CORCEPT THERAPEUTICS INC Q2 FY2025 earnings call

Endocrinology Division

• Sixth consecutive quarter of record new prescribers, prescriptions, and patients on therapy; 49% more tablets shipped vs prior year Q2.
• Pharmacy capacity issues in Q2 but expected to improve in H2 2025, with a second pharmacy coming online in Q4.

CATALYST Study

• Published results show 1 in 4 patients with difficult-to-control diabetes have hypercortisolism; Korlym treatment led to 1.47% reduction in hemoglobin A1c vs 0.15% in placebo over 24 weeks, with significant improvements in other endpoints.

Relacorilant

• PDUFA date for hypercortisolism is Dec 30; supported by GRACE trial and others; potential to be new standard of care for hypercortisolism.

Oncology

• ROSELLA trial in platinum-resistant ovarian cancer showed improved progression-free survival and overall survival with relacorilant plus nab-paclitaxel; BELLA trial enrolling briskly; exploring relacorilant in combination with androgen deprivation therapy, immunotherapy; dazucorilant in ALS showed survival benefit; miricorilant in NASH metabolic dysfunction associated steatohepatitis showed liver fat reduction.

In the second quarter of 2025, Corcept's revenue was $194.4 million, compared to $163.8 million in the prior year period. The Endocrinology division had an excellent quarter with a record number of new prescribers, prescriptions, and patients on therapy. They shipped 49% more tablets than the second quarter last year. However, pharmacy capacity issues impacted revenue fully reflecting the surge in demand. Financially, the endocrinology division's revenue growth was substantial but not fully realized due to pharmacy constraints.

• Modified 2025 revenue guidance to $850 million to $900 million.
• Relacorilant expected to be approved for hypercortisolism by end of 2025 and for oncology next year.

• Pharmacy capacity issues that initially affected revenue realization and could continue to impact if not resolved.
• Patent litigation with Teva; outcome unknown, and if Teva prevails, could affect market access for relacorilant until Corcept's patents expire in 2037.

Q: Regarding Korlym, what portion of business came from authorized generic during the quarter relative to 1Q, and pricing headwind year-over-year? Also, disconnect between prescriptions written and filled.

A: Sean Maduck stated that over the second quarter, about 2/3 of business is from authorized generic, compared to just over 50% in 1Q; pricing is on average a 30% discount to Korlym's list price. On prescriptions, pharmacy capacity issues led to about a $15 million impact in Q2, with improvement expected in H2 but ongoing volume growth creating challenges.

Q: About the $3 billion to $5 billion peak sales opportunity for hypercortisolism franchise, how much from Korlym and importance of patent appeal with Teva?

A: Joseph Belanoff mentioned relacorilant is a better medication and will likely replace Korlym over time; winning the patent case doesn't directly impact the $3B-$5B estimate as it's about relacorilant's future growth. Sean Maduck added the second pharmacy is expected to impact in Q4 and they plan to expand distribution for relacorilant as needed.

Q: Why wasn't a second pharmacy onboarded earlier given expected demand surge, and why guidance is still lowered despite second pharmacy in Q4?

A: Joseph Belanoff said hindsight shows demand from CATALYST data came faster than expected, and original pharmacy couldn't keep up. Sean Maduck explained the $15M impact in Q2 flows through the model, and patient delays in starting/titrating medication contribute to ongoing guidance adjustments.

Q: BELLA study timeline and other solid tumors for relacorilant?

A: William Guyer said BELLA trial enrollment is brisk and will be enrolled by end of 2025, with results in about a year. Relacorilant is being explored in prostate cancer, endometrial cancer, cervical cancer, and in combination with immunotherapy with no overlapping toxicity concerns.

Q: Physicians' use of relacorilant in earlier vs late-stage ovarian cancer and combination with other therapies?

A: Roberto Vieira stated relacorilant has flexible utilization, with physicians appreciating its safety profile; it's seen as useful in earlier lines of platinum-resistant ovarian cancer and potential for earlier use as data evolves. William Guyer confirmed no overlapping toxicities with combination therapies