Corcept Therapeutics Incorporated (CORT) Q4 2022 Earnings Call Transcript

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Corcept Therapeutics Incorporated (NASDAQ:CORT) Q4 2022 Earnings Conference Call February 28, 2023 5:00 PM ET

Company Participants

Atabak Mokari - Chief Financial Officer

Charlie Robb - Chief Business Officer

Joseph Belanoff - Chief Executive Officer

Bill Guyer - Chief Development Officer

Sean Maduck - President of Endocrinology Division

Conference Call Participants

Raymond Wu - Ladenburg Thalmann

Dennis Ding - Jefferies

Greg Fraser - Truist

Arthur He - H.C. Wainwright


Greetings, and invited to nan Corcept Therapeutics Conference Call. At this time, each participants are successful a listen-only mode. A question-and-answer convention will travel nan general presentation. [Operator Instructions] As a reminder, this convention is being recorded.

I would now for illustration to move nan convention complete to your host, Atabak Mokari, CFO. Thank you. You whitethorn now begin.

Atabak Mokari

Good afternoon, and convey you for joining us. I'm Atabak Mokari, Corcept's Chief Financial Officer. Today, we issued a property merchandise announcing our financial results for nan 4th fourth and providing a firm update. A transcript is disposable astatine Our complete financial results will beryllium disposable erstwhile we record our Form 10-K pinch nan SEC.

Today's telephone is being recorded. A replay will beryllium disposable astatine nan Investors Past Events tab of our website.

Statements during this telephone different than statements of humanities truth are forward-looking statements based connected our plans and expectations that are taxable to risks and uncertainties, which mightiness origin existent results to disagree materially from those specified statements expressed aliases implied. These forward-looking statements are described successful today's property merchandise and nan risks and uncertainties that whitethorn impact them are described successful nan property merchandise and successful our yearly study connected Form 10-K and our quarterly reports connected Form 10-Q. Please mention to those documents for further information. We disclaim immoderate volition aliases work to update forward-looking statements.

Our gross successful nan 4th fourth of 2022 was $103.1 cardinal compared to $98.8 cardinal successful nan 4th fourth of 2021. We expect our gross maturation to proceed and person provided 2023 gross guidance of $430 cardinal to $450 cardinal compared to 2022 gross of $401.9 million.

Net income was $16.6 cardinal successful nan 4th fourth and $101.4 cardinal for nan afloat twelvemonth 2022.

Our rate and investments astatine December 31 was $436.6 cardinal compared to $335.8 cardinal astatine nan extremity of nan anterior year.

I will now move nan telephone complete to Charlie Robb, our Chief Business Officer, to supply a ineligible update. Charlie?

Charlie Robb

Thanks, Atabak.

Since we past spoke, we person successfully terminated 2 lawsuits. On February 13, we announced that we had reached an statement successful rule settling each claims successful nan purported securities people action known arsenic Melucci versus Corcept Therapeutics Incorporated. This suit was brought by plaintiff's attorneys successful March 2019. Since then, our position has not wavered. We said successful March 2019 that we were assured successful nan spot of our ineligible position. Having spent 4 years litigating, we are moreover much confident.

I, and I cognize I speak for my colleagues arsenic well, americium proud of Corcept successful nan measurement we do business. Allegations specified arsenic those asserted successful nan Melucci suit are repugnant. We person looked guardant to our time successful tribunal wherever we tin explicate publically nan reasons for our pridefulness successful what we do and nan measurement we do it. That being said, litigation is simply a distraction for much important matters. Simply put, clip spent preparing for proceedings is clip not spent processing medications aliases helping patients. We presented pinch nan chance to put nan Melucci distraction down america for an magnitude covered by our insurance; we felt compelled to accept.

The 2nd terminated lawsuit concerns Hikma Pharmaceuticals. In March 2021, we sued Hikma to forestall it from trading generic Korlym successful usurpation of our patents. As we announced successful December, we person settled this case. Hikma to statesman trading a generic type of Korlym successful nan United States opening October 01, 2034, much than 11 years from now aliases earlier nether circumstances customary for colony agreements of this type. This is nan aforesaid introduction day arsenic our erstwhile colony pinch Sun Pharmaceuticals.

Finally, location was a improvement yesterday successful our suit against Teva. In March 2018, we sued Teva to forestall it from trading a generic type of Korlym successful usurpation of our patents. In April 2021, we revenge for summary judgement based connected Teva's infringement of our '214 patent. Teva, arsenic expected, responded by filing its ain mobility for summary judgment. Summary judgement is simply a process whereby courts determine a lawsuit without holding a trial. Yesterday, nan tribunal denied some our mobility and Teva's mobility without prejudice and ordered nan parties to statesman negotiating a schedule for pre-trial activities. No proceedings day has been set. It is important to statement that this alteration successful nan procedural posture of our action against Teva has not changed our constituent of view. We stay assured successful nan spot of our ineligible position and are very comfortable receiving nan proceedings if necessary.

I'll now move nan telephone complete to Dr. Joseph Belanoff, our Chief Executive Officer. Joe?

Joseph Belanoff

Thank you, Charlie.

Our Cushing's syndrome business is built connected a coagulated foundation, a life-saving medicine promoted by a commercialized squad that puts nan liking of patients first. Leading endocrinologists progressively judge that location are considerably much patients pinch Cushing's syndrome than was erstwhile assumed. Korlym is an fantabulous curen for patients pinch Cushing's syndrome and location are galore eligible patients who person yet to person it. We are highly optimistic astir nan maturation imaginable of our Cushing's syndrome business and are making important investments to amended nan screening and curen of these patients. We are providing 2023 gross guidance of $430 cardinal to $450 million.

In summation to generating important rate successful 2022, we importantly precocious nan objective improvement programs of our proprietary selective cortisol modulators, relacorilant, dazucorilant and miricorilant. We expect to make further advancement successful nan adjacent 12 months pinch nan submission of relacorilant's NDA successful Cushing's syndrome and enrollment of our confirmatory Phase 3 proceedings of relacorilant successful platinum-resistant ovarian cancer, Phase 2 proceedings of dazucorilant successful ALS, and Phase 2 proceedings of miricorilant successful NASH.

Since inception, our investigation and improvement efforts person built upon nan presumption nan cortisol modulation tin beryllium a powerful therapeutic system successful galore superior disorders. Our proprietary compounds modulate cortisol's effects by binding to nan glucocorticoid receptor, aliases GR. They do not hindrance to nan progesterone receptor, truthful it don't origin immoderate of Korlym's, our approved product's, astir superior off-target effects.

Interestingly, while our compounds modulate cortisol's activity without modulating progesterone's activity, they are not identical. Some transverse nan blood-brain barrier, others do not. Some execute champion successful models of coagulated tumors, others are much potent successful models of metabolic disease. Some look to beryllium tissue-specific, others person much world effects. These divers qualities let america to study a wide assortment of disorders.

Currently, we are conducting programs successful ovarian, adrenal and prostate cancer, ALS, NASH and, of course, Cushing's syndrome. We are investigating cortisol modulation's domiciled successful different diseases and person further compounds successful objective and preclinical development. Our Cushing's syndrome business has funded each of these activities and will proceed to do so.

As astir of you know, we are evaluating relacorilant for nan curen of hypercortisolism successful 2 Phase 3 trials: GRACE and GRADIENT. Relacorilant is simply a selective cortisol modulator. Like Korlym, it achieves its effect by competing pinch cortisol astatine nan glucocorticoid receptor. Unlike Korlym, it does not hindrance to nan progesterone receptor, PR for short, and truthful does not origin PR-related broadside effects, including termination of pregnancy, endometrial thickening and vaginal bleeding. By a different mechanism, relacorilant besides does not look to origin hypokalemia, debased potassium, a superior broadside effect knowledgeable by 44% of patients successful Korlym's pivotal trial. Korlym-induced hypokalemia is simply a starring origin of Korlym discontinuation.

Relacorilant's Phase 2 efficacy and information information were compelling. Patients knowledgeable meaningful improvements successful hypertension and glucose control, arsenic good arsenic successful a assortment of different signs and symptoms of Cushing's syndrome. There were nary relacorilant-induced instances of endometrial thickening aliases vaginal bleeding and nary drug-induced hypokalemia. The proceedings results were published successful Frontiers successful Endocrinology successful July 2021. We are pleased to denote that we judge that we person capable patients and screening successful our GRACE proceedings to complete enrollment successful nan coming weeks. We expect GRACE to service arsenic nan ground for our NDA submission successful Cushing's syndrome, which we scheme to taxable successful nan first 4th of 2024.

Our 2nd Phase 3 proceedings successful hypercortisolism, GRADIENT, is studying relacorilant's effects successful patients whose Cushing's syndrome is caused by an adrenal adenoma aliases adrenal hyperplasia. Patients pinch this etiology of Cushing's syndrome often acquisition a little accelerated decline, but their wellness outcomes are poor. While we do not expect our NDA successful Cushing's syndrome to dangle connected information from GRADIENT, we do expect that its findings will amended nan attraction of these patients.

Finally, we scheme to initiate a randomized double-blind placebo-controlled Phase 4 study successful Korlym this quarter. We person named nan study CATALYST. CATALYST will analyse nan prevalence of hypercortisolism successful patients pinch difficult to power type 2 glucosuria and dainty nan patients wished to person hypercortisolism pinch Korlym. Planned enrollment is 1,000 patients, which we expect to complete by nan extremity of this year. The astir salient diabetologists successful nan state helped creation and are participating successful this study.

Our oncology programme is testing 3 anti-cancer mechanisms first reasoned by investigators astatine nan University of Chicago and later confirmed by different salient researchers. One system is expanding apoptosis, nan programmed compartment decease that chemotherapy is meant to induce successful coagulated tumors. Cortisol useful against nan beneficial effect of chemotherapy by suppressing apoptosis.

In our successful controlled Phase 2 proceedings successful women pinch platinum-resistant ovarian cancer, nan summation of a selective cortisol modulator, relacorilant, enhanced nan effect of chemotherapy, apt by blending cortisol's anti-apoptotic effect. Relacorilant provided meaningful use to galore of nan women successful our study. While these women's illness had progressed connected 2 aliases much erstwhile lines of treatment, including erstwhile taxanes, relacorilant appeared to resensitize nan illness to chemotherapy's beneficial effects successful immoderate women.

Those who received relacorilant intermittently, nan time before, nan time of and nan time aft they received nab-paclitaxel, exhibited a statistically important betterment successful progression-free endurance and long of consequence compared to nan group who received nab-paclitaxel monotherapy. Women successful nan intermittent relacorilant group besides unrecorded longer than those successful nan comparator arm, pinch a p-value that approached statistical significance.

Our study to day indicates that 29% of nan patients who took intermittent relacorilant were live 2 years aft study commencement versus only 14% who took nab-paclitaxel alone. 13% of patients who took intermittent relacorilant are live 3 years aft study commencement compared to nary who took nab-paclitaxel alone. Perhaps moreover much important, nan women who received relacorilant positive nab-paclitaxel knowledgeable nary further broadside effect load compared to those who received nab-paclitaxel alone.

The results from nan study were featured successful podium presentations astatine nan 2021 and 2022 European Society for Medical Oncology, ESMO, meetings, and astatine nan 2022 American Society of Clinical Oncology, ASCO, Annual Meeting.

ROSELLA, our pivotal Phase 3 proceedings successful platinum-resistant ovarian cancer, is progressive and enrolling patients. ROSELLA's creation intimately tracks our Phase 2 study pinch planned enrollment of 360 women, randomized one-to-one to person either relacorilant positive nab-paclitaxel aliases nab-paclitaxel alone. The superior endpoint will beryllium progression-free endurance pinch wide endurance a cardinal secondary endpoint.

We are conducting nan study successful collaboration pinch starring clinicians from nan Gynecologic Oncology Group successful nan United States and nan European Network of Gynecological Oncology Trial groups successful Europe. Our extremity successful Phase 3 is simply to replicate our affirmative Phase 2 results. Leading gynecological oncologists person told this that successful their view, relacorilant's imaginable benefit, improved endurance without accrued broadside effect burden, would represent an important aesculapian advance, and relacorilant positive nab-paclitaxel has nan imaginable to go a caller modular of attraction successful women pinch platinum-resistant ovarian cancer.

A 2nd system by which cortisol modulation whitethorn beryllium useful is by blocking an important tumor maturation pathway. Cortisol stimulation is simply a awesome logic why patients pinch prostate crab treated pinch nan wide prescribed androgen receptor antagonist, enzalutamide, yet acquisition resurgent disease. Deprived of androgen stimulation, their tumor move to cortisol activity to stimulate growth. Our presumption is that adding a cortisol modulator to androgen deprivation therapy will adjacent this tumor flight route. By midyear, our collaborators astatine nan University of Chicago scheme to statesman a randomized placebo-controlled Phase 2 proceedings of relacorilant positive enzalutamide successful patients pinch prostate crab earlier these patients person had an first prostatectomy.

A 3rd therapeutic system seeks to dainty tumors by enhancing nan body's immune response. Cortisol suppresses nan immune system, which whitethorn blunt nan effectiveness of cortisol -- of crab therapies intended to stimulate nan immune system. Our presumption is that adding a cortisol modulator to immunotherapies, specified arsenic checkpoint inhibitors, whitethorn heighten nan effectiveness of these therapies. We are conducting a Phase 1b proceedings of relacorilant positive nan PD-1 checkpoint inhibitor, pembrolizumab, Merck's supplier KEYTRUDA, successful patients pinch precocious adrenal crab whose tumors nutrient excess cortisol.

These patients suffer nan effects of adrenal crab and Cushing's syndrome, a usually quickly lethal combination. Pembrolizumab is seldom effective successful treating this shape of adrenal cancer. Our proceedings is evaluating whether relacorilant tin dainty these patients' Cushing's syndrome by reducing excess cortisol and by reversing cortisol-induced immune suppression, let pembrolizumab to execute its afloat crab sidesplitting effect. The superior endpoint of nan study is nonsubjective consequence rate, pinch secondary endpoints including progression-free survival, long of consequence and wide survival.

ALS, commonly known arsenic Lou Gehrig's disease, is simply a devastating unwellness pinch an urgent request for amended treatment. DAZALS, our 198-patient randomized double-blind placebo-controlled Phase 2 proceedings of dazucorilant successful patients pinch ALS, has begun enrolling patients. Dazucorilant is selective cortisol modulator and has shown awesome committedness successful animal models of ALS, improving centrifugal capacity and reducing neural inflammation and muscular atrophy. We are conducting this important study successful collaboration pinch TRICALS, nan starring ALS world consortium successful Europe.

Finally, I'll move to our programme successful NASH, a superior liver upset that affects millions of patients successful nan United States. Miricorilant, an oral medication, continues to show awesome committedness arsenic a curen for NASH. In our anterior NASH study, patients who received miricorilant exhibited ample accelerated reductions successful liver fat, but besides substantial, albeit transient, elevations of liver enzymes ALT and AST. The betterment successful liver fat successful these patients was greater and occurred overmuch much quickly than we had expected and is seldom seen complete immoderate play of treatment.

Our Phase 1b dose-finding study has identified a scope of doses, each substantially little than our originally-tested doses that look to origin important reductions successful liver fat without causing excessive liver irritation. We expect to stock results from this study by midyear and scheme to commencement a Phase 2 proceedings later this year.

In conclusion, we are highly optimistic astir nan maturation imaginable of our Cushing's syndrome business and are making important investments to amended nan screening and curen of these patients. In nan meantime, nan business continues to make important profits moreover aft backing each of our improvement programs. Our improvement programs proceed to make grounds validating our long-held belief that cortisol modulation has nan imaginable to dainty a wide scope of diseases.

Reducing cortisol activity is simply a straightforward and effective measurement to dainty Cushing's syndrome. It is besides clear that cortisol modulation tin connection important benefits for galore different superior disorders. Ovarian cancer, ALS and NASH are premier examples, but location will beryllium others. And successful summation to relacorilant, dazucorilant and miricorilant, we person galore different cortisol modulators successful our portfolio pinch imaginable -- perchance different and valuable objective attributes.

Corcept continues to beforehand crossed aggregate fronts. I convey our dedicated imaginative labor and loyal investors for making this possible.

I'll extremity present for questions.

Question-and-Answer Session


Thank you. At this time, we'll now beryllium conducting a question-and-answer session. [Operator Instructions] Thank you. Our first mobility is from nan statement of Matt Kaplan pinch Ladenburg Thalmann. Please proceed pinch your question.

Raymond Wu

Hi, guys. This is Raymond successful for Matt. Thanks for taking our mobility today. Congrats connected each nan progress. I conscionable wanted to inquire possibly connected nan ALS program. Specifically, benignant of what endpoints are you benignant of looking for successful nan study? Is it ALSFRS? And do you person immoderate circumstantial guidance from nan FDA if nan study could service arsenic nan ground for nan NDA pilot? Thanks. And I person 1 much question. Thanks.

Joseph Belanoff

Yes, [Matt] (ph). I wanted to reintroduce you to Bill Guyer, who is our Chief Development Officer. Bill will reside that question.

Bill Guyer

Great. Thank you. Appreciate nan question. So, again, DAZALS is for illustration Phase 2 [indiscernible] randomized double-blind, placebo-controlled trial, evaluating nan information and efficacy of dazucorilant successful patients pinch ALS. In this Phase 2 trial, we're going to look astatine 198 patients. The superior endpoint is simply a 24-week endpoint wherever we're going to beryllium evaluating those patients related to placebo. And we're going to look astatine nan efficacy and alteration from baseline for nan ALS functional standing scale, and that is simply a validated FDA endpoint, arsenic good arsenic different superior endpoints of information to measure nan information and efficacy -- aliases nan information of dazucorilant patients pinch ALS. And these are each validated endpoints pinch nan FDA. And if we complete this proceedings and we spot affirmative results, this could extremity up pinch an NDA.

Raymond Wu

So, admit nan color. And I guess, possibly conscionable for nan NASH program, what would you for illustration to spot from nan Phase 1b that is benignant of summation your assurance arsenic you participate nan Phase 2 study? And is it imaginable you would effort aggregate dosing regimens? Thanks.

Joseph Belanoff

Yes, that is nan goal. That's a awesome question. Since, this is an unfastened explanation trial, we're evaluating each nan various different dose. And our extremity has been to find nan correct dose aliases dosing regimen wherever we get a progressive fat nonaccomplishment complete clip pinch past nary ALT rises, and hopefully, we spot ALT improvements. We judge we've identified aggregate doses aliases dosing regimens to move into Phase 2, [where] (ph) we've seen that progressive fat nonaccomplishment complete clip and nary ALT rises. And truthful yes, our scheme is to move to Phase 2 successful nan 4th fourth of this year.

Raymond Wu

Okay. Appreciate that. Thanks. And I'll hop backmost successful nan queue.


Our adjacent mobility is from nan statement of Dennis Ding pinch Jefferies. Please proceed pinch your questions.

Dennis Ding

Hi, guys. Thanks for taking my questions. I conscionable person 1 astir nan guidelines business. Maybe talk astir nan pushes and pulls connected 2023 gross successful position of what tin get you towards nan precocious extremity versus nan debased extremity of your guidance? And possibly what are immoderate of nan different assumptions for you to get there? And arsenic a follow-up, possibly punctual america of nan seasonality rumor for Q1? And erstwhile mightiness we get amended visibility towards maturation acceleration successful 2023? Thank you.

Joseph Belanoff

Good, Dennis. Thank you for those questions. I want to again reintroduce you to Sean Maduck, who is nan President of nan Endocrinology division. And Sean is responsible for each of our business successful Cushing's syndrome. He'll beryllium gladsome to reply that question.

Sean Maduck

Hi, Dennis. Thank you for nan question. I deliberation your mobility was straight successful regards to benignant of nan range. Our scope is driven by nan number of patients that we adhd to our progressive diligent base. Our pricing is known and our mean dose and diligent retention rates person been unchangeable for galore years. So, wherever we autumn wrong nan scope is really driven by nan number of patients that we adhd to our base. And that's nan -- nan pushes and pulls are constant. It's really astir diligent pulls.

Dennis Ding

Right. But arsenic a follow-up possibly talk astir what tin you do aliases what are you guys doing successful position of initiatives that are ongoing that could thrust much diligent adds versus driving little diligent adds, appreciating that location is title retired there?

Sean Maduck

Yes. No, awesome question. So, look, I'll commencement by conscionable saying nan grounds is clear that location are much hypercortisolism patients retired location than we erstwhile thought. Physicians arsenic they go much knowledgeable astir screening and astir curen options that are disposable to them, much patients are going to beryllium diagnosed and treated. And our occupation arsenic an statement is to maximize our position touch points, proceed to raise illness awareness, amended connected screening and past amended connected nan benefits of Korlym. And nan evolving marketplace and our execution will really thrust that maturation into 2023 and beyond.

In position of initiatives, obviously, we person galore going on, but there's a mates I want to touch connected that I deliberation are very important for nan organization. The first is nan maturation of our income force. Last year, we had 45 objective specialists. We presently person 55, going to 60 successful nan adjacent mates of months. Physician consciousness of nan imaginable for Cushing's syndrome successful their diligent organization has accrued substantially. And we deliberation that, that illness consciousness and our streamlined training efforts will make our objective master much productive and for our newest objective master much productive much rapidly.

In position of nan 2nd initiative, which is much agelong term, is what was conscionable discussed and that's nan CATALYST study, nan Phase 4 Korlym study that we announced connected nan telephone today. It's not going to person an effect successful 2023. But it's nan largest prospective study that's ever been done successful this diligent population. As Joe stated, nan investigators are a very salient group of diabetologists and they are typical of a group of physicians that we person not historically called on. So, we judge that patients pinch difficult-to-control glucosuria and -- is simply a very rich | diligent organization for hypercortisolism. And I judge that this study will supply nan definitive prevalence and curen information needed to promote accrued screening and yet curen for this diligent group.

Dennis Ding

Got it. Thanks. And then, connected nan seasonality mobility for Q1 and maturation reacceleration towards nan backmost half of nan year?

Sean Maduck

Yes. So, we ever spot a deed successful nan first quarter, because of nan security reauthorizations and nan doughnut spread this twelvemonth has been nary different than immoderate other. But yes, I conjecture that's each I would adhd there. I don't cognize if there's thing else, Joe, you'd for illustration to add?

Joseph Belanoff

Dennis, I really do understand what you're asking about. Yes, arsenic Sean said, 1 of nan issues, not conscionable for Korlym, but for each medications, peculiarly orphan medications is that security companies make decisions get a reauthorization astatine nan opening of nan year. And that's evidently our occupation to spot if we tin move those -- thief those get turned astir arsenic quickly arsenic possible.

One of nan things I'll conscionable constituent retired is that it's been our accuracy from nan opening of nan company, but anytime a diligent gets a medicine for Cushing's syndrome, they get nan medicine sloppy of whether aliases not they person insurance. So, they proceed to get that medication. We ne'er time off a diligent disconnected of that medication. But getting them backmost connected paid security arsenic they person earlier is, successful immoderate sense, a maneuver that occurs each year. The quicker we do that, nan much it adds backmost to first 4th revenues. And then, erstwhile that's successful place, we're connected our ark for nan remainder of nan year.

Dennis Ding

Got it. Thank you.

Joseph Belanoff



Our adjacent mobility is from nan statement of Greg Fraser pinch Truist. Please proceed pinch your question.

Greg Fraser

Good afternoon, folks. Thanks for taking nan question. I sewage connected a small late, I apologize if you covered this already. But I was hoping you could remark connected nan protocol for nan CATALYST study and talk astir nan enrollment criteria, nan types of patients that will beryllium enrolled? And I'm funny astir it, it seems for illustration it's a study that -- obviously, it's rather ample and it's unprecedented. It seems for illustration a study that could perchance seizure patients that would different beryllium started connected Korlym. I cognize you're -- nan study will beryllium tally by docs that you're not calling on, it sounds like. But could this create a headwind for caller starts connected Korlym? Or americium I reasoning astir that nan incorrect way?

Joseph Belanoff

Hey, Greg, conscionable benignant of sorting this out, I want to springiness nan first portion to Bill, who is conducting nan study. So, Bill, tin you reply nan questions astir protocol.

Bill Guyer

So, CATALYST is an illustration that I deliberation we are showing our continued finance successful our compounds whether approved aliases investigational. And nan CATALYST, arsenic Sean had mentioned, is nan largest study of this kind. We're going to beryllium testing 2 really rigorous important points. One is to understand nan prevalence of hypercortisolism successful patients pinch difficult to power type 2 diabetes. And nan 2nd is to understand nan efficacy and information of Korlym successful these patients. And successful that diligent population, we're going to beryllium looking astatine 1,000 patients, successful wherever we're going to beryllium simply testing them for hypercortisolism pinch a elemental DST. And from there, we're going to beryllium past evaluating them for those who are affirmative will past beryllium selected to and person a prime to spell into nan 2nd portion of nan study, which is that curen portion of nan study.

As Sean had besides antecedently mentioned, we're moving pinch nan apical diabetologists. And while this is simply a ample study, these diabetologists person thousands of patients successful their practice. And person already identified galore of them who could meet nan inclusion and removal criteria of this study. And erstwhile you look astatine that inclusion and removal criteria, I'll springiness you a fewer points there. It's for big patients who are aged 18 to 80; those who are difficult to power diabetes, and that's defined simply by having a hemoglobin A1C of greater than 7.5, but little than 11.5; and are taking aggregate anti-hyperglycemic drugs; positive galore different things. But that's nan elemental creation of nan proceedings of really to get in. We judge by moving pinch these apical diabetologists, that we've designed a proceedings that's easy to enroll and we're connected way to commencement nan proceedings this -- adjacent period successful March and complete enrollment of this proceedings by nan extremity of this year.

Joseph Belanoff

Second portion of nan question, Greg, I'm going to springiness you to Sean.

Sean Maduck

Yes, convey you. And nan mobility was whether aliases not this study will effect perchance Korlym patients that would person been connected Korlym previously. The reply to that is no. Remember, this is simply a group of physicians not only are they not prescribing Korlym today, they're not moreover alert that these hypercortisolism patients beryllium successful their practice. They are treating these patients for their glucosuria and aren't aware. So, again, fto maine spell backmost to what I said a infinitesimal agone is conscionable that nan dream of this study is that, that will supply definitive prevalence successful curen information that will help, I'll say, sway and motivate this group of physicians who presently aren't treating aliases diagnosing.

Greg Fraser

That's very helpful. Thank you. Can you thief pinch really to deliberation astir nan maturation for SG&A and R&D this twelvemonth fixed nan investments that you're making connected nan commercialized broadside and besides connected nan objective broadside pinch nan CATALYST study?

Atabak Mokari

Sure. Greg, it's Atabak. I'll return that one. We person -- arsenic you know, we've historically been profitable and money to stay profitable. Our R&D expenses will summation arsenic we put successful our improvement programs and put successful programs to advance. And connected nan SG&A side, Sean discussed, continued investments we're making connected nan commercialized broadside there. So, you'll spot immoderate increases connected some sides there.

Greg Fraser

Got it. Okay. Last question, I conscionable wanted to inquire astir nan reason. You precocious had nan people action settlement. Curious astir what do you deliberation that mightiness mean if thing for nan different respective cases that are pending and besides for nan DOJ investigation? Thank you.

Joseph Belanoff


Charlie Robb

Yes, sure. So, conscionable nan little inheritance for those who haven't followed nan story. We've been successful this -- defending nan people action aliases purported people action suit since 2018, truthful rather immoderate time. And we -- complete time, arsenic we prepared for proceedings immoderate time successful nan distant future, we started disconnected assured successful our position and assured nan measurement we were doing business and we really only sewage much truthful arsenic things developed and arsenic we sewage complete [indiscernible] and astir and really reviewed each of nan imaginable evidence, we conscionable felt amended and better, but had nan opportunity precocious to settee it.

Because erstwhile I said that litigation is simply a distraction for much important matters, I really dream that everyone will really return that connected board. And ideate you had a time wherever you could walk your clip helping to move a supplier -- promising supplier campaigner done opportunity nan regulatory process aliases nan improvement process aliases you tin reappraisal a elephantine stack of emails from 3 years ago. And that's really nan quality betwixt settling and not settling. So, we chose to settee erstwhile we had an opportunity to do truthful connected advantageous terms.

Now what you're referring to are location are a fistful of benignant of associated civilian cases brought by plaintiff's rule firms benignant of astir nan country. They deliberation of these arsenic benignant of for illustration nan aviator food that onslaught -- connect themselves to sharks arsenic they move done nan water and effort to past disconnected nan nutrient that escapes from nan shark's mouth, that's what these lawsuits are like. And location are a fistful of them. We will dispose of those, 1 measurement aliases nan other, soon following. This is my expectation, but you ne'er -- 1 ne'er tin tell. But 1 point I tin opportunity for judge is that we're very, very assured successful our ineligible position pinch respect to them. So that's what Melucci securities people action portends for those ancillary cases.

I deliberation pinch respect to nan Department of Justice, course, I person nary thought what nan attorneys astatine nan Department of Justice are thinking. However, my knowing is that mostly speaking, nan Department of Justice does salary attraction to what happens arsenic you would ideate and benignant of not loosely related, but benignant of parallel civilian case. There's nary existent ineligible relationship betwixt nan Department of Justice action, our enquiry and nan Melucci people action, but they astir apt person their oculus connected it. And I don't cognize what they're reasoning because they don't and wouldn't show maine obviously. But I dream what they spot is what we see, which is simply a colony connected very advantageous position for nan company, which reflects nan benignant of nan assurance that we person successful nan measurement we do business. So, I dream that's nan belief they return distant from it and that colors their thinking, but of course, I cannot beryllium sure. And that enquiry proceeds and we'll conscionable person to spot really that plays out. We are very comfortable pinch respect to that enquiry also.

Greg Fraser

Great. Thanks for taking nan questions.


Our adjacent mobility is from nan statement of Arthur He pinch H.C. Wainwright. Please proceed pinch your question.

Arthur He

Hey, bully afternoon, gentlemen. This is Arthur connected for RK. Thanks for taking my question. So, first 1 is regarding nan Cushing business. Could you springiness america immoderate colour from your position location astir nan in-person objective interactions successful nan 2nd -- successful 4th fourth and besides what you spot successful nan first 4th this year?

Sean Maduck

Yes. No, acknowledgment for nan question. The mobility was what are nan in-person interactions successful nan 4th fourth of past twelvemonth and into this year. And successful nan past, we've discussed immoderate of nan obstacles that we faced because of COVID restrictions. And I'll show you that done nan 4th fourth and today, our in-person interactions are astatine astir 80% to 90% of pre-COVID levels. And we expect that to beryllium our caller baseline.

Some antecedently accessible physicians closed their doors to manufacture during nan pandemic. And I judge that immoderate of those will support restrictions successful spot permanently. So, we're utilizing replacement intends arsenic a institution to get successful beforehand of these physicians, whether it beryllium virtual meetings, integer trading and acquisition programs to effort to dress up immoderate of that spread and we've seen immoderate occurrence connected that.

Arthur He

Awesome. Thanks for nan color. And so, regarding nan ovarian crab study, could you springiness america much colour connected enrollment status? And truthful far, really galore sites are progressive for now?

Joseph Belanoff


Bill Guyer

Probably, I'll springiness you immoderate colour astir there. Well, I won't springiness you nonstop metrics connected it, because we don't really talk astir metrics, but I'll springiness you much color. Momentum has continued and is search to expectations for our ovarian crab Phase 3 trial. We expect to afloat enroll this proceedings by nan extremity of this year. And we judge that because we've sewage awesome collaborators for illustration nan GOG, which is nan Gynecological Oncology Group present successful nan United States and ENGOT, which is nan European Network of Gynecological Oncology Trial group.

Those groups are helping america get enrolled successful number of sites that we request and we find we request astir 125 sites globally. And of those sites, we've had an interrogator gathering successful nan United States and it was astir apt nan astir affirmative interrogator gathering we've ever had, wherever we talked astir each of nan information and nan investigators successful nan US came distant pinch nan excitement and nan use that they saw for relacorilant that could beryllium utilized successful operation pinch nab-paclitaxel.

Next week, we're having an interrogator gathering successful Europe pinch each of nan apical investigators, I deliberation there's astir 50 investigators attending that interrogator meeting, and we expect to spot nan aforesaid consequence of them seeing nan aforesaid -- and having nan aforesaid excitement of relacorilant positive nab-paclitaxel for women successful their practice.

So, we expect very affirmative things now and moving guardant to this trial.

Arthur He

Thanks truthful overmuch for nan color. My past mobility is again regarding your superior allocation strategy. With decent magnitude of cash, do you guys person immoderate thought connected nan superior allocation? Thanks.

Joseph Belanoff

Yes. Arthur, convey you, and convey you everyone for each of your questions. Look, we person a rate producing business arsenic we person for many, galore years. And so, nan breathtaking point is we person very bully things successful Corcept successful which to put it. Our objective programs are advancing. And arsenic you know, arsenic they win and spell into later-stage studies, nan programs go much costly to do. Of course, occurrence is simply a bully thing. We're very gladsome walk money successful that way.

And so, we're really ever taking a observant look astatine what -- wherever our money goes. It's not a concealed we get solicited each nan clip from earnest finance bankers who person things that they would for illustration america to put in. We, of course, return a observant look astatine that. But astatine this point, we really judge that nan champion point for america to put successful is nan business that we're doing successful Corcept. And so, we will proceed successful that way. Anything changes, I will fto you know, of course. Thank you.

And so, I want to convey each of you for tuning successful this quarter. Hopefully, large advancement successful nan adjacent 3 months, and look guardant to seeing you astatine that constituent successful time. So, bully remainder of nan week. Thank you.


This will reason today's conference. You whitethorn disconnect your lines astatine this time. Thank you for your participation.

Editor: Naga

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