Release Date: July 29, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Corcept Therapeutics Inc (CORT, Financial) reported a 39% increase in revenue for Q2 2024, reaching $163.8 million.
- Net income for Q2 2024 was $35.5 million, up from $27.5 million in the same quarter of the previous year.
- The company has increased its 2024 revenue guidance to $640 million to $670 million.
- Significant progress in clinical development programs, including the CATALYST study showing a higher prevalence of hypercortisolism than previously assumed.
- Positive results from the GRACE study, demonstrating relacorilant's efficacy and safety in treating Cushing's syndrome.
Negative Points
- Ongoing legal battle with Teva over the marketing of a generic version of Korlym, with uncertainty around the timing of the Federal Circuit Court's decision.
- Potential market entry of additional generic competitors, which could impact revenue.
- Delay in the NDA submission for relacorilant to Q4 2024 due to the decision to include data from the GRADIENT trial.
- The CATALYST study's treatment results are still pending, which could affect future revenue projections.
- Challenges in expanding the market for Korlym and relacorilant, including pricing considerations for a potentially larger patient population.
Q & A Highlights
Highlights of Corcept Therapeutics Inc (CORT) Q2 2024 Earnings Call
Q: Joe, you mentioned in your prepared remarks that the screening have you seen an increase in screening treatment in terms of use of Korlym. I guess where are we in terms of the awareness of the prevalence of hypercortisolism and the Endo community now and in terms of the increase in screening?
A: (Joseph Belanoff, CEO) I really think we're just at the beginning of that. The results you're seeing in the second quarter are not a function of the CATALYST study results released in late June. However, in July, we have seen a pickup in interest, and I think that will continue through the year. Ultimately, the treatment portion of the CATALYST study will also be very meaningful.
Q: What are you seeing in terms of generic Korlym in that marketplace?
A: (Sean Maduck, President - Corcept Endocrinology) The Teva product has been available in the channel for many months but has had very little impact on our business.
Q: Following the presentation of the GRACE, open-label, and randomized withdrawal results at the recent conferences, what's been the feedback you've been getting from the Endo community so far?
A: (William Guyer, Chief Development Officer) The reception from investigators and clinicians has been outstanding. They were excited about the relacorilant results because we hit our primary endpoint and saw broad improvements across a range of signs and symptoms of Cushing's syndrome. The safety profile was also a key piece, with no relacorilant-induced adverse effects like hypokalemia or QT prolongation.
Q: As we look forward to the DAZALS' results, what would be a clinically meaningful change in the ALSFRS?
A: (William Guyer, Chief Development Officer) We are powered to see a 2.4-point difference in the ALS Functional Rating Scale, which is considered a clinically meaningful change by ALS experts.
Q: Regarding the Korlym AG, can you talk about your thought process for bringing an AG into the marketplace? How does that play into your thinking regarding the potential for one or two more generic entrants?
A: (Sean Maduck, President - Corcept Endocrinology) Making the AG available ensures that patients and their prescribing physicians have continuity of care and access to our support services. As for other potential generics, the earliest possible date for a second filer was July 19, and that date has passed without any new entrants.
Q: Are new prescribers coming from the endocrinology community or adjacent fields like diabetologists?
A: (Sean Maduck, President - Corcept Endocrinology) We have seen new prescribers emerge in both the diabetology and endocrinology spaces, as well as other specialties.
Q: How does the wider prevalence of hypercortisolism impact your thinking about the pricing of relacorilant?
A: (Sean Maduck, President - Corcept Endocrinology) We expect pricing to be roughly in line with Korlym. However, relacorilant could be priced at a premium due to its favorable efficacy and safety profile. We recognize that the market size will influence the price, and our pricing will reflect the market accurately.
Q: On the quarterly revenue growth, what factors are you taking into account when updating your guidance?
A: (Sean Maduck, President - Corcept Endocrinology) There has been very little impact from CATALYST in our year-to-date results, and we have included modest benefit in our updated guidance. We expect more patients in the second half of the year than initially expected, especially after the treatment arm results of the CATALYST study are available.
Q: What's the reason for the delay in relacorilant NDA submission to 4Q?
A: (Gary Robb, Chief Business Officer) We decided to include data from our GRADIENT trial in the NDA submission. This data will be available in the fourth quarter, so that's when we will submit the NDA.
Q: Regarding the Phase 4 CATALYST trial, how important is the outcome of Part 2 in expanding the TAM?
A: (Joseph Belanoff, CEO) We think the treatment study is very meaningful. The average hemoglobin A1c in patients who entered the CATALYST study was 8.8, indicating another problem, which in a quarter of them is hypercortisolism. Showing that these patients exist and that there is something you can do about it will be very meaningful.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
