Corcept Therapeutics Inc (CORT) 2021 Q2 法說會逐字稿

Good day. Thank you for standing by, and welcome to Corcept Therapeutics Conference Call. (Operator Instructions) I would now like to hand the conference over to your speaker today, Mr. Atabak Mokari. The floor is yours.

Thank you. Good afternoon, and thank you for joining us. I'm Atabak Mokari, Corcept's Chief Financial Officer. Today, we issued a press release announcing our financial results for the second quarter and providing a corporate update. A copy is available at corcept.com. Our complete financial results will be available when we file our Form 10-Q with the SEC. Today's call is being recorded. A replay will be available on the Investors past Events tab of our website. Statements during this call other than statements of historical fact are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties, which might cause actual results to differ materially from those such statements express or imply.

These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals during the COVID-19 pandemic and thereafter, including our ability to generate revenue and cash reserves sufficient to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym, initiation or outcoming of litigation, our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym, and the risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversights and other requirements, and the impact of the COVID -9 pandemic on our employees, consultants and vendors as well as on physicians, patients, insurers, regulators and the practice of medicine general. These and other risks are set forth in our SEC filings which are available at our website and the SEC's website.

Relacorilant, exicorilant, miricorilant, CORT113176, and our other selective cortisol modulators for the treatment of patients with solid tumors, liver disease, hypercortisolism, anti-psychotic-induced weight gain, amyotrophic lateral sclerosis or ALS, and other disorders; the progress, enrollment, timing, design, and results of our clinical trials; our revenue guidance, cash flow and expected growth; our stock repurchase program and its intended funding sources; the impact of the COVID-19 pandemic on our commercial operations, financial performance, clinical development programs, physicians, payers and patients and expectations regarding our financial performance and clinical development programs after the COVID-19 pandemic gets controlled.

The timing, costs, and outcome of litigation, including our lawsuits against Teva, and Hikma Pharmaceuticals have us appeal of its defeat in the post-grant review brought before the Patent Trial and Appeals Board known as PTAB, and our settlement of litigation with Sun Pharmaceuticals as well as the scope and protective power of our intellectual property and the benefits of orphan drug designation. We disclaim any intention or duty to update forward-looking statements.

Our revenue in the second quarter was $91.6 million compared to $88.6 million in the second quarter of 2020 and $79.4 million in the first quarter of 2021. Second quarter 2021 GAAP net income was $26.5 million compared to $28.3 million in the same period last year. Excluding noncash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in the second quarter was $38.2 million, compared to $39.7 million in the second quarter of 2020.

We have reiterated our revenue guidance of $355 million to $385 million, which assumes that pandemic related restrictions will continue to ease in the second half of this year. Our cash and investments totaled $471.6 million at June 30, an increase of $16.8 million from March 31. In the second quarter of this year, we repurchased 1.5 million shares of our common stock, 1.4 million shares pursuant to our stock repurchase program and about 150,000 shares in connection with the net exercise of employee stock options. The total cost of these repurchases was $30.8 million. Under the current terms of our stock repurchase program, $127.6 million remains available for the repurchase of shares. We will determine the timing and size of future repurchases, if any, based on market conditions, our stock price and other factors. And now, Charlie Robb, our Chief Business Officer, will provide a legal update. Charlie?

Thanks, Atabak. I'll briefly review our litigation against generic manufacturers, Teva, Hikma and Sun Pharmaceuticals. In March 2018, we sued Teva in Federal District Court to prevent it from marketing a generic version of Korlym and violation of our patents. Originally, trial was set to start in February of this year. Last quarter, the court vacated this stage in order to parties to be ready for trial in March. That trial ready date was also vacated. A new trial date has not been set.

In April, we asked the court's permission to file for summary judgment based on Teva's alleged infringement of our 214 patent. The court granted permission and Teva responded by filing its own summary judgement motion with respect to the same pattern. Summary judgment is a procedure whereby courts can decide the case without holding a trial. We believe that believe the court has all it needs with respect to the Q1 core patents and decide the case in our favor. Having lots of action before the PTAB, so we can no longer challenge the 214 patents validity in the district court case. So we can only argue that this product is proposed product will not infringe, position we believe has no legal or factual support.

Briefing in this matter is complete, we await the court's decision. The court grants our motion, we will have won the case. Teva would be barred from marketing generic Korlym until 2037 when the 214 patent expires. Teva could appeal the courts, although the district courts bar would remain in place until the appeal is resolved, a process that usually takes 12 to 18 months. The court rules in Teva's favor, we will proceed to trial late this year or sometime next year. There is a present no timetable for the court summary judgment rule, no trial date and no schedule for any trial related activities. In parallel with the District court action, Teva has, as expected, petitioned the Federal Circuit Court of appeals to reverse its PTAB loss. Briefing in this matter is also complete. A federal circuit decision is likely in the first or second quarter of 2022.

Earlier this year, we received notice of another ANDA filer, Hikma Pharmaceuticals. On March 12, we do take in the same federal district court that is adjudicating our case against Teva. The court is inter to schedule for the case that sets a fact discovery deadline of July 1, 2022, next year. Finally, Sun Pharmaceuticals is also seeking to market generic court. In June 2019, we sued Sun to prevent it from doing so. As we announced a few weeks ago, we have settled this case. The settlement agreement allows Sun to begin selling a generic version of Korlym beginning October 1, 2034, more than 14 years from now or earlier under circumstances customary for settlements of this type.

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

Thank you, Charlie. We are pleased with our commercial results in the second quarter. Pandemic related restrictions made it very difficult for our business to grow because those restrictions made it hard for physicians to provide and patients to receive optimal care. Diagnosing and treating patients with a complex disease such as Cushing's syndrome, requires frequent in person contact. For much of the pandemic, this level of contact was for many patients and physicians impossible. We are encouraged that in the second quarter, particularly at the end of the quarter, our commercial activity increased notably throughout the country, clear indications that the country is opening more broadly. It is also heartening that patients recently introduced to Korlym have titrated towards their ideal dose more quickly than occurred in the last year as many physicians are now seeing and testing their patients with pre pandemic frequency.

Looking beyond this year, we expect that our Korlym business will continue to grow. Leading endocrinologists increasingly believe that there are many more patients with hypercortisolism that was once believed. Korlym is an excellent treatment for many of these patients. The foundation of our business and effective life-saving medication promoted by a dedicated commercial team that puts the interest of patients first remains rock solid. We are also excited by the potential of our clinical development programs, which have recently made important advances. From the beginning, our research and development efforts have built on the hypothesis that cortisol modulation is a powerful therapeutic mechanism in many serious disorders.

Korlym's commercial success is provided and will continue to provide the funds needed to enlarge our portfolio of proprietary selective cortisol modulators and to develop the most promising. Many of these selected cortisol modulators are attractive candidates for development. Like Korlym, they bind strongly to the glucocorticoid receptor or GR. unlike Korlym, they have no affinity for the progesterone receptor and so don't cause some of Korlym's most serious off-target effects. Beyond sharing the qualities of strong cortisol modulation and not perturbing the progesterone receptor, pre-clinical testing have shown that our molecules behave differently from one another in important ways. Some cross the blood-brain barrier, others do not. Some perform best in models of solid tumors, others are more potent models, metabolic disease. Some appear to be tissue specific, while others have more systemic effects. Their diverse qualities have allowed us to initiate clinical trials in a wide variety of disorders, including ovarian, adrenal and prostate cancer, antipsychotic-induced weight gain and nonalcoholic steatohepatitis or NASH, and of course of Cushing's syndrome.

We are now planning a Phase 2 trial in patients with ALS, another devastating disease with no particularly effective treatment options. And we have additional compounds in Phase 1 and the latter stages of pre-clinical development. Our oncology program is testing 3 mechanisms: first postulated by investigators at the University of Chicago and confirmed by other prominent researchers. One mechanism is increasing apoptosis. Apoptosis is the program cell death chemotherapy is meant to induce. Cortisol suppresses apoptosis and our successful trial in women with advanced ovarian cancer, addition of the selected cortisol modulator, relacorilant, enhance the effect of chemotherapy by blending cortisol anti-apoptotic effect.

Based on statistically significant and clinically meaningful Phase 2 results, we are excited to initiate a Phase 3 pivotal trial in patients with platinum-resistant ovarian cancer in the first quarter of 2022. As a reminder, our Phase 2 trial is a controlled multicenter study of 178 women with platinum-resistant ovarian cancer, who are randomized to 1 of 3 treatment arms. In addition to nab-paclitaxel, 60 women received 150 milligrams of relacorilant intermittent play, meaning they receive relacorilant on the day before, the day of and the day after they receive nab-paclitaxel. And 58 women received a lower daily relacorilant dose of 100 milligrams per day. 60 women received nab-paclitaxel alone. The trial's primary endpoint was progression-free survival, or PFS.

The women who participated in our study were very ill, all in experienced disease progression despite prior lines of therapy, the median number of prior treatments was 3. It is clear that relacorilant benefited many of these women. Those who received relacorilant intermittently exhibited a statistically significant improvement in PFS compared to the group that received nab-paclitaxel monotherapy. The hazard ratio was 0.66 with a p-value of 0.038. Their median PFS was 5.6 months, 1 point 8 months longer than the nab-paclitaxel monotherapies group, which was 3.8 months.

Safety and tolerability data for the 2 groups were comparable. The women who received a lower dose of relacorilant every day also saw their disease progress more slowly. Inter median PFS was 1.5 months longer than the nab-paclitaxel monotherapy group. Their hazard ratio was 0.83, although this result was not statistically significant. We believe, and more importantly, our investigators believe that these results 1.8 month increase in PFS without an increase in side effects are clinically meaningful. We are honored that our Phase 2 trial results have been accepted for a proper paper oral presentation at the European Society for Medical Oncology, ESMO meeting in September in Paris.

Finally, we anticipate the overall survival results from this study will be available later this year. A second mechanism by which cortisol modulation may prove useful is by blocking an important tumor growth pathway. Horizon stimulation is a major reason, patients treated with a widely prescribed androgen receptor antagonist enzalutamide, eventually experienced resurgent disease, deprivation of androgen stimulation -- sorry, the private androgen stimulation, their tumor switched to cortisol activity to stimulate growth.

Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route. We are conducting the dose-finding study of our selective cortisol modulator, exicorilant, combined with enzalutamide combined with castration-resistant prostate cancer and expect to produce clarifying data next quarter. A third oncologic mechanism recognizes cortisol's ability to reduce inflammation and suppress the immune system. Thus they are often beneficial in healthy people, but in patients with solid tumors diminish the effectiveness of immunotherapy. We are conducting an open-label Phase 1b trial of relacorilant plus the PD-1 checkpoint inhibitor, pembrolizumab, Merck's drug Keytruda, in patients with advanced adrenal cancer whose tumors produce excess cortisol.

These patients suffer the effects of adrenal cancer and Cushing's syndrome, are unusually quickly lethal combination. Pembrolizumab is rarely effective as monotherapy in these patients. We believe that these patients' cortisol excess may be countering the intended effects of pembrolizumab, which is to stimulate the immune system. Our trial is evaluating with relacorilant and treat these patients' Cushing's syndrome by reducing excess cortisol activity and by reversing cortisol induced immune suppression, allow pembrolizumab to achieve its full cancer killing effect. We plan to enroll 20 patients at 5 sites in the United States.

The primary endpoint is subject to response rate with secondary endpoints, including progression-free survival, duration of response and overall survival.

I'll now turn to our programs in metabolic disease and the recent findings of our proprietary selective cortisol modulator, miricorilant in patients with NASH, a serious liver disorder. We have served that patients who receive miricorilant in our Phase 2a trial exhibited large rapid reductions in liver fat, but also substantial 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.

Reductions in liver fat of the magnitude that we observed in our study are rarely seen over any period of treatment. As a reminder, we have powered the trial to detect a 30% reduction after 12 weeks of treatment. The patients in our study exhibited reductions ranging from 39% to 74% after receiving miricorilant for just a month. It may be that the rapidity of miricorilant's fat reducing effect caused ALT and AST to rise. One way the liver sheds fat is by metabolizing it into patty acid, which in excessive amounts irritate the liver. Interestingly, levels of serum lipids in these patients did not increase with treatment, providing further support for the metabolism hypothesis. Our upcoming Phase 1b dose-finding trial in patients with presumed NASH will evaluate if there is a dosing region of miricorilant that can produce such significant reductions in liver fat without causing liver irritation.

We're also evaluating miricorilant as a potential treatment for patients with another serious and widespread disorder, antipsychotic-induced weight gain. In the United States, 6 million people take antipsychotic medications such as olanzapine and risperidone to treat illnesses such as schizophrenia, bipolar disorder and depression. While these drugs are very effective, the exact steep price in the form of rapid and sustained weight gain, cardiovascular disease and other metabolic disturbances. Patients can gain 1 pound per week in the first 10 weeks that they take these medications and their life expectancies decreased on average by 20 years due in part to increased cardiovascular events such as heart attacks and strokes.

We are conducting 2 double-blind placebo-controlled Phase 2 trial of miricorilant in patients with this disorder, gratitude and gratitude 2. These trials seek to build on the positive data from our study of miricorilant in healthy subjects. Last year, we completed a Phase 1b trial in which 96 healthy patient subjects received olanzapine at either 600 milligrams of miricorilant, 900 milligrams of miricorilant or placebo for 14 days. Subject to receive miricorilant gained significantly less weight than those who received placebo. They also exhibited a smaller increase in triglycerides and in ALT and AST. Paper describing these results will be published in the Journal of Clinical psychopharmacology this quarter.

The Gratitude trial is evaluating with a miricorilant can reverse recent antipsychotic-induced weight gain. 100 patients with schizophrenia or bipolar disorder will receive, in addition to their established dose of antipsychotic medication, either 600 milligrams of miricorilant or placebo for 12 weeks. Gratitude is being conducted in 30 centers in the United States. Our Gratitude 2 study is testing miricorilant as a treatment for long-standing antipsychotic-induced weight gain. 150 patients with schizophrenia will receive in addition to their established dose of antipsychotic medication, either 600 milligrams or 900 milligrams of miricorilant or placebo for 26 weeks. Gratitude 2 is being conducted 25 centers in the United States. The primary endpoint in both studies is reduction in body weight. Other important measures of metabolic activity will also be examined. We expect to complete enrollment in gratitude 2 by the end of this year and in gratitude in mid-2022.

As most of you know, relacorilant is our planned successor to Korlym for the treatment of hypercortisolism. We are evaluating it in 2 Phase 3 trials, race and gradients. To repeat what I said earlier, relacorilant is a selective cortisol modulator. Like Korlym achieves its effect by competing with cortisol at the glucocorticoid receptor. Unlike Korlym, it does not bind to the progesterone receptor, PR for short. It is not the abortion pill, and it does not cause other PR related side effects, including endometrial thickening and vaginal bleeding. By different mechanism, relacorilant also does not appear to cause hypokalemia low potassium, a serious side effect experienced by 44% of patients in Korlym's pivotal trial. Korlym induced hypokalemia is a leading cause of Korlym discontinuation.

Our GRACE trial has a planned enrollment of 130 patients with any etiology of Cushing's syndrome at sites in the United States, Canada, Europe and Israel. Relacorilant's Phase 2 efficacy and safety data were strong. The trial results were recently published in frontiers in endocrinology. Patients experienced meaningful improvements in hypertension and glucose control as well as in a variety of other science and symptoms of Cushing's syndrome. There were no relacorilant induced instances of endometrial thicking or vaginal bleeding and no drug-induced hypokalemia. We and our investigators are eager to take GRACE to the finish line. We expect GRACE to serve as the basis for our NDA submission in Cushing's syndrome, which will remain on track to submit in the second quarter of 2023.

Our second Phase III trial, gradient, is studying relacorilant effects in patients whose Cushing's syndrome is caused by an adrenal adenoma or adrenal hyperplasia. Patients with this etiology of Cushing's syndrome often experience a less rapid decline, but ultimately, their health outcomes are poor. GRADIENT has a planned enrollment of 130 patients and is being conducted at many of the sites participating in GRACE. Radiant is the first controlled study dedicated to patients with this type of Cushing's syndrome. While we do not expect our NDA in Cushing's syndrome to depend upon data from Radiant, we do expect that its findings will help improve the care of these increasingly recognized patients.

Last, a brief update on our intellectual property position for relacorilant in Cushing's syndrome. As you are likely aware, we hold the composition of matter patent for relacorilant that is valid through 2033. We were recently issued a method of use patent that we expect will be included in the orange book for relacorilant should have received FDA approval that is valid to 2040.

Finally, a brief word about CORT113176, which has shown promise in animal models of ALS. While we are in discussion with leading clinicians and the FDA regarding our development plans and plan to initiate a Phase 2 trial by early next year. Our belief has always been that cortisol modulation can help treat many serious disorders. Korlym for patients with Cushing's syndrome is one very clear example. The promising data in our ovarian cancer and NASH programs provide increasing proof cortisol, modulations, Brad worth. While the pandemic dampened our commercial results for more than a year, we are confident that our business will resume its growth as conditions continue to improve. It is already growing. Even in the most challenging periods of the pandemic, our commercial business generated more than enough cash to fund our advancing development activities.

Currently, our oncology program is evaluating 2 of our proprietary cortisol modulators in combination with 3 different anticancer agents in 3 tumor types. In addition, our metabolic program is conducting important initial trials in NASH and antipsychotic-induced weight gain. We also continue to enroll patients in our flagship Phase III trial relacorilant and Cushing's syndrome and will advance CORT113176 to treat patients with ALS by early next year. Meanwhile, additional proprietary early stage compounds advance towards the clinic. The breadth of our program reflects the power of our fundamental scientific hypothesis. Cortisol modulation is a potent therapeutic modality. We have proven that in patients with Cushing's syndrome. We are now adding to the body of evidence that proves its work for patients with other serious disorders. I'll stop here for questions as a reminder, to ask a questions.

(Operator Instructions) Your first question comes from the line of Alan Wang from BioWatch.

Congratulations on the quarter but I want to send kudos, especially Sean, for executing on the sales plan in a business environment that was under transition. So I don't know if he's there, but congratulations.

Thanks, Alan.

So this is a question, I guess, for anyone. You mentioned -- Joe, you mentioned about titrating Korlym quickly. Are the physicians more willing to venture into a stronger dose can say, even a couple of years ago or a little more.

Sean, would you like to take that question?

Yes. So just -- the question is, our physicians now more readily open to titrating to a higher dose. Was that the question?

Yes.

And then are you asking that specifically to how it may be different than during the pandemic?

Well, it could be, but more really, really as the physician community, I would expect having more experience or reading more literature or talking to their mate about their experience with Korlym may feel a little bit less reluctant to raise the dose to an optimal level.

Yes. I mean I would say you've hit the nail on the head of that right there. I mean, physicians that have had more experience with the compound are more comfortable using it or more comfortable with the cadence of patient visits that are required to follow-up have definitely move to titrate to a higher dose. And the most efficacious dose for that patient. Now an important point is that it really does vary patient-by-patient is patient dependent. There anything, Joe, you want to add to that?

Yes. I think, Alan, I think really what you're getting at is, is the behavior different than it was several years ago. And the answer to that is, right now, it really isn't at all. And I think that's actually a real positive. It's a very interesting point, which is that we're now seeing patients it -- I'm sorry, physicians titrate their patients doses at the same cadence that we saw pre-pandemic, not more than that. Because at that point in time, they really weren't getting to patients that are ideal dose. The interesting thing -- and again, there were strange things in the pandemic in many areas, was that because doctors could not see patients as frequently, it seemed as if they were not on the same cadence of titration. And so it's just heartening to see that they've returned to pre pandemic behavior at this point. But overall, our average dose per patient is very similar for now many years.

I have one more question. It could be to go add to Andreas. Then regarding the recent NASH results, you had a rapid delivery fat reduction and a little bit -- and the inflammatory markers going up. Did you any -- did you see any notable similar phenomenon or with other NAS drugs, either in pre-clinical or in human trials? done in the literature.

Well, what -- if you're referring to like a transit increase of transaminases in patients with NASH that are treated with drugs to reduce liver fat. There is reports in that there are reports in the literature, that it is a known phenomenon. It's just to scale was different when we look at those, both the scale of the liver fat reduction and the scale of the transaminase elevation, right? What you often -- what's been described with some of the other NASH compounds is an increase of ASC and ALT of like 20%. And we had looked at a much bigger increase. But that's why we're going forward and trying to find our sweet spot, where we achieved a good reduction in liver fat without affecting the liver negatively on the way to that.

I mean, I think that's exactly right, Jason. I just want to add a little color to that, Alan, which is to say, the question is, has this phenomenon been observed of simultaneous decrease in liver fat and increase in liver function sets. The answer to that is yes. But Andreas' point is also -- and the second point is also an important one. Never on the scale that we saw, no one has seen the kind of rapid fat decrease in their studies that. And at the same time, the liver elevation and liver function test, which normalizes as soon as the drug was withdrawn, no one's ever seen that either. And so really, take Andreas' conclusion as it is, what we're really looking to do is that we can really harness this extreme activity without irritating the liver, that's really the goal. And that's what the next study we were looking for the ideal dosing regimen is going to address.

It looks like a pretty interesting next 12 months?

Thank you, Alan. Thank you.

Your next question comes from the line of Matt Kaplan from Ladenburg.

Just wanted to first, congrats on the strength of the quarter, a nice rebound in the revenues. Korlym. To dig into your pipeline a little bit. Can you, I guess, first give us an update in terms of the pace of enrollment and how enrollment is going with the relacorilant Phase III GRACE study and Phase III GRADIENT study in Cushing's syndrome?

Yes. I mean, as I said, Matt, Matt, in my remarks, we have not changed the time line at all, just as it was before. And the only caveat I would add to that is we're in an uncertain time in the world. We see no need at the moment to make any alterations. Things certainly are better than they were a year ago, but we'll just have to see what happens. So I just would refer you to that. The time lines are unchanged.

Okay. Okay. That's helpful. And then, I guess, you're on track to start your Phase III study in ovarian cancer in the first quarter of next year. Can you give us a little color in terms of what that study will look like in terms of design and endpoints and stuff like that?

Yes. Let me just turn that question over to Andreas.

Yes. So we are finalizing some of those questions. And obviously, many of them are important. And I think there are a few things that are clear. One is the dose that -- or the regimen that we're going to test is the intermittent regimen of relacorilant with nab-paclitaxel. The competitor -- we're favoring currently a physician's choice comparator. So we would give like a dealer we would give physicians the choice of single-agent chemotherapy in these platinum resistance or refractory patients. And the primary endpoint, I think our ingoing position is overall survival is going to be required as a primary endpoint for approval. But we're having a lot of conversations with high level opinion leaders and will obviously eventually pretty soon have conversations with the regulators to firm those assumptions.

Okay. That's helpful. And then, I guess, lastly, in terms of the work you're doing with miricorilant and metabolic diseases, specifically antipsychotic use weight gain. How are those studies progressing now? And when could we expect some readout from those? Yes. I mean, you've sure you've read what we shared in the press release, right, that we want to complete enrollment in the GRATITUDE II study by year-end and the initial GRATITUDE study by mid-2022. We're on track for that. And then obviously, we'll have to flip the cards over and see what we see what we observed in these trials. So we're quite excited about it and hope that we can demonstrate a treatment benefit.

And Matt, what I'd just add to that is, as you know, the pandemic created different pressures in different sorts of studies. At the moment, we're actually seeing things progressed right a lot. I just -- again, I'll just add what I said before, it's an uncertain world. But at this moment in time, we really are fine with what we're seeing. And as I said, we've repeated our time lines.

And just a follow-up on that in terms of your sense in terms of moving what you need to see from an impact point of view on the weight gain and the unmet need, I guess, in this patient population. And where miricorilant could play a role there.

Well, let me address this one because, Matt, as you know, these are my patients. I mean, as every psychiatrist prescribes these medications. They're very effective for what they're intended to treat, which is psychosis where as adjuncts to antibodies ants in major depression or bipolar disorder. So from an advocacy point of view, they're very good. Unfortunately, they had this terrible metabolic achilles heel, which is that they really preserve that system. It caused a weight gain, and even though I didn't mention it in my remarks, that's actually a problem for treatment adherence. People don't like how they look. They don't like how they feel. And they are disciplined enough to stay on the medications, ultimately, they develop a lot of the diseases you see with 10% or 15% weight gain or sometimes more than that. So there's no doubt among physicians who treat these patients that there's a great need for something to do with this problem. And so we -- again, I sort of look at where bolt hats here as a treater of these patients and someone developing medications for them. I really believe that if you could come up with something which would help those issues it would be very, very meaningful. It's a large market with a lot of suffering.

And we'll just have to see. I mean, the studies are set up to demonstrate both weight change. And I think, importantly, to metabolic perturbations that come with that. I mean, what change is good, but it would be much better if you could actually develop something which helped with some of the other problems like things like increasing triglycerides or fasting insulin, things which make people less prone to diabetes. So thanks for giving the opportunity to expand it some length. This is a Memento illness as a whole has a lot of stigma and isn't talked about within it. This is a big, big problem, and we can do something about it.

Your last question comes from the line of Arthur He from H.C. Wainwright.

Good afternoon, everyone. This is Arthur in for RK. Most of my questions are being answered. So I'm just curious, besides the share buy program, has the management discussed any other plan to further improve the shareholder value?

We discuss it continuously. You know what plan. No. Look, the most important thing we can do to increase shareholder value is for our programs to succeed in our commercial program to continue on the path that it's at. Other ancillary things, we really do review. Our Board is very conscious of things like that. We feel that our stock is at an inexpensive price right now. As you know, we are committing our own funds to it, and we will continue to do that. But beyond that, when we have something more specific, Arthur, we'll talk about it.

And congratulations on the strong quarter.

Thank you very much. And I want to just thank everyone else for listening to in. I'm sure it's a hot summer afternoon wherever you are. So stay cool and healthy, and we'll talk to you next quarter.

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