CoreSep Therapeutics (CORT) Q2 2025: 49% Prescription Surge Outpaces Pharmacy Capacity, Setting Up Relacorlin Launch
CoreSep’s commercial growth engine is straining existing infrastructure as prescription volume surges 49% year over year, exposing pharmacy fulfillment as a bottleneck rather than a demand issue. The company’s strategic focus is shifting to expand pharmacy capacity and sales force ahead of Relacorlin’s expected approval, while oncology and pipeline programs lay the groundwork for multi-billion dollar opportunities. Execution on capacity and market education will determine how rapidly CoreSep can convert clinical momentum into revenue acceleration as new therapies approach market.
Summary
- Prescription Volume Outpaces Fulfillment: Demand for hypercortisolism therapies is accelerating faster than CoreSep’s pharmacy network can deliver.
- Pipeline Catalysts Nearing: Relacorlin’s pending approval and positive oncology data set up new commercial inflections.
- Execution Risks Center on Capacity: Pharmacy expansion and sales force ramp are critical to unlock full revenue potential.
Performance Analysis
CoreSep’s second quarter saw a dramatic 49% increase in tablets shipped year over year, reflecting both surging new prescriptions and a record number of patients on therapy. However, the company’s revenue growth was constrained by pharmacy fulfillment limitations, which management estimates created a $15 million drag on reported results. The authorized generic (AG) channel now represents two-thirds of business, up from just over half last quarter, and is priced at an average 30% discount to branded Corlum, reflecting payer negotiations and mix shift.
Management cited a strong underlying demand signal, with physician awareness and screening for hypercortisolism expanding rapidly following publication of the CATALYST study. This has led to days where new patient prescriptions now exceed prior monthly volumes. Despite this, delays in patient onboarding and titration due to pharmacy bottlenecks have created a lag between demand and revenue realization. The company is onboarding a second pharmacy, expected to contribute in Q4, and is expanding its clinical specialist team from 60 at the start of the year to a planned 175 by year-end.
- Volume-Driven Drag: Fulfillment delays, not prescription growth, drove the need to lower full-year revenue guidance.
- AG Mix and Pricing: Transition to authorized generic channel is largely complete, with further moderate mix shift expected.
- Sales Force Expansion: Headcount ramp is designed to capitalize on accelerating market education and patient identification.
The disconnect between prescription growth and reported revenue is a function of operational execution, not market demand, positioning CoreSep for a potential revenue catch-up as capacity comes online and Relacorlin launches.
Executive Commentary
"For the sixth quarter in a row, we added a record number of new prescribers and new prescriptions, and there are a record number of patients on therapy. We shipped more tablets to patients than ever before, 49% more, in the second quarter last year. Our financial results don't fully reflect this surge in demand."
Sean Maduke, President, Endocrinology Division
"The CATALYST trial, the largest and most rigorous of its kind, proves that there are far more patients with hypercortisolism than was previously believed, and that cortisol modulation is very beneficial for these patients. We expect [Relacorlin’s] approval on hypercortisolism by the end of this year and are eager to make it available immediately thereafter."
Dr. Joe Belanoff, Chief Executive Officer
Strategic Positioning
1. Hypercortisolism Franchise: Market Expansion and Fulfillment Gaps
CoreSep’s core business is rapidly expanding as new clinical evidence and education drive broader screening and diagnosis of hypercortisolism, but the company’s ability to monetize this growth is currently limited by pharmacy throughput. The transition to an authorized generic channel has largely stabilized, with pricing headwinds now baked into the model.
2. Relacorlin Launch: Next-Generation Growth Catalyst
Relacorlin, a next-generation cortisol modulator, is positioned to become the new standard of care pending its expected approval by year-end. Management forecasts $3-5 billion in annual revenue potential within three to five years, with even greater long-term upside as physician awareness and screening expand. Sales force growth and pharmacy network expansion are being accelerated to support a rapid launch and adoption curve.
3. Oncology Platform: Validated Expansion Beyond Endocrinology
Positive Phase III data from the ROSELLA trial in platinum-resistant ovarian cancer validate cortisol modulation as a new therapeutic mechanism in oncology. Relacorlin plus nab-paclitaxel demonstrated a 30% reduction in risk of progression and significant overall survival benefit, with a clean safety profile. The company is investing in a dedicated oncology division and preparing for regulatory submissions in the US and Europe, while also advancing trials in earlier-stage and other solid tumors.
4. Pipeline Diversification: ALS and Liver Disease Programs
Early signals in ALS and MASH (liver disease) programs suggest further optionality for the cortisol modulation platform, with regulatory engagement ongoing to determine the fastest path to market for ALS and Phase 2b data in liver disease expected next year. These programs represent long-term growth levers that could expand CoreSep’s addressable market well beyond current guidance.
Key Considerations
CoreSep’s quarter underscores a classic commercial inflection, where execution on infrastructure and education will dictate the pace of value realization. The company’s strategic context is shaped by:
Key Considerations:
- Pharmacy Bottleneck: Fulfillment delays are a material drag on near-term revenue, though management expects improvement as a second pharmacy comes online in Q4.
- Sales Force Leverage: Rapid expansion of clinical specialists is intended to accelerate physician education and capture the expanding patient pool.
- Authorized Generic Pricing: The AG channel’s 30% average discount to branded pricing is now a stable, known headwind, with further mix shift expected to be modest.
- Patent Litigation: While the Teva patent appeal outcome remains pending, management emphasizes that Relacorlin’s launch is the primary growth driver going forward.
- Pipeline Optionality: Oncology, ALS, and liver disease programs offer multi-billion dollar potential but require clinical and regulatory execution.
Risks
Execution on pharmacy expansion and patient onboarding remains the most immediate risk, with further delays potentially pushing revenue realization into later quarters. Regulatory timelines for Relacorlin and pipeline assets are critical gating factors, and any slippage could undermine near-term growth. Competitive dynamics in endocrinology and oncology, as well as payer negotiations on AG pricing, represent ongoing strategic risks that could impact market share and margins.
Forward Outlook
For Q3, CoreSep guided to:
- Continued improvement in pharmacy fulfillment, but with some lag as onboarding and training ramp up.
- Further sales force expansion to 175 clinical specialists by year-end, supporting market education efforts.
For full-year 2025, management lowered revenue guidance to:
- $850 to $900 million, reflecting fulfillment delays and longer patient onboarding/titration cycles.
Management highlighted several factors that will shape the outlook:
- Relacorlin’s expected approval and launch in hypercortisolism by year-end.
- Ongoing regulatory and market development for oncology and pipeline programs.
Takeaways
- Infrastructure, Not Demand, Limits Growth: CoreSep’s bottleneck is fulfillment capacity, not market appetite, positioning the company for a potential revenue acceleration as operational constraints ease.
- Relacorlin and Oncology Are Next Major Levers: The upcoming launch and positive trial data set the stage for a new growth phase, with large market opportunities beyond the current franchise.
- Execution and Timing Will Be Critical: Investors should monitor pharmacy onboarding, sales force productivity, and regulatory milestones as the primary drivers of near-term and long-term value creation.
Conclusion
CoreSep’s Q2 results highlight a business at the edge of a major commercial inflection, with clinical momentum and market expansion running ahead of operational capacity. Execution on pharmacy and sales force expansion will determine how quickly the company can translate demand into revenue and realize the full potential of its expanding pipeline.
Industry Read-Through
CoreSep’s experience is a textbook example of how clinical breakthroughs and market education can rapidly expand the addressable market for specialty therapeutics, but also how infrastructure and fulfillment can become chokepoints. For the broader biopharma sector, the quarter underscores the importance of proactive investment in distribution and market access ahead of major launches, especially as real-world demand can quickly outstrip legacy systems. Oncology and rare disease companies should note the potential for rapid physician adoption when supported by robust clinical data and education, but must plan for operational scalability to fully capture the opportunity.