CORCEPT THERAPEUTICS INC (CORT)·Q4 2024 Earnings Summary

Executive Summary

• Q4 revenue was $181.9M, up 34% YoY but essentially flat QoQ (-0.4%); diluted EPS was $0.26 vs $0.28 YoY and $0.41 in Q3, as R&D and SG&A stepped up into late-stage programs and commercialization readiness .
• 2025 revenue guidance was introduced at $900–$950M, implying ~33–41% growth off 2024’s $675.0M; management cited accelerating diagnosis/treatment of hypercortisolism and momentum from CATALYST as drivers .
• Relacorilant NDA for hypercortisolism was submitted Dec 30; management does not expect an AdCom and indicated NDA acceptance timing is imminent per statutory 60-day clock .
• Near-term catalysts: ROSELLA Phase 3 PFS analysis (dual primaries PFS/OS; PFS α=0.04, OS α=0.01) and potential NDA/MAA if PFS hits; if not, OS could mature roughly one year later. Q4 sequential revenue softness was attributed to temporary pharmacy partner onboarding capacity, which management says is being resolved .

What Went Well and What Went Wrong

What Went Well

• Record Korlym adoption: “record number of new Korlym prescribers and a record number of patients receiving Korlym in the quarter,” supporting durable growth in the Cushing’s franchise .
• Strong clinical momentum: CATALYST treatment phase met its primary endpoint (A1c reduction -1.47% vs -0.15% placebo; p<0.0001), reinforcing the prevalence and treatability narrative; long-term relacorilant extension showed durable BP improvements at 24 months .
• Regulatory progress: Relacorilant NDA submitted; management not expecting an AdCom, with acceptance decision expected per the 60-day review clock .

What Went Wrong

• Margins compressed sequentially as Q4 operating margin fell to ~13.9% (vs ~25.5% in Q3) amid higher R&D and SG&A and temporary pharmacy onboarding bottlenecks that slowed revenue recognition despite record patient activity .
• Q4 diluted EPS declined to $0.26 vs $0.41 in Q3 due to elevated operating expenses (R&D: $70.3M vs $59.3M; SG&A: $83.4M vs $73.7M) .
• Legal overhang persists: Teva generic litigation appeal timing slipped; earliest oral arguments now May or later, with decision 3–4 months thereafter, prolonging uncertainty .

Financial Results

Quarterly P&L progression (oldest → newest)

Notes: Margins calculated from reported revenue and operating/net income. Citations point to the income statement line items used.

Q4 YoY comparison and vs estimates

S&P Global consensus could not be retrieved due to system limits; therefore vs-estimate comparisons are unavailable at this time.

Expense mix and drivers (sequential)

Commentary: Management attributed Q4 revenue flatness QoQ to temporary pharmacy partner operational challenges delaying patient starts despite record demand; issues are being resolved and considered in 2025 guidance .

KPIs / Balance Sheet

Segment breakdown: All revenue is product revenue (Korlym); no additional reportable segments disclosed in these materials .

Non-GAAP: Company reports GAAP figures in press releases; no non-GAAP adjustments presented in Q4 materials .

Guidance Changes

No explicit guidance provided for margins, OpEx, tax, or other P&L items in Q4 materials.

Earnings Call Themes & Trends

Management Commentary

• “Once again, we had a record number of new Korlym prescribers and a record number of patients receiving Korlym in the quarter… We are confident that our Cushing’s syndrome business will grow for many years.” — CEO Joseph Belanoff .
• “We submitted our NDA on December 30… We are not expecting an AdCom.” — Chief Business Officer/Head of Regulatory (Gary/Charlie Robb) .
• “CATALYST… Patients who received Korlym exhibited a large reduction, 1.47% in hemoglobin A1c… p<0.0001.” — CEO Joseph Belanoff .
• “We just reached the number of events for PFS… dual primary endpoint of PFS by BICR and OS… PFS p=0.04, OS p=0.01… If we hit PFS, we can proceed to NDA/MAA.” — CDO Bill Guyer .
• “Our pharmacy partner had some operational challenges that impacted our Q4 revenue… issues have been identified and are being resolved… incorporated into guidance.” — President, Endocrinology Sean Maduck .

Q&A Highlights

• NDA acceptance and AdCom: NDA acceptance decision expected per 60-day timeline; management does not expect an AdCom based on efficacy/safety precedent in Cushing’s .
• ROSELLA endpoints: Regulator-aligned move to dual primary PFS/OS gives two “shots on goal”; if PFS misses, OS could mature in ~1 year for filing; if PFS hits, proceed without waiting for OS, with alpha recycling .
• Q4 sequential softness: Attributed to pharmacy partner onboarding capacity amid surging scripts; management expects resolution and incorporated this into 2025 guidance .
• TAM and long-term outlook: With CATALYST, management believes the Cushing’s population is larger than historically assumed; reiterated path to $3–$5B revenue in 3–5 years .

Estimates Context

• Wall Street consensus (S&P Global) for Q4 2024 revenue and EPS could not be retrieved at this time due to system request limits; therefore, beat/miss versus consensus is unavailable. Future updates should anchor to S&P Global consensus when accessible.

Key Takeaways for Investors

• Growth intact despite timing noise: Q4 revenue (-0.4% QoQ) masked record patient activity; pharmacy bottlenecks are temporary and embedded in guidance; watch Q1/Q2 cadence for normalization .
• 2025 guide signals confidence: $900–$950M implies ~33–41% YoY growth, supported by broader screening, Korlym demand, and potential relacorilant approval trajectory .
• Major near-term catalyst: ROSELLA PFS readout with dual primaries de-risks path; a PFS win could unlock oncology expansion and filings; a PFS miss preserves OS optionality (~12 months) .
• Regulatory path for relacorilant (Cushing’s) de-risking: NDA submitted; no AdCom expected; long-term extension and GRADIENT support a broad efficacy/safety profile .
• Margin volatility likely near term: Elevated R&D/SG&A and operational scaling pressured Q4 margins; trajectory should improve with operating leverage if revenue onboarding normalizes and guidance materializes .
• Legal overhang extended: Teva appeal timing pushed; uncertainty persists, but management asserts strong position; outcome could influence generic dynamics and pricing .
• Stock setup: Into multiple binary/near-binary catalysts (ROSELLA, NDA acceptance, subsequent label progress), with strong core cash generation (YE cash/investments $603M) to fund development and commercialization .

Appendix: Additional Q4 Press Releases (Context)

• NDA submission for relacorilant (Cushing’s) announced Dec 30, 2024 .
• Long-term extension (up to 6 years) showed durable cardiometabolic benefits; significant 24-month BP reductions vs extension baseline .
• CATALYST treatment phase met primary endpoint with robust A1c reduction vs placebo .