Sign in
CT

CORCEPT THERAPEUTICS INC (CORT)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 revenue was $157.2M, up 7.1% YoY but down 13.6% sequentially; EPS diluted was $0.17 vs $0.25 YoY, with operating income margin compressing to ~2.2% as SG&A and R&D rose and pharmacy capacity constraints limited shipments early in the quarter . Versus consensus, EPS beat (+$0.03), while revenue missed (−$20.7M), driven by January–February fulfillment constraints and a higher mix of authorized generics lowering net price per tablet by 13% YoY; March–April set records for tablets dispensed, pointing to stabilization and acceleration ahead .
  • 2025 revenue guidance was maintained at $900–$950M; management expects growth to accelerate through the year and into 2026 as pharmacy operations normalize, sales capacity expands, and awareness from CATALYST and MOMENTUM increases screening and treatment .
  • Strategic catalysts: FDA filed the relacorilant NDA in hypercortisolism (PDUFA Dec 30, 2025); ROSELLA Phase 3 (ovarian) met primary PFS endpoint (HR=0.70) with OS benefit (HR=0.69); ovarian NDA expected Q3 2025; ASCO late-breaker in June; ADA CATALYST treatment results presentation June 23 .
  • Litigation: Appeal vs Teva generic Korlym pending at Federal Circuit; oral argument earliest plausible July with decision 3–4 months later—a potential stock-moving legal catalyst .

What Went Well and What Went Wrong

What Went Well

  • “Record number of prescriptions from new and existing prescribers” and record tablets dispensed in March and April as pharmacy operations improved; guidance reiterated . Quote: “Pharmacy operations improved substantially in March and April, with each month setting a record for tablets dispensed” .
  • ROSELLA Phase 3 in platinum-resistant ovarian cancer achieved PFS (HR=0.70; p=0.008) and showed interim OS benefit (HR=0.69; p=0.012) with comparable safety, supporting Q3 NDA/MAA submissions and ASCO late-breaker visibility .
  • FDA filed relacorilant NDA for hypercortisolism (PDUFA Dec 30, 2025), backed by GRACE/GRADIENT and long-term extension data demonstrating efficacy and favorable safety without hypokalemia, progesterone-related AEs, adrenal insufficiency, or QT prolongation .

What Went Wrong

  • Revenue missed consensus due to early-quarter specialty pharmacy capacity constraints, delaying fills; net price per tablet declined 13% YoY as mix shifted toward authorized generic, compressing revenue despite robust prescription growth .
  • Profitability compressed: total operating expenses rose to $153.8M from $117.3M YoY; income from operations fell to $3.4M (EBIT margin ~2.2%), reflecting higher SG&A and R&D and price mix headwinds .
  • ALS Phase 2 (dazucorilant) did not meet primary ALSFRS-R endpoint; while exploratory analysis suggested OS benefit at 300mg, next steps require regulatory input, implying uncertainty and timing risk .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Millions)$182.546 $181.890 $157.214
Net Income ($USD Millions)$47.213 $30.746 $20.547
Diluted EPS ($USD)$0.41 $0.26 $0.17
Total Operating Expenses ($USD Millions)$135.948 $156.628 $153.798
Operating Income (EBIT) ($USD Millions)$46.598 $25.262 $3.416
Gross Margin (%)98.4% 98.4% 98.5%
EBIT Margin (%)25.5% 13.9% 2.2%

Notes:

  • YoY: Q1 2025 revenue $157.2M vs $146.8M in Q1 2024; diluted EPS $0.17 vs $0.25; operating expenses $153.8M vs $117.3M .

Estimates vs Actual (Q1 2025):

MetricConsensusActualBeat/Miss
Revenue ($USD Millions)$177.925*$157.214 MISS
Primary EPS ($USD)$0.1425*$0.17 BEAT

Values retrieved from S&P Global*

KPIs:

KPIQ4 2024Q1 2025
Cash & Investments ($USD Millions)$603.2 $570.8
Stock Repurchase ($USD Millions)$38.0 in FY2024 $43.3 in Q1 2025
Clinical Specialists (headcount)60 at start of 2024 125; plan 175 by YE 2025

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Revenue ($USD Millions)FY 2025$900 – $950 $900 – $950 Maintained

Regulatory/Milestone Timeline (informational):

  • Relacorilant (Hypercortisolism) NDA: FDA filed; PDUFA Dec 30, 2025 .
  • Relacorilant (Ovarian) NDA: submission expected Q3 2025; MAA shortly thereafter .
  • ASCO late-breaker: ROSELLA full results in June 2025 .
  • ADA: CATALYST treatment results presentation June 23, 2025 .
  • MOMENTUM (resistant hypertension prevalence) results by year-end .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024 and Q4 2024)Current Period (Q1 2025)Trend
Pharmacy operations/capacityNoted strong growth; Q4 revenue flat QoQ partly due to pharmacy operational challenges impacting timing of starts Constraints in Jan–Feb suppressed revenue; operations improved substantially in Mar–Apr with record tablets dispensed Improving
Authorized generic pricing mixEmphasis on growth; limited detail on AG mix AG share a little over half; net price per tablet −13% YoY; volume expected to overwhelm price impact Mix shifting to AG; price headwind offset by volume
Prescriber/patient growthRecord prescribers/patients; growing awareness; increased screening “Record” prescriptions; expectation for acceleration as awareness grows Strengthening
CATALYST (diabetes + hypercortisolism)Prevalence 1 in 4; treatment phase data expected by YE 2024 Diabetes Care publication (prevalence); treatment results to be presented at ADA; expected to drive increased screening Building external validation
ROSELLA (ovarian)Anticipated PFS readout; dual primary endpoints clarified later Met PFS; OS benefit at interim; NDA/MAA planned; ASCO late-breaker Positive inflection
Regulatory for relacorilant (Cushing’s)NDA submitted Dec 2024; safety profile emphasized FDA filed; PDUFA set; no AdCom expected Advancing
Litigation (Teva)Appeal pending; schedule uncertain Earliest plausible oral argument July; decision 3–4 months later Near-term legal catalyst

Management Commentary

  • CEO on hypercortisolism paradigm: “A rapidly increasing number of physicians now know that hypercortisolism is much more prevalent… They are screening and treating many more patients than ever before” .
  • CEO on ROSELLA: “The ROSELLA trial met its primary endpoint… median OS of 16 months vs 11.5 months… Safety and tolerability were comparable” .
  • Endocrinology President on operations and growth: “Our first quarter results… were affected by insufficient capacity at our pharmacy vendor… substantial improvement in March and April… expect growth to accelerate” .
  • CDO on CATALYST: “Patients who received Korlym exhibited a large reduction, 1.47% in hemoglobin A1c… p<0.0001… even with GLP-1s onboard” .
  • CDO on ALS: “Dazucorilant did not meet the primary endpoint… exploratory analysis showed significantly improved overall survival… HR 0.16 (p=0.0009)” .

Q&A Highlights

  • Ovarian positioning: Management sees relacorilant+nab-paclitaxel as a new standard across multiple lines, potentially before/after biomarker-driven agents (e.g., Elahere) .
  • Modeling cadence: No “bolus” expected; growth to accelerate through the year, stronger in H2 as initiatives and data roll out .
  • Korlym brand vs authorized generic: “A little over half” on AG; price discount ~12% list with negotiated payer net prices; volume growth expected to overwhelm price erosion .
  • AdCom for Cushing’s NDA: Not expected based on precedents and safety/efficacy profile; ready if requested .
  • Pharmacy fixes: Staffing increases and process remediation; distribution for relacorilant may broaden given no mifepristone diversion risk .
  • ALS path: Company to consult FDA/EMA on potential next steps (accelerated pathways vs additional study) given OS signal .

Estimates Context

  • Q1 2025 comparison: EPS $0.17 vs $0.1425 consensus (beat); revenue $157.2M vs $177.9M consensus (miss). Miss attributable to early-quarter pharmacy capacity constraints and AG price mix shift; EPS benefited from $10.9M income tax benefit and $6.2M interest/other income offsetting low operating income .
  • Outlook for estimates: Management’s reiterated $900–$950M FY revenue implies acceleration in H2; sell-side models may need to shift revenue cadence from Q2 bolus towards steadier ramp, and incorporate lower net price per tablet but higher volume and expanded sales capacity .
    Values retrieved from S&P Global*

Key Takeaways for Investors

  • Near-term trading catalysts: ASCO late-breaker ROSELLA data (June), ADA CATALYST treatment results (June 23), potential Federal Circuit oral argument (earliest July) and decision 3–4 months later—each can move the stock .
  • Operational normalization: Pharmacy constraints have eased; record March–April shipments and expanding clinical specialist headcount (125→175 by YE) support sequential revenue recovery into H2 .
  • Price/mix vs volume: Authorized generic mix reduces net price (−13% YoY), but volume growth from wider screening should overwhelm price dilution—monitor revenue trajectory and margin recovery .
  • Oncology upside: ROSELLA success plus Q3 ovarian NDA submission create a second growth pillar; safety parity with nab-paclitaxel and OS signal strengthen uptake case .
  • Relacorilant (Cushing’s) regulatory path: PDUFA Dec 30, 2025; no AdCom expected; GRACE, GRADIENT, and long-term extension form a robust efficacy/safety package .
  • Profitability watch: Q1 EBIT margin compressed to ~2.2% on higher OpEx and pricing mix; expect operating leverage improvement with volume ramp and stabilized fulfillment .
  • Legal optionality: A favorable appellate outcome could materially impact Korlym generic dynamics; timing suggests potential H2 headline risk/opportunity .