CORT (CORT) Q3 2025: Hypercortisolism Tablets Surge 42.5% as Pipeline Expands Oncology Reach
CORT’s Q3 showcased surging hypercortisolism demand, but capacity bottlenecks and pipeline investments pressured near-term profit. The company’s core business is scaling, with 3,250 active patients and a 42.5% YoY increase in tablets shipped, while leadership is aggressively expanding its specialty pharmacy network and oncology trials. With major regulatory milestones ahead and a broadened clinical pipeline, CORT is positioning for multi-indication growth, though execution risks remain as launches and investments accelerate into 2026.
Summary
- Hypergrowth in Core Demand: Prescriptions and tablets for hypercortisolism set new records as physician awareness rises.
- Operational Strain and Network Transition: Pharmacy capacity constraints drove a shift to new distributors, with transition risks in Q4.
- Pipeline-Driven Expansion: Multiple late-stage trials and regulatory filings set up 2026 as a pivotal year for new indications.
Performance Analysis
CORT’s third quarter revealed robust underlying demand in its hypercortisolism franchise, with tablets shipped up 42.5% year-over-year and a record 3,250 paying patients on therapy at quarter-end. This surge reflects both heightened physician awareness and successful expansion of the clinical sales force, now at 150 specialists compared to 60 at the start of the year. However, financial results were pressured by persistent capacity constraints at the company’s previous pharmacy vendor, limiting the full revenue realization from the record prescription volume.
While revenue guidance was revised to $800 to $850 million for the year, net income fell sharply due to increased investment in R&D and SG&A as the company prepares for multiple launches and expands its clinical pipeline. The authorized generic (AG, lower-priced version of branded drug) now represents over 70% of hypercortisolism business, with a net price about 30% below the branded product, impacting gross margin mix. Despite these headwinds, CORT maintained strong cash reserves, aided by a $50 million share repurchase in Q3.
- Prescriber Base Expansion: The number of active prescribers continued to grow, supporting durable demand trends.
- Pharmacy Network Restructuring: Transition to new specialty pharmacy partners is underway, expected to resolve supply bottlenecks by early 2026.
- Margin Compression Watch: Mix shift to AG and launch investments are expected to weigh on near-term profitability, though management does not anticipate structural margin erosion.
Operational execution in the coming quarters will hinge on seamless pharmacy transition, absorption of new sales resources, and the ability to scale for anticipated demand from upcoming product launches.
Executive Commentary
"Our hypercortisolism business had another quarter of robust growth. In the third quarter, we shipped more tablets to patients than ever before, 42.5% higher than the third quarter of last year, driven by yet another record of prescriptions written for cortisol. Importantly, our base of prescribers has expanded substantially over the last two years. In summary, the underlying strength of our business continues to build. Our financial results don't fully reflect the surge in demand."
Sean Maddux, President, Endocrinology Division
"We have two new drug applications that are rapidly approaching their FDA target action, or PDUFA dates. Our NDA for reliquarylate as a treatment for patients with hypercortisolism has a PDUFA date of December 30th, 2025. Our NDA for reliquarylate as a treatment for women with platinum resistant ovarian cancer has a PDUFA date of July 11th, 2026. We believe the FDA will meet both deadlines."
Joe Belanoff, Chief Executive Officer
Strategic Positioning
1. Hypercortisolism Franchise Scaling
CORT’s core business remains the treatment of hypercortisolism, a rare endocrine disorder. With new prevalence data from the CATALYST study showing the condition is more common than previously thought, management is aggressively scaling its prescriber and sales base. The shift to new specialty pharmacies (Courant, OptiMe, and a third planned for 2026) is designed to match growing demand and prevent future fulfillment bottlenecks.
2. Oncology Pipeline Acceleration
Oncology is emerging as a major second growth pillar, with relacorilant (a selective cortisol modulator) advancing toward potential approval in platinum-resistant ovarian cancer. The company is launching multiple trials in adjacent indications (platinum-sensitive ovarian, endometrial, cervical, and pancreatic cancers), aiming to triple the eligible gynecological cancer patient pool from 20,000 to 60,000 in the US. The oncology strategy is built on the hypothesis that cortisol modulation can broadly enhance chemo and immunotherapy outcomes in solid tumors expressing the glucocorticoid receptor (GR).
3. Diversified Clinical Portfolio and Regulatory Milestones
CORT’s pipeline now spans late-stage trials in MASH (liver disease), ALS, and additional oncology settings, with key data readouts and regulatory decisions expected through 2026. The company’s approach is to match each new proprietary molecule to the therapeutic area where its pharmacology offers the greatest advantage, creating a diversified, multi-asset platform.
4. Capital Allocation and Margin Management
Despite increased R&D and SG&A investment, CORT maintains a strong cash position and continues to return capital via share repurchases. Management expects R&D spending to remain stable year-over-year, while SG&A will climb to support launches and sales force expansion. Margin dynamics will be closely watched as AG mix rises and launch costs ramp in 2026.
Key Considerations
This quarter marks a pivotal point as CORT transitions from a single-product rare disease company to a multi-indication platform with broad clinical ambitions. Investors should weigh the following:
Key Considerations:
- Pharmacy Transition Execution: The shift to new specialty pharmacies is essential to unlock demand and prevent fulfillment delays, but carries operational risk during the transition period.
- Pipeline Catalysts and Regulatory Timing: Multiple late-stage readouts and regulatory decisions (notably the December 2025 PDUFA for relacorilant in hypercortisolism and July 2026 for ovarian cancer) could reshape the company’s revenue base and valuation.
- Authorized Generic Margin Impact: The AG now comprises about 75% of hypercortisolism sales at a 30% price discount, impacting gross margin mix even as volume grows.
- Clinical and Commercial Expansion: Rapid sales force growth and broader prescriber education are expected to further accelerate demand, but require disciplined execution and cost control.
Risks
Key risks include potential delays or setbacks in regulatory approval, especially for relacorilant in hypercortisolism and ovarian cancer, as well as execution risk in transitioning pharmacy networks and scaling commercial infrastructure. The authorized generic’s growing share could pressure margins if not offset by volume or new product launches. Ongoing patent litigation with Teva remains unresolved and could impact exclusivity if CORT does not prevail on appeal.
Forward Outlook
For Q4 2025, CORT guided to:
- Revenue growth acceleration following the specialty pharmacy transition
- Sustained investment in R&D and SG&A to support upcoming launches and trial readouts
For full-year 2025, management maintained guidance of:
- $800 to $850 million in revenue
Management highlighted several factors that will drive performance:
- Completion of the pharmacy transition and onboarding of additional partners to meet demand
- Major regulatory milestones, including the December 2025 PDUFA date for relacorilant in hypercortisolism
Takeaways
Investors should focus on the interplay between surging demand, pharmacy execution, and pipeline-driven expansion.
- Hypergrowth in Tablets and Prescribers: Physician education and expanded sales force are unlocking new demand, but operational execution remains critical as volume outpaces legacy capacity.
- Pipeline Milestones Set Up 2026: Multiple late-stage data readouts and regulatory decisions in hypercortisolism, oncology, MASH, and ALS could transform the revenue profile and risk/reward for shareholders.
- Margin and Mix Headwinds: The AG mix and launch investment will weigh on near-term profitability, but management is confident in the long-term margin structure if volume and new indications ramp as planned.
Conclusion
CORT’s Q3 2025 demonstrates a business at a strategic inflection point, balancing surging core demand with operational and investment challenges as it pivots to a multi-indication growth model. Execution on pharmacy transitions and pipeline milestones will determine whether the company can fully capitalize on its expanding addressable market.
Industry Read-Through
CORT’s experience highlights a broader trend in rare disease and specialty pharma: rapid demand can quickly outstrip legacy distribution and fulfillment capacity, requiring proactive network expansion and robust commercial infrastructure. The company’s pipeline-driven strategy, leveraging new molecular entities tailored to specific disease biology, mirrors a shift toward platform-based growth in biotech. Investors in the sector should watch for similar bottlenecks and transition risks as companies scale from single-product to multi-asset portfolios. Additionally, rising AG mix as a margin headwind is a cautionary signal for peers with maturing rare disease franchises.