Corcept Therapeutics: Fourth Time's A Charm For Mifepristone In PMD?

| About: Corcept Therapeutics (CORT)
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Summary

Mifepristone in psychotic major depression (PMD) has one positive phase 2 and three negative phase 3 clinical trials.

Management has made important trial design changes to the current phase 3 trial, most notably regarding placebo effect and dose.

The potential of mifepristone in psychotic major depression (PMD) is underappreciated by the market.

Corcept Therapeutics (NASDAQ:CORT) is a $368M (as of 4/14/2014) pharmaceutical company located in Menlo Park, CA, with 44 employees. Doctors Joseph Belanoff and Alan Schatzberg co-founded Corcept in 1998. Dr. Belanoff previously held multiple positions in the Department of Psychiatry and Behavioral Sciences at Stanford University and is now the CEO of Corcept. While at Stanford Dr. Belanoff published extensively on glucocorticoid signaling with Dr. Schatzberg. Dr. Schatzberg is a professor in the Stanford University School of Medicine Psychiatry and Behavioral Sciences Department and is an expert on glucocorticoid signaling. In the field of psychiatry he had held important administrative appointments, including President of the American Psychiatric Association, won numerous awards, and has published extensively.

Corcept is investigating the clinical benefit of interfering with cortisol signaling using glucocorticoid receptor (GR) antagonists. Glucocorticoids (cortisol is one) are steroid hormones that regulate many important functions of the body related to neuroendocrinology, metabolism, immunology, and the cardiovascular system. GR antagonists prevent cortisol from binding to the GR, which leads to decreased cortisol signaling. Corcept's lead GR antagonist is Korlym (mifepristone/Corlux) and was approved by the FDA in February 2012 for the treatment of endogenous Cushing's syndrome. Cushing syndrome is a rare disease that is caused by an excess of cortisol production by the adrenal glands. Corcept has already filled for Korlym approval in the EU and is also working on second generation GR antagonists in preclinical development. Corcept is also conducting a phase 1 trial with mifepristone in metastatic triple negative breast cancer (enrollment started April 2, 2014), which has already showed some early signs of efficacy.

The focus of this article will be to exam mifepristone in psychotic major depression (PMD). Mifepristone is currently in a phase 3 clinical trial called Study14 or RECors for treating psychotic symptoms in patients with major depressive disorder with psychotic features (also called psychotic major depression). Neurological clinical trials are historically very difficult due to high placebo responses and meta analysis in major depressive disorder (MDD) showed an average placebo response of 29.7% which ranged from 12.5%-51.8%. To learn more about PMD and mifepristone here is a great summary from Dr. Morgan Snyder. An interim look at the trial data is expected during 2Q14.

Psychotic major depression is associated with alterations in signaling pathways in the brain. More specifically, the hypothalamic pituitary adrenal axis (HPA) is altered. Cortisol is an important signaling component of the HPA, so altering with this pathway might provide patient benefit. There are no FDA approved therapies for PMD. Treatment options are limited to electroconvulsive therapy (ECT), antipsychotics, and antidepressants, which have limited efficacy and debilitating side effects. The primary endpoint for the trials discusses below is a reduction in the Brief Psychiatric Rating Scale - Positive Symptom Subscale scores (BPRS PSS). BPRS is an 18-item rating system that assess' psychopathology and PSS is a subset of four items in the BPRS that specifically measure psychosis (delusions, hallucinations, suspiciousness, and disorganized thinking).

Mifepristone has failed three phase 3 clinical trials in psychotic major depression

A pretty strong bear thesis! Below I summarize the negative trials and describe the lessons learned from the retrospective analysis of the failed trials that helped management make meaning trial design changes to the current phase 3 trial, Study 14.

Study 07 (Negative results Aug. 2006)
Randomized, double-blind, placebo-controlled

257 according to 2013 10-K, 20 sites US and 5 sites Eastern Europe

600mg mifepristone/Corlux or placebo for 7 days

Primary end point responders analysis: >50% decrease in BPRS PSS at both day 7 ("rapid") and day 56 ("sustained")

Results: Responders 30.5% mifepristone/Corlux and 28.6% placebo, no significant difference

Reasoning: High placebo response, for example at day 56 80% responders in both arms. A detailed evaluation of the trial results were published in 2009, I'll review the findings below.

Lessons Learned from Study 07

Issue #1: Site variability showed increased placebo response in Eastern Europe sites

There was a statistically significant difference in site-by-site treatment interaction. More specifically, " Mifepristone produced significantly higher response among the twenty sites who participated from the trial onset (p<0.05), whereas no difference was observed at the nine sites added late in the trial." The original sites showed responses of 26% vs. 13%, p=0.023, in favor of mifepristone while the added sides showed responses of 27% vs. 40%, p=0.384, in favor of placebo (see Table 3 below). Corcept explained further in their 2008 10-K that the 8 (publication said 9) added sites (majority in Eastern Europe) decreased the significance of their placebo arm and ultimately, the whole trial.

The first 150 patients were enrolled at mostly the same clinical sites as previously clinical trials, like the successful Study 03. This group would have shown statistical significance in favor of mifepristone "...before additional sites and promotional activities were added". But the trial continued, enrolling to 215 patients from same sites, which was also statistically significant. The trial continued to enroll, another 42 patients from 8 new sites, most in Eastern Europe. These 42 patients had a high placebo response, so when all the data was analyzed together, Study 07 failed. The difference between the first 215 patients and the later 42 patients showed a statically significant difference by treatment site.

Table 3 from Study 07 publication

FIX #1: Reduce number of sites and limit to US only

Study 14 only has 25 sites (vs. 28) which are limited to only the US to limit placebo response observed in European sites.

Issue #2: Are some patients getting an ineffective mifepristone plasma concentration at the 600mg dose?

Patients who achieve a plasma concentration above a certain threshold are more likely to show a response. Plasma concentrations of patients that were >1,800ng/mL were significantly more likely to respond than placebo patients (41% vs. 23%, p=0.031, Table 4 below). Management determined the optimal plasma level of mifepristone for distinguished responders from non-responders was 1661 ng/ml. The results are equally impressive in favor of the mifepristone arm at the ≥1661ng/mL cutoff, 42% vs. 17%, p=0.018.

Table 4 from Study 07 publication

FIX #2: Increase the mifepristone dose

Study 14 will be using 1,200mg mifepristone, increased from 600mg, which will increase the chance of patients reaching a plasma concentration ≥1661 ng/ml. Dosing will be discussed further below from Study 06.

Issue #3: Reduced placebo arm statistical power due to patient dropout

The number of patients in the placebo arm who dropped out of the trial ((126-97)/126 = 23.0%) is 9.3% higher than the number of patients on the mifepristone arm who dropped out of the trial ((131-113)/131 = 13.7%) (see Table 1 below). This could be because the placebo patients ("non-responders") were not getting benefit, and decided to leave the trial, which would favor the mifepristone arm. Especially since there is a 56 day "sustained" response measurement, the placebo patient who did not respond have no incentive to go back to the hospital and finish the trial.

Table 1 from Study 07 publication

FIX #3: Limit trial to US sites, increase focus on each site, and increase trial size

Difficult issue to fix, and fairly minor, but if patients are not getting a benefit because they are on the placebo arm, nothing stops them for dropping out of the trial. However Corcept can try a few things to retain the power of their intent to treat population arm. 1) Study 14 is only in the US, which might have a lower placebo arm dropout rate because in the Study 07 the placebo dropout rate of the original sites (mostly US) was 5.8% lower than the added Eastern European sites (23.0% vs. 17.2%). 2) With less trial sites to focus on and identifying the issue from previous trial experiences, Corcept might be able to retain placebo participants. 3) Study 14 has more patients, 450 from 257, which increases the statistical power and reduces the effect of dropout on the placebo arm.

Study 09 (Negative results Sept. 2006)
Randomized, double-blind, placebo-controlled

247 patients, 17 sites, Europe

600mg mifepristone/Corlux or placebo for 7 days

Primary end point responders analysis: >50% decrease in BPRS PSS at both day 7 ("rapid") and day 56 ("sustained")

Results: Day 56 approximately 95% responders

Reasoning: High (95%) placebo response

Lessons Learned from Study 09

Issue #1 All European sites and an astounding 95% placebo response

FIX #1 Only do PMD trials in the US

I am half joking, I think management is still scratching their heads on this one.

Study 06 (Negative results March 2007)

Randomized, double-blind, placebo-controlled

443 patients, 45 sites, US and Europe

300mg, 600mg, 1,200mg mifepristone/Corlux or placebo for 7 days

Primary end point responders analysis: >50% decrease in BPRS PSS at both day 7 ("rapid") and day 56 ("sustained")

Results: Did not meet primary endpoint, placebo effect was higher than expected, mifepristone safe and well tolerated at all 3 doses
Reasoning: Higher plasma levels demonstrated desired clinical effects. Predetermine level of 1661ng/mL mifepristone in plasma responders separated from placebo with statistical significance. A detailed evaluation of the results were published in 2011, I will review them below.

Lessons learned from Study 06.

Issue #1. Trial failed, but reported a correlation between mifepristone plasma concentration and clinical response

"This study confirms our previous observation that at higher plasma levels the drug candidate is able to demonstrate desired clinical effects. In particular, those patients in Study 06 who achieved a predetermined level of 1,661 nanograms of CORLUX per milliliter of plasma separated from the placebo group with statistical significance." Important to note, "predetermined level", this was new information used from Study 07. This result is almost as impressive as the Study 07 results: response rate of 52% vs. 34% (p=0.02) in favor of mifepristone when plasma concentrations were > 1661ng/ml (see Table 2 below). Importantly, higher mifepristone dose resulted in more patients achieving a plasma concentration >1661ng/ml in a dose dependent fashion, 300mg-21%, 600mg-45%, and 1,200mg-55% (see Table 3 below). The 1,200mg dose is safe and tolerable.

Table 2 and Table 3 from Study 06 publication

FIX #1: Increase the mifepristone dose

Same lesson learned from Study 07, Study 14 will be using 1,200mg mifepristone which will increase the chance of patients reaching a plasma concentration ≥1661 ng/ml.

Although it is concerning that the 1,200mg dose did not achieve statistical significance. The only rational management gives is that the placebo response was higher than expected. There were only 104 patients on the 1,200mg mifepristone arm and 103 on the placebo arm, so low numbers for a psychosis trial, difficult to get significance. Also concerning, the authors do not show response rates by dose. If there was a better response in the 1,200mg dose arm they probably would have highlighted it. I wonder why some patients are responders at 300mg and 600mg, while others appear to need 1,200mg? This difference might have to do with genetic variation between patients resulting in difference drug clearance rates. Regardless, higher dose does seem to increase the probability of a patient reaching a plasma concentration of >1,600ng/ml, which does predict for response.

Despite three failed phase 3 trials, Corcept initiated a fourth phase 3 trial in 2008, Study 14. If Study 14 was initiated in 2008, why are we still waiting for data in 2014? Well, in March 2009 management switched focus and devoted resources to mifepristone in Cushing syndrome. This probably ended up being a smart move since mifepristone was approved for Cushing syndrome in February 2012. Now management has turned focus back to PMD.

If mifepristone has failed three phase 3 trials in PMD, is there any reason to be optimistic for the fourth phase 3 trial?

There are a few reasons to think they have a chance:

1. Most notably the positive phase 2 trial (Study 03). How could three phase 3 trials all fail after a positive phase 2? One reason could be the modification of the primary endpoint, day 28 was a "sustained" response in the phase 2, but is now day 56 in the phase 3 trials. Also, immediately following the successful phase 2 in 2014, management launched two phase 3 trials in 2004 and a third in 2005, with no opportunity to modify phase 3 trial design. They thought they had it all figured out, when, in hindsight, the obviously did not.

Positive phase 2 (Corcept '03/Study 03) May 2004

Multi-center, randomized, placebo controlled

221 patients, 29 US sites

600mg mifepristone/Corlux or placebo

Primary end point responders analysis: >30% reduction in BPRS at day 7 ("rapid") and day 28 ("sustained")

Results: Detailed results from the trial were published in 2006. Mifepristone patients were significantly more likely to achieve a response than placebo arm, 48.6% vs. 42.2%, p=0.041 for BPRS Total. Although responders with >30% reduction in BPRS was significant, responders with >50% decrease in BPRS PSS were even more significant, 47.6% vs. 34.5%, p=0.006, which is probably the reason management moved forward with the BPRS PSS in future phase 3 trials. An important difference between the phase 2 trial and the phase 3 trials, is that a "sustained" response was only 28 days in the phase 2, the phase 3s have all been 56 days. There was no statistically significant difference in adverse events.

Management does acknowledge the high placebo response, which has been observed through their clinical trials, and offers an explanation: "Another notable finding of the study is the placebo response rate. Historically the placebo response rate in PMD was thought to be quite low with rates have ranging from 0 to 28 (Spiker and Kupfer 1988, Kocsis et al 1990 and Schatzberg and Rothschild 1992). More recently, higher placebo responses have been observed in two PMD inpatient trials (DeBattista et al 2003 and Rothschild et al 2004). There are a number of possibilities for the relatively high placebo response rate in this trial. One is that hospitalization and concurrent medications contributed to a higher placebo response rate than has been historically reported. Despite the precautions taken, it is also conceivable that patients may have entered the trial with a diagnosis that has a higher placebo response rate than does PMD."

The results were so impressive that the FDA even granted fast track status and informed Corcept that they will receive priority review if no other treatment is approved for psychotic features of psychotic depression at the time of NDA submission.

2. The retrospective analysis of the failed trials helped inform the optimal trial design for the current phase 3 trial, Study 14. I'll summarize the phase 3 trial Study 14 design below and comment on the changes management made.

Started Phase 3 (Study 14) March 2008 (NCT00637494)

Interim look expected 2Q14 (225 patients)

450 (up to) patients, 25 sites, US

1,200mg mifepristone for 7 days

Primary end point responders analysis: >50% decrease in BPRS PSS at both day 7 ("rapid") and day 56 ("sustained")

MedAvante centralized clinical rating services will help reduce rater variability and ensure accurate enrollment diagnosis which could help prevent high placebo responders from enrolling

Summary of Why the Fourth Time Might be a Charm for Mifepristone in PMD

1. PLACEBO

A) All sites are in US, to reduce placebo effect from previously observed European (Study 09) and Eastern European (Study 07) sites.

B) Limited to only 25 sites (previously 25, 17, and 47 sites in failed trials) because of previously observed differences between sites, limiting the number of sites limits the variability between sites.

C) Centralized clinical rating service MedAvante will help reduce rater variability and ensure enrollment diagnosis, mitigating potential high placebo responders from enrolling in the trial.

2. DOSE

A) 1,200mg dose (previously 300mg, 600mg, and 1,200mg in failed trials) will increase the probability that each patient will achieve a high plasma concentration of mifepristone and high plasma concentration increases the chances of a response.

3. POWER

Up to 450 patients (previously 257, 247, 443 patients in failed trials).
4. EXPERIENCE

Those three failed phase 3 trials are good for something!

Potential Risks

Valuation Risk

Low: $368M with $55M in cash, 6.7x, plus expected to generate revenue of $24-$28M in 2014.

Financial Risk

Medium: Corcept has $55M in cash plus expects to generate $24-$28M in revenue from approved Korlym in Cushing syndrome in 2014. Net loss was $46M in 2013, so assuming same burn rate, Corcept should have enough cash until 2016.

Development Risk

High: Mifepristone in PMD had failed three previous phase 3 trials. While changes to trial design have been made, there is still plenty of risk, especially when working in a psychosis trial with the potential for high placebo response. Plus, the primary endpoint of "sustained" response changed from the positive phase 2, day 28 day to day 56. Mifepristone in triple negative breast cancer is still in phase 1 and efficacy still needs to be shown.

Regulatory Risk

Medium: PMD is an unmet medical need and mifepristone already received fast track status and has the potential for priority review from the FDA, so >50% improvement responder analysis measured by BPRS PSS primary endpoint appears to be acceptable, although other drugs have not been approved using this primary endpoint. The regulatory path is uncertain for Korlym in Cushing syndrome in the EU, but is expected to follow FDA's lead.

Commercial Risk

Very high: No pharma partner, Korlym launch in Cushing syndrome already disappointed, with very slow launch and market low penetration, limited commercial experience. Risk to PMD launch alone could be equally disappointing, management has not discussed partnering.

Upcoming Events

2Q14 Interim phase 3 (Study 14) mifepristone psychotic major depression .

The data safety monitoring board (DSMB) will look at an interim analysis, the first 226 patients, of the current phase 3 trial, Study 14, and recommend stopping the trial for futility (failure), stopping the trial for efficacy (success) or continue will full enrollment to 450. If the trial is stopped for efficacy, Corcept plans to submit an NDA by the end of 2014. Based on my diligence, I think the chance of success is high for Study 14, 80%, but my predictions for the interim look are below:

Outcome

Chance

Market Cap

Price Movement

Rational

Continuation

40%

$331-$405M

+/-10%

Since I don't think the market is significantly valuing mifepristone in PMD (only ~$119M ($368-$194+$55)), I don't expect the market to react much to continuation news.

Efficacy

40%

$>1,000M

+172%

It is hard to estimate the upside, but modeling for just 30% success in PMD (vs. 10%) increases the valuation to over $1,000M

Futility

20%

$171-$257M

-54-30%

Value from Korlym in Cushing syndrome and cash will cushion the fall ($230+$55, plus -25% for market overreaction, +/-20% range), especially if you add some value for mifepristone in triple negative breast cancer and the second generation GR antagonists.

What is Corcept worth today?

$358M ($3.56/share) Mifepristone in psychotic major depression (PMD) (US and EU) (conservative, assumptions below)

$230M ($2.28/share) Korlym/mifepristone in Cushing syndrome (CS) (US and EU) (assumptions below)

$ 55M Cash ($0.55/share) (as of December 31, 2013)

$ 0M Second generation GR antagonists, mifepristone in triple negative breast cancer, or other indications (37 trials on clinicaltrials.gov)

Summary: The potential of mifepristone in psychotic major depression PMD is underappreciated by the market

$643M ($6.39/share) is about fair value for Corcept today, which is trading at $368M ($3.65/share), so roughly +75% upside. Of course accurate valuations are difficult, especially with the irrational moves of the stock market and macroeconomic factors, but my valuation calculations with assumptions are below. Of course binary bio events are very risky, but sometimes the risk-reward balance appears to be in your favor (high upside potential, low downside potential, see risk chart above). In short, the market is missing the potential value of mifepristone in PMD. I am long shares and August 16, 2014 calls options of Corcept.

Korlym In Psychotic Major Depression in US

15% Discount Rate

Year

Year Out

Potential Market Size

Cost/Year (M)

Penetration Rate

Revenue Opportunity

Royalty

To Market %

Revenue

Next Present Value

2014

1

0

$0.00

0.00%

$0

0

0

$0.00

$0.00

2015

2

0

$0.00

0.00%

$0

1

0

$0.00

$0.00

2016

3

2,200,000

$0.10

0.20%

$440

1

0.1

$44.00

$28.93

2017

4

2,200,000

$0.10

0.25%

$550

1

0.1

$55.00

$31.45

2018

5

2,200,000

$0.10

0.31%

$688

1

0.1

$68.75

$34.18

2019

6

2,200,000

$0.10

0.39%

$859

1

0.1

$85.94

$37.15

2020

7

2,200,000

$0.10

0.49%

$1,074

1

0.1

$107.42

$40.38

2021

8

2,200,000

$0.10

0.61%

$1,343

1

0.1

$134.28

$43.90

2022

9

2,200,000

$0.10

0.76%

$1,678

1

0.1

$167.85

$47.71

2023

10

2,200,000

$0.10

0.95%

$2,098

1

0.1

$209.81

$51.86

NPV

$316

Assumptions:

Potential Market Size

2.2M Psychotic major depression patients . 14.8M U.S. adults with Major Depressive Disorder (MDD) 14.7% have psychotic features (of those with MDD) (Corcept estimates 2-3M MDD patients)

Cost/Year

$10,000 average price per year of newer antipsychotics

Penetration Rate

0.20% starting penetration rare (conservative) in 2015, Study 14 success, file approval 2014, approval 2015, 25% y/y growth (conservative)

Royalty

1, assume they don't partner

To Market %

10% (conservative)

Discount Rate

15% standard

NPV calculate until peak sales to serve as realistic estimation

Korlym In Psychotic Major Depression in EU

15% Discount Rate

Year

Year Out

Potential Market Size

Cost/Year

Penetration Rate

Revenue Opportunity

Royalty

To Market %

Revenue

Next Present Value

2014

1

0

$0.00

0.00%

$0

0

0

$0.00

$0.00

2015

2

0

$0.00

0.00%

$0

0

0

$0.00

$0.00

2016

3

0

$0.10

0.00%

$0

0

0

$0.00

$0.00

2017

4

2,000,000

$0.10

0.20%

$400

0.2

0.1

$8.00

$4.57

2018

5

2,000,000

$0.10

0.25%

$500

0.2

0.1

$10.00

$4.97

2019

6

2,000,000

$0.10

0.31%

$625

0.2

0.1

$12.50

$5.40

2020

7

2,000,000

$0.10

0.39%

$781

0.2

0.1

$15.63

$5.87

2021

8

2,000,000

$0.10

0.49%

$977

0.2

0.1

$19.53

$6.38

2022

9

2,000,000

$0.10

0.61%

$1,221

0.2

0.1

$24.41

$6.94

2023

10

2,000,000

$0.10

0.76%

$1,526

0.2

0.1

$30.52

$7.54

NPV

$42

Assumptions:

Potential Market Size

2.0M Psychotic Major Depression patients . EU28 population 506M, prevalence of EU major depressive episode with psychotic features 0.4%
Cost/Year

$10,000 average price per year of newer antipsychotics

Penetration Rate

0.20% starting penetration rare (conservative) in 2017, Study 14 success, file approval 2015, approval 2016, 25% y/y growth (conservative)

Royalty

20% royalties in EU from pharma partner

To Market %

10% (conservative)

Discount Rate

15% standard

NPV calculate until peak sales to serve as realistic estimation

Korlym In Cushing Syndrome in US

15% Discount Rate

Year

Year Out

Potential Market Size

Cost/Year

Penetration Rate

Revenue Opportunity

Royalty

To Market %

Revenue

Next Present Value

2014

1

3,180

$0.20

3.80%

$24

1

1

$24.48

$21.29

2015

2

3,180

$0.20

5.70%

$37

1

1

$36.72

$27.76

2016

3

3,180

$0.20

8.55%

$55

1

1

$55.08

$36.21

2017

4

3,180

$0.20

12.83%

$83

1

1

$82.62

$47.24

2018

5

3,180

$0.20

19.24%

$124

1

1

$123.93

$61.61

NPV

$194

Assumptions:

Potential Market Size

3,180 Cushing syndrome patients (use conservative estimate 10/million). 318M US population, 10 people per million Cushing syndrome (CS) prevalence. Corcept estimates higher prevalence 20,000. FDA estimates 5,000

Cost/Year

$202,575 price per year, average Korlym dose is 750mg/day priced at $0.74/mg, FDA orphan designation in 2007

Penetration Rate

3.8% penetration for 2014 based on low end of 2014 company revenue estimates $24M, 3,180 patients , 50% y/y growth

Royalty

1, have not partnered

To Market %

1, approved

Discount Rate

15% standard

NPV calculate until peak sales to serve as realistic estimation (2019 lose orphan designation, designation lasts 7 years after approval, 2012)

Korlym In Cushing Syndrome in EU

15% Discount Rate

Year

Year Out

Potential Market Size

Cost/Year

Penetration Rate

Revenue Opportunity

Royalty

To Market %

Revenue

Next Present Value

2014

1

0

$0.00

0.00%

$0

0

0

$0.00

$0.00

2015

2

5,060

$0.20

2.00%

$21

0.2

0.9

$3.69

$2.79

2016

3

5,060

$0.20

3.00%

$31

0.2

0.9

$5.54

$3.64

2017

4

5,060

$0.20

4.50%

$46

0.2

0.9

$8.30

$4.75

2018

5

5,060

$0.20

6.75%

$69

0.2

0.9

$12.45

$6.19

2019

6

5,060

$0.20

10.13%

$104

0.2

0.9

$18.68

$8.08

2021

7

5,060

$0.20

15.19%

$156

0.2

0.9

$28.02

$10.53

2022

8

5,060

$0.20

22.78%

$234

0.2

0.9

$42.03

$13.74

NPV

$36

Assumptions:

Potential Market Size

5,060 Cushing Syndrome patients EU28 population 506M 10 people per million Cushing syndrome (CS) prevalence

Cost/Year

$202,575 price per year, average Korlym dose is 750mg/day priced at $0.74/mg, EU orphan designation in 2011

Penetration Rate

2% penetration for 2015, expect 2015 approval, approval application submitted before Jan. 2014, 50% y/y growth, pharma partner will help penetration

Royalty

20% royalties in EU from pharma partner

To Market %

90%, approved in EU

Discount Rate

15% standard

NPV calculate until peak sales to serve as realistic estimation (2022 lose orphan designation, designation lasts 7 years after approval, estimated approval 2014.

Disclosure: I am long CORT. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: I am also long CORT August 16, 2014 call options