Business Overview and History

Corcept Therapeutics, a commercial-stage pharmaceutical company, has been at the forefront of developing innovative treatments that harness the power of cortisol modulation. With a steadfast focus on addressing severe endocrinologic, oncologic, metabolic, and neurologic disorders, Corcept has established itself as a leader in this dynamic field.

Corcept Therapeutics was incorporated in the State of Delaware in May 1998, with the goal of discovering and developing medications to treat severe endocrinologic, oncologic, metabolic, and neurologic disorders by modulating the effects of the hormone cortisol. The company's pioneering research has led to the development of a robust pipeline of proprietary selective cortisol modulators.

In 2012, Corcept achieved a significant milestone when the United States Food and Drug Administration (FDA) approved Korlym (mifepristone) 300 mg tablets as a once-daily oral medication for the treatment of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. Korlym became Corcept's first and currently its only marketed product.

Since 2012, Corcept has relied on revenues from the sale of Korlym to fund its operations. The company has made significant strides in its research and development efforts, having discovered and patented four structurally distinct series of selective cortisol modulators, consisting of more than 1,000 compounds. These compounds are being developed as potential treatments for a broad range of serious disorders.

In 2018, Corcept faced a challenge when it received a Paragraph IV Notice Letter advising that Teva Pharmaceuticals USA, Inc. had submitted an Abbreviated New Drug Application to the FDA seeking authorization to manufacture and sell a generic version of Korlym prior to the expiration of patents related to Korlym. In response, Corcept filed a lawsuit against Teva for patent infringement, which is currently ongoing. More recently, in June 2024, Corcept took a strategic step by making available an authorized generic version of Korlym.

As Corcept's commercial operations expanded, the company has maintained a strong financial profile. In 2024, the company reported revenue of $675.0 million, a 40% increase over the previous year. This robust revenue growth has been driven by the increasing adoption of Korlym, as well as the company's strategic focus on driving physician awareness and understanding of the prevalence of hypercortisolism.

Corcept's pipeline of selective cortisol modulators extends beyond Korlym, with several promising candidates in various stages of development. The company's lead pipeline asset, relacorilant, is currently undergoing regulatory review for the treatment of Cushing's syndrome. The positive results from the pivotal GRACE and GRADIENT studies have positioned relacorilant as a potential next-generation treatment option, with a favorable safety profile and the ability to address a wider range of Cushing's syndrome symptoms.

In addition to its work in Cushing's syndrome, Corcept is also exploring the therapeutic potential of its cortisol modulators in the oncology space. The company's ROSELLA study, a pivotal Phase 3 trial evaluating relacorilant in combination with nab-paclitaxel for the treatment of platinum-resistant ovarian cancer, recently reported positive topline results. This development underscores Corcept's commitment to expanding the clinical applications of its proprietary compounds.

Financial Performance and Outlook

Corcept's financial performance has been robust, with the company reporting strong revenue growth and profitability in recent years. In 2024, the company reported revenue of $675.0 million, a 40% increase from the previous year. This growth was primarily driven by the continued success of Korlym, as well as the company's efforts to increase physician awareness and diagnosis of Cushing's syndrome.

The company's net income for 2024 was $141.2 million, a 33% increase compared to the prior year. This solid financial performance has allowed Corcept to maintain a strong balance sheet, with cash and investments totaling $603.2 million as of December 31, 2024, compared to $425 million at the end of the prior year.

Looking ahead, Corcept has provided a revenue guidance of $900 million to $950 million for the 2025 fiscal year, indicating the company's confidence in its ability to sustain its growth trajectory. This guidance reflects the company's expectations for continued strong demand for Korlym, as well as the potential approval and commercialization of relacorilant for the treatment of Cushing's syndrome.

In the third quarter of 2024, Corcept reported revenue of $181.9 million, representing a 34.3% year-over-year increase. Net income for the quarter was $30.4 million. The company's financial strength is further evidenced by its healthy liquidity position, with a current ratio of 3.35 and a quick ratio of 3.26. Corcept's debt-to-equity ratio stands at a low 0.01, indicating a conservative approach to leverage.

Product Segments and Pipeline

Corcept's business is currently divided into two main product segments: Korlym and product candidates.

Korlym Segment

Korlym remains Corcept's primary revenue driver and only commercialized product. In the third quarter of 2024, Korlym generated $182.55 million in net product revenue, up from $123.60 million in the same period in 2023. For the first nine months of 2024, Korlym revenue totaled $493.15 million, compared to $346.97 million in the prior year period. These increases were driven primarily by higher sales volumes, accounting for 89% and 78.6% of the revenue growth in the third quarter and first nine months, respectively. A price increase effective January 1, 2024, also contributed to the revenue growth.

Corcept markets Korlym in the U.S. using a specialty pharmacy and distributor model. The company has implemented patient support programs and donates to independent charitable foundations to ensure that patients with Cushing's syndrome can access Korlym regardless of their financial situation.

Product Candidate Segment Corcept's pipeline includes several promising selective cortisol modulators in various stages of development:

1. Relacorilant for Cushing's Syndrome: Having completed two Phase 3 trials (GRACE and GRADIENT), relacorilant has shown clinically meaningful improvements in hypertension, glucose control, weight, and other Cushing's syndrome symptoms. It has received orphan drug designations in both the U.S. and EU for the treatment of Cushing's syndrome.

2. Relacorilant for Platinum-Resistant Ovarian Cancer: The ROSELLA trial, a pivotal Phase 3 study, is evaluating relacorilant in combination with nab-paclitaxel for patients with platinum-resistant ovarian cancer.

3. Dazucorilant for Amyotrophic Lateral Sclerosis (ALS): Corcept has initiated the DAZALS Phase 2 trial to evaluate dazucorilant as a potential treatment for ALS. The FDA has granted orphan drug designation for this indication.

4. Miricorilant for Metabolic Diseases: The MONARCH Phase 2b trial is assessing miricorilant in patients with metabolic dysfunction-associated steatohepatitis (MASH), a severe form of fatty liver disease.

Corcept's research and development expenses totaled $59.34 million and $176.59 million in the third quarter and first nine months of 2024, respectively, reflecting the company's continued investment in advancing its pipeline.

Competitive Landscape and Risks

Corcept operates in a competitive pharmaceutical landscape, with several companies developing treatments for Cushing's syndrome and other cortisol-related disorders. Competitors include Recordati-S.p.A. with its somatostatin analogue Signifor, Xeris Pharmaceuticals with its cortisol synthesis inhibitor Recorlev, and various companies offering off-label use of generic medications such as ketoconazole.

While Corcept has demonstrated success with Korlym, the potential availability of generic versions of the drug, as well as the introduction of new treatment options, could pose a risk to the company's market share and profitability. In January 2024, Teva launched a generic version of Korlym, which may impact Corcept's future revenues. Additionally, the company's pipeline candidates, including relacorilant, are subject to the inherent risks of drug development, such as the potential for failure in clinical trials or delays in the regulatory approval process.

Corcept also faces potential risks related to the regulatory environment, healthcare reforms, and the potential impact of government pricing policies on the company's ability to maintain acceptable pricing and reimbursement for its products.

The company has encountered some legal and regulatory challenges. In November 2021, Corcept received a records subpoena from the U.S. Attorney's Office for the District of New Jersey seeking information relating to the sale and promotion of Korlym, the company's relationships with and payments to healthcare professionals, and prior authorizations and reimbursement for Korlym. Corcept is cooperating with this ongoing investigation.

In March 2019, a purported securities class action complaint was filed against the company and certain executives alleging violations of federal securities laws. This matter was resolved in June 2024 when the court granted final approval of a settlement resolving all claims in the litigation. Additionally, in September 2019 and January 2022, purported shareholder derivative complaints were filed against certain directors and executives of the company. These actions remain ongoing.

Conclusion

Corcept Therapeutics has established itself as a leader in the field of cortisol modulation, with a strong track record of commercial success and a robust pipeline of promising drug candidates. The company's focus on addressing severe endocrinologic, oncologic, metabolic, and neurologic disorders through innovative treatments has positioned it for continued growth and long-term success.

As Corcept navigates the competitive landscape and faces various industry challenges, its commitment to scientific excellence, patient-centric initiatives, and strategic execution has been instrumental in driving its progress. With a solid financial foundation, a diverse pipeline, and a talented management team, Corcept appears well-positioned to capitalize on the significant opportunities in the cortisol modulation space and deliver value to its stakeholders.

The company's strong revenue growth, healthy balance sheet, and promising pipeline provide a solid foundation for future success. However, investors should remain aware of the potential risks associated with the competitive landscape, ongoing legal matters, and the inherent uncertainties of drug development and commercialization in the pharmaceutical industry.