Q3 2023 Corcept Therapeutics Inc Earnings Call
Good day and welcome to the course that Therapeutics conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask the question you'll need to press star one one on your telephone yoga and hear an automated message advising your hand is raised.
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Would now like to hand, the conference over to your speaker today.
Mccarty CFO. Please go ahead.
Hello, everyone.
Afternoon, and thank you for joining.
Today, we issued a press release announcing our financial results for the third quarter, providing a corporate update.
Copies available of course up Tucker.
Financial results will be available when we father Form 10-Q with us.
Today's call is being recorded replay will be available at the investors the best the best.
The purpose.
Statements during this call other than statements of historical fact.
Based on our plans and expectations that are subject to risk and uncertainty which might cause actual results.
Surely those such statements express or implied.
These forward looking statements are described in today's press release, the rest of uncertainty that may affect that are described in the press release and in our annual report.
Mmk or clothes.
Report a Form 10-Q.
Please refer to those documents for additional information.
Disclaim any attention for duty to update forward looking statements.
And a third order of 2023 is $123.6 million, an increase of 22% compared to the third quarter of last year.
We are racing or 2023 revenue guidance again to arrange a 400 7400.
$80 million upfront 455 $470 million.
Net income is $31.4 million or 28 cents per share in the third quarter.
<unk> per cent September 30th or 404, G $8 million, an increase of 51 and a half million dollars.
I will now turn the call over to Charlie.
The cheese business officer to provide a legal lucky alright.
Thanks <unk>.
March 2018, seven pharmaceuticals to prevent it from marketing engineering version of correlate in violation of our pets.
September 26th 28, the case went to trial.
District Court in Camden, New Jersey.
At trial yesterday to test against <unk>, both of which concerned me.
Ministration of <unk> <unk>.
Prescribed class of medications known as strong 638 inhibitors.
It does not and cannot dispute the validity of about.
Matter was settled in our favor by the first Grant review proceedings initiated and lost.
19.
Tevez only the best at trial was to argue that there generic product does not infringe either of our pass. This was the sole issue infringement on either patents before the court.
The trial over here is what will happen next.
As is customary each party has submitted a post trial brief, arguing and it should win give any applicable law and the facts and use the trial in about a week each submit a short reply brief responding to the arguments in the primary.
These documents are publicly available at the government's Piecer website, that's pacer P. A C E R.
When his breathing is complete the judge may or may not ask for oral argument.
<unk> will follow most likely from the first quarter of next year.
The timing is entirely for discretion.
Losing party.
Is entitled to appeal any adverse decision to the federal Circuit Court of Appeals, such an appeal will likely take.
Between 12, and 18 months to complete.
All in all this dispute will likely not be completely resolved until the second or third quarter of 2025.
Those of you have joined our prior calls <unk> and increasingly emphatic toes, but we are confident in our case.
I will say it again, we are confident in the strength of our case <unk>.
<unk> certain it's along the facts are on our side.
<unk>, even more sir.
The facts are on our side, we look forward to the judge's verdict.
I will now turn the call over to June Belanoff, our chief executive loss.
Thank you Charlie.
A strong results in the third quarter reflects physicians, increasing awareness of hyper cortisol or something in the army causes a.
Screening for the disease becomes more common more physicians prescribed and more patients received Carla.
It's changing behavior has led to another record high in our quarterly revenue.
We expect this trend in medical practice and with it our commercial growth to continue.
There's an excellent treatment for patients with Cushing syndrome, and there are many eligible patients who have yet to receive it.
Endocrinologist increasingly believe that there are considerably more patience with Cushing syndrome and was once as soon.
The results of our catalyst study likely provide further evidence to bolster disbelief, which one Charlie physicians to magenta by and provide effective treatment with a large group of patients use hyper realism currently goes on diagnosed.
This advanced medical thinking buoy or cushions syndrome business, we are raising our 20 twenty-three revenue guide range again.
It's time to 472 $480 million.
There are some very excited by the potential of our clinical development programs.
Inception, our research and development efforts built on the hypothesis cortisol modulation as powerful therapeutic mechanism in many serious disorders.
<unk> Terry compounds modulate resolved acts by binding to the glucocorticoid receptors or G. R.
The receptor, which is activated salt levels are high but.
I do not buy into the progesterone receptor and dental cause some of <unk> are approved product most serious off target effects.
Interestingly well all our compounds modulate court is all activity.
<unk> distinctive clinical effects.
Some cross the blood brain barrier, others do not.
Perform best in models of solid tumors, others or more coat and models of metabolic disease. Some appear to be tissue specific others have more global.
These diverse qualities allow us to study a wide variety of disorders. Currently we are conducting programs with three of our proprietary selectric cortisone modulators, <unk> and mirror Portland in ovarian adrenal and prostate cancer.
L S Nash and of course Christians Sandra <unk>.
Additional compounds are in earlier stages of development.
And poured a late stage clinical development milestones are approaching.
In 2024, we expect data from her race gradient catalyst rosella and dazzled study.
We also plan to submit an NDA for <unk> in Cushing syndrome, and your complete enrollment of our fees to be monarch study in patients with Nash. This is a very exciting time for core set.
We are evaluating reliquary left for the treatment of hyper cortisol isn't into phase three trials Grace and gradient roller.
<unk> is a selectric cortisol modulator.
<unk> at a cheese isn't back by competing with cortisol.
<unk> receptor.
Unlike or a limited does not bind you to progesterone receptor and so does not cause progesterone related side effects.
<unk>, let's face too efficacy and safety data work compelling patients experienced meaningful improvements in hypertension glucose control as well as in the other signs and symptoms Cushing syndrome.
There were no <unk> induced instances of endometrial ticketing or vaginal bleeding gestural related side effects and no drug induced hypokalemia.
Cause of Cortland discontinuation.
The phase two trial results were published in the journal Frontiers in Endocrinology and July 2021.
We are focused on finishing our grace trial and preparing R. N D, a which we plan to submit the second quarter of 2024.
<unk> has tremendous promise a treatment for patients with all etiologies seven Dodge discouraging syndrome, and we are eager to make it available.
Our second phase three trial in Hypercard has all this radiant studying relic or faxed in patients, whose Cushing syndrome is caused by an adrenal avenue or adrenal hyperplasia.
Patients with this <unk> syndrome, often experienced a less rapid decline, but their health outcomes are poor, including significantly higher risk of premature death.
Well, we do not expect R. N D. A in Cushing syndrome can depend on data from gradient. We do expect the studied you produce valuable data about the treatment of an ideology pushing syndrome that affects many patients.
Ah base for catalyst trial is the largest study ever conducted to establish the prevalence of hyper cortisol is empty and patients with difficult to control diabetes.
Many independent studies conducted over the last 15 years I've found that the prevalence of hyper cortisol ism in patients with type two diabetes substantially higher than in the general population.
Most prominent diabetologist in the United States <unk> helped us design and are participating in catalyst, which has the potential to become a landmark and guiding physicians understanding of <unk> syndrome.
Expect data from the prevalence space at the catalyst study early next year.
Alright ecology program is testing three anti cancer mechanisms first postulated by investigators at the University of Chicago and later confirm my other prominent researchers.
One mechanism is increasing a pop to assist the program cell death chemotherapy is meant to induce in solid tumors.
What is all works against the beneficial effects of chemotherapy by suppressing aproctous.
And are successful control phase two trial and women with platinum resistant ovarian cancer.
Addition of are selected cortisol modulator MELA cortland enhance the effect of chemotherapy like.
Likely by plunging cortisone anti apoptotic pet.
<unk> provided meaningful benefit too many of the women in our study.
While these women's disease have progressed on to our previous lines of treatment, including previous taxis relic or Raila coraline appeared to resent to touch their tumors to chemotherapy is beneficial effects.
Those who received <unk> intermittently.
Maybe for the day and the day after they receive paclitaxel.
It is statistically significant improvement in progression free survival and duration of response compared to the group will receive paclitaxel monotherapy.
Women in the intermittent umbrella Aurulent group also live longer than those the comparator arm with a P value that approached it just tickles significance, 29% of the patients who took intermittent <unk> for like two years. After study start versus only 14% of those you know paclitaxel alone.
Just as important woman, who received <unk> plus snap paclitaxel experienced no additional side effects burden compared to those who receive paclitaxel alone.
The results from this study were published in the journal of clinical oncology in June of this year results.
Also been featured in podium presentations at the 20th 21 2022 European Society for medical oncology asthma meetings, and that's a 2022 American society of clinical oncology <unk> annual meeting.
Rosella are pivotal multinational phase three trial and platinum resistant ovarian cancer is enrolling patients.
<unk> goal is simply to replicate are positive as to result in a larger group.
Rosella design closely tracks our phase two study.
Plan enrollment is 360 women randomize, one to one to receive either <unk> paclitaxel or not paclitaxel alone.
The primary endpoint is progression free survival with overall survival of cheese secondary endpoint.
We are conducting a study in collaboration needing furnishings.
Annika logical oncology group in the United States and the European network of Gynecological oncology trials group in Europe.
We expect data by the end of next year.
Leading gynecological oncologist told us that relic or alleged potential benefit.
<unk> progression free an overall survival without increased side effects burden constitute an important medical advance and it <unk> one plus not paclitaxel has it been.
Central to become a new standard of care and women with platinum resisted ovarian cancer.
A second mechanism by which cortisol modulation may prove useful despite blocking an important tumor growth pathway.
It is all stimulation is a major reason why patients with prostate cancer treated with a widely prescribed androgen receptor antagonist <unk> eventually experienced research and disease.
Deprived of androgen stimulation there are two or switch to court is all activated activity to stimulate grip.
Our hypothesis is that adding a cortisone modulator to androgen deprivation therapy will close this tumor escape route.
Collaborators at the University of Chicago have initiate a randomized placebo controlled phase two trial umbrella Cortland plus <unk> in patients with prostate cancer before the patience of pattern initial prostatectomy.
Third therapeutic mechanism seeks to treat tumors by enhancing the body's immune response <unk>.
Cortisol suppresses the immune system, which may blunt the effectiveness of cancer therapies intended to stimulate the immune system.
Our hypothesis is that adding a cortisol modulator to immunotherapies such as checkpoint inhibitors may enhance the effectiveness of those therapies. We're.
We're conducting a phase one trial umbrella, Oregon, plus the P. D. One checkpoint inhibitor pampered Elizabeth in patients with advanced adrenal cancer tumors produce excess cortisol Kimberley.
<unk>, there's a map is rarely effective as mono therapy and trading this form of cancer.
L S, commonly known as Luke Eric disease is a devastating illness with an urgent need for better treatment.
Dazzles are 198 patients randomized double blind placebo controlled phase two trial dashy correlate in patients with a L. S is enrolling patients briskly.
<unk> electric cortisol modulator shown great promise in animal models, and NLS, improving motor performance, and reducing neuro inflammation and muscular atrophy.
We are conducting this important study at sites in Europe, and the United States we.
We expect data by the end of next year.
Finally, I'll turn to a program in Nash serious liver disorder, Netflix millions of patients in the United States.
Mira coralline, an oral medication continues to demonstrate grapefruit <unk> as a treatment for Nash.
And our prior Nash study patients, who received 600 milligrams or 900 milligrams, a mirror correlate daily exhibited large rapid reductions in liver fat, but also substantial I'll be a transient elevations of the liver enzymes L. T N E S T.
Operator: Good day, and welcome to the Corcept Therapeutics Conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. So, with all your questions, please press star 11 again. Please be advised that today's conference is being recorded.
You're prudent in liver fat in these patients was greater than a card much more rapidly than we had expected and is rarely seen over any period of treatment.
Our phase one be dose fighting study found that patients who received just 100 milligrams a mirror correlate poorly twice a week for 12 weeks experienced in approximately 30 per cent reduction in liver fat and showed improvements in liver enzymes and mark or some liver disease.
Operator: I would now like to hand the conference over to your speaker today.
Atabak Mokari: Atabak Mokari, CFO, please go ahead. Well, everyone, good afternoon, and thank you for joining. Today, we issued a press release and I'll take our financial results for the third quarter and providing a corporate update. Copy is available of course, up.com. Our complete financial results will be available when we file our form 10Q with the SEC. Today's calls will be recorded. A replay will be available and the investors pass the events tab of our list.
These patients also experienced improvements in key metabolic elevated measures such as home I R. <unk> triglyceride and L. D L.
Importantly, miracle it was very well tolerated with no apparent G I side effects.
Will present these results at the upcoming E S L. The meeting in Boston.
We intend to build on a promising results are a phase one b study with 150 patient randomized double blind placebo controlled base to be monarch trial mirror correlate in patients with biopsy confirmed Nash patient.
Atabak Mokari: Statements during this call, other than statements of historical facts, are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties, which might cause actual results to defer internally from those such statements expressed or in place. These forward-looking statements are described in today's press release and the risks and uncertainties that may affect them are described in the press release and in our annual report on form 10Q or our quarterly reports on form 10Q.
Patients will receive either 100 milligrams a mirror for let's see about we're only twice weekly or 48 weeks. The primary endpoint as production laborer that Nash resolution and fibrosis improvement is key secondary endpoints.
Atabak Mokari: Please refer to those documents for additional information. We display many intentions or duty to update forward looking statements. Our revenue in the third quarter of 2023 was $123.6 million and increase of 22% compared to the third quarter last year. We are raising our 2023 revenue guidance again to arrange a $470 to $480 million up from $455 to $470 million. That income was $31.4 million or $28 per share in the third quarter. Our cash and investments at September 30th were $414.8 million and increase of $51.5 million in the quarter.
In conclusion, we are extremely optimistic about the future of course Yep, Patricia syndrome business has tremendous growth potential and generate substantial profits even as we invest in romancing development programs. We are again, raising our 2023 revenue guidance.
And anticipate growth for years to come.
Data from our large catalyst study will help physicians are better identify and treat patients who just difficult to control diabetes is caused by hydrocortisone lesser.
A population prescription syndrome too frequently goes Ah diagnosed.
Our development programs are generating increasing evidence the cortisol modulation has the potential to treat a wide range of diseases Cushing.
Cushing syndrome, ovarian cancer prostate cancer L. S and Nash are current examples there will be others.
Charlie Robb: I will now turn the call over to Charlie Robb for Chief Business Officer to provide a legal update. Charlie, thanks out of act.
We have many more proprietary select a cortisol modulators in our portfolio with potentially very different clinical atrophies, we would have answered the most promising of these to the clinic.
Charlie Robb: In March 2018, we sued Teva Pharmaceuticals to prevent it from marketing a generic version of Coralum in violation of our patents. This September 26th through 28th, the case went to trial, Federal District Court in Camden, New Jersey. At trial, we asserted two patents against Teva, both of which concerned the co-administration of Coralum for the commonly prescribed class of medications known as strong SIP-3A inhibitors. Teva does not and cannot dispute the validity of our patents.
In 2024, we accept expect data from our Grace gradient and catalyst studies interesting syndrome.
Pivotal rosella trial in ovarian cancer and are dazzled study in a L. S. We.
We expect to submit an N D a for <unk> Cushing syndrome.
Complete enrollment and our monarch days to be study in Nash.
Charlie Robb: That matter was settled in our favor by the post-grant review proceeding to have initiated and lost in 2019. Teva's only defense at trial was to argue that their generic product was not in French either of our patents. This was the sole issue in the management of either patent before the court.
As I have said it is an exciting time for course yet.
Before we take questions I Wanna take a moment to introduce the newest member of our executive team Monica Toledo. His first day at <unk> is today.
Monica is president of emerging markets.
Responsible for our newer therapeutic areas such as Allison Nash.
Charlie Robb: With trial over, here is what will happen next. As this customary, each party has submitted a post trial brief arguing that it should win given the applicable law and the facts deduced to trial, and about a week we will each submit a short reply brief responding to the arguments in the primary briefs. These documents are publicly available at the government's PASER website, that's PASER PACER. Once briefing is complete, the judge may or may not ask for oral arguments, the verdict will follow most likely in the first quarter of next year.
Mmm forward to her contributions Monica welcome to <unk>.
Let's proceed now to questions.
Thank you at this time will conduct a question and answer session. As a reminder to ask a question you will need to press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one one again, one moment for our first question.
Our first question comes from that Catherine.
Charlie Robb: Of course, the timing is entirely for expression. The losing party is entitled to appeal any adverse decision to the Federal Circuit Court of Appeals. Such an appeal will likely take between 12 and 18 months to complete.
Your line is open.
Hey, guys. Thanks for taking our questions and congrats on court.
Four.
Two 2002 pipeline a little bathroom specifically.
Charlie Robb: All in all, this dispute will likely not be completely resolved until the second or third quarter of 2025. Those of you who have joined our prior calls have heard me say an increasingly in spatic tones that we are confident in our case. I will say it again, we are confident in the strength of our case, supremely confident. We walked into court certain that the law and the facts are on our side. We left even more certain that the law and the facts are on our side. We look forward to the judges further.
<unk> 12 24.
Typically first can you talk a little bit more about the quote subtle and what <unk>, what we're looking to shop.
Oh, sorry.
Hey, Matt I apologize I really having trouble hearing your question. The line isn't so good is it possible to.
Either repeat it or a call back in.
A different way.
Joseph Belanoff: I will now turn the call over to Joe Bellinoff for a chief executive officer. Thank you, Charlie. Our strong results in the third quarter reflect positions increasing awareness of hypercoursalism and the harm it causes. A screening for the disease becomes more common, more positions prescribed, and more patients received. This changing behavior has led to another record high in our quarterly revenue. We expect this trend in medical practice and with it our commercial growth to continue.
Okay, So sorry yep.
Great.
Okay.
Matt question.
Can any better.
Yeah, we're just not hearing you I'm, sorry, ma'am okay.
Alright, dialed I get what I want.
<unk> <unk> bye bye again.
Excellent.
Sure.
One moment for our next question.
Joseph Belanoff: Coralum is an excellent treatment for patients with pushing syndrome and there are many eligible patients who have yet to receive it. Leading enter chronologist increasingly believe that there are considerably more patients with pushing syndrome than was once assumed. The results of our catalyst study will likely provide further evidence to bolster this belief, which will in turn lead positions to identify and provide effective treatment for the large group of patients whose hypercoursalism currently goes undiagnosed. This advance in medical thinking bully our cushions syndrome with business.
Our next question comes from David and someone with Piper Sandler Your line is open.
Hey, Thanks, I Hope you can hear me well.
Yeah.
<unk>. So a couple a couple of questions first can you provide specifics on the year over year volume growth for Korlym. That's number one and then I guess as part of that question. My understanding is his third quarter last year. It was.
<unk> with summit weaker so potentially we're looking at more favorable year over your calm. So just talk about the volume growth dynamics I know there was also pricing action earlier. This year just so just help us understand the what was volume what was price and then in terms of your comments on.
Joseph Belanoff: We are raising our 2023 revenue guy range again this time to $470 to $480 million. We're also very excited by the potential of our clinical development programs. Since infection, our research and development efforts have built on the hypothesis that cortisol modulation is a powerful therapeutic mechanism in many serious disorders. Our proprietary compounds modulate cortisol's effects by binding to the glucocorticoid receptor or GR. The receptor which is activated in cortisol levels are high.
Screening for hypercard of all of them in greater diagnoses and and treatments sorry.
What does that mean going forward I know you're not in a position of guide for 24, but is what we're seeing this the seeming inflection is that something that you're looking at a sustainable. Thanks.
Joseph Belanoff: We do not bind to the progesterone receptor and don't cause some of Coralums are approved product most serious off target effects. Interestingly, while all our compounds modulate cortisol activity, they produce distinct clinical effects. Some 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 events. These diverse qualities allow us to study a wide variety of disorders.
Okay. Thank you David I think we've got both of those questions at first wanted to introduce everyone reintroduce everyone to shaman Dooku is the president of our inner chronology Division and he can address your first question David. Thank you for the my questions on terms of your on your growth way of 22 per cent growth, 12% of that was driven by volume.
And 9% was was driven by price.
And I think your next question was service sustainability through through Q4, I mean, that's that's built into our range. We expected the grocery experienced in Q3, and we expect that wrote to continue from any quarters, we have more new physician that existing physicians prescribed hold on for for patients across the country and that's what drove.
Joseph Belanoff: Currently, we are conducting programs with three of our proprietary Selected Cortisol Modulators, Relo-Coreland, Dazzle-Coreland, and Mira-Coreland. In Ovarian, Adrenal, and Prostate Cancer, ALS, Nash, and of course, Cushing Syndrome. Additional compounds are in earlier stages of development.
Our increased guidance range, and the revenue milkshake, yeah, and and and David as a general answer to your second question I think what we're really seeing out of the world is the recognition that hydrocortisone ism is considerably more common and I think people want to see him. While it's not you know, they're not a million people with high <unk>, it's not the.
Joseph Belanoff: Important late-stage clinical development milestones are approaching. In 2024, we expect data from our race, gradient, catalyst, rozella, and dazzle study. We also plant the Sumitran NDA from Relo-Coreland Inc. Cushing Syndrome, and to complete enrollment of our Phase 2B Monarch Study in Patients with Nash. This is a very exciting time for Corset. We are evaluating Relo-Coreland for the treatment of hyper-cortisolism in two Phase 3 Trials, Grace and Gradient. Relo-Coreland is a Selected Cortisol Modulator.
Ultra rare disease that people once thought it was so we actually think that this expansion because.
Really screening is going to continue for a substantial period of time some of those patients will eventually fall to Kuala mothers will be treated in different ways, but the idea that this is an important medical therapeutic area. It has really been under address I think he's gaining acceleration.
That's helpful. If I may sneak in a quick follow up.
Joseph Belanoff: Like Coreland, it achieves its effect by competing with cortisol at the glucocorticoid receptor. Unlike Coreland, it does not bind to the progesterone receptor, and so does not cause progesterone-related side effects. Relo-Coreland's Phase 2 efficacy and safety data were compelling. Patients experienced meaningful improvements in hypertension and glucose control, as well as in the other signs and symptoms of Cushing Syndrome. There were no Relo-Coreland-induced instances of endometrial thickening or vaginal bleeding, progesterone-related side effects, and no drug-induced hypokalemia, a leading cause of Coreland's discontinuation.
In terms of the the new starts in just the growth or are you getting a good chunk of that growth from physicians, who are new to carlin treatment.
I'm Gonna pass you back to Sean Yeah. Thanks for your thank you for the questions were getting a a mix of both we have a new prescribers every single month every single order and we also have opposite positions that have previously prescribed column prescribed again for for many subsequent patient potentially so the short answer is yes across loafers.
Okay. That's helpful.
Thank you.
Okay.
Mmm moment for my next question.
Joseph Belanoff: The Phase 2 trial results were published in the journal Run Tears in Interchronology in July 2021. We are focused on finishing our Grace trial and preparing our NDA, which we planned to submit in the second quarter of 2024. Relo-Coreland has tremendous promise of treatment for patients with all etiologies of endogenous Cushing Syndrome, and we are eager to make it available. Our second Phase 3 trial in hyperchorusolism, Radiant, is studying Relo-Coreland's effects and patients whose Cushing Syndrome is caused by an adrenal adenoma for adrenal hyperplasia.
Our next question comes from that Catherine the Clattenburg. Your line is open.
Hi can you hear me now much better thank them at great great Great. Yeah. So you know first off congrats on a very strong quarter.
I just wanted to <unk>.
Just just wanted to focus a little bit on your your pipeline. Obviously 2024 is going to be a significant ear for you guys with with a lot of data Readouts and and just in terms of the near term Readouts can you give us a little bit more color on on the great study and what you're looking to show their primary endpoint.
Joseph Belanoff: Patients with this etiology of Cushing Syndrome often experience a less rapid decline, but their health outcomes are poor, including a significantly higher risk of premature death. While we do not expect our NDA in Cushing Syndrome to depend on data from Radiant, we do expect the study to produce valuable data about the treatment of etiology of Cushing Syndrome that affects many patients. Our Phase 4 catalyst trial is the largest study ever conducted to establish the prevalence of hyperchorusolism in patients with difficult to control diabetes.
And and and I guess, so should be potentially available in the first quarter, giving your your desire to file a an NDA and in and in the second quarter.
Thanks, Matt we'd be we heard all of that I I want to reintroduce the room to build guy or Bill runs all of our development programme, saying he can answer your specific questions great. Thanks, Matt Uhm. So let me remind you the grace trial as it is an ongoing study with two partners. It's basically two studies and won the first part of the open label part of the study murmur Uhm.
While you're waiting escalation of dosing from 100 milligrams up to the maximum dose of 400 milligrams and for those who meet response criteria for diabetes and hypertension, Oh, then get into the randomized withdrawal spending which is our primary appointment of that study.
Joseph Belanoff: Many independent studies conducted over the last 15 years have found that the prevalence of hyperchorusolism in patients with Type 2 diabetes is substantially higher than in the general population. The most prominent diabetologist in the United States helped us design and are participating in catalysts, which has the potential to become a landmark in guiding physicians understanding the patient. Syndrome.
Sure. It's your credit you know top line results and overall results. When there is material information within that first half of the year as we progressed towards R. M B a.
And do you think of a success. The success for this program would be treating patients with Cushings separate me seeing their cushy syndrome improve dramatically.
Joseph Belanoff: We expect data from the prevalent space of the catalyst study early next year. Our oncology program is testing three anti-cancer mechanisms, first post-related by investigators at the University of Chicago, and later confirmed by other prominent researchers. One mechanism is increasing apoptosis. The program's cell death in people in therapy is meant to induce insolent tumors. Cortisol works against the beneficial effect of chemotherapy by suppressing apoptosis. In our successful control phase two trial, and women with platinum-resistant ovarian cancer, the addition of our selective cortisol modulator, Rela Coraland, enhanced the effect of chemotherapy, likely by blending cortisol's anti-apoptotic effect.
We're really trading very sick patients Cushing syndrome, and the British trial, and we're all Carlin is a key and that treatment because of modifying the underlying disease in Cushing syndrome <unk>.
Success, when you look at the primary endpoint would be to evaluate those patients who respond to <unk> and when they go into the randomize withdrawal part a gift switch to either stay on <unk> switching to placebo somewhere evaluating the maintenance of the response of hypertension diabetes control or losing.
That response, and that's what we're going to be evaluated.
Okay.
Okay. That's that's very helpful.
Thank you Bill and then and then if you could.
Joseph Belanoff: Rela Coraland provided meaningful benefit to many of the women in our study. While these women's disease had progressed on two or more previous lines of treatment, including previous tax aims, Rela Coraland appeared to resensitize their tumors to chemotherapies beneficial effects. Those who received Rela Coraland intermittently, the day before, the day after, and the day after they received NAPACl attacks, so exhibited a statistically significant improvement in progression-free survival and duration of response compared to the group who received NAPACl attacks on monotherapy.
A little bit more color in terms of the data that you're expecting from the first part of the the study where you're taking a look at the catalyst in terms of the prevalence what should you what what should we be expecting as you know to the prevalence of results in the first quarter.
Sure. Thanks for that second question, you know the golf with a catalyst trial, it's pretty simple it's to replicate confirm the research from Pat in the past 15 years from Palpitations of coverage studies, showing the patients with difficult to control diabetes and I will have a positive dexamethasone dexamethasone suppression test them, what we call a D. S T.
Joseph Belanoff: Women in the intermittent Rela Coraland group also live longer than those of the comparator arm, with a p-value that approached statistical significance. 29% of the patients who took intermittent Rela Coraland were live two years after study start versus only 14% of those who took NAPACl attacks alone. Just as important, the women who received Rela Coraland plus NAPACl attacks experience no additional side effect burden compared to those who received NAPACl attacks alone.
With a prevalence in the range of approximately 10% to 20% and so right now we're well within that range from the capital of study we looked a complete that study.
By the end of this quarter and publicize that within the first quarter of next year.
Okay. Okay. Thank.
Thank you and I'll <unk> I'll jump back into the queue Netflix.
Thanks for that <unk>.
One moment Alright, My next question.
Our next question comes from Pro Ana Ruiz Leslie rank your line is open.
Joseph Belanoff: The results from this study were published in the Journal of Clinical Oncology in June of this year. Results have also been featured in podium presentations at the 2021 and 2022 European Society for Medical Oncology, Esmo meetings, and at the 2022 American Society of Clinical Oncology, Asco Annual Meeting. Rosela, our pivotal multinational phase 3 trial and platinum resistance ovarian cancer is enrolling patients. Rosela's goal is simply to replicate our positive phase 2 results in a larger group.
Hi, everyone. So.
So uhm I just question Hi, curious if you could update us about your Ah remind us about your I P expectations for <unk>, and then <unk> <unk>, which is curious if there are any implications that we should think about with a recent developments with your litigation with that there.
Joseph Belanoff: Rosela's design closely tracks our phase 2 study. Grand enrollment is 360 women, randomized one to one to receive either Rela Coraland plus NAPACl attacks or NAPACl attacks alone. The primary endpoint is progression-free survival with overall survival a key secondary endpoint. We are conducting the study in collaboration leading clinicians from the gynecological oncology group in the United States and the European network of gynecological oncology trials group in Europe.
Yeah, I'm Gonna pass you back to Charlie Rob, who really is responsible for all of our legal legal issues.
Yeah, Hi, Yeah, I I I guess I'll start taken into into two parts. Obviously are are because our I P. <unk>.
Protections for coral them and for relic correlate are really sure completely separate as far as the you know developments go with respect to correlate minutes as I mentioned, we have the trial at the end of September and I really want to stress that.
They're the patterns. We are defending that we are asserting against server really concern you know the the co administration of Harlem with it really broadly prescribed class of drugs that are important drugs for everyone. But also are commonly prescribed to patients Cushing syndrome. So the trial I think.
Joseph Belanoff: We expect data by the end of next year. Leading gynecological oncologists have told us that Rela Coraland's potential benefit improved progression-free and overall survival without increased side effect burden would constitute an important medical advance. And the Rela Coraland plus NAPACl attacks alone has the potential to become a new standard of care and women with platinum resisted ovarian cancer. A second mechanism by which cortisol modulation may prove useful is by blocking an important tumor growth pathway.
Went very well I think we made exactly the case, we needed to make and so in terms of commentary on our forum I P. I feel very good about it I think we <unk>. We we brought it out into court perform very well and you know I'm confident that is now in the hands of the judge that I P runs through 2030 <unk>.
Seven.
So those two patents and their will or maybe further patents that come out of our our work in the in the coming months and years with respect to Cortland, but right now we're protected through 2037 <unk>.
Joseph Belanoff: Cortisol stimulation is a major reason why patients with prostate cancer treated with a widely prescribed Androgen Receptor antagonist and Zalutamide eventually experienced resurgent disease. Deprived of Androgen stimulation, their tumors switch to cortisol activity to stimulate growth. Our hypothesis is that adding a cortisol modulator to Androgen Deprobation Therapy will close this tumor and escape root. Our collaborators at the University of Chicago have initiated a randomized placebo control based on trial and relic Portland plus Zalutamide in patients with prostate cancer before these patients have had an initial prostatectomy.
Is is you know a novel proprietary compounds. Unlike cortland, which is the active ingredient is a generic kind of pet so with respect to <unk>. We have patents on its composition of matter we have patterns for a variety of uses for the compound and for a sister compounds in a <unk>.
<unk> disorders, including the ones that were studying now and that protection runs past 24th. So we have I think extremely robust sort of multi layered sort of IP surrounding relic correlate in there will be more being developed as our investigations continue to make new invention.
Joseph Belanoff: A third therapeutic mechanism seeks to treat tumors by enhancing the body's immune response. Cortisol suppresses the immune system, which may blunt the effectiveness of cancer therapies intended to stimulate the immune system. Our hypothesis is that adding a cortisol modulator to immunotherapies such as checkpoint inhibitors may enhance the effectiveness of those therapies. We are conducting a phase 1v trial of relic Portland plus the PD1 checkpoint inhibitor, Pembrolysmab, in patients with advanced adrenal cancer whose tumors produce excess cortisol. Pembrolysmab is rarely effective as monotherapy in treating this form of adrenal cancer.
That are worthy of patent protection, So I hope that answers your question.
Yep that helps and then a second one I had just hanging on about the Grace tryout reading reading out soon I was just curious kid explain what the statistical pairing is for the end point, there and anything else, we should think about in the data.
Sure I'll I'll answer that question just Repowering is to look at the loss of response, we have 90 per cent power can protect a loss of responsive about 50 per cent difference between staying on <unk> and maintaining that response.
Joseph Belanoff: ALS commonly known as Lou Gehrig's disease is a devastating illness with an urgent need for better treatment. Dazzles are 198 patients randomized double-blind placebo controlled phase 2 trial of Dazzle Coralant in patients with ALS is enrolling patients briskly. Dazzle Coralant is a selective cortisol modulator that has shown great promise in animal models of ALS, improving motor performance and reducing neuroimplimation and muscular atrophy. We are conducting this important study at sites in Europe and the United States.
Or switching to placebo and losing their response.
Got it thanks for clarifying.
Joseph Belanoff: We expect data by the end of next year.
Sure.
One moment for our next question.
Our next question comes from Geneva chest. Your line is open.
And that's with a strong quarter I have a question on timing of the NDA submission second quarter a picture yeah. What do you want to wait for the gradient study by mid year to submit a a more fuller picture of the drug, but what's the rush there and what the F. D. A want us yet and the the other question is you know.
Joseph Belanoff: Finally, I'll turn to our program in Nash, a serious liver disorder that afflicts millions of patients in the United States. Miracoralant and oral medication continues to demonstrate great promise as a treatment for Nash. In our prior Nash study, patients who received 600 milligrams or 900 milligrams of Miracoralant daily exhibited large rapid reductions in liver fat but also substantial albeit transient elevations of the liver enzymes ALT and AST. The improvement in liver fat in these patients was greater and occurred much more rapidly than we had expected and has rarely seen over any period of treatment.
What are the drivers of call the franchise that keeps surprising you to the upside.
Okay two different questions, let let me Ah June give your first to Charlie for the N B a question.
So yeah.
Yeah, where there we.
We.
Think that the you know the most important demonstrator embraces safety in Africa. According to safety and efficacy in Cushing syndrome will be the greatest trial, we think that's sufficient support R. N D. A and so we're going to go with that because it will be ready and ready first ready to proceed and just continue to remove our.
Business forward as expeditiously as possible, we will be in a position just procedurally too <unk> additional data to the F. D. A is grading comes in if that's important too pressing the N. B a forward. So I think we retain some real optionality there without having to sacrifice the pace of our our timelines.
Joseph Belanoff: Our phase 1B dose-finding study found that patients who received just 100 milligrams of Miracoralant orally twice a week for 12 weeks experience an approximately 30% reduction of liver fat and showed improvements in liver enzymes and markers of liver disease. These patients also experienced improvements in key metabolic and lipid measures, such as Homa IR, Serum Triglycerides, and LDL. Importantly, Miracorallant was very well tolerated with no apparent GI side effects. We will present these results at the upcoming ASLV meeting in Boston.
Okay and.
And in June 2nd question would you please repeat that.
Yeah, Yeah. So what are the drivers of quality franchise that.
Surprising you to the upside you upgraded guidance I think two quarters in a row that I'm not mistaken yeah. Just curious what's that driver what's a driver of that.
Good no I don't understand the question that I'm Gonna pass back to what Sean Yeah June. Thank you for the question I mean these these results have been expected given this is where we have an investment in in in the past I've talked a little bit about some of the initiatives, we've been investing through our business and I thought I'd take a minute update everybody on on one of those are at now.
Joseph Belanoff: We intend to build on the promising results our phase 1B study with our 150 patient randomized, double-wide placebo-controlled phase 2B monarch trial, Miracorallant and patients with biopsy confirmed NASH. Patients will receive either 100 milligrams of Miracorallant or placebo-worldly, twice weekly, or 48 weeks. The primary endpoint is reduction liver fat with NASH resolution and fibrosis improvement as key secondary endpoints.
Before I do that though I want to highlight I think an important factor and that's it you have a very clear understanding now more so than in the past, but this is a multi billion dollar market opportunity and the investments that we made it through our business and we will continue to make our highly leveraged and we expect that they will <unk>.
After the opportunity and then yield higher rate of return.
Joseph Belanoff: In conclusion, we are extremely optimistic about the future of Corcept. Partition syndrome business has tremendous growth potential and generates substantial profits even as we invest in our advancing development programs. We are, again, raising our 2023 Revenue Guidance and anticipate growth for years to come. Data from our large catalyst study will help physicians better identify and treat patients whose difficulty-controlled diabetes is caused by hyperchlorosolism. A population with Cushing Syndrome, two frequently goes undiagnosed.
Affirmative and initiative standpoint, which is what you're talking about there's three that we've previously discussed on calls the first being the expansion of our sales force.
Is that gonna be increased effectiveness of a team and then a third being the initiation as a catalyst study, which which bill just spoke about.
In terms of a sales force and the size of that team are currently in the mid sixties, and we're going to need to ask uncle specialist around the country or target right. Now is about 75, but we're unlikely to stop there and we're gonna continue to have top sales talent as we find it and so you know part of the driver as a result is seeing that are put her existing clinical special.
Joseph Belanoff: Our development programs are generating increasing evidence the cortisol modulation as the potential to treat a wide range of diseases. Cushing Syndrome, Ovarian Cancer, Prostate Cancer, ALS and NASH are current examples. There will be others. We have many more proprietary selective cortisol modulators in our portfolio with potentially very different clinical attributes. We will advance the most promising of these to the clinic.
Some some of our Neurofibril specialists are starting to become more effective in Bruce Moore does.
The second initiative really hasn't been around my productivity driver and what we've done is the strength kindness to remind our training program with the goal to do what I just touched on make her existing people more effective in and make our newer hires more effective more quickly again, we're starting to see results from that effort. So the last pieces from the vestments standpoint.
As as catalyst Bill just talk through the the historical studies in 10% to 20% range, but what I want.
Joseph Belanoff: In 2024, we expect data from our grace, gradient, and catalyst studies in Cushing Syndrome, our pivotal Resella trial in Ovarian Cancer, and our Dazzle Study in ALS. We expect to submit an NDA for Relicoral and Cushing Syndrome and to complete enrollment in our Monoc Phase 2B Study in NASH. As I have said, it is an exciting time for Corcept.
Alright, one less thing to recognize is the catalyst is gonna be the largest perspective studying <unk> and I believe personally on others do as well that will be the definitive study for this patient population that's really gonna cement. These these findings from a study scheme before now if we can replicate that 10 to 20 per cent <unk>, there's gonna be an extremely meaningful.
Driver for business you have to recognize that there are still many physicians out there that think the prevalence in this patient population is near zero sore throat today has been driven by slowly educating physicians to both screen and look for this disease uhm, but we expect that with the addition of that data will see that continue to a ball. So in summary, we.
Joseph Belanoff: Before we take questions, I want to take a moment to introduce the newest member of our executive team, Monica Toledo, whose first day at Corcept is today. Monica, as president of emerging markets, will be responsible for our new therapeutic areas, such as ALS and NASH, we look forward to her contributions. Monica, welcome to Corcept.
A lot of different initiatives and <unk>, but we're at the very early stages of C. B the value from those many of them are just getting boring and we expect to see growth not just.
Operator: Let's proceed now to questions. Thank you. At this time, we'll conduct the question and answer session as a reminder to ask a question. You will need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. One moment for our first question.
Enjoy the rest of this year, but in into 2024 I'm young.
Excellent. Thank you so much I'm looking for <unk> called the catalyst.
Thank you Jim.
Alright, well listen thank you all for tuning in this quarter happy day after Halloween and we look forward to seeing you in a three months uhm.
Matthew Kaplan: Our first question comes from Matt Kaplan, with Latinburg, your line is open. Hey guys, thank you for taking the questions and graphs on a strong order. To delve into your pipeline a little bit, specifically, and which one we'd ask to have come up in 2024.
With really progress once again bye.
Bye bye.
Thank you for your participation in today's conference. This does conclude the program you may now disconnect.
Unknown Executive: I think specifically, first things, I'll go a little bit more about the group studies and the climate and what they're working with Jeff and that sort of study. Hey, Matt, I apologize. I really don't have a choice. I just want to double-fearing your question, why isn't it so good?
Mmm.
[music].
Operator: Is it possible to either repeat it or call back in? I don't know. Oh, sorry. Thanks. One moment for our next question.
David Amsellem: Our next question comes from David Amsellem with Piper Sandler. Your line is open. Hey, thanks. I hope you can hear me well. So couple of questions. First, can you provide specifics on the year over year volume growth for Coralem? That's number one. And then, I guess, as part of that question, my understanding is third quarter last year was somewhat weaker, so potentially we're looking at more favorable year over year comp. So just talk about the volume growth dynamics.
David Amsellem: I know there was also pricing action earlier this year. Just to just help us understand what was volume, what was price. And then, in terms of your comments on screening for hypercortisolism and greater diagnoses and treatment starts, what does that mean going forward? I know you're not in a position to guide for 24, but is what we're seeing this, this seeming inflection. Is that something that you're looking at as sustainable? Thanks. Okay. Thank you, David. I think we got bolder those questions.
Sean Maduck: I personally want to introduce everyone, reintroduce everyone to Shaman Duke who is the president of our inter-chronology division, and he can address your first question. David, thank you for the questions. On terms of year on year growth, we had 22% growth. 12% of that was driven by volume. And 9% was driven by price. And then your next question was sort of the sustainability through Q4. I mean, that's built into our range.
Sean Maduck: We expected the growth experience to Q3 and we expect that growth to continue for many quarters. We had more new positions and existing positions prescribed for patients across the country, and that's what drove our increased kinds range and the revenue is increasing. Yeah. And David, as a general answer to your second question, I think what we're really seeing out in the world is the recognition that hypercortisolism is considerably more common than I think people want to assume.
Sean Maduck: While it's not, you know, they're not a million people with hypercortisolism. It's not the ultra rare disease that people once thought it was. So we actually think that this expansion because of really screening is going to continue for a substantial period of time. Some of those patients will eventually fall to qualum, others will be treated in different ways. But the idea that this is an important medical therapeutic area that has really been under interest. I think it's being acceleration. That's helpful.
Sean Maduck: If I may speak in a quick follow up in terms of the new starts and just the growth, are you getting a good chunk of that growth from physicians who are new to Corlan treatment? I'm going to pass you back to Sean. Yeah, thanks you. Thank you for the questions. We're getting a mix about the new prescribers every single month, every single quarter and we also have positions that have previously prescribed Corlan prescribed again for many subsequent patients. So the short answer is yes across both groups. Thank you.
Operator: One moment for our next question.
Matthew Kaplan: Our next question comes from Matt Kaplan with Laddenburg. Your line is open. Hi, can you hear me now? Much better. Thank you, Matt. Great.
William Guyer: Yeah, so, you know, first off congrats on a very strong quarter. I just wanted to focus just wanted to focus a little bit on your your pipeline. Obviously 2024 is going to be a significant year for you guys with with a lot of data readouts. And just in terms of the near term readouts, can you give us a little bit more color on the great study and what you're looking to show their primary endpoint and I guess results should be potentially available in the first quarter given your your desire to file an NDA in the second quarter. Thanks, Matt. We heard all of that.
William Guyer: I want to reintroduce the group to Bill Guy or Bill runs all of our development programs and he can answer your specific question. Great. Thanks, Matt. So let me remind you the great trial is that is an ongoing study with two parts today. It's basically two studies in one. The first part is the open label part of the study where we're evaluating escalation of dosing from 100 milligrams up to the maximum dose of 400 milligrams.
William Guyer: And for those who meet response criteria for diabetes and or hypertension will both then get into the randomized withdrawal study, which is our primary endpoint of that study. We're going to share, you know, top line results and overall results when there is material information within that first half of year as we progress toward their NDA. When you think of a success, you know, the success for this program would be treating patients with cushions and we're seeing their cushions and improve dramatically.
William Guyer: I mean, we're really treating very sick patients with cushions and drum in the brace trial and relic Portland is a key in that treatment because it modifies the underlying disease of cushions and drum. A success when you look at the primary endpoint would be to evaluate those patients who respond to relic Portland, and when they go into the randomized withdrawal part, they get switched to either staying on relic Portland or switching to placebo. And so we're evaluating the maintenance of their response, the hypertension or diabetes control or losing that response. And that's what we're going to be evaluating. Okay. That's very helpful. Thank you, Bill.
William Guyer: And then, and then if you could a little bit more color in terms of the data that you're expecting from the first part of the study where you're taking a look at the catalyst in terms of the prevalence, what should you, what should we be expecting as you announce the prevalence results? in the first quarter. Sure, thank you for that second question. You know, the goal for the catalyst trial is pretty simple.
William Guyer: It's to replicate and confirm the research from the past 15 years from publications of cohort studies showing the patients with difficult control diabetes. You know, we'll have a positive dexamethasone suppression test of what we call a DST with a prevalence in the range of approximately 10 to 20 percent. And so right now, we're well within that range for the catalyst study. We look to complete that study by the end of this quarter and publicize that within the first quarter of the next year. Okay, okay. Thank you. And I'll jump back in. Thank you now. Thanks for that. Thank you.
Operator: For the moment, our next question.
Charlie Robb: Our next question comes from Rowanna Ruiz with the link. Your line is open. Hi, afternoon, everyone. So first question. Hi, curious if you could update us about your or remind us about your IP expectations for Coralim and Relo Coralin and endogenous cushions. Just with this curious if there are any implications that we should think about with the recent developments with your litigation with Teva there. Yeah, I'm going to pass you back to Charlie Robb who really is responsible for all of our legal legal education.
Charlie Robb: Yeah. Hi. Yeah, I guess I'll sort of take it into two parts, obviously, our because our IP protections for Coralim and Relo Coralin are really completely separate. As far as the developments go with respect to Coralim, as you guys I mentioned, we had the trial at the end of September. And I really want to stress that there the patents we are defending that we are starting against Teva, really concerned, you know, the co-administration of Coralim with a really broadly prescribed class of drugs, that are important drugs for everyone but also are commonly prescribed to patients with pushing syndrome.
Charlie Robb: So the trial I think went very well. I think we made exactly the case we needed to make. And so in terms of commentary on our Coralim IP, I feel very good about it. I think we've, we brought it out into court to perform very well. And, you know, I'm confident now in the hands of the judge, that IP runs through 2037. So those two patents and there will, or maybe further patents that come out of our work in the coming months and years with respect to Coralim.
Charlie Robb: But right now, we're protected through 2037. Now Relo Coralin is a, you know, a novel proprietary compound unlike Coralim, which is an active ingredient as a generic compound. And so with respect to Relo Coralin, we have patents on its composition of matter. We have patents for a variety of uses for the compound and for its sister compounds in a range of disorders, including the ones that we're studying now. And that protection runs past 2040.
Charlie Robb: So we have, I think, extremely robust sort of multi-layered IP surrounding Relo Coralin and there will be more being developed as our investigations continue to, you know, making new inventions that are worthy of patent protection. So I hope that answers your question. Yep, that helps.
William Guyer: And then a second one I had just talking on about the grace trial, reading out, reading out soon. I was just curious if you could explain what the statistical powering is for the end point there and anything else we should think about in the data. Sure, I'll answer that question. So the statistical powering is to look at the loss of response. We have 90% power to protect a loss of response of about a 50% difference between staying on relic orland and maintaining that response or switching to placebo and losing their response. Got it. Thanks for clarifying. One moment for our next question.
Joon Lee: Our next question comes from Joon Lee with truth. Your line is open. And that's for the strong quarter.
Unknown Executive: I have a question on timing of the NDA submission and second quarter of next year. You know, wouldn't you want to wait for the gradient study by mid-year to submit more full a picture of the drug? What's the rush there? And would the FDA want to see it? And the other question is, you know, one of the drivers of call and franchise that keeps surprising you to the upside.
Charlie Robb: Okay, two different questions. Let me, Joon, give you a first to Charlie for the NDA question. So, um, yeah, we're the, we think that the, you know, the most important demonstrator of increases safety and efficacy of relic orland safety and efficacy in Christian syndrome will be the grace trial. We think that's efficient support our NDA. And so we're going to go with that because it will be ready. And ready first, ready to proceed and just continue to remove our business forward as expeditiously as possible.
Charlie Robb: We will be in a position just procedurally to, um, submitting additional data to the FDA as grading comes in if that's important to pressing the NDA forward. So I think we retain some real optionality there without having this factor twice the pace of our, our timelines.
Sean Maduck: Okay. And, and, and Joon, um, second question, would you please repeat that? Yeah, yeah. So, one of the drivers of call and franchise that keeps surprising you to the upside. You upgraded guidance. I think two quarters in a row. I'm not mistaken. Yeah. So just curious, uh, what's, uh, driver, what's the driver of that? Good. No, I don't understand the question. I'm going to pass you back to what Sean. Yeah, Joon.
Sean Maduck: Thank you for the question. I mean, these, these results have been expected, given this is where we have been investing. And in the past, I've talked a little bit about some of the initiatives we've been investing in through our business. And I thought I'd take a minute to update everybody on where those are at. Now, before I do that, though, I want to highlight an important fact. And that's that we have a very clear understanding now more so than in the past that this is a multi-billion dollar market opportunity. And the investment said we have made through our business and we will continue to make our highly leveraged. And we expect that they will both capture the opportunity and then yield a higher aid return.
Sean Maduck: So from an initiative standpoint, which is what we're talking about, there's three that we previously discussed on calls. The first being the expansion of our sales force. The second is the increased effectiveness of the team. And then the third being the initiation of the catalyst state, which, which Bill just spoke about. Now, in terms of the sales force, uh, and the size of that team, we're currently in the mid-60s. And we are continuing to add clinical specialists throughout the country.
Sean Maduck: Our target right now is about 75, but we're unlikely to stop there. And we're going to continue to add top sales talent as we find it. And so, you know, part of the driver's result is seeing that are both our existing clinical specialists and some of our newer clinical specialists are starting to become more effective and produce more. The second initiative really has been around that productivity driver. And what we've done is strengthen its Reminer training program with the goal to do what I just touched on, make our existing people more effective and make our newer hires more effective more quickly.
Sean Maduck: And again, we're starting to see results from that effort. So the last piece is from the vestment standpoint is catalyst. Bill just talked through the historical studies and the 10 to 20 percent range. But what I want. I want to listen to to recognize that catalyst is going to be the largest prospective study I would have done for this group and I believe personally and others do as well that it will be the definitive study for this patient population.
Sean Maduck: It's really going to cement these findings from the studies that came before it. Now, if we can replicate that 10 to 20% prevalence rate is going to be an extremely meaningful driver for business. You have to recognize that there are still many physicians out there that think the prevalence in this patient population is near zero. So our growth today has been driven by slowly educating physicians to both screen and look for this disease, but we expect that with the addition of that data, we'll see that continue to evolve.
Sean Maduck: So in summary, we have a lot of different initiatives of play, but we're at the very early early stages of seeing the value from those many of them are just getting going and we expect to see growth not just through the rest of this year, but into 2024 beyond.
Operator: Excellent. Thank you so much. I'm looking forward to you all there. Thank you, Jim.
Operator: All right. Well, listen, thank you all for tuning in this quarter. Happy day after Halloween and we look forward to seeing you in three months with really progress once again.
Operator: Bye bye.
Operator: Thank you for your participation in today's conference. This does conclude the program. You may not disconnect.
Operator: Thank you.