Executive Summary / Key Takeaways

• Corcept Therapeutics is poised for significant growth, transitioning from a single-product company to a multi-franchise biopharmaceutical leader, driven by its proprietary cortisol modulation platform.
• Relacorilant, a next-generation selective cortisol modulator, is expected to receive FDA approval for hypercortisolism by December 30, 2025, and for platinum-resistant ovarian cancer by July 11, 2026, with management projecting $3 billion to $5 billion in annual revenue from hypercortisolism alone within 3-5 years.
• The company's robust pipeline, including promising candidates for ALS (dazucorilant) and MASH (miricorilant), alongside expansion into other oncology indications, underscores the broad therapeutic potential of cortisol modulation.
• Despite recent operational challenges with pharmacy vendors impacting 2025 revenue guidance, Corcept is aggressively expanding its distribution network and sales force to capitalize on rapidly growing market awareness for hypercortisolism.
• Corcept's specialized technology and deep R&D focus provide a competitive moat, enabling targeted efficacy and improved safety profiles compared to existing treatments and generic alternatives, positioning it for market leadership in its niche areas.

The Dawn of a New Era in Cortisol Modulation

Corcept Therapeutics, founded in 1998, has meticulously built a foundational expertise in modulating the effects of the hormone cortisol, a mechanism now proving to be a powerful therapeutic tool across a spectrum of severe endocrinologic, oncologic, metabolic, and neurologic disorders. From its initial FDA approval of Korlym (mifepristone) in 2012 for Cushing's syndrome, Corcept has evolved into a commercial-stage biopharmaceutical company with a robust pipeline of proprietary selective cortisol modulators. This specialized focus positions Corcept as a leader in a niche but expanding market, differentiating it from larger, more diversified pharmaceutical players.

The company's overarching strategy centers on leveraging its deep understanding of cortisol biology to develop highly targeted therapies that offer superior efficacy and safety profiles. This approach is critical in a competitive landscape where established players like Recordati and Xeris Pharmaceuticals also operate in endocrine disorders, and larger entities like AbbVie (ABBV) have broad oncology and endocrinology portfolios. Corcept's commitment to in-house development of novel cortisol modulators, rather than relying heavily on partnerships, underpins its unique value proposition in precision medicine.

Technological Edge: Precision in Cortisol Modulation

Corcept's core technological differentiation lies in its discovery and patenting of over 1000 structurally distinct selective cortisol modulators. This extensive library allows the company to develop compounds with tailored pharmacological profiles for specific diseases. The flagship example of this innovation is relacorilant, a proprietary selective cortisol modulator that exhibits affinity for the glucocorticoid receptor (GR) but, critically, lacks affinity for the progesterone receptor (PR).

This PR-sparing characteristic of relacorilant offers significant tangible benefits over Korlym, which is mifepristone, also approved for early pregnancy termination. Relacorilant avoids side effects associated with PR affinity, such as endometrial thickening and vaginal bleeding. Furthermore, it does not meaningfully increase cortisol levels, thereby mitigating the risk of hypokalemia (low potassium), a potentially serious condition that affected 44% of patients in Korlym's pivotal trial. Unlike other currently approved treatments for hypercortisolism, relacorilant also does not prolong the heart's QT interval, a potentially deadly off-target effect. These distinct safety and tolerability advantages are expected to make relacorilant a new standard of care, driving significant patient adoption and providing a strong competitive moat.

Beyond relacorilant, Corcept's R&D initiatives extend to other selective cortisol modulators. Dazucorilant, designed to cross the blood-brain barrier, demonstrated an 84% reduction in the risk of early death in ALS patients in its Phase 2 DAZALS trial, with a p-value of 0.0009. Miricorilant, with potent liver activity, showed a 30% reduction in liver fat and improved metabolic markers in a Phase 1b study for MASH, without the common GI side effects seen with other MASH treatments. The company is also advancing nenocorilant, a new selective cortisol receptor antagonist, into a Phase 1b study for solid tumors in combination with immunotherapy, aiming to reduce cortisol-activated immune suppression. These developments highlight Corcept's strategic intent to broaden its therapeutic reach by matching specific modulator profiles to diverse disease mechanisms, enhancing its competitive position through differentiated efficacy and safety.

Financial Performance and Operational Dynamics

Corcept's financial performance in 2025 reflects a period of robust underlying demand growth coupled with operational challenges. For the nine months ended September 30, 2025, product revenue reached $559.3 million, up from $493.2 million in the comparable period of 2024. This 13.4% increase was primarily driven by a 39% rise in sales volume, partially offset by an 18.4% decrease in average price due to the increasing adoption of the authorized generic version of Korlym. In the third quarter of 2025 alone, product revenue was $207.6 million, a 13.7% increase year-over-year, with sales volume up 42.5% but average price down 20.2%.

Despite this strong volume growth, net income for the nine months ended September 30, 2025, decreased to $75.364 million from $110.463 million in the prior year period. This decline was largely due to higher operating expenses, including increased research and development (R&D) and selling, general, and administrative (SG&A) costs. Cost of sales as a percentage of revenue also increased, partly due to a $1 million write-off of scrapped inventory.

R&D expenses for the nine months ended September 30, 2025, were $190.052 million, up from $176.587 million in 2024, reflecting the advancement of multiple clinical programs. SG&A expenses surged to $318.488 million from $196.948 million, driven by expanded sales and marketing activities in anticipation of new product launches.

A significant operational headwind impacting 2025 revenues was the insufficient capacity of Corcept's previous specialty pharmacy vendor. This bottleneck, which began in late 2024 and persisted through Q3 2025, created a disconnect between surging prescription demand and actual filled prescriptions, impacting Q2 2025 results by approximately $15 million. In response, Corcept has initiated a transition to a new pharmacy, Curant Rare, in Q4 2025, and plans to onboard a second and third specialty pharmacy in early 2026 to ensure adequate distribution capacity for anticipated growth, particularly with relacorilant's launch.

As of September 30, 2025, Corcept maintained a strong liquidity position with $524.2 million in cash, cash equivalents, and marketable securities.

While net cash provided by operating activities decreased to $103.5 million for the nine months ended September 30, 2025, due to higher operating expenses, the company remains confident in its ability to fund operations and R&D for the next 12 months and beyond without needing to raise additional capital.

Strategic Outlook and Growth Catalysts

Corcept's future growth is anchored by its hypercortisolism and oncology franchises. The company's 2025 revenue guidance was adjusted to $800 million to $850 million, reflecting the impact of pharmacy fulfillment issues and the shift to its authorized generic. However, management anticipates accelerated growth in the second half of 2025 and beyond, driven by increased market awareness and expanded distribution.

The hypercortisolism market is undergoing a significant re-evaluation, largely due to Corcept's CATALYST study. This study revealed that one in four patients with difficult-to-control diabetes has hypercortisolism, a prevalence far higher than previously assumed. The study also demonstrated that Korlym significantly reduced HbA1c by 1.47% in these patients, even those unresponsive to potent GLP-1 agonists. These findings, coupled with the upcoming MOMENTUM trial in resistant hypertension, are expected to substantially accelerate screening and treatment. With relacorilant's PDUFA date of December 30, 2025, and its superior safety profile, Corcept projects $3 billion to $5 billion in annual revenue from hypercortisolism alone within 3-5 years, emphasizing that this is not considered peak sales. To support this, the sales force has expanded from 60 specialists in early 2024 to 150 by Q3 2025, with plans for 175 by year-end.

In oncology, relacorilant is a significant growth driver. The NDA for relacorilant plus nab-paclitaxel for platinum-resistant ovarian cancer has a PDUFA date of July 11, 2026, following positive results from the pivotal ROSELLA trial. ROSELLA demonstrated a 30% reduction in the risk of disease progression and a meaningful 31% reduction in the risk of death, with a median overall survival of 16 months versus 11.5 months for nab-paclitaxel alone, all without increased safety burden. This groundbreaking success has led to the establishment of a dedicated oncology division and plans to expand into earlier lines of ovarian cancer, endometrial, cervical, and pancreatic cancers, potentially tripling the addressable gynecological cancer patient population in the U.S. from 20,000 to 60,000.

R&D expenditures are expected to remain consistent in 2026 compared to 2025, as new studies are initiated while others conclude. SG&A expenses are projected to increase as the company invests heavily in commercialization efforts for relacorilant in both hypercortisolism and ovarian cancer.

Competitive Landscape and Risk Factors

Corcept operates in a competitive environment. In hypercortisolism, it faces competition from Recordati (RCDTF)'s pasireotide and osilodrostat, and Xeris (XERS)'s levoketoconazole, as well as off-label generic ketoconazole. The launch of Teva 's generic Korlym in January 2024 and the availability of Corcept's own authorized generic have introduced pricing pressures, with the authorized generic priced at about a 30% discount to Korlym's list price. Corcept is actively appealing a December 2023 court ruling that favored Teva in patent litigation, with a decision expected soon. The outcome of this appeal could impact Korlym's market exclusivity until 2037.

In oncology, while relacorilant has shown compelling results, it will compete with existing chemotherapies and targeted agents. Corcept's strategy to combine relacorilant with other anti-cancer agents, leveraging its ability to resensitize tumors, is a key differentiator. The company's proprietary cortisol modulators offer a unique mechanism of action, providing a competitive edge in efficacy and safety that rivals may find difficult to replicate.

Key risks include ongoing legal proceedings, particularly the Teva (TEVA) patent and antitrust litigations, which could divert resources and impact financial results. Regulatory scrutiny, including a records subpoena from the NJ USAO regarding Korlym's promotion and reimbursement, poses potential compliance risks. Public perception of mifepristone, Korlym's active ingredient, due to its use in pregnancy termination, could also create challenges. Furthermore, government regulations like the IRA and OBBBA are expected to limit Medicare and Medicaid revenues, respectively, impacting profitability from 2026 onwards. Clinical development risks, including potential trial failures or delays, and the complex and costly landscape of data privacy regulations (HIPAA, GDPR, CCPA) also present ongoing challenges.

Conclusion

Corcept Therapeutics stands at an inflection point, transitioning from a niche player to a potential leader in multiple therapeutic areas through its innovative cortisol modulation platform. The imminent FDA approval of relacorilant for hypercortisolism and its promising trajectory in platinum-resistant ovarian cancer represent significant catalysts for revenue acceleration. The company's deep pipeline, underpinned by a strong technological moat and a strategic focus on differentiated efficacy and safety, positions it to capture substantial market share in underserved patient populations.

While operational hurdles related to pharmacy distribution and ongoing competitive and regulatory pressures require diligent management, Corcept's aggressive expansion of its commercial infrastructure and continued R&D investment signal a clear commitment to realizing its multi-billion dollar revenue potential. The "so what" for investors is a compelling growth story driven by scientific innovation, expanding market awareness, and a strategic vision to leverage cortisol modulation across a broad spectrum of serious diseases, making Corcept Therapeutics a noteworthy investment in the biopharmaceutical sector.