CORCEPT THERAPEUTICS INC

Previous wording

Our Products. We sell Korlym and a generic version of Korlym in the United States (our “Products”) using sales representatives to call on physicians caring for patients with hypercortisolism. We also have a field-based force of medical science liaisons. We use a specialty pharmacy and a specialty distributor to distribute our Products and provide logistical support to physicians and patients. Our policy is that no patient with hypercortisolism will be denied access to our Products for financial reasons. To help us achieve that goal, we have patient support programs and donate money to independent charitable foundations that help patients pay for all aspects of their hypercortisolism care, whether or not that care includes taking our Products.

Current wording

Our Products. We sell Korlym and a generic version of Korlym in the United States (our “Products”) using sales representatives to call on physicians caring for patients with hypercortisolism. We also have a field-based force of medical science liaisons. We use specialty pharmacies and a specialty distributor to distribute our Products and provide logistical support to physicians and patients. Our policy is that no patient with hypercortisolism will be denied access to our Products for financial reasons. To help us achieve that goal, we have patient support programs and donate money to independent charitable foundations that help patients pay for all aspects of their hypercortisolism care, whether or not that care includes taking our Products.

Previous wording

In December 2024, we submitted a New Drug Application (“NDA”) to the United States Food and Drug Administration (“FDA”) seeking approval to market relacorilant as a treatment for patients with endogenous hypercortisolism. In March 2025, the FDA accepted the NDA for filing and assigned a Prescription Drug User Fee Act target action date of December 30, 2025. The NDA is based on positive results from our pivotal GRACE trial, with confirmatory evidence from our Phase 3 GRADIENT trial, our Phase 3 long-term extension study and our Phase 2 study. Patients in these trials exhibited clinically meaningful improvements in a wide range of hypercortisolism signs and symptoms, including hypertension, glucose control, weight and body composition. Relacorilant has been well-tolerated in all of its trials. Notably, patients did not experience some of the serious adverse events that can arise in patients taking Korlym or other currently approved treatments.

Current wording

In December 2024, we submitted a New Drug Application (“NDA”) to the United States Food and Drug Administration (“FDA”) seeking approval to market relacorilant as a treatment for patients with endogenous hypercortisolism. In March 2025, the FDA accepted the NDA for filing and assigned a Prescription Drug User Fee Act target action date (“PDUFA date”) of December 30, 2025. The NDA is based on positive results from our pivotal GRACE trial, with confirmatory evidence from our Phase 3 GRADIENT trial, our Phase 3 long-term extension study and our Phase 2 study. Patients in these trials exhibited clinically meaningful improvements in a wide range of hypercortisolism signs and symptoms, including hypertension, glucose control, weight and body composition. Relacorilant has been well-tolerated in all of its clinical trials. Notably, patients did not experience some of the serious adverse events that can arise in patients taking Korlym or other currently approved treatments.

Previous wording

GRACE had two-parts. The first, open-label phase enrolled 152 patients with any etiology of hypercortisolism. Each patient received relacorilant for 22 weeks. Patients who exhibited pre-specified improvements in either hypertension, hyperglycemia or both symptoms were eligible to proceed to GRACE’s second, double-blind, randomized withdrawal phase, in which half of the patients continued to receive relacorilant and half received placebo for 12 weeks. GRACE’s primary endpoint was the number of patients in the relacorilant group who lost blood pressure control compared to the number who lost blood pressure control in the placebo group.

Current wording

The GRACE trial had two parts. The first, open-label phase enrolled 152 patients with any etiology of hypercortisolism. Each patient received relacorilant for 22 weeks. Patients who exhibited pre-specified improvements in either hypertension, hyperglycemia or both symptoms were eligible to proceed to GRACE’s second, double-blind, randomized withdrawal phase, in which half of the patients continued to receive relacorilant and half received placebo for 12 weeks. GRACE’s primary endpoint was the number of patients in the relacorilant group who lost blood pressure control compared to the number who lost blood pressure control in the placebo group.

Previous wording

Patients who completed our GRACE, GRADIENT and Phase 2 trials were eligible to enter our open-label, long-term extension study. Of the 116 patients who chose to do so, the duration of the treatment has been up to six years. In December 2024, we announced that patients who remained in the study for 24 months exhibited, at that time, further clinically meaningful and statistically significant reductions in systolic (10.0 mm Hg; p-value: 0.012) and diastolic blood pressure (7.3 mm Hg; p-value: 0.016), compared to their blood pressure at entry into the long-term extension study. These patients had also maintained response in other cardiometabolic measures, such as glycemic control and body weight. Consistent with its known safety profile, relacorilant was well-tolerated.

Current wording

Patients who completed our GRACE, GRADIENT and Phase 2 trials were eligible to enter our open-label, long-term extension study. Of the 116 patients who chose to do so, the duration of the treatment has been up to seven years. In December 2024, we announced that patients who remained in the study for 24 months exhibited, at that time, further clinically meaningful and statistically significant reductions in systolic (10.0 mm Hg; p-value: 0.012) and diastolic blood pressure (7.3 mm Hg; p-value: 0.016), compared to their blood pressure at entry into the long-term extension study. These patients had also maintained response in other cardiometabolic measures, such as glycemic control and body weight. Consistent with its known safety profile, relacorilant was well-tolerated.

Previous wording

The FDA and the European Commission (“EC”) have designated relacorilant as an orphan drug for the treatment of hypercortisolism. In the United States, relacorilant’s orphan designation confers tax credits, reduced regulatory fees and, provided we obtain approval for the treatment of patients with hypercortisolism, seven years of exclusive marketing rights. Benefits of orphan drug designation by the EC are similar, but also include protocol assistance from the European Medicines Agency (“EMA”), access to the centralized marketing authorization procedure in the European Union (“EU”) and, if we obtain approval, ten years of exclusive marketing rights in the EU for the treatment of patients with hypercortisolism.

Current wording

The FDA and the European Commission (“EC”) have designated relacorilant as an orphan drug for the treatment of hypercortisolism. In the United States, relacorilant’s orphan designation confers tax credits, reduced regulatory fees and, provided we obtain approval for the treatment of patients with hypercortisolism, seven years of exclusive marketing rights. Benefits of orphan drug designation by the EC are similar, but include protocol assistance from the European Medicines Agency (“EMA”), access to the centralized marketing authorization procedure in the European Union (“EU”) and, if we obtain approval, ten years of exclusive marketing rights in the EU for the treatment of patients with hypercortisolism.

Previous wording

There is substantial evidence that cortisol activity at the GR reduces the efficacy of certain anti-cancer therapies and that modulating cortisol’s activity may help anti-cancer treatments achieve their intended effect. In some cancers, cortisol retards cellular apoptosis – the tumor-killing effect many treatments are meant to stimulate. In other cancers, cortisol activity promotes tumor growth. Cortisol also suppresses the body’s immune response; activating – not suppressing – the immune system is beneficial in fighting certain cancers. Many types of solid tumors express the GR and are potential targets for cortisol modulation therapy, among them ovarian, adrenal and prostate cancer.

Current wording

There is substantial evidence that cortisol activity at the GR reduces the efficacy of certain anti-cancer therapies and that modulating cortisol’s activity may help anti-cancer treatments achieve their intended effect. In some cancers, cortisol retards cellular apoptosis – the tumor-killing effect many treatments are meant to stimulate. In other cancers, cortisol activity promotes tumor growth. Cortisol also suppresses the body’s immune response; activating – not suppressing – the immune system is beneficial in fighting certain cancers. Many types of solid tumors express the GR and are potential targets for cortisol modulation therapy, among them ovarian, endometrial, pancreatic and prostate cancer.

Previous wording

Relacorilant in Patients with Platinum-Resistant Ovarian Cancer. In July 2025, we submitted an NDA to the FDA seeking approval to market relacorilant plus nab-paclitaxel as a treatment for patients with platinum-resistant ovarian cancer. The NDA is based on positive results from our pivotal Phase 3 ROSELLA and Phase 2 trials. Patients in these trials exhibited clinically meaningful improvements in progression free survival (“PFS”) and overall survival (“OS”). Relacorilant was well-tolerated and did not increase the safety burden of patients who took it.

Current wording

Relacorilant in Combination with Chemotherapy. In July 2025, we submitted an NDA seeking approval to market relacorilant plus the chemotherapy medication nab-paclitaxel as a treatment for patients with platinum-resistant ovarian cancer in the United States. In September 2025, the FDA accepted our NDA for filing and assigned a PDUFA date of July 11, 2026. In October 2025, we submitted a Marketing Authorization Application (“MAA”) to the EMA seeking approval in the European Union. Our NDA and MAA are based on positive results from our pivotal Phase 3 ROSELLA and Phase 2 trials, in which patients exhibited clinically meaningful improvements in progression free survival (“PFS”) and overall survival (“OS”). In both trials, relacorilant was well-tolerated and did not increase the safety burden of patients who took it.

Previous wording

In March 2025, we announced that ROSELLA had met its PFS endpoint. Patients treated with relacorilant in addition to nab-paclitaxel experienced a clinically and statistically significant 30 percent reduction in risk of disease progression compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.70; p-value: 0.008). PFS as assessed by ROSELLA’s clinical investigators was also positive (hazard ratio: 0.71; p-value: 0.0030). Although final data with respect to OS are not yet available, an interim analysis of survival data as of the date of the PFS analysis showed that patients who received relacorilant in addition to nab-paclitaxel had exhibited a meaningful 31 percent reduction in risk of death (hazard ratio: 0.69; p-value:

Current wording

In March 2025, we announced that ROSELLA had met its PFS endpoint. Patients treated with relacorilant in addition to nab-paclitaxel experienced a clinically and statistically significant 30 percent reduction in risk of disease progression compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.70; p-value: 0.008). PFS improvement as assessed by ROSELLA’s clinical investigators was also positive (hazard ratio: 0.71; p-value: 0.0030). Although final data with respect to OS are not yet available, an interim analysis as of the date of the PFS analysis showed that patients who received relacorilant in addition to nab-paclitaxel exhibited a meaningful 31 percent reduction in risk of death (hazard ratio: 0.69; p-value: 0.012), with a median OS of 16.0 months, compared to 11.5 months in patients receiving nab-paclitaxel alone. Both PFS and OS benefits were seen in all clinically relevant patient subgroups, including those with poor prognoses.

Previous wording

Importantly, relacorilant did not increase the safety burden of patients who took it. Relacorilant was well-tolerated and, when adjusted for duration of treatment, the rate, type and severity of adverse events in patients who received it were similar to those experienced by patients who received nab-paclitaxel alone.

Current wording

Importantly, relacorilant did not increase the safety burden of patients who took it. Relacorilant was well-tolerated and, when adjusted for duration of treatment, the rate, type and severity of adverse events in patients who received it were comparable to those experienced by patients who received nab-paclitaxel alone.

Previous wording

Patients in both of the relacorilant plus nab-paclitaxel treatment arms of the Phase 2 trial experienced longer PFS than did the patients who received nab-paclitaxel alone. Patients who received a higher dose of relacorilant intermittently exhibited a statistically significant improvement in median PFS (5.6 months versus 3.8 months, hazard ratio: 0.66; p-value: 0.038). Patients who received a lower dose of relacorilant daily exhibited a median PFS that was 1.5 months longer than did the patients who received nab-paclitaxel alone (5.3 months versus 3.8 months, hazard ratio: 0.83; p-value: not significant). Patients who received relacorilant intermittently also had a longer median duration of response (“DoR”) (5.6 months versus 3.7 months, hazard ratio: 0.36; p-value: 0.006) compared to those who received nab-paclitaxel alone. Patients who received relacorilant intermittently also lived longer (median OS: 13.9 months versus 12.2 months, hazard ratio: 0.67; p-value: 0.066) compared to those who received nab-paclitaxel alone.

Current wording

Patients in both relacorilant plus nab-paclitaxel treatment arms of the Phase 2 trial experienced longer PFS than did patients who received nab-paclitaxel alone. Patients who received a higher dose of relacorilant intermittently exhibited a statistically significant improvement in median PFS (5.6 months versus 3.8 months, hazard ratio: 0.66; p-value: 0.038). Patients who received a lower dose of relacorilant daily exhibited a median PFS that was 1.5 months longer than did the patients who received nab-paclitaxel alone (5.3 months versus 3.8 months, hazard ratio: 0.83; p-value: not significant). Patients who received relacorilant intermittently also had a longer median duration of response (“DoR”) (5.6 months versus 3.7 months, hazard ratio: 0.36; p-value: 0.006) compared to those who received nab-paclitaxel alone. Patients who received relacorilant intermittently also lived longer (median OS: 13.9 months versus 12.2 months, hazard ratio: 0.67; p-value: 0.066) compared to those who received nab-paclitaxel alone.

Previous wording

As was the case in ROSELLA, the addition of relacorilant to treatment with nab-paclitaxel did not increase the adverse event burden for patients. Safety and tolerability of relacorilant and nab-paclitaxel combination treatment were comparable to the safety and tolerability of nab-paclitaxel monotherapy.

Current wording

As was the case in ROSELLA, the addition of relacorilant to treatment with nab-paclitaxel did not increase patients’ adverse event burden. The safety and tolerability of relacorilant and nab-paclitaxel combination treatment were comparable to nab-paclitaxel monotherapy.

Previous wording

The EC has designated relacorilant as an orphan drug for the treatment of ovarian cancer.

Current wording

The EC has designated relacorilant as an orphan drug for the treatment of ovarian and pancreatic cancers.

Previous wording

Relacorilant in Patients with Prostate Cancer. Androgen deprivation is the standard treatment for prostate cancer because androgens stimulate prostate tumor growth. Prostate cancer tumors eventually escape androgen deprivation therapy; one of the prime reasons is that these tumors begin to be stimulated by cortisol’s activity. Combining a cortisol modulator with an androgen modulator may block this escape route. Our collaborators at the University of Chicago have initiated a randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer, pre-prostatectomy. We are providing relacorilant and placebo for the study. Patents we have licensed from the University of Chicago cover the use of relacorilant combined with anticancer agents, including enzalutamide, to treat patients with this disease.

Current wording

Relacorilant in Combination with Androgen Deprivation Therapy. Androgen deprivation is the standard treatment for prostate cancer because androgens stimulate prostate tumor growth. Prostate cancer tumors eventually escape androgen deprivation therapy; one of the prime reasons is that these tumors begin to be stimulated by cortisol’s activity. Combining a cortisol modulator with an androgen modulator may block this escape route. Our collaborators at the University of Chicago have initiated a randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer, pre-prostatectomy. Patents we have licensed from the University of Chicago cover the use of relacorilant combined with anticancer agents, including enzalutamide, to treat patients with this disease.

Previous wording

Following these compelling results, we initiated a Phase 2 trial (“DAZALS”) of dazucorilant in patients with ALS. Two hundred forty-nine patients were randomized on a double-blind basis 1:1:1 to receive either 150 mg of dazucorilant, 300 mg of dazucorilant or placebo daily for 24 weeks. Upon completion of the trial, patients were eligible to enter an open-label, long-term extension study, in which they receive 300 mg of dazucorilant for up to 132 weeks.

Current wording

ALS, also known as Lou Gehrig’s disease, is a devastating neuromuscular illness. Our selective cortisol modulator dazucorilant improved motor performance and reduced neuroinflammation and muscular atrophy in an animal model of ALS. Following these compelling results, we initiated a Phase 2 trial (“DAZALS”) of dazucorilant in patients with ALS. Two hundred forty-nine patients were randomized on a double-blind basis 1:1:1 to receive either 150 mg of dazucorilant, 300 mg of dazucorilant or placebo daily for 24 weeks. Upon completion of the trial, patients were eligible to enter an open-label, long-term extension study, in which they receive 300 mg of dazucorilant for up to 132 weeks.

Previous wording

DAZALS did not meet its primary endpoint, which was the change from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R) in patients who received dazucorilant compared to those who received placebo. However, a statistically significant reduction in early death was observed at week 24 of the study. An exploratory analysis at the one-year mark found that this benefit continued. Patients who were randomized to receive 300 mg of dazucorilant from the start of DAZALS had an 84 percent reduction in risk of death, compared to patients who received only placebo, with a hazard ratio of 0.16 (p-value: 0.0009). A similar survival benefit was observed in an exploratory analysis of patients who received 300 mg of dazucorilant for greater than 24 weeks, either in the treatment period or in the extension study, compared to patients who received either placebo or 150 mg of dazucorilant for 24 weeks and did not receive dazucorilant in the extension study (hazard ratio: 0.36; p-value 0.02).

Current wording

Although DAZALS did not meet its primary endpoint – change from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R) in patients who received dazucorilant compared to those who received placebo – a statistically significant reduction in early death was observed at week 24 of the study. An exploratory analysis at the one-year mark found that this benefit continued. Patients who were randomized to receive 300 mg of dazucorilant from the start of DAZALS had an 84 percent reduction in risk of death, compared to patients who received only placebo, with a hazard ratio of 0.16 (p-value: 0.0009). A similar survival benefit was observed in an exploratory analysis of patients who received 300 mg of dazucorilant for greater than 24 weeks, either in the treatment period or in the extension study, compared to patients who received either placebo or 150 mg of dazucorilant for 24 weeks and did not receive dazucorilant in the extension study (hazard ratio: 0.36; p-value 0.02).

Previous wording

Liver Disease. Metabolic dysfunction-associated steatohepatitis (“MASH”) is an advanced form of metabolic dysfunction-associated fatty liver disease that afflicts millions of patients and is a leading cause of liver-related mortality. Our Phase 1b trial of the selective cortisol modulator miricorilant as a potential treatment for MASH identified a dosing regimen that reduced liver fat, improved liver health and key metabolic and lipid measures and was well-tolerated. Following these compelling results, we initiated a randomized, double-blind, placebo-controlled, Phase 2b trial (“MONARCH”) of miricorilant in patients with MASH in October 2023. MONARCH has two patient cohorts. Cohort A is enrolling patients with biopsy-confirmed MASH, randomized 2:1 to receive either 100 mg of miricorilant twice weekly or placebo for 48 weeks. Screening for Cohort A has closed. The primary endpoint of Cohort A is reduction in liver fat, with MASH resolution and fibrosis improvement being key secondary endpoints. Cohort B has completed enrollment of 93 patients with presumed MASH, randomized 2:1 to receive either 100 mg of miricorilant twice weekly for 6 weeks and then 200 mg of miricorilant twice weekly for 18 weeks or placebo for 24 weeks. The primary endpoint of Cohort B is reduction in liver fat.

Current wording

Liver Disease. Metabolic dysfunction-associated steatohepatitis (“MASH”) is an advanced form of metabolic dysfunction-associated fatty liver disease that afflicts millions of patients and is a leading cause of liver-related mortality. Our Phase 1b trial of the selective cortisol modulator miricorilant as a potential treatment for MASH identified a dosing regimen that reduced liver fat, improved liver health and key metabolic and lipid measures and was well-tolerated. Following these compelling results, we initiated a randomized, double-blind, placebo-controlled, Phase 2b trial (“MONARCH”) of miricorilant in patients with MASH in October 2023. MONARCH has completed enrollment in two patient cohorts. Cohort A enrolled 82 patients with biopsy-confirmed MASH, randomized 2:1 to receive either 100 mg of miricorilant twice weekly or placebo for 48 weeks. The primary endpoint of Cohort A is reduction in liver fat, with MASH resolution and fibrosis improvement being key secondary endpoints. Cohort B enrolled 93 patients with presumed MASH, randomized 2:1 to receive either 100 mg of miricorilant twice weekly for 6 weeks and then 200 mg of miricorilant twice weekly for 18 weeks or placebo for 24 weeks. The primary endpoint of Cohort B is reduction in liver fat.

Previous wording

We continue to create new selective cortisol modulators, the most promising of which we advance towards the clinic.

Current wording

We continue to create new selective cortisol modulators and advance the most promising of them towards the clinic.

Previous wording

The IRA also imposes a one percent excise tax on certain share repurchases and introduces a 15 percent corporate alternative minimum tax on adjusted financial statement income. The corporate alternative minimum tax became effective for us on January 1, 2024. We do not expect either of these provisions to significantly affect our consolidated financial statements.

Current wording

The IRA also imposes a one percent excise tax on certain share repurchases and introduces a 15 percent corporate alternative minimum tax on adjusted financial statement income. The corporate alternative minimum tax became effective for us on January 1, 2024. We do not expect either of these provisions to significantly affect our condensed consolidated financial statements.

Previous wording

Net product revenue was $194.4 million and $351.6 million for the three and six months ended June 30, 2025, respectively, compared to $163.8 million and $310.6 million for the comparable periods in 2024. The increases were driven by 49.0 percent and 36.8 percent increases in sales volume, partially offset by 20.3 percent and 17.3 percent decreases in average price due to higher sales volume from our authorized generic version of Korlym in the three and six months ended June 30, 2025, respectively.

Current wording

Net product revenue was $207.6 million and $559.3 million for the three and nine months ended September 30, 2025, respectively, compared to $182.5 million and $493.2 million for the comparable periods in 2024. The increases were driven by 42.5 percent and 39.0 percent increases in sales volume, partially offset by 20.2 percent and 18.4 percent decreases in average price due to higher sales volume from our authorized generic version of Korlym in the three and nine months ended September 30, 2025, respectively. The decreases in average price were partially offset by a price increase of our Products in August 2025.

Previous wording

Cost of sales was $3.4 million and $5.8 million for the three and six months ended June 30, 2025, respectively, compared to $2.5 million and $5.1 million for the comparable periods in 2024. Cost of sales as a percentage of revenue was 1.8 percent and 1.7 percent for the three and six months ended June 30, 2025, respectively, compared to 1.5 percent and 1.6 percent for the comparable periods in 2024, respectively. The increase in cost of sales as a percentage of revenue for the three months ended June 30, 2025 was primarily due to increased manufacturing and distribution costs. The increase in cost of sales as a percentage of revenue for the six months ended June 30, 2025 was due to increased manufacturing and distribution costs, offset by a one-time $0.5 million write-off of API that was scrapped during the manufacturing phase in the three months ended March 31, 2024, which did not recur in 2025.

Current wording

Cost of sales was $4.6 million and $10.4 million for the three and nine months ended September 30, 2025, respectively, compared to $2.9 million and $7.9 million for the comparable periods in 2024. Cost of sales as a percentage of revenue was 2.2 percent and 1.9 percent for the three and nine months ended September 30, 2025, respectively, compared to 1.6 percent for each of the comparable periods in 2024. The increases in cost of sales as a percentage of revenue were primarily due to the write-off of $1.0 million of scrapped inventory in the three months ended September 30, 2025 and increased manufacturing and distribution costs.

Previous wording

Research and development expense – Research and development expense includes the cost of (1) recruiting and compensating development personnel, (2) clinical trials, (3) manufacturing investigational drug product, (4) preclinical studies, (5) drug discovery research and (6) the development of new drug formulations and manufacturing processes.

Current wording

Research and development expense – Research and development expense includes the cost of (1) recruiting and compensating development personnel, (2) clinical trials, (3) manufacturing investigational drug products, (4) preclinical studies, (5) drug discovery research and (6) the development of new drug formulations and manufacturing processes.

Previous wording

Research and development expense was $60.5 million and $121.2 million for the three and six months ended June 30, 2025, respectively, compared to $58.7 million and $117.3 million for the comparable periods in 2024. The increases were primarily due to increased employee compensation expenses and expenses related to the advancement of our development programs, partially offset by decreased expenses related to development programs that are nearing completion.

Current wording

Research and development expense was $68.8 million and $190.1 million for the three and nine months ended September 30, 2025, respectively, compared to $59.3 million and $176.6 million for the comparable periods in 2024. The increases were primarily due to increased expenses related to the advancement of our development programs and employee compensation expenses, partially offset by decreased expenses related to development programs that are nearing completion.

Previous wording

It is difficult to predict the timing and cost of development activities, which are subject to many uncertainties and risks, including inconclusive or negative results, slow patient enrollment, adverse side effects and difficulties in the formulation or manufacture of study drugs and lack of drug-candidate efficacy. In addition, clinical development is subject to government oversight and regulations that may change without notice. We expect our research and development expense to be higher in 2025 than in 2024 as our clinical programs advance and we initiate new clinical trials. Research and development spending in future years will depend on the outcome of our pre-clinical and clinical trials and our development plans.

Current wording

It is difficult to predict the timing and cost of development activities, which are subject to many uncertainties and risks, including inconclusive or negative results, slow patient enrollment, adverse side effects and difficulties in the formulation or manufacture of study drugs and lack of drug-candidate efficacy. In addition, clinical development is subject to government oversight and regulations that may change without notice. We expect our research and development expense to be higher in

Previous wording

Selling, general and administrative expense– Selling, general and administrative expense includes (1) compensation of employees, consultants and contractors engaged in commercial and administrative activities, (2) the cost of vendors supporting commercial activities and (3) legal and accounting fees.

Current wording

Selling, general and administrative expense– Selling, general and administrative expense includes (1) recruiting and compensating commercial and administrative personnel, (2) the cost of vendors supporting commercial activities and (3) legal and accounting fees.

Previous wording

Selling, general and administrative expense was $103.9 million and $194.5 million for the three and six months ended June 30, 2025, respectively, compared to $66.9 million and $123.2 million for the comparable periods in 2024. The increases were primarily due to increased employee compensation expenses and sales and marketing activities to support commercialization of our existing and potential future products.

Current wording

Selling, general and administrative expense was $124.0 million and $318.5 million for the three and nine months ended September 30, 2025, respectively, compared to $73.7 million and $196.9 million for the comparable periods in 2024. The increases were primarily due to increased sales and marketing activities and employee compensation expenses to support commercialization of our existing and potential future products.

Previous wording

Interest and other income- Interest and other income was $5.0 million and $11.2 million for the three and six months ended June 30, 2025, respectively, compared to $6.0 million and $11.5 million for the comparable periods in 2024 and consisted primarily of interest income from marketable securities. The decreases were due to market-wide decreases in interest rates.

Current wording

Interest and other income- Interest and other income was $5.0 million and $16.2 million for the three and nine months ended September 30, 2025, respectively, compared to $6.3 million and $17.8 million for the comparable periods in 2024 and consisted primarily of interest income from marketable securities. The decreases were primarily due to market-wide decreases in interest rates.

Previous wording

Income tax benefit (expense)- Income tax benefit was $3.5 million and $14.4 million for the three and six months ended June 30, 2025, respectively, compared to income tax expense of $6.1 million and $13.3 million for the comparable periods in 2024. The decreases in income tax expense were primarily due to increased stock compensation deductions and decreases in year-to-date pretax income.

Current wording

Income tax benefit (expense)- Income tax benefit was $4.4 million and $18.8 million for the three and nine months ended September 30, 2025, respectively, compared to income tax expense of $5.7 million and $19.1 million for the comparable periods in 2024. The decreases in income tax expense were primarily due to increased stock compensation deductions and decreased pretax income.

Previous wording

As of June 30, 2025, we had cash, cash equivalents and marketable securities of $515.0 million, consisting of cash and cash equivalents of $102.7 million and marketable securities of $412.3 million, compared to cash, cash equivalents and marketable securities of $603.2 million, consisting of cash and cash equivalents of $127.7 million and marketable securities of $475.5 million as of December 31, 2024.

Current wording

As of September 30, 2025, we had cash, cash equivalents and marketable securities of $524.2 million, consisting of cash and cash equivalents of $125.1 million and marketable securities of $399.1 million, compared to cash, cash equivalents and marketable securities of $603.2 million, consisting of cash and cash equivalents of $127.7 million and marketable securities of $475.5 million as of December 31, 2024.

Previous wording

Net cash provided by operating activities was $49.1 million for the six months ended June 30, 2025, compared to $64.9 million for the comparable period in 2024. The decrease was primarily due to lower net income resulting from higher operating expenses to support increased sales and marketing activities.

Current wording

Net cash provided by operating activities was $103.5 million for the nine months ended September 30, 2025, compared to $138.2 million for the comparable period in 2024. The decrease was primarily due to lower net income resulting from higher operating expenses to support increased sales and marketing activities.

Previous wording

Net cash provided by investing activities was $67.0 million for the six months ended June 30, 2025, compared to net cash used in investing activities of $69.2 million for the comparable period in 2024. The increase was primarily due to a higher allocation of cash proceeds from maturities of marketable securities towards cash equivalents to purchase shares in connection with our Stock Repurchase Program during the six months ended June 30, 2025.

Current wording

Net cash provided by investing activities was $81.6 million for the nine months ended September 30, 2025, compared to net cash used in investing activities of $113.2 million for the comparable period in 2024. The increase was primarily due to a higher allocation of cash proceeds from maturities of marketable securities towards cash equivalents to purchase shares in connection with our Stock Repurchase Program during the nine months ended September 30, 2025.

Previous wording

Net cash used in financing activities was $142.7 million for the six months ended June 30, 2025, compared to $2.7 million for the comparable period in 2024. In the six months ended June 30, 2025, we spent $158.7 million acquiring shares of our common stock, comprised of $130.5 million pursuant to our Stock Repurchase Program, $7.7 million to satisfy tax withholding requirements from vesting of restricted stock grants and $20.5 million acquiring shares of our common stock in connection with the net exercise of employee and director stock options, offset by $5.0 million received in connection with our ESPP and $11.0 million net cash received from the exercise of stock options. In the comparable period in 2024, we spent $7.6 million acquiring shares of our common stock, comprised of $4.0 million pursuant to our Stock Repurchase Program, $2.0 million to satisfy tax withholding requirements from vesting of restricted stock grants and $1.6 million acquiring shares of our common stock in connection with the net exercise of employee and director stock options, offset by $2.6 million received in connection with our ESPP and $2.3 million net cash received from the exercise of stock options.

Current wording

Net cash used in financing activities was $189.2 million for the nine months ended September 30, 2025, compared to $23.8 million for the comparable period in 2024. In the nine months ended September 30, 2025, we spent $209.3 million acquiring shares of our common stock, comprised of $172.9 million pursuant to our Stock Repurchase Program, $24.6 million acquiring shares of our common stock in connection with the net exercise of employee and director stock options and $11.8 million to satisfy tax withholding requirements from vesting of restricted stock grants, offset by $13.0 million net cash received from the exercise of stock options and $7.2 million received in connection with our ESPP. In the comparable period in 2024, we spent $31.0 million acquiring shares of our common stock, comprised of $15.7 million pursuant to our Stock Repurchase Program, $12.2 million acquiring shares of our common stock in connection with the net exercise of employee and director stock options, and $3.1 million to satisfy tax withholding requirements from vesting of restricted stock grants, offset by $3.9 million received in connection with our ESPP and $3.3 million net cash received from the exercise of stock options.

Previous wording

As of June 30, 2025, we had retained earnings of $599.4 million.

Current wording

As of September 30, 2025, we had retained earnings of $619.1 million.

Previous wording

Our contractual payment obligations and purchase commitments are disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024. Our payment obligations and purchase commitments did not change materially during the six months ended June 30, 2025. See Note 4 to our Unaudited Condensed Consolidated Financial Statements for more information regarding our purchase commitments.

Current wording

Our contractual payment obligations and purchase commitments are disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024. Our payment obligations and purchase commitments did not change materially during the nine months ended September 30, 2025. See Note 4 to our Unaudited Condensed Consolidated Financial Statements for more information regarding our purchase commitments.