Quarterlytics / Healthcare / Biotechnology / Corcept Therapeutics

Corcept Therapeutics

cort · NASDAQ Healthcare
Claim this profile
Ticker cort
Exchange NASDAQ
Sector Healthcare
Industry Biotechnology
Employees 51-200
← All annual reports
FY2022 Annual Report · Corcept Therapeutics
Sign in to download
Loading PDF…
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, 2022

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:

None

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 ☒

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. ☒

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in

the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation

received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

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,  2022  was  $2,058,080,161,
based on the closing price of $23.78 for shares of the Registrant’s common stock as reported on the Nasdaq Stock Market on June 30, 2022. 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 21, 2023 there were 107,899,316 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 2023 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, 2022

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.

[Reserved]

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.

ITEM 9C.

Other Information

Disclosure Regarding Foreign Jurisdictions That Prevent Inspections

PART III

ITEM 10.

Directors, Executive Officers and Corporate Governance

ITEM 11.

Executive Compensation

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

Page

1

11

26

26

26

28

29

30

31

37

37

37

37

39

39

40

40

40

40

40

41

44

45

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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;

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;

estimates regarding our future revenue, income and capital requirements; and

the impact of the COVID-19 pandemic and our response to it.

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 medications to treat severe endocrine, oncologic, metabolic and

neurological disorders by modulating the effects of the 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.

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  with  fatty  liver  disease  and  non-alcoholic  steatohepatitis  (“NASH”),  which  are  precursors  of  liver  fibrosis  and  cirrhosis,  and  in
patients at risk of weight gain caused by

1

antipsychotic medications (referred to as antipsychotic induced weight gain, or “AIWG”). Pre-clinical data also suggest that modulating cortisol activity
may lead to treatments for patients with amyotrophic lateral sclerosis (“ALS”).

Since  2012,  we  have  marketed  Korlym  (mifepristone)  in  the  United  States  for  the  treatment  of  patients  suffering  from  Cushing’s  syndrome.  The
challenge in treating a patient with Cushing’s syndrome is modulating cortisol’s effects without either 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”).

Because Korlym’s active ingredient, mifepristone, reduces the binding of excess cortisol to the 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  the  GR  but  have  no  affinity  for  the  PR  and  so  do  not  cause
Korlym’s PR-related side effects. These novel molecules are “selective” cortisol modulators: they share Korlym’s affinity for the 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. The composition of our selective cortisol modulators 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,  advanced  ovarian

cancer, adrenal cancer with cortisol excess, prostate cancer, ALS and NASH.

COVID-19 Pandemic

Public  health  restrictions  put  in  place  to  reduce  the  impact  of  the  global  COVID-19  pandemic,  as  well  as  measures  voluntarily  undertaken  by

patients, physicians, hospitals and medical clinics, have reduced our revenue growth and make it difficult to grow our Korlym business.

The  pandemic’s  impact  on  the  pace  of  our  clinical  development  programs  has  been  variable.  Some  of  our  trials  of  indications  not  considered
immediately life-threatening, such as Cushing’s syndrome, have experienced slower enrollment. In addition, some clinical sites have reduced the frequency
with  which  physicians  see  study  participants.  Our  trials  in  patients  with  immediately  life-threatening  diseases,  such  as  our  Phase  2  trial  in  women  with
platinum-resistant ovarian cancer, have not encountered delays.

We expect that pandemic-related impediments to our business will continue so long as there are COVID-19 public health restrictions and/or risk-

reducing behavior by physicians and patients.

Please see the risk factor under Item 1A of this Annual Report, “The COVID-19 pandemic has adversely affected and is continuing to adversely

affect our business.”

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 per year 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 result in a range of complications.

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 patients with the disorder. We also have a field-based force of medical science liaisons.

2

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 (named GRACE and GRADIENT) of our proprietary, selective cortisol modulator, relacorilant,
as a treatment for patients with Cushing’s syndrome. Relacorilant was well-tolerated in its Phase 1 and Phase 2 trials. Patients in the Phase 2 trial exhibited
meaningful  improvements  in  glucose  control,  hypertension,  weight,  liver  function,  coagulopathy,  cognition,  mood,  insulin  resistance  and  quality  of  life
measures. Relacorilant shares Korlym’s affinity for GR, but, unlike Korlym, has no affinity for PR, and so is not the “abortion pill” and does not cause
other effects associated with PR affinity, including endometrial thickening and vaginal bleeding. Relacorilant also does not appear to cause hypokalemia
(low  potassium),  a  potentially  serious  condition  that  is  a  leading  cause  of  patients  stopping  treatment  with  Korlym.  Forty-four  percent  of  patients  in
Korlym’s pivotal trial experienced hypokalemia.

In the GRACE trial, each patient receives relacorilant for 22 weeks. Patients who exhibit pre-specified improvements in hypertension and/or glucose
metabolism enter a 12-week, double-blind, “randomized withdrawal” phase, in which half of the patients continue receiving relacorilant and half receive
placebo. The trial’s primary endpoint is the rate and degree of relapse of hypertension in patients receiving placebo measured against the rate and degree of
relapse of hypertension in those continuing relacorilant. GRACE has a planned enrollment of 130 patients with Cushing’s syndrome at sites in the United
States, Canada, Europe and Israel. If successful, we expect GRACE to provide the basis for a new drug application (“NDA”) for relacorilant as a treatment
for patients with any etiology of endogenous Cushing’s syndrome.

Our second Phase 3 trial of relacorilant, GRADIENT, is studying patients whose Cushing’s syndrome is caused by a benign adrenal tumor. These
patients often exhibit less severe symptoms or have a more gradual course of disease than patients with other etiologies of Cushing’s syndrome, although
their  health  outcomes  are  ultimately  poor.  Half  of  the  patients  in  GRADIENT  will  receive  relacorilant  for  22  weeks  and  half  will  receive  placebo.  The
trial’s primary endpoints are improvements in glucose metabolism and hypertension. The planned enrollment for this study is 130 patients. Many of the
clinical sites in GRACE are participating in GRADIENT.

The United States Food and Drug Administration (“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 patients with Cushing’s syndrome, seven years of exclusive marketing rights. 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.

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 and GRADIENT trials. 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  evidence  that  cortisol  activity  at  the  GR  reduces  the  efficacy  of  certain  anti-cancer  therapies  and  that  modulating  cortisol’s
activity may help anti-cancer treatments achieve their intended effect. In some cancers, cortisol retards cellular apoptosis – the tumor-killing effect many
treatments  are  meant  to  stimulate.  In  other  cancers,  cortisol  activity  promotes  tumor  growth.  Cortisol  also  suppresses  the  body’s  immune  response;
activating – not suppressing – the immune system is beneficial in fighting certain cancers. Many types of solid tumors express the GR and are potential
targets for cortisol modulation therapy, among them ovarian, adrenal and prostate cancer.

Relacorilant in Patients with Advanced Ovarian Cancer. In May 2021, we announced preliminary results from our 178-patient, controlled, multi-
center, Phase 2 trial of relacorilant combined with nab-paclitaxel in patients with platinum-resistant ovarian cancer. Study participants were randomized to
one of three treatment arms: 60 women received 150 mg of relacorilant

3

intermittently (the day before, the day of and the day after their weekly nab-paclitaxel infusion) and 58 women received a daily relacorilant dose of 100 mg
per day in addition to nab-paclitaxel. Sixty women received nab-paclitaxel alone. The trial’s primary endpoint was progression-free survival (i.e., the time
from random assignment in a clinical trial to disease progression or death from any cause or “PFS”).

Patients  in  both  of  the  relacorilant  plus  nab-paclitaxel  treatment  arms  experienced  longer  PFS  than  did  the  patients  who  received  nab-paclitaxel
alone. Patients who received a higher dose of relacorilant intermittently exhibited a statistically significant improvement in median PFS (5.6 months versus
3.8 months, hazard ratio: 0.66; p-value: 0.038). Patients who received a lower dose of relacorilant daily exhibited a median PFS that was 1.5 months longer
than did the patients who received nab-paclitaxel alone (5.3 months versus 3.8 months, hazard ratio: 0.83; p-value: not significant). Patients who received
relacorilant  intermittently  also  had  a  longer  median  duration  of  response  (“DoR”)  (5.6  months  versus  3.7  months,  hazard  ratio:  0.36;  p-value:  0.006)
compared to those who received nab-paclitaxel alone. Patients who received relacorilant intermittently also lived longer (median OS: 13.9 months versus
12.2 months, hazard ratio: 0.67; p-value: 0.066) compared to those who received nab-paclitaxel alone.

Safety and tolerability of relacorilant plus nab-paclitaxel were comparable to nab-paclitaxel monotherapy.

In June 2022, we initiated a pivotal Phase 3 trial (“ROSELLA”) that seeks to replicate the positive results observed in our Phase 2 study. ROSELLA
has a planned enrollment of 360 women with recurrent, platinum-resistant ovarian cancer, randomized 1:1 to receive either relacorilant plus nab-paclitaxel
or nab-paclitaxel monotherapy. The primary endpoint is PFS, with overall survival as a key secondary endpoint. Patients in ROSELLA will have received
prior bevacizumab therapy, which is the standard of care in the United States for patients with platinum-resistant ovarian cancer. Women with a history of
tumors that do not respond to initial platinum-based treatments (i.e., women with “primary platinum-refractory” disease) and those who have received more
than three prior lines of therapy will be excluded.

In our Phase 2 trial, women who met the entry criteria for ROSELLA and received relacorilant intermittently experienced significantly improved
PFS (median: 7.3 months versus 3.7 months, hazard ratio: 0.40; p-value: 0.005) and OS (median: 17.9 months versus 12.6 months, hazard ratio: 0.38; p-
value: 0.011) relative to patients in the comparator arm. The patients in the intermittent arm also experienced a significant improvement in DoR relative to
those in the comparator arm (median: 5.6 months versus 3.1 months, hazard ratio: 0.29; p-value: 0.016).

Relacorilant in Patients with Adrenal Cancer with Cortisol Excess. We are conducting an open-label, Phase 1b trial of relacorilant plus the PD-1
checkpoint  inhibitor  pembrolizumab  in  patients  with  metastatic  or  unresectable  adrenal  cancer  whose  tumors  produce  cortisol.  The  trial  is  examining
whether  adding  relacorilant  to  pembrolizumab  therapy  reduces  cortisol-activated  immune  suppression  sufficiently  to  help  pembrolizumab  achieve  its
intended  tumor-killing  effect.  Relacorilant  is  also  expected  to  treat  the  patients’  Cushing’s  syndrome  generated  by  their  tumors’  excess  production  of
cortisol.

Relacorilant  in  Patients  with  Prostate  Cancer.  Androgen  deprivation  is  the  standard  treatment  for  prostate  cancer  because  androgens  stimulate
prostate tumor growth. Tumors often escape androgen deprivation therapy when cortisol’s activity at the GR stimulates tumor growth. Combining a cortisol
modulator with an androgen modulator may block this escape route. Our collaborators at the University of Chicago plan to initiate a randomized, placebo-
controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer, pre-prostatectomy. We are providing relacorilant and placebo for
the study and have licensed patents covering the use of relacorilant combined with anticancer agents such as enzalutamide in the treatment of patients with
this indication.

ALS

ALS,  also  known  as  Lou  Gehrig’s  disease,  is  a  devastating  neuromuscular  illness.  Our  selective  cortisol  modulator  dazucorilant  improved  motor
performance  and  reduced  neuroinflammation  and  muscular  atrophy  in  animal  models  of  ALS.  Following  these  compelling  results,  in  October  2022  we
initiated a Phase 2 trial of dazucorilant (the “DAZALS” trial) in patients with ALS. DAZALS has a planned enrollment of 198 patients, randomized 1:1:1
to receive either 150 mg or 300 mg of dazucorilant or placebo daily for 24 weeks. The primary endpoint is the difference between dazucorilant and placebo
demonstrated by patients on the ALS Functional Rating Scale-Revised (ALSFRS-R).

Metabolic Diseases

Liver Disease. NASH is an advanced form of nonalcoholic fatty liver disease that afflicts millions of patients and is a leading cause of liver-related
mortality. In April 2021, we suspended our Phase 2a trial of our selective cortisol modulator miricorilant as a potential treatment for NASH after four of the
five patients who received miricorilant exhibited both elevated liver enzymes and large rapid reductions in liver fat. Liver enzyme levels in all affected
patients returned to baseline or below baseline after miricorilant was withdrawn. Our ongoing Phase 1b dose-finding trial in patients with presumed NASH
has

4

identified a range of doses that appear to cause large reductions in liver fat without causing excessive liver irritation. We plan to start a Phase 2 trial in the
fourth quarter of 2023.

AIWG.  In  the  United  States,  six  million  people  take  antipsychotic  medications  such  as  olanzapine  and  risperidone  to  treat  illnesses  such  as
schizophrenia,  bipolar  disorder  and  depression.  While  these  drugs  are  very  effective,  they  often  cause  rapid  and  sustained  weight  gain,  other  metabolic
disturbances and, ultimately, cardiovascular disease. Patients taking these medications experience a 10 to 25-year reduction in life expectancy, due largely
to increased cardiovascular events, such as heart attacks and strokes. Patients in our two double-blind, placebo-controlled, Phase 2 trials of miricorilant
(GRATITUDE and GRATITUDE II) did not experience reversal of AIWG. However, multiple replicated pre-clinical results as well as the results of our
double-blind,  placebo-controlled  trial  (published  in  the  Journal  of  Clinical  Psychopharmacology  (Hunt  et  al.,  2021))  suggest  that  miricorilant  has  the
potential to significantly reduce weight gain caused by the administration of olanzapine. Accordingly, we plan to further study miricorilant’s potential to
prevent AIWG.

Development of our Other Selective Cortisol Modulators

Our portfolio of proprietary selective cortisol modulators consists of four structurally distinct series. More than 1,000 of these compounds, including
relacorilant, exicorilant, miricorilant and dazucorilant, potently bind to the 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.”

We continue to identify selective cortisol modulators and plan to advance 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 and 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, sarcoma, melanoma and solid tumors, including triple-negative breast, prostate, ovarian and non-small cell
lung cancers.

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.  Syneos  Health  is  helping  us  conduct  our  ROSELLA  trial.  Julius  Clinical  is  helping  us  conduct  our  DAZALS  trial.  We  may
terminate our agreements with ICON, Syneos Health and Julius Clinical on 60 days’ written notice.

Research and Development Spending

We incurred $131.0 million, $113.9 million and $114.8 million of research and development expense in the years ended December 31, 2022, 2021

and 2020, respectively, which accounted for 45 percent, 47 percent and 51 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. At December 31, 2021, the agreement was extended through
December 31, 2022. At December 31, 2022, the agreement was further extended through December 31, 2023.

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

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, and metyrapone, which is approved for testing hypothalamic-

5

pituitary function. Korlym also competes with Signifor  (pasireotide) Injection and Isturisa  (osilodrostat). Both of these 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, and both are sold
by the Italian pharmaceutical company Recordati S.p.A (“Recordati”). Cushing’s disease is a subset of Cushing’s syndrome. In the EU, osilodrostat is also
approved  as  a  treatment  for  Cushing’s  syndrome.  Korlym  also  competes  with  Recorlev   (levoketoconazole),  a  chiral  form  of  the  commonly-prescribed
cortisol synthesis inhibitor ketoconazole, that is sold by Xeris Biopharma Holdings, Inc. (“Xeris”), as a treatment for patients with 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. We sued
Teva Pharmaceuticals USA, Inc. (“Teva”) in federal district court to prevent them from marketing generic versions of Korlym in violation of our patents. 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. On March 12, 2021, Teva appealed its loss to the Federal Circuit
Court of Appeals. On December 7, 2021, the Federal Circuit Court of Appeals affirmed the PTAB’s decision, upholding the validity of all claims in this
PGR in Corcept’s favor. See “Part I, Item 3, Legal Proceedings.”

Intellectual Property

Overview.  Patents  and  other  proprietary  rights  are  important  to  our  business.  We  own  U.S.  composition  of  matter  patents  related  to  our  next-
generation cortisol modulators. Foreign counterparts of some of these patents have issued in Europe, Japan, China, Canada, Australia and other countries.
The expiration dates of these patents and their foreign counterparts range from 2025 to 2039.

We  also  own  U.S.  and  foreign  patents  directed  to  the  use  of  our  selective  cortisol  modulators  in  the  treatment  of  a  variety  of  serious  disorders,

including Cushing’s syndrome, various cancers, fatty liver disease, antipsychotic-induced weight gain, and other disorders.

We continue to file patent applications in the United States and abroad. There can be no guarantee that any of these 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 that the production and use of our patented compounds and methods do not infringe the 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, as described below.

Cushing’s Syndrome. The composition of matter patent covering Korlym’s active ingredient, mifepristone, has expired. We own U.S. method of use
patents directed to the use of Korlym in the treatment of patients with Cushing’s syndrome, with expiration dates ranging from 2028 to 2038. Furthermore,
we own U.S. compound and method of use patents using our proprietary selective cortisol modulators directed to the treatment of patients with Cushing’s
syndrome, with expiration dates ranging from 2033 to 2040.

Oncology.  We  own  U.S.  patents  covering  methods  of  treating  cancer  using  our  proprietary  selective  cortisol  modulators  with  expiration  dates
ranging from 2023 to 2041. In addition, we have exclusively licensed from the University of Chicago 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 (“CRPC”). 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. See “Business – License Agreements.”

We hold U.S. and international patents covering relacorilant’s composition of matter, as well as U.S. patents covering its use to treat patients with
ovarian  and  pancreatic  cancer.  We  also  own  or  have  exclusively  licensed  U.S.  and  European  patents  covering  the  use  of  GR  modulators,  including
relacorilant, to treat a variety of disorders, including CRPC and other solid tumors. Relacorilant has been designated an orphan drug in both the United
States and the EU for the treatment of pancreatic cancer.

Other Indications. In addition to the United States and foreign patents we own or have licensed relating to Cushing’s syndrome and various cancers,
we  also  own  U.S.  and  foreign  patents  for  the  use  of  cortisol  modulators  to  treat  AIWG,  fatty  liver  disease,  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 also own patents covering the improvement of therapeutic response to electroconvulsive therapy
and inhibition of

6

cognitive deterioration in adults with Down’s Syndrome. The expiration dates of these patents and their foreign counterparts range from 2023 to 2039.

Government Regulation

Prescription  pharmaceutical  products  are  subject  to  extensive  pre-  and  post-approval  regulation  governing  the  research,  development,  testing,
manufacturing,  safety,  efficacy,  labeling,  storage,  record  keeping,  and  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 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.

Prior to beginning the first clinical trial with a product candidate in the United States, a sponsor must submit an investigational new drug application
(“IND”) to the FDA. An IND is a request for authorization from the FDA to administer an investigational new drug product to humans. The central focus
of an IND submission is on the general investigational plan and the protocol(s) for clinical studies. The IND also includes results of animal and in vitro
studies  assessing  the  toxicology,  pharmacokinetics,  pharmacology,  and  pharmacodynamics  characteristics  of  the  drug,  chemistry,  manufacturing,  and
controls  information,  and  any  available  human  data  or  literature  to  support  the  use  of  the  investigational  drug.  An  IND  must  become  effective  before
human clinical trials may begin.

Clinical trials involve the administration of the investigational drug to human subjects under the supervision of qualified investigators in accordance
with Good Clinical Practice regulations, which include the requirement that all research subjects provide their informed consent for their participation in
any  clinical  study.  Clinical  trials  are  conducted  under  protocols  detailing,  among  other  things,  the  objectives  of  the  study,  the  parameters  to  be  used  in
monitoring safety and the effectiveness criteria to be evaluated. Typically, human clinical trials are conducted in three sequential phases that may overlap.

•

•

•

Phase 1. The product candidate is administered to a small number of healthy subjects or patients with the target disease or condition to provide
preliminary  information  as  to  its  safety,  tolerability  and  pharmacokinetics  and  sometimes  to  provide  preliminary  information  as  to  its  activity
and/or efficacy.
Phase 2. The product candidate is administered to a limited patient population with a specified disease or condition to evaluate its preliminary
efficacy, optimal dosages and to identify possible adverse events and safety risks.
Phase  3.  The  product  candidate  is  administered  to  a  larger  group  of  patients  with  the  target  disease  or  condition  to  further  evaluate  dosage,
establish its risk/benefit ratio and to provide an adequate basis for product approval.

The FDA and the institutional review boards associated with clinical trial sites closely monitor the progress of clinical trials conducted in the United
States  and  may  reevaluate,  alter,  suspend  or  terminate  a  trial  at  any  time  for  various  reasons,  including  a  belief  that  the  subjects  are  being  exposed  to
unacceptable risks. The FDA may also require that additional trials be conducted to address and evaluate any potential safety risks.

Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, drug developers will submit the
results of preclinical studies, clinical trials, formulation studies and data supporting manufacturing to the FDA in the form of an NDA requesting approval
to market the drug for one or more indications. The submission of an NDA requires payment of a substantial application user fee to the FDA, unless a
waiver or exemption applies. Within 60 days following submission of the application, the FDA reviews an NDA submitted to determine if it is substantially
complete  before  the  FDA  accepts  it  for  filing.  Once  filed,  the  FDA  reviews  an  NDA  to  determine,  among  other  things,  whether  a  product  is  safe  and
effective for its intended use and whether its manufacturing is sufficient to assure and preserve the drug’s identity, strength, quality and purity. Under the
Prescription Drug User Fee Act, the FDA has a goal of responding to NDAs within ten months of the filing date for standard review, and six months for
priority review, which the FDA may undertake, in its sole discretion, if a sponsor shows that its drug candidate is designed to treat a serious condition, and
if  approved,  would  provide  a  significant  improvement  in  safety  or  effectiveness  compared  to  marketed  drugs.  FDA  approvals  may  not  be  granted  on  a
timely basis or at all.

In addition, under the Orphan Drug Act, the FDA may grant orphan designation to a drug intended to treat a rare disease or condition, defined as a
disease  or  condition  with  a  patient  population  of  fewer  than  200,000  individuals  in  the  United  States,  or  a  patient  population  greater  than  200,000
individuals in the United States and when there is no reasonable expectation that the cost of developing and making available the drug in the United States
will be recovered from sales in the United States for that drug. If a product that has orphan drug designation subsequently receives the first FDA approval
for a particular active ingredient for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means

7

that the FDA may not approve any other applications, including a full NDA, to market the same drug for the same indication for seven years, except in
limited circumstances. Orphan drug exclusivity does not prevent the FDA from approving a different drug for the same disease or condition, or the same
drug for a different disease or condition. Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the NDA
application user fee.

If the FDA approves the marketing of a new drug, such approval will be granted for particular indications and may entail limitations on the indicated
uses for which such product may be marketed. The FDA may withdraw its approval at any time if compliance with regulatory standards is not maintained.
The holder of an approved NDA 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.

In  addition,  most  changes  to  an  approved  drug,  such  as  adding  new  indications  or  other  labeling  claims,  are  subject  to  prior  FDA  review  and
approval.  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. In addition, 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 abide by these regulations can result in penalties including the issuance of a warning letter or untitled letter directing
a  company  to  correct  deviations  from  FDA  regulations,  mandated  modification  of  promotional  materials  and  labeling,  the  issuance  of  corrective
information,  clinical  holds,  restrictions  on  manufacturing,  product  recalls,  product  detentions  or  seizures,  refusal  to  approve  pending  applications  or
supplements and injunctions, in addition to state and federal civil and criminal penalties.

Marketing Approvals Outside the United States

If we choose to distribute our product candidates outside the United States, we 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 United States 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.

Examples of legislation in this area include the Patient Protection and Affordable Care Act (“ACA”) which was passed in 2010, and the Inflation
Reduction Act of 2022 (the “IRA”). The ACA 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. More recently, the Inflation Reduction Act of 2022 (the “IRA”) was signed into law on August 16, 2022, which, among other things,
requires the Secretary of the U.S. Department of Health and Human Services (“HHS”) to negotiate the price of a set number of high Medicare spend drugs
starting in 2026, requires rebates from manufacturers who increase their drug prices above inflation, and makes several changes to the Medicare Part D
benefit that will increase manufacturer liability for drug costs previously borne by the government and beneficiaries under the program. We also expect
there to be other healthcare reform measures that could impact coverage, reimbursement, and drug prices.

Other Healthcare Laws

In addition to the laws and regulations outlined in the “Government Regulations” section, we are subject to healthcare regulation and enforcement by

the federal government and the states where we conduct business. These laws include, without

8

limitation,  state  and  federal  anti-kickback,  fraud  and  abuse,  false  claims,  and  physicians’  sunshine  (e.g.  transparency)  laws  and  regulations.  Foreign
governments  have  comparable  regulations,  and  violating  these  laws  and  regulations  in  any  jurisdiction  could  result  in  significant  criminal,  civil,  and
administrative sanctions.

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. 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 and other third parties. The Anti-Kickback Statute is subject to evolving interpretations, and in the absence of substantive guidance, it is possible
for future initiatives or engagements with healthcare professionals to be challenged under this Statute, which could adversely impact our operations. While
this Statute has a number of exceptions and regulatory safe harbors that safeguard certain common, industry practices from prosecution, these exceptions
and safe harbors are narrowly defined, and parties must satisfy all elements of an available exception or safe harbor to avoid scrutiny. 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.  For  example,  through
legislative action, the government may assert that an Anti-Kickback Statute violation could implicate the federal civil False Claims Act. 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.

The civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to federal
programs (including Medicare and Medicaid). Actions under the False Claims Act may be brought directly by the government or as a qui tam action by a
private individual (acting as a “whistleblower”) in the name of the government. In addition, as noted directly above, 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 federal
False  Claims  Act.  Violations  of  the  False  Claims  Act  can  result  in  significant  monetary  penalties  including  treble  damages,  and  carry  the  potential  for
exclusion from participation in federal healthcare programs. The federal government has and continues to use 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 potential or actual
false claims resulting from promotion of products for unapproved uses or other sales and marketing practices. The government has obtained multi-billion
dollar settlements under the False Claims Act and individual criminal convictions under applicable criminal statutes. We expect that the government will
continue to devote substantial resources to investigating potential or actual violations of the False Claims Act.

The federal criminal statute on false statements makes it a crime to knowingly and willfully (in connection with the delivery of or payment for health
care benefits, items, or services): (i) falsify, conceal, or cover up any material fact, (ii) make any materially false, fictitious, or fraudulent statements or
representations, or (iii) make or use any materially false writing or document while knowing such writings or documents contain materially false, fictitious,
or fraudulent statements.

The Civil Monetary Penalties Law provides the government the ability to impose civil monetary penalties against any party or entity who offers or
transfers anything of value to a federal health care program beneficiary when a party or entity knows or should know that providing a transfer of value is
likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier for the order or receipt of any item or service reimbursable by
a federal health care program. Notably, while pharmaceutical and biotech companies are generally not considered “providers, practitioners, or suppliers,”
offering anything of value to a beneficiary that is likely to influence the beneficiary to select a particular provider, practitioner, or supplier (e.g., a physician
or pharmacy) could implicate the Civil Monetary Penalties Law.

The  federal  Health  Insurance  Portability  and  Accountability  Act  of  1996  (“HIPAA”)  prohibits,  among  other  things,  knowingly  and  willfully
executing a scheme to defraud any healthcare benefit program. Similar to the federal Anti-Kickback Statute, 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 federal physician Payments Sunshine Act (generally referred to as the Open Payments™ Program) is a provision under the Patent Protection and
Affordable Care Act (“ACA”). The Open Payments Program imposes reporting requirements on covered entities (e.g., drug manufacturers) for payments
made  or  transfers  of  value  provided  by  them  to  certain  healthcare  organizations  (e.g.,  teaching  hospitals)  and  physicians,  which  is  broadly  defined  to
include doctors, dentists, optometrists, podiatrists and chiropractors, and certain non-physician practitioners (e.g., physician assistants, nurse practitioners,
clinical  nurse  specialists,  anesthesiologist  assistants,  certified  registered  nurse  anesthetists,  anesthesiology  assistants  and  certified  nurse  midwives).
Covered entities are also required to report ownership and investment interests held by physicians and their immediate family members (as it relates to the
Covered entities). This information is then analyzed and made public, available via searchable databases. 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

9

annual submission. Similarly, certain states also mandate the tracking and reporting of gifts, compensation and other remuneration to physicians. Some of
these states also require the implementation of commercial compliance programs and impose restrictions on drug manufacturer marketing practices.

Federal and state agencies continue to spend time, energy and resources combating healthcare fraud and abuse. This regulatory environment, taken
together with the evolving commercial compliance environment and the need to build, enhance and maintain robust and expandable systems and controls 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.

In addition to the above “fraud and abuse” laws and regulations, we must also account for other applicable state and foreign laws and regulations
that  could  impact  our  business  activities.  For  example,  some  states  require  pharmaceutical  companies  to  certify  that  they  are  in  compliance  with  the
pharmaceutical  industry’s  voluntary  compliance  guidelines  and  certain  federal  government  compliance  guidance,  while  other  states  (and  some  local
governments) require the public registration of pharmaceutical sales representatives.

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 United States Department of Health and Human Services (“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. In 2022, the FTC also began a rulemaking proceeding to develop additional data
privacy rules and requirements, which may add additional complexity to compliance obligations going forward.

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,  the  California  Consumer  Privacy  Act  (“CCPA”)  which  took  effect  on  January  1,  2020,  created  individual
privacy  rights  for  California  consumers  and  increased  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. Further, the California Privacy Rights Act (“CPRA”) revised and expanded the CCPA, adding
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 also created a new California data protection agency authorized to issue
substantive regulations and could result in increased privacy and information security enforcement. The CPRA is in full effect as of January 1, 2023, and
similar  laws  passed  in  Virginia,  Colorado,  Connecticut,  and  Utah  will  take  effect  starting  in  2023.  As  a  result,  additional  compliance  investment  and
potential business process changes may be required. In the event that we are subject to or affected by HIPAA, the CCPA, the CPRA or other domestic
privacy and data protection laws, any liability from failure to comply with the requirements of these laws could adversely affect our financial condition.
Additional legislation

10

proposed  at  the  federal  level  and  in  other  states,  along  with  increased  regulatory  action,  reflect  a  trend  toward  more  stringent  privacy  legislation  in  the
United States.

In Europe, the General Data Protection Regulation (“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 European Economic
Area (“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. 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 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.
Transfers  of  personal  information  out  of  the  European  Union  face  a  constantly  shifting  set  of  requirements,  as  courts  in  Europe  have  invalidated
intergovernmental agreements and European regulators have required changes to standard contracting terms, which themselves do not fit all situations. As a
result, significant uncertainty exists with respect to GDPR compliance and the attendant obligations going forward as the regulatory environment is rapidly
developing. In addition, from January 1, 2021, companies have had to comply with both the GDPR and the GDPR 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  EC  has  adopted  an
adequacy decision in favor of the United Kingdom, enabling data transfers from EU member states to the United Kingdom without additional safeguards.
However, the UK adequacy decision will automatically expire in June 2025 unless the EC re-assesses and renews/extends that decision. Outside Europe,
significant data privacy regulatory regimes exist in major markets including Brazil, India, China, and elsewhere. The ever-shifting landscape of global data
privacy regulation requires significant investment and attention to avoid significant noncompliance liabilities.

Employees

We are managed by experienced pharmaceutical executives and also enlist the expertise of independent advisors with extensive pharmaceutical
experience.  As  of  December  31,  2022,  we  had  299  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, performance bonuses and equity grants, as well as
industry-leading  health,  retirement  and  childcare  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.

11

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 has adversely affected and is continuing to adversely affect our business.
If  generic  versions  of  Korlym  are  successfully  commercialized,  our  business,  results  of  operations  and  financial  position  would  be  adversely
affected.

• New laws, government regulations, or changes to existing laws and regulations could make it difficult or impossible for us to obtain acceptable
prices  or  adequate  insurance  coverage  and  reimbursement  for  Korlym,  which  would  adversely  affect  our  results  of  operations  and  financial
position.

Risks Related to our Research and Development Activities

• Our efforts to discover, develop and commercialize our product candidates may not succeed. 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 time.
The COVID-19 pandemic has lengthened the time it takes to initiate and advance some of our clinical trials.

•
• Vendors  perform  many  of  the  activities  necessary  to  carry  out  our  clinical  trials,  including  drug  product  distribution,  trial  management  and
oversight  and  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.

• We  may  be  unable  to  obtain  or  maintain  regulatory  approvals  for  our  product  or  product  candidates,  which  would  prevent  us  from

commercializing 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.

•

To succeed, we must secure, maintain and effectively assert 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.

Risks Relating to our Intellectual Property

The price of our common stock fluctuates widely and is likely to continue to do so. Opportunities for investors to sell shares 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.

Risks Related to our Stock

• We  rely  on  information  technology  to  conduct  our  business.  A  breakdown  or  breach  of  our  information  technology  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.

General Risks

Risk Factors – Discussion

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

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

12

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  competing  treatments  for  Cushing’s  syndrome,  including  off-label  treatments  and  generic  versions  of
Korlym, should any such generic versions be introduced;

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; and

lack of availability of government or private insurance, the shift of a significant number of patients to Medicaid, which reimburses Korlym at a
significantly lower price, or the introduction of government price controls or other price-reducing regulations, such as the Inflation Reduction Act
of 2022, that may significantly limit Medicare reimbursement rates.

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 has adversely affected and is continuing to adversely affect our business.

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, reacted by instituting quarantines, “lockdowns” and other public health restrictions on leisure activities, work
and  travel.  Although  pandemic-related  restrictions  have  been  eased  or  removed  in  some  places,  including  California,  our  business  remains  subject  to
pandemic-related  controls,  which  may  become  more  restrictive  at  any  time.  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 difficult to grow our commercial business. Many physicians have reduced the frequency of patient office visits and barred
office  visits  by  third  parties,  including  our  clinical  specialists  and  medical  science  liaisons.  In  addition,  many  patients  have  postponed  visits  to  their
physicians or testing at clinical laboratories or imaging centers. These precautions have made it harder for physicians to identify patients who may benefit
from Korlym, begin their treatment, arrive at an optimum dose and maintain their patients’ regimens.

We  cannot  predict  the  duration  of  these  impacts  on  our  business  or  how  severe  future  impacts  may  be,  including  supply-chain  disruptions  and
inflationary impacts. 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.

If  generic  versions  of  Korlym  are  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 Korlym’s approved indication, provided such parties 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.

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. We have sued Teva in Federal District Court with respect to their proposed generic versions of Korlym. In
November 2020, the PTAB ruled against Teva in a challenge Teva had brought to one of our patents, a ruling which the Federal Circuit Court of Appeals
has affirmed. We had also sued Sun and Hikma with respect to their proposed generic version of Korlym, although we settled those lawsuits in June 2021
and December 2022, respectively. The terms of our settlement with Sun and Hikma are subject to customary review by the Federal Trade Commission and
Department of Justice. Please see “Part I, Item 3, Legal Proceedings.” Because Teva has received FDA approval, Teva may choose to begin marketing its
generic product at any time, notwithstanding our ongoing litigation. We would seek a court order stopping such a course of action, but even if we were to
prevail and Teva were to withdraw its product

13

and pay us damages the temporary availability of a generic version of Korlym might materially harm our results of operations and financial condition.

It is likely that other companies will seek FDA approval to market a generic version of Korlym. While we will vigorously protect our intellectual

property, there can be no assurance our efforts will be successful.

Natural disasters, some possibly related to the increasing effects of climate change, could damage or destroy clinical trial sites, our office spaces,
the  residences  of  our  employees  or  the  facilities  or  residences  of  our  vendors,  contractors  or  consultants,  which  could  significantly  harm  our
operations.

We are vulnerable to natural disasters, including earthquakes, fires, hurricanes, floods, blizzards and the extended periods of extreme heat, cold and
precipitation  made  more  frequent  and  severe  by  global  warming.  For  example,  our  headquarters  are  in  the  San  Francisco  Bay  Area,  which  experiences
earthquakes, wildfires and flooding. Our specialty pharmacy, tablet manufacturers and warehouses are in areas subject to hurricanes and tornadoes. All our
activities, as well as the activities of our vendors, consultants, clinical investigators, patients, physicians and regulators, are subject to the risks posed by
global warming.

The loss of life, property damage and disruptions to electrical power distribution, communications, travel and shipping caused by natural disasters
could  make  it  difficult  or  impossible  to  conduct  our  commercial  activities  or  complete  our  drug  discovery  activities  or  clinical  trials.  Patients  may  be
unwilling or unable to travel to clinical trial sites, for example, or clinical materials or data may be lost.

Our insurance, if available at all, would likely be insufficient to cover losses resulting from disasters or other business interruptions.

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.

®

On December 30, 2021, Xeris received FDA approval to market the cortisol synthesis inhibitor Recorlev  (levoketoconazole) to treat patients with
Cushing’s syndrome in the United States. Levoketoconazole is an enantiomer of the generic anti-fungal medication, ketoconazole, that is prescribed off-
label to treat patients with Cushing’s syndrome.

®

Osilodrostat and levoketoconazole have been designated orphan drugs in both the EU and the United States.

Physician  preference  for  any  of  these  medications,  or  for  the  off-label  use  of  generic  medications  such  as  ketoconazole,  to  treat  patients  with

Cushing’s syndrome could reduce our revenue materially and harm our results of operations, which would cause our stock price to decline.

New laws, government regulations, or changes to existing laws and regulations could make it difficult or impossible for us to obtain acceptable
prices  or  adequate  insurance  coverage  and  reimbursement  for  Korlym,  which  would  adversely  affect  our  results  of  operations  and  financial
position.

The  commercial  success  of  Korlym  depends  on  the  availability  of  acceptable  pricing  and  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. 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.  If  government  or  private  payers  cease  to  provide  adequate  and  timely  coverage,  pricing  and
reimbursement for Korlym, physicians may not prescribe the medication and patients may not purchase it, even if it is prescribed, or the price we receive
may be reduced, which would reduce our revenue.

In the United States, there have been and continue to be legislative initiatives to contain healthcare costs. The Patient Protection and Affordable Care

Act (“ACA”) which was passed in 2010, substantially changed the way health care is financed

14

by both governmental and private insurers. The Inflation Reduction Act of 2022, or IRA, introduced some of the most significant changes to Medicare
payment for prescription drugs since the ACA. Among its many provisions, the IRA requires the Secretary of the U.S. Department of Health and Human
Services  (“HHS”)  to  negotiate  Medicare  prices  for  selected  drugs  and  biologicals,  including  both  physician-administered  products  covered  under
Medicare’s Part B benefit and self-administered drugs covered under the Part D benefit. Each year, the Secretary will select for price negotiation a specified
number of negotiation-eligible drugs with the highest total Part B or D expenditures over a preceding 12-month period. To be eligible for price negotiation
a drug must have been on the market for at least seven years without generic competition. Orphan drugs indicated for only one rare disease or condition and
drugs with less than $200 million in annual Medicare expenditures are exempt from the negotiation program. For the first two years of the program, 2026
and 2027, only Part D drugs are eligible. The Secretary will publish the negotiated price, known as the “Maximum Fair Price”, or MFP, for each of the
selected  products.  Manufacturers  of  selected  drugs  would  be  required  to  offer  the  drug  for  Medicare  recipients  at  the  MFP.  Manufacturers  who  fail  to
negotiate  or  offer  the  MFP  can  face  significant  civil  money  penalties  or  excise  tax  liability  on  sales  of  that  drug.  Depending  on  the  share  of  Medicare
spending each year that is attributed to Korlym or any other drug candidate that we develop and whether or not those drugs become eligible for Medicare
negotiation, those drugs and our revenue may be adversely impacted by this provision.

The IRA also establishes an inflation rebate program that requires manufacturers to pay rebates to the Medicare program if any of the medications
they provide Medicare recipients increase in price faster than the rate of inflation. The Part D inflation rebate provision went into effect on October 1, 2022.
Although manufacturers are generally familiar with inflation rebates under the Medicaid program, where they have existed for decades, the IRA represents
the first time that inflation rebates have been extended to the Medicare program.

Beginning  in  2025,  the  IRA  will  also  shift  a  significant  portion  of  the  Medicare  beneficiary  costs  from  the  government  and  beneficiaries  to

manufacturers. We anticipate that this provision will significantly limit the revenue Corcept receives and may materially reduce our revenue and profits.

There continues to be federal and state initiatives to contain healthcare costs, in part informed by the current atmosphere of mounting criticism of
prescription drug costs in the United States. We expect governmental oversight and scrutiny of pharmaceutical companies will continue to increase and
there will continue to be proposals to change the healthcare system in ways that could harm our ability to sell Korlym profitably. We anticipate that the
United States Congress, state legislatures, and regulators may implement healthcare policies intended to curb healthcare costs, such as federal and state
controls  on  reimbursement  for  drugs  (including  under  Medicare  and  commercial  health  plans),  new  or  increased  requirements  to  pay  prescription  drug
rebates and penalties to government health care programs and policies that require drug companies to disclose and justify the prices they charge.

Recently enacted 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 Korlym revenues and our ability to develop and commercialize our product candidates.

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 active pharmaceutical ingredient (“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, Produits Chimiques Auxiliaires et de Synthese SA (“PCAS”), supplies the API in Korlym. Two other third-party
manufacturers are approved to produce and bottle Korlym tablets. The current term of our agreement with PCAS continues until December 31, 2023. We
use a single specialty pharmacy, Optime, to dispense Korlym and perform related pharmacy operations, patient support and related services, including the
collection of 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 extends to March 31, 2024, 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  our  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”) or the Medicines and

15

Healthcare products Regulatory Agency (“MHRA”). 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, MHRA 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.

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. On June 24, 2022, the
United States Supreme Court published its decision in the case of Dobbs v. Jackson Women’s Health Organization (“Dobbs”), which overturned Roe v.
Wade, the 1973 Supreme Court decision establishing a woman’s right to terminate her pregnancy, subject to certain limitations. Dobbs has stimulated many
states to enact laws making abortion illegal in virtually every circumstance, including during early pregnancy. More laws banning or heavily restricting
termination of pregnancy may be adopted and existing laws may be made more restrictive. Heightened public perception of mifepristone as an abortifacient
may draw the attention of hostile state government officials or political activists to Korlym – even though Korlym is not approved for the termination of
pregnancy,  we  do  not  promote  it  for  that  use  and  we  have  taken  measures  to  minimize  the  chance  that  it  will  accidentally  be  prescribed  to  a  pregnant
woman. In addition, physicians and patients may choose not to use Korlym as a treatment for Cushing’s syndrome simply to avoid the risk of terminating a
pregnancy.

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 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 (“GCPs”). 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 new drug applications (“NDAs”) or supplemental NDAs, and suspension or revocation of product approvals.

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,” manufacturers
are prohibited from engaging in any of “off-label” promotion. In the

16

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.  Among  other  activities,  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 may restrict our ability to promote our products, which could adversely impact our business.

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,” untitled 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 prohibiting 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  United  States  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. And, although we
structure our applicable business arrangements in accordance with the safe harbors, it is difficult to determine exactly how the law will be applied
in  specific  circumstances.  Accordingly,  it  is  possible  that  certain  practices  of  ours  may  be  challenged  under  the  federal  Anti-Kickback  Statute.
From a liability perspective, 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. The federal False Claims Act is unique in that it allows private individuals (whistleblowers) to bring actions on behalf of the federal
government  via  qui  tam  actions.  Importantly,  under  the  False  Claims  Act  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;

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;

• 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 (or sometimes referred to as the Open Payments
 Program), 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, certain non-physician practitioners, teaching
hospitals, and ownership or investment interests held by physicians and their immediate family members;

TM

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.

17

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 and scrutiny. 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.

In  November  2021,  we  received  a  records  subpoena  from  the  United  States  Attorney’s  Office  for  the  District  of  New  Jersey  (the  “NJ  USAO”)
seeking information relating to the sale and promotion of Korlym, our relationships with and payments to health care professionals who can prescribe or
recommend Korlym and prior authorizations and reimbursement for Korlym. The NJ USAO has informed us that it is investigating whether any criminal or
civil violations by us occurred in connection with the matters referenced in the subpoena. It has also informed us that it does not currently consider us a
defendant but rather an entity whose conduct is within the scope of the government’s investigation. We are cooperating with the investigation. Please see
“Part I, Item 3, Legal Proceedings.”

If  we  are  found  in  violation  of  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

Our efforts to discover, develop and commercialize our product candidates may not succeed. 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 time.

Clinical development is costly, time-consuming and unpredictable. Positive 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 seek regulatory approval.

Clinical trials may take longer to complete, cost more than expected and fail for many reasons, including:

failure to show efficacy or acceptable safety;

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.

•

•

•

•

•

•

•

•

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 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

18

COVID-19 pandemic increase the likelihood of delays in initiating or completing our planned and ongoing clinical trials, thereby increasing their costs.
Please see the risk factor, “The COVID-19 pandemic has lengthened the time it takes to initiate and advance some of our clinical trials.”

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, thereby delaying or preventing the completion of development and
increase its cost. Even if we conduct the clinical trials and supportive studies that we consider appropriate and the results are positive, we may not receive
regulatory approval. Following regulatory approval, there are significant risks to its commercial success, such as development of competing products by
other companies or the reluctance of physicians to prescribe it.

The COVID-19 pandemic has lengthened the time it takes to initiate and advance some of our clinical trials.

We conduct clinical trials at sites in the United States, Canada, Europe and Israel. In the United States, Canada and Europe, authorities have imposed
significant  public  health  restrictions  of  varying  degrees  of  severity  which  are  likely  to  persist  as  long  as  COVID-19  public  health  concerns  remain.  In
addition, physicians, patients and medical institutions have changed their behavior in an attempt to reduce the risk of infection, which makes clinical trials
more expensive, time-consuming and risky to initiate and conduct.

Some  of  the  sites  where  we  are  conducting  clinical  trials  have,  from  time-to-time,  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. Studies of diseases perceived to be acutely life-threatening, such as our Phase 2 trial in women with platinum-resistant
ovarian cancer, did not experience delay or disruption.

We may continue to experience disruptions from the COVID-19 pandemic, which could have a material adverse impact on our clinical trial plans

and timelines, including:

•

•

•

•

•

•

•

•

•

•

•

•

delays in enrolling patients or the loss of enrolled patients due to COVID-19 related restrictions;

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 or public health restrictions implemented by clinical trial sites which make trial
participation more time consuming or difficult;

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; and

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

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.

19

Vendors  perform  many  of  the  activities  necessary  to  carry  out  our  clinical  trials,  including  drug  product  distribution,  trial  management  and
oversight  and  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 GCPs, 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. Outside parties may have staffing difficulties, may undergo changes in priorities or may become financially
distressed, adversely affecting their willingness or ability to conduct our clinical trials. Problems with the timeliness or quality of the work of a CRO may
lead us to seek to terminate the relationship and use an alternative service provider. However, making this change may be costly and may delay our trials,
and it may be challenging to find a replacement organization that can conduct our trials in an acceptable manner and at an acceptable cost. 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.

We  may  be  unable  to  obtain  or  maintain  regulatory  approvals  for  our  product  or  product  candidates,  which  would  prevent  us  from
commercializing our product candidates.

We cannot sell a product without the approval of the FDA or comparable foreign regulatory authority. Obtaining such approval is difficult, uncertain,
lengthy and expensive. Failure can occur at any stage. In order to receive FDA approval for a new drug, 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,
untitled 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. 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. 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. 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 requirements and oversight by the FDA and other regulatory
authorities, such as continued safety and other reporting requirements and possibly post-approval marketing restrictions and additional costly clinical trials.
If we are not able to maintain regulatory compliance, we may be required to stop development of a product candidate or to stop selling a product that has
already  been  approved.  We  may  also  be  subject  to  product  recalls  or  seizures.  Future  governmental  action  or  changes  in  regulatory  authority  policy  or
personnel may also result in delays or rejection of pending or anticipated product approvals.

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  a  clinical  trial  or  commercialization
efforts, the commercial prospects of the affected product candidates or products may be harmed and our ability to generate product revenues from them
may be delayed or eliminated.

20

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:

•

•

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, 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;

•

the product may become less competitive;

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

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

Any of these events could seriously harm our business.

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. 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.

Risks Relating to our Intellectual Property

To succeed, we must secure, maintain and effectively assert 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.

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.”

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.

Risks Related to our Stock

The price of our common stock fluctuates widely and is likely to continue to do so. Opportunities for investors to sell shares 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 21, 2023, our average daily trading
volume was approximately 736,105 shares and the intra-day sales prices per share of our common stock on The Nasdaq Stock Market ranged from $17.19
to $30.14. As of February 21, 2023, our officers, directors and principal stockholders beneficially owned approximately 19 percent of our common stock.

21

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:

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;

changes in the expected or actual timing of our competitors’ development programs;

general market and economic conditions, including the effects of the COVID-19 pandemic;

disputes or other developments relating to our intellectual property, including developments in ANDA litigation;

short-selling  of  our  common  stock,  the  publication  of  speculative  opinions  about  our  business  or  other  market  manipulation  activities  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 public guidance we have provided;

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

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

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

technological innovations by us, our collaborators or our competitors;

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

additions or departures of key personnel;

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

additional financing activities.

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

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 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  forecast.  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.

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

General Risk Factors

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;

•

•

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

continue to develop our administrative systems and controls.

22

Failure to accomplish any of these tasks, which are 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 and turnover rates have reached record highs within our industry and
the geographical areas from which we recruit. 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.

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 Federal Trade Commission 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  (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 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  2022,  the  FTC  also  began  a
rulemaking proceeding to develop additional data privacy rules and requirements, which may add additional complexity to compliance obligations going
forward.

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, the California Consumer Privacy Act, or the CCPA, which took effect on January 1, 2020, created individual
privacy  rights  for  California  consumers  and  increased  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. Further, the California Privacy Rights Act, or CPRA, revised and expanded the CCPA, adding
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 also created a new California data protection agency authorized to issue
substantive regulations and could result in increased privacy and information security enforcement. The CPRA is in full effect as of January 1, 2023, and
similar  laws  passed  in  Virginia,  Colorado,  Connecticut  and  Utah  will  take  effect  starting  in  2023.  As  a  result,  additional  compliance  investment  and
potential business process changes may be required. In the event that we are subject to or affected by HIPAA, the CCPA, the CPRA or other domestic
privacy and data protection laws, any liability from failure to comply with the requirements of these laws could adversely affect our financial condition.
Additional legislation proposed at the federal level and in other states, along with increased regulatory action, reflect a trend toward more stringent privacy
legislation in the United States.

Outside the United States, many jurisdictions have or are in the process of enacting sweeping data privacy regulatory regimes. In Europe, the GDPR
took effect in 2018, and is imposing stringent requirements for controllers and processors of personal data of individuals within the EEA, particularly with
respect to clinical trials. The GDPR provides that EEA member

23

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 added complexity and compliance uncertainty regarding certain transfers of information from
the  EEA  to  the  United  States.  Following  EU  court  decisions,  updated  standard  contractual  clauses  (“SCCs”)  were  adopted  to  account  for  these  judicial
decisions, imposing new requirements on data transfers. The revised SCCs must be used for relevant new data transfers from September 27, 2021, and
existing SCC arrangements were required to be migrated by December 27, 2022. There is some uncertainty around whether the revised clauses can be used
for  all  types  of  data  transfers,  particularly  whether  they  can  be  relied  on  for  data  transfers  to  non-EEA  entities  subject  to  the  GDPR.  As  supervisory
authorities  issue  further  guidance  on  personal  data  export  mechanisms,  including  circumstances  where  the  SCCs  cannot  be  used,  and/or  start  taking
enforcement  action,  we  could  suffer  additional  costs,  complaints  and/or  regulatory  investigations  or  fines,  and/or  if  we  are  otherwise  unable  to  transfer
personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our services, the geographical
location or segregation of our relevant systems and operations, and could adversely affect our financial results. 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. From January 1, 2021, we have had to comply with the
GDPR  and  separately  the  United  Kingdom  GDPR,  which,  together  with  the  amended  United  Kingdom  Data  Protection  Act  2018,  retains  the  GDPR  in
United Kingdom national law, each regime having the ability to fine up to the greater of €20 million/ £17.5 million or 4% of global turnover. It is unclear
how United Kingdom data protection laws and regulations will develop in the medium to longer term and these changes may lead to additional costs and
increase our overall risk exposure. On June 28, 2021, the EC adopted an adequacy decision in favor of the United Kingdom, enabling data transfers from
EU member states to the United Kingdom without additional safeguards. However, the United Kingdom adequacy decision will automatically expire in
June 2025 unless the EC renews or extends that decision and remains under review by the Commission during this period.

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  on  information  technology  to  conduct  our  business.  A  breakdown  or  breach  of  our  information  technology  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.
Despite our security measures, our networks and the networks of our vendors are at risk of break-ins, installation of malware or ransomware, denial-of-
service attacks, data theft and other forms of malfeasance by persons seeking to commit fraud or theft, which could result in unauthorized access to, and/or
misuse  of,  our  clinical  data  or  other  confidential  information,  including  confidential  information  relating  to  our  patients  or  employees.  COVID-19  may
continue to 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.

We and our vendors have experienced data breaches, theft, “phishing” attacks and other unauthorized access to confidential data and information.
Russia’s invasion of Ukraine or another war of international dispute may cause an increase in the number and severity of such malicious incidents. There
can be no assurance that our cybersecurity systems and processes will prevent unauthorized access in the future that causes serious harm to us, our patients
or employees. 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.

24

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

Our earnings are subject to federal, state and local taxes. 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 15, Notes to Consolidated Financial Statements – Income Taxes.” Certain
provisions of the recently enacted Inflation Reduction Act of 2022, effective January 1, 2023, including a 1% excise tax on share repurchases and a 15%
corporate alternative minimum tax, may impact our income tax expense, profitability and capital allocation decisions. Changes to existing tax laws could
materially increase the amounts we pay, which would reduce our after tax net income.

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 and innovative biotechnology companies, many of 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 and the prospects of
our product candidates.

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 our outstanding shares are eligible for sale, subject to applicable volume and certain other
resale restrictions.

Changes in laws and regulations may significantly increase our costs or reduce our revenue, 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, marketing and pricing 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, the Dodd Frank Act of 2010 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.

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 and the
governance and other requirements of the Dodd Frank Act of 2010, 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

25

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  21,  2023,  our  officers  and  directors  beneficially  owned  approximately  19  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.

We have in the past and may in the future be subject to short selling strategies that may drive down the market price of our common stock.

Short sellers have in the past and may attempt in the future to drive down the market price of our common stock. Short selling is the practice of
selling securities that the seller does not own but may have borrowed with the intention of buying identical securities back at a later date. The short seller
hopes to profit from a decline in the value of the securities between the time the securities are borrowed and the time they are replaced. As it is in the short
seller’s best interests for the price of the stock to decline, many short sellers (sometime known as “disclosed shorts”) publish, or arrange for the publication
of, negative opinions regarding the relevant issuer and its business prospects to create negative market momentum. Although traditionally these disclosed
shorts  were  limited  in  their  ability  to  access  mainstream  business  media  or  to  otherwise  create  negative  market  rumors,  the  rise  of  the  Internet  and
technological  advancements  regarding  document  creation,  videotaping  and  publication  by  weblog  (“blogging”)  have  allowed  many  disclosed  shorts  to
publicly attack a company’s credibility, strategy and veracity by means of so-called “research reports” that mimic the type of investment analysis performed
by large Wall Street firms and independent research analysts. These short attacks have, in the past, led to selling of shares in the market. Further, these short
seller publications are not regulated by any governmental, self-regulatory organization or other official authority in the U.S. and they are not subject to
certification requirements imposed by the SEC. Accordingly, the opinions they express may be based on distortions, omissions or fabrications. Companies
that  are  subject  to  unfavorable  allegations,  even  if  untrue,  may  have  to  expend  a  significant  amount  of  resources  to  investigate  such  allegations  and/or
defend  themselves,  including  shareholder  suits  against  the  company  that  may  be  prompted  by  such  allegations.  We  may  in  the  future  be  the  subject  of
shareholder suits that we believe were prompted by allegations made by short sellers.

ITEM 1B. UNRESOLVED STAFF COMMENTS

None.

ITEM 2. PROPERTIES

We lease 47,022 square feet of office space in Menlo Park, California for our corporate facilities. Our current lease expires in June 2023.

ITEM 3. LEGAL PROCEEDINGS

Teva Litigation

In February 2018, we received a Paragraph IV Notice Letter advising that Teva Pharmaceuticals USA, Inc. (“Teva”) had submitted an Abbreviated
New Drug Application (“ANDA”) to the FDA seeking authorization to manufacture and sell a generic version of Korlym prior to the expiration of patents
related to Korlym that are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”). On March 15,
2018, we filed a lawsuit in the United States District Court for the District of New Jersey against Teva for infringement of our patents. On October 12,
2018, Teva received tentative approval from the FDA for its ANDA. In accordance with the Hatch-Waxman Act, however, FDA final approval of Teva’s
ANDA was stayed until August 1, 2020.

On  July  6,  2018,  we  filed  an  amended  complaint,  and  on  February  8,  2019,  we  filed  a  separate  lawsuit  against  Teva,  asserting  infringement  of
several  patents,  including  U.S.  Patent  No.  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

26

consolidated our lawsuits against Teva into a single action and set a trial date of February 2, 2021, which it later vacated. A new trial date has not been set.

On May 7, 2019, Teva submitted to the Patent Trial and Appeal Board (“PTAB”) a petition for post-grant review (“PGR”) of the ’214 patent. On
November 20, 2019, the PTAB agreed to initiate the PGR, and on November 19, 2020 issued a decision upholding the validity of the ’214 patent in its
entirety. Teva appealed its loss to the Federal Circuit Court of Appeals, which on December 7, 2021, ruled in our favor.

The time for Teva to appeal or seek reconsideration of these adverse decisions has passed. This matter is closed.

This  lawsuit  against  Teva  currently  asserts  the  ‘214  patent  and  the  ‘216  patent.  The  parties  have  completed  briefing  cross-motions  for  summary

judgment regarding infringement of the ’214 patent. On February 27, 2023, the Court denied both motions without prejudice. No trial date has been set.

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

Hikma ANDA Litigation and Settlement

On February 1, 2021, we received a Paragraph IV Notice Letter advising that Hikma Pharmaceuticals USA Inc. (“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,  alleging  that  these  patents  will  not  be

infringed by Hikma’s proposed product, are invalid and/or are unenforceable.

On March 12, 2021, we filed a lawsuit in the United States District Court for the District of New Jersey against Hikma for infringement of the ’214

patent, the ʼ216 patent, U.S. Patent Nos. 10,842,800 and U.S. Patent Nos. 10,842,801.

On December 7, 2022, we entered into an agreement with Hikma resolving this litigation. Pursuant to the agreement, we have granted Hikma the
right  to  sell  a  generic  version  of  Korlym  in  the  United  States  beginning  October  1,  2034  or  earlier  under  circumstances  customary  for  settlement
agreements of this type. As required by law, we and Hikma have submitted the settlement agreement to the United States Federal Trade Commission and
the United States Department of Justice for review.

Other Matters

On March 14, 2019, a purported securities class action complaint was filed in the United States 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  “Melucci  litigation”).  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 extending 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.

On February 8, 2023, we reached an agreement in principle (the “Proposed Settlement”) to resolve all claims in the Melucci litigation. Under the
Proposed Settlement, we have agreed to make a one-time payment of $14.0 million, which will be covered in full by our insurers. The Proposed Settlement
is subject to the final approval of the United States District Court for the Northern District of California.

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, captioned Lauren Williams v. G. Leonard Baker, et al., Civil Action No. 1:19-cv-01830. The complaint named our board of directors,
Chief Executive Officer and current Chief Business 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. On
December 20, 2020, the case was further stayed pending a resolution of our motion to dismiss the third amended complaint in the Melucci litigation. On
September 30, 2021, the case was further stayed pending a resolution of the Melucci litigation.

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, captioned Jeweltex Pension Plan v. James N. Wilson, et al., Civil Action

27

No.  1:19-cv-02308.  The  complaint  named  our  board  of  directors,  Chief  Executive  Officer  and  current  Chief  Business  Officer  as  defendants,  and  us  as
nominal defendant. The complaint alleges 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 damages in an amount 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 our motion to dismiss the third amended complaint in the Melucci litigation. On September 30, 2021, the case was further
stayed pending a resolution of the Melucci litigation.

On January 31, 2022, a purported shareholder derivative complaint was filed in the Delaware Court of Chancery by Joel B. Ritchie, captioned Joel
B.  Ritchie  v.  G.  Leonard  Baker,  et  al.,  Case  No.  2022-0102-SG.  The  complaint  named  our  board  of  directors,  Chief  Executive  Officer,  current  Chief
Business Officer and President of Corcept Endocrinology as defendants, and us as nominal defendant. The complaint alleges a single cause of action for
breach  of  fiduciary  duty.  The  complaint  seeks  damages  in  an  amount  to  be  proved  at  trial.  On  April  20,  2022,  the  case  was  further  stayed  pending  a
resolution of the Melucci litigation.

We will respond vigorously to the above allegations but cannot predict the outcome of these matters.

In  November  2021,  we  received  a  records  subpoena  from  the  United  States  Attorney’s  Office  for  the  District  of  New  Jersey  (the  “NJ  USAO”)
pursuant  to  Section  248  of  the  Health  Insurance  Portability  and  Accountability  Act  of  1996  (“HIPAA”)  seeking  information  relating  to  the  sale  and
promotion of Korlym, our relationships with and payments to health care professionals who can prescribe or recommend Korlym and prior authorizations
and reimbursement for Korlym. The NJ USAO has informed us that it is investigating whether any criminal or civil violations by us occurred in connection
with the matters referenced in the subpoena. It has also informed us that it does not currently consider us a defendant but rather an entity whose conduct is
within the scope of the government’s investigation.

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

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

28

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 21, 2023, we had 107,899,316 shares of common stock outstanding held by 28 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 purchases of our common stock in the three months ended December 31, 2022 as part of the

cashless net exercises of stock options (in thousands, except average price per share):

Fiscal Period

October 1, 2022 to October 31, 2022
November 1, 2022 to November 30, 2022
December 1, 2022 to December 31, 2022
Total

Total Number of Shares
Purchased

(1)

Average Price Per Share

Total Purchase Price of
Shares

(2)

19  $
81 
24 
124  $

27.75  $
25.74 
22.55 
25.45  $

536 
2,079 
532 
3,147 

(1) In October 2022, we issued 29,584 shares of common stock as part of net-share settlement of cashless option exercises, of which 19,306 shares were surrendered to us in satisfaction of
related exercise cost and tax obligations. In November 2022, we issued 120,595 shares of common stock as part of net-share settlement of cashless option exercises, of which 80,770 shares were
surrendered to us. In December 2022, we issued 60,480 shares of common stock as part of net-share settlement of cashless option exercises, of which 23,590 shares were surrendered to us.

(2) We paid $0.7 million to satisfy the tax withholding obligations associated with the net-share settlement of these cashless option exercises.

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,  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.

29

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

the Nasdaq US Benchmark TR Index (NQUSBT) and

the Nasdaq Biotechnology Index (NBI)

ITEM 6. [RESERVED]

30

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” within the meaning of the federal securities laws. For a complete discussion of such
statements and the potential risks and uncertainties that may affect their accuracy, see the “Risk Factors” section of 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 medications to treat severe endocrine, oncologic, metabolic and

neurological disorders by modulating the effects of the hormone cortisol.

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 patients with 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 (named GRACE and GRADIENT) of our proprietary, selective cortisol modulator, relacorilant,
as a treatment for patients with Cushing’s syndrome. Relacorilant was well-tolerated in its Phase 1 and Phase 2 trials. Patients in the Phase 2 trial exhibited
meaningful  improvements  in  glucose  control,  hypertension,  weight,  liver  function,  coagulopathy,  cognition,  mood,  insulin  resistance  and  quality  of  life
measures. Relacorilant shares Korlym’s affinity for the glucocorticoid receptor (“GR”), but, unlike Korlym, has no affinity for the progesterone receptor
(“PR”), and so is not the “abortion pill” and does not cause other effects associated with PR affinity, including endometrial thickening and vaginal bleeding.
Relacorilant  also  does  not  appear  to  cause  hypokalemia  (low  potassium),  a  potentially  serious  condition  that  is  a  leading  cause  of  patients  stopping
treatment with Korlym. Forty-four percent of patients in Korlym’s pivotal trial experienced hypokalemia.

In the GRACE trial, each patient receives relacorilant for 22 weeks. Patients who exhibit pre-specified improvements in hypertension and/or glucose
metabolism enter a 12-week, double-blind, “randomized withdrawal” phase, in which half of the patients continue receiving relacorilant and half receive
placebo. The trial’s primary endpoint is the rate and degree of relapse of hypertension in patients receiving placebo measured against the rate and degree of
relapse of hypertension in those continuing relacorilant. GRACE has a planned enrollment of 130 patients with Cushing’s syndrome at sites in the United
States, Canada, Europe and Israel. If successful, we expect GRACE to provide the basis for a new drug application (“NDA”) for relacorilant as a treatment
for patients with any etiology of endogenous Cushing’s syndrome.

Our second Phase 3 trial of relacorilant, GRADIENT, is studying patients whose Cushing’s syndrome is caused by a benign adrenal tumor. These
patients often exhibit less severe symptoms or have a more gradual course of disease than patients with other etiologies of Cushing’s syndrome, although
their  health  outcomes  are  ultimately  poor.  Half  of  the  patients  in  GRADIENT  will  receive  relacorilant  for  22  weeks  and  half  will  receive  placebo.  The
trial’s primary endpoints are improvements in glucose metabolism and hypertension. The planned enrollment for this study is 130 patients. Many of the
clinical sites in GRACE are participating in GRADIENT.

The United States Food and Drug Administration (“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 patients with Cushing’s syndrome, seven years of exclusive marketing rights. Benefits of orphan drug designation by
the EC are similar, but also

31

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

There  is  substantial  evidence  that  cortisol  activity  at  the  GR  reduces  the  efficacy  of  certain  anti-cancer  therapies  and  that  modulating  cortisol’s
activity may help anti-cancer treatments achieve their intended effect. In some cancers, cortisol retards cellular apoptosis – the tumor-killing effect many
treatments  are  meant  to  stimulate.  In  other  cancers,  cortisol  activity  promotes  tumor  growth.  Cortisol  also  suppresses  the  body’s  immune  response;
activating – not suppressing – the immune system is beneficial in fighting certain cancers. Many types of solid tumors express the GR and are potential
targets for cortisol modulation therapy, among them ovarian, adrenal and prostate cancer.

Relacorilant in Patients with Advanced Ovarian Cancer. In May 2021, we announced preliminary results from our 178-patient, controlled, multi-
center, Phase 2 trial of relacorilant combined with nab-paclitaxel in patients with platinum-resistant ovarian cancer. Study participants were randomized to
one  of  three  treatment  arms:  60  women  received  150  mg  of  relacorilant  intermittently  (the  day  before,  the  day  of  and  the  day  after  their  weekly  nab-
paclitaxel infusion) and 58 women received a daily relacorilant dose of 100 mg per day in addition to nab-paclitaxel. Sixty women received nab-paclitaxel
alone. The trial’s primary endpoint was progression-free survival (i.e., the time from random assignment in a clinical trial to disease progression or death
from any cause or “PFS”).

Patients  in  both  of  the  relacorilant  plus  nab-paclitaxel  treatment  arms  experienced  longer  PFS  than  did  the  patients  who  received  nab-paclitaxel
alone. Patients who received a higher dose of relacorilant intermittently exhibited a statistically significant improvement in median PFS (5.6 months versus
3.8 months, hazard ratio: 0.66; p-value: 0.038). Patients who received a lower dose of relacorilant daily exhibited a median PFS that was 1.5 months longer
than did the patients who received nab-paclitaxel alone (5.3 months versus 3.8 months, hazard ratio: 0.83; p-value: not significant). Patients who received
relacorilant  intermittently  also  had  a  longer  median  duration  of  response  (“DoR”)  (5.6  months  versus  3.7  months,  hazard  ratio:  0.36;  p-value:  0.006)
compared to those who received nab-paclitaxel alone. Patients who received relacorilant intermittently also lived longer (median OS: 13.9 months versus
12.2 months, hazard ratio: 0.67; p-value: 0.066) compared to those who received nab-paclitaxel alone.

Safety and tolerability of relacorilant plus nab-paclitaxel were comparable to nab-paclitaxel monotherapy.

In June 2022, we initiated a pivotal Phase 3 trial (“ROSELLA”) that seeks to replicate the positive results observed in our Phase 2 study. ROSELLA
has a planned enrollment of 360 women with recurrent, platinum-resistant ovarian cancer, randomized 1:1 to receive either relacorilant plus nab-paclitaxel
or nab-paclitaxel monotherapy. The primary endpoint is PFS, with overall survival as a key secondary endpoint. Patients in ROSELLA will have received
prior bevacizumab therapy, which is the standard of care in the United States for patients with platinum-resistant ovarian cancer. Women with a history of
tumors that do not respond to initial platinum-based treatments (i.e., women with “primary platinum-refractory” disease) and those who have received more
than three prior lines of therapy will be excluded.

In our Phase 2 trial, women who met the entry criteria for ROSELLA and received relacorilant intermittently experienced significantly improved
PFS (median: 7.3 months versus 3.7 months, hazard ratio: 0.40; p-value: 0.005) and OS (median: 17.9 months versus 12.6 months, hazard ratio: 0.38; p-
value: 0.011) relative to patients in the comparator arm. The patients in the intermittent arm also experienced a significant improvement in DoR relative to
those in the comparator arm (median: 5.6 months versus 3.1 months, hazard ratio: 0.29; p-value: 0.016).

Relacorilant in Patients with Adrenal Cancer with Cortisol Excess. We are conducting an open-label, Phase 1b trial of relacorilant plus the PD-1
checkpoint  inhibitor  pembrolizumab  in  patients  with  metastatic  or  unresectable  adrenal  cancer  whose  tumors  produce  cortisol.  The  trial  is  examining
whether  adding  relacorilant  to  pembrolizumab  therapy  reduces  cortisol-activated  immune  suppression  sufficiently  to  help  pembrolizumab  achieve  its
intended  tumor-killing  effect.  Relacorilant  is  also  expected  to  treat  the  patients’  Cushing’s  syndrome  generated  by  their  tumors’  excess  production  of
cortisol.

Relacorilant  in  Patients  with  Prostate  Cancer.  Androgen  deprivation  is  the  standard  treatment  for  prostate  cancer  because  androgens  stimulate
prostate tumor growth. Tumors often escape androgen deprivation therapy when cortisol’s activity at the GR stimulates tumor growth. Combining a cortisol
modulator with an androgen modulator may block this escape route. Our collaborators at the University of Chicago plan to initiate a randomized, placebo-
controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer, pre-prostatectomy. We are providing relacorilant and placebo for
the study and have licensed patents covering the use of relacorilant combined with anticancer agents such as enzalutamide in the treatment of patients with
this indication.

32

Amyotrophic Lateral Sclerosis (“ALS”)

ALS,  also  known  as  Lou  Gehrig’s  disease,  is  a  devastating  neuromuscular  illness.  Our  selective  cortisol  modulator  dazucorilant  improved  motor
performance  and  reduced  neuroinflammation  and  muscular  atrophy  in  animal  models  of  ALS.  Following  these  compelling  results,  in  October  2022  we
initiated a Phase 2 trial of dazucorilant (the “DAZALS” trial) in patients with ALS. DAZALS has a planned enrollment of 198 patients, randomized 1:1:1
to receive either 150 mg or 300 mg of dazucorilant or placebo daily for 24 weeks. The primary endpoint is the difference between dazucorilant and placebo
demonstrated by patients on the ALS Functional Rating Scale-Revised (ALSFRS-R).

Metabolic Diseases

Liver Disease. NASH is an advanced form of nonalcoholic fatty liver disease that afflicts millions of patients and is a leading cause of liver-related
mortality. In April 2021, we suspended our Phase 2a trial of our selective cortisol modulator miricorilant as a potential treatment for NASH after four of the
five patients who received miricorilant exhibited both elevated liver enzymes and large rapid reductions in liver fat. Liver enzyme levels in all affected
patients returned to baseline or below baseline after miricorilant was withdrawn. Our ongoing Phase 1b dose-finding trial in patients with presumed NASH
has identified a range of doses that appear to cause large reductions in liver fat without causing excessive liver irritation. We plan to start a Phase 2 trial in
the fourth quarter of 2023.

Antipsychotic-Induced  Weight  Gain  (“AIWG”).  In  the  United  States,  six  million  people  take  antipsychotic  medications  such  as  olanzapine  and
risperidone  to  treat  illnesses  such  as  schizophrenia,  bipolar  disorder  and  depression.  While  these  drugs  are  very  effective,  they  often  cause  rapid  and
sustained weight gain, other metabolic disturbances and, ultimately, cardiovascular disease. Patients taking these medications experience a 10 to 25-year
reduction in life expectancy, due largely to increased cardiovascular events, such as heart attacks and strokes. Patients in our two double-blind, placebo-
controlled,  Phase  2  trials  of  miricorilant  (GRATITUDE  and  GRATITUDE  II)  did  not  experience  reversal  of  AIWG.  However,  multiple  replicated  pre-
clinical results as well as the results of our double-blind, placebo-controlled trial (published in the Journal of Clinical Psychopharmacology (Hunt et al.,
2021)) suggest that miricorilant has the potential to significantly reduce weight gain caused by the administration of olanzapine. Accordingly, we plan to
further study miricorilant’s potential to prevent AIWG.

COVID-19 Pandemic

Public  health  restrictions  put  in  place  to  reduce  the  impact  of  the  global  COVID-19  pandemic,  as  well  as  measures  voluntarily  undertaken  by

patients, physicians, hospitals and medical clinics, have reduced our revenue growth and make it difficult to grow our Korlym business.

The  pandemic’s  impact  on  the  pace  of  our  clinical  development  programs  has  been  variable.  Some  of  our  trials  of  indications  not  considered
immediately life-threatening, such as Cushing’s syndrome, have experienced slower enrollment. In addition, some clinical sites have reduced the frequency
with  which  physicians  see  study  participants.  Our  trials  in  patients  with  immediately  life-threatening  diseases,  such  as  our  Phase  2  trial  in  women  with
platinum-resistant ovarian cancer, have not encountered delays.

We expect that pandemic-related impediments to our business will continue so long as there are COVID-19 public health restrictions and/or risk-

reducing behavior by physicians and patients.

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 has adversely affected and is continuing to adversely affect our business.”

Inflation Reduction Act of 2022

The Inflation Reduction Act of 2022 (“IRA”) was enacted on August 16, 2022. The IRA includes provisions imposing a 1% excise tax on share
repurchases  that  occur  after  December  31,  2022  and  introduces  a  15%  corporate  alternative  minimum  tax  (“CAMT”)  on  adjusted  financial  statement
income. The CAMT will be effective for us beginning on January 1, 2024. We do not expect the CAMT to have a significant effect on our consolidated
financial statements.

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 $401.9 million for the year ended December 31, 2022, compared to $366.0 million and $353.9 million for the years ended

December 31, 2021 and 2020, respectively. For the years ended December 31, 2022 and 2021, sales

33

volume accounted for 54.6 percent and 20.7 percent of the increases, respectively. Increases in the average price of Korlym accounted for the remaining
growth due to price increases effective January 1, 2022 and March 1, 2021.

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

Cost of sales was $5.4 million for the year ended December 31, 2022, compared to $5.3 million and $5.6 million for the years ended December 31,
2021 and 2020, respectively. Cost of sales as a percentage of revenue was 1.3 percent, 1.4 percent and 1.6 percent for the years ended December 31, 2022,
2021  and  2020,  respectively.  The  decreases  in  cost  of  sales  as  a  percentage  of  revenue  are  due  to  reduced  manufacturing  costs  and  increased  price  of
Korlym.

Research  and  development  expense  –  Research  and  development  expense  includes  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  expense  was  $131.0  million  for  the  year  ended  December  31,  2022,  compared  to  $113.9  million  for  the  comparable
period  in  2021.  The  increase  was  primarily  due  to  the  advancement  of  our  development  programs  and  increased  spending  on  employee  compensation
expenses.

Research  and  development  expense  was  $113.9  million  for  the  year  ended  December  31,  2021,  compared  to  $114.8  million  for  the  comparable
period in 2020. The decrease was primarily due to a decline in spending on our oncology program due to timing and completion of patient enrollments in
our clinical trials, partially offset by increased spending on employee recruiting and compensation expenses and the advancement of our other development
programs.

Development programs:
Oncology
Cushing’s syndrome
Metabolic diseases
Pre-clinical and early-stage selective cortisol modulators and ALS
Unallocated activities, including manufacturing and regulatory activities
Stock-based compensation

Total research and development expense

2022

Year Ended December 31,
2021
(in thousands)

2020

(1)

$

$

20,987  $
30,031 
24,270 
26,084 
16,819 
12,800 
130,991  $

17,984  $
28,639 
20,594 
21,924 
10,617 
14,106 
113,864  $

34,207 
26,821 
20,408 
14,726 
7,380 
11,222 
114,764 

 Beginning in the first quarter of 2021, expenses for the year ended December 31, 2020 previously allocated to oncology and endocrinology were re-

(1)
allocated between Cushing's syndrome, metabolic diseases and pre-clinical development programs.

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, difficulties in the formulation or manufacture of study drugs and the lack of drug-candidate
efficacy. In addition, clinical development is subject to government oversight and regulations that may change without notice. We expect our research and
development expense to be higher in 2023 than in 2022 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 expense – Selling, general and administrative expense includes (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.

Selling,  general  and  administrative  expense  was  $152.8  million  for  the  year  ended  December  31,  2022,  compared  to  $122.4  million  for  the

comparable period in 2021. The increase was primarily due to increased sales and marketing activities, employee compensation expenses, and legal fees.

Selling,  general  and  administrative  expense  was  $122.4  million  for  the  year  ended  December  31,  2021,  compared  to  $105.3  million  for  the
comparable period in 2020. The increase was primarily due to increases in employee recruiting and compensation expenses, sales and marketing expenses
and professional services.

34

 
 
 
 
 
We  expect  our  selling,  general  and  administrative  expense  to  be  higher  in  2023  than  in  2022  due  to  increased  commercial  and  administrative

activities, including litigation and administrative support for increased research and development and marketing efforts.

Settlement expense and insurance recovery related to Melucci litigation – In connection with the Proposed Settlement of the Melucci litigation, we
recorded  a  settlement  expense  of  $14.0  million  and  corresponding  insurance  recovery  of  $14.0  million  in  Operating  Expenses  on  our  Consolidated
Statement of Income in the fourth quarter of 2022.

Interest and other income – Interest and other income for the years ended December 31, 2022, 2021 and 2020 was $3.6 million, $0.5 million and
$3.4 million, respectively, and consisted primarily of interest income from marketable securities. Interest and other income increased for the year ended
December 31, 2022 from the comparable periods in 2021 and 2020 due to a higher cash and investment balance and market-wide increases in interest rates.

Income tax expense – Income tax expense was $14.8 million for the year ended December 31, 2022, compared to $12.5 million for the comparable
period  in  2021.  Income  tax  expense  increased  for  the  year  ended  December  31,  2022  from  the  comparable  period  in  2021  due  to  decreased  excess  tax
benefits for stock option exercises compared to 2021. Income tax expense was $12.5 million for the year ended December 31, 2021, compared to $25.6
million  for  the  comparable  period  in  2020.  Income  tax  expense  decreased  for  the  year  ended  December  31,  2021  from  the  comparable  period  in  2020
primarily due to increases in excess tax benefits for stock option exercises compared to 2020. While our core effective tax rate has remained relatively
consistent throughout the years, the tax rate can vary based upon the timing of provisions related to discrete tax items, including current and future excess
tax benefits from stock-based compensation.

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 over the next 12
months and beyond 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 and funds raised through collaborations with other companies may
require us to relinquish certain rights in our product candidates.

As of December 31, 2022, we had cash, cash equivalents and marketable securities of $436.6 million, consisting of cash and cash equivalents of
$66.3 million and marketable securities of $370.3 million, compared to cash, cash equivalents and marketable securities of $335.8 million, consisting of
cash and cash equivalents of $77.6 million and marketable securities of $258.2 million as of December 31, 2021.

The cash in our bank accounts and our marketable securities could be reduced or our access to them restricted if the financial institutions holding
them were to fail or severely adverse conditions were to arise in the markets for public or private debt securities. We have never experienced a lack of
access to cash or material realized losses.

Net cash provided by operating activities for the years ended December 31, 2022, 2021 and 2020 was $120.3 million, $167.9 million and $152.0
million, respectively. The decrease for the year ended December 31, 2022 compared to 2021 was primarily due to higher current income taxes resulting
from the capitalization of research and development costs for tax purposes. The increase for the year ended December 31, 2021 compared to 2020 was
primarily due to higher revenue.

Net cash (used in) provided by investing activities for the year ended December 31, 2022, 2021 and 2020 was $(114.3) million, $136.1 million and
$(119.3) million, respectively. The change for the year ended December 31, 2022 compared to 2021 was primarily due to allocation of cash generated from
our operating activities towards marketable securities rather than share repurchases. The change for the years ended December 31, 2021 compared to 2020
was primarily due to our use of cash for the repurchase of our common stock instead of increasing our investment in marketable securities.

In the year ended December 31, 2022, we spent $21.7 million acquiring shares of our common stock in connection with the net exercise of employee
and director stock options and vesting of restricted stock grants, offset by $4.4 million received from the exercise of stock options and purchases through
our Employee Stock Purchase Plan, resulting in net cash used in financing activities of $17.3 million. In the comparable periods in 2021 and 2020, we
spent $318.8 million and $11.0 million, respectively, acquiring shares of our common stock, offset by $16.2 million and $23.2 million received from the
exercise  of  stock  options,  respectively,  resulting  in  net  cash  used  in  financing  activities  of  $302.6  million  for  the  year  ended  and  net  cash  provided  by
financing activities of $12.2 million for the year ended December 31, 2020.

As of December 31, 2022, we had retained earnings of $296.4 million.

35

Manufacturing Purchase Commitments

We have 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.

As of December 31, 2022, we had $1.5 million remaining in commitments to purchase API from PCAS and have a $0.2 million commitment to

purchase Korlym tablets.

Net Operating Loss Carryforwards

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

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 specialty distributor (“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, even if they concern transactions occurring in prior periods.

Government Rebates

Korlym is eligible for purchase by, or qualifies for reimbursement from, Medicaid, Medicare 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,  then  estimate  the  portion  of  total  rebates  we  expect  will  be
claimed. We (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 the full
amount of any related discounts by reducing its payment to us (this reduction is called a “chargeback”). Chargebacks sometimes relate to Korlym sold to
the 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

36

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 uninsured patients who do not qualify for charitable support.

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, 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 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.

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

The primary objective of our investment activities is to preserve capital. As of December 31, 2022, the fair value of our cash and cash equivalents
and  marketable  securities  was  $436.6  million.  Our  marketable  securities  consisted  of  corporate  notes,  commercial  paper,  asset-backed  securities,  U.S.
Treasury and government agency 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. Additionally, except for securities issued by the United States government or its agencies, securities of
any one issuer may not make up more than ten percent of our portfolio’s market value. 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,
2022.

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.

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.

As of December 31, 2022, 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 upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that
our disclosure controls and procedures were effective at the reasonable assurance level.

There were no changes in our internal controls over financial reporting during the quarter ended December 31, 2022 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.

37

As of December 31, 2022, 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 our internal control over financial reporting based upon the framework in “Internal Control-Integrated
Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based upon that evaluation, our Chief Executive
Officer and Chief Financial Officer concluded that our internal control over financial reporting was effective as of December 31, 2022.

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

below.

(c) Inherent Limitations on Effectiveness of Controls

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.

(d) 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, 2022, 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, 2022, based on the COSO criteria.

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, 2022 and 2021, the related consolidated statements of income, comprehensive income, cash flows and stockholders’
equity  for  each  of  the  three  years  in  the  period  ended  December  31,  2022,  and  the  related  notes  and  our  report  dated  February  28,  2023  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

38

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

San Mateo, California

February 28, 2023

ITEM 9B. OTHER INFORMATION

None.

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

Not applicable.

39

PART III

Certain information required by Part III is omitted from this Form 10-K because we expect to file with the United States 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  2023  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.

40

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 Income
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
10
11

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

10.1#

10.2† 

10.3†

10.4†

10.5†

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 (incorporated by reference to Exhibit 4.2 to the registrant’s Annual Report on Form 10-K filed on February
23, 2021)

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).

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).

41

 
 
 
 
 
 
 
 
 
 
 
 
 
Exhibit Number

Description of Document

10.6†

10.7†

10.8†

10.9†

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).

10.10†

Form of 2012 Incentive Award Plan Stock Option Grant Notice and Agreement

10.11†

Form of 2012 Incentive Award Plan Restricted Stock Unit Grant Notice and Agreement

10.12†

Form of 2012 Incentive Award Plan Restricted Stock Award Grant Notice and Agreement

10.13

10.14#

10.15#

10.16

10.17

10.18

10.19#

10.20#

10.21#

10.22#

10.23##

10.24##

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).

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).

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  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).

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).

Amendment No. 1 to Distribution Services Agreement by and between Optime Care, Inc. and Corcept Therapeutics Incorporated, made
and entered into as of August 1, 2022. (incorporated by reference to Exhibit 10.3 to the registrant’s Quarterly Report on Form 10-Q filed
on November 3, 2022).

Amendment No. 2 to Distribution Services Agreement by and between Optime Care, Inc. and Corcept Therapeutics Incorporated, made
and entered into as of August 1, 2022. (incorporated by reference to Exhibit 10.4 to the registrant’s Quarterly Report on Form 10-Q filed
on November 3, 2022)

42

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exhibit Number

Description of Document

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.

10.25#

10.26#

Amendment No. 1 to the Manufacturing and Supply Agreement effective March 19, 2014 with PCAS SA, dated July 25, 2018

10.27

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

10.28

10.29

10.30

10.31

10.32†

10.33†

10.34†

10.35

10.36

10.37†

10.38†

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.

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).

Employment  offer  letter  to  Atabak  Mokari,  dated  March  1,  2021  (incorporated  by  reference  to  Exhibit  10.1  to  the  registrant’s  Current
Report on Form 8-K filed on March 1, 2021).

Severance  and  Change  in  Control  Agreement  by  and  between  Corcept  Therapeutics  Incorporated  and  Atabak  Mokari,  dated  March  1,
2021 (incorporated by reference to Exhibit 10.2 to the registrant’s Current Report on Form 8-K filed on March 1, 2021).

10.39†

Employment offer letter to William Guyer, dated July 2, 2021.

10.40†

10.41

23.1

24.1

31.1

31.2

32.1

Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and William Guyer, dated February 9,
2022.

Seventh Amendment to Office Lease Agreement by and between Exponent Realty, LLC and Corcept Therapeutics Incorporated, made and
entered into as of March 18, 2022.

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 Atabak Mokari

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

43

 
 
 
 
 
 
 
 
 
 
Exhibit Number

Description of Document

32.2

Certification pursuant to 18 U.S.C. Section 1350 of Atabak Mokari

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
Certain identified information has been omitted pursuant to Item 601(b)(10) of Regulation S-K because such information is both (i) not material
and (ii) information that the registrant treats as private or confidential. The Registrant hereby undertakes to furnish supplemental copies of the
unredacted exhibit upon request by the SEC.
Management contract or compensatory plan or arrangement

ITEM 16. FORM 10-K SUMMARY

None.

44

 
 
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 28, 2023

POWER OF ATTORNEY

KNOW  ALL  PERSONS  BY  THESE  PRESENTS,  that  each  person  whose  signature  appears  below  hereby  constitutes  and  appoints  Joseph  K.
Belanoff  and  Atabak  Mokari,  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:

45

 
 
 
 
 
 
 
 
 
  Chief Executive Officer, President and Director

February 28, 2023

Title

Date

Signature

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

/s/ ATABAK MOKARI
Atabak Mokari

(Principal Executive Officer)

Chief Financial Officer

(Principal Financial Officer)

/s/ JOSEPH DOUGLAS LYON
Joseph Douglas Lyon

Chief Accounting Officer

(Principal Accounting Officer)

February 28, 2023

February 28, 2023

/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/ JOSHUA MURRAY
Joshua Murray

/s/ KIMBERLY PARK
Kimberly Park

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

Director and Chairman of the Board of Directors

February 28, 2023

Director

Director

Director

Director

Director

Director

Director

46

February 28, 2023

February 28, 2023

February 28, 2023

February 28, 2023

February 28, 2023

February 28, 2023

February 28, 2023

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CORCEPT THERAPEUTICS INCORPORATED

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

Report of Independent Registered Public Accounting Firm (EY US PCAOB #42)
Audited Financial Statements

Consolidated Balance Sheets

Consolidated Statements of Income

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

10

11

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, 2022 and 2021,
the related consolidated statements of income, comprehensive income, cash flows and stockholders’ equity for each of the three years in the period ended
December 31, 2022, 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, 2022 and 2021, and the results of its operations
and its cash flows for each of the three years in the period ended December 31, 2022, 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,  2022,  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 28, 2023 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,  2022,  the  Company  had  $17.0  million  of  inventory  which  included  $7.8
million of work in progress and $9.2 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.

San Mateo, California
February 28, 2023

3

 
 
CORCEPT THERAPEUTICS INCORPORATED

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

December 31,

2022

2021

ASSETS
Current assets:
Cash and cash equivalents
Short-term marketable securities
Trade receivables, net of allowances
Insurance recovery receivable related to Melucci litigation (Note 10)
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 and amortization
Long-term marketable securities
Other assets
Deferred tax assets, net

Total assets
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
Accrued research and development expenses
Accrued and other liabilities
Accrued settlement related to Melucci litigation (Note 10)
Short-term operating lease liability
Total current liabilities
Long-term accrued income taxes payable
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 as of
December 31, 2022 and December 31, 2021
Common stock, par value $0.001 per share, 280,000 shares authorized and 130,959 issued and 107,835
outstanding as of December 31, 2022 and 127,218 shares issued and 105,940 outstanding as of December 31,
2021
Treasury stock; at cost; 23,124 shares of common stock as of December 31, 2022 and 21,278 shares of
common stock as of December 31, 2021
Additional paid-in capital
Accumulated other comprehensive loss
Retained earnings
Total stockholders’ equity

Total liabilities and stockholders’ equity

$

$

$

$

66,329  $
365,343 
31,057 
14,000 
6,100 
16,424 
499,253 
10,931 
1,143 
633 
4,947 
5,058 
61,465 
583,430  $

11,976  $
14,573 
30,799 
14,000 
1,143 
72,491 
9,097 
81,588 

— 

131 

(456,148)
662,342 
(869)
296,386 
501,842 
583,430  $

77,617 
145,918 
27,625 
— 
4,988 
10,315 
266,463 
12,962 
514 
1,002 
112,277 
3,083 
27,455 
423,756 

6,908 
12,442 
27,665 
— 
526 
47,541 
409 
47,950 

— 

127 

(410,411)
591,349 
(227)
194,968 
375,806 
423,756 

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

4

 
 
 
 
 
 
 
 
 
 
CORCEPT THERAPEUTICS INCORPORATED

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

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

Net income

Net income attributable to common stockholders

Basic net income per common share

Diluted net income per common share

Year Ended December 31,
2021

2022

2020

$

401,858  $

365,978  $

353,874 

5,385 
130,991 
152,848 
14,000 
(14,000)
289,224 
112,634 
3,557 
116,191 
(14,773)
101,418  $

5,281 
113,864 
122,356 
— 
— 
241,501 
124,477 
529 
125,006 
(12,494)
112,512  $

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

101,288  $

112,512  $

106,011 

0.95  $

0.97  $

0.87  $

0.89  $

0.92 

0.85 

$

$

$

$

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

Diluted

106,787 

115,966 

115,653 

125,963 

115,412 

124,194 

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

5

CORCEPT THERAPEUTICS INCORPORATED

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

Net income
Other comprehensive income (loss):
Unrealized loss on available-for-sale investments, net of tax impact of $105, $198, and $15
Foreign currency translation loss, net of tax

Total comprehensive income

Year Ended December 31,
2021

2022

2020

$

101,418  $

112,512  $

106,011 

(331)
(311)
100,776 

(621)
(21)
111,870 

(50)
204 
106,165 

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

6

CORCEPT THERAPEUTICS INCORPORATED

CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)

7

Cash flows from operating activities:
Net income
Adjustments to reconcile net income to net cash provided by operations:
Stock-based compensation
Amortization of interest income
Depreciation and amortization of property and equipment
Deferred income taxes
Non-cash amortization of right-of-use asset
Other
Changes in operating assets and liabilities:
Trade receivables
Insurance recovery receivable related to Melucci litigation
Inventory
Prepaid expenses and other current assets
Other assets
Accounts payable
Accrued research and development expenses
Accrued and other liabilities
Accrued settlement related to Melucci litigation
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
Proceeds from sales of marketable securities
Purchases of marketable securities
Net cash (used in) provided by investing activities
Cash flows from financing activities:
Proceeds from issuance of common stock under our incentive award plan, net of issuance
costs
Repurchase of common stock in connection with Tender Offer
Repurchases of common stock in connection with Stock Repurchase Program
Cash paid to satisfy statutory withholding requirement for net settlement of cashless option
exercises and vesting of restricted stock grants
Net cash (used in) provided by financing activities
Net (decrease) increase 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
Exercise cost of shares repurchased for net settlement of cashless option exercises
Recognition of right-of-use asset and lease liability

8

Year Ended December 31,
2021

2022

2020

$

101,418  $

112,512  $

106,011 

42,442 
1,383 
782 
(33,905)
2,187 
— 

(3,432)
(14,000)
1,199 
(6,080)
(1,975)
4,757 
2,131 
2,927 
14,000 
8,688 
(2,199)
120,323 

(413)
241,152 
— 
(355,066)
(114,327)

4,381 
— 
— 

(21,665)
(17,284)
(11,288)
77,617 
66,329  $

42,931 
5,083 
1,072 
4,346 
1,995 
10 

(1,427)
— 
3,444 
(3,597)
1,917 
(3,597)
(1,262)
6,479 
— 
11 
(2,025)
167,892 

(469)
398,937 
50,463 
(312,805)
136,126 

16,229 
(207,500)
(88,485)

(22,835)
(302,591)
1,427 
76,190 
77,617  $

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 

39,747  $
24,388  $
2,816  $

9,104  $
15,796  $
—  $

10,856
2,079
775

$

$
$
$

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

9

CORCEPT THERAPEUTICS INCORPORATED

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(In thousands)

Additional
Paid-in
Capital

Treasury
Stock

Accumulated
Other
Comprehensive
Income (Loss)

Retained Earnings
(Accumulated
Deficit)

Total
Stockholders'
Equity

Common Stock

Shares

Amount

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
Other comprehensive income, net of tax
Purchase of treasury stock
Net income

Balance at December 31, 2020
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
Other comprehensive loss, net of tax
Purchase of treasury stock in connection with Stock
Repurchase Program
Purchase of treasury stock in connection with Tender Offer
Net income

Balance at December 31, 2021
Issuance of common stock under our incentive award plan
Shares tendered to satisfy cost and statutory withholding
requirements for net settlement of cashless option exercises
Stock-based compensation
Other comprehensive loss, net of tax
Net income

114,549 
2,819 

$

$

120 
2 

457,060 
25,303 

$

(62,704)
— 

$

(154)
— 
— 
(479)
— 

116,735 
4,632 

(1,560)
— 
— 

(3,867)
(10,000)
— 

105,940 
3,741 

(1,846)
— 
— 
— 

— 
— 
— 
— 
— 

122 
5 

— 
— 
— 

— 
— 
— 

127 
4 

— 
— 
— 
— 

— 
33,777 
— 
— 
— 

516,140 
32,041 

— 
43,168 
— 

— 
— 
— 

591,349 
28,478 

42,515 
— 
— 

(3,146)
— 
— 
(9,945)
— 

(75,795)
— 

(38,631)
— 
— 

(88,485)
(207,500)
— 

(410,411)
— 

(45,737)
— 
— 
— 

261 
— 

— 
— 
154 
— 
— 

415 
— 

— 
— 
(642)

— 
— 
— 

(227)
— 

— 
— 
(642)
— 

$

(23,555)
— 

$

— 
— 
— 
— 
106,011 

82,456 
— 

— 
— 
— 

— 
— 
112,512 

194,968 
— 

— 
— 
— 
101,418 

Balance at December 31, 2022

107,835 

$

131 

$

662,342 

$

(456,148)

$

(869)

$

296,386 

$

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

371,182 
25,305 

(3,146)
33,777 
154 
(9,945)
106,011 

523,338 
32,046 

(38,631)
43,168 
(642)

(88,485)
(207,500)
112,512 

375,806 
28,482 

(45,737)
42,515 
(642)
101,418 

501,842 

10

 
 
 
 
 
CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

1. Basis of Presentation and Summary of Significant Accounting Policies

Description of Business and Basis of Presentation

Corcept Therapeutics Incorporated (collectively, “Corcept,” the “Company,” “we,” “us” and “our”) is a commercial-stage pharmaceutical company
engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the
effects of the hormone cortisol. In 2012, the United States 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  and  government  agency  securities,  asset-
backed  securities  and  commercial  paper.  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 statements of income.

11

 
CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

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 and asset-backed securities with less than a 36-
month maturity at the time of purchase. 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,” a member of the Seqens Group). 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.

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 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 monitor our exposure and record an allowance against uncollectible trade receivables as necessary. To date, we have not recorded an
allowance for 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 expense at the time such costs are
incurred. Once a product candidate is approved by the FDA, we begin capitalizing manufacturing costs. 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, 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 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 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 each of the years ended December 31,
2022, 2021 and 2020.

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 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

12

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

estimates, we adjust our estimates, which changes 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, Medicare 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, then estimate the portion of total rebates we
expect  will  be  claimed.  We  (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 an 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 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 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 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 years ended December 31, 2022,

2021 and 2020:

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
Provision related to current period sales
Provision related to prior period sales
Credit or payments made during the period
Balance at December 31, 2021
Provision related to current period sales
Provision related to prior period sales
Credit or payments made during the period

Balance at December 31, 2022

Chargebacks

Government
Rebates
(in thousands)

Total

$

$

277  $
519 
(3)
(630)
163 
394 
(29)
(478)
50 
557 
78 
(455)
230  $

8,209  $

27,698 
(631)
(25,864)
9,412 
33,709 
(1,047)
(30,900)
11,174 
38,745 
(68)
(38,753)
11,098  $

8,486 
28,217 
(634)
(26,494)
9,575 
34,103 
(1,076)
(31,378)
11,224 
39,302 
10 
(39,208)
11,328 

13

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

Leases

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.

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 collateralized 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 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, 2022 or 2021.

Research and Development

Research  and  development  expense  includes  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 one operating

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

Stock-Based Compensation

We  recognize  stock-based  compensation  expense  for  stock  options,  restricted  stock  awards  (“RSAs”)  and  restricted  stock  units  (“RSUs”),  net  of
estimated  forfeitures,  on  a  straight-line  basis  over  the  period  during  which  an  employee  is  required  to  provide  services  in  exchange  for  the  award  (the
vesting period of the award). We estimate future forfeitures during the first quarter of each fiscal year, and revise the estimates, if necessary, in subsequent
periods if actual forfeitures differ significantly from those estimates.

We determine the fair value of stock options based on the value of the award at the grant date, 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.

In addition, we have issued RSAs in connection with our Employee Stock Purchase Plan (“ESPP”) that vest on the condition that the participating
employee hold the corresponding shares purchased under the ESPP for one year from the purchase date. The participating employee is granted one RSA for
each share purchased in the ESPP. We initially measure the

14

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

fair  value  of  these  RSAs  based  on  the  grant  date  fair  value  determined  using  the  closing  price  of  our  common  stock  on  the  date  the  purchase  of  the
corresponding ESPP shares is made. This fair value of the RSA is amortized over the one-year holding period. As a result of the RSA’s being reported as
liability-classified  awards,  they  must  be  remeasured  at  each  reporting  date  until  settlement.  Ultimately,  the  compensation  cost  recognized  for  the  RSA
award  will  equal  the  fair  value  of  the  Company’s  common  stock  on  the  date  the  RSA  is  fully  vested  and  settled.  See  Note  7,  Preferred  Stock  and
Stockholders’ Equity regarding our ESPP.

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  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 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 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 expense.

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 was five years. In August 2022, we amended our agreement to extend its term to September 30, 2022.
In September 2022, we amended our agreement to further extend its term to March 31, 2024, 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 to 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 agreement was renewed through December 31, 2023. The amendment provides exclusivity between PCAS and Corcept. In the
event PCAS cannot meet our requirements, we

15

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

may  purchase  API  from  another  supplier.  As  of  December  31,  2022,  we  had  non-cancelable  commitments  to  purchase  $1.5  million  worth  of  API  from
PCAS over the next 12 months.

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.

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

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

Year Ended December 31,
2021
2022

(in thousands)

$

$

36,380  $
365,343 
4,947 
406,670  $

45,088 
145,918 
112,277 
303,283 

Fair Value
Hierarchy
Level

Amortized
Cost

December 31, 2022

Gross
Unrealized
Gains

Gross
Unrealized
Losses

Corporate bonds
Commercial paper
U.S. government agency
securities
Asset-backed securities
U.S. Treasury securities
Money market funds

Level 2
Level 2

Level 2
Level 2
Level 1
Level 1

$

151,069 
136,132 

$

25,113 
185 
58,536 
36,379 

Total marketable securities

$

407,414 

$

— 
— 

23 
— 
— 
— 

23 

$

(625)
— 

— 
— 
(142)
— 

Estimated Fair
Value

Amortized
Cost

(in thousands)

$

150,444 
136,132 

$

125,370 
30,963 

$

25,136 
185 
58,394 
36,379 

— 
57,801 
44,473 
45,088 

December 31, 2021

Gross
Unrealized
Gains

Gross
Unrealized
Losses

Estimated Fair
Value

3 
— 

— 
— 
— 
— 

$

$

(276)
— 

125,097 
30,963 

— 
(67)
(72)
— 

— 
57,734 
44,401 
45,088 

$

(767)

$

406,670 

$

303,695 

$

3 

$

(415)

$

303,283 

We estimate the fair value of marketable securities classified as Level 1 using quoted market prices obtained from a commercial pricing service for
these or identical investments. 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 the issuer’s poor credit or other reasons. If the
fair value of our investment is less than our amortized cost, we evaluate quantitative and subjective factors – including, but not limited to, the nature of
security,  changes  in  credit  ratings  and  analyst  reports  concerning  the  security’s  issuer  and  industry,  and  interest  rate  fluctuations  and  general  market
conditions to determine whether an allowance for credit losses is appropriate.

None  of  our  investments,  including  those  with  unrealized  losses,  are  impaired.  Unrealized  losses  on  our  investments  are  due  to  interest  rate
fluctuations. We do not intend to sell investments that currently have unrealized losses and it is highly unlikely that we will sell any investment before
recovery of its amortized cost basis, which may be at maturity. Accordingly, we have not recorded an allowance for credit losses for these investments.

We  classified  accrued  interest  on  our  marketable  securities  of  $1.8  million  and  $1.4  million  as  of  December  31,  2022  and  2021,  respectively,  as

prepaid and other current assets on our consolidated balance sheets.

As of December 31, 2022, all our marketable securities had original maturities of less than two years and all our marketable securities classified as
short-term have maturities of less than one year. The weighted-average maturity of our holdings was four months. As of December 31, 2022, our long-term
marketable securities had remaining maturities of 15

16

 
 
 
 
 
CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

months. None of our marketable securities changed from one fair value hierarchy to another during the year ended December 31, 2022.

4. Composition of Certain Balance Sheet Items

Inventory

Work in progress
Finished goods
Total inventory
Less strategic inventory classified as non-current

Total inventory classified as current

Year Ended December 31,
2021
2022

(in thousands)
7,827  $
9,204 
17,031 
(10,931)

6,100  $

11,450 
6,500 
17,950 
(12,962)
4,988 

$

$

Because we rely on a single manufacturer to produce Korlym’s API, we have purchased and hold significant quantities of API, included in work in

progress inventory. 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, net of accumulated depreciation and amortization

Furniture and equipment
Software
Leasehold improvements
Total property and equipment
Less accumulated depreciation and amortization

Property and equipment, net of accumulated depreciation and amortization

Accrued and other liabilities

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

Total accrued and other liabilities

Other assets

Year Ended December 31,
2021
2022

(in thousands)
1,235  $
1,508 
1,597 
4,340 
(3,707)

633  $

Year Ended December 31,
2021
2022

(in thousands)

15,511  $
11,098 
2,673 
434 
211 
89 
783 
30,799  $

1,157 
1,508 
1,262 
3,927 
(2,925)
1,002 

13,339 
11,174 
842 
1,351 
150 
513 
296 
27,665 

$

$

$

$

As of December 31, 2022 and 2021, other assets included $4.9 million and $2.9 million of deposits for clinical trials, respectively.

17

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

5. Leases

We lease our office facilities in Menlo Park, California. In March 2022, we amended our lease to extend its term from March 31, 2022 to June 30,
2023. As a result of this amendment, we recognized an additional right-of-use asset and corresponding lease liability of $2.8 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 expressly state an 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  collateralized  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, 2022, 2021 and 2020 was $2.3 million, $2.1 million and $1.9 million, respectively.

Our right-of-use assets and related lease liabilities were as follows (in thousands, except weighted average amounts):

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

Year Ended December 31,

2022

2021

$
$

$
$

2,265 
2,816 
6 months
4.0 %

As of December 31, 2022, future minimum lease payments under non-cancelable operating leases were as follows (in thousands):

2023
Total operating lease payments
Less imputed interest

Present value of operating lease liabilities

6. Related Party Transactions

$

$

2,104 
— 
3 months
4.8 %

1,157 
1,157 
(14)
1,143 

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, 2022, 2021, and 2020.

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 10.0
million  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, 2022
and 2021, we had no outstanding shares of preferred stock.

Common Stock

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”). The terms of this program did not require us to acquire any shares and allowed for repurchases by a variety of methods,
including open market purchases, privately negotiated transactions, block

18

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

trades, accelerated share repurchase transactions or any combination of such methods. The Stock Repurchase Program expired by its terms on September
30, 2021.

During the years ended December 31, 2021 and 2020, we purchased 3.9 million and 0.5 million shares of common stock under the Stock Repurchase
Program in open market transactions at an average price of $22.88 and $21.08 per share, for an aggregate purchase price of $88.5 million and $9.7 million,
respectively. Over the term of the Stock Repurchase Program, we repurchased 4.3 million shares at an average price of $22.69 per share and a total cost of
$98.2 million.

On November 8, 2021, we announced that our Board of Directors approved a tender offer to purchase up to 10 million shares of our common stock.
The tender offer commenced on November 8, 2021 and expired on December 15, 2021. We repurchased 10 million shares through the tender offer at a
price of $20.75 per share for an aggregate purchase price of $207.5 million, excluding fees and expenses relating to the tender offer.

We recorded purchased shares as treasury stock on our consolidated balance sheets, at cost. It has not been determined whether purchased shares will

be retired or sold.

We have never declared or paid any dividends.

Incentive Award Plan

We have one stock option plan – the Corcept Therapeutics Incorporated 2012 Incentive Award Plan (the “2012 Plan”).

In  2012,  our  Board  of  Directors  and  stockholders  approved  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.

As of December 31, 2022, we had 10.9 million shares available for future issuance under the 2012 plan.

Option activity during 2022

The following table summarizes option activity under the 2012 Plan:

Balance at December 31, 2021

Options granted
Options exercised
Options cancelled and forfeited

Balance at December 31, 2022

Options exercisable at December 31, 2022

Options fully vested and expected to vest at
December 31, 2022

Outstanding Options

Number of
Options
(in thousands)

Weighted-
Average Exercise
Price

Weighted-
Average
Remaining
Contractual Life
(in years)

Aggregate
Intrinsic Value
(in thousands)

24,453  $
2,958  $
(3,681) $
(532) $
23,198  $

16,850  $

13.50 
20.38 
7.56 
21.79 

15.13 

12.74 

6.20 $

152,681 

5.38 $

141,743 

22,789  $

15.00 

6.16 $

152,179 

The total intrinsic value of options exercised during the years ended December 31, 2022, 2021 and 2020 was $63.4 million, $78.9 million and $28.8

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

19

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

The total fair value of options that vested during the years ended December 31, 2022, 2021 and 2020 was $43.2 million, $40.4 million and $34.0

million, respectively.

As  of  December  31,  2022,  we  had  $68.7  million  of  unrecognized  compensation  expense  for  options  outstanding,  which  had  a  weighted-average

remaining vesting period of 2.36 years.

RSA and RSU (collectively, “restricted stock”) activity during 2022

The following table summarizes restricted stock activity under the 2012 Plan:

Balance at December 31, 2021
Restricted stock granted
Restricted stock vested
Restricted stock cancelled and forfeited

Balance at December 31, 2022

Outstanding Restricted Stock
Weighted-
Average
Remaining
Vesting Life
(in years)

Weighted-
Average Grant
Date Fair Value

Number of
Restricted Stock
(in thousands)

Aggregate
Intrinsic Value
(in thousands)

—  $
534  $
(34) $
(45) $
455  $

— 
23.37 
19.49 
20.87 

23.91 

3.35 $

896 

As  of  December  31,  2022,  we  had  $7.8  million  of  unrecognized  compensation  expense  for  restricted  stock  outstanding,  which  had  a  weighted-

average remaining vesting period of 3.32 years.

ESPP

In February 2022, we adopted an ESPP that allows employees to set aside, by means of payroll deductions, up to ten percent of their annual cash
compensation for the purchase of our common stock. Shares are issued to participating employees from the 2012 Plan on March 1st and September 1st of
each  year  (or,  if  those  dates  fall  on  holidays  or  weekends,  on  the  first  business  day  thereafter)  at  the  then-current  fair  market  value  of  our  stock,  as
determined at the close of trading on those days. Payroll deductions for participating employees began April 1, 2022, and the first purchase under the plan
took place on September 1, 2022.

In January 2023, we increased the number of ESPP purchase dates to occur quarterly on March 1st, June 1st, September 1st and December 1st (or, if

those dates fall on holidays or weekends, on the first business day thereafter).

For each purchased share, the participating employee will receive one matching share, also issued from the 2012 Plan, if certain conditions are met.
There is no vesting requirement for shares issued pursuant to the ESPP purchase. The matching share will be granted in the form of a RSA that will vest on
the  one-year  anniversary  of  the  respective  ESPP  purchase  date,  net  of  any  applicable  tax  withholding.  The  vesting  condition  on  the  RSA  is  that  the
participating  employee  hold  the  corresponding  share  purchased  under  the  ESPP  for  one  year  from  the  purchase  date.  Shares  purchased  pursuant  to  the
ESPP and any matching shares issued upon satisfaction of the one-year holding requirement may be held, sold or transferred at the employee’s discretion.

As of December 31, 2022, we recorded $0.2 million of stock-based compensation related to RSAs granted in connection with our ESPP in “Accrued

and other liabilities” on our consolidated balance sheet.

20

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

Option Valuation Assumptions

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

Weighted-average assumptions for 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,
2021

2022

2020

1.97%
6.4 years
56.5%
0%
$11.27

0.76%
6.3 years
60.7%
0%
$15.06

1.20%
6.0 years
59.1%
0%
$7.55

The expected term of options reflected in the table above is 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.

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.

Stock-based Compensation

The following table summarizes our 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

2022

Year Ended December 31,
2021
(in thousands)

2020

$

$

280  $
70 
12,800 
29,572 
42,722  $

237  $
59 
14,106 
28,766 
43,168  $

238 
66 
11,222 
22,251 
33,777 

We compute our basic and diluted net income per share in conformity with the two-class method required for companies with participating shares.
Under the two-class method, net income is determined by allocating net income between common stock and unvested RSAs. We compute basic net income
per  share  by  dividing  our  net  income  attributable  to  common  stockholders  by  the  weighted-average  number  of  common  shares  outstanding  during  the
period.  We  compute  diluted  net  income  per  share  by  dividing  our  net  income  attributable  to  common  stockholders  by  the  weighted-average  number  of
common shares outstanding during the period, including potentially dilutive stock options and unvested RSUs, less unvested RSAs. We use the treasury
stock method to determine the number of dilutive shares of common stock resulting from stock options and unvested RSUs.

21

 
 
 
CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

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

2022

Year Ended December 31,
2021
(in thousands, except per share data)

2020

Numerator:
Net income attributable to common stockholders
Denominator:
Weighted-average shares used to compute basic net income per common share
Dilutive effect of employee stock options and unvested RSUs
Weighted-average shares used to compute diluted net income per common share
Net income per share attributable to common stockholders
Basic

Diluted

$

$

$

101,288  $

112,512  $

106,011 

106,787 
9,179 
115,966 

115,653 
10,310 
125,963 

0.95  $

0.87  $

0.97  $

0.89  $

115,412 
8,782 
124,194 

0.92 

0.85 

We  excluded  from  the  computation  of  diluted  net  income  per  share,  on  a  weighted-average  basis,  7.3  million  stock  options  and  unvested  RSUs
outstanding during the year ended December 31, 2022, and 4.5 million and 11.2 million stock options outstanding during the years ended December 31,
2021 and 2020, respectively, because including them would have reduced dilution.

9. Income Taxes

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

Domestic
Foreign

Income before income taxes

22

2022

Year Ended December 31,
2021
(in thousands)

2020

$

$

116,871  $
(680)
116,191  $

126,308  $
(1,302)
125,006  $

131,634 
(32)
131,602 

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

The income tax expense for the years ended December 31, 2022, 2021, and 2020 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 provision for income taxes

2022

Year Ended December 31,
2021
(in thousands)

2020

$

$

39,132  $
(28,122)
11,010 

9,515 
(5,313)
4,202 

30 
(469)
(439)
14,773  $

4,675  $
5,066 
9,741 

3,432 
(274)
3,158 

41 
(446)
(405)
12,494  $

6,094 
14,418 
20,512 

5,368 
520 
5,888 

41 
(850)
(809)
25,591 

Beginning in 2022, the Tax Cuts and Jobs Act of 2017 eliminates the right to deduct research and development expenditures for tax purposes in the
period the expenses were incurred and instead requires all U.S. and foreign research and development expenditures to be amortized over five and fifteen tax
years,  respectively.  Congress  has  considered  legislation  that  would  defer  the  amortization  requirement  to  later  years,  but  as  of  December  31,  2022,  the
requirement has not been modified. Accordingly, we have capitalized our research and development expenses for tax purposes, resulting in higher cash paid
for taxes as compared to prior years.

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
Capitalized research expenditures
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,
2021
2022

(in thousands)
4,882  $
1,911 
36,465 
9,963 
17,956 
280 
5,127 
76,584 
(14,839)

(280)
(280)
61,465  $

5,377 
3,412 
— 
9,953 
17,831 
130 
3,851 
40,554 
(12,972)

(127)
(127)
27,455 

$

$

Each quarter, we assess the likelihood that we will generate sufficient taxable income to use our federal and state deferred tax assets. Except for the
valuation allowances that offset the value of our California net deferred tax assets, we have determined that it is more likely than not we will realize the
benefit related to our deferred tax assets. To the extent we increase

23

CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

a valuation allowance, we will include an expense in the Consolidated Statement of Income in the period in which such determination is made.

The  valuation  allowance  increased  by  $1.9  million,  $1.4  million  and  $0.2  million  for  the  years  ended  December  31,  2022,  2021  and  2020,

respectively.

As of December 31, 2022, we had California net operating loss carryforwards of $68.6 million, which will begin to expire in the year 2032, and net

operating loss carryforwards from other states of $1.5 million, which will begin to expire in the year 2035 if not utilized.

As of December 31, 2022, we also had California research and development credits of $14.1 million, which have no expiration date.

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, net of federal benefit
Non-deductible compensation
Stock-based compensation
Other
Total

2022

Year Ended December 31,
2021
(in thousands)

2020

$

$

24,400  $
(9,114)
3,320 
4,354 
(7,980)
(207)
14,773  $

26,251  $
(7,579)
2,495 
990 
(9,568)
(95)
12,494  $

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

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:

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

2022

Year Ended December 31,
2021
(in thousands)

2020

$

$

9,237  $
53 
— 
2,135 
— 
11,425  $

7,471  $
103 
— 
1,663 
— 
9,237  $

6,029 
158 
— 
1,284 
— 
7,471 

As  of  December  31,  2022,  the  amount  of  unrecognized  tax  benefits  that  would  favorably  impact  the  effective  tax  rate  were  approximately  $9.3
million, and approximately $2.2 million of unrecognized tax benefits would be offset by a change in the 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 insignificant
amounts of accrued interest and no accrued penalties related to unrecognized tax benefits as of December 31, 2022, 2021 and 2020. 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  2022  remain  open  and

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

24

 
 
 
CORCEPT THERAPEUTICS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued

10. Commitments and Contingencies

Manufacturing Agreements

We have entered into a number of agreements to purchase API for the manufacturing of relacorilant, miricorilant and exicorilant. See the discussion

in Note 2, Significant Agreements, for further discussion regarding the commitments under these agreements.

In December 2021, to ensure we have sufficient API to meet future demand for Korlym tablets, we committed to purchase 162 kilograms of API
from PCAS for a total price of $2.3 million. In January 2022, we committed to purchase an additional 75 kilograms of API from PCAS for a total price of
$0.9 million. As of December 31, 2022, there remained a $1.5 million obligation in connection with this purchase commitment.

Taxes

As of December 31, 2022, we have recorded non-current taxes payable of $9.1 million related to uncertain tax positions.

Legal Proceedings

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.

Melucci Litigation and Settlement

On March 14, 2019, a purported securities class action complaint was filed in the United States 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 “Melucci litigation”). 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 extending 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.

On February 8, 2023, we reached an agreement in principle (the “Proposed Settlement”) to resolve all claims in the Melucci litigation. Under the
Proposed Settlement, we have agreed to make a one-time payment of $14.0 million, which will be covered in full by our insurers. In connection with the
Proposed Settlement, we recorded a settlement expense of $14.0 million and corresponding insurance recovery of $14.0 million in Operating Expenses on
our Consolidated Statement of Income in the fourth quarter of 2022. Accordingly, we recorded an accrued liability of $14.0 million for this settlement and a
corresponding insurance recovery receivable of $14.0 million on our Consolidated Balance Sheet. The Proposed Settlement is subject to the final approval
of the United States District Court for the Northern District of California.

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

25

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, 333-236601, 333-253413 and 333-262752) pertaining to the 2012 Incentive Award Plan of 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 28, 2023, 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, 2022.

/s/ Ernst & Young LLP

San Mateo, California
February 28, 2023

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, 2022 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
(Principal Executive Officer)
February 28, 2023

Exhibit 31.2

I, Atabak Mokari, certify that:

CERTIFICATION

1.

I have reviewed this Annual Report on Form 10-K for the period ended December 31, 2022 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/ Atabak Mokari
Atabak Mokari
Chief Financial Officer
(Principal Financial Officer)
February 28, 2023

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, 2022, 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
(Principal Executive Officer)
February 28, 2023

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, 2022, as
filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Atabak Mokari, 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/ Atabak Mokari
Atabak Mokari
Chief Financial Officer
(Principal Financial Officer)
February 28, 2023

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.