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Msg  4342 of 4455  at  2/28/2023 6:20:08 PM  by


 In response to msg 4341 by  Bio_Tech_Boss
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Q4 call

 FWIW I thought it more positive than the PR.
(1) Charlie indicated that other securities litigation (other potential class action suits) will get resolved in due course now that they settled the first one.  Teva litigation may head to trial or perhaps settlement as judge denied summary judgement (after a year of deliberation).  So Teva moving very very slowly and may be even slower than Rela NDA filing!
(2) Revenue guidance is for 10% growth.  Slow and steady sales in 2023, that continue to cover growing trial expenses and investments....Jefferies "concern" about sales shot down IMHO.
(3) Making investments to grow Cushing's franchise -- will increase sales headcount by about 20% over next year and more importantly launching a 1,000 subject Phase 4 (with Mife) to establish potential role for helping patients with difficult to treat diabetes with GR modulators (if during screening they show elevated cortisol).  This trial will be a sleeper but IMHO could significantly increase addressable market for GR modulators.  Dig up Alan's old notes on "brittle diabetes" opportunity.  The large trial size and guidance of readout by year end 2023 was the positive surprise.
(4) Finally have enough subjects in screening to get topline of Rela P3 in Cushing's by early 2024, with NDA in Q1 (think March 2024).  The investment is the large P4 and sales force expansion (along with GRADIENT readout) sets the stage to make Rela a billion-dollar drug IMHO over next 5 years (assuming success in P3).
(5) Good news in other indications.  Guyer stated that ALS trial if sufficiently positive could be NDA enabling.   Expected Ovarian to be fully enrolled by year end 2023 based on number of trial sites recruiting and clinical investigator enthusiasm.  Lastly in NASH identified number of doses substantially lower that the initial (150mg) that result in significant fat reduction without any liver function elevation.  Now it seems they are trying to see how low they can go and still substantially effect liver fat with perhaps an improvement in liver function.  That last bit stuck me as being way better than anything I thought was possible.  That also explains the new 30mg cohort that they added in NASH trial.  So bottom line is that good progress and more optimism in all three of these indications - each as they make progress could be stock price moving.
I continue to think that sub 20 is a good entry point for swing shares with mid 20s exit.  Maybe we get there tomorrow is the sell side continues to focus on lackluster sales growth and misses the underlying positive news....

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