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Corcept Therapeutics

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FY2020 Annual Report · Corcept Therapeutics
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

☒

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2020

or

☐

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 000-50679

CORCEPT THERAPEUTICS INCORPORATED

(Exact Name of Corporation as Specified in Its Charter)

Delaware
(State or other jurisdiction of incorporation or organization)

77-0487658
(I.R.S. Employer Identification No.)

149 Commonwealth Drive
Menlo Park, CA 94025
(Address of principal executive offices) (zip code)

(650) 327-3270
(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12 (b) of the Act: 

Title of each class
Common Stock, $0.001 par
value

Trading Symbol(s)

Name of each exchange on
which registered

CORT

The Nasdaq Stock Market

Securities registered pursuant to Section 12 (g) of the Act: 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Acts. Yes ☒ No ☐

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

None

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports); and (2) has been subject to such filing
requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405

of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or
an  emerging  growth  company.  See  the  definitions  of  “large  accelerated  filer,”  “accelerated  filer,”  “smaller  reporting  company,”  and  “emerging  growth
company” in Rule 12b-2 of the Exchange Act.:

Large accelerated filer
Non-accelerated filer

☒
☐  

Accelerated filer
Smaller reporting company
Emerging growth company

☐
☐
☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any

new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal
control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared
or issued its audit report. ☒

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒ 

The  aggregate  market  value  of  voting  and  non-voting  common  equity  held  by  non-affiliates  of  the  Registrant  as  of  June  30,  2020  was  $1,632,998,185,
based on the closing price of $16.82 for shares of the Registrant’s common stock as reported on the Nasdaq Stock Market on June 30, 2020. Shares of
common stock beneficially owned by each executive officer, director and holder of more than 10% of our common stock have been excluded, in that such
persons may be deemed to be affiliates. This calculation does not reflect a determination that certain persons are affiliates of the Registrant for any other
purpose.

On February 17, 2021 there were 117,312,341 shares of common stock outstanding at a par value of $0.001 per share. 

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the Registrant’s definitive proxy statement for its 2021 Annual Meeting of Stockholders are incorporated by reference in Items 10, 11,

12, 13 and 14 of Part III. 

TABLE OF CONTENTS

Form 10-K

For the year ended December 31, 2020

ITEM 1.

Business

ITEM 1A.

Risk Factors

ITEM 1B.

Unresolved Staff Comments

ITEM 2.

ITEM 3.

Properties

Legal Proceedings

ITEM 4.

  Mine Safety Disclosures

PART I

PART II

ITEM 5.

  Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

ITEM 6.

Selected Financial Data

ITEM 7.

  Management’s Discussion and Analysis of Financial Condition and Results of Operations

ITEM 7A.

Quantitative and Qualitative Disclosures About Market Risk

ITEM 8.

ITEM 9.

Financial Statements and Supplementary Data

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

ITEM 9A.

Controls and Procedures

ITEM 9B.

Other Information

ITEM 10.

Directors, Executive Officers and Corporate Governance

ITEM 11.

Executive Compensation

PART III

ITEM 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

ITEM 13.

Certain Relationships and Related Transactions, and Director Independence

ITEM 14.

Principal Accounting Fees and Services

PART IV

ITEM 15.

Exhibits, Financial Statement Schedules

ITEM 16.

Form 10-K Summary

Signatures and Power of Attorney

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This  Annual  Report  on  Form  10-K  (“Form  10-K”)  contains  forward-looking  statements  within  the  meaning  of  Section  21E  of  the  Securities
Exchange  Act  of  1934,  as  amended  (“Exchange  Act”),  and  Section  27A  of  the  Securities  Act  of  1933,  as  amended  (“Securities  Act”).  All  statements
contained  in  this  Form  10-K,  other  than  statements  of  historical  fact,  are  forward-looking  statements.  When  used  in  this  report,  the  words  “believe,”
“anticipate,” “intend,” “plan,” “estimate,” “expect,” “may,” “will,” “should, “would,” “could,” “seek” and similar expressions are forward-looking
statements  based  on  management’s  current  expectations.  The  absence  of  these  words  does  not  mean  that  a  statement  is  not  forward-looking.  Forward-
looking statements include, but are not limited to, statements about:

PART I

•

•

•

•

•

•

•

•

•

our ability to manufacture, market and sell Korlym  (mifepristone) 300 mg Tablets (“Korlym”);

®

our estimates regarding enrollment in and the completion dates of our clinical trials and the anticipated results of these trials;

the progress and timing of our research and development programs and the regulatory activities associated with them;

our ability to realize the benefits of orphan drug designation for Korlym and the impact of possible future competition for Korlym or our product
candidates;

our estimates for future performance, including revenue and profits;

the  timing  of  regulatory  submissions  seeking  approval  of  product  candidates  and  the  commercialization  of  any  product  candidates  that  are
approved;

our ability to manufacture, market, commercialize and achieve market acceptance for our product candidates;

uncertainties associated with obtaining and enforcing patents; and

estimates regarding our future revenue, income and capital requirements.

Forward-looking  statements  involve  risks  and  uncertainties  and  are  not  guarantees  of  future  performance.  Actual  events  or  results  may  differ
materially for many reasons. For a more detailed discussion of the risks and uncertainties that may affect the accuracy of our forward-looking statements,
see  the  “Risk  Factors,”  “Overview”  and  “Liquidity  and  Capital  Resources”  sections  of  the  “Management’s  Discussion  and  Analysis  of  Financial
Condition  and  Results  of  Operations”  sections  of  this  Form  10-K.  You  should  also  carefully  consider  the  other  reports  and  documents  we  file  with  the
Securities and Exchange Commission (“SEC”).

Forward-looking  statements  in  this  Form  10-K  reflect  our  view  only  as  of  the  date  of  this  report.  Except  as  required  by  law,  we  undertake  no

obligation to update forward-looking statements.

Unless stated otherwise, all references in this document to “we,” “us,” “our,” “Corcept,” the “Company,” “our company” and similar words and

phrases refer to Corcept Therapeutics Incorporated.

ITEM 1. BUSINESS

Overview

We  are  a  commercial-stage  company  engaged  in  the  discovery  and  development  of  drugs  to  treat  severe  metabolic,  oncologic  and  psychiatric

disorders by modulating the effects of the steroid hormone cortisol.

Cortisol plays a significant role in the body’s response to stress and is essential for survival. Cortisol influences metabolism and the immune system
and contributes to emotional stability. Cortisol levels follow a diurnal rhythm that is essential to health, peaking upon awakening and decreasing during the
day.  Insufficient  cortisol  activity  may  lead  to  dehydration,  hypotension,  shock,  fatigue  and  hypoglycemia.  Excessive  cortisol  activity,  known  as
hypercortisolism, may lead to a suppressed immune response, impaired glucose tolerance, diabetes, obesity, fatty liver disease, depressed mood, psychosis,
wasting of the arms and legs, edema, fatigue, hypertension and other problems.

In addition, pre-clinical and clinical data suggest that cortisol reduces a patient’s immune response to oncogenesis, shields certain cancer cells from
the apoptotic effects of chemotherapy and facilitates the growth of others. Pre-clinical and clinical data also indicate that modulating cortisol activity may
improve outcomes in patients suffering from weight gain caused by antipsychotic medications (“AIWG”) and in patients with fatty liver disease and non-
alcoholic steatohepatitis (“NASH”), precursors of liver fibrosis and cirrhosis.

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Since  2012,  we  have  marketed  the  cortisol  modulator  Korlym  in  the  United  States  for  the  treatment  of  patients  with  a  form  of  hypercortisolism
known  as  endogenous  Cushing’s  syndrome.  The  challenge  in  treating  a  patient  with  Cushing’s  syndrome  is  modulating  cortisol’s  effects  without
suppressing them below normal levels or disrupting cortisol’s normal diurnal rhythm. Simply reducing or destroying the ability of the body to make cortisol
can cause serious harm. Cortisol activity can be modulated effectively by a drug that competes with cortisol as it attempts to bind to the glucocorticoid
receptor (“GR”). We do not sell Korlym internationally.

Because Korlym’s active ingredient, mifepristone, reduces the binding of excess cortisol to GR, it can modulate the effects of abnormal levels and
release patterns of cortisol without compromising cortisol’s healthy functions and rhythms. However, mifepristone also binds to the progesterone receptor
(“PR”), thereby terminating pregnancy and causing other adverse effects, including endometrial thickening and vaginal bleeding, a debilitating condition
suffered by a significant portion of women who take Korlym.

We have discovered more than 1,000 proprietary cortisol modulators that bind to GR but have no affinity for PR and so do not cause Korlym’s PR-
related  side  effects.  These  novel  molecules  share  Korlym’s  affinity  for  the  glucocorticoid  receptor  GR,  but,  unlike  Korlym,  do  not  bind  to  the  PR  and
therefore  do  not  cause  effects  arising  from  antagonism  of  progesterone  activity,  such  as  termination  of  pregnancy,  endometrial  thickening  and  vaginal
bleeding.  They  are  “selective”  cortisol  modulators.  The  composition  of  these  compounds  and  their  methods  of  use  in  a  wide  range  of  indications  are
covered by U.S. and foreign patents.

Our  lead  compounds  have  entered  the  clinic  as  potential  treatments  for  a  variety  of  serious  disorders  –  Cushing’s  syndrome,  solid  tumors  (i.e.,
advanced,  high-grade  serous  ovarian  cancer,  metastatic  pancreatic  cancer,  castration-resistant  prostate  cancer  and  adrenocortical  cancer  with  cortisol
excess), AIWG and NASH.

COVID-19 Pandemic

Due to the COVID-19 pandemic, much of the world is subject to public health orders of varying degrees of stringency, including in California,
where  our  headquarters  are  located,  and  the  states  where  most  of  our  clinical  specialists  and  medical  science  liaisons  live.  Restrictions  have  also  been
implemented  in  the  jurisdictions  where  our  clinical  trial  sites  are  located.  We  are  exempt  from  some  of  these  restrictions  in  some  jurisdictions  because
pharmaceutical companies are often deemed “essential businesses” that are allowed wider freedom to operate. Nonetheless, to protect the public health and
the health of our employees, we are conducting a significant portion of our business by means of video and teleconferences and e-mail. Most of our third-
party manufacturers, distributors (including the specialty pharmacy that dispenses Korlym), information technology service providers, law and accounting
firms, clinical research organizations and others are also subject to pandemic-related restrictions.

Public  health  restrictions,  as  well  as  measures  taken  by  patients,  physicians,  hospitals  and  medical  clinics  to  reduce  the  risk  of  coronavirus
infection  have  reduced  our  sales  and  made  it  difficult  to  grow  our  Korlym  business.  Many  hospitals  and  medical  practices  have  suspended  or  severely
restricted  visits  by  pharmaceutical  company  representatives,  which  has  reduced  the  effectiveness  of  our  sales  and  marketing  efforts.  When  educating
physicians about Cushing’s syndrome and Korlym’s potential to benefit their patients, close contact with our clinical specialists is important, especially for
physicians who are new to the medication. While we have implemented a program of teleconference and video meetings, which are useful, they are not as
effective as meeting in-person. Many physicians and patients have reduced the frequency of office visits, which, together with pandemic-related closures of
laboratory facilities and imaging centers and the reluctance of many patients to leave their homes, has made diagnosing and optimally treating patients with
Cushing’s syndrome difficult. All of these factors make it difficult to increase the number of patients who receive Korlym, which has reduced our sales,
even though there remain many patients who could benefit from the medication but have not received it.

The  pandemic’s  impact  on  the  pace  of  our  clinical  development  programs  has  been  variable.  Enrollment  has  slowed  significantly  in  trials  of
indications not considered immediately life-threatening, such as Cushing’s syndrome, CRPC, AIWG and NASH. In addition, to reduce the risk of COVID-
19 transmission and preserve medical resources for the treatment of patients with COVID-19, some clinical sites have stopped enrolling new patients or
have reduced the frequency with which physicians see study participants. Some sites have suspended or halted the initiation of new clinical trials. These
changes have lengthened the time it will take to complete most of our development programs, although trials in patients with immediately life-threatening
diseases, such as advanced pancreatic and ovarian cancer, have experienced many fewer disruptions and delays.

Please see the risk factor under Item 1A of this Annual Report, “The COVID-19 pandemic or other public health emergencies, natural disasters,
terrorism or other catastrophes could disrupt our activities and render our own or our vendors’ facilities and equipment inoperable or inaccessible and
require us to curtail or cease operations.”

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Cushing’s Syndrome

Background. Cushing’s syndrome is the clinical manifestation of hypercortisolism. An estimated 10 to 15 of every one million people are diagnosed
with  Cushing’s  syndrome  each  year,  resulting  in  approximately  3,000  new  patients  and  a  patient  population  in  the  United  States  of  about  20,000,
approximately half of whom are cured by surgery. Cushing’s syndrome most often affects adults between the ages of 20 and 50.

Most people with Cushing’s syndrome have one or more of the following symptoms: high blood sugar, diabetes, high blood pressure, upper body
obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances
and depression are also common. Cushing’s syndrome can affect every organ system in the body and can be lethal if not treated. The preferred treatment is
surgery,  which,  if  successful,  can  cure  the  disease.  In  approximately  half  of  patients,  surgery  is  not  successful  because  the  tumor  cannot  be  located  or
removed completely. Depending on the type of tumor, surgery can also result in a range of complications.

Korlym  to  Treat  Patients  with  Cushing’s  Syndrome.  We  sell  Korlym  in  the  United  States,  using  experienced  sales  representatives  to  call  on
physicians caring for patients with endogenous Cushing’s syndrome (hypercortisolism). Because many people who suffer from Cushing’s syndrome are
undiagnosed or inadequately treated, we have developed and continue to refine and expand programs to educate physicians and patients about screening for
hypercortisolism and the role Korlym can play in treating the disorder. We also have a field-based force of medical science liaisons.

We  use  one  specialty  pharmacy  and  one  specialty  distributor  to  distribute  Korlym  and  provide  logistical  support  to  physicians  and  patients.  Our
policy is that no patient with Cushing’s syndrome will be denied access to Korlym for financial reasons. To help us achieve that goal, we fund our own
patient support programs and donate money to independent charitable foundations that help patients pay for all aspects of their Cushing’s syndrome care,
whether or not that care includes taking Korlym.

Relacorilant  to  Treat  Patients  with  Cushing’s  Syndrome.  We  are  conducting  two  Phase  3  trials  of  our  proprietary,  selective  cortisol  modulator,
relacorilant,  as  a  potential  treatment  for  hypercortisolism.  Relacorilant  was  well-tolerated  in  its  Phase  1  and  Phase  2  trials.  Patients  in  the  Phase  2  trial
exhibited meaningful improvements in glucose control and hypertension, as well as weight loss, improved liver function, coagulopathy, cognition, mood,
insulin resistance and quality of life. Importantly, relacorilant shares Korlym’s affinity for GR, but unlike Korlym, has no affinity for PR and so does not
cause the effects associated with PR affinity, including termination of pregnancy, endometrial thickening and vaginal bleeding. Relacorilant also does not
appear  to  cause  hypokalemia  (low  potassium),  a  potentially  serious  adverse  event  that  is  the  leading  cause  of  patients  stopping  treatment  with  Korlym.
Forty-four percent of patients in Korlym’s pivotal trial experienced hypokalemia.

Our  Phase  3  “GRACE”  trial  has  a  planned  enrollment  of  130  patients  at  sites  in  the  United  States,  Canada,  Europe  and  Israel.  Each  patient  in
GRACE will receive relacorilant for 22 weeks. Those who exhibit pre-specified improvements in hypertension or glucose metabolism will enter a 12-week,
double-blind, “randomized withdrawal” phase, in which half of the patients will continue receiving relacorilant and the rest will receive placebo. GRACE’s
primary endpoints are the rate and degree of relapse in patients receiving placebo compared to those continuing treatment with relacorilant. If successful,
we expect GRACE to provide the basis for a new drug application (“NDA”) for relacorilant to treat patients with all etiologies of Cushing’s syndrome.

Last year, we initiated our double-blind, placebo-controlled Phase 3 “GRADIENT” trial to evaluate relacorilant as a potential treatment for patients
whose  Cushing’s  syndrome  is  caused  by  an  adrenal  tumor.  Patients  with  this  etiology  of  Cushing’s  syndrome  typically  have  a  more  indolent  course  of
disease, although their health outcomes are poor. This etiology of Cushing’s syndrome has not been rigorously studied. Patients with adrenal Cushing’s
syndrome would benefit from an improved understanding of the role cortisol modulation may play in their treatment.

GRADIENT has a planned enrollment of 130 patients, half of whom will receive relacorilant and half of whom will receive placebo for 26 weeks.
GRADIENT’s  primary  endpoints  are  improvements  in  hypertension  and  glucose  metabolism.  Many  of  the  clinical  sites  in  GRACE  are  participating  in
GRADIENT. Pandemic-related restrictions and disruptions have slowed enrollment in these trials.

The United States Food and Drug Association (“FDA”) and the European Commission (“EC”) have designated relacorilant as an orphan drug for the
treatment  of  Cushing’s  syndrome.  In  the  United  States,  relacorilant’s  orphan  designation  confers  tax  credits,  reduced  regulatory  fees  and,  provided  we
obtain approval for the treatment of Cushing’s syndrome, seven years of exclusive marketing rights for the treatment of patients with Cushing’s syndrome.
Benefits of orphan drug designation by the EC are similar, but also include protocol assistance from the European Medicines Agency (“EMA”), access to
the EU’s centralized marketing authorization procedure and, if we obtain approval, ten years of exclusive marketing rights in the

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European Union (“EU”) for the treatment of patients with Cushing’s syndrome. The EC based its orphan designation on its finding that there was plausible
evidence of relacorilant’s efficacy and potential to confer significant clinical benefit compared to already approved treatments.

In  neither  the  United  States  nor  the  EU  does  orphan  drug  designation  shorten  the  drug  approval  process,  make  approval  more  likely  or  prevent

competitors from marketing other drugs for the treatment of Cushing’s syndrome.

FKBP5 Gene Expression Assay. The tests used to diagnose patients with hypercortisolism and optimize their treatment are imprecise and often fail
to  identify  patients  with  less  severe  manifestations  of  the  disease.  We  have  developed  an  assay  to  measure  expression  of  the  gene  FKBP5,  which  is
stimulated by cortisol activity, and have completed analytical validation pursuant to the Clinical Laboratory Improvement Amendments (“CLIA”). Clinical
data indicate that FKBP5 levels are high in patients suffering from hypercortisolism (i.e., excess cortisol activity), but subside when they are successfully
treated. We are testing this hypothesis in the GRACE trial. We believe successful development of this assay will enable physicians to identify new patients
with hypercortisolism more easily and to better treat those already in their care.

Oncology

There is substantial in vitro, in vivo and clinical evidence that cortisol’s activity allows certain solid tumors to resist treatment. In some cancers,
cortisol  activity  promotes  tumor  growth.  In  other  cancers,  cortisol  stimulates  genes  that  retard  cellular  apoptosis.  Cortisol  also  suppresses  the  body’s
immune  response.  However,  activating,  not  suppressing,  the  immune  system  is  beneficial  in  fighting  certain  cancers.  Adding  a  cortisol  modulator  to  a
treatment regimen may help the patient’s immune system combat the disease. Many types of solid tumors express GR and are potential targets for cortisol
modulation therapy, among them pancreatic, ovarian, castration-resistant prostate and adrenocortical cancer. We own, or have exclusively licensed, several
patents covering the use of cortisol modulators to treat pancreatic, cervical, breast and prostate cancers.

Relacorilant in Patients with Solid Tumors.  In  July  2020,  we  completed  enrollment  in  our  178-patient,  controlled,  Phase  2  trial  of  relacorilant  in
combination  with  nab-paclitaxel  in  patients  with  advanced,  high-grade  serous  ovarian  tumors.  We  randomized  two-thirds  of  the  patients  to  receive
relacorilant plus nab-paclitaxel, while the rest receive nab-paclitaxel alone. The trial’s primary endpoint is progression-free survival, as measured using the
Response Evaluation Criteria in Solid Tumors. Secondary endpoints include overall response rate, duration of response, best overall response and overall
survival. We expect data from this trial to be available in the first half of 2021.

We are also conducting a Phase 3 trial (“RELIANT”) of relacorilant plus nab-paclitaxel to treat patients with metastatic pancreatic cancer. RELIANT
is expected to enroll 80 patients, all of whom will receive relacorilant plus nab-paclitaxel. We plan to perform an interim analysis of data from the first 43
patients (the last of which enrolled in January 2021) in the first half of 2021.

We  have  initiated  an  open-label,  Phase  1b  trial  of  relacorilant  plus  the  PD-1  checkpoint  inhibitor  pembrolizumab  in  20  patients  with  advanced
adrenocortical cancer with cortisol excess. Because adrenocortical tumors produce cortisol, these patients suffer from both cancer and Cushing’s syndrome.
Our  trial  will  evaluate  whether  relacorilant  can,  by  reducing  the  effects  of  excess  cortisol  activity,  treat  these  patients’  Cushing’s  syndrome  and,  by
reversing cortisol-induced immune suppression, help pembrolizumab achieve its maximum tumor-killing effect.

Cortisol Modulators to Treat Patients with CRPC. Because androgens stimulate prostate tumor growth, androgen deprivation is a common treatment
for metastatic prostate cancer. Tumors eventually escape androgen deprivation therapy through the proliferation of cells for which cortisol’s stimulation of
GR and cortisol’s stimulation of mutated androgen receptors are primary growth factors. Combining a cortisol modulator with an androgen modulator such
as Xtandi (enzalutamide) may block this escape route.

We  are  conducting  a  dose-finding  trial  of  our  proprietary,  selective  cortisol  modulator  exicorilant  in  combination  with  Xtandi  in  patients  with
metastatic CRPC. Independently, investigators at the University of Chicago are conducting a dose-finding trial of relacorilant combined with Xtandi in the
same patient population. We are providing relacorilant.

Relacorilant has been designated an orphan drug in both the United States and the EU for the treatment of pancreatic cancer. In addition, we hold
U.S. and international patents covering relacorilant’s composition of matter and U.S. patents covering its use to treat patients with pancreatic and ovarian
cancer. In  addition,  we  own  or  have  exclusively  licensed  U.S.  and  European  patents  covering  relacorilant’s  composition  of  matter  and  its  use  to  treat  a
variety of disorders, including pancreatic cancer, castration-resistance prostate cancer (“CRPC”) and other solid tumors.

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Metabolic Disorders

Antipsychotic-Induced Weight Gain (“AIWG”). In animal models, our proprietary selective cortisol modulator miricorilant prevents and reverses
the weight gain caused by the antipsychotic medication olanzapine. These findings are similar to the results generated with mifepristone in the same animal
models and from placebo-controlled clinical trials in which mifepristone significantly reduced the weight gain and adverse metabolic effects experienced
by healthy subjects administered olanzapine or the antipsychotic medication risperidone. The results of these trials were published in the journals Advances
in Therapy, Gross et al (2009) and Obesity, Gross et al (2010).

Extensive  pre-clinical  and  clinical  data  suggest  that  our  propriety,  selective  cortisol  modulator  miricorilant  can  prevent  weight  gain  and  other
metabolic side-effects caused by antipsychotic medications such as olanzapine. In a double-blind, placebo-controlled Phase 1b trial, 96 healthy subjects
received daily doses of olanzapine (10 mg) and either miricorilant (600 mg or 900 mg) or placebo for 14 days. Study participants who received miricorilant
gained less weight than subjects receiving placebo. In addition, markers of liver damage that rise temporarily at the start of olanzapine therapy increased
less sharply in subjects receiving miricorilant, suggesting that miricorilant may have protective effects in the liver.

We  are  conducting  two  Phase  2,  double-blind,  placebo-controlled  trials  of  miricorilant  in  the  reversal  of  AIWG  –  “GRATITUDE”  and

“GRATITUDE II.”

GRATITUDE  has  a  planned  enrollment  of  100  patients  with  schizophrenia  or  bipolar  disorder  with  recent  weight  gain  at  30  sites  in  the  United
States. Study participants will receive their established antipsychotic medication and either miricorilant (600 mg) or placebo for 12 weeks. GRATITUDE II
has a planned enrollment of 150 patients with schizophrenia and long-standing AIWG at 35 centers in the United States. The primary endpoint in both trials
is reduction in body weight.

NASH. Miricorilant is potent in animal models of fatty liver and liver fibrosis, which are precursors of cirrhosis. We are conducting a double-blind,
placebo-controlled, Phase 2 trial that is expected to enroll 150 patients with NASH, as determined by MRI, at 15 sites in the United States. Patients will
receive a daily dose of miricorilant (600 mg or 900 mg) or placebo for 12 weeks. The primary endpoint is reduction in liver fat content.

Development of our Other Selective Cortisol Modulators

Our portfolio of proprietary selective cortisol modulators consists of four structurally distinct series totaling more than 1,000 compounds, including
relacorilant, exicorilant and miricorilant. These compounds potently bind to GR but not the progesterone, estrogen or androgen receptors. We hold U.S. and
foreign patents covering these compounds and their methods of use in a wide range of indications. We have applied, and will continue to apply, for patents
covering the composition and method of use of our products and product candidates. See “Business – Intellectual Property.”

Many  of  our  proprietary  compounds  have  demonstrated  positive  results  in  animal  or  in  vitro  models  of  cortisol  modulation.  One  such  molecule,
CORT113176, has shown promise in animal models of amyotrophic lateral sclerosis (“ALS”). It has completed Phase 1 and we plan to advance it to Phase
2 as a potential treatment for that disease. We plan to continue identifying selective cortisol modulators and advancing the most promising of them towards
the clinic.

Studies by Independent Investigators

For many years we have advanced our understanding of cortisol modulation by supporting the work of independent academic investigators. These
researchers have studied the potential utility of mifepristone or our proprietary selective cortisol modulators in a wide range of disorders, including central
serous  retinopathy,  post-traumatic  stress  disorder,  anxiety,  alcoholism,  cocaine  addiction,  Alzheimer’s  disease,  ALS,  Cushing’s  syndrome,  metabolic
syndrome, atherosclerosis, fatty liver disease and solid tumors, including triple-negative breast, prostate, ovarian and non-small cell lung cancers, as well as
sarcoma and melanoma.

Clinical Trial Agreements

We typically conduct our clinical trials with the assistance of clinical research organizations (“CROs”). ICON plc is helping us conduct our GRACE
and GRADIENT trials. IQVIA Inc. is helping us conduct our Phase 2 trial of relacorilant to treat patients with metastatic ovarian cancer and our dose-
finding trial of exicorilant to treat patients with CRPC. Medpace, Inc. is helping us conduct our GRATITUDE, GRATITUDE II and RELIANT trials. We
may terminate our agreements with ICON and IQVIA on 60 days’ written notice. Our agreement with Medpace may be terminated by us without cause at
any time.

5

Research and Development Spending

We incurred $114.8 million, $89.0 million and $75.2 million of research and development expenses in the years ended December 31, 2020, 2019 and

2018, respectively, which accounted for 51 percent, 46 percent and 47 percent, respectively, of our total operating expenses in those years.

Manufacturing Korlym

We  rely  on  contract  manufacturers  to  produce  Korlym  and  our  product  candidates.  In  March  2014,  we  entered  into  an  agreement  with  Produits
Chimiques  Auxiliaires  et  de  Synthese  SA  (“PCAS”)  to  produce  mifepristone,  the  active  pharmaceutical  ingredient  (“API”)  in  Korlym.  In  2018,  we
amended this agreement and extended its term to December 31, 2021, with two one-year renewals that will occur automatically unless either party gives 12
months advance written notice of its intent not to renew. The amendment also provides for exclusivity between PCAS and Corcept, unless PCAS is unable
to meet our requirements, in which case we may purchase mifepristone from another supplier.

We have agreements with two third-party manufacturers to produce and bottle Korlym tablets.

Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act (“FDCA”)

The  FDCA  establishes  an  approval  process  for  generic  versions  of  already  approved  (or  “Innovator”)  drugs  through  the  submission  of  an
Abbreviated  New  Drug  Application  (“ANDA”).  The  proposed  generic  drug  must  have  the  same  active  ingredients,  dosage  form,  strength,  route  of
administration,  labeling,  performance  characteristics  and  intended  use,  among  other  things,  as  the  Innovator  drug.  ANDAs  are  termed  “abbreviated”
because they need not include data establishing safety or efficacy. Generally, generic applicants must only demonstrate that their product is bioequivalent
to, or performs in the same manner as, the Innovator drug.

ANDA  applicants  must  certify  that  any  patents  listed  by  the  owner  of  the  Innovator  drug  in  the  Orange  Book  are  expired,  invalid  or  will  not  be
infringed by the manufacture, use or sale of the proposed generic product. This is known as a “Paragraph IV certification.” If the owner of the Innovator
drug sues the ANDA applicant for infringement of one or more Orange Book patents within 45-days of receiving notice of a Paragraph IV certification, the
FDA approval of the ANDA application is automatically stayed until the earlier of (i) 30 months from the receipt of the Paragraph IV certification or (ii) a
trial court decision finding the asserted Orange Book patents are invalid, unenforceable or not infringed. This prohibition is commonly referred to as the
“30-month stay.” Owners of Innovator drugs regularly challenge paragraph IV certifications and trigger 30-month stays.

We are engaged in ANDA litigation with Teva Pharmaceuticals USA, Inc. (“Teva”) and Sun Pharmaceutical Industries Limited (“Sun Ltd.”) with
respect  to  their  proposed  generic  versions  of  Korlym.  In  addition,  Teva  challenged  the  validity  of  one  of  our  patents  in  a  post  grant  review  (“PGR”)
proceeding before the Patent Trial and Appeal Board (“PTAB”). In November 2020, the PTAB decided all of Teva’s claims in this PGR in Corcept’s favor.
Teva has until March 12, 2021 to file its appeal brief with Federal Circuit Court of Appeals. In addition, on February 1, 2021, we received a Paragraph IV
Notice  Letter  advising  that  Hikma  Pharmaceuticals  USA  Inc.  (“Hikma”)  submitted  an  ANDA  to  the  FDA  seeking  authorization  from  the  FDA  to
manufacture, use or sell a generic version of Korlym in the United States. Under the terms of the Hatch Waxman Act, we have until March 15, 2021 to
bring suit against Hikma.

See “Part I, Item 3, Legal Proceedings.”

Competition for Korlym

Korlym  competes  with  established  treatments,  including  surgery,  radiation  and  other  medications,  including  “off-label”  uses  of  drugs  such  as
ketoconazole, an anti-fungal medication. Korlym also competes with Signifor® (pasireotide) Injection and Isturisa  (osilodrostat). Both drugs are sold by
the Italian pharmaceutical company Recordati S.p.A. (“Recordati”). Both drugs are approved by the FDA for the treatment of adult patients with Cushing’s
disease who are not candidates for pituitary surgery or for whom surgery did not work. Cushing’s disease is a subset of Cushing’s syndrome. In the EU,
Isturisa is also approved as a treatment for Cushing’s syndrome.

®

The  orphan  drug  marketing  exclusivity  period  for  Korlym  ended  in  February  2019,  which  means  a  competitor  that  receives  FDA  approval  for  a
generic equivalent of Korlym may market its drug to patients with Cushing’s syndrome, provided doing so would not infringe any of our patents. Korlym
may  also  experience  competition  from  new  compounds.  Strongbridge  Biopharma  plc  is  seeking  approval  in  the  United  States  and  Europe  to  market
levoketoconazole, a chiral form of the commonly-prescribed cortisol synthesis inhibitor ketoconazole, as a treatment for patients with Cushing’s syndrome.

6

Intellectual Property

Patents and other proprietary rights are important to our business. We own ten U.S. composition of matter patents covering our selective cortisol
modulators and 55 U.S. patents covering the use of cortisol modulators to treat a variety of serious disorders, including Cushing’s syndrome and own an
extensive  portfolio  of  patents  in  countries  around  the  world.  We  have  applied,  and  will  continue  to  apply,  for  U.S.  and  foreign  patents  covering  the
composition and method of use of our products and product candidates.

Korlym.  The  composition  of  matter  patent  covering  Korlym’s  active  ingredient,  mifepristone,  has  expired.  The  only  other  FDA-approved  use  of
mifepristone is to terminate pregnancy. We hold 16 U.S. method of use patents listed in the FDA Orange Book covering various uses of Korlym in the
treatment of patients with Cushing’s syndrome, with additional patent applications that may be suitable for listing in the Orange Book under examination at
the USPTO. Our current Orange Book patents have expiration dates ranging from 2028 to 2038.

To  protect  our  market  for  Korlym  we  rely  on  (1)  our  method  of  use  patents,  (2)  the  significant  restrictions  imposed  by  the  FDA  on  the  use  of
mifepristone  to  terminate  pregnancy  and  (3)  the  different  patient  populations,  administering  physicians  and  treatment  settings  between  the  use  of
mifepristone to terminate pregnancy and to treat Cushing’s syndrome.

Oncology. We have exclusively licensed eight U.S. method of use patents from the University of Chicago covering the use of glucocorticoid receptor
antagonists,  including  mifepristone,  in  the  treatment  of  castration-resistant  prostate  cancer  in  combination  with  androgen  deprivation  agents  and  triple-
negative breast cancer in combination with anti-cancer agents. This license also covers related applications in countries around the world. See “Business -
License Agreements.”

Other Method of Use Patents. In addition to our patents relating to Cushing’s syndrome, we own U.S. and foreign patents for the use of cortisol
modulators  in  the  treatment  of  pancreatic  cancer,  weight  gain  caused  by  antipsychotic  medications,  mild  cognitive  impairment,  delirium,  catatonia,
psychosis induced by interferon-alpha therapy, migraine headaches, gastroesophageal reflux disease, neurological damage in premature infants and in the
treatment of diseases using combination steroid and GR antagonist therapy. We own patents covering the optimization of mifepristone plasma levels in the
treatment  of  patients  suffering  from  disorders,  including  Cushing’s  syndrome,  amenable  to  treatment  with  mifepristone.  We  also  own  patents  covering
prevention and treatment of stress disorders, improvement of therapeutic response to electroconvulsive therapy and inhibition of cognitive deterioration in
adults with Down’s Syndrome. The expiration dates of these patents and their foreign counterparts range from 2020 to 2039.

Composition of Matter Patents Covering Our Proprietary, Selective Cortisol Modulators. We have ten U.S. composition of matter patents containing
claims relating to our next-generation cortisol modulators. Foreign counterparts of five of these patents have issued in Europe. The expiration dates of these
patents and their foreign counterparts range from 2025 to 2034.

We have filed, in appropriate jurisdictions, foreign patent applications corresponding to our U.S. patents and applications. We cannot assure you that
any  of  our  patent  applications  will  result  in  the  issuance  of  patents,  that  any  issued  patent  will  include  claims  of  the  breadth  we  are  seeking,  or  that
competitors or other third-parties will not successfully challenge or circumvent our patents if they are issued.

We believe our patents are valid and do not infringe the patents or other proprietary rights of others. Accordingly, we believe we are not obligated to

pay royalties relating to the use of intellectual property to any third parties except the University of Chicago, from which we have licensed certain patents.

License Agreements

We  have  exclusively  licensed  from  the  University  of  Chicago  eight  U.S.  patents  for  (a)  the  use  of  cortisol  modulators  in  the  treatment  of  triple-
negative breast cancer, and (b) the use of cortisol modulators to treat castration-resistant prostate cancer. We are required to pay the University of Chicago
customary milestone fees and royalties on revenue from products commercialized under the issued patents or patents that may issue pursuant to the pending
applications. Our license will end upon expiration of the licensed patents in 2031 and 2033 or upon notification by us to the University of Chicago. Three
patents that were licensed from Stanford University expired in October 2018. See “Business – Intellectual Property.”

Government Regulation

Prescription  pharmaceutical  products  are  subject  to  extensive  pre-  and  post-approval  regulation  governing  the  testing,  manufacturing,  safety,
efficacy, labeling, storage, record keeping, advertising and promotion of the products under the Federal Food, Drug and Cosmetic Act. All of our product
candidates  require  regulatory  approval  by  government  agencies  prior  to  commercialization  and  are  subject  to  continued  regulatory  oversight  thereafter.
Before a new drug may be marketed in the United States the FDA generally requires completion of preclinical laboratory and animal testing, performance
of adequate and

7

well-controlled human clinical trials to establish the safety and efficacy of the proposed drug’s intended use and approval by the FDA. Complying with
these and other federal and state statutes and regulations involves significant time and expense.

If the FDA approves the marketing of a new drug, physicians may prescribe it to patients in the United States. The FDA may withdraw its approval
at any time if compliance with regulatory standards is not maintained. The drug developer must submit periodic reports to the FDA, including reports of
adverse patient experiences, which could cause the FDA to impose marketing restrictions through labeling changes or remove the drug from the market.
The FDA may also require post-approval studies, referred to as “Phase 4 studies,” to monitor or further explore the effect of approved products, and may
limit marketing of the drug based on the results of such studies.

The FDA imposes complex regulations regarding the promotion and sale of pharmaceuticals, including standards for direct-to-consumer advertising,
off-label promotion, and industry-sponsored scientific and educational activities. Failure to abide by these regulations can result in penalties including the
issuance of a warning letter directing a company to correct deviations from FDA regulations, mandated modification of promotional materials and labeling
and the issuance of corrective information in addition to state and federal civil and criminal penalties.

Facilities involved in the manufacture of drugs must comply with FDA-mandated current Good Manufacturing Practices regulations (“cGMP”) and
are subject to periodic inspection by the FDA and other regulatory authorities. Failure to comply with statutory and regulatory requirements subjects the
manufacturer to possible legal or regulatory action, including suspension of manufacturing or a product recall.

Marketing Approvals Outside the United States

If we choose to distribute our product candidates outside the United States, we (or our potential future partners) will have to complete an approval
process similar to the one imposed by the FDA. The approval procedure and the time required for approval vary from country to country and may involve
additional preclinical and clinical trials. Foreign approvals may not be granted on a timely basis, or at all. Regulatory approval of pricing is required in
most  countries  other  than  the  United  States,  which  pricing  may  be  too  low  to  generate  an  acceptable  return.  We  are  not  seeking  regulatory  approval  to
market Korlym outside the United States.

Coverage and Reimbursement

Sales  of  our  products  will  depend,  in  part,  on  the  extent  to  which  they  will  be  covered  by  government  health  care  programs  and  commercial
insurance and managed healthcare organizations. Third-party payers are increasingly limiting coverage and reducing reimbursements for medical products
and services, although this trend has not to-date had a material impact on the amount or timing of our revenues. In addition, the U.S. government, state
legislatures  and  foreign  governments  have  continued  implementing  cost-containment  programs,  including  price  controls,  restrictions  on  coverage  and
reimbursement  and  requirements  for  substitution  of  generic  products.  Adoption  of  price  controls  and  cost-containment  measures  and  adoption  of  more
restrictive policies in jurisdictions with existing controls and measures could limit our revenue. Decreases in third-party reimbursement for our products or
a  decision  by  a  third-party  payer  to  not  cover  our  products  could  reduce  our  sales  and  have  a  material  adverse  effect  on  our  results  of  operations  and
financial condition.

Other Healthcare Laws

We are subject to healthcare regulation and enforcement by the federal government and the states where we conduct business. These laws include,
without  limitation,  state  and  federal  anti-kickback,  fraud  and  abuse,  false  claims,  privacy  and  security  and  physicians’  sunshine  laws  and  regulations.
Foreign governments have comparable regulations.

The  federal  Anti-Kickback  Statute  prohibits,  among  other  things,  any  person  from  knowingly  and  willfully  offering,  soliciting,  receiving  or
providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or
service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs. The Anti-Kickback Statute is
subject to evolving interpretations. In the past, the government has enforced the Anti-Kickback Statute to reach large settlements with healthcare companies
based on sham consulting and other financial arrangements with physicians. Further, a person or entity does not need to have actual knowledge of these
statutes  or  specific  intent  to  violate  them  to  have  committed  a  violation.  The  majority  of  states  also  have  anti-kickback  laws  which  establish  similar
prohibitions and in some cases may apply to items or services reimbursed by any third-party payor, including commercial insurers.

Additionally,  the  civil  False  Claims  Act  prohibits  knowingly  presenting  or  causing  the  presentation  of  a  false,  fictitious  or  fraudulent  claim  for
payment to the U.S. government. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual
in the name of the government. In addition, the government may assert

8

that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes
of  the  federal  False  Claims  Act.  Violations  of  the  False  Claims  Act  can  result  in  very  significant  monetary  penalties  and  treble  damages.  The  federal
government is using the False Claims Act, and the accompanying threat of significant liability, in its investigation and prosecution of pharmaceutical and
biotechnology companies in connection with the promotion of products for unapproved uses and other sales and marketing practices. The government has
obtained multi-billion dollar settlements under the False Claims Act in addition to individual criminal convictions under applicable criminal statutes. We
expect  that  the  government  will  continue  to  devote  substantial  resources  to  investigating  healthcare  providers’  and  manufacturers’  compliance  with
applicable fraud and abuse laws.

The  federal  Health  Insurance  Portability  and  Accountability  Act  of  1996,  or  HIPAA,  prohibits,  among  other  things,  knowingly  and  willfully
executing a scheme to defraud any healthcare benefit program. In addition, HIPAA, as amended by the Health Information Technology for Economic and
Clinical Health Act, or HITECH, and their implementing regulations, imposes certain requirements relating to the privacy, security and transmission of
protected health information on HIPAA covered entities, which include certain healthcare providers, health plans and healthcare clearinghouses, and their
business associates who conduct certain activities for or on their behalf involving protected health information on their behalf. Even when HIPAA does not
apply, according to the Federal Trade Commission or the FTC, failing to take appropriate steps to keep consumers’ personal information secure constitutes
unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act, or the FTCA, 15 U.S.C § 45(a). The
FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds,
the  size  and  complexity  of  its  business,  and  the  cost  of  available  tools  to  improve  security  and  reduce  vulnerabilities.  Individually  identifiable  health
information is considered sensitive data that merits stronger safeguards. The FTC’s guidance for appropriately securing consumers’ personal information is
similar to what is required by the HIPAA Security Rule.

In  addition,  there  has  been  increased  federal  and  state  regulation  of  payments  made  to  physicians  and  other  healthcare  providers.  The  Patent
Protection and Affordable Care Act (“ACA”), among other things, imposes new reporting requirements on drug manufacturers for payments made by them
to  physicians  (defined  to  include  doctors,  dentists,  optometrists,  podiatrists  and  chiropractors),  certain  health  care  professionals  beginning  in  2022  and
teaching  hospitals,  as  well  as  ownership  and  investment  interests  held  by  physicians  and  their  immediate  family  members.  Failure  to  submit  required
information may result in significant civil monetary penalties for any payments, transfers of value or ownership or investment interests that are not timely,
accurately and completely reported in an annual submission. Drug manufacturers must report such payments to the government by the 90th day of each
calendar  year.  Certain  states  also  mandate  implementation  of  commercial  compliance  programs,  impose  restrictions  on  drug  manufacturer  marketing
practices and/or require the tracking and reporting of gifts, compensation and other remuneration to physicians.

State and foreign laws and regulations restrict business practices in the pharmaceutical industry and complicate our compliance efforts. For example,
some  states  require  companies  to  comply  with  the  pharmaceutical  industry’s  voluntary  compliance  guidelines  and  the  federal  government’s  compliance
guidance  or  otherwise  restrict  payments  to  healthcare  providers  and  other  potential  referral  sources.  Some  states  require  manufacturers  to  file  reports
relating to pricing and marketing information. Some state and local governments require the public registration of pharmaceutical sales representatives.

Certain state and foreign laws also govern the privacy and security of health information in ways that differ significantly from one another and are
not preempted by HIPAA. For example, California recently enacted legislation, the California Consumer Privacy Act, or CCPA, which went into effect
January 1, 2020. The CCPA, among other things, creates new data privacy obligations for covered companies and provides new privacy rights to California
residents, including the right to opt out of certain disclosures of their information. The CCPA also creates a private right of action with statutory damages
for certain data breaches, thereby potentially increasing risks associated with a data breach. Although the law includes limited exceptions, including for
“protected  health  information”  maintained  by  a  covered  entity  or  business  associate,  it  may  regulate  or  impact  our  processing  of  personal  information
depending on the context. In Europe, the General Data Protection Regulation, or GDPR, went into effect in May 2018 and imposes stringent data protection
requirements for controllers and processors of personal data of persons within the EU. The GDPR applies to any company established in the EU as well as
to those outside the EU if they collect and use personal data in connection with the offering of goods or services to individuals in the EU or the monitoring
of  their  behavior.  Companies  that  must  comply  with  the  GDPR  face  increased  compliance  obligations  and  risk,  including  more  robust  regulatory
enforcement  of  data  protection  requirements  and  potential  fines  for  noncompliance  of  up  to  €20  million  or  4%  of  the  annual  global  revenues  of  the
noncompliant company, whichever is greater. In addition, the United Kingdom leaving the EU could also lead to further legislative and regulatory changes.
It remains unclear how the United Kingdom data protection laws or regulations will develop in the medium to longer term and how data transfer to the
United Kingdom from the EU will be regulated, especially following the United Kingdom’s departure from the EU on January 31, 2020. However, the
United Kingdom has transposed the GDPR into domestic law with the Data Protection Act 2018, which remains in force following the United Kingdom’s
departure from the EU.

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The  shifting  commercial  compliance  environment  and  the  need  to  build  and  maintain  robust  and  expandable  systems  to  comply  with  different
compliance  and/or  reporting  requirements  in  multiple  jurisdictions  increase  the  possibility  that  a  healthcare  company  may  violate  one  or  more  of  the
requirements. If our operations are found to be in violation of any of such laws or any other governmental regulations that apply to us, we may be subject to
penalties,  including,  without  limitation,  civil  and  criminal  penalties,  damages,  fines,  the  curtailment  or  restructuring  of  our  operations,  exclusion  from
participation in federal and state healthcare programs and imprisonment, any of which could adversely affect our ability to operate our business and our
financial results.

Data Privacy and Security

Numerous state, federal and foreign laws and regulations govern the collection of, disclosure of, use of, access to, transfer of, and confidentiality and
security  of  health-related  and  other  personal  information,  and  could  apply  now  or  in  the  future  to  our  operations  or  the  operations  of  our  partners.  For
example,  HIPAA,  as  amended  by  the  Health  Information  Technology  for  Economic  and  Clinical  Health  Act,  or  HITECH,  and  their  implementing
regulations,  imposes  requirements  relating  to  the  privacy,  security  and  transmission  of  protected  health  information  on  HIPAA  covered  entities,  which
include certain healthcare providers, health plans and healthcare clearinghouses, and their business associates who conduct certain activities for or on their
behalf involving protected health information on their behalf. Entities that are found to be in violation of HIPAA as the result of a breach of unsecured
protected  health  information,  a  complaint  about  privacy  practices  or  an  audit  by  the  U.S.  Department  of  Health  and  Human  Services,  or  HHS,  may  be
subject to significant civil, criminal and administrative fines and penalties and/or additional reporting and oversight obligations if required to enter into a
resolution  agreement  and  corrective  action  plan  with  HHS  to  settle  allegations  of  HIPAA  non-compliance.  Further,  entities  that  knowingly  receive
individually  identifiable  health  information  from  a  HIPAA-covered  entity  in  a  manner  that  is  not  authorized  or  permitted  by  HIPAA  may  be  subject  to
criminal penalties.

Even when HIPAA does not apply, according to the Federal Trade Commission or the FTC, failing to take appropriate steps to keep consumers’
personal information secure constitutes unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act.
The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it
holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities. Individually identifiable health
information is considered sensitive data that merits stronger safeguards.

Certain state and foreign laws also govern the privacy and security of health information in ways that differ significantly from one another and are
not preempted by HIPAA. For example, California recently enacted legislation, the California Consumer Privacy Act, or CCPA, which went into effect
January 1, 2020. The CCPA, among other things, creates new data privacy obligations for covered companies and provides new privacy rights to California
residents, including the right to opt out of certain disclosures of their information. The CCPA also creates a private right of action with statutory damages
for certain data breaches, thereby potentially increasing risks associated with a data breach. Although the law includes limited exceptions, including for
health-related information, including clinical trial data, it may regulate or impact our processing of personal information depending on the context. Further,
the  California  Privacy  Rights  Act  (CPRA),  recently  passed  in  California.  The  CPRA  will  impose  additional  data  protection  obligations  on  covered
businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain
uses of sensitive data. It will also create a new California data protection agency authorized to issue substantive regulations and could result in increased
privacy and information security enforcement. The majority of the provisions will go into effect on January 1, 2023, and additional compliance investment
and potential business process changes may be required.

In Europe, the General Data Protection Regulation, or GDPR, went into effect in May 2018 and imposes stringent data protection requirements for

controllers and processors of personal data of persons within the EU. The GDPR applies to any company established in the EU or the EEA as well as to
those outside the EU or the EEA if they collect and use personal data in connection with the offering of goods or services to individuals in the EU or the
monitoring of their behavior. In addition, the GDPR increases the scrutiny of transfers of personal data from clinical trial sites located in the EEA to the
United States and other jurisdictions that the EC does not recognize as having “adequate” data protection laws; in July 2020, the Court of Justice of the
European Union limited how organizations could lawfully transfer personal data from the EEA to the United States by invalidating the EU-US Privacy
Shield and imposing further restrictions on use of the standard contractual clauses, which could increase our costs and our ability to efficiently process
personal data from the EEA. Companies that must comply with the GDPR face increased compliance obligations and risk, including more robust regulatory
enforcement of data protection requirements and potential fines for noncompliance of up to €20 million or 4% of the annual global revenues of the
noncompliant company, whichever is greater. In addition, the United Kingdom leaving the EU could also lead to further legislative and regulatory changes.
Relatedly, following the United Kingdom’s withdrawal from the European Economic Area and the European Union, and the expiry of the transition period,
companies have to comply with both the GDPR and the GDPR

10

as incorporated into United Kingdom national law, the latter regime having the ability to separately fine up to the greater of £17.5 million or 4% of global
turnover. The relationship between the United Kingdom and the European Union in relation to certain aspects of data protection law remains unclear, for
example around how data can lawfully be transferred between each jurisdiction, which may expose us to further compliance risk.

Employees

We are managed by experienced pharmaceutical executives and also enlist the expertise of independent advisors with extensive pharmaceutical
experience.  As  of  December  31,  2020,  we  had  236  employees.  We  consider  our  employee  relations  to  be  good.  Our  employees  are  not  covered  by  a
collective bargaining agreement.

We seek to hire, retain and motivate smart, ethical, hard-working employees, officers and directors. To achieve this goal, we offer a collegial work
environment where creativity, collaboration and initiative are encouraged. We offer competitive salaries and industry-leading health benefits. To align our
people’s goals with Corcept’s goals, we offer annual performance-based cash bonuses and stock-based compensation.

About Corcept

We were incorporated in the State of Delaware on May 13, 1998. Our registered trademarks include Corcept  and Korlym . Other service marks,

®

®

trademarks and trade names referred to in this document are the property of their respective owners.

Available Information

We are subject to the information requirements of the Securities Exchange Act of 1934, as amended, and we therefore file periodic reports, proxy
statements and other information with the SEC relating to our business, consolidated financial statements and other matters. The SEC maintains an Internet
site, www.sec.gov, that contains reports, proxy statements and other information regarding issuers such as Corcept.

For more information about Corcept, including free access to our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on
Form  8-K  and  amendments  to  those  reports,  visit  our  website  at  www.corcept.com  or  the  SEC’s  website,  www.sec.gov.  The  information  found  on  or
accessible through our website is not incorporated into, and does not form a part of, this Form 10-K.

ITEM 1A. RISK FACTORS

Investing in our common stock involves significant risks. Before investing, carefully consider the risks described below and the other information in
this Annual Report on Form 10-K, including our consolidated financial statements and related notes. The risks and uncertainties described below are the
ones we believe may materially affect us. Many of them have been or may become exacerbated by the COVID-19 pandemic. There may be others of which
we are unaware that could materially harm our business or financial condition and cause the price of our stock to decline, in which case you could lose all
or part of your investment.

Summary of Principal Risks

The following bullet points summarize the principal risks we face, each of which could adversely affect our business, operations, and financial
results. For  clarity  of  presentation,  we  have  arranged  these  risks  by  the  part  of  our  business  they  most  directly  affect  –  (i)  commercial  operations,  (ii)
research and development, (iii) capital need and financial results, (iv) intellectual property and (v) our stock price. A sixth group of “general risks” lists
risks that affect our business as a whole.

Risks Related to our Commercial Activities

•
•

•

Failure to generate sufficient revenue from the sale of Korlym would harm our financial results and would likely cause our stock price to decline.
The  COVID-19  pandemic  or  other  public  health  emergencies,  natural  disasters,  terrorism  or  other  catastrophes  could  disrupt  our  activities  and
render our own or our vendors’ facilities and equipment inoperable or inaccessible and require us to curtail or cease operations.
If generic versions of Korlym are approved and successfully commercialized, our business, results of operations and financial position would be
adversely affected.

• Other companies offer or are attempting to develop different medications to treat patients with Cushing’s syndrome. The availability of competing

treatments could limit our revenue from Korlym.

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•

If we cannot continue to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym, we will be unable to generate
significant revenues.

• We depend on vendors to manufacture Korlym’s active ingredient, form it into tablets, package it and dispense it to patients. We also depend on
vendors to manufacture the API and capsules or tablets for our product candidates. If our suppliers become unable or unwilling to perform these
functions and we cannot transfer these activities to replacement vendors in a timely manner, our business will be harmed.

Risks Related to our Research and Development Activities

•

Clinical drug development is lengthy, expensive and often unsuccessful. Results of early studies and trials are often not predictive of later trial
results. Failure can occur at any stage of drug development. Our efforts to discover, develop and commercialize our product candidates may not
succeed.
The COVID-19 pandemic has made initiating and advancing our clinical development programs more difficult.

•
• Vendors  manufacture  and  distribute  the  drug  product  we  use  in  our  trials,  conduct  and  manage  some  of  our  clinical  trials  and  perform  data
collection and analysis. Failure of these vendors to perform their duties or meet expected timelines may prevent or delay approval of our product
candidates.

• Our  products  and  product  candidates  may  cause  undesirable  side  effects  that  halt  their  clinical  development,  prevent  their  regulatory  approval,

limit their commercial potential or cause us significant liability.

• We may need additional capital to fund our operations or for strategic reasons. Such capital may not be available on acceptable terms or at all.

Risks Related to our Capital Needs and Financial Results

Risks Relating to Our Intellectual Property

To succeed, we must secure and maintain adequate patent protection for the composition and methods of use of our proprietary, selective cortisol
modulators and for the use of Korlym to treat Cushing’s syndrome and other disorders.
Third parties may allege that our patents infringe their rights. Defending against such allegations may result in costly litigation and may require us
to obtain a license or bar us from commercializing our product candidates or Korlym for a new indication.

Risks Related to Our Stock

The price of our common stock fluctuates widely and is likely to continue to do so. Opportunities for the sale of shares at any particular time may
be limited.

•

•

•

• Our  stock  price  may  decline  if  our  financial  performance  does  not  meet  the  guidance  we  have  provided  to  the  public,  estimates  published  by

research analysts or other investor expectations.

General Risks

• We are subject to government regulation and other legal obligations relating to privacy and data protection. Compliance with these requirements is

complex and costly. Failure to comply could materially harm our business.

• We may be unable to obtain or maintain regulatory approvals for our product or product candidates.
• Anti-takeover provisions in our charter and bylaws and under Delaware law may make an acquisition of us or a change in our management more

expensive or difficult, even if an acquisition or a management change would be beneficial to our stockholders.

• We  rely  heavily  on  information  technology  systems  to  conduct  our  business.  A  breakdown  or  breach  of  these  systems  or  our  failure  to  protect
confidential information concerning our business, patients or employees could interrupt the operation of our business and subject us to liability.

• Our officers, directors and principal stockholders, acting as a group, could significantly influence corporate actions.

Risk Factors - Discussion

The following section discusses the principal risks listed above, as well as other risks we believe to be material.

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Risks Related to our Commercial Activities

Failure to generate sufficient revenue from the sale of Korlym would harm our financial results and would likely cause our stock price to decline.

Our  ability  to  generate  revenue  and  to  fund  our  commercial  operations  and  development  programs  is  dependent  on  the  sale  of  Korlym  to  treat
patients with Cushing’s syndrome. Physicians will prescribe Korlym only if they determine that it is preferable to other treatments, even if those treatments
are not approved for Cushing’s syndrome. Because Cushing’s syndrome is rare, most physicians are inexperienced diagnosing or caring for patients with
the illness and it can be hard to persuade them to identify appropriate patients and treat them with Korlym.

Many factors could limit our Korlym revenue, including:

the preference of some physicians for off-label treatments for Cushing’s syndrome, such as ketoconazole;

competition from non-medical treatments, such as surgery and radiation;

natural disasters or other catastrophes, such as the COVID-19 pandemic, that reduce the ability or willingness of physicians to see patients or of
patients to bear the risk of leaving their homes to seek medical care;

the introduction of competing treatments, including generic versions of Korlym;

lack of availability of government or private insurance, which may be exacerbated if (i) the U.S. Supreme Court strikes down the Affordable Care
Act, which greatly increased the number of Americans with health insurance or (ii) significant increases in unemployment cause patients to lose
employer-provided  private  health  insurance  and  either  shift  to  Medicaid,  which  reimburses  Korlym  at  a  significantly  lower  price,  or  become
uninsured, which would decrease our revenue and increase the burden on our financial assistance and free drug programs and on the independent
charities we support; and

negative publicity and political concerns about Korlym’s active ingredient, mifepristone, which is approved in another drug for the termination of
pregnancy

•

•

•

•

•

•

Failure to generate sufficient Korlym revenue could prevent us from fully funding our planned commercial and clinical activities and would likely

cause our stock price to decline.

The COVID-19 pandemic or other public health emergencies, natural disasters, terrorism or other catastrophes could disrupt our activities and
render our own or our vendors’ facilities and equipment inoperable or inaccessible and require us to curtail or cease operations.

COVID-19,  a  serious  and  sometimes  fatal  illness,  has  spread  to  every  country  in  the  world  and  throughout  the  United  States.  Many  countries,
including most states of the United States, have reacted by instituting quarantines, “lockdowns” and other public health restrictions on leisure activities,
work and travel. In California, where our headquarters are located, and in the states where our clinical specialists and medical science liaisons live and
work,  residents  are  subject  to  significant  public  health  restrictions.  Attempts  by  some  states  to  lift  these  restrictions  have  led  to  a  sharp  increase  in  the
number  of  new  COVID-19  infections,  hospitalizations  and  deaths,  which  in  turn  has  led  to  the  reimposition  of  restrictions,  as  well  as  to  voluntary
reductions  in  public  activities  by  residents  concerned  for  their  health.  Although  many  jurisdictions  consider  pharmaceutical  companies  as  “essential
businesses” with wide freedom to operate, we have been managing our business primarily by video conference, teleconference and email. We rely on third-
party manufacturers, distributors (including the specialty pharmacy that dispenses Korlym), information technology and software service providers, law
and accounting firms, clinical research organizations and consultants who are subject to, or may become subject to, pandemic-related controls. If these third
parties cannot perform the services we require in a timely way and we cannot successfully implement replacements or workarounds, our business, results of
operations and financial condition could be harmed.

COVID-19 has made it more difficult to interact with physicians who treat patients with Cushing’s syndrome. Steps physicians have taken to reduce
the risk of COVID-19 infection in their practices include reducing the frequency of patient office visits and barring office visits by third parties, including
our  clinical  specialists  and  medical  science  liaisons.  Pandemic-related  closures  of  clinical  laboratories  and  imaging  centers,  as  well  as  the  reluctance  of
patients  to  leave  the  safety  of  their  homes,  has  made  it  difficult  for  many  physicians  to  identify  patients  who  may  benefit  from  Korlym,  begin  their
treatment, titrate to an optimum dose and maintain their regimen, which has reduced our revenue. If physicians do not prescribe Korlym to new patients or
have difficulty increasing a patient’s Korlym dose to its optimal level, or if patients already receiving Korlym discontinue treatment, our revenue will be
unlikely to grow and may decline further.

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Other natural or man-made disasters could harm our business, operating results and financial condition. Our headquarters are in the San Francisco
Bay Area, which experiences earthquakes. Our specialty pharmacy, tablet manufacturers and warehouses are in areas subject to hurricanes and tornadoes.
Political considerations relating to mifepristone put us and our manufacturers at increased risk of protests and disruptive events. If a disaster were to occur,
we might not be able to operate our business. Our insurance, if available at all, would likely be insufficient to cover losses resulting from disasters or other
business interruptions.

If generic versions of Korlym are approved and successfully commercialized, our business, results of operations and financial position would be
adversely affected.

The marketing exclusivity provided by Korlym’s orphan drug designation expired in February 2019, which means other companies may now seek to
introduce generic equivalents of Korlym for the treatment of Cushing’s syndrome, provided they receive FDA approval and can show that they would not
infringe our applicable patents or that those patents are invalid or unenforceable. If our patents are successfully challenged and a generic version of Korlym
becomes available, our sales of Korlym tablets and their price could decline rapidly and significantly, which would reduce our revenue and materially harm
our results of operations and financial position. Competition from a generic version of Korlym may also cause our revenue to be materially less than the
public guidance we have provided, which would likely cause the price of our common stock to decline.

We have sued Teva and Sun in Federal District Court with respect to their proposed generic versions of Korlym. In addition, Teva has challenged the
validity of one of our patents in a proceeding before the Patent Trial and Appeals Board. Legal action to enforce or defend intellectual property rights is
complex, costly and involves significant commitments of management time. There can be no assurance of a successful outcome. Please see “Part I, Item 3,
Legal Proceedings.” Furthermore, the 30-month stay provided by the Hatch-Waxman Act expired on August 2, 2020, which means Teva now has final
approval  from  the  FDA  to  market  its  generic  version  of  Korlym  and  may  choose  to  do  so  at  any  time,  notwithstanding  any  ongoing  litigation  or
administrative disputes with us. Even if we prevail in our legal actions and Teva withdraws its product and pays us damages, the temporary availability of a
generic version of Korlym would materially harm our results of operations and financial condition.

On February 1, 2021, we received a Paragraph IV notice from Hikma stating that is seeking FDA approval to market a generic version of Korlym. It
is likely that other companies will do the same. While we will vigorously protect our intellectual property, there can be no assurance our efforts will be
successful.

Other companies offer or are attempting to develop different medications to treat patients with Cushing’s syndrome. The availability of competing
treatments could limit our revenue from Korlym.

Since  2012,  a  medication  owned  by  the  Italian  pharmaceutical  company  Recordati-S.p.A.,  the  somatostatin  analogue  Signifor   (pasireotide)
Injection, has been marketed in both the United States and the EU for adult patients with Cushing’s disease (a subset of Cushing’s syndrome). On March 6,
2020, the FDA granted Recordati approval to market another cortisol synthesis inhibitor, Isturisa® (osilodrostat) tablets, to treat patients with Cushing’s
disease. Osilodrostat is approved in the EU for the treatment of patients with Cushing’s syndrome. Osilodrostat has been designated an orphan drug in both
the EU and the United States.

®

Strongbridge  Biopharma  plc  (“Strongbridge”)  has  received  orphan  drug  designation  in  the  United  States  and  the  EU  for  the  use  of  the  cortisol
synthesis inhibitor levoketoconazole to treat patients with Cushing’s syndrome. Levoketoconazole is an enantiomer of the generic anti-fungal medication,
ketoconazole, that is prescribed off-label to treat patients with Cushing’s syndrome. Strongbridge has completed two Phase 3 trials, which met their primary
endpoints of reducing cortisol synthesis, and expects to submit a new drug application (“NDA”) to the FDA in the first quarter of 2021.

If we cannot continue to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym, we will be unable to generate
significant revenues.

The commercial success of Korlym depends on the availability of adequate insurance coverage and reimbursement. Government payers, including
Medicare,  Medicaid  and  the  Veterans  Administration,  as  well  as  private  insurers  and  health  maintenance  organizations,  are  increasingly  attempting  to
contain  healthcare  costs  by  limiting  reimbursement  for  medicines.  If  government  or  private  payers  cease  to  provide  adequate  and  timely  coverage  and
reimbursement for Korlym, physicians may not prescribe the medication and patients may not purchase it, even if it is prescribed. In addition, delays in
coverage for individual patients may reduce our revenues.

The  COVID-19  pandemic  has  caused  a  global  economic  contraction  that  may  last  a  long  time.  Significant  increases  in  unemployment  stemming
from  the  pandemic  may  cause  some  patients  to  lose  their  employer-sponsored  insurance  and  may  increase  patient  reliance  on  Medicaid  (which  pays
significantly less for Korlym) and our financial assistance and free drug

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programs and on the independent charities we support. There may also be delays in coverage as patients secure authorization for Korlym treatment from a
new insurer. If the pandemic causes any of these effects, our revenue would decline and our charitable donation expense would increase.

In many foreign markets, drug prices and the profitability of prescription medications are subject to government control. In the United States, we
expect that there will continue to be federal and state proposals for similar controls. Also, the trends toward managed health care in the United States and
recent laws and legislation intended to increase the public visibility of drug prices and reduce the cost of government and private insurance programs could
significantly influence the purchase of health care services and products and may result in lower prices for Korlym.

In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs. The Patient Protection and
Affordable Care Act, or ACA, which was passed in 2010, substantially changed the way health care is financed by both governmental and private insurers.
The  ACA,  among  other  things,  expanded  Medicaid  program  eligibility  and  access  to  commercial  health  insurance  coverage,  increased  the  minimum
Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals enrolled in Medicaid
managed care organizations, established annual fees and taxes on manufacturers of certain branded prescription drugs, and promoted a new Medicare Part
D coverage gap discount program. The ACA also appropriated funding to comparative clinical effectiveness research, although it remains unclear how the
research will affect Medicare coverage and reimbursement or how new information will influence other third-party payer policies.

Since its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA, and we expect there will be additional
challenges and amendments to the ACA in the future. For example, the Tax Cuts and Jobs Acts (the “Tax Act”) was enacted, which, among other things,
removed  penalties  for  not  complying  with  the  individual  mandate  to  carry  health  insurance.  On  December  14,  2018,  a  U.S.  District  Court  Judge  in  the
Northern District of Texas, ruled that the individual mandate is a critical and inseverable feature of the ACA, and therefore, because it was repealed as part
of the Tax Act, the remaining provisions of the ACA are invalid as well. On December 18, 2019, the U.S. Court of Appeals for the 5th Circuit upheld the
District  Court’s  decision  that  the  individual  mandate  was  unconstitutional  but  remanded  the  case  back  to  the  District  Court  to  determine  whether  the
remaining provisions of the Affordable Care Act are invalid as well. On March 2, 2020, the U.S. Supreme Court granted the petitions for writs of certiorari
to review the case, although it is unclear when the decision will be made or how these decisions, subsequent appeals, if any, and the Supreme Court will
rule.  In  addition,  there  may  be  other  efforts  to  challenge,  replace  or  repeal  the  ACA  that  may  affect  the  law  or  our  business.  Any  new  limitations  on,
changes to, or uncertainty with respect to the ability of individuals to enroll in governmental reimbursement programs or other third-party payer insurance
plans could reduce Korlym sales, which in turn could affect our ability to successfully develop and commercialize new products.

Other legislative and regulatory changes have been proposed and adopted in the United States since the ACA was enacted. These changes included
an aggregate reduction in Medicare payments to providers of 2 percent per fiscal year, which went into effect on April 1, 2013 and will remain in effect
through 2030, with the exception of a temporary suspension from May 1, 2020 through March 31, 2021, unless additional Congressional action is taken. In
addition, the American Taxpayer Relief Act of 2012, which further reduced Medicare payments to several providers, including hospitals, imaging centers
and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five
years. Moreover, the federal government and the individual states in the United States have become increasingly active in developing proposals, passing
legislation  and  implementing  regulations  designed  to  control  drug  pricing,  including  price  or  patient  reimbursement  constraints,  discounts,  formulary
flexibility, marketing cost disclosure and transparency measures.

These new laws and the regulations and policies implementing them, as well as other healthcare-related measures that may be adopted in the future,

could materially reduce our ability to develop and commercialize our product candidates.

The unfavorable public perception of mifepristone may limit our ability to sell Korlym.

The  active  ingredient  in  Korlym,  mifepristone,  is  approved  by  the  FDA  in  another  drug  for  the  termination  of  early  pregnancy.  As  a  result,
mifepristone is the subject of considerable debate in the United States and elsewhere. Public perception of mifepristone may limit the acceptance of Korlym
by patients and physicians. Even though we have taken measures to minimize the chance that Korlym will accidentally be prescribed to a pregnant woman,
physicians may choose not to prescribe Korlym to a woman simply to avoid the risk of terminating a pregnancy.

15

We depend on vendors to manufacture Korlym’s active ingredient, form it into tablets, package it and dispense it to patients. We also depend on
vendors to manufacture the API and capsules or tablets for our product candidates. If our suppliers become unable or unwilling to perform these
functions and we cannot transfer these activities to replacement vendors in a timely manner, our business will be harmed.

A single third-party manufacturer, PCAS, supplies the API in Korlym. Two other third-party manufacturers produce and bottle Korlym tablets. Our
agreement with PCAS automatically renews for two one-year terms, unless either party provides 12-months’ written notice of its intent not to renew. A
single  specialty  pharmacy,  Optime  Care,  Inc.  (“Optime”)  dispenses  Korlym  directly  to  patients  and  collects  payments  from  insurers  representing
approximately 99 percent of our revenue. If Optime does not adhere to its agreements with payers, it may not be able to collect some or all of the payments
due  to  us.  Our  agreement  with  Optime  has  a  five-year  term  and  renews  upon  the  written  consent  of  both  parties,  subject  to  customary  termination
provisions,  including  the  right  of  Optime  to  terminate  in  the  event  of  a  material  breach  by  us  that  we  do  not  cure  in  a  reasonable  period  of  time  after
receiving written notice. In addition, we may terminate the agreement for convenience. In the event any of these vendors fails to perform its contractual
obligations  to  us  or  is  materially  impaired  in  its  performance  by  the  COVID-19  pandemic  or  for  any  other  reason,  we  may  experience  disruptions  and
delays  in  our  supply  chain  and  our  ability  to  deliver  Korlym  to  patients,  which  would  adversely  affect  our  business,  results  of  operations  and  financial
position.

The facilities used by our vendors to manufacture and package the API and drug product for Korlym and our product candidates must be approved
by  the  FDA  and,  in  some  cases,  the  European  Medicines  Agency  (“EMA”).  We  do  not  control  the  activities  of  these  vendors,  including  whether  they
maintain  adequate  quality  control  and  hire  qualified  personnel.  We  are  dependent  on  them  for  compliance  with  the  regulatory  requirements  known  as
current  good  manufacturing  practices  (“cGMPs”).  If  our  vendors  cannot  manufacture  material  that  conforms  to  our  specifications  and  the  strict
requirements of the FDA or others, they will not be able to maintain regulatory authorizations for their facilities and we could be prohibited from using the
API or drug product they have provided. If the FDA, EMA or other regulatory authorities withdraw regulatory authorizations of these facilities, we may
need  to  find  alternative  vendors  or  facilities,  which  would  be  time-consuming,  complex  and  expensive  and  could  significantly  hamper  our  ability  to
develop, obtain regulatory approval for and market our products. Sanctions could be imposed on us, including fines, injunctions, civil penalties, refusal of
regulators to approve our product candidates, delays, suspensions or withdrawals of approvals, seizures or recalls of products, operating restrictions and
criminal prosecutions, any of which could harm our business.

We may not have adequate insurance to cover our exposure to product liability claims.

We may be subject to product liability or other claims based on allegations that Korlym or one of our product candidates has harmed a patient. Such
a  claim  may  damage  our  reputation  by  raising  questions  about  Korlym  or  our  product  candidates’  safety  and  could  prevent  or  interfere  with  product
development  or  commercialization.  Less  common  adverse  effects  of  a  pharmaceutical  product  are  sometimes  not  known  until  long  after  the  product  is
approved for marketing. Because the active ingredient in Korlym is used to terminate pregnancy, clinicians using Korlym in clinical trials and physicians
prescribing  the  medicine  to  women  must  take  strict  precautions  to  ensure  that  it  is  not  administered  to  pregnant  women.  Failure  to  observe  these
precautions could result in significant product liability claims.

Our insurance may not fully cover our potential product liabilities. Inability to obtain adequate insurance coverage could inhibit development of our

product candidates or result in significant uninsured liability. Defending a lawsuit could be costly and divert management from productive activities.

If we are unable to maintain regulatory approval of Korlym for the treatment of patients with Cushing’s syndrome or if we fail to comply with
other requirements, we will be unable to generate revenue and may be subject to penalties.

We are subject to oversight by the FDA and other regulatory authorities in the United States and elsewhere with respect to our research, testing,
manufacturing,  labeling,  distribution,  adverse  event  reporting,  storage,  advertising,  promotion,  recordkeeping  and  sales  and  marketing  activities.  These
requirements  include  submissions  of  safety  information,  annual  updates  on  manufacturing  activities  and  continued  compliance  with  FDA  regulations,
including cGMPs, good laboratory practices and good clinical practices (“GCP”). The FDA enforces these regulations through inspections of us and the
laboratories,  manufacturers  and  clinical  sites  we  use.  Foreign  regulatory  authorities  have  comparable  requirements  and  enforcement  mechanisms.
Discovery  of  previously  unknown  problems  with  a  product  or  product  candidate,  such  as  adverse  events  of  unanticipated  severity  or  frequency  or
deficiencies  in  manufacturing  processes  or  management,  as  well  as  failure  to  comply  with  FDA  or  other  U.S.  or  foreign  regulatory  requirements,  may
subject us to substantial civil and criminal penalties, injunctions, holds on clinical trials, product seizure, refusal to permit the import or export of products,
restrictions on product marketing, withdrawal of the product from the market, product recalls, total or partial suspension of production, refusal to approve
pending NDAs or supplemental NDAs, and suspension or revocation of product approvals.

16

We may be subject to civil or criminal penalties if our marketing of Korlym violates FDA regulations or health care fraud and abuse laws.

We are subject to FDA regulations governing the promotion and sale of medications. Although physicians are permitted to prescribe drugs for any
indication they choose, manufacturers may only promote products for their FDA-approved use. All other uses are referred to as “off-label.” In the United
States, we market Korlym to treat hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2
diabetes mellitus or glucose intolerance and for whom surgery has failed or is not an option. We provide promotional materials and training programs to
physicians covering the use of Korlym for this indication. The FDA may change its policies or enact new regulations at any time that restrict our ability to
promote our products.

If the FDA were to determine that we engaged in off-label promotion, the FDA could require us to change our practices and subject us to regulatory
enforcement actions, including issuance of a public “warning letter,” injunction, seizure, civil fine or criminal penalties. Other federal or state enforcement
authorities might act if they believe that the alleged improper promotion led to the submission and payment of claims for an unapproved use, which could
result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement. Even if it is determined that
we are not in violation of these laws, we may receive negative publicity, incur significant expenses and be forced to devote management time to defending
our position.

In addition to laws restricting off-label promotion, we are also subject to federal and state healthcare fraud and abuse laws and regulations designed
to  prevent  fraud,  kickbacks,  self-dealing,  and  other  abusive  practices.  The  U.S.  healthcare  laws  and  regulations  that  may  affect  our  ability  to  operate
include, but are not limited to:

•

•

•

•

•

the  federal  Anti-Kickback  Statute,  which  prohibits,  among  other  things,  knowingly  and  willfully  soliciting,  receiving,  offering  or  paying
remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation
of, any good or service for which payment may be made under federal health care programs such as Medicare and Medicaid. A person or entity
does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

federal false claims laws, including, without limitation, the False Claims Act, which prohibit any person from knowingly presenting, or causing to
be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to get a false
claim paid. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback
Statute constitutes a false or fraudulent claim for purposes of the False Claims Act. Pharmaceutical companies have been prosecuted under these
laws  for  a  variety  of  promotional  and  marketing  activities,  such  as  allegedly  providing  free  product  to  or  entering  into  “sham”  consulting
arrangements  with  customers  to  induce  such  customers  to  purchase,  order  or  recommend  the  company’s  products  in  violation  of  the  Anti-
Kickback Statute and federal false claims laws and regulations; reporting to pricing services inflated average wholesale prices that were then used
by  certain  governmental  programs  to  set  reimbursement  rates;  engaging  in  the  promotion  of  “off-label”  uses  that  caused  customers  to  submit
claims to and obtain reimbursement from governmental payers for non-covered “off-label” uses; and submitting inflated best price information to
the Medicaid Drug Rebate Program; the government may assert that a claim including items and services resulting from a violation of the federal
Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;

the  federal  Civil  Monetary  Penalties  law,  which  prohibits,  among  other  things,  offering  or  transferring  remuneration  to  a  federal  healthcare
beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable
by the government from a particular provider or supplier;

the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created federal criminal laws that prohibit executing a
scheme to defraud any health care benefit program or making false statements relating to health care matters; similar to the federal Anti-Kickback
Statute,  a  person  or  entity  does  not  need  to  have  actual  knowledge  of  the  statute  or  specific  intent  to  violate  it  in  order  to  have  committed  a
violation;

federal “sunshine” laws, including the federal Physician Payment Sunshine Act, that require transparency regarding financial arrangements with
health care providers, such as the reporting and disclosure requirements imposed by the ACA on drug manufacturers regarding any “transfer of
value”  made  or  distributed  to  physicians  (defined  to  include  doctors,  dentists,  optometrists,  podiatrists  and  chiropractors),  certain  health  care
professionals  beginning  in  2022,  teaching  hospitals,  and  ownership  or  investment  interests  held  by  physicians  and  their  immediate  family
members. Manufacturers are required to submit reports detailing these financial arrangements by the 90th day of each calendar year;

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federal  consumer  protection  and  unfair  competition  laws,  which  broadly  regulate  marketplace  activities  and  activities  that  potentially  harm
consumers; and

state  law  equivalents  of  each  of  the  above  federal  laws,  such  as  anti-kickback  and  false  claims  laws  which  may  apply  to  items  or  services
reimbursed  by  any  third-party  payer,  including  commercial  insurers;  state  laws  that  require  pharmaceutical  companies  to  comply  with  the
pharmaceutical  industry’s  voluntary  compliance  guidelines  and  the  relevant  compliance  guidance  promulgated  by  the  federal  government  or
otherwise restrict payments that may be made to healthcare providers; and state laws that require drug manufacturers to report information related
to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information.

The risk of being found in violation of these laws and regulations is increased by the fact that many of them have not been definitively interpreted by
regulatory authorities or the courts and their provisions are open to a variety of interpretations. Because of the breadth of these laws and the narrowness of
the  statutory  exceptions  and  safe  harbors  available  under  them,  it  is  possible  that  some  of  our  business  activities,  including  our  relationships  with
physicians and other healthcare providers (some of whom recommend, purchase and/or prescribe our products) and the manner in which we promote our
products, could be subject to challenge. We are also exposed to the risk that our employees, independent contractors, principal investigators, consultants,
vendors,  distributors,  and  contract  research  organizations  (“CROs”)  may  engage  in  fraudulent  or  other  illegal  activity.  Although  we  have  policies  and
procedures  prohibiting  such  activity,  it  is  not  always  possible  to  identify  and  deter  misconduct  and  the  precautions  we  take  may  not  be  effective  in
controlling  unknown  risks  or  in  protecting  us  from  governmental  investigations  or  other  actions  or  lawsuits  stemming  from  a  failure  to  comply  with
applicable laws and regulations.

If we violate any of the laws described above or any other government regulations, we may be subject to civil and criminal penalties, damages, fines,
exclusion from governmental health care programs, a corporate integrity agreement or other agreement to resolve allegations of non-compliance, individual
imprisonment, and the curtailment or restructuring of our operations, any of which could adversely affect our financial results and ability to operate.

Risks Related to our Research and Development Activities

Clinical drug development is lengthy, expensive and often unsuccessful. Results of early studies and trials are often not predictive of later trial
results. Failure can occur at any stage of drug development. Our efforts to discover, develop and commercialize our product candidates may not
succeed.

Clinical development is expensive, lengthy and often unsuccessful. Data from clinical trials are susceptible to varying interpretations, which could
delay, limit or prevent regulatory approval. The results from early clinical trials are often not predictive of results in later clinical trials. Product candidates
may  fail  to  show  the  desired  safety  and  efficacy  traits  despite  having  produced  positive  results  in  preclinical  studies  and  initial  clinical  trials.  Many
companies have suffered significant setbacks in late-stage clinical trials due to lack of efficacy or unanticipated or unexpectedly severe adverse events.

Our current clinical trials may prove inadequate to support marketing approvals. Even trials that generate positive results may have to be confirmed

in much larger, more expensive and lengthier trials before we could realistically seek regulatory approval of a product candidate.

Clinical trials may be delayed by many factors, including:

slow patient enrollment or delayed activation of clinical trial sites due to the COVID-19 pandemic or other factors;

delays  obtaining  regulatory  permission  to  start  a  trial,  changes  to  the  size  or  design  of  a  trial  or  changes  in  regulatory  requirements  for  a  trial
already underway;

inability to secure acceptable terms with vendors and an appropriate number of clinical trial sites;

delays or inability to obtain institutional review board (“IRB”) approval at prospective trial sites;

failure of patients or investigators to comply with the clinical trial protocol;

unforeseen safety issues; and

negative findings of inspections of clinical sites or manufacturing operations by us, the FDA or other authorities.

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A trial may also be suspended or terminated by us, the trial’s data safety monitoring board, the IRBs governing the sites where the trial is being

conducted or the FDA for many reasons, including failure to comply with regulatory requirements or

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clinical protocols, negative findings in an inspection of our clinical trial operations or trial sites by the FDA or other authorities, unforeseen safety issues,
failure to demonstrate a benefit or changes in government regulations. Disruptions caused by the COVID-19 pandemic increase the likelihood of delays in
initiating or completing our planned and ongoing clinical trials. Please see the risk factor, “The COVID-19 pandemic has made conducting our clinical
development programs more difficult.”

During the development of a product candidate, we may decide, or the FDA or other regulatory authorities may require us, to conduct more pre-
clinical or clinical studies or to change the size or design of a trial already underway, which could delay or prevent the completion of development and
increase its cost. Even if we conduct all of the clinical trials and supportive studies that we consider appropriate and the results are positive, we may not
receive regulatory approval.

The COVID-19 pandemic has made initiating and advancing our clinical development programs more difficult.

We conduct clinical trials at sites in the United States, Canada, Europe and Israel. In all of these places, authorities have imposed significant public
health  restrictions  of  varying  degrees  of  severity  which  are  likely  to  persist  until  a  COVID-19  vaccine  or  effective  treatment  is  widely  available.  In
addition, physicians, patients and medical institutions have changed their behavior in an attempt to reduce the risk of infection that makes clinical trials
more expensive, time-consuming and risky to initiate and conduct.

Some of the sites where we are conducting clinical trials have stopped enrolling new patients or reduced the frequency with which enrolled patients
see their physicians. Some clinical sites have temporarily stopped initiating new trials. Many patients are reluctant to participate in procedures required by
our clinical trial protocols because they fear infection. In general, COVID-19 has slowed the pace of our clinical trials, including our studies in Cushing’s
syndrome, AIWG and NASH. Studies of diseases perceived to be acutely life-threatening, such as advanced solid tumors, have been experienced less delay
and disruption.

If COVID-19 remains prevalent, we may experience additional disruptions, which could have a material adverse impact on our clinical trial plans

and timelines, including:

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delays in enrolling patients in our clinical trials;

delays in clinical site initiation, including difficulties in recruiting clinical investigators and staff;

delays in receiving authorizations from local regulatory authorities and internal review boards to initiate clinical trials or amend existing protocols;

delays in clinical sites receiving necessary supplies and materials due to interruptions in local and global shipping;

changes in local regulations that require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs or
cause us to suspend or discontinue a trial in the affected jurisdiction;

diversion of healthcare resources, including facilities, supplies and staff, away from the conduct of clinical trials;

interruption of key clinical trial activities, such as clinical trial site monitoring, patient visits and follow-up, study procedures and data collection,
that could affect the integrity of clinical trial data, due to limitations on travel;

the infection of patients enrolled in our clinical trials with COVID-19, which could affect the results of the clinical trial, including by increasing
the number of observed adverse events or by causing patients to drop out of the study;

patient discontinuations due to fear of infection with COVID-19;

interruptions or delays in preclinical studies due to restricted or limited operations at laboratory facilities;

delays  in  necessary  interactions  with  local  regulators,  ethics  committees  and  other  third  parties  and  contractors  due  to  limitations  in  employee
resources or the furlough of government employees;

limitations caused by the sickness of our employees or their families or the desire of employees to avoid contact with large groups of people; and

the possible refusal of the FDA or other regulatory authorities to accept data from clinical trials in affected geographies.

The extent to which the COVID-19 pandemic affects our business, preclinical studies and clinical trials will depend on future developments, which

are highly uncertain and cannot be predicted with confidence.

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Vendors  manufacture  and  distribute  the  drug  product  we  use  in  our  trials,  conduct  and  manage  some  of  our  clinical  trials  and  perform  data
collection and analysis. Failure of these vendors to perform their duties or meet expected timelines may prevent or delay approval of our product
candidates.

Third-party clinical investigators and clinical sites enroll patients and CROs manage many of our trials and perform data collection and analysis.
Although we control only certain aspects of these third-parties’ activities, we are responsible for ensuring that every study adheres to its protocol and meets
regulatory and scientific standards. If any of our vendors does not perform its duties or meet expected deadlines or fails to adhere to applicable GCP, or if
the quality or accuracy of the data it produces is compromised, affected clinical trials may be extended, delayed or terminated and we may be unable to
obtain approval for our product candidates. Failure of our manufacturing vendors to perform their duties or comply with cGMPs may require us to recall
drug product or repeat clinical trials, which would delay regulatory approval. If our agreements with any of these vendors terminate, we may not be able to
enter into alternative arrangements in a timely manner or on reasonable terms.

Our ability to physically inspect our vendors and clinical sites has been limited by the COVID-19 pandemic and associated public health restrictions,

which increases the risk that failures to meet applicable requirements will go undetected.

Obtaining regulatory approval of product candidates in foreign jurisdictions would be costly and difficult. Failure to obtain such approvals would
prevent us from commercializing our product candidates outside the United States.

We  may  seek  to  commercialize  our  products  in  international  markets,  which  would  require  us  to  receive  a  marketing  authorization  and,  in  many
cases, pricing approval, from the appropriate regulatory authorities. These approval processes include all of the risks associated with the FDA’s approval
process  and,  in  some  cases,  more.  Approval  procedures  vary  between  countries  and  can  require  additional  pre-clinical  or  clinical  studies.  Obtaining
approval  may  take  longer  than  it  does  in  the  United  States.  Although  approval  by  the  FDA  does  not  ensure  approval  by  regulatory  authorities  in  other
countries, and approval by one foreign regulatory authority does not ensure approval by others, failure or delay in obtaining regulatory approval in one
country may have a negative effect on the regulatory process in others.

Our products and product candidates may cause undesirable side effects that halt their clinical development, prevent their regulatory approval,
limit their commercial potential or cause us significant liability.

Patients  in  clinical  trials  report  changes  in  their  health,  including  new  illnesses,  injuries,  and  discomforts,  to  their  study  doctor.  Often,  it  is  not
possible to determine whether or not these conditions were caused by the drug candidate being studied or something else. As we test our product candidates
in  larger,  longer  and  more  extensive  clinical  trials,  or  as  use  of  them  becomes  more  widespread  if  we  receive  regulatory  approval,  patients  may  report
serious adverse events that did not occur or went undetected in previous trials. Many times, serious side effects are only detected in large-scale, Phase 3
clinical trials or following commercial approval.

Adverse events reported in clinical trials can slow or stop patient recruitment, prevent enrolled patients from completing a trial and could give rise to
liability  claims.  Regulatory  authorities  could  respond  to  reported  adverse  events  by  interrupting  or  halting  our  clinical  trials  or  limiting  the  scope  of,
delaying or denying marketing approval. If we elect, or are required by authorities, to delay, suspend or terminate any clinical trial or commercialization
efforts, the commercial prospects of such product candidates or products may be harmed, and our ability to generate product revenues from them may be
delayed or eliminated.

If one of our product candidates receives marketing approval, and we or others later identify undesirable side effects or adverse events, potentially

significant negative consequences could result, including but not limited to:

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regulatory authorities may suspend, limit or withdraw approvals of such product;

regulatory authorities may require additional warnings on the label, including “boxed” warnings, or issue safety alerts and other safety information
about the product;

• we may be required to change the way the product is administered or conduct additional studies or clinical trials;

• we may be required to create a Risk Evaluation and Mitigation Strategy (REMS), which could include a medication guide outlining the risks of

such side effects for distribution to patients, a communication plan for healthcare providers and/or other elements to assure safe use;

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the product may become less competitive;

• we may be subject to fines, injunctions or the imposition of criminal penalties; and

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• we could be sued and held liable for harm caused to patients;

Any of these events could seriously harm our business.

We need to increase the size of our organization and may experience difficulties in managing growth.

Our  commercial  and  research  and  development  efforts  are  constrained  by  our  limited  administrative,  operational  and  management  resources.  To
date, we have relied on a small management team. Growth will impose significant added responsibilities on members of management, including the need to
recruit and retain additional employees. Our financial performance and ability to compete will depend on our ability to manage growth effectively. To that
end, we must:

• manage our sales and marketing efforts, clinical trials, research and manufacturing activities effectively;

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hire more management, clinical development, administrative and sales and marketing personnel; and

continue to develop our administrative systems and controls.

Failure to accomplish any of these tasks, which will be more difficult during the COVID-19 pandemic, could harm our business.

If  we  lose  key  personnel  or  are  unable  to  attract  more  skilled  personnel,  we  may  be  unable  to  pursue  our  product  development  and
commercialization goals.

Our  ability  to  operate  successfully  and  manage  growth  depends  upon  hiring  and  retaining  skilled  managerial,  scientific,  sales,  marketing,  and
financial personnel. The job market for qualified personnel is intensely competitive. We depend on the principal members of our management and scientific
staff. Any officer or employee may terminate his or her relationship with us at any time and work for a competitor. We do not have employment insurance
covering any of our personnel. The loss of key individuals could delay our research, development and commercialization efforts.

Risks Related to our Capital Needs and Financial Results

We may need additional capital to fund our operations or for strategic reasons. Such capital may not be available on acceptable terms or at all.

We  are  dependent  on  revenue  from  the  sale  of  Korlym  and  our  cash  reserves  to  fund  our  commercial  operations  and  development  programs.  If
Korlym revenue declines significantly, we may need to curtail our operations or raise funds to support our plans. We may also choose to raise funds for
strategic reasons. We cannot be certain funding will be available on acceptable terms or at all. The COVID-19 pandemic has increased volatility and may
reduce liquidity in the equity markets, which would make raising additional capital more difficult and expensive. Equity financing would cause dilution,
debt financing may involve restrictive covenants. Neither type of financing may be available to us on attractive terms or at all. If we obtain funds through
collaborations  with  other  companies,  we  may  have  to  relinquish  rights  to  one  or  more  of  our  product  candidates.  If  our  revenue  declines  and  our  cash
reserves are depleted, and if adequate funds are not available from other sources, we may have to delay, reduce the scope of, or eliminate one or more of
our development programs.

If we are unable to obtain or maintain orphan designation for our product candidates our financial results may be negatively affected.

In the United States and the EU, orphan drug designation confers financial incentives such as opportunities for grant funding towards clinical trial
costs, tax advantages, and reduction of fees or fee waivers. Although we have received orphan drug designation for relacorilant for the treatment of patients
with Cushing’s syndrome and patients with pancreatic cancer in both the United States and EU, we may be unable to maintain these designations or to
obtain designations for our other product candidates, which may negatively affect our financial results.

Risks Relating to Our Intellectual Property

To succeed, we must secure and maintain adequate patent protection for the composition and methods of use of our proprietary, selective cortisol
modulators and for the use of Korlym to treat Cushing’s syndrome and other disorders.

Patents are uncertain, involve complex legal and factual questions and are frequently the subject of litigation. The patents issued or licensed to us
may be challenged at any time. Competitors may take actions we believe infringe our intellectual property, causing us to take legal action to defend our
rights. Intellectual property litigation is lengthy, expensive and requires significant management attention. Outcomes are uncertain. If we do not protect our
intellectual property, competitors may erode our competitive advantage. Please see “Part I, Item 3, Legal Proceedings.”

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Our patent applications may not result in issued patents and patents issued to us may be challenged, invalidated, held unenforceable or circumvented.
Our patents may not prevent third parties from producing competing products. The foreign countries where we may someday operate may not protect our
intellectual property to the extent the laws of the United States do. If we fail to obtain adequate patent protection in other countries, others may produce
products in those countries based on our technology.

Third parties may allege that our patents infringe their rights. Defending against such allegations may result in costly litigation and may require
us to obtain a license or bar us from commercializing our product candidates or Korlym for a new indication.

Our development and commercialization of Korlym or our selective cortisol modulators may give rise to claims that our patents or the patents we
have  licensed  infringe  the  rights  of  others,  which  may  require  us  to  engage  in  costly,  time-consuming  and  possibly  unsuccessful  litigation.  If  it  is
determined that one of our products or product candidates infringe others’ patent rights, we may have to obtain licenses to those rights or delay or suspend
commercial activity while we attempt to design around the infringed patent. If our efforts fail, we may be unable to commercialize the infringing product or
product candidate. We do not have liability insurance for patent infringement.

We do not believe that we infringe any patents or other proprietary rights. We are not obligated to pay royalties relating to the use of intellectual
property except to the University of Chicago. To maintain our licenses from the University of Chicago, we must make milestone and royalty payments. If
we do not comply with our obligations under these licenses, we may lose the right to commercialize cortisol modulators, including mifepristone, for the
treatment of TNBC and CRPC.

Our patents concerning mifepristone cover its use, not its composition, which may make it harder to prevent patent infringement.

We  own  or  have  exclusively  licensed  issued  U.S.  patents  covering  the  use  of  cortisol  modulators,  including  mifepristone,  to  treat  a  variety  of
disorders. A method of use patent covers only a particular use of a compound, not its composition. Because our patents do not cover the composition of
mifepristone, we cannot prevent others from commercializing mifepristone to treat disorders not covered by our method of use patents. The availability of
mifepristone for these disorders may enable patients to obtain mifepristone from other companies for indications covered by our patents. Although such
“off-label” use would violate our patents, effectively monitoring compliance and enforcing our rights may be difficult and costly. Mifepristone is sold in the
United  States  by  Danco  Laboratories  for  the  termination  of  pregnancy.  We  cannot  be  certain  that  patients  with  Cushing’s  syndrome  will  not  be  able  to
obtain mifepristone from Danco or another company, should that company receive approval to market mifepristone for any indication.

Risks Related to Our Stock

The price of our common stock fluctuates widely and is likely to continue to do so. Opportunities for the sale of shares at any particular time may
be limited.

We cannot assure investors that a liquid trading market for our common stock will exist at any particular time. As a result, holders of our common
stock may not be able to sell shares quickly or at the current market price. During the 52-week period ended February 17, 2021, our average daily trading
volume was approximately 1,466,131 shares and the intra-day sales prices per share of our common stock on The Nasdaq Stock Market ranged from $9.70
to $31.18. As of February 17, 2021, our officers, directors and principal stockholders beneficially owned approximately 16 percent of our common stock.

Our  stock  price  can  experience  extreme  price  and  volume  fluctuations  that  are  unrelated  or  disproportionate  to  our  operating  performance  or
prospects. Securities class action lawsuits are often instituted against companies following periods of stock market volatility. Such litigation is costly and
diverts management’s attention from productive efforts.

Factors that may cause the price of our common stock to fluctuate rapidly and widely include:

changes in the expected or actual timing of our competitors’ potential development programs, including developments in ANDA litigation and
proceedings before the PTAB and the announcement of ANDA filings seeking approval for generic versions of Korlym;

general  market  and  economic  conditions,  including  the  economic,  social  and  emotional  costs  and  dislocations  arising  from  the  COVID-19
pandemic;

actual or anticipated variations in our operating results or changes to any public guidance we have provided;

actual or anticipated timing and results of our clinical trials;

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disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our
technologies;

short  selling  of  our  common  stock,  the  publication  of  speculative  opinions  about  our  business  or  other  market  manipulation  activities  by  third
parties that are intended to lower our stock price or increase its volatility;

changes  in  estimates  or  recommendations  by  securities  analysts  or  the  failure  of  our  performance  to  meet  the  published  expectations  of  those
analysts or any public guidance we have provided;

actual or anticipated regulatory approvals of our product candidates or of competing products;

purchases or sales of our common stock by our officers, directors or stockholders;

changes in laws or regulations applicable to our product candidates or our competitors’ products;

technological innovations by us, our collaborators or our competitors;

changes in the trading volume of our common stock;

conditions in the pharmaceutical industry, including the market valuations of companies similar to Corcept;

additions or departures of key personnel;

announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments;

additional financing activities; and

our cash and short-term investment position.

Our  stock  price  may  decline  if  our  financial  performance  does  not  meet  the  guidance  we  have  provided  to  the  public,  estimates  published  by
research analysts or other investor expectations.

The guidance we provide as to our expected 2021 revenue is only an estimate of what we believe is realizable at the time we give such guidance. It
is difficult to predict our revenue and our actual results may vary materially from our guidance. The effect on our business of the COVID-19 pandemic is
difficult  to  estimate.  In  addition,  the  rate  of  physician  adoption  of  Korlym  and  the  actions  of  government  and  private  payers  is  uncertain.  We  may
experience competition from generic versions of Korlym, which our public revenue guidance does not anticipate. We may not meet our financial guidance
or  other  investor  expectations  for  other  reasons,  including  those  arising  from  the  risks  and  uncertainties  described  in  this  report  and  in  our  other  public
filings and public statements. Research analysts publish estimates of our future revenue and earnings based on their own analysis. The revenue guidance we
provide may be one factor they consider when determining their estimates.

General Risk Factors

We are subject to government regulation and other legal obligations relating to privacy and data protection. Compliance with these requirements
is complex and costly. Failure to comply could materially harm our business.

We and our partners are subject to federal, state and foreign laws and regulations concerning data privacy and security, including HIPAA and the EU
General Data Protection Regulation, or the GDPR. These and other regulatory frameworks are evolving rapidly as new rules are enacted and existing ones
updated and made more stringent.

In the United States, numerous federal and state laws and regulations, including state data breach notification laws, state health information privacy,
laws,  and  federal  and  state  consumer  protection  laws  and  regulations  (e.g.,  Section  5  of  the  FTC  Act),  that  govern  the  collection,  use,  disclosure,  and
protection  of  health-related  and  other  personal  information  could  apply  to  our  operations  or  the  operations  of  our  partners.  In  addition,  we  may  obtain
health  information  from  third  parties  (including  research  institutions  from  which  we  obtain  clinical  trial  data)  that  are  subject  to  privacy  and  security
requirements under HIPAA. Depending on the facts and circumstances, we could be subject to criminal penalties if we knowingly obtain, use, or disclose
individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.

Even  when  HIPAA  does  not  apply,  according  to  the  Federal  Trade  Commission  or  the  FTC,  violating  consumers’  privacy  or  failing  to  take
appropriate steps to keep consumers’ personal information secure may constitute unfair acts or practices in or affecting commerce in violation of Section
5(a) of the Federal Trade Commission Act. The FTC expects a

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company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and
complexity  of  its  business,  and  the  cost  of  available  tools  to  improve  security  and  reduce  vulnerabilities.  Individually  identifiable  health  information  is
considered sensitive data that merits stronger safeguards.

In addition, certain state laws govern the privacy and security of health information in certain circumstances, some of which are more stringent than
HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Failure to
comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation. For example, the
California Confidentiality of Medical Information Act imposes restrictive requirements regulating the use and disclosure of health information and other
personally identifiable information. Further, on June 28, 2018, California enacted the California Consumer Privacy Act, or the CCPA, which took effect on
January  1,  2020.  The  CCPA  creates  individual  privacy  rights  for  California  consumers  and  increases  the  privacy  and  security  obligations  of  entities
handling certain personal information. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that is
expected to increase data breach litigation. The CCPA may increase our compliance costs and potential liability. Similar laws have been proposed at the
federal level and in other states.

The GDPR went into effect in 2018 and has become binding against all EEA member states. It imposes stringent requirements for controllers and
processors of personal data, particularly with respect to clinical trials. The GDPR provides that EEA member states may make their own further laws and
regulations limiting the processing of health data, which could limit our ability to use and share personal data or could cause our costs to increase and harm
our business and financial condition. In addition, the GDPR increases the scrutiny that clinical trial sites located in the EEA should apply to transfers of
personal  data  from  such  sites  to  countries  that  are  considered  to  lack  an  adequate  level  of  data  protection,  such  as  the  United  States.  Recent  legal
developments have also created complexity and compliance uncertainty regarding certain transfers of information from the EEA to the United States. For
example,  on  June  16,  2020,  the  Court  of  Justice  of  the  European  Union  (“CJEU”)  declared  the  EU-U.S.  Privacy  Shield  framework  to  be  invalid.  As  a
result, Privacy Shield is no longer a valid mechanism for transferring personal data from the EU to the United States. Moreover, it is uncertain whether the
standard  contractual  clauses  will  also  be  invalidated  by  the  European  courts  or  legislature.  The  GDPR  imposes  substantial  fines  for  breaches  of  data
protection requirements, which can be up to four percent of global revenue for the preceding financial year or €20 million, whichever is greater, and it also
confers a private right of action on data subjects for breaches of data protection requirements. Compliance with European data protection laws is a rigorous
and  time  intensive  process  that  may  increase  our  cost  of  doing  business,  and  despite  those  efforts,  there  is  a  risk  that  we  may  be  subject  to  fines  and
penalties, litigation and reputational harm in connection with our European activities. Additionally, following the United Kingdom’s withdrawal from the
EU, we have to comply with the GDPR and separately the GDPR as implemented in the United Kingdom, each regime having the ability to fine up to the
greater of €20 million/ £17.5 million or 4% of global turnover. The relationship between the United Kingdom and the EU in relation to certain aspects of
data  protection  law  remains  unclear,  for  example  around  how  data  can  lawfully  be  transferred  between  each  jurisdiction,  which  exposes  us  to  further
compliance risk.

Complying with U.S. and foreign privacy and security laws and regulations is complex and costly. Failure to comply by us or our vendors could

subject us to litigation, government enforcement actions and substantial penalties and fines, which could harm our business.

We  rely  heavily  on  information  technology  systems  to  conduct  our  business.  A  breakdown  or  breach  of  these  systems  or  our  failure  to  protect
confidential information concerning our business, patients or employees could interrupt the operation of our business and subject us to liability.

We store valuable confidential information relating to our business, patients and employees on our computer networks and on the networks of our
vendors.  In  addition,  we  rely  heavily  on  internet  technology,  including  video  conference,  teleconference  and  file-sharing  services,  to  conduct  business
during the COVID-19 pandemic. Despite the implementation of security measures, our networks and the networks of our vendors are subject to the risk of
cyberattacks,  “phishing”  attacks,  computer  hackers,  service  provider  or  vendor  error,  or  malfeasance  or  other  intentional  or  unintentional  acts  by  third
parties and bad actors, including vendors, computer viruses, unauthorized access, natural disasters, terrorism, war and internet and electrical failures. They
may also be manipulated by criminals seeking to commit fraud or theft.

COVID-19  may  increase  our  cybersecurity  risks,  due  to  our  reliance  on  internet  technology  and  the  number  of  our  employees  that  are  working
remotely, which may create additional opportunities for cybercriminals to exploit vulnerabilities. In addition, system failures could cause the loss, theft,
exposure,  or  unauthorized  access  or  use  of  valuable  clinical  trial  data  as  a  result  of  accidents,  errors  or  malfeasance  by  our  employees,  independent
contractors or others working with us or on our behalf or otherwise disrupt our clinical and commercial activities and be expensive and time-consuming to
remedy. Our servers and systems, and those of our vendors, may be vulnerable to computer malware, break-ins, denial-of-service attacks, and similar

24

disruptions  from  unauthorized  tampering  with  our  computer  systems,  which  could  result  in  someone  obtaining  unauthorized  access  to  our  confidential
information, including our clinical data, or the confidential information of our patients or employees.

The  computer  systems  of  the  CRO  that  managed  one  of  our  early-stage  clinical  trials  was  breached  and  confidential  information,  including
information about some of the patients who participated in our trial, was exposed. Under applicable law, this breach is the responsibility of the CRO, which
has  notified  the  affected  patients  and  is  cooperating  closely  with  regulatory  and  law  enforcement  authorities.  We  do  not  expect  this  breach  to  have  any
impact on our development programs or financial performance.

We have experienced “phishing” attacks and other unauthorized access to certain data and information. There is no assurance that our cybersecurity
systems and processes will be effective in preventing unauthorized access in the future. Furthermore, because the techniques used to obtain unauthorized
access  to,  or  to  sabotage,  systems  change  frequently  and  often  are  not  recognized  until  launched  against  a  target,  we  may  be  unable  to  anticipate  these
techniques or implement adequate preventative measures. We may also experience security breaches that remain undetected for an extended period.

Disruptions or security breaches that result in the disclosure of confidential or proprietary information could cause us to incur liability and delay or
otherwise  harm  our  research,  development  and  commercialization  efforts.  We  may  be  liable  for  losses  suffered  by  patients  or  employees  or  other
individuals whose confidential information is stolen as a result of a breach of the security of the systems that we or third parties and our vendors store this
information on, and any such liability could be material. Even if we are not liable for such losses, any breach of these systems could expose us to material
costs in notifying affected individuals, as well as regulatory fines or penalties. In addition, any breach of these systems could disrupt our normal business
operations and expose us to reputational damage and harm our business, operating results and financial condition. Any insurance we maintain against the
risk of this type of loss may not be sufficient to cover actual losses, or may not apply to the circumstances relating to any particular loss.

We  are  dependent  on  the  continued  functioning  of  the  FDA  and  other  federal  instrumentalities.  Inadequate  funding  of  these  instrumentalities,
their  partial  or  complete  closure,  their  diversion  of  resources  to  work  on  pandemic-related  issues,  or  their  inability  to  hire  and  retain  talented
professionals could materially harm our business.

The government’s ability to carry out its mandated functions is affected by a variety of factors, including adequate government funding, the ability to
hire  and  retain  key  personnel,  statutory,  regulatory  and  policy  changes,  possible  diversion  of  resources  and  limited  operating  capacity  and  diversion  of
resources caused by the COVID-19 pandemic or other events that may reduce the government’s ability to perform routine functions. Disruptions at the
FDA and other agencies may slow the time to review new drug applications and respond to other inquiries. Disruptions at the Securities and Exchange
Commission (“SEC”) may temporarily stop its ability to review and approve proposed financing transactions. Several times in the last few years, including
for 35 days beginning on December 22, 2018, the U.S. government has shut down and many regulatory agencies, including the FDA and SEC, have had to
furlough  employees  and  stop  critical  activities.  If  a  prolonged  government  shutdown  occurs,  it  could  significantly  impair  the  FDA,  SEC  and  other
authorities’ ability to process our submissions, which could materially harm our business.

Separately, in response to the COVID-19 pandemic, on March 10, 2020 the FDA announced its intention to postpone most inspections of foreign
manufacturing  facilities,  and  on  March  18,  2020,  the  FDA  temporarily  postponed  routine  surveillance  inspections  of  domestic  manufacturing  facilities.
Subsequently, on July 10, 2020 the FDA announced its intention to resume certain on-site inspections of domestic manufacturing facilities subject to a risk-
based prioritization system. The FDA intends to use this risk-based assessment system to identify the categories of regulatory activity that can occur within
a given geographic area, ranging from mission critical inspections to resumption of all regulatory activities. Regulatory authorities outside the United States
may adopt similar restrictions or other policy measures in response to the COVID-19 pandemic. If a prolonged government shutdown occurs, or if global
health  concerns  continue  to  prevent  the  FDA  or  other  regulatory  authorities  from  conducting  their  regular  inspections,  reviews,  or  other  regulatory
activities,  it  could  significantly  impact  the  ability  of  the  FDA  or  other  regulatory  authorities  to  timely  review  and  process  our  regulatory  submissions,
which could have a material adverse effect on our business.

Changes in federal, state and local tax laws may reduce our net earnings.

Our earnings are subject to federal, state and local tax. We offset a portion of our earnings using net operating losses and our taxes using research

and development tax credits, which reduces the amount of tax we pay. Some jurisdictions require that we pay taxes or fees calculated as a percentage of
sales, payroll expense, or other indicia of our activities. Please see “Part IV, Item 16, Notes to Consolidated Financial Statements - Income Taxes.” Changes
to existing tax laws that we cannot control or predict could materially increase the amount of taxes and fees we must pay. For example, an increase in
income tax rates or a reduction or elimination of net operating losses and research and development tax credits could significantly increase our tax expense,
which would reduce our net income and adversely affect our results of operations.

25

We may be unable to obtain or maintain regulatory approvals for our product or product candidates.

We cannot promote a product candidate unless the FDA or comparable foreign regulatory authorities approves it, which may not happen. Obtaining
regulatory  approval  of  a  drug  is  difficult,  uncertain,  lengthy  and  expensive.  Failure  can  occur  at  any  stage.  In  order  to  receive  FDA  approval,  we  must
demonstrate to the FDA’s satisfaction that the new drug is safe and effective for its intended use and that our manufacturing processes comply with cGMPs.
Our inability or the inability of our vendors to comply with applicable FDA and other regulatory requirements can result in delays in or denials of new
product approvals, warning letters, fines, consent decrees restricting or suspending manufacturing operations, injunctions, civil penalties, recall or seizure
of  products,  total  or  partial  suspension  of  product  sales  and  criminal  prosecution. Any  of  these  or  other  regulatory  actions  could  materially  harm  our
business and financial condition.

If we receive regulatory approval for a product candidate, we will be subject to ongoing FDA requirements and oversight, such as continued safety
and other reporting requirements and post-marketing restrictions. If we are not able to maintain regulatory compliance, we may not be permitted to develop
our product candidates or market our products and may be subject to product recalls or seizures. Any regulatory approvals for our product candidates may
require costly post-marketing studies. Future governmental action or changes in FDA policy or personnel may also result in delays or rejection of an NDA
or supplemental NDA.

We may face competition from companies with greater financial, technical and marketing resources than our own.

The  pharmaceutical  industry  is  competitive  and  subject  to  rapid  technological  change.  Our  potential  competitors  include  large  pharmaceutical
companies, which have greater clinical, marketing and sales resources than our own and may develop and commercialize medications that are superior to
and less expensive than ours, which could negatively affect our financial results.

If we acquire products or product candidates, we will incur significant costs and may not realize the benefits we anticipate.

We may acquire a product or product candidate that complements our strategic plan. Such an acquisition may give rise to unforeseen difficulties and
costs  and  may  absorb  significant  management  attention.  We  may  not  realize  the  anticipated  benefits  of  any  acquisition,  which  could  dilute  our
stockholders’ ownership interest or cause us to incur significant expenses and debt.

Our ability to compete could be diminished if we are unable to protect our trade secrets and proprietary information.

In addition to patents, we rely on a combination of confidentiality, nondisclosure and other contractual provisions, laws protecting trade secrets and
security measures to protect our proprietary information. These measures may not be adequate, in which case competitors could exploit our proprietary
information to our disadvantage. If employees, consultants or anyone else breaches their agreements with us regarding our proprietary information, we may
not have adequate remedies for the breach.

Research analysts may not continue to provide or initiate coverage of our common stock or may issue negative reports.

The market for our common stock may be affected by the reports financial analysts publish about us. If any of the analysts covering us downgrades
or  discontinues  coverage  of  our  stock,  the  price  of  our  common  stock  could  decline  rapidly  and  significantly.  Paucity  of  research  coverage  may  also
adversely affect our stock price.

Sale of a substantial number of shares of our common stock may cause its price to decline.

Sales of a substantial number of shares of our stock in the public market could reduce its price. As additional shares of our stock become available
for public resale, whether by the exercise of stock options by employees or directors or because of an equity financing by us, the supply of our stock will
increase, which could cause its price to fall. Substantially all of the shares of our stock are eligible for sale, subject to applicable volume and other resale
restrictions.

Changes in laws and regulations may significantly increase our costs, which could harm our financial results.

New  laws  and  regulations,  as  well  as  changes  to  existing  laws  and  regulations,  including  statutes  and  regulations  concerning  taxes  and  the
development,  approval,  and  marketing  of  medications,  the  provisions  of  the  ACA  requiring  the  reporting  of  aggregate  spending  related  to  health  care
professionals,  the  provisions  of  the  Sarbanes-Oxley  Act  of  2002  and  rules  adopted  by  the  SEC  and  by  The  Nasdaq  Stock  Market  have  and  will  likely
continue to increase our cost of doing business and divert management’s attention from revenue-generating activities.

26

We  may  fail  to  comply  with  our  public  company  obligations,  including  securities  laws  and  regulations.  Such  compliance  is  costly  and  requires
significant management attention.

The federal securities laws and regulations, including the corporate governance and other requirements of the Sarbanes-Oxley Act of 2002, impose
complex and continually changing regulatory requirements on our operations and reporting. These developing requirements will continue to increase our
compliance costs. Section 404 of the Sarbanes-Oxley Act of 2002 requires that we evaluate the effectiveness of, and provide a management report with
respect to, our internal controls over financial reporting. It also requires that the independent registered public accounting firm auditing our consolidated
financial statements must attest to and report on the effectiveness of our internal controls over financial reporting. If we are unable to complete the required
assessment and report or if our independent registered public accounting firm is unable to issue an unqualified opinion as to the effectiveness of our internal
control over financial reporting, investors could lose confidence in our financial reporting and our stock price would likely decline.

Anti-takeover provisions in our charter and bylaws and under Delaware law may make an acquisition of us or a change in our management more
expensive or difficult, even if an acquisition or a management change would be beneficial to our stockholders.

Provisions in our charter and bylaws may delay or prevent an acquisition of us or a change in our management. Some of these provisions allow us to
issue  preferred  stock  without  any  vote  or  further  action  by  the  stockholders,  require  advance  notification  of  stockholder  proposals  and  nominations  of
candidates for election as directors and prohibit stockholders from acting by written consent. In addition, a supermajority vote of stockholders is required to
amend our bylaws. Our bylaws provide that special meetings of the stockholders may be called only by our Chairman, President or the Board of Directors
and that the authorized number of directors may be changed only by resolution of the Board of Directors. These provisions may prevent or delay a change
in  our  Board  of  Directors  or  our  management,  which  our  Board  of  Directors  appoints.  In  addition,  because  we  are  incorporated  in  Delaware,  we  are
governed  by  the  provisions  of  Section  203  of  the  Delaware  General  Corporation  Law.  Section  203  may  prohibit  large  stockholders,  in  particular  those
owning 15 percent or more of our outstanding voting stock, from merging or combining with us. These provisions in our charter and bylaws and under
Delaware law could reduce the price that investors would be willing to pay for shares of our common stock.

Our officers, directors and principal stockholders, acting as a group, could significantly influence corporate actions.

As  of  February  17,  2021,  our  officers  and  directors  beneficially  owned  approximately  16  percent  of  our  common  stock.  Acting  together,  these
stockholders  could  significantly  influence  any  matter  requiring  approval  by  our  stockholders,  including  the  election  of  directors  and  the  approval  of
mergers or other business combinations. The interests of this group may not always coincide with our interests or the interests of other stockholders and
may prevent or delay a change in control. This significant concentration of share ownership may adversely affect the trading price of our common stock
because many investors perceive disadvantages to owning stock in companies with controlling stockholders.

ITEM 1B. UNRESOLVED STAFF COMMENTS

None.

ITEM 2. PROPERTIES

We lease 36,062 square feet of office space in Menlo Park, California for our corporate facilities. Our current lease expires in March 2022.

ITEM 3. LEGAL PROCEEDINGS

Teva ANDA Litigation.

In February 2018, we received a Paragraph IV Notice Letter advising that Teva had submitted an Abbreviated New Drug Application (“ANDA”) to
the FDA seeking authorization to manufacture, use or sell a generic version of Korlym in the United States prior to the expiration of certain of our patents
related  to  Korlym  -  U.S.  Patent  No.  8,921,348  (the  “’348  patent”)  and  U.S.  Patent  No.  9,829,495  (the  “’495  patent”)  -  which  are  listed  in  the  FDA’s
Approved  Drug  Products  with  Therapeutic  Equivalence  Evaluations  (the  “Orange  Book”).  Teva’s  February  5,  2018  Notice  Letter  alleges  that  the  ’348
patent,  with  an  expiration  date  in  August  2028,  and  the  ’495  patent,  with  an  expiration  date  in  August  2036,  will  not  be  infringed  by  Teva’s  proposed
product, are invalid and/or are unenforceable. On March 15, 2018, we filed a lawsuit in the U.S. District Court for the District of New Jersey against Teva
for  infringement  of  these  patents.  On  October  12,  2018,  Teva  received  tentative  approval  from  the  FDA  for  its  ANDA.  In  accordance  with  the  Hatch-
Waxman Act, however, as a result of filing a timely lawsuit against Teva, FDA final approval of Teva’s ANDA was stayed for 30 months, until August 1,
2020.

27

On July 6, 2018, we filed an amended complaint against Teva, asserting infringement of U.S. Patent No. 9,943,526 (the “’526 patent”). On February
8, 2019, we filed a second lawsuit against Teva, asserting infringement of U.S. Patent Nos. 10,166,242 (the “ʼ242 patent”), 10,166,243 (the “ʼ243 patent”)
and 10,195,214 (the “ʼ214 patent”). On December 13, 2019, we filed a third lawsuit against Teva, asserting infringement of U.S. Patent Nos. 10,500,216
(the “ʼ216 patent”). The District Court consolidated our lawsuits against Teva into a single action and set a trial date of February 2, 2021. On September 24,
2020, the Court vacated the February 2, 2021 trial date and ordered the parties to complete trial preparations by March 17, 2021. A new trial date has not
been set.

No new 30-month stay resulted from the filing of the amended complaint or new lawsuits.

On May 7, 2019, Teva submitted to the PTAB a petition for post-grant review (“PGR”) of the ’214 patent, which we opposed. On November 20,
2019, the PTAB granted Teva’s petition. On November 19, 2020, the PTAB issued a decision upholding the validity of the ’214 patent against all of Teva’s
claims. Teva has until March 12, 2021 to file its appeal brief with Federal Circuit Court of Appeals.

We will vigorously enforce our intellectual property rights relating to Korlym, but cannot predict the outcome of these matters.

Sun ANDA Litigation

On  June  10,  2019,  we  received  a  Paragraph  IV  Notice  Letter  advising  that  Sun  had  submitted  an  ANDA  to  the  FDA  seeking  authorization  to
manufacture, use or sell a generic version of Korlym in the United States prior to the expiration of certain of our patents related to Korlym listed in the
Orange Book (the “Korlym Patents”).

The Notice Letter alleges that the Korlym Patents will not be infringed by Sun Ltd.’s proposed product, are invalid and/or are unenforceable. On July
22, 2019, we filed a lawsuit in the U.S. District Court for the District of New Jersey against Sun Pharma Global FZE (“Sun FZE”), Sun Pharma Global Inc.
(“Sun Pharma”), Sun Pharmaceutical Industries, Inc. (“Sun Inc.”), and Sun Ltd. (collectively, “Sun”) for infringement of the ’348, ’214, and ’495 patents.
On January 23, 2020, we filed an amended complaint against Sun asserting infringement of the ’216 patent. Sun has denied our allegations.

In accordance with the Hatch-Waxman Act, as a result of filing a timely lawsuit against Sun, FDA approval of Sun Ltd.’s ANDA will be stayed until
the earlier of (i) 30 months from our June 10, 2019 receipt of Sun Ltd.’s Paragraph IV Notice Letter or (ii) a District Court decision finding that the ’348,
’214, and ’495 patents are invalid, unenforceable or not infringed.

We will vigorously enforce our intellectual property rights relating to Korlym, but cannot predict the outcome of this matter.

Hikma Paragraph IV Notice Letter

On February 1, 2021, we received a Paragraph IV Notice Letter advising that Hikma had submitted an ANDA to the FDA seeking authorization to

manufacture, use or sell a generic version of Korlym in the United States.

The  Notice  Letter  contains  Paragraph  IV  certifications  against  certain  of  our  patents  related  to  Korlym,  specifically  U.S.  Patent  Nos.  ’348,  ’495,
10,006,924  (the  “ʼ924  patent”),  ’526,  10,151,763  (the  “ʼ763  patent”),  ’242,  ’243,  ’214,  10,231,983  (the  “ʼ983  patent”),  10,314,850  (the  “ʼ850  patent”),
10,495,650 (the “ʼ650 patent”), ʼ216, 10,660,904 (the “ʼ904 patent”), 10,780,097 (the “ʼ097 patent”), 10,842,800 (the “ʼ800 patent”), and 10,842,801 (the
“ʼ801 patent”) (collectively, the “Korlym Patents”), which are listed in the Orange Book. The Notice Letter alleges that the Korlym Patents will not be
infringed by Hikma’s proposed product, are invalid and/or are unenforceable.

We intend to vigorously enforce our intellectual property rights relating to Korlym, but we cannot predict the outcome of any litigation that could be

filed.

Other matters

On  March  14,  2019,  a  purported  securities  class  action  complaint  was  filed  in  the  U.S.  District  Court  for  the  Northern  District  of  California  by
Nicholas  Melucci  (Melucci  v.  Corcept  Therapeutics  Incorporated,  et  al.,  Case  No.  5:19-cv-01372-LHK).  The  complaint  named  us  and  certain  of  our
executive officers as defendants asserting violations of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder and alleges
that the defendants made false and materially misleading statements and failed to disclose adverse facts about our business, operations, and prospects. The
complaint asserts a putative class period stemming from August 2, 2017 to February 5, 2019 and seeks unspecified monetary relief, interest and attorneys’
fees. On October 7, 2019, the Court appointed a lead plaintiff and lead counsel. The lead plaintiff’s consolidated complaint was filed on December 6, 2019.

28

We  moved  to  dismiss  the  consolidated  complaint  on  January  27,  2020.  Rather  than  oppose  our  motion  to  dismiss,  on  March  20,  2020,  the  lead
plaintiff filed a second amended complaint. On May 11, 2020, we moved to dismiss the second amended complaint. We received plaintiff’s opposition to
our motion on June 25, 2020 and filed our reply on July 27, 2020. On November 20, 2020, the Court granted our motion to dismiss in full and granted
plaintiff leave to file a third amended complaint, which plaintiff did on December 21, 2020. On February 19, 2021, we filed our motion to dismiss the third
amended complaint. Plaintiff’s opposition to our motion is due on April 20, 2021 and our reply is due on June 4, 2021.

We will respond vigorously to plaintiff’s claims but cannot predict the outcome of this matter.

On September 30, 2019, a purported shareholder derivative complaint was filed in the United States District Court for the District of Delaware by
Lauren Williams, and captioned Lauren Williams v. G. Leonard Baker, et al., Civil Action No. 1:19-cv-01830. The complaint named our board of directors,
including our Chief Executive Officer and Chief Financial Officer as defendants and us as nominal defendant. The complaint alleges breach of fiduciary
duty,  violation  of  Section  14(a)  of  the  Exchange  Act,  insider  selling,  misappropriation  of  insider  information  and  waste  of  corporate  assets  and  seeks
damages  in  an  amount  to  be  proved  at  trial.  On  October  23,  2019,  this  action  was  stayed  pending  a  resolution  of  our  motions  to  dismiss  the  Melucci
litigation. We will respond to this complaint vigorously but cannot predict the outcome of this matter.

On  December  19,  2019,  a  second  purported  shareholder  derivative  complaint  was  filed  in  the  United  States  District  Court  for  the  District  of
Delaware  by  Jeweltex  Pension  Plan,  and  captioned  Jeweltex  Pension  Plan  v.  James  N.  Wilson,  et  al.,  Civil  Action  No.  1:19-cv-02308.  The  complaint
named  our  board  of  directors,  including  our  Chief  Executive  Officer,  as  well  as  our  Chief  Financial  Officer  as  defendants  and  Corcept  Therapeutics
Incorporated as nominal defendant. The complaint seeks to allege causes of action for breach of fiduciary duty, violation of section 14(a) of the Exchange
Act,  waste  of  corporate  assets,  contribution  and  indemnification,  aiding  and  abetting,  and  gross  mismanagement.  The  complaint  seeks  an  amount  of
damages to be proved at trial. On April 6, 2020, this action was stayed pending a resolution of our motions to dismiss the Melucci litigation. On December
20, 2020, the case was further stayed pending a resolution of Corcept’s forthcoming motion to dismiss the third amended complaint. We will respond to this
complaint vigorously but cannot predict the outcome of this matter.

In addition to the matters described above, we are involved from time to time in other legal proceedings in the ordinary course of business. Although
the outcome of any pending matters and the amount, if any, of our ultimate liability with respect to them cannot be predicted with certainty, we do not
believe that the ultimate outcome of such matters will have a material adverse effect on our business, results of operations or financial position.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

29

ITEM  5.  MARKET  FOR  REGISTRANT’S  COMMON  EQUITY,  RELATED  STOCKHOLDER  MATTERS  AND  ISSUER  PURCHASES  OF
EQUITY SECURITIES

PART II

Market Information

Our common stock is traded on The Nasdaq Capital Market under the symbol “CORT.”

Stockholders of Record and Dividends

As of February 17, 2021, we had 117,312,341 shares of common stock outstanding held by 29 stockholders of record. Because almost all of our
common  stock  is  held  by  brokers,  nominees  and  other  institutions  on  behalf  of  stockholders,  we  are  unable  to  estimate  the  actual  number  of  our
stockholders. We have never declared or paid cash dividends. We do not anticipate paying cash dividends in the foreseeable future.

Sale of Unregistered Securities

None.

Repurchases of Securities

The following table contains information relating to the repurchases of our common stock as part of a publicly announced stock repurchase program

(“Stock Repurchase Program”) in the three months ended December 31, 2020 (in thousands, except per share data):

Fiscal Period

October 1, 2020 to October 31, 2020
November 1, 2020 to November 30, 2020
December 1, 2020 to December 31, 2020
Total

Total Number of Shares
Purchased

Average Price Paid Per
Share

Approximate Dollar
Amount of Shares That
May Yet be Purchased
(1)
Under the Program

—  $
450 
9 
459  $

—  $

21.05 
22.64 
21.08  $

— 
190,526 
190,331 
190,331 

(1)

  On  November  3,  2020,  our  Board  of  Directors  authorized  the  repurchase  of  up  to  $200  million  of  our  common  stock  pursuant  to  our  Stock  Repurchase  Program.  Unless  terminated  or

suspended prior, the Stock Repurchase Program will remain in effect until September 30, 2021.

The following table contains information relating to the repurchases of our common stock as part of the cashless net exercises of stock options in the

three months ended December 31, 2020 (in thousands, except per share data):

Fiscal Period

October 1, 2020 to October 31, 2020
November 1, 2020 to November 30, 2020
December 1, 2020 to December 31, 2020
Total

Total Number of Shares
Purchased

(2)

Average Price Paid Per
Share

Approximate Dollar
Amount of Shares

—  $
31 
58 
89  $

—  $

22.88 
24.74 
24.09  $

— 
714 
1,443 
2,157 

(2)

 In November 2020, we issued 50,000 shares of common stock as part of a net-share settlement of a cashless option exercise, of which 31,225 shares were tendered to us in satisfaction of
related exercise costs. In December 2020, we issued 89,902 shares of common stock as part of a net-share settlement of a cashless option exercise, of which 58,324 shares were tendered to us in
satisfaction of related exercise costs.

Market Performance Graph

The graph and the accompanying text below is not “soliciting material,” is not deemed filed with the SEC and is not to be incorporated by reference
in  any  filings  by  us  under  the  Securities  Act  or  the  Exchange  Act,  whether  made  before  or  after  the  date  hereof  and  irrespective  of  any  general
incorporation language in such filing.

We  have  elected  to  use  the  Nasdaq  US  Benchmark  TR  Index  and  Nasdaq  Biotechnology  Index  (consisting  of  a  group  of  120  companies  in  the

biotechnology sector, including us) for purposes of the performance comparison that appears below,

30

which shows the cumulative stockholder return assuming the investment of $100 and the reinvestment of any dividends and is based on the returns of the
component companies weighted according to their market capitalizations.

The graph shows the cumulative total stockholder return assuming the investment of $100 and the reinvestment of any dividends and is based on the
returns of the component companies weighted according to their market capitalizations as of the end of the period for which returns are indicated. We have
never paid dividends on our common stock.

The return shown in the graph below for our common stock is not necessarily indicative of future performance. We do not make or endorse any

predictions as to future stockholder returns.

Five-Year Cumulative Total Returns of our Common Stock (CORT),

the Nasdaq US Benchmark TR Index (NQUSBT) and

the Nasdaq Biotechnology Index (NBI)

31

ITEM 6. SELECTED FINANCIAL DATA

SELECTED FINANCIAL DATA
(in thousands, except per share data)

The selected financial data set forth below are derived from our audited consolidated financial statements. The statement of operations data for the
years ended December 31, 2020, 2019 and 2018 and the balance sheet data as of December 31, 2020 and 2019 are derived from our audited consolidated
financial statements included in this Annual Report. The statement of operations data for the years ended December 31, 2017 and 2016 and the balance
sheet data as of December 31, 2018, 2017 and 2016 have been derived from our audited financial statements, which are not included in this Annual Report.
Our  historical  results  are  not  necessarily  indicative  of  our  results  for  any  future  period.  The  selected  financial  data  set  forth  below  should  be  read  in
conjunction with our financial statements, the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
included elsewhere in this Annual Report.

Statement of Operations Data:
Product revenue, net
Operating expenses:

Cost of sales
Research and development
Selling, general and administrative

Total operating expenses

Income from operations
Interest and other income (expense), net
Income before income taxes
Income tax expense (benefit)

Net income
Net income per share:

Basic
Diluted

Weighted average shares – basic

Weighted average shares – diluted

Includes certain non-cash expenses, of the following:

Stock-based compensation

Cost of sales
Research and development
Selling, general and administrative
Total stock-based compensation

Non-operating expense related to accretion of interest on long-term
obligation

Total non-cash expenses

2020

Year Ended December 31,
2019
2017
2018
(In thousands, except per share data)

2016

$

353,874  $

306,486  $

251,247  $

159,201  $

81,321 

5,582 
114,764 
105,326 
225,672 
128,202 
3,400 
131,602 
25,591 
106,011  $

5,504 
89,017 
100,359 
194,880 
111,606 
5,070 
116,676 
22,495 
94,181  $

5,215 
75,247 
81,289 
161,751 
89,496 
2,657 
92,153 
16,743 
75,410  $

3,554 
40,376 
62,416 
106,346 
52,855 
(49)
52,806 
(76,316)
129,122  $

0.92  $
0.85  $

0.82  $
0.77  $

0.65  $
0.60  $

1.14  $
1.04  $

115,412 

124,194 

114,349 

122,566 

115,343 

126,688 

113,527 

124,515 

66  $

144  $

259  $

—  $

11,222 
22,251 
33,539 

9,541 
19,628 
29,313 

7,012 
16,476 
23,747 

3,743 
9,618 
13,361 

— 
33,539  $

— 
29,313  $

— 
23,747  $

456 
13,817  $

2,058 
23,844 
45,240 
71,142 
10,179 
(2,039)
8,140 
— 
8,140 

0.07 
0.07 

110,566 

116,139 

— 
1,312 
5,746 
7,058 

1,929 
8,987 

$

$
$

$

$

32

 
 
 
 
 
 
 
 
Balance Sheet Data:
Cash, cash equivalents and investments
Working capital
Total assets
Debt obligation - current portion
Total stockholders’ equity

2020

2019

December 31,
2018
(In thousands)

2017

2016

$

476,892  $
431,007 
571,731 
— 
523,338 

315,314  $
268,517 
412,312 
— 
371,182 

206,760  $
201,247 
311,694 
— 
275,882 

104,025  $
94,616 
220,537 
— 
190,968 

51,536 
38,315 
68,753 
14,664 
41,379 

33

 
 
 
 
 
 
 
 
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) is intended to help the reader
understand  our  results  of  operations  and  financial  condition  and  is  provided  as  a  supplement  to,  and  should  be  read  in  conjunction  with,  our  audited
consolidated financial statements and the accompanying notes to financial statements, risk factors and other disclosures included in this Form 10-K. Our
consolidated financial statements have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“U.S. GAAP”).

We make statements in this section that are forward-looking statements within the meaning of the federal securities laws. For a complete discussion
of such forward-looking statements and the potential risks and uncertainties that may affect their accuracy, see “Forward-Looking Statements” included in
“Risk Factors” in this Form 10-K and the “Overview” and “Liquidity and Capital Resources” sections of this MD&A.

Overview

We  are  a  commercial-stage  company  engaged  in  the  discovery  and  development  of  drugs  that  treat  severe  metabolic,  oncologic  and  psychiatric
disorders  by  modulating  the  effects  of  the  hormone  cortisol.  Since  2012,  we  have  marketed  Korlym®  (mifepristone)  for  the  treatment  of  patients  who
suffer from Cushing’s syndrome. Our portfolio of proprietary selective cortisol modulators consists of four structurally distinct series totaling more than
1,000 compounds, including relacorilant, exicorilant and miricorilant.

Cushing’s Syndrome

Korlym.  We  sell  Korlym  in  the  United  States,  using  experienced  sales  representatives  to  call  on  physicians  caring  for  patients  with  endogenous
Cushing’s  syndrome  (hypercortisolism).  Because  many  people  who  suffer  from  Cushing’s  syndrome  are  undiagnosed  or  inadequately  treated,  we  have
developed and continue to refine and expand programs to educate physicians and patients about screening for hypercortisolism and the role Korlym can
play in treating the disorder. We also have a field-based force of medical science liaisons.

We  use  one  specialty  pharmacy  and  one  specialty  distributor  to  distribute  Korlym  and  provide  logistical  support  to  physicians  and  patients.  Our
policy is that no patient with Cushing’s syndrome will be denied access to Korlym for financial reasons. To help us achieve that goal, we fund our own
patient support programs and donate money to independent charitable foundations that help patients pay for all aspects of their Cushing’s syndrome care,
whether or not that care includes taking Korlym.

Relacorilant.  We  are  conducting  two  Phase  3  trials  of  our  proprietary,  selective  cortisol  modulator,  relacorilant,  as  a  treatment  for  patients  with

Cushing’s Syndrome.

Our Phase 3 GRACE trial is expected to enroll 130 patients at sites in the United States, Canada, Europe and Israel. Each patient in GRACE will
receive relacorilant for 22 weeks. Patients who exhibit pre-specified improvements in hypertension or glucose metabolism enter a 12-week, double-blind,
“randomized withdrawal” phase in which half of the patients continue receiving relacorilant and the rest receive placebo. If successful, we expect GRACE
to provide the basis for a new drug application to treat patients with all etiologies of Cushing’s syndrome.

Our Phase 3 GRADIENT trial is expected to enroll 130 patients whose Cushing’s syndrome is caused by an adrenal tumor. Half of patients will

receive relacorilant for 26 weeks and half will receive placebo. Many of the clinical sites in GRACE are participating in GRADIENT.

The United States Food and Drug Association (“FDA”) and the European Commission (“EC”) have designated relacorilant as an orphan drug for the
treatment  of  Cushing’s  syndrome.  In  the  United  States,  relacorilant’s  orphan  designation  confers  tax  credits,  reduced  regulatory  fees  and,  provided  we
obtain approval, seven years of exclusive marketing rights for the treatment of patients with Cushing’s syndrome. Benefits of orphan drug designation by
the EC are similar, but also, include protocol assistance from the European Medicines Agency (“EMA”), access to the centralized marketing authorization
procedure in the European Union (“EU”) and, if we obtain approval, ten years of exclusive marketing rights in the EU for the treatment of patients with
Cushing’s syndrome.

Oncology

Relacorilant  in  Patients  with  Solid  Tumors.  In  July  2020,  we  completed  enrollment  in  a  178-patient,  controlled  Phase  2  trial  of  relacorilant  in

combination with nab-paclitaxel in patients with advanced, high-grade serous ovarian tumors, which we

34

are conducting at sites in the United States and Europe. We expect top-line data from this trial to be available in the first half of 2021.

In  addition,  our  Phase  3  RELIANT  trial  of  relacorilant  plus  nab-paclitaxel  in  patients  with  metastatic  pancreatic  cancer  is  expected  to  enroll  80
patients, all of whom will receive relacorilant plus nab-paclitaxel. We expect to complete an interim analysis of data from the first 43 patients in the first
half of 2021.

We are also conducting an open-label, Phase 1b trial of relacorilant plus the PD-1 checkpoint inhibitor pembrolizumab in 20 patients with advanced

adrenocortical cancer with cortisol excess.

Cortisol  Modulators  in  Patients  with  CRPC.  We  are  conducting  an  open  label,  dose-finding  trial  of  our  proprietary,  selective  cortisol  modulator
exicorilant in combination with Xtandi in patients with metastatic CRPC. Investigators at the University of Chicago are conducting a dose-finding trial of
relacorilant combined with Xtandi in the same patient population. We are providing relacorilant.

Metabolic Diseases

Antipsychotic-Induced Weight Gain (“AIWG”). We are studying our selective cortisol modulator miricorilant as a potential treatment for AIWG.
In 2020, we completed a double-blind, placebo-controlled Phase 1b trial, in which 96 healthy subjects received daily doses of the antipsychotic medication
olanzapine (10 mg) and either miricorilant (600 mg or 900 mg) or placebo for 14 days. Study participants who received miricorilant gained less weight than
subjects receiving placebo. In addition, markers of liver damage that rise temporarily at the start of olanzapine therapy increased less sharply in subjects
receiving miricorilant.

Our  double-blind,  placebo-controlled,  Phase  2  GRATITUDE  trial  is  studying  the  ability  of  miricorilant  to  reverse  recent  AIWG,  with  a  planned
enrollment of 100 patients with schizophrenia or bipolar disorder at 30 sites in the United States. Study participants receive their established antipsychotic
medication plus either miricorilant or placebo for 12 weeks. Our double-blind, placebo-controlled Phase 2 GRATITUDE II trial is studying the ability of
miricorilant to reverse long-standing AIWG in 120 patients with schizophrenia at 35 centers in the United States.

Liver Disease. We are conducting a double-blind, placebo-controlled, Phase 2 trial of miricorilant as a potential treatment for NASH. The trial has a
planned enrollment of 150 patients at 15 sites in the United States. Patients will receive a daily dose of miricorilant (600 mg or 900 mg) or placebo for 12
weeks.

Continued Discovery and Development

Our  selective  cortisol  modulator  CORT113176,  which  has  shown  promise  in  animal  models  of  amyotrophic  lateral  sclerosis  (or  “ALS”),  has
completed its Phase 1 trial. We plan to advance it to Phase 2 as a potential treatment for that disease. In addition, we continue to identify selective cortisol
modulators and plan to advance the most promising of them towards the clinic.

COVID-19 Pandemic

Much of the world is subject to pandemic-related public health restrictions, including in California, where we are headquartered, and in the states
where we sell Korlym and where our clinical trial sites are located. Most of our third-party manufacturers, distributors (including the specialty pharmacy
that dispenses Korlym), information technology service providers, law and accounting firms, clinical research organizations and others are also subject to
pandemic-related restrictions.

These restrictions, as well as measures voluntarily undertaken by patients, physicians, hospitals and medical clinics to reduce the risk of coronavirus
infection have reduced our revenue and make it difficult to grow our Korlym business. The pandemic’s impact on the pace of our clinical development
programs  has  been  variable.  Enrollment  has  slowed  significantly  in  trials  of  indications  not  considered  immediately  life-threatening,  such  as  Cushing’s
syndrome,  CRPC,  AIWG  and  NASH.  In  addition,  some  clinical  sites  have  stopped  enrolling  new  patients  or  have  reduced  the  frequency  with  which
physicians see study participants. Some sites have suspended or halted the initiation of new clinical trials. These changes lengthen the time it takes us to
complete our development programs, although trials in patients with immediately life-threatening diseases, such as advanced pancreatic and ovarian cancer,
have experienced many fewer disruptions and delays.

Please see "COVID-19 Pandemic" under Item 1 of this Annual Report and the risk factor under Item 1A of this Annual Report, “The COVID-19
pandemic or other public health emergencies, natural disasters, terrorism or other catastrophes could disrupt our activities and render our own or our
vendors’ facilities and equipment inoperable or inaccessible and require us to curtail or cease operations.”

35

Results of Operations

Net Product Revenue – Net product revenue is gross product revenue from sales to our customers less deductions for estimated government rebates

and chargebacks.

Net product revenue was $353.9 million for the year ended December 31, 2020, compared to $306.5 million and $251.2 million for the years ended
December 31, 2019 and 2018, respectively. For the years ended December 31, 2020, 2019 and 2018, higher sales volumes accounted for 31.9 percent, 58.4
percent and 85.7 percent of the increases in net revenue, respectively, as we shipped Korlym to more patients. Increases in the average price of Korlym
tablets accounted for the remainder of the increases. The increase in Korlym’s price for the year ended December 31, 2020 was due to a relative decrease in
the  number  of  patients  covered  by  Medicaid  (which  reimburses  Korlym  at  a  lower  rate),  a  statutorily-mandated  increase  in  the  price  paid  by  other
government programs, one price increase that took effect on August 1, 2019 and another on January 1, 2020.

Cost of sales – Cost of sales includes the cost of API, tableting, packaging, personnel, overhead, stability testing and distribution.

Cost of sales was $5.6 million for the year ended December 31, 2020, compared to $5.5 million and $5.2 million for the years ended December 31,
2019 and 2018, respectively. The dollar value of our cost of sales increased in both years due to greater sales unit volumes. Cost of sales was 1.6 percent,
1.8 percent and 2.1 percent of our net product revenue for the years ended December 31, 2020, 2019 and 2018, respectively. Cost of sales as a percentage
of revenue declined due to an increase in the average price of Korlym as well as a decrease in its cost of manufacture.

Research  and  development  expenses  –  Research  and  development  expenses  include  the  cost  of  (1)  recruiting  and  compensating  development
personnel, (2) clinical trials, (3) drug product and preclinical studies in support of clinical trials and regulatory submissions, (4) discovery research and (5)
the development of drug formulations and manufacturing processes.

Research  and  development  expenses  increased  to  $114.8  million  for  the  year  ended  December  31,  2020  from  $89.0  million  for  the  comparable
period in 2019. The increase was due to increased spending on the advancement of our oncology and endocrinology development programs and on the
recruitment and compensation of development personnel.

Research and development expenses increased to $89.0 million for the year ended December 31, 2019 from $75.2 million in 2018. The increase was
primarily  due  to  increased  spending  on  the  recruitment  and  compensation  of  development  personnel  and  on  the  discovery  and  advancement  of  new
selective cortisol modulators, partially offset by the completion of drug-drug interaction studies related to relacorilant.

Development programs:
Oncology
Endocrinology
Pre-clinical and clinical selective cortisol modulators
Unallocated activities, including pre-clinical, manufacturing and regulatory activities
Stock-based compensation

Total research and development expense

2020

Year Ended December 31,
2019
(in thousands)

2018

$
$
$
$
$
$

34,163  $
48,435  $
11,580  $
9,364  $
11,222  $
114,764  $

21,098  $
35,988  $
11,120  $
11,270  $
9,541  $
89,017  $

11,965 
18,392 
29,380 
8,498 
7,012 
75,247 

It is difficult to predict the timing and cost of development activities, which are subject to many uncertainties and risks, including inconclusive or
negative  results,  slow  patient  enrollment,  adverse  side  effects  and  difficulties  in  the  formulation  or  manufacture  of  study  drugs  and  the  lack  of  drug-
candidate  efficacy.  In  addition,  clinical  development  is  subject  to  intensive  government  oversight  and  regulations  that  may  change  unpredictably  and
without  notice.  We  expect  our  research  and  development  expense  to  be  higher  in  2021  than  in  2020  as  our  clinical  programs  advance.  Research  and
development spending in future years will depend on the outcome of our pre-clinical and clinical trials and our development plans.

Selling, general and administrative expenses - Selling, general and administrative expenses include (1) compensation of employees, consultants and
contractors engaged in commercial and administrative activities, (2) the cost of vendors supporting commercial activities and (3) legal and accounting fees.

36

 
 
 
 
 
Selling,  general  and  administrative  expenses  increased  to  $105.3  million  for  the  year  ended  December  31,  2020  from  $100.4  million  for  the
comparable  period  in  2019.  The  increase  in  selling,  general  and  administrative  expenses  was  primarily  due  to  increases  in  employee  recruiting  and
compensation expenses, increased legal and marketing costs, volume-related pharmacy and other distribution costs and professional service fees.

Selling,  general  and  administrative  expenses  increased  to  $100.4  million  for  the  year  ended  December  31,  2019  from  $81.3  million  for  the
comparable period in 2018. The increase in selling, general and administrative expenses was primarily due to increased spending on the recruitment and
compensation of additional employees, increased legal and marketing costs, and added distribution expenses arising from increased Korlym sales volumes.

We  expect  our  selling,  general  and  administrative  expenses  to  be  higher  in  2021  than  in  2020  due  to  increased  commercial  and  administrative

activities arising from increased sales volumes, litigation and administrative support for increased research and development activities.

Interest and other income - Interest and other income for the years ended December 31, 2020, 2019 and 2018 was $3.4 million, $5.1 million and
$2.7 million, respectively, and consisted primarily of interest income from marketable securities. Interest and other income decreased for the year ended
December  31,  2020  from  the  comparable  period  in  2019  primarily  due  to  market-wide  reductions  in  interest  rates.  The  increase  from  the  year  ended
December 31, 2019 from the comparable period in 2018 was due to growth in our holdings of cash and marketable securities.

Income  tax  expense  -  Income  tax  expense  for  the  years  ended  December  31,  2020,  2019  and  2018  was  $25.6  million,  $22.5  million,  and  $16.7
million, respectively. The increases in income tax expense during the years ended December 31, 2020, 2019 and 2018 were primarily due to increases in
net income and decreased discrete benefits from exercises of non-qualified stock options.

Liquidity and Capital Resources

Since 2015, we have relied on revenues from the sale of Korlym to fund our operations. Based on our current plans and expectations, we expect to
fund our operations and planned research and development activities without needing to raise additional funds, although we may choose to raise additional
funds  for  other  reasons.  If  we  were  to  raise  funds,  equity  financing  would  be  dilutive.  Debt  financing  could  involve  restrictive  covenants.  Funds  raised
through collaborations with other companies may require us to relinquish certain rights in our product candidates.

As of December 31, 2020, we had cash, cash equivalents and marketable securities of $476.9 million, consisting of cash and cash equivalents of
$76.2 million and marketable securities of $400.7 million, compared to cash and cash equivalents of $31.3 million and marketable securities of $284.0
million as of December 31, 2019.

The cash in our bank accounts and our marketable securities could be affected if the financial institutions holdings them were to fail or severely

adverse conditions were to rise in the markets for public or private debt securities. We have never experienced a loss or lack of access to cash.

Net cash provided by operating activities for the years ended December 31, 2020, 2019 and 2018 was $152.0 million, $136.1 million and $115.7
million, respectively. These increases were primarily due to greater revenue, as a result of an increase in Korlym’s price as well as shipping Korlym to more
patients.

Net cash used in investing activities for the years ended December 31, 2020, 2019 and 2018 was $119.3 million, $117.8 million and $90.8 million,

respectively, primarily due to increased purchases of marketable securities with cash generated by our operating activities.

Net cash provided by financing activities for the year ended December 31, 2020 was $12.2 million. Net cash used in financing activities for the years
ended December 31, 2019 and 2018 was $28.6 million and $14.3 million, respectively. For the same periods, stock option exercises provided $23.2 million,
$8.4 million and $9.3 million, respectively. We repurchased an aggregate of $9.7 million of our common stock during the year ended December 31, 2020
pursuant  to  our  program  to  repurchase  up  to  $200  million  of  our  common  stock  (the  “Stock  Repurchase  Program”).  In  the  first  quarter  of  2020,  we
purchased from our Chief Executive Officer $0.3 million of our common stock at the current market price to provide him liquidity to satisfy tax liability
arising from his net (cashless) exercise in 2019 of stock options that were about to expire. We repurchased an aggregate of $31.0 million and $23.7 million
during the years ended December 31, 2019 and 2018, respectively, pursuant to our program to repurchase up to $100 million of our common stock that
expired  on  June  30,  2019.  During  the  years  ended  December  31,  2020  and  2019,  we  also  acquired  0.1  million  and  0.5  million  shares  at  a  cost  of  $1.1
million  and  $6.1  million,  respectively,  in  satisfaction  tax  withholding  requirements  for  the  settlement  of  employee  option  exercises.  We  had  no  such
transactions in 2018.

37

As of December 31, 2020, we had retained earnings of $82.5 million.

Contractual Obligations and Commitments

The following table presents our estimates of obligations under contractual agreements as of December 31, 2020.

Contractual Obligations

Manufacturing purchase commitments
(2)
Lease obligations
Research and development studies

(3)

(1)

Total other contractual obligations

Total

Less than
1 year

1-3
Years
(in thousands)

$
$
$
$

159  $
2,639  $
116  $
2,914  $

159  $
2,109  $
116  $
2,384  $

—  $
530  $
—  $
530  $

3-5
Years

More than
5 Years

—  $
—  $
—  $
—  $

— 
— 
— 
— 

(1)

(2)

 As of December 31, 2020, we had no remaining commitments to purchase API from PCAS and have a $0.2 million commitment to purchase Korlym tablets.
 In October 2019, we amended our office lease to add more space and extend its term from March 31, 2020 through March 31, 2022 for the original office space and on April 1, 2020, the lease
term would begin for additional space through March 31, 2022. In June 2020, we amended our office lease to commence the additional space on June 15, 2020. As of December 31, 2020, the
remaining minimum rental payments due under the lease were $2.6 million.
(3)

 In December 2013, we entered into an agreement with Quotient Sciences Limited (“Quotient”), a clinical research organization, to assist in the management and conduct of our Phase 1 studies

of miricorilant and our other selective cortisol modulators. As of December 31, 2020, the total non-cancelable commitment under the agreement was approximately $0.1 million.

We  have  other  contractual  payment  obligations  and  purchase  commitments,  the  timing  of  which  are  contingent  on  future  events,  including  the
initiation  and  completion  of  manufacturing  projects.  In  March  2014,  we  entered  into  a  long-term  agreement  with  one  contract  manufacturer,  PCAS  to
produce  mifepristone,  the  API  for  Korlym.  On  July  25,  2018,  we  amended  this  agreement  to  add  a  second  manufacturing  site  and  extend  its  term  to
December 31, 2021, with two one-year automatic renewals, unless either party provides 12 months advance written notice of its intent not to renew. The
amendment provides exclusivity between PCAS and Corcept. If PCAS is unable to meet our requirements, we may purchase mifepristone from another
supplier.

We have agreements with two third-party manufacturers to produce and bottle Korlym tablets.

We enter into contracts in the normal course of business with CROs for preclinical studies and clinical trials. The contracts are cancellable, with
varying provisions regarding termination. If a contract with a specific vendor were to be terminated, we would only be obligated for products and services
we had received as of the effective date of the termination and any applicable cancellation fees.

Net Operating Loss Carryforwards

See Note 9, Income Taxes in our audited consolidated financial statements.

Off-Balance Sheet Arrangements

None.

Critical Accounting Policies and Estimates

Our consolidated financial statements have been prepared in accordance with U.S. GAAP, which requires us to make estimates and judgments that
affect the amount of assets, liabilities and expenses we report. We base our estimates on historical experience and on other assumptions we believe to be
reasonable. Actual results may differ from our estimates. Our significant accounting policies are described in Note 1, Basis of Presentation and Summary
of  Significant  Accounting  Policies,  of  the  Notes  to  Consolidated  Financial  Statements  included  in  Part  IV  of  this  Annual  Report  on  Form  10-K.  We
believe the following accounting estimates and policies to be critical:

Net Product Revenue

To  determine  net  product  revenue,  we  deduct  from  sales  the  cost  of  our  patient  co-pay  assistance  program  and  our  estimates  of  (i)  government
chargebacks and rebates, (ii) discounts provided to our SD for prompt payment and (iii) reserves for expected returns. We record these estimates at the time
we recognize revenue and update them as new information becomes available. Our estimates take into account our understanding of the range of possible
outcomes. If results differ from our estimates, we adjust our estimates, which changes our net product revenue and earnings. We report any changes in the
period they become known to us, even if they concern transactions occurring in prior period.

38

 
Government Rebates

Korlym is eligible for purchase by, or qualifies for reimbursement from, Medicaid and other government programs that are eligible for rebates on the
price  they  pay  for  Korlym.  To  determine  the  appropriate  amount  to  reserve  against  these  rebates,  we  identify  Korlym  sold  to  patients  covered  by
government-funded  programs,  apply  the  applicable  government  discount  to  these  sales  and  then  estimate  the  portion  of  total  rebates  we  expect  will  be
claimed. We then (i) deduct this reserve from revenue in the period to which the rebates relate and (ii) include in accrued expenses on our consolidated
balance sheet a current liability of equal amount.

Chargebacks

Although we sell Korlym to the SD at full price, some of the government entities to which the SD sells receive a discount. The SD recovers such
discounts by reducing its payment to us (this reduction is called a “chargeback”). Chargebacks sometimes relate to Korlym sold to SD in prior periods. We
deduct from our revenue in each period chargebacks claimed by the SD for Korlym we sold to the SD that period. We also create a reserve for chargebacks
we estimate the SD will claim in future periods against Korlym it purchased in the current period but has not yet resold. We determine the amount of this
reserve based on our experience with SD chargebacks and our understanding of the SD’s customer base and business practices. We deduct this reserve from
revenue and include in accrued expenses on our consolidated balance sheet a current liability of equal amount.

Patient Assistance Program and Charitable Support

It is our policy that no patient be denied Korlym due to inability to pay. We provide financial assistance to eligible patients whose insurance policies
have high deductibles or co-payments and deduct the amount of such assistance from gross revenue. We determine the assistance we provide each patient
by applying our program guidelines to that patient’s financial position and their insurance policy’s co-payment and deductible requirements. We also donate
cash to charities that help patients with financial need pay for the treatment of Cushing’s syndrome (which treatment may not include Korlym). We do not
include in our revenue payments these charities make on behalf of patients receiving Korlym. We provide Korlym at no cost to patients without insurance
who do not qualify for charitable support.

Sales Returns

For safety reasons, federal law prohibits patients from returning Korlym they have received. Korlym sold to our SD is subject to return. We deduct
the amount of Korlym we estimate the SD will return from each period’s gross revenue. We base our estimates on quantitative and qualitative information
including, but not limited to, historical return rates, the amount of Korlym held by the SD and projected demand. If we cannot reasonably estimate returns
with respect to a particular sale, we defer recognition of revenue until we can make a reasonable estimate. To date, returns have not been material.

Leases

We account for leases in accordance with ASC 842, Leases, which requires lease transactions with terms longer than 12 months to be recognized on

the balance sheet as a liability (“lease liabilities”), offset by an asset of equal amount (“right-of-use assets”).

We  recognize  right-of-use  assets  and  lease  liabilities  at  lease  commencement.  We  measure  lease  liabilities  based  on  the  present  value  of  lease
payments over the lease term discounted by the rate equal to the rate we would pay on a loan with monthly payments and a term equal to the monthly
payments and remaining term of our lease. We estimate our incremental borrowing rate based on bank quotes and an analysis of public companies with
debt and credit carrying terms similar to our lease term. We do not include in the lease term options to extend or terminate the lease unless it is reasonably
certain  at  commencement  that  we  will  exercise  any  such  options.  We  account  for  the  lease  components  separately  from  non-lease  components  for  our
operating leases.

Inventory and Cost of Sales

We value inventory at the lower of cost or net realizable value and determine the cost of inventory we sell using the specific identification method,
which approximates a first-in, first-out basis. We assess our inventory levels at each reporting period and write down inventory that is either expected to be
at risk of expiration prior to sale, or has a cost basis in excess of its expected net realizable value, or for which there are inventory quantities in excess of
expected requirements. We destroy expired inventory and recognize the related costs as cost of sales in that period’s statement of comprehensive income.

Cost  of  sales  includes  the  cost  of  manufacturing  Korlym,  including  materials,  third-party  manufacturing  costs  and  indirect  personnel  and  other
overhead  costs,  based  on  the  number  of  Korlym  tablets  for  which  we  recognize  revenue,  as  well  as  costs  of  stability  testing,  logistics  and  distribution
incurred during the applicable period.

39

Accruals of Research and Development Costs

We base our accruals for discovery research, preclinical studies and clinical trials on our estimates of work completed, milestones achieved, patient
enrollment and past experience with similar activities. Our estimates include assessments of information from contract research organizations and the status
of our own research, development and administrative activities.

Stock-based compensation

We account for stock-based compensation under the fair value method, based on the value of the award at the grant date. To date, our stock-based
compensation has consisted entirely of option grants, which we value using the Black-Scholes model. We recognize stock-based compensation expense
over the applicable vesting period, net of estimated forfeitures. If actual forfeitures differ from our estimates, we adjust stock-based compensation expense
accordingly.

We recognize the expense of options granted to non-employees based on their fair value at the time of vesting.

Income Taxes

We  account  for  income  taxes  in  accordance  with  ASC  740,  Income  Taxes  (“ASC  740”),  which  requires  recognition  of  deferred  tax  assets  and
liabilities for the expected tax consequences of our future financial and operating activities. Under ASC 740, we determine deferred tax assets and liabilities
based on the temporary difference between the financial statement and tax bases of assets and liabilities using the tax rates in effect for the year in which
we expect such differences to reverse. If we determine that it is more likely than not that we will not generate sufficient taxable income to realize the value
of some or all of our deferred tax assets (net of our deferred tax liabilities), we establish a valuation allowance offsetting the amount we do not expect to
realize. We perform this analysis each reporting period and reduce or increase the size of our valuation allowance accordingly.

The  deferred  tax  assets  that  we  record  each  period  depend  primarily  on  our  ability  to  generate  future  taxable  income  in  the  United  States.  Each
period, we evaluate the need for a valuation allowance against our deferred tax assets and, if necessary, adjust the valuation allowance so that net deferred
tax assets are recorded on our balance sheet only to the extent we conclude it is more likely than not that these deferred tax assets will be realized. If our
outlook for future taxable income changes significantly, our assessment of the need for, and the amount of, a valuation allowance may also change.

We also account for uncertain tax positions in accordance with ASC 740, which requires us to adjust our consolidated financial statements to reflect
only those tax positions that are more-likely-than-not to be sustained upon review by federal or state examiners. We recognize in the consolidated financial
statements the largest expected tax benefit that has a greater than 50 percent likelihood of being sustained on examination by the taxing authorities. We
report interest and penalties related to unrecognized tax benefits as income tax expenses.

Recently Issued Accounting Pronouncements

See Note 1, Basis of Presentation and Summary of Significant Accounting Policies in our audited consolidated financial statements.

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Quantitative and Qualitative Disclosures About Market Risk

The primary objective of our investment activities is to preserve principal. As of December 31, 2020, the fair value of our cash and cash equivalents
and marketable securities was $476.9 million. Our marketable securities consisted primarily of commercial paper, corporate notes, asset-backed securities,
repurchase  agreements,  U.S.  Treasury  securities  and  a  money  market  fund  invested  in  short-term  U.S.  Treasury  securities  maintained  at  a  major  U.S.
financial institution. To minimize our exposure to interest rate and other market risks, we have limited the maturities of our investments to less than three
years,  with  the  duration  of  our  portfolio  not  to  exceed  two  years.  Due  to  the  short-term  nature  and  high  liquidity  of  these  instruments,  an  increase  or
decrease in market interest rates by 25 basis points would not have a material impact on the total value of our portfolio as of December 31, 2020.

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

The consolidated financial statements required by this item are set forth beginning at page F-1 and are incorporated herein by reference.

40

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

None.

ITEM 9A. CONTROLS AND PROCEDURES

(a) Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports we file with the
SEC is recorded, processed, summarized and filed within the time periods specified in the SEC’s rules and forms and that such information is accumulated
and  discussed  with  our  management,  including  our  Chief  Executive  Officer  and  Chief  Financial  Officer,  so  as  to  allow  timely  decisions  regarding
disclosure. Management recognizes that controls and procedures, no matter how well designed and operated, can only provide reasonable, not absolute,
assurance  the  desired  control  objectives  will  be  met.  In  reaching  a  reasonable  level  of  assurance,  management  has  weighed  the  cost  of  contemplated
controls against their intended benefits. The design of any system of controls is based on management’s assumptions about the likelihood of future events.
We cannot assure you that our controls will achieve their stated goals under all possible conditions. Changes in future conditions may render our controls
inadequate  or  may  cause  our  degree  of  compliance  with  them  to  deteriorate.  Because  of  the  inherent  limitations  in  a  cost-effective  control  system,
misstatements due to error or fraud may occur and not be detected.

As of December 31, 2020, our Chief Executive Officer and Chief Financial Officer evaluated our disclosure controls and procedures (as defined in

Rules 13a-15(e) and 15d-15(e) of the Exchange Act). Based on their evaluation, they concluded that they are effective.

There were no changes in our internal controls over financial reporting during the quarter ended December 31, 2020 that materially affected, or are

reasonably likely to materially affect, our internal control over financial reporting.

(b) Management’s Report on Internal Control Over Financial Reporting

Our  management  is  responsible  for  establishing  and  maintaining  adequate  internal  control  over  financial  reporting,  as  such  term  is  defined  in
Exchange Act Rule 13a-15(f). Our internal control system is designed to provide reasonable assurance regarding the preparation and fair presentation of
externally-reported consolidated financial statements in accordance with U.S. GAAP. As discussed in Item 9A(a) above, internal control systems, no matter
how well designed, have inherent limitations and can provide only reasonable assurance that their objectives have been met.

As of December 31, 2020, our management conducted an evaluation, under the supervision and with the participation of our Chief Executive Officer
and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and
15d-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”). Based upon that evaluation, our Chief Executive Officer and Chief Financial
Officer  concluded  that,  as  of  December  31,  2020,  our  disclosure  controls  and  procedures  were  effective  to  provide  reasonable  assurance  that  the
information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and
reported within the time periods specified in SEC rules and forms and that such information is accumulated and communicated to the officers who certify
our financial reports and to the members of the Company’s senior management and board of directors as appropriate to allow timely decisions regarding
required disclosure at the reasonable assurance level.

Our  independent  registered  public  accounting  firm  has  issued  an  attestation  report  on  our  internal  control  over  financial  reporting.  It  is  set  forth

below.

(c) Report of Independent Registered Public Accounting Firm

To the Stockholders and Board of Directors of Corcept Therapeutics Incorporated

Opinion on Internal Control over Financial Reporting

We have audited Corcept Therapeutics Incorporated’s internal control over financial reporting as of December 31, 2020, based on criteria established in
Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO
criteria).  In  our  opinion,  Corcept  Therapeutics  Incorporated  (the  Company)  maintained,  in  all  material  respects,  effective  internal  control  over  financial
reporting as of December 31, 2020, based on the COSO criteria.

41

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated
balance sheets as of December 31, 2020 and 2019, the related consolidated statements comprehensive income, stockholders’ equity and cash flows for each
of the three years in the period ended December 31, 2020, and the related notes and our report dated February 23, 2021 expressed an unqualified opinion
thereon.

Basis for Opinion

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of
internal  control  over  financial  reporting  included  in  the  accompanying  Management’s  Report  on  Internal  Control  over  Financial  Reporting.  Our
responsibility  is  to  express  an  opinion  on  the  Company’s  internal  control  over  financial  reporting  based  on  our  audit.  We  are  a  public  accounting  firm
registered  with  the  PCAOB  and  are  required  to  be  independent  with  respect  to  the  Company  in  accordance  with  U.S.  federal  securities  laws  and  the
applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether effective internal control over financial reporting was maintained in all material respects.

Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and
evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered
necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

Definition and Limitations of Internal Control Over Financial Reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control
over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit
preparation  of  financial  statements  in  accordance  with  generally  accepted  accounting  principles,  and  that  receipts  and  expenditures  of  the  company  are
being  made  only  in  accordance  with  authorizations  of  management  and  directors  of  the  company;  and  (3)  provide  reasonable  assurance  regarding
prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial
statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness  to  future  periods  are  subject  to  the  risk  that  controls  may  become  inadequate  because  of  changes  in  conditions,  or  that  the  degree  of
compliance with the policies or procedures may deteriorate.

/s/ Ernst & Young LLP

Redwood City, California

February 23, 2021

ITEM 9B. OTHER INFORMATION

None.

42

PART III

Certain  information  required  by  Part  III  is  omitted  from  this  Form  10-K  because  we  expect  to  file  with  the  U.S.  Securities  and  Exchange
Commission, not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K, a definitive proxy statement (“Proxy
Statement”),  pursuant  to  Regulation  14A  in  connection  with  the  solicitation  of  proxies  for  our  2021  Annual  Meeting  of  Stockholders,  and  certain
information included therein is incorporated herein by reference.

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

The information required by this Item will be included in the Proxy Statement and is incorporated herein by reference.

ITEM 11. EXECUTIVE COMPENSATION

Compensation Discussion and Analysis

The information required by this Item will be included in the Proxy Statement and is incorporated herein by reference.

ITEM  12.  SECURITY  OWNERSHIP  OF  CERTAIN  BENEFICIAL  OWNERS  AND  MANAGEMENT  AND  RELATED  STOCKHOLDER
MATTERS

The information required by this Item will be included in the Proxy Statement and is incorporated herein by reference.

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

The information required by this Item will be included in the Proxy Statement and is incorporated herein by reference.

ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES

The information required by this Item will be included in the Proxy Statement and is incorporated herein by reference.

43

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

The following documents are filed as part of this Form 10-K

(1) Financial Statements:

PART IV

Report of Independent Registered Public Accounting Firm

Audited Consolidated Financial Statements

Consolidated Balance Sheets

Consolidated Statements of Comprehensive Income

Consolidated Statements of Cash Flows

Consolidated Statement of Stockholders’ Equity

Notes to Consolidated Financial Statements

(2) Financial Statement Schedules:

Page

2

4

5

6

7

8

All schedules have been omitted because the information required to be set forth therein is not applicable or is shown in the financial statements or

notes thereto.

(3) Exhibits:

Item 601 of Regulation S-K requires the exhibits listed below. Each management contract or compensatory plan or arrangement required to be filed

as an exhibit to this Form 10-K has been identified.

(A)    EXHIBITS

Exhibit Number

Description of Document

3.1

3.2

4.1

4.2

4.3

4.4

4.5

4.6

Amended  and  Restated  Certificate  of  Incorporation,  as  amended  (incorporated  by  reference  to  Exhibit  3.1  to  the  registrant’s  Quarterly
Report on Form 10-Q filed on August 9 2012).

Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the registrant’s Current Report on Form 8-K filed on February
13, 2017).

Specimen  Common  Stock  Certificate  (incorporated  by  reference  to  Exhibit  4.1  to  the  registrant’s  Registration  Statement  on  Form  S-1
(Registration No. 333-112676) filed on February 10, 2004).

Description of Common Stock

Registration  Rights  Agreement  by  and  among  Corcept  Therapeutics  Incorporated  and  the  investors  signatory  thereto,  dated  March  14,
2008 (incorporated by reference to Exhibit 10.25 to the registrant’s Annual Report on Form 10-K filed on March 31, 2008).

Amendment to Registration Rights Agreement by and among Corcept Therapeutics Incorporated and the investors signatory thereto, dated
November 11, 2008 (incorporated by reference to Exhibit 10.30 to the registrant’s Annual Report on Form 10-K filed on March 31, 2009).

Registration Rights Agreement dated as of April 21, 2010 by and among Corcept Therapeutics Incorporated and the investors signatory
thereto (incorporated by reference to Exhibit 4.2 to the registrant’s Current Report on Form 8-K filed on April 23, 2010).

Registration Rights Agreement, dated as of March 29, 2012, by and among Corcept Therapeutics Incorporated and the investors signatory
thereto (incorporated by reference to Exhibit 4.2 to the registrant’s Current Report on Form 8-K filed on March 29, 2012).

44

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exhibit Number

Description of Document

License  Agreement  by  and  between  The  Board  of  Trustees  of  the  Leland  Stanford  Junior  University  and  Corcept  Therapeutics
Incorporated, dated as of July 1, 1999 (incorporated by reference to Exhibit 10.6 to the registrant’s Registration Statement on Form S-1
(Registration No. 333-112676) filed on February 10, 2004).

Manufacturing Agreement with Produits Chimiques Auxiliaires et de Synthese SA, dated November 8, 2006 (incorporated by reference to
Exhibit 10.15 to the registrant’s Annual Report on Form 10-K filed on April 2, 2007).

Form of Indemnification Agreement for directors and officers approved by the Board of Directors on September 24, 2007 (incorporated by
reference to Exhibit 10.7 to the registrant’s Quarterly Report on Form 10-Q filed on November 14, 2007).

Securities Purchase Agreement by and among Corcept Therapeutics Incorporated and the purchasers named therein, dated March 14, 2008
(incorporated by reference to Exhibit 10.24 to the registrant’s Annual Report on Form 10-K filed on March 31, 2008).

Amended and Restated Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Joseph K.
Belanoff, M. D., dated September 19, 2008 (incorporated by reference to Exhibit 10.25 to the registrant’s Annual Report on Form 10-K
filed on March 31, 2009).

Amended and Restated Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and James N.
Wilson, dated September 19, 2008 (incorporated by reference to Exhibit 10.28 to the registrant’s Annual Report on Form 10-K filed on
March 31, 2009).

Amended and Restated 2004 Equity Incentive Plan (incorporated by reference to the registrant’s Proxy Statement on Schedule 14A filed
on May 7, 2009).

Securities  Purchase  Agreement  by  and  among  Corcept  Therapeutics  Incorporated  and  the  purchasers  named  therein,  dated  October  12,
2009 (incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed on November 12, 2009).

Form  of  Option  Agreement  for  options  granted  pursuant  to  the  Amended  and  Restated  2004  Equity  Incentive  Plan  (incorporated  by
reference to Exhibit 10.25 to the registrant’s Annual Report on Form 10-K filed on March 15, 2011).

Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Charles Robb, dated September 1,
2011 (incorporated by reference to Exhibit 10.2 to the registrant’s Quarterly Report on Form 10-Q filed on November 8, 2011).

Employment offer letter to Charles Robb dated August 12, 2011 (incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly
Report on Form 10-Q filed on November 8, 2011).

Corcept  Therapeutics  Incorporated  2012  Incentive  Award  Plan  (incorporated  by  reference  to  Appendix  A  to  the  registrant’s  Definitive
Proxy Statement on Schedule 14A filed with the SEC on May 21, 2012).

Commercial Outsourcing Services Agreement with Integrated Commercialization Solutions, Inc., dated as of April 14, 2011 (incorporated
by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed on August 9, 2012).

Form of 2012 Incentive Award Plan Stock Option Grant Notice and Agreement (incorporated by reference to Exhibit 4.5 to the registrant’s
Registration Statement on Form S-8 filed with the SEC on August 13, 2012).

Amendment to Manufacturing Agreement with Produits Chimiques Auxiliaires et de Synthese SA, dated February 21, 2013 (incorporated
by reference to Exhibit 10.31 to the registrant’s Annual Report on Form 10-K filed on March 15, 2013).

Pharmaceutical Manufacturer Services Agreement with Centric Health Resources, Inc., dated May 21, 2013 (incorporated by reference to
Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed on August 9, 2013).

Amendment to Pharmaceutical Manufacturer Services Agreement with Centric Health Resources, Inc., dated July 22, 2013 (incorporated
by reference to Exhibit 10.3 to the registrant’s Quarterly Report on Form 10-Q filed on August 9, 2013).

Amendment to Manufacturing Agreement with Produits Chimiques Auxiliaires et de Synthese SA, dated August 1, 2013 (incorporated by
reference to Exhibit 10.4 to the registrant’s Quarterly Report on Form 10-Q filed on August 9, 2013).

10.1

10.2#

10.3† 

10.4

10.5†

10.6†

10.7†

10.8

10.9†

10.10†

10.11†

10.12†

10.13#

10.14†

10.15

10.16#

10.17#

10.18

45

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exhibit Number

Description of Document

10.19

10.20

10.21#

10.22

10.23#

10.24

10.25

10.26#

10.27†

10.28†

10.29#

10.30#

Amendment to Manufacturing Agreement with Produits Chimiques Auxiliaires et de Synthese SA, dated November 7, 2013 (incorporated
by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed on November 12, 2013).

Amendment to Manufacturing Agreement with Produits Chimiques Auxiliaires et de Synthese SA, dated January 27, 2014 (incorporated
by reference to Exhibit 10.34 to the registrant’s Annual Report on Form 10-K filed on March 14, 2014).

Manufacturing and Supply Agreement with Produits Chimiques Auxiliaires et de Synthese SA, dated March 20, 2014 (incorporated by
reference to Exhibit 10.2 to the registrant’s Quarterly Report on Form 10-Q filed on May 12, 2014).

First Amendment to the Commercial Outsourcing Services Agreement with Integrated Commercialization Solutions, Inc., effective as of
April 14, 2014 (incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed on August 8, 2014).

Manufacturing  Agreement  with  AAI  Pharma  Services  Corp.,  dated  April  7,  2014  (incorporated  by  reference  to  Exhibit  10.2  to  the
registrant’s Quarterly Report on Form 10-Q filed on August 8, 2014).

Second Amendment to the Commercial Outsourcing Services Agreement with Integrated Commercialization Solutions, Inc., effective as
of June 11, 2014 (incorporated by reference to Exhibit 10.3 to the registrant’s Quarterly Report on Form 10-Q filed on August 8, 2014).

Third Amendment to the Commercial Outsourcing Services Agreement with Integrated Commercialization Solutions, Inc., effective as of
August 11, 2014 (incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed on November 7, 2014).

Second  Amendment  to  Pharmaceutical  Manufacturer  Services  Agreement  with  Dohmen  Life  Science  Services,  LLC  (as  successor  in
interest  to  Centric  Health  Resources,  Inc.)  dated  October  6,  2014  (incorporated  by  reference  to  Exhibit  10.41to  the  registrant’s  Annual
Report on Form 10K filed on March 13, 2015).

Employment  offer  letter  to  Robert  S.  Fishman  dated  September  16,  2015  (incorporated  by  reference  to  Exhibit  10.2  to  the  registrant’s
Quarterly Report on Form 10-Q filed on November 6, 2015).

Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Robert S. Fishman, dated September
28, 2015 (incorporated by reference to Exhibit 10.3 to the registrant’s Quarterly Report on Form 10-Q filed on November 6, 2015).

Distribution Services Agreement, dated August 4, 2017, between Corcept Therapeutics Incorporated and Optime Care, Inc. (incorporated
by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed on November 3, 2017).

Task  Order  Number  One  to  Distribution  Services  Agreement,  dated  August  4,  2017,  between  Corcept  Therapeutics  Incorporated  and
Optime  Care,  Inc.  (incorporated  by  reference  to  Exhibit  10.2  to  the  registrant’s  Quarterly  Report  on  Form  10-Q  filed  on  November  3,
2017.

10.31#

Amendment N°1 to the Manufacturing and Supply Agreement effective 19 March 2014 with PCAS SA, dated July 25, 2018

10.32†

10.33†

Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Andreas Grauer, M.D. dated March
18, 2019 (incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed on May 9, 2019).

Employment  offer  letter  to  Andreas  Grauer,  M.D.  dated  March  18,  2019  (incorporated  by  reference  to  Exhibit  10.2  to  the  registrant’s
Quarterly Report on Form 10-Q filed on May 9, 2019).

10.34

Office Lease Agreement by and between Exponent Realty, LLC and Corcept Therapeutics Incorporated, effective as of April 1, 2016.

10.35

10.36

10.37

First Amendment to Office Lease Agreement by and between Exponent Realty, LLC and Corcept Therapeutics Incorporated, made and
entered into as of June 1, 2017.

Second Amendment to Office Lease Agreement by and between Exponent Realty, LLC and Corcept Therapeutics Incorporated, made and
entered into as of March 12, 2018.

Third Amendment to Office Lease Agreement by and between Exponent Realty, LLC and Corcept Therapeutics Incorporated, made and
entered into as of November 8, 2018.

46

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exhibit Number

Description of Document

10.38

10.39†

10.40†

10.41†

10.42

10.43

23.1

24.1

31.1

31.2

32.1

32.2

Fourth Amendment to Office Lease Agreement by and between Exponent Realty, LLC and Corcept Therapeutics Incorporated, made and
entered into as of October 23, 2019.

Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Hazel Hunt, dated August 3, 2020
(incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed on August 4, 2020).

Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Joseph Douglas (“J.D.”) Lyon, dated
August 3, 2020 (incorporated by reference to Exhibit 10.2 to the registrant’s Quarterly Report on Form 10-Q filed on August 4, 2020).

Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Sean Maduck, dated August 3, 2020
(incorporated by reference to Exhibit 10.3 to the registrant’s Quarterly Report on Form 10-Q filed on August 4, 2020).

Fifth Amendment to Office Lease Agreement by and between Exponent Realty, LLC and Corcept Therapeutics Incorporated, made and
entered into as of June 17, 2020 (incorporated by reference to Exhibit 10.4 to the registrant’s Quarterly Report on Form 10-Q filed on
August 4, 2020).

Sixth Amendment to Office Lease Agreement by and between Exponent Realty, LLC and Corcept Therapeutics Incorporated, made and
entered  into  as  of  July  22,  2020  (incorporated  by  reference  to  Exhibit  10.1  to  the  registrant’s  Quarterly  Report  on  Form  10-Q  filed  on
November 3, 2020).

Consent of Independent Registered Public Accounting Firm

Power of Attorney (See signature page)

Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 of Joseph K. Belanoff, M.D.

Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 of Charles Robb

Certification pursuant to 18 U.S.C. Section 1350 of Joseph K. Belanoff, M.D.

Certification pursuant to 18 U.S.C. Section 1350 of Charles Robb

101.INS

XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within
the Inline XBRL document

101.SCH

XBRL Schema Document

101.CAL

XBRL Calculation Linkbase Document

101.DEF

XBRL Definition Linkbase Document

101.LAB

XBRL Labels Linkbase Document

101.PRE XBRL Presentation Linkbase Document

104

Cover Page Interactive Data File - the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags
are embedded within the Inline XBRL Document

#

†

Confidential treatment granted

Management contract or compensatory plan or arrangement

ITEM 16. FORM 10-K SUMMARY

None.

47

 
 
 
 
 
 
 
 
 
 
 
 
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on

its behalf by the undersigned thereunto duly authorized.

SIGNATURES

CORCEPT THERAPEUTICS INCORPORATED

By:

Date:

/s/ JOSEPH K. BELANOFF
Joseph K. Belanoff, M.D.,
Chief Executive Officer and President
February 23, 2021

POWER OF ATTORNEY

KNOW  ALL  PERSONS  BY  THESE  PRESENTS,  that  each  person  whose  signature  appears  below  hereby  constitutes  and  appoints  Joseph  K.
Belanoff  and  Charles  Robb,  and  each  of  them  acting  individually,  as  his  or  her  true  and  lawful  attorneys-in-fact  and  agents,  each  with  full  power  of
substitution, for him or her in any and all capacities, to sign any and all amendments to this report on Form 10-K and to file the same, with exhibits thereto
and  other  documents  in  connection  therewith,  with  the  Securities  and  Exchange  Commission,  granting  unto  said  attorneys-in-fact  and  agents,  with  full
power  of  each  to  act  alone,  full  power  and  authority  to  do  and  perform  each  and  every  act  and  thing  requisite  and  necessary  to  be  done  in  connection
therewith, as fully for all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and
agents, or his or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Exchange Act, this Annual Report on Form 10-K has been signed by the following persons on behalf of the

registrant and in the capacities and on the dates indicated:

48

 
 
 
 
 
 
 
 
 
  Chief Executive Officer, President and Director

February 23, 2021

Title

Date

Signature

/s/ JOSEPH K. BELANOFF
Joseph K. Belanoff, M.D.

/s/ CHARLES ROBB
Charles Robb

(Principal Executive Officer)

Chief Financial Officer and Secretary 

(Principal Financial Officer)

/s/ JOSEPH DOUGLAS LYON
Joseph Douglas Lyon

Chief Accounting Officer

(Principal Accounting Officer)

February 23, 2021

February 23, 2021

/s/ JAMES N. WILSON
James N. Wilson

/s/ GREGG ALTON
Gregg Alton

/s/ G. LEONARD BAKER, JR.
G. Leonard Baker, Jr.

/s/ GILLIAN CANNON
Gillian Cannon

/s/ DAVID L. MAHONEY
David L. Mahoney

/s/ KIMBERLY PARK
Kimberly Park

/s/ DANIEL N. SWISHER, JR
Daniel N. Swisher, Jr.

Director and Chairman of the Board of Directors

February 23, 2021

Director

Director

Director

Director

Director

Director

49

February 23, 2021

February 23, 2021

February 23, 2021

February 23, 2021

February 23, 2021

February 23, 2021

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CORCEPT THERAPEUTICS INCORPORATED

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

Report of Independent Registered Public Accounting Firm

Audited Financial Statements

Consolidated Balance Sheets

Consolidated Statements of Comprehensive Income

Consolidated Statements of Cash Flows

Consolidated Statement of Stockholders’ Equity

Consolidated Notes to Financial Statements

1

Page

2

4

5

6

7

8

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Stockholders and Board of Directors of Corcept Therapeutics Incorporated

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Corcept Therapeutics Incorporated (the Company) as of December 31, 2020 and 2019,
the  related  consolidated  statements  of  comprehensive  income,  stockholders’  equity  and  cash  flows  for  each  of  the  three  years  in  the  period  ended
December 31, 2020, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial
statements present fairly, in all material respects, the financial position of the Company at December 31, 2020 and 2019, and the results of its operations
and its cash flows for each of the three years in the period ended December 31, 2020, in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s
internal  control  over  financial  reporting  as  of  December  31,  2020,  based  on  criteria  established  in  Internal  Control-Integrated  Framework  issued  by  the
Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February 23, 2021 expressed an unqualified
opinion thereon.

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial
statements  based  on  our  audits.  We  are  a  public  accounting  firm  registered  with  the  PCAOB  and  are  required  to  be  independent  with  respect  to  the
Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the
PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance  about  whether  the  financial  statements  are  free  of  material  misstatement,  whether  due  to  error  or  fraud.  Our  audits  included  performing
procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to
those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits
also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the
financial statements. We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matter

The  critical  audit  matter  communicated  below  is  a  matter  arising  from  the  current  period  audit  of  the  financial  statements  that  was  communicated  or
required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2)
involved  our  especially  challenging,  subjective,  or  complex  judgments.  The  communication  of  the  critical  audit  matter  does  not  alter  in  any  way  our
opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate
opinion on the critical audit matter or on the account or disclosure to which it relates.

2

Inventory Excess and Obsolescence Reserve
Description of the Matter

How We Addressed the Matter in Our Audit

As  of  December  31,  2020,  the  Company  had  $21.2  million  of  inventory  which  included  $1.7
million of raw materials, $12.9 million of work in progress and $6.6 million of finished goods. As
disclosed  in  Note  1,  inventories  are  stated  at  the  lower  of  cost  or  net  realizable  value.  The
Company  assesses  its  inventory  levels  each  reporting  period  and  writes  down  inventory  that  is
either expected to be at risk of expiration prior to sale, or has a cost basis in excess of its expected
net  realizable  value,  or  for  which  there  are  inventory  quantities  in  excess  of  expected
requirements.

Auditing  management's  estimates  for  excess  and  obsolete  inventory  involved  subjective  auditor
judgment  because  the  estimates  rely  on  a  number  of  factors  that  are  affected  by  market  and
economic  conditions  outside  the  Company's  control.  In  particular,  the  obsolete  and  excess
inventory calculations are sensitive to significant assumptions, including the expected demand for
the  Company’s  products,  assumptions  about  the  drug’s  life  cycle,  the  effect  on  demand  of
competitive products and the Company's purchase commitments.

We  obtained  an  understanding,  evaluated  the  design,  and  tested  the  operating  effectiveness  of
internal  controls  over  the  Company's  excess  and  obsolete  inventory  reserve  process  including
management’s  review  of  the  significant  assumptions  described  above  and  controls  over  the
completeness and accuracy of the information used to develop the estimate.

Our substantive audit procedures included, among others, evaluating methodologies used and data
utilized in the analysis for inventory expected to be at risk for expiration or excess. We evaluated
purchase commitments or alternative uses, compared forecasted demand to historical trends,
compared actual inventory levels to forecasted demand requirements and evaluated the sensitivity
of sales forecast assumptions on the amount of inventory reserves recorded.

/s/ Ernst & Young LLP

We have served as the Company’s auditor since 2001.

Redwood City, California
February 23, 2021

3

CORCEPT THERAPEUTICS INCORPORATED

CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)

December 31,

2020

2019

ASSETS
Current assets:
Cash and cash equivalents
Short-term marketable securities
Trade receivables, net of allowances
Inventory
Prepaid expenses and other current assets
Total current assets
Strategic inventory
Operating lease right-of-use asset
Property and equipment, net of accumulated depreciation
Long-term marketable securities
Other assets
Deferred tax assets, net

Total assets
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
Accrued clinical expenses
Accrued and other liabilities
Short-term operating lease liability
Total current liabilities
Long-term operating lease liability
Long-term accrued income taxes
Total liabilities
Commitments and contingencies (Note 10)
Stockholders’ equity:
Preferred stock, par value $0.001 per share, 10,000 shares authorized and no shares outstanding at December
31, 2020 and December 31, 2019
Common stock, par value $0.001 per share, 280,000 shares authorized and 122,586 issued and 116,735
outstanding at December 31, 2020 and 119,767 shares issued and 114,549 outstanding at December 31, 2019
Treasury stock; at cost; 5,851 shares of common stock at December 31, 2020 and 5,218 shares of common
stock at December 31, 2019
Additional paid-in capital
Accumulated other comprehensive gain
Retained earnings (accumulated deficit)
Total stockholders’ equity

Total liabilities and stockholders’ equity

$

$

$

$

76,190  $
364,506 
26,198 
4,910 
6,697 
478,501 
16,247 
2,509 
1,675 
36,196 
5,000 
31,603 
571,731  $

10,554  $
13,704 
21,186 
2,050 
47,494 
501 
398 
48,393 

— 

122 

(75,795)
516,140 
415 
82,456 
523,338 
571,731  $

31,269 
244,693 
19,928 
5,424 
6,044 
307,358 
11,981 
3,446 
1,050 
39,352 
3,448 
45,677 
412,312 

7,537 
6,477 
23,269 
1,558 
38,841 
1,903 
386 
41,130 

— 

120 

(62,704)
457,060 
261 
(23,555)
371,182 
412,312 

The accompanying notes are an integral part of these consolidated financial statements.

4

 
 
 
 
 
 
 
 
 
 
CORCEPT THERAPEUTICS INCORPORATED

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(In thousands, except per share data)

Product revenue, net
Operating expenses:
Cost of sales
Research and development
Selling, general and administrative
Total operating expenses
Income from operations
Interest and other income
Income before income taxes
Income tax expense

Net income
Other comprehensive income:
Net unrealized (loss) gain on available-for-sale investments, net of tax impact of $15, $(104)
and $22
Foreign currency translation gain, net of tax

Total comprehensive income

Basic net income per share

Diluted net income per share

Year Ended December 31,
2019

2020

2018

$

353,874  $

306,486  $

251,247 

5,582 
114,764 
105,326 
225,672 
128,202 
3,400 
131,602 
25,591 
106,011  $

(50)
204 
106,165  $

5,504 
89,017 
100,359 
194,880 
111,606 
5,070 
116,676 
22,495 
94,181  $

327 
4 
94,512  $

0.92  $

0.82  $

0.85  $

0.77  $

5,215 
75,247 
81,289 
161,751 
89,496 
2,657 
92,153 
16,743 
75,410 

5 
— 
75,415 

0.65 

0.60 

$

$

$

$

Weighted average shares outstanding used in computing net income per share
Basic

Diluted

115,412 

124,194 

114,349 

122,566 

115,343 

126,688 

The accompanying notes are an integral part of these consolidated financial statements.

5

CORCEPT THERAPEUTICS INCORPORATED

CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)

Cash flows from operating activities:
Net income
Adjustments to reconcile net income to net cash provided by operations:
Stock-based compensation
Amortization (accretion) of interest income
Depreciation and amortization of property and equipment
Deferred income taxes
Non-cash amortization of right-of-use asset
Others
Changes in operating assets and liabilities:
Trade receivables
Other receivable
Inventory
Prepaid expenses and other current assets
Other assets
Accounts payable
Accrued clinical expenses
Accrued and other liabilities
Long-term accrued income taxes
Operating lease liability
Net cash provided by operating activities
Cash flows from investing activities:
Purchases of property and equipment
Proceeds from maturities of marketable securities
Purchases of marketable securities
Net cash used in investing activities
Cash flows from financing activities:
Proceeds from exercise of stock options, net of issuance costs
Repurchase of common stock
Cash paid to satisfy statutory withholding requirement for the net settlement of cashless
option exercise
Net cash provided by (used in) financing activities
Net increase (decrease) in cash and cash equivalents
Cash and cash equivalents, at beginning of period

Cash and cash equivalents, at end of period

Supplemental disclosure:
Income taxes paid
Cost of shares repurchased for net settlement of cashless option exercise
Recognition of right-of-use asset and lease liability

Year Ended December 31,
2019

2020

2018

$

106,011  $

94,181  $

75,410 

33,539 
1,303 
525 
14,089 
1,712 
148 

(6,270)
— 
(3,514)
(653)
(1,552)
3,161 
7,227 
(2,083)
12 
(1,685)
151,970 

(1,238)
302,089 
(420,114)
(119,263)

23,226 
(9,945)

(1,067)
12,214 
44,921 
31,269 
76,190  $

10,856  $
2,079  $
775  $

$

$
$
$

29,313 
(1,738)
703 
16,877 
1,468 
— 

(2,340)
— 
(1,044)
1,696 
(3,398)
(735)
2,956 
(517)
147 
(1,452)
136,117 

(1,088)
182,295 
(299,035)
(117,828)

8,419 
(30,975)

(6,089)
(28,645)
(10,356)
41,625 
31,269  $

23,747 
(1,721)
236 
14,067 
— 
— 

(2,288)
12,896 
(7,779)
(5,071)
— 
(389)
1,274 
5,044 
239 
— 
115,665 

(298)
142,655 
(233,124)
(90,767)

9,322 
(23,657)

— 
(14,335)
10,563 
31,062 
41,625 

6,744  $
1,983  $
4,913  $

1,351
—
—

The accompanying notes are an integral part of these consolidated financial statements

6

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CORCEPT THERAPEUTICS INCORPORATED

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(in thousands) 

Common Stock

Additional
Paid-in
Capital

Treasury
Stock

Accumulated
Other
Comprehensive
Income (Loss)

Retained Earnings
(Accumulated
Deficit)

Total
Stockholders'
Equity

Balance at December 31, 2017
Issuance of common stock upon exercise of options
Stock-based compensation related to employee and director
options
Other comprehensive loss, net of tax
Purchase of treasury stock
Net income
Balance at December 31, 2018
Issuance of common stock upon exercise of options
Shares tendered to satisfy cost and statutory withholding
requirements for net settlement of cashless option exercises
Stock-based compensation related to employee and director
options
Stock-based compensation related to non-employee options
Other comprehensive income, net of tax
Purchase of treasury stock
Net income
Balance at December 31, 2019
Issuance of common stock upon exercise of options
Shares tendered to satisfy cost and statutory withholding
requirements for net settlement of cashless option exercises
Stock-based compensation related to employee and director
options
Other comprehensive income, net of tax
Purchases of treasury stock
Net income

Balance at December 31, 2020

Shares
114,717 
2,121 

$

— 
— 
(1,807)
— 
115,031 
2,929 

(631)

— 
— 
— 
(2,780)
— 
114,549 
2,819 

(154)

— 
— 
(479)
— 
116,735 

$

Amount

115 
2 

— 
— 
— 
— 
117 
3 

— 

— 
— 
— 
— 
— 
120 
2 

— 

— 
— 
— 
— 
122 

$

384,074 
9,320 

$

$

— 
— 

23,834 
— 
— 
— 
417,228 
10,399 

— 
— 
(23,657)
— 
(23,657)
— 

— 

(8,072)

29,201 
232 
— 
— 
— 
457,060 
25,303 

33,777 
— 
— 
— 
516,140 

$

$

— 
— 
— 
(30,975)
— 
(62,704)
— 

(3,146)

— 
— 
(9,945)
— 
(75,795)

$

(75)
— 

— 
5 
— 
— 
(70)
— 

— 

— 
— 
331 
— 
— 
261 
— 

— 

— 
154 
— 
— 
415 

$

(193,146)
— 

$

— 
— 
— 
75,410 
(117,736)
— 

— 

— 
— 
— 
— 
94,181 
(23,555)
— 

— 

— 
— 
— 
106,011 
82,456 

$

$

190,968 
9,322 

23,834 
5 
(23,657)
75,410 
275,882 
10,402 

(8,072)

29,201 
232 
331 
(30,975)
94,181 
371,182 
25,305 

(3,146)

33,777 
154 
(9,945)
106,011 
523,338 

The accompanying notes are an integral part of these consolidated financial statements

7

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

8

1. Basis of Presentation and Summary of Significant Accounting Policies

Description of Business and Basis of Presentation

Corcept Therapeutics Incorporated is a commercial-stage pharmaceutical company engaged in the discovery and development of medications that
treat  severe  metabolic,  oncologic  and  psychiatric  disorders  by  modulating  the  effect  of  the  hormone  cortisol.  In  2012,  the  U.S.  Food  and  Drug
Administration (“FDA”) approved Korlym (“mifepristone”) 300 mg tablets, as a once-daily oral medication for the treatment of hyperglycemia secondary
to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery
or are not candidates for surgery. We have discovered and patented four structurally distinct series of selective cortisol modulators, consisting of more than
1,000 compounds. We are developing compounds from these series as potential treatments for a broad range of serious disorders.

We were incorporated in the State of Delaware in May 1998. Our headquarters are located in Menlo Park, California.

Basis of Presentation

The consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”).

Principles of Consolidation

Our  consolidated  financial  statements  include  the  financial  position  and  results  of  operations  of  Corcept  Therapeutics  UK  Limited,  our  wholly

owned subsidiary, which we incorporated in the United Kingdom in March 2017.

Use of Estimates

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that

affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates.

We reevaluate our estimates and assumptions each quarter, including those related to revenue recognition, recognition and measurement of income
tax assets and liabilities, inventory, allowances for doubtful accounts and other accrued liabilities, including our bonus accrual, clinical trial accruals and
stock-based compensation.

Fair Value Measurements

We value financial instruments using assumptions we believe third-party market participants would use. When choosing which assumptions to make
when determining the value of a financial instrument, we look first for quoted prices in active markets for identical instruments (“Level 1 inputs”). If no
Level 1 inputs are available, we consider (i) quoted prices in non-active markets for identical instruments; (ii) active markets for similar instruments; (iii)
inputs other than quoted prices for the instrument; and (iv) inputs that are not directly observable, but that can be corroborated by observable data (“Level 2
inputs”).  In  the  absence  of  Level  2  inputs,  we  rely  on  unobservable  inputs,  such  as  our  estimates  of  the  assumptions  market  participants  would  use  in
pricing the instrument (“Level 3 inputs”).

Cash and Cash Equivalents and Marketable Securities

We  consider  highly  liquid  investments  that  will  mature  in  three  months  or  less  from  the  time  we  purchase  them  to  be  cash  equivalents.  Cash

equivalents are valued using Level 1 inputs, which approximate our cost.

We invest the majority of our funds in marketable securities, primarily corporate notes, U.S. Treasury securities, asset-backed securities, commercial
paper and repurchase agreements. We classify our marketable securities as available-for-sale securities and report them at fair value as “cash equivalents”
or “marketable securities” on our consolidated balance sheet, with related unrealized gains and losses included in stockholders' equity. Realized gains and
losses and permanent declines in value are included in “interest and other income (expense)” on our consolidated statement of comprehensive income.

Credit and Concentration Risks

Our cash, cash equivalents and marketable securities are held in one financial institution. We are subject to credit risk from our cash equivalents and
marketable  securities.  We  limit  our  investments  to  U.S.  Treasury  obligations  and  high-grade  corporate  debt,  asset-backed  securities  and  repurchase
agreements with less than a 36-month maturity at the time of purchase.

9

 
CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

These  investments  are  diversified  and  do  not  expose  us  to  concentrations  of  credit  risk.  We  have  never  experienced  a  loss  in,  or  lack  of  access  to,  our
operating or investment accounts.

We have a single-source manufacturer of mifepristone, the active pharmaceutical ingredient (API), in Korlym - Produits Chimiques Auxiliaires et de
Synthèse SA (PCAS). If PCAS is unable or unwilling to manufacture API in the amounts and time frames required, we may not be able to manufacture
Korlym in a timely manner. In order to mitigate this risk, we have purchased and hold in inventory a reserve quantity of mifepristone API.

We have a concentration of risk in regard to the distribution of our product. A single specialty pharmacy, Optime Care, Inc. (“Optime”), dispenses
Korlym to patients for us. Optime is an independent third party. Its unwillingness or inability to dispense Korlym to patients in a timely manner would
harm our business.

We sell the Korlym that Optime dispenses directly to patients, with title to the medicine passing directly from us to the patient upon the patient’s
receipt  of  the  drug.  Our  receivables  risk  is  spread  among  various  third-party  payers  -  pharmacy  benefit  managers,  insurance  companies,  government
programs and private charities. We extend credit to third-party payers based on their creditworthiness. We monitor our exposure and record an allowance
against uncollectible trade receivables as necessary. To date, we have not incurred any credit losses.

Inventory and Cost of Sales

Regulatory  approval  of  product  candidates  is  uncertain.  Because  product  manufactured  prior  to  regulatory  approval  may  not  be  sold  unless
regulatory approval is obtained, we record the cost of manufacturing our product candidates as research and development expenses at the time such costs
are incurred. We capitalize to inventory manufacturing costs related to Korlym.

We value inventory at the lower of cost or net realizable value and determine the cost of inventory we sell using the specific identification method,
which approximates a first-in, first-out basis. We assess our inventory levels at each reporting period and write down inventory that is either expected to be
at risk of expiration prior to sale, or has a cost basis in excess of its expected net realizable value, or for which there are inventory quantities in excess of
expected requirements. We destroy expired inventory and recognize the related costs as cost of sales in that period’s statement of comprehensive income.

Cost of sales also includes the cost of manufacturing Korlym, including materials, third-party manufacturing costs and indirect personnel and other

overhead costs, based on the number of Korlym tablets for which we recognize revenue, as well as costs of stability testing, logistics and distribution.

We classify inventory we do not expect to sell or use in clinical studies within 12 months of the balance sheet date as strategic inventory, a non-

current asset.

Net Product Revenue

We  sell  Korlym  directly  to  patients  through  a  single  specialty  pharmacy.  We  also  sell  Korlym  to  a  specialty  distributor  (“SD”),  for  which  we
recognize revenue at the time the SD receives Korlym. SD sales were less than one percent of our net revenue in the years ended December 31, 2020, 2019
and 2018.

To determine our revenue from the sale of Korlym, we (i) identify our contract with each customer; (ii) identify the obligations of Corcept and the
customer under the contract; (iii) determine the contracted transaction price; (iv) allocate the transaction price to the contract’s performance obligations,
which in our case consists of delivering Korlym to the customer; and (v) recognize revenue once Korlym has been delivered, provided we deem it probable
that we will collect the payment due to us.

Confirmation of coverage by private or government insurance or by a third-party charity is a prerequisite for selling Korlym to a patient.

To  determine  net  product  revenue,  we  deduct  from  sales  the  cost  of  our  patient  co-pay  assistance  program  and  our  estimates  of  (a)  government
chargebacks and rebates, (b) discounts provided to our SD for prompt payment and (c) reserves for expected Korlym returns. We record these estimates at
the time we recognize revenue and update them as new information becomes available. Our estimates take into account our understanding of the range of
possible outcomes. If results differ from our estimates, we adjust our estimates, causing a change to our net product revenue and earnings. We report any
changes in the period they become known, even if they concern transactions occurring in prior periods.

Government Rebates: Korlym is eligible for purchase by, or qualifies for reimbursement from, Medicaid and other government programs that are

eligible for rebates on the price they pay for Korlym. To determine the appropriate amount to

10

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

reserve against these rebates, we identify Korlym sold to patients covered by government-funded programs, apply the applicable government discount to
these sales, then estimate the portion of total rebates we expect will be claimed.

Chargebacks. Although we sell Korlym to the SD at full price, some of the government entities to which the SD sells receive a discount. As it makes
such  sales,  SD  recovers  the  full  amount  of  any  related  discounts  by  reducing  its  payment  to  us  (this  reduction  is  called  a  “chargeback”).  Chargebacks
sometimes relate to Korlym purchased by the SD in prior periods. We deduct from our revenue in each period chargebacks claimed by the SD for Korlym it
purchased in that period. We also create each period a reserve for chargebacks we estimate the SD will claim in future periods against Korlym it has not yet
resold.  We  determine  the  amount  of  this  reserve  based  on  our  experience  with  SD  chargebacks  and  our  understanding  of  the  SD’s  customer  base  and
business practices. We then deduct this reserve from revenue and include in accrued expenses on our consolidated balance sheet a current liability of equal
amount.

Patient Assistance Program and Charitable Support: It is our policy that no patient be denied Korlym due to inability to pay. We provide financial
assistance to eligible patients whose insurance policies have high deductibles or co-payments and deduct the amount of such assistance from gross revenue.
We determine the assistance we provide each patient by applying our program guidelines to that patient’s financial position and their insurance policy’s co-
payment and deductible requirements for the purchase of Korlym. We donate cash to charities that help patients with financial need pay for the treatment of
Cushing’s syndrome. We do not include payments from these charities in revenue, but as a deduction to selling, general and administrative expenses. We
provide Korlym at no cost to uninsured patients who do not qualify for charitable support.

Sales Returns: Federal law prohibits the return of Korlym sold to patients. Sales to our SD are subject to return. We deduct the amount of Korlym we
estimate the SD will return from each period’s gross revenue. We base our estimates on quantitative and qualitative information including, but not limited
to, historical return rates, the amount of Korlym held by the SD and projected demand. If we cannot reasonably estimate returns with respect to a particular
sale, we defer recognition of revenue until we can make a reasonable estimate. To date, returns have not been significant.

The following table summarizes activity in each of the product revenue allowance and reserve categories for the year ended December 31, 2020:

Balance at December 31, 2017:
Provision recorded during the period
Provision related to prior period sales
Credit or payments made during the period
Balance at December 31, 2018:
Provision related to current period sales
Provision related to prior period sales
Credit or payments made during the period
Balance at December 31, 2019:
Provision related to current period sales
Provision related to prior period sales
Credit or payments made during the period

Balance at December 31, 2020:

Leases

Chargebacks

$

$

927  $

2,687 
— 
(3,268)
346 
783 
— 
(852)
277 
519 
(3)
(630)
163  $

Government
Rebates
(in thousands)

7,961  $

28,628 
532 
(25,988)
11,133 
24,374 
(95)
(27,203)
8,209 
27,698 
(631)
(25,864)

9,412  $

Total

8,888 
31,315 
532 
(29,256)
11,479 
25,157 
(95)
(28,055)
8,486 
28,217 
(634)
(26,494)
9,575 

We determine whether an arrangement contains a lease at inception. A contract is or contains a lease if the contract conveys the right to control the
use of an identified asset for a period of time in exchange for consideration. To determine whether a contract is or contains a lease, we consider all relevant
facts and circumstances to assess whether the customer has the right to both (i) obtain substantially all of the economic benefits from use of the identified
asset and (ii) direct the use of the identified asset.

11

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

We  recognize  right-of-use  assets  and  lease  liabilities  at  lease  commencement.  We  measure  lease  liabilities  based  on  the  present  value  of  lease
payments over the lease term discounted using the rate equal to the rate we would pay on a loan with monthly payments and a term equal to the monthly
payments  and  remaining  term  of  our  lease.  We  estimate  our  incremental  borrowing  rate  based  on  non-tender  bank  quotes  and  an  analysis  of  public
companies with debt and credit carrying terms similar to our lease term. We do not include in the lease term options to extend or terminate the lease unless
it  is  reasonably  certain  at  commencement  that  we  will  exercise  any  such  options.  We  account  for  the  lease  components  separately  from  non-lease
components for our operating leases.

We  measure  right-of-use  assets  based  on  the  corresponding  lease  liabilities  adjusted  for  (i)  prepayments  made  to  the  lessor  at  or  before  the
commencement date, (ii) initial direct costs we incur, and (iii) tenant incentives under the lease. We evaluate the recoverability of our right-of-use assets for
possible impairment in accordance with our long-lived assets policy. We do not recognize right-of-use assets or lease liabilities for leases with a term of
twelve months or less; rather, we recognize the associated lease payments in the consolidated statements of comprehensive income on a straight-line basis
over the lease term.

Operating  leases  are  reflected  on  our  consolidated  balance  sheets  as  operating  lease  right-of-use  assets,  short-term  operating  lease  liabilities  and

long-term operating lease liabilities.

We begin recognizing operating lease expense when the lessor makes the underlying asset available to us. We recognize operating lease expense

under our operating leases on a straight-line basis. Variable lease payments are expensed as incurred.

The Company did not have any finance leases at either December 31, 2020 or 2019.

Research and Development

Research  and  development  expenses  include  the  direct  cost  of  discovering  and  screening  new  compounds,  pre-clinical  studies,  clinical  trials,
manufacturing  development,  submissions  to  regulatory  agencies  and  related  overhead  costs.  We  expense  nonrefundable  payments  and  the  cost  of
technologies and materials used in research and development as we incur them.

We base our accruals for discovery research, preclinical studies and clinical trials on our estimates of work completed, milestones achieved, patient
enrollment and past experience with similar activities. Our estimates include assessments of information from contract research organizations and the status
of our own research, development and administrative activities. 

Segment Reporting

We  determine  our  operating  segments  based  on  the  way  we  organize  our  business,  make  decisions  and  assess  performance.  We  have  only  one

operating segment, which is the discovery, development and commercialization of pharmaceutical products.

Stock-Based Compensation

We account for stock-based compensation under the fair value method, based on the value of the award at the grant date. To date, our stock-based
compensation has consisted entirely of option grants, which we value using the Black-Scholes model. We recognize stock-based compensation expense
over the applicable vesting period, net of estimated forfeitures. If actual forfeitures differ from our estimates, we adjust stock-based compensation expense
accordingly.

Income Taxes

We  account  for  income  taxes  in  accordance  with  ASC  740,  Income  Taxes  (“ASC  740”),  which  requires  recognition  of  deferred  tax  assets  and
liabilities for the expected tax consequences of our future financial and operating activities. Under ASC 740, we determine deferred tax assets and liabilities
based on the temporary difference between the financial statement and tax bases of assets and liabilities using the tax rates in effect for the year in which
we expect such differences to reverse. If we determine that it is more likely than not that we will not generate sufficient taxable income to realize the value
of some or all of our deferred tax assets (net of our deferred tax liabilities), we establish a valuation allowance offsetting the amount we do not expect to
realize.  We  perform  this  analysis  each  reporting  period  and  reduce  our  measurement  of  deferred  taxes,  if  the  likelihood  we  will  realize  them  becomes
uncertain.

The deferred tax assets we record each period depend primarily on our ability to generate future taxable income in the United States. Each period,
we evaluate the need for a valuation allowance against our deferred tax assets and, if necessary, adjust the valuation allowance so that net deferred tax
assets are recorded only to the extent we conclude it is more likely than

12

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

not that these deferred tax assets will be realized. If our outlook for future taxable income changes significantly, our assessment of the need for, and the
amount of, a valuation allowance may also change.

We are also required to evaluate and quantify other sources of taxable income, such as the possible reversal of future deferred tax liabilities, should
any arise, and the implementation of tax planning strategies. Evaluating and quantifying these amounts is difficult and involves significant judgment, based
on all of the available evidence and assumptions about our future activities.

We account for uncertain tax positions in accordance with ASC 740, which requires us to adjust our consolidated financial statements to reflect only
those  tax  positions  that  are  more-likely-than-not  to  be  sustained  upon  review  by  federal  or  state  examiners.  We  recognize  in  the  consolidated  financial
statements the largest expected tax benefit that has a greater than 50 percent likelihood of being sustained on examination by the taxing authorities. We
report interest and penalties related to unrecognized tax benefits as income tax expenses.

Recently Adopted Accounting Pronouncements

In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments-Credit Losses (Topic 326), Measurement of Credit Losses on Financial

Instruments,” which changes the methodology for measuring credit losses on financial instruments and when such losses are recorded. This standard is
effective for fiscal years, and interim periods within those years, beginning after December 15, 2019. We adopted this standard on January 1, 2020 using
the modified retrospective approach with the cumulative effect of the adoption recorded as an adjustment to retained earnings. It had no impact on our
consolidated financial statements.

Recently Issued Accounting Pronouncements Not Yet Adopted

In December 2019, the FASB issued ASU No. 2019-12 (ASC Topic 740), “Simplifying the Accounting for Income Taxes.” This standard simplifies
accounting for income taxes by removing certain exceptions to the general principles and clarifying existing guidance. This standard will be effective for
fiscal years, and interim periods within those years, beginning after December 15, 2020. We will adopt the new standard in the first quarter of 2021. The
adoption of this standard is not expected to have a significant impact on our consolidated financial statements.

2. Significant Agreements

Commercial Agreements

In August 2017, we entered into a distribution services agreement with an independent third party, Optime, to provide exclusive specialty pharmacy
and patient services programs for Korlym beginning August 10, 2017. Under the terms of this agreement, Optime acts as the exclusive specialty pharmacy
distributor of Korlym in the United States, subject to certain exceptions. Optime provides services related to pharmacy operations; patient intake, access
and  reimbursement;  patient  support;  claims  management  and  accounts  receivable;  and  data  and  reporting.  We  provide  Korlym  to  Optime,  which  it
dispenses to patients. Optime does not purchase Korlym from us and it does not take title to the product. Title passes directly from us to the patient at the
time the patient receives the medicine.

The initial term of our agreement with Optime is five years, unless terminated earlier by us upon 90 days’ notice. The agreement contains additional
customary termination provisions, representations, warranties and covenants. Subject to certain limitations, we have agreed to indemnify Optime for certain
third-party claims related to the product, and we have each agreed to indemnify the other for certain breaches of representations, warranties, covenants and
other specified matters.

Manufacturing Agreements Related to Korlym

We purchase all of our API for Korlym from PCAS. On July 25, 2018, we amended our agreement with PCAS to add a second manufacturing site
and  extend  its  term  to  December  31,  2021,  with  two  one-year  automatic  renewals,  unless  either  party  provides  12  months  advance  written  notice  of  its
intent not to renew. The amendment provides exclusivity between PCAS and Corcept. In the event PCAS cannot meet our requirements, we may purchase
API from another supplier. As of December 31, 2020, there were no minimum future purchase obligations under this agreement.

We have agreements with two third-party manufacturers to produce and bottle Korlym tablets.

Lease Agreement

See discussion below in Note 5, Leases, regarding our office lease.

13

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

3. Available for Sale Securities and Fair Value Measurements

The available-for-sale securities in our Consolidated Balance Sheets are as follows:

Cash equivalents
Short-term marketable securities
Long-term marketable securities

Total marketable securities

Year Ended December 31,
2019
2020

(in thousands)

$

$

50,524  $
364,506 
36,196 
451,226  $

18,461 
244,693 
39,352 
302,506 

The following table presents our available-for-sale securities grouped by asset type:

December 31, 2020

December 31, 2019

Fair Value
Hierarchy
Level

Amortized
Cost

Gross
Unrealized
Gains

Gross
Unrealized
Losses

Estimated Fair
Value

Amortized
Cost

(in thousands)

Gross
Unrealized
Gains

Gross
Unrealized
Losses

Estimated Fair
Value

Corporate bonds
Commercial paper
Asset-backed securities
Repurchase agreements
U.S. treasury securities
Money market funds

Total Marketable securities

Level 2
Level 2
Level 2
Level 2
Level 1
Level 1

$

$

96,999 
139,791 
39,243 
— 
124,461 
50,524 
451,018 

$

$

74 
— 
15 
— 
131 
— 
220 

$

$

(9)
— 
(1)
— 
(2)
— 
(12)

$

$

97,064 
139,791 
39,257 
— 
124,590 
50,524 
451,226 

$

$

109,780 
41,237 
57,195 
18,000 
75,574 
461 
302,247 

$

$

136 
— 
63 
— 
71 
— 
270 

$

$

(6)
— 
(5)
— 
— 
— 
(11)

$

$

109,910 
41,237 
57,253 
18,000 
75,645 
461 
302,506 

We estimate the fair value of marketable securities classified as Level 1 using quoted market prices for these or similar investments obtained from a
commercial  pricing  service.  We  estimate  the  fair  value  of  marketable  securities  classified  as  Level  2  using  inputs  that  may  include  benchmark  yields,
reported trades, broker/dealer quotes and issuer spreads.

We periodically review our debt securities to determine if any of our investments is impaired due to credit-related or other issues. If the fair value of
our investment in any debt security is less than our amortized cost basis, we determine whether an allowance for credit losses is appropriate by assessing
quantitative and subjective factors including, but not limited to, the nature of security, changes in credit ratings, analyst reports concerning the security’s
issuer and industry, interest rate fluctuations and general market conditions.

Unrealized  losses  on  our  available-for-sale  debt  securities  as  of  December  31,  2020  were  not  significant  and  were  primarily  due  to  changes  in

interest rates, and not increased credit risk. Accordingly, we have not recorded an allowance for credit losses associated with these investments.

We do not intend to sell the investments that are currently in an unrealized loss position, and it is highly unlikely that we will be required to sell the

investments before recovery of their amortized cost basis, which may be maturity.

We  classified  accrued  interest  on  our  marketable  securities  of  $1.3  million  and  $1.0  million  as  of  December  31,  2020  and  2019,  respectively,  as

prepaid and other current assets on our consolidated balance sheet.

As  of  December  31,  2020,  all  our  marketable  securities  had  original  maturities  of  less  than  two  years.  The  weighted-average  maturity  of  our
holdings was five months. As of December 31, 2020, our long-term marketable securities had remaining maturities ranging from 13 to 17 months. None of
our marketable securities changed from one fair value hierarchy to another during the year ended December 31, 2020.

14

 
 
 
CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

4. Composition of Certain Balance Sheet Items

Inventory

Raw materials
Work in progress
Finished goods

Total inventory

Less strategic inventory classified as non-current

Total inventory classified as current

Year Ended December 31,
2019
2020

(in thousands)
1,685  $

12,916 
6,556 
21,157 
(16,247)

4,910  $

1,389 
10,086 
5,930 
17,405 
(11,981)
5,424 

$

$

Because we rely on a single manufacturer for the API for Korlym, we have purchased and hold significant quantities of API. We classify inventory

we do not expect to sell within 12 months of the balance sheet date as “Strategic Inventory,” a long-term asset.

Property and Equipment

Furniture and equipment
Software
Leasehold improvements

Less accumulated depreciation

Property and equipment, net of accumulated depreciation

Accrued and other liabilities

Accrued compensation
Government rebates
Accrued selling and marketing costs
Legal fees
Professional fees
Other

Total accrued and other liabilities

    Other assets

Year Ended December 31,
2019
2020

(in thousands)

810  $

1,485 
1,233 
3,528 
(1,853)
1,675  $

Year Ended December 31,
2019
2020

(in thousands)

10,144  $
9,412 
665 
612 
151 
202 
21,186  $

304 
1,541 
533 
2,378 
(1,328)
1,050 

12,331 
8,209 
491 
1,087 
367 
784 
23,269 

$

$

$

$

    As of December 31, 2020 and 2019, other assets includes $4.8 million and $3.3 million of deposits for clinical trials, respectively.

15

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

5. Leases

We lease our office facilities in Menlo Park, California. In January 2019, we recognized a right-of-use asset and a corresponding lease liability of
$1.9 million. In October 2019, we amended the lease to extend its term from March 31, 2020 to March 31, 2022 and to add more space beginning April 1,
2020. In June 2020, we amended our lease commencement date for additional space to June 15, 2020. As a result of this amendment, we recognized an
additional right-of-use asset and corresponding lease liability of $0.8 million. The right-of-use asset and lease liability recognized equals the present value
of the remaining payments due under our amended lease.

As  the  operating  lease  for  our  facilities  does  not  include  an  expressly  stated  interest  rate,  we  calculated  the  present  value  of  remaining  lease
payments using a discount rate equal to the interest rate we would pay on a loan with monthly payments and a term equal to the monthly payments and
remaining term of our lease. We recognize operating lease payments as expenses using the straight-line method over the term of the lease.

Operating  lease  expense  for  the  years  ended  December  31,  2020  and  2019  was  approximately  $1.9  million  and  $1.5  million,  respectively.  Rent

expense for the year ended December 31, 2018 was $1.3 million.

Our right-of-use assets and related lease liabilities were as follows:

Cash paid for operating lease liabilities
Right-of-use assets obtained in connection with operating lease obligations
Weighted-average remaining lease term (years)
Weighted-average discount rate

Year Ended December 31,

2020

2019

(in thousands)

$
$

$
$

1,840 
775 
15 months
4.8 %

1,551 
4,913 
27 months
5.0 %

As of December 31, 2020, future minimum lease payments under non-cancelable operating leases were as follows (in thousands):

2021
2022

Less imputed interest

Total operating lease liabilities

6. Related Party Transactions

$

$

2,109 
530 
2,639 
(88)
2,551 

In February 2020, we purchased from our Chief Executive Officer $0.3 million of our common stock at a price of $13.54 per share, which was the
last quoted price per share on the Nasdaq Capital Market on the date of purchase. We purchased the shares in order to provide him with liquidity to satisfy
the tax liability arising from his net (cashless) exercise in 2019 of stock options that were about to expire.

There were no other related party transactions during the years ended December 31, 2020, 2019, and 2018.

7. Preferred Stock and Stockholders’ Equity

Preferred Stock

Our  Board  of  Directors  is  authorized,  subject  to  any  limitations  prescribed  by  law,  without  stockholder  approval,  to  issue  up  to  an  aggregate  of
10,000,000 shares of preferred stock at $0.001 par value in one or more series and to fix the rights, preferences, privileges and restrictions granted to or
imposed upon the preferred stock, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences. The rights
of the holders of common stock will be subject to the rights of holders of any preferred stock that may be issued in the future. As of December 31, 2020 and
2019, we had no outstanding shares of preferred stock.

16

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

Common Stock

Significant stock transactions

On November 3, 2020, we announced that our Board of Directors approved a program to repurchase up to $200 million of our common stock (the
“Stock  Repurchase  Program”).  Unless  it  is  terminated  or  suspended  prior  to  its  expiration,  the  Stock  Repurchase  Program  will  remain  in  effect  until
September 30, 2021. The timing and amount of any repurchases pursuant to it will be determined based on market conditions, stock price and other factors.
The Stock Repurchase Program does not require us to acquire any specific number of shares and it may be modified, suspended or discontinued at any time
without  notice.  Repurchases  pursuant  to  the  Stock  Repurchase  Program  may  be  made  through  a  variety  of  methods,  including  open  market  purchases,
privately negotiated transactions, block trades, accelerated share repurchase transactions or any combination of such methods.

During  the  year  ended  December  31,  2020,  we  repurchased  0.5  million  shares  of  common  stock  under  the  Stock  Repurchase  Program  in  open
market transactions at a cost of $9.7 million (average price of $21.08 per share). During the years ended December 31, 2019 and 2018, we repurchased 2.8
million and 1.8 million shares of common stock at a cost of $31.0 million and $23.7 million, respectively, under a Stock Repurchase Program that expired
on June 30, 2019. We recorded repurchased shares as treasury stock on our consolidated balance sheet, at cost. We have not decided whether repurchased
shares will be retired or sold.

During the years ended December 31, 2020, 2019 and 2018, we issued 2.8 million, 2.9 million and 2.1 million shares, respectively, of our common

stock upon the exercise of stock options.

We have never declared or paid any dividends.

Shares of common stock reserved for future issuance as of December 31, 2020 are as follows:

Common stock:
Exercise of outstanding options
Shares available for grant under stock option plans

(in thousands)
24,946 
9,041 
33,987 

On February 4, 2021, our Board of Directors authorized an additional increase of 4.7 million shares in the number of shares available under the 2012

Equity Incentive Plan (the “2012 Plan”), which was equivalent to 4% of the shares of our common stock outstanding at December 31, 2020.

Stock Option Plans

We have two stock option plans – the 2004 Equity Incentive Plan (the “2004 Plan”) and the 2012 Incentive Award Plan (the “2012 Plan”).

In 2004, our Board of Directors and stockholders approved the 2004 Plan, which became effective upon the completion of our initial public offering
(IPO). Under the 2004 Plan, options, stock purchase and stock appreciation rights and restricted stock awards can be issued to our employees, officers,
directors  and  consultants.  The  2004  Plan  provided  that  the  exercise  price  for  incentive  stock  options  will  be  no  less  than  100%  of  the  fair  value  of  the
Company’s common stock, as of the date of grant. Options granted under the 2004 Plan vest over periods ranging from one year to five years. The vesting
period of the options is generally equivalent to the requisite service period.

In 2012, our Board of Directors and stockholders approved the 2012 Plan. As of the effective date of the 2012 Plan, 5.3 million shares that remained
available for issuance of new grants under the 2004 Plan were transferred to the 2012 Plan. After that date, no additional options were or will be issued
under the 2004 Plan. Vested options under the 2004 Plan that are not exercised within the remaining contractual life and any options under the 2004 Plan
that do not vest because of terminations after the effective date of the 2012 Plan will be added to the pool of shares available for future grants under the
2012 Plan.

Under  the  2012  Plan,  we  can  issue  options,  stock  purchase  and  stock  appreciation  rights  and  restricted  stock  awards  to  our  employees,  officers,
directors and consultants. The 2012 Plan provides that the exercise price for incentive stock options will be no less than 100 percent of the fair value of our
common stock as of the date of grant. Options granted under the 2012 Plan carry a contractual term of ten years and are expected to vest over periods
ranging from one year to four years. We assume the vesting period of the options that we grant under the 2012 Plan to be equal to the option grantee’s
period of service.

17

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

Upon exercise of options, new shares are issued.

Option activity during 2018, 2019 and 2020

The following table summarizes all activity under the 2004 Plan and the 2012 Plan:

Outstanding Options

Shares
Available For
Future Grant
(in thousands)

Options
Shares
Subject to
Options
Outstanding
(in thousands)

Weighted-
Average
Exercise
Price

Weighted-
Average
Remaining
Contractual
Life
(in years)

Aggregate
Intrinsic
Value
(in thousands)

8,624 
4,582 
(5,225)
— 
1,060 
9,041 

23,600  $
— 
5,225  $
(2,819) $
(1,060) $
24,946  $

17,047  $

8.77 

13.84 
8.97 
13.11 

9.62 

7.83 

6.17 $

412,494 

5.09 $

312,481 

24,254  $

9.51 

6.10 $

403,738 

Balance at December 31, 2019

Increase in shares authorized for grant
Shares granted
Shares exercised
Shares canceled and forfeited

Balance at December 31, 2020

Options exercisable at December 31, 2020

Options fully vested and expected to vest 
at December 31, 2020

The total intrinsic value of options exercised during the years ended December 31, 2020, 2019 and 2018 was $28.8 million, $26.6 million and $26.6

million, respectively, based on the difference between the closing price of our common stock on the date of exercise of the options and the exercise price.

The total fair value of options that vested during the years ended December 31, 2020, 2019 and 2018 was $34.0 million, $30.2 million and $22.6

million, respectively.

Stock-Based Compensation related to Employee and Director Options

The following table summarizes the weighted-average assumptions and resultant fair value-based measurements for options granted to employees

and directors.

Weighted-average assumptions for stock options granted:

Risk-free interest rate
Expected term
Expected volatility of stock price
Dividend rate

Weighted-average grant date fair value-based measurement

Year Ended December 31,
2019

2020

2018

1.20%
6.0 years
59.1%
0%
$7.55

2.34%
6.0 years
67.4%
0%
$7.09

2.68%
5.9 years
67.9%
0%
$10.11

The expected term of options reflected in the table above has been based on a formula that considers the expected service period and expected post-

vesting termination behavior depending on whether the option holder is an employee, officer or director.

18

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

The expected volatility of our stock used in determining the fair value-based measurement of option grants to employees, officers and directors is
based  on  the  volatility  of  our  stock  price.  The  volatility  is  based  on  historical  data  of  the  price  for  our  common  stock  for  periods  of  time  equal  to  the
expected term of these grants.

We  calculate  employee  stock-based  compensation  expense  using  the  number  of  options  we  expect  to  vest,  based  on  our  estimate  of  the  option
grantees’ average length of employment, and reduced by our estimate of option forfeitures. We estimate forfeitures at the time of option grant and revise
this estimate in subsequent periods if actual forfeitures differ from our estimates.

As of December 31, 2020, we had $54.8 million of unrecognized compensation expense for employee and director options outstanding as of that

date, which had a weighted-average remaining vesting period of 2.39 years.

Summary of Stock-based Compensation

The following table presents a summary of stock-based compensation by financial statement classification. 

Stock-based compensation capitalized in inventory
Cost of sales
Research and development
Selling, general and administrative

Total stock-based compensation

8. Net Income Per Share

2020

Year Ended December 31,
2019
(in thousands)

2018

$

$

238  $
66 
11,222 
22,251 
33,777  $

120  $
144 
9,541 
19,628 
29,433  $

87 
259 
7,012 
16,476 
23,834 

We  compute  basic  and  diluted  net  income  per  share  by  dividing  our  net  income  by  the  weighted-average  number  of  common  shares  outstanding
during the period. We used the treasury stock method to determine the number of dilutive shares of common stock resulting from the potential exercise of
stock options. The statements of consolidated comprehensive income show the computation of net income per share for each period, including the number
of weighted-average shares outstanding.

The following table shows the computation of net income per share for each period:

2020

Year Ended December 31,
2019
(in thousands, except per share data)

2018

Numerator:

Net income
Denominator:

Weighted-average shares used to compute basic net income per share
Dilutive effect of employee stock options

Weighted-average shares used to compute diluted net income per share
Net income per share

Basic

Diluted

$

$

$

106,011  $

94,181  $

75,410 

115,412 
8,782 
124,194 

114,349 
8,217 
122,566 

0.92  $

0.85  $

0.82  $

0.77  $

115,343 
11,345 
126,688 

0.65 

0.60 

As of December 31, 2020, 2019, and 2018 we had 24.9 million, 23.6 million, and 22.8 million stock options outstanding, respectively.

Because including them would have reduced dilution, we excluded from the computation of diluted net income per share, on a weighted-average

basis 11.2 million, 9.9 million and 5.0 million stock options outstanding during the years ended December 31, 2020, 2019, and 2018, respectively,

19

 
 
 
CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

9. Income Taxes 

The domestic and foreign components of income before income taxes were as follows:

Domestic
Foreign

Income before income taxes

2020

Year Ended December 31,
2019
(in thousands)

2018

$

$

131,634  $
(32)
131,602  $

116,676  $
— 
116,676  $

92,153 
— 
92,153 

The income tax expense for the year ended December 31, 2020, 2019, and 2018 consisted of the following:

U.S. federal taxes:

Current
Deferred
Total U.S. federal taxes

State taxes:
Current
Deferred
Total state taxes

Foreign taxes:

Current
Deferred
Total foreign taxes

Total

2020

Year Ended December 31,
2019
(in thousands)

2018

$

6,094  $

1,716  $

14,418 
20,512 

5,368 
520 
5,888 

15,944 
17,660 

3,900 
935 
4,835 

$
$

$

41  $
(850) $
(809)
25,591  $

—  $
—  $
— 
22,495  $

— 
14,243 
14,243 

2,676 
(176)
2,500 

— 
— 
— 
16,743 

20

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

Deferred  income  taxes  reflect  the  net  tax  effects  of  temporary  differences  between  the  carrying  amounts  of  assets  and  liabilities  for  financial

reporting purposes and the amounts used for income tax purposes. Significant components of our deferred tax assets are as follows:

Deferred tax assets:

Federal and state net operating losses
Capitalized research and patent costs
Research credits
Stock-based compensation costs
Operating lease liability
Other
Total deferred tax assets

Valuation allowance
Deferred tax liabilities

Operating lease right-of-use asset
Total deferred tax liabilities

Net deferred tax assets

Year Ended December 31,
2019
2020

(in thousands)
5,412  $
5,139 
15,107 
14,043 
630 
3,473 
43,804 
(11,581)

(620)
(620)
31,603  $

7,391 
7,317 
26,164 
12,026 
857 
4,186 
57,941 
(11,410)

(854)
(854)
45,677 

$

$

Each quarter, we assess the likelihood that we will generate sufficient taxable income to use our federal and state deferred tax assets. If we believe
that  recovery  of  these  deferred  tax  assets  is  not  more  likely  than  not,  we  will  establish  a  valuation  allowance.  Significant  judgment  is  required  in
determining  any  valuation  allowance  recorded  against  deferred  tax  assets.  In  assessing  the  need  for  a  valuation  allowance,  we  consider  all  available
evidence, including recent operating results, projections of future taxable income, our ability to utilize net operating losses and tax credit carryforwards,
and the feasibility of tax planning strategies. Other than valuation allowances against our California net deferred tax assets, we have determined that it is
more likely than not we will realize the benefit related to all other deferred tax assets. If we increase a valuation allowance, we will include an expense of
equal amount in the Condensed Consolidated Statement of Comprehensive Income in the period in which such determination is made.

The valuation allowance increased by $0.2 million and $0.2 million for the years ended December 31, 2020 and 2019, respectively, and decreased by

$1.3 million for the year ended December 31, 2018.

At December 31, 2020, we had California net operating loss carryforwards of $75.2 million, which will begin to expire in the year 2032, and net
operating loss carryforwards from other states of $2.9 million, which will begin to expire in the year 2024 if not utilized. On June 29, 2020, the California
governor  signed  Assembly  Bill  85  (“AB  85”)  into  law.  AB  85  limits  the  use  of  business  incentive  tax  credits  and  suspends  the  use  of  California  net
operating  losses  for  2020,  2021  and  2022  for  companies  with  taxable  income  of  $1  million  or  more.  AB  85  will  not  have  a  material  impact  on  our
condensed consolidated financial statements.

At  December  31,  2020,  we  also  had  federal  research  and  development  tax  credits  of  $6.8  million  and  orphan  drug  tax  credits  of  $7.8  million,
respectively, and California research and development credits of $8.5 million. The federal research credits will expire in the years 2039 through 2040 and
the California research credits have no expiration date.

21

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

The following table presents a reconciliation from the statutory federal income tax rate to the effective rate.

U.S. federal taxes at statutory rate
R&D and other credits
State income taxes
Non-deductible compensation
Stock-based compensation
Other
Total

2020

Year Ended December 31,
2019
(in thousands)

2018

$

$

27,636  $
(6,666)
4,651 
1,508 
(1,551)
13 
25,591  $

24,502  $
(4,504)
3,819 
657 
(2,107)
128 
22,495  $

19,354 
(2,178)
1,975 
394 
(3,165)
363 
16,743 

We  maintain  liabilities  for  uncertain  tax  positions.  The  measurement  of  these  liabilities  involves  considerable  judgment  and  estimation  and  are
continuously monitored by management based on the best information available, including changes in tax regulations, the outcome of relevant court cases,
and other pertinent information.

The aggregate annual changes in the balance of gross unrecognized tax benefits are as follows (in thousands):

Beginning Balance
Increase in tax positions for prior years
Decrease in tax positions for prior years
Increase in tax positions for current year
Decrease in tax positions for current year
Ending Balance

Year Ended December 31,
2019

2020

2018

6,029  $
158 
— 
1,284 
— 
7,471  $

4,756  $
261 
— 
1,012 
— 
6,029  $

4,139 
— 
(135)
752 
— 
4,756 

$

$

As  of  December  31,  2020,  the  amount  of  unrecognized  tax  benefits  that  would  favorably  impact  the  effective  tax  rate  were  approximately  $6.1
million,  and  approximately  $1.4  million  of  unrecognized  tax  benefits  would  be  offset  by  a  change  in  valuation  allowance.  A  valuation  allowance  is
maintained on the remaining tax benefits related to California deferred tax assets and would not impact the effective tax rate. We had no or immaterial
amounts of accrued interest and no accrued penalties related to unrecognized tax benefits as of December 31, 2020, 2019 and 2018. We do not expect our
unrecognized tax benefits to change materially over the next 12 months.

While we believe we have adequately provided for all tax positions, amounts asserted by tax authorities could be greater or less than the recorded
position. Accordingly, our provisions on federal and state tax-related matters to be recorded in the future may change as revised estimates are made or the
underlying matters are settled or otherwise resolved.

The  Company’s  primary  tax  jurisdiction  is  the  United  States.  For  federal  and  state  tax  purposes,  the  years  1999  through  2020  remain  open  and

subject to tax examination by the appropriate federal or state taxing authorities.

10. Commitments and contingencies

We  have  entered  into  a  number  of  agreements  to  purchase  API  for  the  manufacturing  of  relacorilant,  miricorilant  and  exicorilant.  We  have  also
entered into a number of agreements to perform clinical studies on miricorilant and CORT113176. See the discussion in Note 2, Significant Agreements,
for further discussion regarding the commitments under these agreements.

In March 2020, to ensure we have sufficient API to meet future demand for Korlym tablets, we committed to purchase an additional 400 kilograms

of API from Produits Chimiques Auxiliaires et de Synthese SA (“PCAS,” a member of the Seqens Group) for a total price of $5.9 million. As of
December 31, 2020, there remained no obligation in connection with this purchase commitment.

22

 
 
 
CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

In the ordinary course of business, we may be subject to legal claims and regulatory actions that could have a material adverse effect on our business
or financial position. We assess our potential liability in such situations by analyzing the possible outcomes of various litigation, regulatory and settlement
strategies. If we determine a loss is probable and its amount can be reasonably estimated, we accrue an amount equal to the estimated loss.

No losses and no provision for a loss contingency have been recorded to date.

11. Quarterly Financial Data (Unaudited)

The following table is in thousands, except per share amounts:

Quarter Ended

March 31

June 30

September 30

December 31

2020
Product revenue, net
Gross profit on product revenue
Net income
Basic net income per share
Diluted net income per share

2019
Product revenue, net
Gross profit on product revenue
Net income
Basic net income per share
Diluted net income per share

88,565  $
87,331 
28,327 

0.25  $
0.23  $

72,257  $
70,880 
20,186 

0.18  $
0.17  $

86,327  $
85,111 
21,625 

0.19  $
0.17  $

81,505  $
80,054 
26,340 

0.23  $
0.22  $

85,735 
84,481 
25,994 
0.22 
0.20 

87,895 
86,459 
29,381 
0.26 
0.24 

$

$
$

$

$
$

93,247  $
91,369 
30,065 

0.26  $
0.25  $

64,829  $
63,589 
18,274 

0.16  $
0.15  $

23

DESCRIPTION OF

COMMON STOCK

Exhibit 4.2

The  following  description  of  Corcept’s  common  stock  is  a  summary.  This  summary  is  subject  to  the  General  Corporation  Law  of  the  State  of
Delaware (the “DGCL”)  and  the  complete  text  of  Corcept’s  amended  and  restated  certificate  of  incorporation  (the  “certificate  of  incorporation”) and
amended and restated bylaws (the “bylaws”), filed as Exhibits 3.1 and 3.2, respectively, to our Annual Report on Form 10-K. We encourage you to read
that law and those documents carefully.

Common Stock

General

The certificate of incorporation authorizes 280,000,000 shares of common stock, $0.001 par value per share.

Voting Rights

Each holder of common stock is entitled to one vote for each share on all matters submitted to a vote of the stockholders, including the election of
directors,  provided,  however,  that  except  as  otherwise  required  by  law,  holders  of  common  stock  are  not  entitled  to  vote  on  any  amendment  to  the
certificate of incorporation that relates solely to the terms of one or more outstanding series of preferred stock if the holders of such affected series are
entitled, either separately or together as a class with the holders of one or more other such series, to vote thereon by law or pursuant to the certificate of
incorporation. No holder of our common stock has cumulative voting rights. Accordingly, the holders of a majority of the shares of common stock entitled
to vote in any election of directors can elect all of the directors standing for election, if they so choose.

Dividends

Subject  to  preferences  that  may  be  applicable  to  any  then  outstanding  preferred  stock,  holders  of  common  stock  are  entitled  to  receive  ratably

those dividends, if any, as may be declared from time to time by the board of directors out of legally available funds.

Liquidation

In the event of Corcept’s liquidation, dissolution or winding up, holders of common stock will be entitled to share ratably in the net assets legally
available for distribution to stockholders after the payment of all of Corcept’s debts and other liabilities and the satisfaction of any liquidation preference
granted to the holders of any outstanding shares of preferred stock.

Rights and Preferences

Holders of common stock have no preemptive rights or conversion rights or other subscription rights, and there are no redemption or sinking fund
provisions applicable to the common stock. The rights, preferences and privileges of the holders of common stock are subject to, and may be adversely
affected by, the rights of the holders of shares of any series of preferred stock which we may designate in the future.

Fully Paid and Non-assessable

All outstanding shares of common stock are fully paid and non-assessable.

Annual Stockholder Meetings

The certificate of incorporation and bylaws provide that annual stockholder meetings will be held at such place, on such date and at such time as
designated by resolution of the board of directors from time to time. To the extent permitted under applicable law, we may but are not obligated to conduct
meetings by remote communications, including by webcast.

Anti-Takeover Effects of Provisions

Some provisions of Delaware law and the certificate of incorporation and bylaws could make the following transactions difficult: acquisition by
means  of  a  tender  offer;  acquisition  by  means  of  a  proxy  contest  or  otherwise;  or  removal  of  incumbent  officers  and  directors.  It  is  possible  that  these
provisions could make it more difficult to accomplish or could deter transactions that stockholders may otherwise consider to be in their best interest or in
the best interests of Corcept, including transactions that might result in a premium over the market price for shares of common stock.

These provisions, summarized below, are expected to discourage coercive takeover practices and inadequate takeover bids. These provisions are
also designed to encourage persons seeking to acquire control to first negotiate with Corcept’s board of directors. We believe that the benefits of protection
to Corcept’s potential ability to negotiate with the proponent of an

unfriendly  or  unsolicited  proposal  to  acquire  or  restructure  Corcept  outweigh  the  disadvantages  of  discouraging  these  proposals  because  negotiation  of
these proposals could result in an improvement of their terms.

Delaware Anti-Takeover Statute

Section 203 of the DGCL prohibits persons deemed “interested stockholders” from engaging in a “business combination” with a publicly-held
Delaware corporation for three years following the date these persons become interested stockholders unless the business combination is, or the transaction
in  which  the  person  became  an  interested  stockholder  was,  approved  in  a  prescribed  manner  or  another  prescribed  exception  applies.  Generally,  an
“interested  stockholder”  is  a  person  who,  together  with  affiliates  and  associates,  owns,  or  within  three  years  prior  to  the  determination  of  interested
stockholder  status  did  own,  15%  or  more  of  a  corporation’s  voting  stock  and  a  “business  combination”  includes  a  merger,  asset  or  stock  sale,  or  other
transaction resulting in a financial benefit to the interested stockholder. The existence of this provision may have an anti-takeover effect with respect to
transactions not approved in advance by the board of directors, such as discouraging takeover attempts that might result in a premium over the market price
of our common stock.

Undesignated Preferred Stock

Under  our  amended  and  restated  certificate  of  incorporation,  our  board  of  directors  has  the  authority,  without  action  by  our  stockholders,  to
designate and issue up to 10,000,000 shares of preferred stock, par value $0.001 per share, in one or more series and to designate the rights, preferences and
privileges of each series, any or all of which may be greater than the rights of our common stock. It is not possible to state the actual effect of the issuance
of any shares of preferred stock upon the rights of holders of our common stock until our board of directors determines the specific rights of the holders of
preferred  stock.  However,  the  effects  might  include,  among  other  things,  restricting  dividends  on  the  common  stock,  diluting  the  voting  power  of  the
common stock, impairing the liquidation rights of the common stock and delaying or preventing a change in control of our common stock without further
action by our stockholders and may adversely affect the market price of our common stock. As of January 31, 2021, no shares of our preferred stock were
outstanding.

Special Stockholder Meetings

The bylaws provide that a special meeting of stockholders may be called only by the chairman of the board of directors or secretary of Corcept at

the request in writing of a majority of the board of directors.

Requirements for Advance Notification of Stockholder Nominations and Proposals

The bylaws sets forth advance notice procedures with respect to stockholder proposals and the nomination of candidates for election as directors,

other than nominations made by or at the direction of the board of directors or a committee of the board of directors.

Composition of the Board of Directors; Election and Removal of Directors; Filling Vacancies

The  size  of  the  board  of  directors  shall  be  fixed  from  time  to  time  exclusively  by  the  board  of  directors  pursuant  to  a  resolution  adopted  by  a
majority of the board of directors. In any uncontested elections of directors, a director nominee for the board of directors will be elected by the affirmative
vote of a majority of the votes cast with respect to such director by the shares represented and entitled to vote at a meeting of the stockholders for the
election of directors at which a quorum is present, voting together as a single class. An incumbent director who is nominated for an uncontested election
and fails to receive a majority of the votes present and voting for such director’s reelection would be required to tender his or her resignation to the board of
directors.

In a contested election, a plurality voting standard will apply to director elections. The directors are elected until the expiration of the term for

which they are elected and until their respective successors are duly elected and qualified.

The  directors  may  be  removed  only  by  the  affirmative  vote  of  at  least  a  majority  of  the  holders  of  our  then-outstanding  common  stock.
Furthermore, any vacancy on the board of directors, however occurring, including a vacancy resulting from an increase in the size of the board, may be
filled only by a majority vote of the board of directors then in office, even if less than a quorum, or by the sole remaining director. This system of electing
and removing directors and filling vacancies may tend to discourage a third party from making a tender offer or otherwise attempting to obtain control of
Corcept, because it generally makes it more difficult for stockholders to replace a majority of the directors.

Amendment of the Certificate of Incorporation and Bylaws

The amendment of any of the provisions in the certificate of incorporation requires approval by a stockholder vote by the holders of at least a
majority of the voting power of the then outstanding voting stock. The bylaws may be amended by a majority of the board of directors or by the holders of
at least sixty six and two thirds percent (66 2/3%) of the voting power of the then outstanding voting stock.

The  provisions  of  the  DGCL,  the  certificate  of  incorporation  and  bylaws  could  have  the  effect  of  discouraging  others  from  attempting  hostile
takeovers and, as a consequence, they may also inhibit temporary fluctuations in the market price of our common stock that often result from actual or
rumored hostile takeover attempts. These provisions may also have the effect of preventing changes in the management of Corcept. It is possible that these
provisions could make it more difficult to accomplish transactions that stockholders may otherwise deem to be in their best interests.

Limitations of Liability and Indemnification Matters

The certificate of incorporation contains provisions that limit the liability of the directors and officers for monetary damages to the fullest extent
permitted  by  Delaware  law.  Consequently,  directors  and  officers  are  not  personally  liable  to  Corcept  or  its  stockholders  for  monetary  damages  for  any
breach of fiduciary duties as directors, except liability for:

•

•

•

•

any breach of the director’s or officer’s duty of loyalty to Corcept or its stockholders;

any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;

unlawful payments of dividends or unlawful stock repurchases or redemptions as provided in Section 174 of the DGCL; or

any transaction from which the director or officer derived an improper personal benefit.

Each of the certificate of incorporation and bylaws provides that we are required to indemnify the directors and officers, in each case to the fullest
extent permitted by Delaware law. The bylaws also obligate us to advance expenses incurred by a director or officer in advance of the final disposition of
any action or proceeding, and permit us to secure insurance on behalf of any officer, director, employee or other agent for any liability arising out of his or
her actions in that capacity regardless of whether we would otherwise be permitted to indemnify him or her under Delaware law. We have entered into
agreements to indemnify the directors, executive officers and other employees as determined by the board of directors. With specified exceptions, these
agreements  provide  for  indemnification  for  related  expenses  including,  among  other  things,  attorneys’  fees,  judgments,  fines  and  settlement  amounts
incurred by any of these individuals in any action or proceeding to the fullest extent permitted by applicable law. We believe that these bylaw provisions
and indemnification agreements are necessary to attract and retain qualified persons as directors and officers. Corcept also maintains directors’ and officers’
liability insurance.

The limitation of liability and indemnification provisions in the certificate of incorporation and bylaws may discourage stockholders from bringing
a  lawsuit  against  the  directors  and  officers  for  breach  of  their  fiduciary  duty.  They  may  also  reduce  the  likelihood  of  derivative  litigation  against  the
directors and officers, even though an action, if successful, might benefit Corcept and its stockholders. Furthermore, a stockholder’s investment may be
adversely affected to the extent that we pay the costs of settlement and damage.

Stock Exchange Listing

Shares of common stock are listed on Nasdaq under the symbol “CORT.”

No Sinking Fund

The shares of common stock have no sinking fund provisions.

Transfer Agent and Registrar

The transfer agent and registrar for our common stock is Continental Stock Transfer & Trust Company. The transfer agent and registrar’s address

is 17 Battery Place, New York, NY 10004.

Exhibit 23.1

 We consent to the incorporation by reference in the following Registration Statements: 

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

(1)   Registration Statements (Form S-8 Nos. 333-150199, 333-158406, 333-164531, 333-172841 and 333-180073) pertaining to the Amended and

Restated 2004 Equity Incentive Plan of Corcept Therapeutics Incorporated,

(2)   Registration Statements (Form S-8 Nos. 333-183284, 333-187316, 333-194663, 333-202753, 333-210076, 333-216658, 333-223318, 333-

229857 and 333-236601) pertaining to the 2012 Incentive Award Plan for Corcept Therapeutics Incorporated, and

(3)   Registration Statements (Form S-3 Nos. 333-150204, 333-181672 and 333-216659) of Corcept Therapeutics Incorporated and in the related

Prospectuses; 

of our reports dated February 23, 2021, with respect to the consolidated financial statements of Corcept Therapeutics Incorporated and the effectiveness of
internal control over financial reporting of Corcept Therapeutics Incorporated included in this Annual Report (Form 10-K) of Corcept Therapeutics
Incorporated for the year ended December 31, 2020.

/s/ Ernst & Young LLP

Redwood City, California

February 23, 2021

Exhibit 31.1

I, Joseph K. Belanoff, M.D., certify that:

CERTIFICATION

1.

I have reviewed this Annual Report on Form 10-K for the period ended December 31, 2020 of Corcept Therapeutics Incorporated;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the

financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in

Exchange Act Rules 13a-15(e) and 15d-15(e) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))
for the registrant and have:

(a)

(b)

(c)

(d)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles;

Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent
fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant's internal control over financial reporting; and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the

registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)

(b)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.

/s/ Joseph K. Belanoff
Joseph K. Belanoff, M.D.
Chief Executive Officer and President
February 23, 2021

Exhibit 31.2

I, G. Charles Robb, certify that:

CERTIFICATION

1.

I have reviewed this Annual Report on Form 10-K for the period ended December 31, 2020 of Corcept Therapeutics Incorporated;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the

financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in

Exchange Act Rules 13a-15(e) and 15d-15(e) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))
for the registrant and have:

(a)

(b)

(c)

(d)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles;

Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent
fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant's internal control over financial reporting; and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the

registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)

(b)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.

/s/ G. Charles Robb
G. Charles Robb
Chief Financial Officer and Secretary
February 23, 2021

Corcept Therapeutics Incorporated

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Exhibit 32.1

In connection with the Annual Report of Corcept Therapeutics Incorporated (the “Company”) on Form 10-K for the period ended December 31, 2020, as
filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Joseph K. Belanoff, M.D., Chief Executive Officer of the
Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

/s/ Joseph K. Belanoff
Joseph K. Belanoff, M.D.
Chief Executive Officer and President
February 23, 2021

This certification is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Corcept
Therapeutics Incorporated under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, irrespective of any general
incorporation language contained in such filing.

 
Corcept Therapeutics Incorporated

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Exhibit 32.2

In connection with the Annual Report of Corcept Therapeutics Incorporated (the “Company”) on Form 10-K for the period ended December 31, 2020, as
filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, G. Charles Robb, Chief Financial Officer of the Company, certify,
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

/s/ G. Charles Robb
G. Charles Robb
Chief Financial Officer and Secretary
February 23, 2021

This certification is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Corcept
Therapeutics Incorporated under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, irrespective of any general
incorporation language contained in such filing.