I have no idea.

The case was tied to a new judge sometime ago, and Thats always knew Jud just to take a while too.

To get their feet under them.

<unk> backlog.

Criminal cases take priority over civil cases.

So really if things have been extremely quiet and we just can't say.

Just just cannot study.

Okay, Okay fair enough.

And then in terms of your clinical development programs.

What's your current thinking our current plan for.

The pivotal study.

Ovarian cancer and I guess.

What we are proposed it looked like the FDA when you meet with them.

Thanks, Matt and good to hear from you I'm going to turn you over to Bill Guy here, who is our chief development officer to address that question.

Great. Thanks, very much first and foremost I got to reiterate what Joe stated I'm really excited about 2022, because I've been told my team that this is going to be an epic year for not only development by per course, because there are a lot of ongoing trials.

We will see results throughout this year that will move this company forward one of those being in ovarian cancer.

Our planned next study.

In ovarian cancer is going to be with the intermittent dose of <unk> plus Nab paclitaxel in a controlled study versus investigator choice of treatment.

While this study will be larger than our phase II trial, we plan to have approximately 360 patients, but we basically just want to replicate the great results. We saw in phase II, where we saw statistically significant improvements in PFS and duration of response.

We've actively worked with two leading organizations one being the <unk>, which is the gynecological oncology group here in the U S and another being and got which is the European network of Gynecological Oncologist trial group in Europe .

Collectively they are both very excited to partner with us and starting this trial and we plan to start this trial in the second quarter.

Great. Okay. Thanks for thanks for taking the questions.

Thanks, Brett.

Thank you. Our next question comes from Chris Howerton with Jefferies. You May proceed with your question.

Great. Thanks, so much and congratulations on all the progress for me I think maybe just to yeah, hey, Thanks, Joe.

Just maybe two quick questions from me one is on the phase III Grace trial.

I know, you're just kind of went through the high level design, but is there maybe you could help us understand what the timelines are leading up to your expected <unk> 23 NDA submission.

What kind of gives you the confidence in those timelines at this point. The second question I have would be around the commercial business and the guidance that you're expecting.

Just to what degree do you expect.

Kind of dose titration in person visits to be a continued headwind and how has that kind of played into your thinking in terms of those topline numbers for next year. Thank you.

Thanks, Thanks, Chris I think we put both of your questions, but you need clarification, let us know, but first question. Let me turn you back to Bill to talk about the Grace trial. So for the Grace trial, we're driving towards our timeline of submitting an NDA in the second quarter of 2022 and here of course step we're taking an all hands on deck approach with the <unk> team internally as well.

Well as with our partnership with investigators to drive towards those timelines. Just recently, we've completed two investigator meetings one in the U S and one in Europe . Both meetings were very successful because we personally saw the engagement of each investigator and their excitement for the trial, but I think most importantly, their commitment to increase.

<unk> recruitment for this trial to help us drive towards those timelines.

Hey, Christian and just just one small thing I think Bill said 2022 for the NDA since 2012.

I was going to say the same thing actually thanks, Jeff.

Let me next turn it over to Sean to Duke who runs all of our hydro cortisol businesses.

And I think it has interest to your question.

Thanks, Joe and thanks, Chris for the question.

You all know forecasting revenue during the pandemic is has been and continues to be challenging, but we're confident that the forecast range that we put forth.

Accounts for both internal and external drivers that we believe have the potential to impact our pharma business. So its something ive said in the past.

In person visits matter, it's really a key driver for our business both for patients and for clinical specialists and as restrictions continuing to ease we're going to be able to engage more frequently with physicians and more patients are going to be screened which ultimately we believe.

Will lead to more prescriptions, but we are seeing an improvement in access after the omni product search.

Back at the end of last year and through the first part of this year.

The other thing I'll touch on quickly is dose as you brought that up and I just want to remind everybody just on previous.

Calls, we've talked a little bit about how we have seen a modest decrease in our average dose.

Over the course of the pandemic and we were concerned that patients were not being optimally treated we've actually seen that dose decline stabilized and in fact, we've seen a modest reversal of that trend.

Positive on both fronts.

Excellent.

That's fantastic I really appreciate it and I don't know if you'll let me, but I do have another quick question, if you wouldn't mind.

Yeah go ahead, Chris.

Yes, so I was actually I was thinking about.

Couple of years ago, when I initiated coverage on the company. There was a discussion around urinary biomarker of activity of Korlym in glucocorticoid receptor blockade and as we're kind of getting closer to the great finish line I guess I was just curious if there is any update or progress on that scientific front in terms of how.

You can evaluate.

Glucocorticoid receptor blockade clinically.

Yes.

Chris.

At the risk of taking people off a little bit into the scientific.

And you remember that.

<unk> to give you a chance to really talk about just a little bit. So Chris is really referring to is that all of the measures. We have now a cortisol or all cortisol level the amount of cortisol in the urine or blood or this alive, but they don't really represent.

One for one way, what's really important which is the amount of cortisol activity. That's really stems from the fact that patients who have modestly elevated cortisol levels can actually have very bad symptoms of Cushing syndrome, and people with pretty high cortisol levels and have only moderate symptoms of Cushing syndrome.

So clearly what matters is in fact, the activity really at the GM level and so we began work on a specific team which is.

Measuring that can be specific team, which is activated by cortisol and it's called the FTP side.

Just the name of the Chi and although we haven't talked about it in a while and research into it has continued in fact, there is a very interesting publication from late last year.

To demonstrate and studied surgically treated patients with cushings disease that causes that <unk> levels are in fact quite high for successful surgery, and then declined to normal levels with surgery and if the surgeries unsuccessful. They don't decline so that measures actually being captured Chris and all.

All of our studies, we think its really potentially very important.

And sprint.

Actually maybe bolt diagnosing and treating patients with Cushings syndrome, and I don't have anything.

Anything further to tell you except that the research continues and since I know you are an avid reader of the scientific literature, if you're paying us I'll be sure to send you a copy of the published paper.

Okay, well, that's fantastic I really appreciate it Joe thanks, so much.

Sure.

Thank you. Our next question comes from Greg Fraser with Truth Securities. You May proceed with your question.

Thanks, and good afternoon folks.

I was wondering if you could comment perhaps high level on korlym demand trends year to date and whether you've seen any breaks from the typical trends that you see early in the year that might be related.

Yes, I'm going to just turn it back to Sean just so everyone knows who speak hi, Greg. Thanks for the question I'll, just speak a little bit on sort of army proud of the impact on our business.

In fact at the end of 2021 and the early part of this year I would say similar to other times during the pandemic over the last two years.

Restrictions increase and it became much more difficult for us to meet with physicians and physicians to be with patients and I just mentioned on the last question that obviously, that's a key to our business on the other.

The interesting thing about this wave is with army kron and its broad rapid spread we actually had some of our own field employees contract of ours, although everybody vaccinated and is fine if it required quarantine, which affected time in the field and affected some normal promotional activity I would say, though that the positive there is a positive.

And any of us with omni proud is that the surge was rapid and unlike what we saw with with the prolonged impact of delta things seem to be improving very quickly. So restrictions are easing throughout the country and our sales personnel are healthy and back out there and things are slowly returning to normal and we're optimistic that we'll continue on that.

On that path.

Got it that's helpful.

I know, it's early days for <unk>, but I'm curious any feedback that come through your sales team on how docs are viewing that drug in.

Whether theres been any counter detailing the korlym that you've heard about.

It's very early with a quarter left and we have not heard that feedback, but I'll say, both with <unk> and history to this date, we have not seen any impact on our business and truthfully, we're happy but other companies are out there educating physicians on the illness on hypercriticism proper screening because.

This improves patient care overall, so it's a good thing.

Got it Okay, and then for prostate cancer once you select the optimal dose of either <unk> land in the second quarter will you then move.

<unk> into a phase III study this year.

So thank you for that question and we're going to take a look at both of the study data in the second quarter of this year and make that decision and it depends upon which drug we choose both drugs were excited about extra korlym to enbrel La Portland, but we will evaluate the safety data, we will evaluate what efficacy data, we get from that trial and.

Then we will determine internally what the best path forward is for us to take either one of those drugs into a phase II trial.

Our plan would be yes, we would go to a next trial with one of the drugs and pick the optimal dose.

Great. Thank you.

Thank you. Our next question comes from his team along with <unk>.

Bank of America, you May proceed with your question.

Hi, good afternoon, and thank you for taking my questions.

I have two the first would be on the gravitas studies.

Can you.

Joe about what is the average amount of weight gain.

Yes.

Indoors during treatment with anti Psychotics.

Is there a minimum amount of weight loss.

Think would be needed to be clinically meaningful just based on your conversations with physicians.

And then the second question is on ovarian cancer.

Good good.

Guidance on what you think the trial design will be the pivotal study, but is there anything that you would want to wait to see from your upcoming update of the phase two data, which is due later this quarter, where I think youre going to have updated overall survival data that you would need to potentially tweak that trial design for the pivotal.

Thank you.

I think I think you and I think they do understand in both of your questions and I know disease.

<unk>.

The company for very long time, but I'm, a psychiatrist by training and so on.

The weight gain and metabolic issues.

Our very close to me because these are my patients and they need to take anti psychotic indications, which are very effective for the psychosis, but really have tremendous metabolic achilles' heel.

It is rare for patients to not gain weight and sometimes the weight gain.

The gain is.

I think it would be very surprised I mean, I personally have had patients who have been between 50 to 100 pounds on these medications, we cant tends to be rapid which is why there is actually really an issue about treating healthy people.

Phase one studies for very long the average amount of weight gain that we saw in.

In two weeks and patients in our healthy studies its about 10 pounds.

Really is obviously would be problematic for all of us. So it's a very potent effect and one that is of great concern to all treating.

<unk>. So you asked me a question, which is a little harder to answer which is how much of a weight loss would actually be.

Beneficial to patients.

I don't really know exactly what the answer to that is I will tell you. This that we gain is our loss would be looked at in the context of what are the other metabolic.

For the patients.

Together.

It's not just the amount of weight. It's all the other things that happens when people gain weight, that's really very meaningful and I think it's treating psychiatrist you'd want to look at the entire picture. So for instance, a drug which caused less weight gain or creating small amount of weight loss without affecting any of the other variables isn't as valuable as a drug.

Which creates the exact same amount of weight loss or perhaps the same amount of weight gain and does some of those other things. So it's really going to be picture of in total for what's going on this is the first studies back. Both of these are the first studies I should say, we've actually ever done in patients and I think we're going to learn a tremendous amount.

As to how the drug works, how the patients respond to it.

Both tolerability and efficacy of Mei.

We'll go from there, but I really wanted to highlight this because this is the first time, we treated patients have been very pleased by what we've seen in healthy people will see how much of that translates to what really is a terrible problem in patients who must take these medications. So that's the answer to that question I think the second question.

Related to the ovarian cancer program, and I think I'd like to turn that over to bill and I'll fill in if there is anything that I need to thank you for that question. So.

Harding <unk> data to me, we have a solid regulatory path forward with or without the OS data with what we have today because I would remind you. We saw great results from the phase II study showing that the intermittent arm umbrella korlym plus Nab Paclitaxel showed statistically significant improvements in PFS that was the primary endpoint of that study that will be the primary endpoint of our.

Next study as well so that's the key piece there, but then also back to OS. This study the phase II study was not powered to see a difference in OS and to be honest. There is no study are no drug that has shown a statistical significance and improvement in overall survival in these types of patients with recurrent platinum resistant ovarian cancer patients.

And so if we would see a significant difference in OS that would be unprecedented.

And very positive.

You'll see when we reach that <unk>.

Total when we get the total events of 120 events, which we hope to see later this quarter.

Okay and would that be in a press release that you would reveal some updated data.

Once we get the data we will make it available.

Assuming we get the data.

Thanks for taking my question.

<unk>.

Thank you. Our next question comes from Michelle Gilson with Canaccord Genuity you May proceed with your question.

Hi, Thank you for taking my question.

Sure.

Hoping you guys could.

Give us a better sense of what's in the guidance and what might get you to the high end of that guidance and some of the factors.

Have you considered.

In there and then.

Q you spoke already about.

The in person interactions and the dose starting to normalize.

Trends towards.

Starting to normalize from what you've seen previously prior to Covid, but.

I was wondering if you're also seeing any upticks in terms of the diagnostic I guess, the diagnosis of patients with Cushings syndrome, and maybe some of those COVID-19 delays in diagnosis starting to subside.

Thank you, Michelle and I'm going to again, just so people recognize the.

Turn it over to Sean again.

Perfect. Thank you for the question Michelle.

In terms of the first question of sort of the range again interactions are really an important part of this so thats been built in assuming that we're going to see an easing of some of the restrictions that have existed for.

For quite a window of time here, where practices have been close to become specialists and in some cases some of their patients and the other piece that I haven't touched on yet today as I field expansion that we actually undertook prior to actually COVID-19 occurring we scaled up our salesforce they were new to the field and immediately they were basically.

At home and not able to go into the field.

With the opening up of the country, we're going to have a more clinical specialists actively calling on physicians.

We've ever had.

We believe that will also add to the value and the ability to educate more more positions and through that seem more patients being screened.

To your second part of your question around around diagnosis.

Right.

Patients are when theyre able to see their doctors.

<unk> has been educated on this they are they are actively being screened during COVID-19 .

Was not occurring because it takes many visits to take a patient from sort of first first concern in first half through the multitude of tests and following the guidelines and as again restrictions. So these patients are seeing their physicians more frequently through that are able to get sort of the multiple tests that they may need to be diagnosed.

That we've seen an increase in that diagnosis.

And if I can also ask.

Question on ROIC.

Pretty good.

So you said that the market for a relic correlate you would expect to be substantially larger.

Then the market for Korlym and I was wondering if you could just expand on a bit more and sort of the biggest drivers that you would expect for relic correlate to be able to grow the market.

Persistence or patients dropping off coming back on her.

<unk> never have considered courtland that maybe would consider a relic correlate.

If you could expand a little bit on what you would expect from the Cushing syndrome market for Roddick correlate verses Portland.

Yes, Michelle.

Glad you asked.

It's an important question.

So first again and I know we have.

Listeners who are various degrees of their understanding.

<unk> is an excellent medication people, who have hyper cortisol or something.

Really turns that thermostat down in a way, which makes for much more of a normal situation.

Just remind people it's now almost a decade ago, but when we did our clinical study, which got the drug approved 87% of the patients who are substantial.

So communicated by outsiders. So it really works in that regard and so.

We love Korlym.

Unfortunately, korlym or tax ingredient risks note is not a specific drug for cortisol. It does a couple of things, which actually are problematic one and it was known as this before it was ever used Cushing syndrome is the potent predict.

<unk> receptor antagonist.

As we've said, it's the active ingredient, which is frequently called the abortion pill. So nothing to do with cortisol, but it has affected entirely by progesterone receptor antagonist.

So.

Discovery program was really to see if we could find a mechanism, which could takeaways that problem and in fact, our wonderful head of medicinal chemistry at that time now our chief Scientific Officer, Hazel Hunt was actually to create able to create three different series of compounds of which milk, where when it comes from A&P each series.

Exactly that potent cortisol modulation no effect.

And so that was really the first and obvious benefit to take away that particular medical problem and frankly political problem, but the second one as it turned out was really something that we discovered as we were developing it which is that.

Yeah.

As the <unk>, Unlike korlym doesn't seem to cause what's called hypokalemia or low potassium we understand the mechanism why that occurs with korlym. It's a manageable problem really have to pay attention to it with Korlym <unk> does not seem as if that's really an issue at all and it just creates for ease of use so.

Those medical things are really.

Important reasons why <unk> is not just another purple pill, it really is a significantly better medication and.

I have to say in the United States, the idea of being related to termination of pregnancy or abortion creates political toxicity that I think will also be.

It's meaningful that that will really be not an issue with.

Okay. Thank you.

Maybe if I can just ask one more.

One would be that you are running in Nash the dose exploration study are you starting to see anything in that study. So far that's validating your hypothesis that that will have key signals.

There may be related to the magnitude or the rapidity.

That you saw in the phase two around the liver fat reductions.

Michel I am going to have to keep you on the edge of your seat.

We do actually.

We have information, it's an open label study, but we will resolve that information when we have accumulated.

Alright, thanks for taking my questions.

Sure.

Thank you. Our next question comes from Arthur he with.

HC Wainwright you May proceed with your question.

Hey, good afternoon, guys and thank you for taking my question.

So just follow up on the Nash study.

Can you guys give us more color on the enrollment status for these for the dosing escalation part.

Yes, I am Bill would you like to answer that question sure. So for the enrollment status I mean, our phase <unk> study.

<unk> with multiple cohorts looking at lower doses of mirror Cortland, each cohort was gated by the evaluation of safety and efficacy every six weeks and we saw great enrollment in the ended the year and even at the beginning of this year, we see great excitement by the investigators and for patients into this trial. So we're seeing good steady enrollment.

For this trial.

And I'll just add to that are there.

Important thing, we really think we have hooked a big one here.

We really do think that this medication is very potent.

All the investigators who've worked with have really described it is perhaps not just be potent medications, but the most potent medications have you ever seen for Pat.

And so we really do think it's worth doing the work to get it.

Precise dose as is possible to actually provide the maximum benefit and.

The greatest ease of use.

And so I'll just reiterate Bill's point, we've had no trouble attracting people to be in this study I think it offers them even in these fees real benefit and.

We're going to work hard to get the fastest dose as quick as we can we can't tell you exactly when that is because of the protocols are in the process of running.

Thank you. Thank you for that additional color regarding the gratitude study.

Could you remind us besides the.

The weight loss data.

Is there any biomarker data we can get it from.

Data update later this year.

Yes. The answer is all of the standard metabolic deal like triglycerides in lipids and so forth all of those things are being measured in this study and again as a practitioner I can tell you all of them are meaningful.

That's great. Thanks, Thanks for that the last one I wanted to pick up your brand for.

Considering the current macro environment.

What's your appetite for the BD.

Idea.

Alright.

I was wondering when someone would ask us that question.

The answer is that we we have good business.

Produce enough money to run our development programs as you know and so we just sort of get you to the bottom line.

<unk> ideas on a very regular basis.

Let me really TBD.

Most important to understanding.

We really like what we're doing we think our development program is terrific and it's going to provide benefit to many different types of patients. It is by far our highest priority to make sure that this programs wanted to their finish line get us. The best results, we can and that we are not distracted from doing that in the optimal way. So yes, we can.

Take a look at a lot of things that come in the door. Some are easy to Smith, some require more thought and obviously some potentially has put something could be so attractive that we'd really have to give it serious thought but keep in mind thats not our priority. Our priority is really to optimize cortisol modulation and all of the diseases.

We feel it can be effective in treating.

Sounds great. Thank you and thank you for answering my question.

Okay.

Thank you. Our next question comes from Greg Fraser with true Security can May proceed with your question.

Thanks for taking the follow up I just wanted to see if theres been any progress or if there's anything new to report on the New Jersey Usao investigation.

Yeah.

Happy to happy to answer that so theres been no.

No developments to report, but I think there are a couple of things that.

Folks should keep in mind as they think about that.

And so and before I start talking about that let me just backup will give just a little bit of background for those who aren't familiar with what you're talking about back in December of last year. We disclosed that we received a document subpoena from the department of Justice actually the.

New Jersey U S Attorney's office.

Seeking.

Documents related sort of broadly speaking for our commercial business are our relationships with health care providers, our promotional practices to korlym prior authorization information things of that nature.

And.

And I think the first thing to keep in mind is the <unk>.

Subject matter covered by those documents is the same as the sort of swirl that's been kicked up around us for years Star.

Starting with the short seller report that was published back in January 2019, which wed sort of at night.

Though as night follows day.

The Securities Class action suit that we are at.

Ryan you through right now and that we have this department of Justice inquiry.

That's the first thing to keep in mind.

Sort of an entire ecosystem.

Second thing is that it's very common to say as is true with us that we are cooperating fully with the government's investigation because we most certainly are.

First and foremost that's the right thing to do.

But what is not as commonly stated.

It's almost never.

Is that many companies not all but many companies wildly core operating simultaneously.

We'll move it slowly as past that.

That is not the case with us as I should have mentioned with respect to the civil suit.

Certainly true here.

We want things to go as quickly as possible, we are producing documents and information to the department of Justice as fast as we can and our goal is to always be ahead of the.

Because.

We believe.

First what was the best outcome for our course and our shareholders is to get all of the facts for the government as quickly as we can.

So nothing to announce at the moment, but I think it's important for folks to keep those couple of things in mind.

Great. Thanks for the color.

Thanks, Jeff.

For all those who've tuned and thank you very much we'll talk to you in another quarter and this is really.

Very exciting year for <unk>.

I really if youre just being introduced to the company. This is a good time to take a serious look we'll talk to you in another quarter. Thank you very much.

The rest of the day.

Thank you. This concludes today's conference call. Thank you for participating you may now disconnect.

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This conference maybe recorded.

Any further assistance. Please press star Zero I would now like to hand, the conference over to your speaker today Arthur <unk>.

Please go ahead.

Good afternoon, and thank you for joining us.

<unk> Mccarthy of course, that's chief Financial Officer.

Today, we issued a press release announcing our financial results for the fourth quarter and providing a corporate update copies available of course dot com, our complete financial results will be available when we file our Form 10-K with the SEC.

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

From those statements expressed or implied.

Please refer to those documents for additional information regarding these forward looking statements and the factors that may affect them.

Claim any intention or duty to update forward looking statements.

Our revenue in the fourth quarter of 2021 with $98 8 million, an increase of 15% compared to the prior year period.

We expect our growth to continue and have provided 2022 revenue guidance of $400 million to $430 million compared.

Compared to 2021 revenue of 366 million.

GAAP net income was $32 1 million in the fourth quarter and $112 5 billion for the full year 2021.

non-GAAP net income, which excludes non cash expenses related to stock based compensation and the utilization of deferred tax assets together with related income tax effects was $42 6 million in the fourth quarter and $149 5 million for the full year.

Our cash and investments of $335 8 million at December 31.

Flex the purchase of $10 million of course of shares or about 9% of our shares outstanding for $207 5 million in the fourth quarter.

Now Charlie Robb, our Chief business Officer, who will provide a legal update Charlie.

You added back.

Again by reminding everyone that in December .

Last year, there was an important positive development in our type of.

Pharmaceuticals.

As many of you know in March 2018, we suit Federal District court to prevent it from marketing and generic version of Korlym violation of our patents two years ago in the midst of our federal Court litigation have a challenged one of our patents 214 patent before the patent trial and Appeals board the procedure now.

One is post grant review or PBR.

In November of 2020 peak have rejected <unk> argument.

All in the $2 14 to one four patents in its entirety.

Hello appeal of its lost in the Federal Circuit Court of Appeals, where in December this past December at loss again.

The deadline for Teva to file further appeals or reconsideration of its claims have passed this matter is closed.

This now final determination by the debt means that Teva is barred from challenging 214 patents validity in district court and so has reduced arguing thats proposed product we're not infringe position, we believe has no legal or factual support.

So where do things stand.

Last April the district court granted us permission to file for summary judgment based on service infringement of the two one for Pat.

Teva responded by filing an sone summary judgment motion.

Murray judgment as a reminder, this procedure whereby of course can decide the case without holding a truck.

We believe the court has all that needs to decide this case in our favor.

<unk> motion, we will have one turbine would be barred from marketing generic korlym to one four patent expires in 2037.

If the court ruled in <unk> favor, we will proceed to trial, perhaps sometime this year.

There is at present no timetable for the court's summary judgment ruling no trial date and no scheduled for any trial related activities.

In March 2021, we sued another Anda filer, Hikma Pharmaceuticals, and same federal District Court for the hearing our case against.

This matter the court has set a fact discovery deadline of July one.

Nothing is scheduled after that.

With respect to both Kevin Hikma, we are confident in the strength of our legal position.

I will now turn the call over to Dr. Joseph <unk>, Our Chief Executive Officer, Joe.

Thank you Charlie.

The past two years have shown how sensitive the growth of our commercial business is to pandemic conditions.

Look health restrictions and precautions taken by patients and physicians make it more difficult for physicians to identify diagnose and optimally treat all of their patients and especially those with complex disorders, such as Cushings syndrome.

Having acknowledged the challenges posed by the pandemic I want to stress how optimistic we are about the present and the future of our Cushing syndrome business.

Our Cushings syndrome business is built on a strong foundation and effective lifesaving medication promoted by a dedicated commercial team puts the interest of patients first.

Leading endocrinologist increasingly believe that there are substantially more patients with Cushings syndrome and was once assumed for <unk>.

Any of these patients Korlym is an excellent treatment.

As pandemic conditions and fears recede as they already have in certain locations. We expect our growth to continue and we are providing 2022 revenue guidance of $400 million to $430 million.

We're also extremely optimistic about our clinical development programs. We have said for years that cortisol modulation has the potential to help treat many serious diseases in 2021, the data generated by our ovarian cancer and Nash programs provide an evidence of cortisol modulations broad application and <unk>.

'twenty two we will see important results for many of our ongoing clinical programs.

These programs are examining lead candidates from our portfolio of more than 1000 proprietary cortisol modulators, many of which are attractive candidates our development like.

Like Korlym these compounds binds strongly to the glucocorticoid receptor GR.

Unlike korlym they have no affinity for the progesterone receptor and so don't cause summit carlin's Ms serious off target effects.

Beyond sharing the qualities strong cortisol modulation and not perturbing, the progesterone receptor preclinical and clinical testing have shown that our molecules behave differently from one another in important ways.

Cross the blood brain barrier, others do not some perform best in models of solid tumors, others are more potent in models of metabolic disease. Some appear to be tissue specific others have more global effects.

We plan to start a phase II trial in patients with ALS in the second quarter and have additional compounds in phase one in preclinical development.

Heartlands commercial success has provided the funds to advance all of these programs.

Our oncology program is testing three anti cancer mechanisms first postulated by investigators at the University of Chicago and confirmed by other prominent researchers.

One mechanism is increasing a pop ptosis programmed cell death, and chemotherapy is meant to induce in solid tumors.

Cortisol suppresses apoptosis, meaning cortisol works against the beneficial effects of chemotherapy.

Our successful trial in women with advanced ovarian cancer. The addition of our selective cortisol modulator MELA cortland enhance the effects of chemotherapy likely by blunting cortisol anti apoptotic effect.

While these patients disease had progressed on two or more previous lines of treatment <unk> appeared to re sensitize. Some of these patients to the beneficial effects of chemotherapy.

As a reminder, our phase two trial is a controlled multicenter study of 178 women with platinum resistant ovarian cancer, who were randomized to one of three treatment arms 60 women received a higher dose umbrella carlin on the day before.

And the day after they receive Nab Paclitaxel, we call this the intermittent arm.

58 women receive a lower daily dose in combination with Nab Paclitaxel, we call. This the continuous xyrem and.

60 women received Nab Paclitaxel loan we call this the comparator arm.

<unk> primary endpoint was progression free survival or PFS.

The women, who participated in our study were very ill and including those with platinum refractory disease, all had experienced disease progression. Despite prior lines of therapy their.

Median number of prior treatments was three.

As the results we presented at the European Society for medical oncology ESMO.

Congress clearly showed.

<unk> orland, providing benefits to many of these women.

Those who received <unk> intermittently exhibit a statistically significant improvement in PFS PFS compared to the group that received Nab Paclitaxel monotherapy.

They're hazard ratio was <unk> 66, with a P value of 0.38. The median PFS was $5 six months, one eight months longer than the Nab Paclitaxel monotherapy groups, which is three eight months.

The women in the intermittent arm also experienced a statistically significant improvement in their duration of response relative to those in the comparator arm five six months versus three seven months with a hazard ratio of <unk>, three six and a P value of 0.006, while.

While the overall survival or OS data collection had accumulated only 63% of the target 120 events at the time of the database cut off on the progression free survival results at that time the women in the intermittent arm exhibited a median OS of 12 nine months compared to $10 four months in.

The comparator arm safety and Tolerability data from the two groups were comparable.

We are quite heartened that women in our study on the <unk>.

<unk> and we and our investigators anticipated.

We have received very positive feedback from leading gynecological oncologist regarding the promise of <unk> Cortland as a potential treatment.

Tired to seats in their view railcar ones potential benefit delays disease progression without increased side effect burden with constitute an important medical advance we plan to meet with the FDA in the coming months to discuss the optimal path forward.

Our second Ms mechanisms by which cortisol modulation may prove useful so by blocking an important tumor growth pathway.

The results stimulation is a major reason why.

My patients with metastatic prostate cancer treated with widely prescribed androgen receptor antagonist and dilutive might eventually experienced resurgent disease.

Deprived of the androgen stimulation their tumor switched to cortisol activity stimulate growth.

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

We recently completed enrollment in our dose finding study of our selective cortisol modulator <unk> lines combined with <unk> in men with castration resistant prostate cancer.

Investigators at the University of Chicago are conducting a similar study of relevant wireless combined with <unk> in the same patient population.

We expect to select an optimum dose of either <unk> or exit wireline to take forward in the second quarter of this year.

A third therapeutic mechanism seeks to reduce cortisol suppression of the immune system.

Quality of cortisol that likely launch the effectiveness of immunotherapy.

We are conducting an open label phase one b trial of <unk>, plus the PD, one checkpoint inhibitor Emerald isn't that.

Merck's drug keytruda in patients with advanced adrenal cancer, whose tumors produce excess cortisol.

These patients suffer the effects of adrenal cancer and Cushing syndrome are usually quickly lethal combination.

<unk> is a map is rarely effective as monotherapy in these patients. We believe that these patients cortisol excess maybe counteracting the intended impact September listen map, which is to stimulate the immune system.

Our trial is evaluating with the relic Portland can treat these patients cushings syndrome by reducing cortisol activity and by reversing cortisol induced immune suppression.

Allowing premarin listen that to achieve its full cancer, killing effect.

I'll now turn to our programs in metabolic disease and the recent findings of our selective cortisol modulator <unk> in patients with Nash are serious liver disorder.

Patients who received <unk> in our phase II trial exhibited large rapid reductions in liver fat, but also substantial transient elevations of liver enzymes LT and ESG.

The improvement in liver fat in these patients with greater than a card much more rapidly than we had expected and are rarely seen over any period of treatment as.

As a reminder, the trial's primary endpoint was a 30% reduction in liver fat after 12 weeks of treatment and.

In fact patients exhibited reductions ranging from 38, 5% to 73, 8% after receiving mirror correlate for just a month.

It may be that the rapidity of mirror correlates fat reducing effect caused the patients <unk> to rise.

One way to liver shed satisfy metabolized metabolizing into fatty acids, which an excessive amount <unk> deliver.

Interestingly lipids in the blood of these patients did not increase providing support the idea that mirror korlym caused the excess fat to be metabolized in the liver.

The goal of our phase <unk> dosing dose finding trial in patients with presumed Nash is to identify a dosing regimen that significantly reduces fat without causing an access of liberty irritation.

We're also evaluating mirror korlym as a potential treatment for patients with another serious and widespread disorder anti psychotic induced weight gain.

In the United States 6 million people take anti psychotic medications, such as Olanzapine and risperidone to treat illnesses, including schizophrenia bipolar disorder and depression.

While these drugs are very effective the exact steep price in the form of rapid and sustained weak which leads to cardiovascular and metabolic disease.

Average life expectancy of patients in the United States to chronically take antipsychotic medications decreased by 20 years.

Frequently due to increased cardiovascular events, such as heart attacks and strokes.

We are conducting two double blind placebo controlled phase II trials of urine correlate in patients with this disorder.

Ratatouille and gratitude.

I'm pleased to say that enrollment and gratitude two is complete and we expect gratitude to be fully enrolled by mid year.

These trials seek to build on the positive data from our study of <unk> in healthy subjects. In 2020, we completed trial, which 96 healthy subjects received olanzapine and either 600 milligrams of <unk> 900 milligrams of New York correlate or placebo for 14 days.

Subjects, who received mirror korlym significantly less weight and those who received placebo. They also exhibited a smaller increase in triglycerides and in <unk>, which typically exhibit sharp transient increases at the start of Olanzapine therapy.

A paper describing these results was published in the journal of clinical Psychopharmacology.

The gratitude trial has a planned enrollment of 100 patients and is evaluating with the mirror Korlym can reverse recent antipsychotic induced weight gain.

Patients with schizophrenia or bipolar disorder. We received in addition to their established dose of anti psychotic medication, either 600 milligrams of <unk> or placebo for 12 weeks.

Gratitude is being conducted at 30 centers in the United States.

Our gratitude to study enrolled 150 patients and is testing mirror korlym as a treatment for long standing antipsychotic induced weight gain.

<unk> with schizophrenia receive in addition to their established disappear anti psychotic medication, either 600 milligrams or 900 milligrams of New York, Portland, or placebo for 26 weeks gratitude.

Gratitude two is being conducted 35 centers in the United States.

Primary endpoint in both studies is reduction in body weight. Other important measures of metabolic activity will also be examined.

We look forward to the data readouts for both trials, which we expect in the fourth quarter.

As most of you know <unk> is our planned successor to Korlym for the treatment of hyper cortisol.

We are evaluating in two phase III trials Grace ingredient.

Like all of our proprietary molecules rella Marlin is a selective cortisol modulator.

<unk> core loan achieves its efficacy its impact by competing with cortisol at the glucocorticoid receptor.

Unlike korlym it does not bind to the progesterone receptor PR for short.

It is not the abortion pill and it does not cause other PR related side effects, including interim drill thickening and vaginal bleeding.

By a different mechanism rella Korlym also does not appear to cause hypokalemia low potassium.

Serious side effects experienced by 44% of patients in <unk> pivotal trial.

Harlem induced hypokalemia is a leading cause of korlym discontinuation.

Well look more on phase II efficacy and safety data was strong.

<unk> experienced meaningful improvements in hypertension, and glucose control as well as in a variety of other signs and symptoms Cushing syndrome.

There were no rolla, korlym induced instances of endometrial thickening or vaginal bleeding and no drug induced hypokalemia.

While results were published in frontier and endocrinology.

Our Grace trial has a planned enrollment of 130 patients with any etiology of Cushing syndrome. As a reminder, grace has a randomized withdrawal trial design.

All patients receive <unk> for 22 weeks in an open label phase those in need response criteria for improvement in glucose control hypertension or bulk are randomized to continue treatment with <unk> or placebo for 12 weeks while.

While the pandemic has and continues to impact the execution of this trial, we and our and our investigators are eager to take race to the finish line, we expect rates to serve as the basis for our NDA submission and Cushing syndrome, which we plan to submit in the second quarter of 2023.

Our second phase III trial gradient is studying <unk> in patients, whose cushings syndrome is caused by an adrenal adenomas or adrenal hyperplasia.

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

<unk> has a planned enrollment of 130 patients and is being conducted at many of the sites participating in grace.

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

While we do not expect our NDA Cushings syndrome should depend on data from gradient. We do expect that its findings will help improve the pair these increasingly recognized patients.

Finally, a brief word about Gaza correlate previously known as Cort 113 hundred 76, which has shown promise in animal models of AOS, we have been refining our development plans with leading clinicians and regulators in the United States and Europe and plan to initiate a phase II trial in the second quarter.

We believe cortisol modulation can treat many serious disorders, I believe for which our development programs that provided a growing body of evidence.

Portland for patients with Cushings syndrome is one example.

Cortisol modulations benefit.

In 2021.

<unk> generated by our ovarian cancer and Nash programs provided evidence of cortisol modulations broad applications and.

In 2022, we expect to see very important clinical results. Our oncology program is evaluating two of our proprietary cortisol modulators in three tumor types ovarian prostate and injury.

Our metabolic program is following up encouraging clinical data in Nash and anti psychotic induced weak.

We continue to enroll patients in our phase III trials with Korlym and Cushing syndrome.

Next quarter, we will start a phase II trial, using another of our proprietary compounds tattoo cortland to treat patients with ALS.

Additional proprietary compounds are advancing towards the clinic.

This is an exciting time at <unk> I'd like to thank our employees for their tremendous effort and dedication we are expanding our team to support what we believe is a substantial commercial opportunity and an incredibly broad and strong pipeline.

I'll stop here for questions.

Thank you as a reminder is that a question you will need to press star one on your telephone to withdraw your question press. The pound key our first question comes from Matt Kaplan with Ladenburg Thalmann. You May proceed with your question.

Hi, good afternoon, and congrats on the progress.

Just wanted to I guess, one for one for Charlie just to follow up on.

The.

We will update.

What's your sense in terms of the potential timing for.

The summer summary judgment motion decision.

Hi, Matt.

The answer to that is as simple as it is satisfying.

No idea.

The case was tied to a new judge sometime ago, and Thats always knew Ted just to take a while too.

Get their feet under them.

The backlog of cases already criminal cases take priority over civil cases.

So really if things have been extremely quiet and we just can't say.

Just cannot study.

Okay, Okay fair enough.

Okay.

And then in terms of your clinical development programs.

What's your current thinking our current plan for.

Pivotal study.

In ovarian cancer.

Yes.

We are proposed it look like to the FDA when you meet with them.

Thanks, Matt and good good to hear from you I'm going to turn you over to Bill Guy here, who is our chief development officer to address that question Greg.

Great. Thanks, very much first and foremost I got to reiterate what Joe stated I'm really excited about 2022 because of even tell my team that this is going to be an epic year for not only development by per course, because there are a lot of ongoing trials.

We will see results throughout this year that will move this company forward one of those being in ovarian cancer.

Our planned next study.

In ovarian cancer is going to be with the government and dose of <unk> plus Nab paclitaxel in a controlled study versus investigator choice of treatment.

Collectively they are both very excited to partner with us in starting this trial and we plan to start this trial in the second quarter.

Great. Okay. Thanks for thanks for taking the questions.

Thanks, Matt.

Thank you. Our next question comes from Chris Howerton with Jefferies. You May proceed with your question.

Great. Thanks, so much and.

Congratulations on all the progress.

For me I think maybe just to yes, hey, thanks, Joe.

Just maybe two quick questions from me one is on the phase III Grace trial.

I know, you're just kind of went through the high level design, but is there maybe you could help us understand what the timelines are leading up to your expected <unk> 23 NDA submission.

What kind of gives you the confidence in those timelines at this point. The second question I have would be around the commercial business and the guidance that youre expecting.

Just to what degree do you expect.

Of dose titration in in person visits to be a continued headwind and how has that kind of played into your thinking in terms of those topline numbers for next year. Thank you.

Thanks, Thanks, Chris I think we put both of your questions, but any clarification, let us know the first question. Let me turn you back to Bill to talk about the great strides so far the Grace trial, we're driving towards our timeline of submitting an NDA in the second quarter of 2022 and here of course separate we're taking an all hands on deck approach with of course, FTE internally as well as.

With our partnership with investigators to drive towards those timelines. Just recently, we've completed two investigator meetings one in the U S and one in Europe . Both meetings were very successful because we personally saw the engagement of each investigator and their excitement for the trial, but I think most importantly, their commitment to increasing.

Recruitment for this trial to help us drive towards those timelines.

And just one small thing I think Bill said 2022 for the NDA since 2012.

I was going to say the same thing actually thanks, Jeff.

Uh huh.

Let me next turn it over to Sean to Duke who runs all of our hyper cortisol Ism business.

Commercially and I think it has.

To your question.

Joe and thanks, Chris for the question.

As you all know forecasting revenue during the pandemic is has been and continues to be challenging, but we are confident that the forecasting range that we put forth.

Accounts for both sort of internal and external drivers that we believe have the potential to impact our current business something I've said in the past.

In person visits matter, it's really a key driver for our business both for patients and for our clinical specialists and as restrictions continue to ease we're going to be able to engage more frequently with physicians and more patients are going to be screened which ultimately we believe.

Will lead to more prescriptions, but we are seeing an improvement in access after the omni product search.

Back at the end of last year and through the first part of this year.

The other thing I'll touch on quickly is dose as you brought that up and I just want to remind everybody just on previous.

Calls, we've talked a little bit about how we have seen a modest decrease in our average dose.

Positive on both fronts.

Excellent.

That's fantastic I really appreciate it and I don't know if you let me, but I do have another quick question, if you wouldn't mind.

Yeah go ahead, Chris.

Yes, so I was actually I was thinking about.

Couple of years ago, when I initiated coverage on the company. There was a discussion around urinary biomarker of activity of Korlym in glucocorticoid receptor blockade and <unk>.

We're kind of getting closer to the great finish line I guess I was just curious if there is any update or progress on that scientific front in terms of how you can evaluate glick.

Glucocorticoid receptor blockade clinically.

Yes.

Chris.

At the risk of taking people off a little bit into the scientific.

Please remember that.

And B is to give you a chance to really talk about just a little bit. So what Chris is really referring to is that all of the measures. We have now a cortisol or all cortisol level the amount of cortisol in the urine or blood or the supply.

Don't really represent.

One for one way, what's really important which is the amount of cortisol activity. It's really stems from the fact that patients who have modestly elevated cortisol levels can actually have very bad symptoms of Cushing syndrome, and people with pretty high cortisol levels and have only moderate symptoms of Cushing syndrome.

So clearly what matters is in fact, the activity really at the GM level and so we began work on a specific gene which is.

Measuring that can be specific team, which is activated by cortisol and it's called the FTP side.

Is the name of the Chi and although we haven't talked about it in a while a research Intuit has continued that theres. Some very interesting publication from late last year.

To demonstrate and studied surgically treated patients with cushings disease that causes that <unk> levels are in fact quite hyped for successful surgery, and then decline to normal levels with surgery and if the surgeries unsuccessful. They don't decline so that measures actually being captured Chris and all.

All of our studies, we think its really potentially very important.

Vance.

Actually maybe both diagnosing and treating patients with Cushings syndrome, and I don't have anything.

Okay, well, that's fantastic I really appreciate it Joe thanks, so much.

Sure.

Thank you. Our next question comes from Greg Fraser with Truth Securities. You May proceed with your question.

Thanks, and good afternoon folks.

I was wondering if you could comment perhaps higher level on korlym demand trends year to date and whether you've seen any breaks from the typical trends that you see early in the year that might be related.

Yes, I'm going to just turn it back to Sean just so everyone knows who speak hi, Greg Thanks for the question.

Just speak a little bit on sort of army proud of the impact on our business.

In fact at the end of 2021 and the early part of this year I would say similar to other times during the pandemic over the last two years.

Restrictions increase and it became much more difficult for us to meet with physicians and physicians to meet with patients that I just mentioned on the last question that obviously, that's a key to our business and the other interesting thing about this wave is with army kron in its broad and rapid spread we actually had some of our own field employees contract ours, although everybody vaccinated.

Fine if it required quarantine, which affected time in the field and affected some normal promotional activity I would say, though that the positive there is a positive.

As with Army proud is that the surge was rapid and unlike what we saw with with the prolonged impact of delta things seem to be improving very quickly. So restrictions are easing throughout the country and our sales personnel are healthy and back out there and things are slowly returning to normal and we're optimistic that we'll continue on that on that path.

Okay.

Got it that's helpful.

I know, it's early days for <unk>, but I'm curious any feedback that's come through your sales team on how docs are viewing that drug in.

Whether theres been any counter detailing the korlym that you've heard about.

It's very early with record level, and we have not heard that feedback, but I will say, both with <unk> and history to this date, we have not seen any impact on our business and truthfully I mean, we're happy that other companies are out there educating physicians on an illness on hyper protocol with them and on proper screening because.

This improves patient care overall, so it's a good thing.

Got it Okay, and then for prostate cancer once you select the optimal dose of either <unk> in the second quarter will you then move.

<unk> into a phase II study this year.

So thank you for that question, we're going to take a look at both of the study data in the second quarter of this year and make that decision and it depends upon which drug we choose both drugs were excited about extra korlym to enbrel La Portland, but we will evaluate the safety data, we will evaluate what efficacy data, we get from that trial and.

Then we will determine internally what the best path forward is for us to take either one of those drugs into a phase II trial.

Our plan would be yes, we would go to a next trial with one of the drugs and pick the optimum dose.

Great. Thank you.

Thank you. Our next question comes from of the game along with.

Bank of America, you May proceed with your question.

Hi, good afternoon, and thank you for taking my questions.

Hey, Bill.

First would be on the gratitude studies.

Can you remind us.

Joe about what is the average amount of weight gain.

With patient.

Doors during treatment with anti Psychotics.

Is there a minimum amount of weight loss.

Bank would be needed to be clinically meaningful just based on your conversations with physicians.

And then the second question is on ovarian cancer.

I'd give.

<unk> on what you think the trial design will be the pivotal study, but is there anything that you would want to wait to see from your upcoming update of the phase two data, which is due later this quarter, where I think youre going to have updated overall survival data that you would need to potentially tweak that trial design for the pivotal.

Thank you.

I think I think you and I think they do understand both of your questions.

No disease.

Those distributions as the company for very long time, but.

I'm, a psychiatrist by training and so.

The weight gain and metabolic issues.

Our very close to me because these are my patients and they need to take anti psychotic indications, which are very effective for the psychosis, but really have tremendous metabolic achilles' heel.

It is rare for patients to not gain weight and sometimes the weekend.

The gain is.

I think it would be very surprised I mean, I personally have had patients who have been between 50 to 100 pounds on these medications weekend tends to be rapid which is why there is actually really an issue about treating healthy people in.

Phase one studies for very long the average amount of weight gain that we saw in <unk>.

In two weeks and patients in our healthy studies its about 10 pounds.

Which really is obviously would be problematic for all of them. So it's a very potent effect and one that is of great concern to all treating psychiatrist.

You asked me a question, which is a little harder to answer which is how much of a weight loss would actually be.

An official to patients.

I don't really know exactly what the answer to that is I will tell you. This that we gain is.

We've lost would be looked at in the context of what are the other metabolic.

Renovations.

Together.

It's not just the amount of weight. It's all the other things that happens when people gain weight, it's really very meaningful and I think it is treating psychiatrist you'd want to look at the entire picture. So for instance, a drug which caused less weight gain or creating small amount of weight loss without affecting any of the other variables isn't as valuable as a drug.

Kris the exact same amount of weight loss or prevents the same amount of weight gain and does some of those other things. So it's really going to be a picture of in total for what's going on this is the first studies back both each these are the first studies I should say, we've actually ever done in patients and I think we're going to learn a tremendous amount.

How the drug works, how the patients respond to it.

Both tolerability and efficacy of Mei.

The answer to that question I think the second question related to the ovarian cancer program and I think I'd like to turn that over to bill and I'll fill in if there's anything that I need to thank you for that question. So.

Do us data to me, we have a solid regulatory path forward with or without the OS data with what we have today because I would remind you. We saw great results from the phase II study showing that the intermittent arm umbrella korlym plus Nab Paclitaxel showed statistically significant improvements in PFS that was the primary endpoint of that study that will be the primary endpoint of our.

Next study as well so thats the key piece there, but then also back to OS. This study the phase II study was not powered to see a difference in OS and to be honest. There is no study are no drug that has shown a statistically significant improvement in overall survival in these types of patients with recurrent platinum resistant ovarian cancer patients.

And so if we were to see a significant difference in OS that would be unprecedented.

And very positive.

See when we reach that.

Total when we get the total events of 120 events, which we hope to see later this quarter.

Okay and would that be in Chris.

Chris relief that you would be open.

Some updated data.

Once we get the data we will make it available.

Assuming we get the data.

Excellent. Thanks for taking my question.

Thank you gene.

Thank you. Our next question comes from Michelle Gilson with Canaccord Genuity you May proceed with your question.

Hi, Thank you for taking my question.

I was hoping you guys could.

Give us a better sense of what's in the guidance and what might get you to the high end of that guidance and some of the factors that you considered.

And there and then.

Q you spoke already about.

The in person interactions and the dose starting to normalize.

Trends towards.

Starting to normalize from what you've seen previously prior to Covid, but.

I was wondering if you're also seeing any upticks in terms of the diagnostic.

The diagnosis of patients with Cushings syndrome, and maybe some of those COVID-19 delays in diagnosis starting to subside.

Thank you Michelle and I am going to again, just so people recognize it turn you over to Sean again.

Perfect. Thank you for the question Michele.

In terms of the first question of sort of the range again interactions are really an important part of it. So that's been built and assuming that we're going to see an easing of some of the restrictions that have existed for.

For quite a window of time here, where practices have been close to become specialists and in some cases some of their patients and the other piece that I haven't touched on yet today as I feel expansion that we actually undertook prior to actually COVID-19 occurring we scaled up our sales force they were new to the field and immediately they were basically.

At home and not able to go into the field.

So with the opening up of the country, we're going to have a more clinical specialists actively calling on physicians.

Ever had.

We believe that will also add to that.

Value and the ability to educate more more positions and through that seeing more patients being screened.

To your second part of your question around around diagnosis.

Alright.

Patients are when they are able to see their doctors and physicians has been educated on this they are they are actively being screened during COVID-19 .

It was not occurring because it takes many visits to take a patient from sort of first first concern in first half through the multitude of tests and following the guidelines and as again restrictions. So these patients are seeing their physicians more frequently through that are able to get sort of the multiple tests that they may need to be diagnosed and through that we've seen an increase in that.

Yes.

And if I can also ask.

Question on ROIC.

Previously you said that the market for a relic correlate you would expect to be substantially larger.

Then the market for Korlym and I was wondering if you could just expand on a bit more and sort of the biggest drivers that you would expect for rella correlate to be able to grow the market.

Persistence or patients dropping off cutting back on our pace.

Patients never have considered courtland that maybe would consider a relic correlate.

If you could expand a little bit on what you would expect from the Cushing syndrome market for Roddick correlate verses Portland.

Yes, Michelle budget.

Glad you asked.

It's an important question.

So first again and I know we have.

Listeners who have various degrees of their understanding.

<unk> is an excellent medication people, who have hyper cortisol ism, it really turns that thermostat down in a way, which makes for much more of a normal situation.

Just remind people it's now almost a decade ago, but when we did our clinical study, which got the drug approved 87% of the patients saw a substantial clinical improvement as adjudicated by outsiders. So it really works in that regard.

So.

We love Korlym.

As we've said, it's the active ingredient, which is frequently called the abortion pill, so nothing to do with cortisol.

Entirely by progesterone receptor antagonist and so full discovery program was really to see if we could find a mechanism, which could takeaways that problem and in fact are.

Our wonderful head of medicinal chemistry at that time now our Chief Scientific Officer, Hazel Hunt was actually to treat able to create three different series of compounds of which korlym. It comes from each series.

To do exactly that potent cortisol modulation no effect.

And so that was really the first and obvious benefit to takeaway that particular medical problem and frankly political problem, but the second one as it turned out was really something that we discovered as we were developing it which is that.

As the milacron, Unlike korlym doesn't seem to cause what's called hypokalemia or low potassium we understand the mechanism why that occurs with korlym. It's a manageable problem really have to pay attention to it with Korlym <unk> does not seem as that's really an issue at all and it just creates for ease of use.

So I think those medical things are really.

Important reasons why <unk> is not just another purple pill. It really is a significantly better medication and I just I have to say in the United States. The idea of being related to termination of pregnancy or abortion creates political toxicity that I think will also be.

It's meaningful that that will really be not an issue with it.

Okay. Thank you and.

Maybe if I can just ask one more this season won't be that you are running in Nash. The dose exploration study are you starting to see anything in that study. So far that's validating your hypothesis that the RFP.

Signals.

Where may be related to the magnitude or the rapidity.

That you saw in the phase two around the liver fat reductions.

Michel I am going to have to keep you on the edge of your seat.

We do actually.

We have information to open label study, but we will resolve that information when we have accumulated.

Alright, thanks for taking my questions.

Sure.

Thank you. Our next question comes from Arthur he with it.

HC Wainwright you May proceed with your question.

Hey, good afternoon guys.

Thank you for taking my question.

So just follow up on the Nash study.

Could you guys give us more color on the enrollment status for these for the Doe.

Thing escalation part.

Yes, I am Bill would you like to answer that question sure. So for the enrollment status I mean, our phase <unk> study started with multiple cohorts looking at lower doses of mirror Cortland. Each cohort was gated by the evaluation of safety and efficacy every six weeks and we saw great enrollment in the ended the year end.

At the beginning of this year, we see great excitement by the investigators and for patients into this trial. So we're seeing good steady enrollment for this trial.

And I'll just add to that are there.

Important thing, we really think we have hooked a big one here.

We really do think that this medication is very potent all.

All the investigators who we work with have.

Really described it is perhaps not just the potent medications, but the most potent medications have you ever seen for Pat.

And so we really do think it's worth doing the work to get it.

As precise a dose as possible to actually provide the maximum benefit.

With the greatest ease of use and so I'll just reiterate Bill's point, we've had no trouble attracting people to be in this study I think it offers them even in these fees real benefit.

We're going to work hard to get the fastest dose as quick as we can we can't tell you exactly when that is because the protocols are in the process of running.

Thank you. Thank you for that additional color.

The gratitude study.

Besides the could you remind us besides the.

The weight loss data.

Is there any biomarker data we can get from.

Data update later.

Later this year.

Yes. The answer is all of the standard metabolic deal.

This rise in lipids and so forth all of those things are being measured in this study and again as a practitioner I can tell you all of them are meaningful.

That's great. Thanks, Thanks for that the last one I wanted to pick up your brand for.

Considering the current macro environment.

What's your appetite for the BD.

<unk> idea.

Alright, well.

I was wondering when someone would ask us that question. The answer is that we we have good business, we produce enough money to run our development programs as you know and so we just sort of get you to the bottom line I'm pitched ideas on a very regular basis.

John .

Yeah.

Let me really.

The most important to understanding we really like what we're doing we think our development program is terrific and it's can provide benefit to many different types of patients. It is by far our highest priority to make sure that this programs onto their finish line to get us. The best results, we can and that we are not distracted.

From doing that in the optimal way. So yes, we take a look at a lot of things that come in the door. Some are easy to dismiss some require more thought obviously, some potentially I suppose something could be so attractive that we really have to give it serious thought but keep in mind thats not our priority our priority is really to optimize.

Cortisol modulation and all of the diseases that we feel it can be effective in treating.

Sounds great. Thank you. Thank you for taking my question.

Okay.

Thank you. Our next question comes from Greg Fraser with true Security can May proceed with your question.

Thanks for taking the follow up.

Wanted to see if theres been any progress or if there's anything new to report on that New Jersey Usao investigation.

Yes.

Yeah.

Happy to happy to answer that so theres been no.

No developments to report, but I think there are a couple of things that.

Should keep in mind as they think about that.

And so and before I start talking about that let me just backup will give just a little bit of background for those who aren't familiar with.

Talking about back in December of last year, we disclosed that we received.

Document subpoena from the department of Justice actually.

New Jersey U S Attorney's office.

King.

<unk> related sort of broadly speaking for our commercial business, our relationships with health care providers, our promotional practices to korlym prior authorization information things of that nature.

And.

And I think the first thing to keep in mind is that.

Our subject matter covered by those documents is the same as the sort of swirl that's been kicked up around us for years.

Starting with the short seller report that was published back in January 2019, which wed sort of at night.

As night follows day.

The Securities Class action suit that we are grinding through right now and that we have this department of Justice inquiry.

The first thing that has been mined.

Sort of an entire ecosystem.

Second thing is that it's very common to say as is true with us that we are cooperating fully with the government's investigation because we most certainly are.

First and foremost that's the right thing to do.

But what is not as commonly stayed where it is.

It's almost never.

Is that many companies not all but many companies wildly core operating simultaneously.

We'll move it slowly as past that.

That is not the case with us as I should have mentioned with respect to the civil suit.

Certainly true here.

You want things to go as quickly as possible, we are producing documents and information to the department of Justice as fast as we can and our goal is to always be ahead of the.

Because.

We believe that.

Desktop was the best outcome for our course and our shareholders is to get all of the facts before the government as quickly as we can.

So nothing to announce at the moment, but I think it's important for folks to keep those couple of things in mind.

Great. Thanks for the color.

Thanks, Jeff.

For all those who've tuned and thank you very much we'll talk to you in another quarter and this is really a V.

Very exciting year for <unk>.

I really if youre just being introduced to the company. This is a good time to take a serious look.

Up to you in another quarter. Thank you very much.

The rest of the day.

Thank you. This concludes today's conference call. Thank you for participating you may now disconnect.

Q4 2021 Corcept Therapeutics Inc Earnings Call

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