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, 2021
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission File Number: 000-50679
CORCEPT THERAPEUTICS INCORPORATED
(Exact Name of Corporation as Specified in Its Charter)
Delaware
(State or other jurisdiction of incorporation or organization)
77-0487658
(I.R.S. Employer Identification No.)
149 Commonwealth Drive
Menlo Park, CA 94025
(Address of principal executive offices) (zip code)
(650) 327-3270
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12 (b) of the Act:
Title of each class
Common Stock, $0.001 par
value
Trading Symbol(s)
Name of each exchange on
which registered
CORT
The Nasdaq Stock Market
Securities registered pursuant to Section 12 (g) of the Act:
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Acts. Yes ☒ No ☐
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
None
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports); and (2) has been subject to such filing
requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405
of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or
an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth
company” in Rule 12b-2 of the Exchange Act.:
Large accelerated filer
Non-accelerated filer
☒
☐
Accelerated filer
Smaller reporting company
Emerging growth company
☐
☐
☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal
control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared
or issued its audit report. ☒
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The aggregate market value of voting and non-voting common equity held by non-affiliates of the Registrant as of June 30, 2021 was $2,122,097,933,
based on the closing price of $22.00 for shares of the Registrant’s common stock as reported on the Nasdaq Stock Market on June 30, 2021. 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 8, 2022 there were 105,962,389 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 2022 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, 2021
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
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This Annual Report on Form 10-K (“Form 10-K”) contains forward-looking statements within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended (“Exchange Act”), and Section 27A of the Securities Act of 1933, as amended (“Securities Act”). All statements
contained in this Form 10-K, other than statements of historical fact, are forward-looking statements. When used in this report, the words “believe,”
“anticipate,” “intend,” “plan,” “estimate,” “expect,” “may,” “will,” “should, “would,” “could,” “seek” and similar expressions are forward-looking
statements based on management’s current expectations. The absence of these words does not mean that a statement is not forward-looking. Forward-
looking statements include, but are not limited to, statements about:
PART I
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•
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•
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our ability to manufacture, market and sell Korlym (mifepristone) 300 mg Tablets (“Korlym”);
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our estimates regarding enrollment in and the completion dates of our clinical trials and the anticipated results of these trials;
the progress and timing of our research and development programs and the regulatory activities associated with them;
our ability to realize the benefits of orphan drug designation for Korlym and the impact of possible future competition for Korlym or our product
candidates;
our estimates for future performance, including revenue and profits;
the timing of regulatory submissions seeking approval of product candidates and the commercialization of any product candidates that are
approved;
our ability to manufacture, market, commercialize and achieve market acceptance for our product candidates;
uncertainties associated with obtaining and enforcing patents;
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 drugs that treat severe metabolic, oncologic and neuropsychiatric
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 suffering from weight gain caused by antipsychotic
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medications (referred to as antipsychotic induced weight gain, or “AIWG”), in patients with fatty liver disease and non-alcoholic steatohepatitis (“NASH”),
which are precursors of liver fibrosis and cirrhosis. Pre-clinical data also suggests 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 with 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 GR, it can modulate the effects of abnormal levels and
release patterns of cortisol without compromising cortisol’s healthy functions and rhythms. However, mifepristone also binds to the progesterone receptor
(“PR”), thereby terminating pregnancy and causing other adverse effects, including endometrial thickening and vaginal bleeding, a debilitating condition
suffered by a significant portion of women who take Korlym.
We have discovered more than 1,000 proprietary cortisol modulators that bind to GR but have no affinity for PR and so do not cause Korlym’s PR-
related side effects. These novel molecules are “selective” cortisol modulators: they share Korlym’s affinity for GR, but, unlike Korlym, do not bind to 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, solid tumors (i.e.,
advanced, high-grade serous ovarian cancer, castration-resistant prostate cancer (“CRPC”) and adrenocortical cancer with cortisol excess), AIWG, and
NASH.
COVID-19 Pandemic
Much of the world is subject to varying degrees of pandemic-related public health restrictions, including California, where we are headquartered,
and the places where we sell Korlym and where we conduct clinical trials. Most of our third-party manufacturers, distributors (including the specialty
pharmacy that dispenses Korlym), information technology service providers, law and accounting firms, clinical research organizations and others are also
subject to pandemic-related restrictions.
These restrictions, as well as protective measures voluntarily undertaken by patients, physicians, hospitals and medical clinics, have reduced our
revenue and made it difficult to grow our Korlym business. Many physicians have reduced the frequency of patient office visits and have barred visits by
third parties, including our clinical specialists and medical science liaisons. Many patients have postponed visits to their physicians or the clinical
laboratories or imaging centers that are essential for optimal care. These restrictions have made it more difficult for physicians to identify patients who may
benefit from Korlym, begin their treatment, titrate to an optimum Korlym dose and maintain their patients’ regimens.
The pandemic’s impact on the pace of our clinical development programs has been variable. Our trials of indications not considered immediately
life-threatening, such as Cushing’s syndrome, CRPC and AIWG, have experienced slower enrollment. In addition, some clinical sites have stopped
enrolling new patients or have reduced the frequency with which physicians see study participants. Some sites have suspended or halted the initiation of
new clinical trials. Our trials in patients with immediately life-threatening diseases, such as advanced ovarian cancer, did not encounter delays.
We expect that pandemic-related impediments to our business will continue so long as there are COVID-19 public health restrictions and 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. Other public health emergencies, natural disasters, terrorism or other catastrophes could disrupt our activities and render our own or
our vendors’ facilities and equipment inoperable or inaccessible and require us to curtail or cease operations.”
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.
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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 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 loss, 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 the
effects associated with PR affinity, including endometrial thickening and vaginal bleeding. Relacorilant also does not appear to cause hypokalemia (low
potassium), a potentially serious adverse event 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 in patients receiving placebo measured against the rate and degree of relapse in those
continuing relacorilant. GRACE has a planned enrollment of 130 patients with any etiology of endogenous 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 26 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 Association (“FDA”) and the European Commission (“EC”) have designated relacorilant as an orphan drug for the
treatment of Cushing’s syndrome. In the United States, relacorilant’s orphan designation confers tax credits, reduced regulatory fees and, provided we
obtain approval for the treatment of 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.
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Oncology
There is substantial in vitro, in vivo and clinical evidence that cortisol’s activity allows certain solid tumors to resist treatment. In some cancers,
cortisol 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.
Modulating cortisol’s activity may help existing anti-cancer treatments achieve their intended effect. Many types of solid tumors express GR and are
potential targets for cortisol modulation therapy, among them ovarian, adrenocortical and CRPC.
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, with titration to 150 mg per day permitted at the investigator’s
discretion, in addition to nab-paclitaxel. Sixty women received nab-paclitaxel alone. The trial’s primary endpoint was progression-free survival (“PFS”).
Patients in both 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: <0.05). 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 (5.6 months versus 3.7 months, hazard ratio: 0.36; p-value: 0.006) compared to
those who received nab-paclitaxel alone. While the overall survival (“OS”) data were only 63% mature at the time of the database cut-off (March 2021),
the women who received relacorilant intermittently exhibited a median OS of 12.9 months versus 10.4 months for those who received nab-paclitaxel alone
(hazard ratio: 0.63; p-value: 0.12). We expect updated overall survival data from this trial in the first quarter of 2022. Safety and tolerability of relacorilant
plus nab-paclitaxel were comparable to nab-paclitaxel monotherapy.
We plan to initiate a pivotal Phase 3 trial in the second quarter of 2022.
Relacorilant in Patients with Advanced Cancer with Cortisol Excess. We are also conducting an open-label, Phase 1b trial of relacorilant plus the
PD-1 checkpoint inhibitor pembrolizumab in 20 patients with metastatic or unresectable adrenal cancer with cortisol excess. 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, while relacorilant treats the Cushing’s syndrome caused by excess cortisol activity.
Exicorilant and Relacorilant in Patients with CRPC. Androgen deprivation is the standard treatment for metastatic prostate cancer because
androgens stimulate prostate tumor growth. Tumors often escape androgen deprivation therapy when cortisol’s activity at GR supplants androgen’s in
stimulating tumor growth. Combining a cortisol modulator with an androgen modulator may block this escape route.
We are conducting a dose-finding trial of our proprietary, selective cortisol modulator exicorilant in combination with enzalutamide in patients with
metastatic CRPC. Investigators at the University of Chicago are conducting a dose-finding trial of relacorilant combined with enzalutamide in the same
patient population.
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.
Metabolic Disorders
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 in large
part to increased cardiovascular events, such as heart attacks and strokes. We are studying our selective cortisol modulator miricorilant as a potential
treatment for AIWG.
In 2020, we completed a double-blind, placebo-controlled Phase 1b trial, in which 96 healthy subjects received daily doses of the antipsychotic
medication olanzapine (10 mg) and either miricorilant (600 mg or 900 mg) or placebo for 14 days.
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Study participants who received miricorilant gained less weight than subjects receiving placebo. In addition, markers of liver damage that rise temporarily
at the start of olanzapine therapy increased less sharply in subjects receiving miricorilant. The results of this study were published in the Journal of Clinical
Psychopharmacology (Hunt et al., 2021) and are consistent with the findings of similar studies we conducted in healthy volunteers using mifepristone
(published in Advances in Therapy and Obesity in 2009 and 2010).
Based on these positive results in healthy subjects and compelling pre-clinical data, we are conducting two double-blind, placebo-controlled, Phase 2
trials of miricorilant – GRATITUDE and GRATITUDE II.
GRATITUDE is evaluating whether a daily dose of miricorilant (600 mg) can reverse recent AIWG. Study participants receive their established
antipsychotic medication plus either miricorilant or placebo for 12 weeks. GRATITUDE has planned enrollment of 100 patients with schizophrenia or
bipolar disorder and is being conducted at 30 sites in the United States.
GRATITUDE II is evaluating whether miricorilant can reverse long-standing AIWG. Study participants receive their established antipsychotic
medication plus either miricorilant (600 mg or 900 mg daily) or placebo for 26 weeks. GRATITUDE II has planned enrollment of 150 patients with
schizophrenia and is being conducted at 35 centers in the United States.
The primary endpoint in both the GRATITUDE and GRATITUDE II trials is the change in body weight from baseline, relative to placebo. Other
metabolic variables are also being examined.
Liver Disease. We are also studying miricorilant as a potential treatment for NASH. In April 2021, we suspended our Phase 2a trial after observing
elevated liver enzymes in four of the five patients who received miricorilant, which resolved after miricorilant was withdrawn. The patients with elevated
liver enzymes also exhibited large, rapid reductions in liver fat. We have initiated a Phase 1b dose-finding trial in patients with presumed NASH to see if an
alternative dosing regimen can capture this benefit without causing excessive liver irritation.
ALS
Our selective cortisol modulator dazucorilant (formerly, “CORT113176”) has shown promise in animal models of ALS and has completed its Phase
1 trial. In 2022, we plan to advance it to Phase 2 as a potential treatment for ALS.
Development of our Other Selective Cortisol Modulators
Our portfolio of proprietary selective cortisol modulators consists of four structurally distinct series totaling more than 1,000 compounds, including
relacorilant, exicorilant, miricorilant and dazucorilant. These compounds potently bind to GR but not the progesterone, estrogen or androgen receptors. We
hold U.S. and foreign patents covering these compounds and their methods of use in a wide range of indications. We have applied, and will continue to
apply, for patents covering the composition and method of use of our products and product candidates. See “Business – Intellectual Property.”
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. IQVIA Inc. is helping us conduct our Phase 2 trial of relacorilant to treat patients with metastatic ovarian cancer and our dose-
finding trial of exicorilant to treat patients with CRPC. Medpace, Inc. is helping us conduct our GRATITUDE and GRATITUDE II trials. We may
terminate our agreements with ICON and IQVIA on 60 days’ written notice. Our agreement with Medpace may be terminated by us without cause at any
time.
Research and Development Spending
We incurred $113.9 million, $114.8 million and $89.0 million of research and development expense in the years ended December 31, 2021, 2020 and
2019, respectively, which accounted for 47 percent, 51 percent and 46 percent, respectively, of our total operating expenses in those years.
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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.
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. 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.
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Korlym may also experience competition from new compounds. On December 31, 2021, Xeris Biopharma Holdings, Inc. received approval to
market in the United States levoketoconazole, a chiral form of the commonly-prescribed cortisol synthesis inhibitor ketoconazole, as a treatment for
patients with Cushing’s syndrome. Xeris is also seeking approval in the EU.
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 have
sued Teva Pharmaceuticals USA, Inc. (“Teva”) and Hikma Pharmaceuticals USA Inc. (“Hikma”) 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. The expiration dates of these patents and their foreign
counterparts range from 2025 to 2034.
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 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 selective cortisol modulators with expiration dates ranging from 2023
to 2039. In addition, we have exclusively licensed from the University of Chicago U.S.
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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 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.”
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, mild cognitive impairment, delirium, catatonia,
psychosis induced by interferon-alpha therapy, migraine headaches, gastroesophageal reflux disease, neurological damage in premature infants and in the
treatment of diseases using combination steroid and GR antagonist therapy. We also own patents covering the prevention and treatment of stress disorders,
improvement of therapeutic response to electroconvulsive therapy and inhibition of cognitive deterioration in adults with Down’s Syndrome. The
expiration dates of these patents and their foreign counterparts range from 2022 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, 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.
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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
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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 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.
Other Healthcare Laws
We are subject to healthcare regulation and enforcement by the federal government and the states where we conduct business. These laws include,
without limitation, state and federal anti-kickback, fraud and abuse, false claims, and physicians’ sunshine laws and regulations. Foreign governments have
comparable regulations.
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The federal Anti-Kickback Statute prohibits, among other things, any person from knowingly and willfully offering, soliciting, receiving or
providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or
service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs. The Anti-Kickback Statute is
subject to evolving interpretations. In the past, the government has enforced the Anti-Kickback Statute to reach large settlements with healthcare companies
based on sham consulting and other financial arrangements with physicians. Further, a person or entity does not need to have actual knowledge of these
statutes or specific intent to violate them to have committed a violation. The majority of states also have anti-kickback laws which establish similar
prohibitions and in some cases may apply to items or services reimbursed by any third-party payor, including commercial insurers.
Additionally, the civil False Claims Act prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for
payment to the United States government. Actions under the False Claims Act may be brought directly by the government or as a qui tam action by a
private individual in the name of the government. In addition, the government may assert that a claim including items or services resulting from a violation
of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act. Violations of the False Claims Act
can result in very significant monetary penalties and treble damages. The federal government is using the False Claims Act, and the accompanying threat of
significant liability, in its investigation and prosecution of pharmaceutical and biotechnology companies in connection with the promotion of products for
unapproved uses and other sales and marketing practices. The government has obtained multi-billion dollar settlements under the False Claims Act in
addition to individual criminal convictions under applicable criminal statutes. We expect that the government will continue to devote substantial resources
to investigating healthcare providers’ and manufacturers’ compliance with applicable fraud and abuse laws.
The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, prohibits, among other things, knowingly and willfully
executing a scheme to defraud any healthcare benefit program. 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.
In addition, there has been increased federal and state regulation of payments made to physicians and other healthcare providers. The Patent
Protection and Affordable Care Act (“ACA”), among other things, imposes new reporting requirements on drug manufacturers for payments made by them
to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician practitioners (physician assistants,
nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists, anesthesiology assistants and certified nurse
midwives) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. Failure to submit
required information may result in significant civil monetary penalties for any payments, transfers of value or ownership or investment interests that are not
timely, accurately and completely reported in an annual submission. Drug manufacturers must report such payments to the government by the 90th day of
each calendar year. Certain states also mandate implementation of commercial compliance programs, impose restrictions on drug manufacturer marketing
practices and/or require the tracking and reporting of gifts, compensation and other remuneration to physicians.
State and foreign laws and regulations restrict business practices in the pharmaceutical industry and complicate our compliance efforts. For example,
some states require companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the federal government’s compliance
guidance or otherwise restrict payments to healthcare providers and other potential referral sources. Some states require manufacturers to file reports
relating to pricing and marketing information. Some state and local governments require the public registration of pharmaceutical sales representatives.
The shifting commercial compliance environment and the need to build and maintain robust and expandable systems to comply with different
compliance and/or reporting requirements in multiple jurisdictions increase the possibility that a healthcare company may violate one or more of the
requirements. If our operations are found to be in violation of any of such laws or any other governmental regulations that apply to us, we may be subject to
penalties, including, without limitation, civil and criminal penalties, damages, fines, the curtailment or restructuring of our operations, exclusion from
participation in federal and state healthcare programs and imprisonment, any of which could adversely affect our ability to operate our business and our
financial results.
Data Privacy and Security
Numerous state, federal and foreign laws and regulations govern the collection of, disclosure of, use of, access to, transfer of, and confidentiality and
security of health-related and other personal information, and could apply now or in the future to our operations or the operations of our partners. For
example, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their implementing
regulations, imposes requirements relating to the privacy, security and transmission of protected health information on HIPAA covered entities, which
include
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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, or HHS, may be
subject to significant civil, criminal and administrative fines and penalties and/or additional reporting and oversight obligations if required to enter into a
resolution agreement and corrective action plan with HHS to settle allegations of HIPAA non-compliance. Further, entities that knowingly receive
individually identifiable health information from a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA may be subject to
criminal penalties.
Even when HIPAA does not apply, according to the Federal Trade Commission or the FTC, failing to take appropriate steps to keep consumers’
personal information secure constitutes unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act.
The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it
holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities. Individually identifiable health
information is considered sensitive data that merits stronger safeguards.
Certain state and foreign laws also govern the privacy and security of health-related and other personal information in ways that differ significantly
from one another and are not preempted by HIPAA. For example, California recently enacted legislation, the California Consumer Privacy Act, or CCPA,
which went into effect January 1, 2020. The CCPA, among other things, creates certain data privacy obligations for covered companies and provides
privacy rights to California residents, including the right to opt out of certain disclosures of their information. The CCPA also creates a private right of
action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach. Although the law includes
limited exceptions, including for health-related information, including clinical trial data, it may regulate or impact our processing of personal information
depending on the context. Further, the California Privacy Rights Act (“CPRA”), recently passed in California. The CPRA will impose additional data
protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher
risk data, and opt outs for certain uses of sensitive data. It will also create a new California data protection agency authorized to issue substantive
regulations and could result in increased privacy and information security enforcement. The majority of the provisions will go into effect on January 1,
2023, and additional compliance investment and potential business process changes may be required.
In Europe, the General Data Protection Regulation (“GDPR”) went into effect in May 2018 and imposes stringent data protection requirements for
controllers and processors of personal data of persons within the EU. The GDPR applies to any company established in the EU or the EEA as well as to
those outside the EU or the EEA if they collect and use personal data in connection with the offering of goods or services to individuals in the EU or the
monitoring of their behavior. In addition, the GDPR increases the scrutiny of transfers of personal data from clinical trial sites located in the EEA to the
United States and other jurisdictions that the EC does not recognize as having “adequate” data protection laws; in July 2020, the Court of Justice of the
European Union limited how organizations could lawfully transfer personal data from the EEA to the United States by invalidating the EU-US Privacy
Shield and imposing further restrictions on use of the standard contractual clauses, which could increase our costs and our ability to efficiently process
personal data from the EEA. Companies that must comply with the GDPR face increased compliance obligations and risk, including more robust regulatory
enforcement of data protection requirements and potential fines for noncompliance of up to €20 million or 4% of the annual global revenues of the
noncompliant company, whichever is greater. In addition, 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 relationship between the United Kingdom and the European Union in relation to certain aspects of data protection law remains unclear, for
example around how data can lawfully be transferred between each jurisdiction, which may expose us to further compliance risk. 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.
Employees
We are managed by experienced pharmaceutical executives and also enlist the expertise of independent advisors with extensive pharmaceutical
experience. As of December 31, 2021, we had 238 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.
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About Corcept
We were incorporated in the State of Delaware on May 13, 1998. Our registered trademarks include Corcept and Korlym . Other service marks,
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trademarks and trade names referred to in this document are the property of their respective owners.
Available Information
We are subject to the information requirements of the Securities Exchange Act of 1934, as amended, and we therefore file periodic reports, proxy
statements and other information with the SEC relating to our business, consolidated financial statements and other matters. The SEC maintains an Internet
site, www.sec.gov, that contains reports, proxy statements and other information regarding issuers such as Corcept.
For more information about Corcept, including free access to our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on
Form 8-K and amendments to those reports, visit our website at www.corcept.com or the SEC’s website, www.sec.gov. The information found on or
accessible through our website is not incorporated into, and does not form a part of, this Form 10-K.
ITEM 1A. RISK FACTORS
Investing in our common stock involves significant risks. Before investing, carefully consider the risks described below and the other information in
this Annual Report on Form 10-K, including our consolidated financial statements and related notes. The risks and uncertainties described below are the
ones we believe may materially affect us. Many of them have been or may become exacerbated by the COVID-19 pandemic. There may be others of which
we are unaware that could materially harm our business or financial condition and cause the price of our stock to decline, in which case you could lose all
or part of your investment.
Summary of Principal Risks
The following bullet points summarize the principal risks we face, each of which could adversely affect our business, operations, and financial
results. For clarity of presentation, we have arranged these risks by the part of our business they most directly affect – (i) commercial operations, (ii)
research and development, (iii) capital need and financial results, (iv) intellectual property and (v) our stock price. A sixth group of “general risks” lists
risks that affect our business as a whole.
Risks Related to our Commercial Activities
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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. Other public health emergencies, natural
disasters, terrorism or other catastrophes could disrupt our activities and render our own or our vendors’ facilities and equipment inoperable or
inaccessible and require us to curtail or cease operations.
If new government regulations or changes to existing regulations make it difficult or impossible for us to obtain acceptable prices or adequate
insurance coverage and reimbursement for Korlym, our results of operations and financial position would be adversely affected.
If generic versions of Korlym are approved and successfully commercialized, our business, results of operations and financial position would be
adversely affected.
• Other companies offer or are attempting to develop different medications to treat patients with Cushing’s syndrome. The availability of competing
treatments could limit our revenue from Korlym.
• We depend on vendors to manufacture Korlym’s active ingredient, form it into tablets, package it and dispense it to patients. We also depend on
vendors to manufacture the API and capsules or tablets for our product candidates. If our suppliers become unable or unwilling to perform these
functions and we cannot transfer these activities to replacement vendors in a timely manner, our business will be harmed.
Risks Related to our Research and Development Activities
• 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.
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• 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.
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• 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
Risks Related to our Stock
The price of our common stock fluctuates widely and is likely to continue to do so. An investor’s ability to sell shares at any particular time may
be limited.
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• Our stock price may decline if one or more of our clinical development efforts fail or if our financial performance does not meet the guidance we
have provided to the public, estimates published by research analysts or other investor expectations.
General Risks
• We are subject to government regulation and other legal obligations relating to privacy and data protection. Compliance with these requirements is
complex and costly. Failure to comply could materially harm our business.
• We may be unable to hire and retain the skilled, experienced people we need to grow our business.
• We may be unable to obtain or maintain regulatory approvals for our product or product candidates.
• We rely on information technology systems to conduct our business. A breakdown or breach of these systems or our failure to protect confidential
information concerning our business, patients or employees could interrupt the operation of our business and subject us to liability.
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 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:
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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.
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. Other public health emergencies, natural
disasters, terrorism or other catastrophes could disrupt our activities and render our own or our vendors’ facilities and equipment inoperable or
inaccessible and require us to curtail or cease operations.
COVID-19, a serious and sometimes fatal illness, has spread to every country in the world and throughout the United States. Many countries,
including most states of the United States, reacted by instituting quarantines, “lockdowns” and other
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public health restrictions on leisure activities, work and travel. In California, where our headquarters are located, and in the states where our clinical
specialists and medical science liaisons live and work, residents have been subject to significant public health restrictions. We have been managing our
business with limited in-person activities, supplemented primarily by video conference, teleconference and email. Although pandemic-related restrictions
have been eased or removed in certain geographies, 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, titrate to 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. 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.
Other disasters could harm our business, operating results and financial condition. Our headquarters are in the San Francisco Bay Area, which
experiences earthquakes. Our specialty pharmacy, tablet manufacturers and warehouses are in areas subject to hurricanes and tornadoes. Political
considerations relating to mifepristone put us and our manufacturers at increased risk of protests and disruptive events. If a disaster were to occur, we might
not be able to operate our business. Our insurance, if available at all, would likely be insufficient to cover losses resulting from disasters or other business
interruptions.
If generic versions of Korlym are approved and successfully commercialized, our business, results of operations and financial position would be
adversely affected.
The marketing exclusivity provided by Korlym’s orphan drug designation expired in February 2019, which means other companies may now seek to
introduce generic equivalents of Korlym for 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 and Hikma 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 Federal Circuit Court of
Appeals has affirmed. We had also sued Sun with respect to its proposed generic version of Korlym, although we settled that lawsuit in June 2021. The
terms of our settlement with Sun 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 (i.e., Teva were to withdraw its product 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.
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.
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On December 31, 2021, Xeris Biopharma Holdings, Inc. (“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.
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. 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 many foreign markets, drug prices and the profitability of prescription medications are subject to government control. In the United States, we
expect that there will continue to be federal and state proposals for similar controls. Also, the trends toward managed health care in the United States and
recent laws and legislation intended to increase the public visibility of drug prices and reduce the cost of government and private insurance programs could
significantly influence the purchase of health care services and products and may result in lower prices for Korlym.
In the United States, there have been and continue to be legislative initiatives to contain healthcare costs. The Patient Protection and Affordable Care
Act, or ACA, which was passed in 2010, substantially changed the way health care is financed by both governmental and private insurers. The ACA,
among other things, expanded Medicaid program eligibility and access to commercial health insurance coverage, increased the minimum Medicaid rebates
owed by manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals enrolled in Medicaid managed care
organizations, established annual fees and taxes on manufacturers of certain branded prescription drugs, and promoted a new Medicare Part D coverage gap
discount program. The ACA also appropriated funding to comparative clinical effectiveness research, although it remains unclear how the research will
affect Medicare coverage and reimbursement or how new information will influence other third-party payer policies.
Other legislative and regulatory changes have been adopted in the United States since the ACA was enacted. These changes included an aggregate
reduction in Medicare payments to providers of 2 percent per fiscal year, which went into effect on April 1, 2013 and will remain in effect through 2030,
with the exception of a temporary suspension from May 1, 2020 through March 31, 2022, unless additional Congressional action is taken. In addition, the
American Taxpayer Relief Act of 2012, further reduced Medicare payments to several providers, including hospitals, imaging centers and cancer treatment
centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. In March 2021,
the American Rescue Plan Act of 2021 was also signed into law, which, among other things, eliminated the statutory cap on drug manufacturers’ Medicaid
Drug Rebate Program rebate liability, effective January 1, 2024. Under current law enacted as part of the ACA, drug manufacturers’ Medicaid Drug Rebate
Program rebate liability is capped at 100% of the average manufacturer price for a covered outpatient drug. Moreover, the federal government and the
individual states in the United States have become increasingly active in developing proposals, passing legislation and implementing regulations designed
to control drug pricing, including price or patient reimbursement constraints, discounts, formulary flexibility, marketing cost disclosure and transparency
measures.
There also continue 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. For
example, measures have been introduced in Congress that would impose caps on prescription drug prices and would require manufacturers to negotiate
drug pricing with the government.
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.
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We depend on vendors to manufacture Korlym’s active ingredient, form it into tablets, package it and dispense it to patients. We also depend on
vendors to manufacture the API and capsules or tablets for our product candidates. If our suppliers become unable or unwilling to perform these
functions and we cannot transfer these activities to replacement vendors in a timely manner, our business will be harmed.
A single third-party manufacturer, Produits Chimiques Auxiliaires et de Synthese SA (“PCAS”), supplies the API in Korlym. Two other third-party
manufacturers produce and bottle Korlym tablets. Our agreement with PCAS automatically renews for two one-year terms, unless either party provides 12-
months’ written notice of its intent not to renew. A single specialty pharmacy, Optime Care, Inc. (“Optime”) dispenses Korlym directly to patients and
collects payments from insurers representing approximately 99 percent of our revenue. If Optime does not adhere to its agreements with payers, it may not
be able to collect some or all of the payments due to us. Our agreement with Optime has a five-year term and renews upon the written consent of both
parties, subject to customary termination provisions, including the right of Optime to terminate in the event of a material breach by us that we do not cure
in a reasonable period of time after receiving written notice. In addition, we may terminate the agreement for convenience. In the event any of these
vendors fails to perform its contractual obligations to us or is materially impaired in its performance by the COVID-19 pandemic or for any other reason,
we may experience disruptions and delays in our supply chain and our ability to deliver Korlym to patients, which would adversely affect our business,
results of operations and financial position.
The facilities used by our vendors to manufacture and package the API and drug product for Korlym and our product candidates must be approved
by the FDA and, in some cases, the EMA or the Medicines and 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. As a result,
mifepristone is the subject of considerable debate in the United States and elsewhere. Public perception of mifepristone may limit the acceptance of Korlym
by patients and physicians. Even though we have taken measures to minimize the chance that Korlym will accidentally be prescribed to a pregnant woman,
physicians may choose not to prescribe Korlym to a woman simply to avoid the risk of terminating a pregnancy.
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 (“GCP”). The FDA enforces these regulations through inspections of us and the
laboratories,
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manufacturers and clinical sites we use. Foreign regulatory authorities have comparable requirements and enforcement mechanisms. Discovery of
previously unknown problems with a product or product candidate, such as adverse events of unanticipated severity or frequency or deficiencies in
manufacturing processes or management, as well as failure to comply with FDA or other U.S. or foreign regulatory requirements, may subject us to
substantial civil and criminal penalties, injunctions, holds on clinical trials, product seizure, refusal to permit the import or export of products, restrictions
on product marketing, withdrawal of the product from the market, product recalls, total or partial suspension of production, refusal to approve pending
NDAs or supplemental NDAs, and suspension or revocation of product approvals.
We may be subject to civil or criminal penalties if our marketing of Korlym violates FDA regulations or health care fraud and abuse laws.
We are subject to FDA regulations governing the promotion and sale of medications. Although physicians are permitted to prescribe drugs for any
indication they choose, manufacturers may only promote products for their FDA-approved use. All other uses are referred to as “off-label.” In the United
States, we market Korlym to treat hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2
diabetes mellitus or glucose intolerance and for whom surgery has failed or is not an option. We provide promotional materials and training programs to
physicians covering the use of Korlym for this indication. The FDA may change its policies or enact new regulations at any time that restrict our ability to
promote our products.
If the FDA were to determine that we engaged in off-label promotion, the FDA could require us to change our practices and subject us to regulatory
enforcement actions, including issuance of a public “warning letter,” 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:
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the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying
remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation
of, any good or service for which payment may be made under federal health care programs such as Medicare and Medicaid. A person or entity
does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
federal false claims laws, including, without limitation, the False Claims Act, which prohibit any person from knowingly presenting, or causing to
be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to get a false
claim paid. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback
Statute constitutes a false or fraudulent claim for purposes of the False Claims Act. Pharmaceutical companies have been prosecuted under these
laws for a variety of promotional and marketing activities, such as allegedly providing free product to or entering into “sham” consulting
arrangements with customers to induce such customers to purchase, order or recommend the company’s products in violation of the Anti-
Kickback Statute and federal false claims laws and regulations; reporting to pricing services inflated average wholesale prices that were then used
by certain governmental programs to set reimbursement rates; engaging in the promotion of “off-label” uses that caused customers to submit
claims to and obtain reimbursement from governmental payers for non-covered “off-label” uses; and submitting inflated best price information to
the Medicaid Drug Rebate Program; the government may assert that a claim including items and services resulting from a violation of the federal
Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;
the federal Civil Monetary Penalties law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare
beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable
by the government from a particular provider or supplier;
the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created federal criminal laws that prohibit executing a
scheme to defraud any health care benefit program or making false statements relating to health care matters; similar to the federal Anti-Kickback
Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a
violation;
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federal “sunshine” laws, including the federal Physician Payment Sunshine Act, that require transparency regarding financial arrangements with
health care providers, such as the reporting and disclosure requirements imposed by the ACA on drug manufacturers regarding any “transfer of
value” made or distributed to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician
practitioners (physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists,
anesthesiology assistants and certified nurse midwives), teaching hospitals, and ownership or investment interests held by physicians and their
immediate family members. Manufacturers are required to submit reports detailing these financial arrangements by the 90th day of each calendar
year;
federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm
consumers; and
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services
reimbursed by any third-party payer, including commercial insurers; state laws that require pharmaceutical companies to comply with the
pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or
otherwise restrict payments that may be made to healthcare providers; and state laws that require drug manufacturers to report information related
to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information.
The risk of being found in violation of these laws and regulations is increased by the fact that many of them have not been definitively interpreted by
regulatory authorities or the courts and their provisions are open to a variety of interpretations. Because of the breadth of these laws and the narrowness of
the statutory exceptions and safe harbors available under them, it is possible that some of our business activities, including our relationships with
physicians and other healthcare providers (some of whom recommend, purchase and/or prescribe our products) and the manner in which we promote our
products, could be subject to challenge. We are also exposed to the risk that our employees, independent contractors, principal investigators, consultants,
vendors, distributors, and contract research organizations (“CROs”) may engage in fraudulent or other illegal activity. Although we have policies and
procedures prohibiting such activity, it is not always possible to identify and deter misconduct and the precautions we take may not be effective in
controlling unknown risks or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with
applicable laws and regulations. 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;
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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 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 made initiating and advancing our clinical
development programs more difficult.”
During the development of a product candidate, we may decide, or the FDA or other regulatory authorities may require us, to conduct more pre-
clinical or clinical studies or to change the size or design of a trial already underway, 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 and AIWG. Studies of diseases perceived to be acutely life-threatening, such as advanced solid tumors, have not
experienced 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:
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delays in enrolling patients;
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;
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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.
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 GCP, or if
the quality or accuracy of the data it produces is compromised, affected clinical trials may be extended, delayed or terminated and we may be unable to
obtain approval for our product candidates. Failure of our manufacturing vendors to perform their duties or comply with cGMPs may require us to recall
drug product or repeat clinical trials, which would delay regulatory approval. If our agreements with any of these vendors terminate, we may not be able to
enter into alternative arrangements in a timely manner or on reasonable terms.
Our ability to physically inspect our vendors and clinical sites has been limited by the COVID-19 pandemic and associated public health restrictions,
which increases the risk that failures to meet applicable requirements will go undetected.
We may be unable to obtain or maintain regulatory approvals for our 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, as well as 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.
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Adverse events reported in clinical trials can slow or stop patient recruitment, prevent enrolled patients from completing a trial and could give rise to
liability claims. Regulatory authorities could respond to reported adverse events by interrupting or halting our clinical trials or limiting the scope of,
delaying or denying marketing approval. If we elect, or are required by authorities, to delay, suspend or terminate any clinical trial or commercialization
efforts, the commercial prospects of such product candidates or products may be harmed, and our ability to generate product revenues from them may be
delayed or eliminated.
If one of our product candidates receives marketing approval, and we or others later identify undesirable side effects or adverse events, potentially
significant negative consequences could result, including but not limited to:
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regulatory authorities may suspend, limit or withdraw approvals of such product;
regulatory authorities may require additional warnings on the label, including “boxed” warnings, or issue safety alerts and other safety information
about the product;
• we may be required to change the way the product is administered or conduct additional studies or clinical trials;
• we may be required to create a Risk Evaluation and Mitigation Strategy (REMS), which could include a medication guide outlining the risks of
such side effects for distribution to patients, a communication plan for healthcare providers and/or other elements to assure safe use;
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the product may become less competitive;
• we may be subject to fines, injunctions or the imposition of criminal penalties; and
• 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.
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Risks Related to our Stock
The price of our common stock fluctuates widely and will 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 8, 2022, our average daily trading
volume was approximately 848,907 shares and the intra-day sales prices per share of our common stock on The Nasdaq Stock Market ranged from $15.82
to $31.18. As of February 8, 2022, our officers, directors and principal stockholders beneficially owned approximately 19 percent of our common stock.
Our stock price can experience extreme price and volume fluctuations that are unrelated or disproportionate to our operating performance or
prospects. Securities class action lawsuits are often instituted against companies following periods of stock market volatility. Such litigation is costly and
diverts management’s attention from productive efforts.
Factors that may cause the price of our common stock to fluctuate rapidly and widely include:
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 and proceedings before the PTAB;
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.
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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 2022 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.
21
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.
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 FTC Act), that govern the collection, use, disclosure, and
protection of health-related and other personal information could apply to our operations or the operations of our partners. In addition, we may obtain
health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security
requirements under HIPAA. Depending on the facts and circumstances, we could be subject to criminal penalties if we knowingly obtain, use, or disclose
individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.
Even when HIPAA does not apply, according to the Federal Trade Commission or the FTC, violating consumers’ privacy or failing to take
appropriate steps to keep consumers’ personal information secure may constitute unfair acts or practices in or affecting commerce in violation of Section
5(a) of the Federal Trade Commission Act. The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity
and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce
vulnerabilities. Individually identifiable health information is considered sensitive data that merits stronger safeguards.
In addition, certain state laws govern the privacy and security of health information in certain circumstances, some of which are more stringent than
HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Failure to
comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation. For example, the
California Confidentiality of Medical Information Act imposes restrictive requirements regulating the use and disclosure of health information and other
personally identifiable information. Further, on June 28, 2018, California enacted the California Consumer Privacy Act, or the CCPA, which took effect on
January 1, 2020. The CCPA creates individual privacy rights for California consumers and increases the privacy and security obligations of entities
handling certain personal information. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that is
expected to increase data breach litigation. The CCPA may increase our compliance costs and potential liability. Further, the California Privacy Rights Act,
or CPRA, recently passed in California. The CPRA will impose additional data protection obligations on covered businesses, including additional
22
consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data. It will also
create a new California data protection agency authorized to issue substantive regulations and could result in increased privacy and information security
enforcement. The majority of the provisions will go into effect on January 1, 2023, and additional compliance investment and potential business process
changes may be required. In 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. Similar laws have been passed
in Virginia and Colorado, and have been proposed at the federal level and in other states, reflecting a trend toward more stringent privacy legislation in the
United States.
The GDPR went into effect in 2018 and imposes 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 states may make their own further laws and regulations limiting the
processing of health data, which could limit our ability to use and share personal data or could cause our costs to increase and harm our business and
financial condition. In addition, the GDPR increases the scrutiny that clinical trial sites located in the EEA should apply to transfers of personal data from
such sites to countries that are considered to lack an adequate level of data protection, such as the United States. Recent legal developments have also
created complexity and compliance uncertainty regarding certain transfers of information from the EEA to the United States. For example, on June 16,
2020, the Court of Justice of the European Union, or the CJEU, limited how organizations could lawfully transfer personal data from the EEA to the United
States by invalidating the EU-US Privacy Shield Framework for purposes of international transfers and imposing further restrictions on use of the standard
contractual clauses, or SCCs. These restrictions include a requirement for companies to carry out a transfer impact assessment which, among other things,
assesses the laws governing access to personal data in the recipient country and considers whether supplementary measures that provide privacy protections
additional to those provided under SCCs will need to be implemented to ensure an essentially equivalent level of data protection to that afforded in the
EEA. The EC issued revised SCCs on June 4, 2021 to account for the decision of the CJEU and recommendations made by the European Data Protection
Board. The revised SCCs must be used for relevant new data transfers from September 27, 2021; existing standard contractual clauses arrangements must
be migrated to the revised clauses 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 systems to conduct our business. A breakdown or breach of these systems or our failure to protect confidential
information concerning our business, patients or employees could interrupt the operation of our business and subject us to liability.
We store valuable confidential information relating to our business, patients and employees on our computer networks and on the networks of our
vendors. In addition, we rely heavily on internet technology, including video conference, teleconference and file-sharing services, to conduct business.
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
misuse of, our clinical data or other confidential information, including confidential information relating to our patients or employees.
23
COVID-19 may increase our cybersecurity risks, due to our reliance on internet technology and the number of our employees that are working remotely,
which may create additional opportunities for cybercriminals to exploit vulnerabilities.
We and our vendors have experienced data breaches, theft, “phishing” attacks and other unauthorized access to confidential data and information.
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.
We are dependent on the continued functioning of the FDA and other federal instrumentalities. Their partial or complete closure, whether due to
public health concerns or a budgetary dispute, or their diversion of significant resources to advance pandemic-related issues could materially
harm our business.
The government’s ability to carry out its mandated functions is affected by a variety of factors, including diversion of resources and limited
operating capacity caused by the COVID-19 pandemic, as well as other events that may reduce the government’s ability to perform routine functions, such
as inadequate funding, the inability to hire and retain key personnel, and statutory, regulatory and policy changes. If a prolonged government shutdown
occurs, or if global health concerns continue to prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other
regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory
submissions, which could have a material adverse effect on our business. Similarly, disruptions at the Securities and Exchange Commission (“SEC”) could
temporarily stop its ability to review and approve proposed financing transactions.
In March 2020, the FDA announced that in response to the COVID-19 pandemic, it would postpone most inspections of foreign manufacturing
facilities and was postponing routine surveillance inspections of domestic manufacturing facilities. In July 2020, the FDA resumed certain on-site
inspections of domestic manufacturing facilities subject to a risk-based prioritization system, which it used to determine when and where it was safest to
conduct prioritized domestic inspections. In April 2021, the FDA issued a guidance document in which it described its plans to conduct voluntary remote
interactive evaluations of certain drug manufacturing facilities and clinical research sites, among other facilities. According to the guidance, the FDA may
request such remote interactive evaluations where it determines that remote evaluation would be appropriate based on mission needs and travel limitations.
In July 2021, the FDA resumed standard inspections of domestic facilities. The FDA has continued to monitor and implement changes to its inspection
practices to ensure the safety of its employees and those of the firms it regulates. Regulatory authorities outside the United States may adopt similar
changes.
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.” Changes to existing tax laws could materially increase the amounts we pay, which would reduce our after tax net income. Beginning in 2022, the
Tax Cuts and Jobs Act of 2017 (“TCJA”) eliminates the option to deduct research and development expenditures currently and requires taxpayers to
amortize them over five years pursuant to IRC Section 174. Although Congress is considering legislation that would defer the amortization requirement to
later years, it is not certain that the provision will be repealed or otherwise modified. If the requirement is not modified, it will reduce our cash flows
beginning in 2022.
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.
24
Research analysts may not continue to provide or initiate coverage of our common stock or may issue negative reports.
The market for our common stock may be affected by the reports financial analysts publish about us. If any of the analysts covering us downgrades
or discontinues coverage of our stock, the price of our common stock could decline rapidly and significantly. Paucity of research coverage may also
adversely affect our stock price.
Sale of a substantial number of shares of our common stock may cause its price to decline.
Sales of a substantial number of shares of our stock in the public market could reduce its price. As additional shares of our stock become available
for public resale, whether by the exercise of stock options by employees or directors or because of an equity financing by us, the supply of our stock will
increase, which could cause its price to fall. Substantially all of the shares of our stock are eligible for sale, subject to applicable volume and other resale
restrictions.
Changes in laws and regulations may significantly increase our costs 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 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.
If we acquire products or product candidates, we will incur significant costs and may not realize the benefits we anticipate.
We may acquire a product or product candidate that complements our strategic plan. Such an acquisition may give rise to unforeseen difficulties and
costs and may absorb significant management attention. We may not realize the anticipated benefits of any acquisition, which could dilute our
stockholders’ ownership interest or cause us to incur significant expenses and debt.
We may fail to comply with our public company obligations, including securities laws and regulations. Such compliance is costly and requires
significant management attention.
The federal securities laws and regulations, including the corporate governance and other requirements of the Sarbanes-Oxley Act of 2002, impose
complex and continually changing regulatory requirements on our operations and reporting. These developing requirements will continue to increase our
compliance costs. Section 404 of the Sarbanes-Oxley Act of 2002 requires that we evaluate the effectiveness of, and provide a management report with
respect to, our internal controls over financial reporting. It also requires that the independent registered public accounting firm auditing our consolidated
financial statements must attest to and report on the effectiveness of our internal controls over financial reporting. If we are unable to complete the required
assessment and report or if our independent registered public accounting firm is unable to issue an unqualified opinion as to the effectiveness of our internal
control over financial reporting, investors could lose confidence in our financial reporting and our stock price would likely decline.
Anti-takeover provisions in our charter and bylaws and under Delaware law may make an acquisition of us or a change in our management more
expensive or difficult, even if an acquisition or a management change would be beneficial to our stockholders.
Provisions in our charter and bylaws may delay or prevent an acquisition of us or a change in our management. Some of these provisions allow us to
issue preferred stock without any vote or further action by the stockholders, require advance notification of stockholder proposals and nominations of
candidates for election as directors and prohibit stockholders from acting by written consent. In addition, a supermajority vote of stockholders is required to
amend our bylaws. Our bylaws provide that special meetings of the stockholders may be called only by our Chairman, President or the Board of Directors
and that the authorized number of directors may be changed only by resolution of the Board of Directors. These provisions may prevent or delay a change
in our Board of Directors or our management, which our Board of Directors appoints. In addition, because we are incorporated in Delaware, we are
governed by the provisions of Section 203 of the Delaware General Corporation Law. Section 203 may prohibit large stockholders, in particular those
owning 15 percent or more of our outstanding voting stock, from merging or combining with us. These provisions in our charter and bylaws and under
Delaware law could reduce the price that investors would be willing to pay for shares of our common stock.
Our officers, directors and principal stockholders, acting as a group, could significantly influence corporate actions.
As of February 8, 2022, 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
25
the election of directors and the approval of mergers or other business combinations. The interests of this group may not always coincide with our interests
or the interests of other stockholders and may prevent or delay a change in control. This significant concentration of share ownership may adversely affect
the trading price of our common stock because many investors perceive disadvantages to owning stock in companies with controlling stockholders.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 2. PROPERTIES
We lease 36,062 square feet of office space in Menlo Park, California for our corporate facilities. Our current lease expires in March 2022.
ITEM 3. LEGAL PROCEEDINGS
Teva ANDA Litigation
In February 2018, we received a Paragraph IV Notice Letter advising that Teva had submitted an Abbreviated New Drug Application (“ANDA”) to
the FDA seeking authorization to manufacture, use or sell a generic version of Korlym in the United States prior to the expiration of patents related to
Korlym that are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”). Teva’s February 5, 2018
Notice Letter alleged that our patents would not be infringed by Teva’s proposed product, were invalid and/or were unenforceable. 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 for 30 months, 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 consolidated our lawsuits against Teva into a single action and set a trial date of
February 2, 2021. On September 24, 2020, the Court vacated the February 2, 2021 trial date. A new trial date has not been set.
Our current lawsuit against Teva asserts the ‘214 patent and the ‘216 patent. The parties have completed briefing cross-motions for summary
judgment regarding infringement of the ’214 patent. There is no timetable as to when the Court will rule on these motions and there are currently no further
calendared dates for the litigation.
We will vigorously enforce our intellectual property rights relating to Korlym but cannot predict the outcome of this matter.
On May 7, 2019, Teva submitted to the 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 Corcept’s favor.
The time for Teva to appeal or seek reconsideration of these adverse decisions has passed. This matter is closed.
Sun ANDA Litigation and Settlement
On June 10, 2019, we received a Paragraph IV Notice Letter advising that Sun had submitted an ANDA to the FDA seeking authorization to
manufacture, use or sell a generic version of Korlym in the United States prior to the expiration of certain of our patents related to Korlym listed in the
Orange Book.
On July 22, 2019, we filed a lawsuit in the United States District Court for the District of New Jersey against Sun for infringement of our patents. On
January 23, 2020, we filed an amended complaint against Sun asserting infringement of two additional patents.
On June 9, 2021, we entered into an agreement with Sun resolving this litigation. Pursuant to the agreement, we have granted Sun 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 Sun have submitted the settlement agreement to the United States Federal Trade Commission and the United States Department
of Justice for review.
26
Hikma ANDA Litigation
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. The 30-month stay of FDA approval of Hikma’s ANDA expires on
August 1, 2023. Hikma responded to our complaint on May 17, 2021, denying our claims. On July 13, 2021, the Court entered a schedule for the case
setting a fact discovery deadline of July 1, 2022.
We intend to vigorously enforce our intellectual property rights relating to Korlym but cannot predict the outcome of this matter.
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.
We moved to dismiss the consolidated complaint on January 27, 2020. Rather than oppose our motion to dismiss, on March 20, 2020, the lead
plaintiff withdrew its consolidated complaint and filed a second amended complaint. On May 11, 2020, we moved to dismiss the second amended
complaint. On November 20, 2020, the Court granted our motion to dismiss, while granting plaintiff leave to file a third amended complaint, which
plaintiff did on December 21, 2020. On February 19, 2021, we moved to dismiss this third amended complaint. Plaintiff filed its opposition to our motion
on April 20, 2021 and we filed our reply on June 4, 2021.
On August 24, 2021, the Court granted our motion in part, but also denied it in part, which means certain of plaintiff’s claims may proceed to
discovery.
We will respond vigorously to plaintiff’s claims but cannot predict the outcome of this matter.
On September 30, 2019, a purported shareholder derivative complaint was filed in the United States District Court for the District of Delaware by
Lauren Williams, 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.
We will respond to this complaint vigorously but cannot predict the outcome of this matter.
On December 19, 2019, a second purported shareholder derivative complaint was filed in the United States District Court for the District of
Delaware by Jeweltex Pension Plan, captioned Jeweltex Pension Plan v. James N. Wilson, et al., Civil Action 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.
27
We will respond to this complaint vigorously but cannot predict the outcome of this matter.
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 Chief Commercial Officer 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.
We will respond to this complaint vigorously but cannot predict the outcome of this matter.
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, Corcept’s 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 Corcept that it is investigating whether any criminal or civil violations by Corcept occurred in
connection with the matters referenced in the subpoena. It has also informed Corcept that it does not currently consider Corcept a defendant but rather an
entity whose conduct is within the scope of the government’s investigation.
From time-to-time, in the ordinary course of business, we are involved in legal proceedings in addition to the matters described above. 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.
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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 8, 2022, we had 105,962,389 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, 2021 as part of a
publicly announced tender offer (in thousands, except average price per share):
Fiscal Period
October 1, 2021 to October 31, 2021
November 1, 2021 to November 30, 2021
December 1, 2021 to December 31, 2021
Total
Total Number of Shares
Repurchased
Average Price Paid Per
Share
Dollar Amount of Shares
Purchased Under the
Tender Offer
(1)
— $
—
10,000
10,000 $
— $
—
20.75
20.75 $
—
—
207,500
207,500
(1)
On November 8, 2021, we announced a tender offer to purchase up to 10 million shares of our common stock. The tender offer commenced on that date and expired on December 15, 2021.
The following table contains information relating to the purchases of our common stock in the three months ended December 31, 2021 as part of the
cashless net exercises of stock options (in thousands, except average price per share):
Fiscal Period
October 1, 2021 to October 31, 2021
November 1, 2021 to November 30, 2021
December 1, 2021 to December 31, 2021
Total
Total Number of Shares
Purchased
(2)
Average Price Paid Per
Share
Total Purchase Price of
Shares
(3)
230 $
111
63
404 $
21.26 $
22.82
18.68
21.28 $
4,900
2,529
1,178
8,607
(2) In October 2021, we issued 304,166 shares of common stock as part of a net-share settlement of a cashless option exercise, of which 230,489 shares were surrendered to us in satisfaction of
related exercise cost and tax obligations. In November 2021, we issued 190,851 shares of common stock as part of a net-share settlement of a cashless option exercise, of which 110,858 shares
were surrendered to us. In December 2021, we issued 84,388 shares of common stock as part of a net-share settlement of a cashless option exercise, of which 63,041 shares were surrendered to
us.
(3) We paid $2.5 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,
29
which shows the cumulative stockholder return assuming the investment of $100 and the reinvestment of any dividends and is based on the returns of the
component companies weighted according to their market capitalizations.
The graph shows the cumulative total stockholder return assuming the investment of $100 and the reinvestment of any dividends and is based on the
returns of the component companies weighted according to their market capitalizations as of the end of the period for which returns are indicated. We have
never paid dividends on our common stock.
The return shown in the graph below for our common stock is not necessarily indicative of future performance. We do not make or endorse any
predictions as to future stockholder returns.
Five-Year Cumulative Total Returns of our Common Stock (CORT),
the Nasdaq US Benchmark TR Index (NQUSBT) and
the Nasdaq Biotechnology Index (NBI)
ITEM 6. [RESERVED]
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ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) is intended to help the reader
understand our results of operations and financial condition and is provided as a supplement to, and should be read in conjunction with, our audited
consolidated financial statements and the accompanying notes to financial statements, risk factors and other disclosures included in this Form 10-K. Our
consolidated financial statements have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“U.S. GAAP”).
We make statements in this section that are forward-looking statements within the meaning of the federal securities laws. For a complete discussion
of such forward-looking statements and the potential risks and uncertainties that may affect their accuracy, see “Forward-Looking Statements” included in
“Risk Factors” in this Form 10-K and the “Overview” and “Liquidity and Capital Resources” sections of this MD&A.
Overview
We are a commercial-stage company engaged in the discovery and development of drugs that treat severe metabolic, oncologic and neuropsychiatric
disorders by modulating the effects of the hormone cortisol. Since 2012, we have marketed Korlym (mifepristone) for the treatment of patients suffering
from Cushing’s syndrome. Our portfolio of proprietary selective cortisol modulators consists of four structurally distinct series totaling more than 1,000
compounds.
Cushing’s Syndrome
Korlym. We sell Korlym in the United States, using experienced clinical 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.
Each patient in GRACE receives relacorilant for 22 weeks. Patients who exhibit pre-specified improvements in hypertension or glucose metabolism
enter a 12-week, double-blind, “randomized withdrawal” phase, in which half of the patients continue receiving relacorilant and half receive placebo. The
trial’s primary endpoint is the rate and degree of relapse in patients receiving placebo measured against the rate and degree of relapse in those continuing
relacorilant. GRACE has a planned enrollment of 130 patients with any etiology of endogenous Cushing’s syndrome at sites in the United States, Canada,
Europe and Israel.
Our GRADIENT trial is studying patients whose Cushing’s syndrome is caused by a benign adrenal tumor. Half of the patients in GRADIENT will
receive relacorilant for 26 weeks and half will receive placebo. The trial’s primary endpoints are improvement 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 FDA and the EC have designated relacorilant as an orphan drug for the treatment of Cushing’s syndrome.
Oncology
There is substantial in vitro, in vivo and clinical evidence that cortisol’s activity allows certain types of solid tumors to resist treatment. Many types
of solid tumors express GR and are potential targets for cortisol modulation therapy.
Relacorilant in Patients with Advanced Ovarian Cancer. In May 2021, we announced positive 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.
Based on these positive results, we plan to initiate a pivotal Phase 3 trial in the second quarter of 2022.
31
Exicorilant and Relacorilant in Patients with Castration-Resistant Prostate Cancer (“CRPC”). Androgen deprivation is the standard treatment for
metastatic prostate cancer. Tumors often escape androgen deprivation therapy when cortisol activity at GR supplants androgen activity at its receptor in
stimulating tumor growth. We are conducting a dose-finding trial of our proprietary, selective cortisol modulator exicorilant in combination with
enzalutamide in patients with metastatic CRPC. Investigators at the University of Chicago are conducting a dose-finding trial of relacorilant combined with
enzalutamide in the same patient population.
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 20 patients with metastatic or unresectable adrenal cancer with cortisol excess. 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, while relacorilant treats the Cushing’s syndrome caused by excess cortisol activity.
Metabolic Diseases
AIWG. We are conducting two double-blind, placebo-controlled, Phase 2 trials of miricorilant in patients with AIWG – GRATITUDE and
GRATITUDE II.
GRATITUDE is evaluating whether a daily dose of miricorilant can reverse recent AIWG. Study participants receive their established antipsychotic
medication plus either miricorilant or placebo for 12 weeks. GRATITUDE has planned enrollment of 100 patients with schizophrenia or bipolar disorder
and is being conducted at 30 sites in the United States.
GRATITUDE II is evaluating whether miricorilant can reverse long-standing AIWG. Study participants receive their established antipsychotic
medication plus either miricorilant or placebo for 26 weeks. GRATITUDE II has planned enrollment of 150 patients with schizophrenia and is being
conducted at 35 centers in the United States.
The primary endpoint in both the GRATITUDE and GRATITUDE II trials is the change in body weight from baseline, relative to placebo.
Liver Disease. We are also studying miricorilant as a potential treatment for nonalcoholic steatohepatitis (“NASH”). In April 2021, we suspended
our Phase 2a trial after observing elevated liver enzymes in four of the five patients who received miricorilant, which resolved after miricorilant was
withdrawn. The patients with elevated liver enzymes exhibited large, rapid reductions in liver fat. We are conducting a Phase 1b dose-finding trial in
patients with presumed NASH to see if an alternative dosing regimen can capture this benefit without causing excessive liver irritation.
Neurological Disorders
Our selective cortisol modulator dazucorilant (formerly “CORT113176”), which has shown promise in animal models of amyotrophic lateral
sclerosis (“ALS”), has completed its Phase 1 trial. We plan to advance it to Phase 2 as a potential treatment for that disease.
COVID-19 Pandemic
Much of the world is subject to varying degrees of pandemic-related public health restrictions, including California, where we are headquartered,
and in the jurisdictions where our vendors are located and where we sell Korlym and conduct clinical trials.
These restrictions, as well as measures voluntarily undertaken by patients, physicians, hospitals and medical clinics, have reduced our revenue and
make it difficult to grow our Korlym business.
The pandemic’s impact on the pace of our clinical development programs has been variable. Our trials of indications not considered immediately
life-threatening, such as Cushing’s syndrome, CRPC and AIWG have experienced slower enrollment. In addition, some clinical sites have stopped
enrolling new patients or have reduced the frequency with which physicians see study participants. Some sites have suspended or halted the initiation of
new clinical trials. Our trials in patients with immediately life-threatening diseases, such as advanced pancreatic and ovarian cancer, did not encounter
delays.
We expect that pandemic-related impediments to our business will continue so long as there are COVID-19 public health restrictions and risk-
reducing behavior by physicians and patients in the locations where we do business and conduct our clinical trials.
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. Other public
32
health emergencies, natural disasters, terrorism or other catastrophes could disrupt our activities and render our own or our vendors’ facilities and
equipment inoperable or inaccessible and require us to curtail or cease operations.”
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 $366.0 million for the year ended December 31, 2021, compared to $353.9 million and $306.5 million for the years ended
December 31, 2020 and 2019, respectively. For the years ended December 31, 2021 and 2020, higher sales volumes accounted for 20.7 percent and 31.9
percent of the increases, respectively, as we shipped Korlym to more patients. Increases in the average price of Korlym accounted for the remaining
growth. The increase in Korlym’s price for the year ended December 31, 2021 was primarily due to a price increase effective 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 $5.3 million for the year ended December 31, 2021, compared to $5.6 million and $5.5 million for the years ended December 31,
2020 and 2019, respectively. Cost of sales as a percentage of revenue was 1.4 percent, 1.6 percent and 1.8 percent for the years ended December 31, 2021,
2020 and 2019, respectively. The decreases in cost of sales as a percentage of revenue are due to the increased average price of Korlym and reduced
manufacturing costs.
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 $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.
Research and development expense was $114.8 million for the year ended December 31, 2020, compared to $89.0 million for the comparable period
in 2019. The increase was due to increased spending on the advancement of our development programs and employee recruiting and compensation
expenses.
Development programs:
Oncology
Cushing’s syndrome
Metabolic diseases
Pre-clinical and early-stage selective cortisol modulators
Unallocated activities, including manufacturing and regulatory activities
Stock-based compensation
Total research and development expense
2021
Year Ended December 31,
2020
(in thousands)
(1)
2019
(1)
$
$
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 $
20,657
24,010
19,545
10,546
4,718
9,541
89,017
Beginning in the first quarter of 2021, expenses for the years ended December 31, 2020 and 2019 previously allocated to oncology and endocrinology
(1)
were re-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 2022 than in 2021 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.
33
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 $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.
Selling, general and administrative expense was $105.3 million for the year ended December 31, 2020, compared to $100.4 million for the
comparable period in 2019. The increase was primarily due to increases in employee recruiting and compensation expenses, legal and marketing costs,
volume-related pharmacy and other distribution costs and professional service fees.
We expect our selling, general and administrative expense to be higher in 2022 than in 2021 due to increased commercial and administrative
activities, including litigation and administrative support for increased research and development.
Interest and other income - Interest and other income for the years ended December 31, 2021, 2020 and 2019 was $0.5 million, $3.4 million and
$5.1 million, respectively, and consisted primarily of interest income from marketable securities. Interest and other income decreased for the year ended
December 31, 2021 from the comparable periods in 2020 and 2019 primarily due to market-wide reductions in interest rates.
Income tax expense - 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. The decrease in income tax expense was due to a decrease in our effective tax rate from 10 percent for the year ended December 31, 2021
compared to 19.4 percent for the comparable period in 2020. The decrease in the effective tax rate in 2021 as compared to 2020 and 2019 is primarily due
to increased excess tax benefits from stock-based compensation in 2021. 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, 2021, we had 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, compared to cash, cash equivalents and marketable securities of $476.9 million, consisting of
cash and cash equivalents of $76.2 million and marketable securities of $400.7 million as of December 31, 2020.
The cash in our bank accounts and our marketable securities could be affected if the financial institutions holdings them were to fail or severely
adverse conditions were to rise in the markets for public or private debt securities. We have never experienced a loss or lack of access to cash.
Net cash provided by operating activities for the years ended December 31, 2021, 2020 and 2019 was $167.9 million, $152.0 million and $136.1
million, respectively. These increases were primarily due to higher revenue as a result of increases in Korlym’s price and shipping volume.
Net cash provided by investing activities for the year ended December 31, 2021 was $136.1 million. Net cash used in investing activities for the
years ended December 31, 2020 and 2019 was $119.3 million and $117.8 million, respectively. The change in net cash from investing activities for the year
ended December 31, 2021 compared to 2020 was primarily due to our use of cash for financing activities (specifically, the repurchase of our common
stock) instead of increasing our investment in marketable securities. The change in net cash used in investing activities for the years ended December 31,
2020 compared to 2019 was primarily due to increased purchases of marketable securities with cash generated by our operating activities.
In the year ended December 31, 2021, we spent $318.8 million acquiring shares of our common stock ($207.5 million pursuant to our tender offer,
$88.5 million pursuant to our Stock Repurchase Program that expired on September 31, 2021 and $22.8 million in connection with the net exercise of
employee and director stock options), offset by $16.2 million received from
34
the exercise of stock options, resulting in net cash used in financing activities of $302.6 million. In the comparable periods in 2020 and 2019, we spent
$11.0 million and $37.1 million, respectively, acquiring shares of our common stock, offset by $23.2 million and $8.4 million received from the exercise of
stock options, respectively, resulting in net cash provided by financing activities of $12.2 million for the year ended December 31, 2020 and net cash used
in financing activities of $28.6 million for the year ended December 31, 2019.
As of December 31, 2021, we had retained earnings of $195.0 million.
Manufacturing Purchase Commitments
We have other contractual payment obligations and purchase commitments, the timing of which are contingent on future events, including the
initiation and completion of manufacturing projects. In March 2014, we entered into a long-term agreement with one contract manufacturer, PCAS to
produce mifepristone, the API for Korlym. On July 25, 2018, we amended this agreement to add a second manufacturing site and extend its term to
December 31, 2021, with two one-year automatic renewals, unless either party provides 12 months advance written notice of its intent not to renew. The
amendment provides exclusivity between PCAS and Corcept. If PCAS is unable to meet our requirements, we may purchase mifepristone from another
supplier.
We have agreements with two third-party manufacturers to produce and bottle Korlym tablets.
As of December 31, 2021, we had $2.0 million remaining in commitments to purchase API from PCAS and have a $0.1 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 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
35
base and business practices. We deduct this reserve from revenue and include in accrued expenses on our consolidated balance sheet a current liability of
equal amount.
Patient Assistance Program and Charitable Support
It is our policy that no patient be denied Korlym due to inability to pay. We provide financial assistance to eligible patients whose insurance policies
have high deductibles or co-payments and deduct the amount of such assistance from gross revenue. We determine the assistance we provide each patient
by applying our program guidelines to that patient’s financial position and their insurance policy’s co-payment and deductible requirements. We also donate
cash to charities that help patients with financial need pay for the treatment of Cushing’s syndrome (which treatment may not include Korlym). We do not
include in our revenue payments these charities make on behalf of patients receiving Korlym. We provide Korlym at no cost to 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. To date, returns have not been material.
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 comprehensive income.
Cost of sales includes the cost of manufacturing Korlym, including materials, third-party manufacturing costs and indirect personnel and other
overhead costs, based on the number of Korlym tablets for which we recognize revenue, as well as costs of stability testing, logistics and distribution.
Recently Issued Accounting Pronouncements
See Note 1, Basis of Presentation and Summary of Significant Accounting Policies in our audited consolidated financial statements.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The primary objective of our investment activities is to preserve capital. As of December 31, 2021, the fair value of our cash and cash equivalents
and marketable securities was $335.8 million. Our marketable securities consisted of corporate notes, commercial paper, asset-backed securities, U.S.
Treasury securities and a money market fund invested in short-term U.S. Treasury securities maintained at a major U.S. financial institution. To minimize
our exposure to interest rate and other market risks, we have limited the maturities of our investments to less than three years, with the duration of our
portfolio not to exceed two years. 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, 2021.
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.
36
ITEM 9A. CONTROLS AND PROCEDURES
(a) Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports we file with the
SEC is recorded, processed, summarized and filed within the time periods specified in the SEC’s rules and forms and that such information is accumulated
and discussed with our management, including our Chief Executive Officer and Chief Financial Officer, so as to allow timely decisions regarding
disclosure. Management recognizes that controls and procedures, no matter how well designed and operated, can only provide reasonable, not absolute,
assurance the desired control objectives will be met. In reaching a reasonable level of assurance, management has weighed the cost of contemplated
controls against their intended benefits. The design of any system of controls is based on management’s assumptions about the likelihood of future events.
We cannot assure you that our controls will achieve their stated goals under all possible conditions. Changes in future conditions may render our controls
inadequate or may cause our degree of compliance with them to deteriorate. Because of the inherent limitations in a cost-effective control system,
misstatements due to error or fraud may occur and not be detected.
As of December 31, 2021, 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.
During the quarter ended March 31, 2021, we completed the implementation of an enterprise resource planning (“ERP”) system, which we expect
will improve the efficiency of certain financial and related transactional processes. We changed our internal controls so that they continue to operate
effectively following the ERP implementation. Our Chief Financial Officer and other members of management evaluated the changes in our internal
control over financial reporting during the quarter ended December 31, 2021 and concluded that there was no change during the quarter that materially
affected, or is reasonably likely to materially affect, our internal control over financial reporting.
(b) Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in
Exchange Act Rule 13a-15(f). Our internal control system is designed to provide reasonable assurance regarding the preparation and fair presentation of
externally-reported consolidated financial statements in accordance with U.S. GAAP. As discussed in Item 9A(a) above, internal control systems, no matter
how well designed, have inherent limitations and can provide only reasonable assurance that their objectives have been met.
As of December 31, 2021, 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, 2021.
Our independent registered public accounting firm has issued an attestation report on our internal control over financial reporting. It is set forth
below.
(c) Report of Independent Registered Public Accounting Firm
To the Stockholders and Board of Directors of Corcept Therapeutics Incorporated
Opinion on Internal Control over Financial Reporting
We have audited Corcept Therapeutics Incorporated’s internal control over financial reporting as of December 31, 2021, 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, 2021, 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, 2021 and 2020, the related consolidated statements comprehensive income, cash flows and stockholders’ equity for each
of the three years in the period ended December 31, 2021, and the related notes and our report dated February 15, 2022 expressed an unqualified opinion
thereon.
37
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of
internal control over financial reporting included in the accompanying Management’s Report on Internal Control over Financial Reporting. Our
responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm
registered with the PCAOB and are required to be independent with respect to the Company in accordance with U.S. federal securities laws and the
applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether effective internal control over financial reporting was maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and
evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered
necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control
over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are
being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding
prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial
statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of
compliance with the policies or procedures may deteriorate.
/s/ Ernst & Young LLP
Redwood City, California
February 15, 2022
ITEM 9B. OTHER INFORMATION
None.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
38
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 2022 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.
39
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
The following documents are filed as part of this Form 10-K
(1) Financial Statements:
PART IV
Report of Independent Registered Public Accounting Firm
Audited Consolidated Financial Statements
Consolidated Balance Sheets
Consolidated Statements of Comprehensive Income
Consolidated Statements of Cash Flows
Consolidated Statement of Stockholders’ Equity
Notes to Consolidated Financial Statements
(2) Financial Statement Schedules:
Page
2
4
5
6
8
9
All schedules have been omitted because the information required to be set forth therein is not applicable or is shown in the financial statements or
notes thereto.
(3) Exhibits:
Item 601 of Regulation S-K requires the exhibits listed below. Each management contract or compensatory plan or arrangement required to be filed
as an exhibit to this Form 10-K has been identified.
(A) EXHIBITS
Exhibit Number
Description of Document
3.1
3.2
4.1
4.2
4.3
4.4
4.5
4.6
Amended and Restated Certificate of Incorporation, as amended (incorporated by reference to Exhibit 3.1 to the registrant’s Quarterly
Report on Form 10-Q filed on August 9 2012).
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the registrant’s Current Report on Form 8-K filed on February
13, 2017).
Specimen Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the registrant’s Registration Statement on Form S-1
(Registration No. 333-112676) filed on February 10, 2004).
Description of Common Stock (incorporated by reference to Exhibit 4.2 to the registrant’s Annual Report on Form 10-K filed on February
23, 2021)
Registration Rights Agreement by and among Corcept Therapeutics Incorporated and the investors signatory thereto, dated March 14,
2008 (incorporated by reference to Exhibit 10.25 to the registrant’s Annual Report on Form 10-K filed on March 31, 2008).
Amendment to Registration Rights Agreement by and among Corcept Therapeutics Incorporated and the investors signatory thereto, dated
November 11, 2008 (incorporated by reference to Exhibit 10.30 to the registrant’s Annual Report on Form 10-K filed on March 31, 2009).
Registration Rights Agreement dated as of April 21, 2010 by and among Corcept Therapeutics Incorporated and the investors signatory
thereto (incorporated by reference to Exhibit 4.2 to the registrant’s Current Report on Form 8-K filed on April 23, 2010).
Registration Rights Agreement, dated as of March 29, 2012, by and among Corcept Therapeutics Incorporated and the investors signatory
thereto (incorporated by reference to Exhibit 4.2 to the registrant’s Current Report on Form 8-K filed on March 29, 2012).
40
Exhibit Number
Description of Document
License Agreement by and between The Board of Trustees of the Leland Stanford Junior University and Corcept Therapeutics
Incorporated, dated as of July 1, 1999 (incorporated by reference to Exhibit 10.6 to the registrant’s Registration Statement on Form S-1
(Registration No. 333-112676) filed on February 10, 2004).
Manufacturing Agreement with Produits Chimiques Auxiliaires et de Synthese SA, dated November 8, 2006 (incorporated by reference to
Exhibit 10.15 to the registrant’s Annual Report on Form 10-K filed on April 2, 2007).
Form of Indemnification Agreement for directors and officers approved by the Board of Directors on September 24, 2007 (incorporated by
reference to Exhibit 10.7 to the registrant’s Quarterly Report on Form 10-Q filed on November 14, 2007).
Securities Purchase Agreement by and among Corcept Therapeutics Incorporated and the purchasers named therein, dated March 14, 2008
(incorporated by reference to Exhibit 10.24 to the registrant’s Annual Report on Form 10-K filed on March 31, 2008).
Amended and Restated Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Joseph K.
Belanoff, M. D., dated September 19, 2008 (incorporated by reference to Exhibit 10.25 to the registrant’s Annual Report on Form 10-K
filed on March 31, 2009).
Amended and Restated Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and James N.
Wilson, dated September 19, 2008 (incorporated by reference to Exhibit 10.28 to the registrant’s Annual Report on Form 10-K filed on
March 31, 2009).
Amended and Restated 2004 Equity Incentive Plan (incorporated by reference to the registrant’s Proxy Statement on Schedule 14A filed
on May 7, 2009).
Securities Purchase Agreement by and among Corcept Therapeutics Incorporated and the purchasers named therein, dated October 12,
2009 (incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed on November 12, 2009).
Form of Option Agreement for options granted pursuant to the Amended and Restated 2004 Equity Incentive Plan (incorporated by
reference to Exhibit 10.25 to the registrant’s Annual Report on Form 10-K filed on March 15, 2011).
Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Charles Robb, dated September 1,
2011 (incorporated by reference to Exhibit 10.2 to the registrant’s Quarterly Report on Form 10-Q filed on November 8, 2011).
Employment offer letter to Charles Robb dated August 12, 2011 (incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly
Report on Form 10-Q filed on November 8, 2011).
Corcept Therapeutics Incorporated 2012 Incentive Award Plan (incorporated by reference to Appendix A to the registrant’s Definitive
Proxy Statement on Schedule 14A filed with the SEC on May 21, 2012).
Commercial Outsourcing Services Agreement with Integrated Commercialization Solutions, Inc., dated as of April 14, 2011 (incorporated
by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed on August 9, 2012).
10.1
10.2#
10.3†
10.4
10.5†
10.6†
10.7†
10.8
10.9†
10.10†
10.11†
10.12†
10.13#
10.14†
Form of 2012 Incentive Award Plan Stock Option Grant Notice and Agreement
10.15
10.16#
10.17#
10.18
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).
41
Exhibit Number
Description of Document
10.19
10.20
10.21#
10.22
10.23#
10.24
10.25
10.26#
10.27†
10.28†
10.29#
10.30#
Amendment to Manufacturing Agreement with Produits Chimiques Auxiliaires et de Synthese SA, dated November 7, 2013 (incorporated
by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed on November 12, 2013).
Amendment to Manufacturing Agreement with Produits Chimiques Auxiliaires et de Synthese SA, dated January 27, 2014 (incorporated
by reference to Exhibit 10.34 to the registrant’s Annual Report on Form 10-K filed on March 14, 2014).
Manufacturing and Supply Agreement with Produits Chimiques Auxiliaires et de Synthese SA, dated March 20, 2014 (incorporated by
reference to Exhibit 10.2 to the registrant’s Quarterly Report on Form 10-Q filed on May 12, 2014).
First Amendment to the Commercial Outsourcing Services Agreement with Integrated Commercialization Solutions, Inc., effective as of
April 14, 2014 (incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed on August 8, 2014).
Manufacturing Agreement with AAI Pharma Services Corp., dated April 7, 2014 (incorporated by reference to Exhibit 10.2 to the
registrant’s Quarterly Report on Form 10-Q filed on August 8, 2014).
Second Amendment to the Commercial Outsourcing Services Agreement with Integrated Commercialization Solutions, Inc., effective as
of June 11, 2014 (incorporated by reference to Exhibit 10.3 to the registrant’s Quarterly Report on Form 10-Q filed on August 8, 2014).
Third Amendment to the Commercial Outsourcing Services Agreement with Integrated Commercialization Solutions, Inc., effective as of
August 11, 2014 (incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed on November 7, 2014).
Second Amendment to Pharmaceutical Manufacturer Services Agreement with Dohmen Life Science Services, LLC (as successor in
interest to Centric Health Resources, Inc.) dated October 6, 2014 (incorporated by reference to Exhibit 10.41to the registrant’s Annual
Report on Form 10K filed on March 13, 2015).
Employment offer letter to Robert S. Fishman dated September 16, 2015 (incorporated by reference to Exhibit 10.2 to the registrant’s
Quarterly Report on Form 10-Q filed on November 6, 2015).
Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Robert S. Fishman, dated September
28, 2015 (incorporated by reference to Exhibit 10.3 to the registrant’s Quarterly Report on Form 10-Q filed on November 6, 2015).
Distribution Services Agreement, dated August 4, 2017, between Corcept Therapeutics Incorporated and Optime Care, Inc. (incorporated
by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed on November 3, 2017).
Task Order Number One to Distribution Services Agreement, dated August 4, 2017, between Corcept Therapeutics Incorporated and
Optime Care, Inc. (incorporated by reference to Exhibit 10.2 to the registrant’s Quarterly Report on Form 10-Q filed on November 3,
2017.
10.31#
Amendment N°1 to the Manufacturing and Supply Agreement effective 19 March 2014 with PCAS SA, dated July 25, 2018
10.32†
10.33†
Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Andreas Grauer, M.D. dated March
18, 2019 (incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed on May 9, 2019).
Employment offer letter to Andreas Grauer, M.D. dated March 18, 2019 (incorporated by reference to Exhibit 10.2 to the registrant’s
Quarterly Report on Form 10-Q filed on May 9, 2019).
10.34
Office Lease Agreement by and between Exponent Realty, LLC and Corcept Therapeutics Incorporated, effective as of April 1, 2016.
10.35
10.36
10.37
First Amendment to Office Lease Agreement by and between Exponent Realty, LLC and Corcept Therapeutics Incorporated, made and
entered into as of June 1, 2017.
Second Amendment to Office Lease Agreement by and between Exponent Realty, LLC and Corcept Therapeutics Incorporated, made and
entered into as of March 12, 2018.
Third Amendment to Office Lease Agreement by and between Exponent Realty, LLC and Corcept Therapeutics Incorporated, made and
entered into as of November 8, 2018.
42
Exhibit Number
Description of Document
10.38
10.39†
10.40†
10.41†
10.42
10.43
10.44†
10.45†
10.46†
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).
Separation Agreement by and between Corcept Therapeutics Incorporated and Andreas Grauer, M.D., dated August 11, 2021
(incorporated by reference to Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on August 10, 2021).
10.1
Employment offer letter to William Guyer, dated July 2, 2021.
10.2
23.1
24.1
31.1
31.2
32.1
32.2
Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and William Guyer, dated February 9,
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.
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
43
Exhibit Number
Description of Document
104
Cover Page Interactive Data File - the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags
are embedded within the Inline XBRL Document
#
†
Confidential treatment granted
Management contract or compensatory plan or arrangement
ITEM 16. FORM 10-K SUMMARY
None.
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 15, 2022
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 15, 2022
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 15, 2022
February 15, 2022
/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 15, 2022
Director
Director
Director
Director
Director
Director
Director
46
February 15, 2022
February 15, 2022
February 15, 2022
February 15, 2022
February 15, 2022
February 15, 2022
February 15, 2022
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 Comprehensive Income
Consolidated Statements of Cash Flows
Consolidated Statement of Stockholders’ Equity
Consolidated Notes to Financial Statements
1
Page
2
4
5
6
8
9
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, 2021 and 2020,
the related consolidated statements of comprehensive income, cash flows and stockholders’ equity for each of the three years in the period ended
December 31, 2021, 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, 2021 and 2020, and the results of its operations
and its cash flows for each of the three years in the period ended December 31, 2021, 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, 2021, 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 15, 2022 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, 2021, the Company had $18 million of inventory which included $11.5
million of work in progress and $6.5 million of finished goods. As disclosed in Note 1, inventories
are stated at the lower of cost or net realizable value. The Company assesses its inventory levels
each reporting period and writes down inventory that is either expected to be at risk of expiration
prior to sale, or has a cost basis in excess of its expected net realizable value, or for which there
are inventory quantities in excess of expected requirements.
Auditing management's estimates for excess and obsolete inventory involved subjective auditor
judgment because the estimates rely on a number of factors that are affected by market and
economic conditions outside the Company's control. In particular, the obsolete and excess
inventory calculations are sensitive to significant assumptions, including the expected demand for
the Company’s products, assumptions about the drug’s life cycle, the effect on demand of
competitive products and the Company's purchase commitments.
We obtained an understanding, evaluated the design, and tested the operating effectiveness of
internal controls over the Company's excess and obsolete inventory reserve process including
management’s review of the significant assumptions described above and controls over the
completeness and accuracy of the information used to develop the estimate.
Our substantive audit procedures included, among others, evaluating methodologies used and data
utilized in the analysis for inventory expected to be at risk for expiration or excess. We evaluated
purchase commitments or alternative uses, compared forecasted demand to historical trends,
compared actual inventory levels to forecasted demand requirements and evaluated the sensitivity
of sales forecast assumptions on the amount of inventory reserves recorded.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2001.
Redwood City, California
February 15, 2022
3
CORCEPT THERAPEUTICS INCORPORATED
CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
December 31,
2021
2020
ASSETS
Current assets:
Cash and cash equivalents
Short-term marketable securities
Trade receivables, net of allowances
Inventory
Prepaid expenses and other current assets
Total current assets
Strategic inventory
Operating lease right-of-use asset
Property and equipment, net of accumulated depreciation
Long-term marketable securities
Other assets
Deferred tax assets, net
Total assets
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
Accrued clinical expenses
Accrued and other liabilities
Short-term operating lease liability
Total current liabilities
Long-term operating lease liability
Long-term accrued income taxes
Total liabilities
Commitments and contingencies (Note 10)
Stockholders’ equity:
Preferred stock, par value $0.001 per share, 10,000 shares authorized and no shares outstanding at
December 31, 2021 and December 31, 2020
Common stock, par value $0.001 per share, 280,000 shares authorized and 127,218 issued and 105,940
outstanding at December 31, 2021 and 122,586 shares issued and 116,735 outstanding at December 31, 2020
Treasury stock; at cost; 21,278 shares of common stock at December 31, 2021 and 5,851 shares of common
stock at December 31, 2020
Additional paid-in capital
Accumulated other comprehensive (loss) gain
Retained earnings
Total stockholders’ equity
Total liabilities and stockholders’ equity
$
$
$
$
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 $
76,190
364,506
26,198
4,910
6,697
478,501
16,247
2,509
1,675
36,196
5,000
31,603
571,731
10,554
13,704
21,186
2,050
47,494
501
398
48,393
—
122
(75,795)
516,140
415
82,456
523,338
571,731
The accompanying notes are an integral part of these consolidated financial statements.
4
CORCEPT THERAPEUTICS INCORPORATED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(In thousands, except per share data)
Product revenue, net
Operating expenses:
Cost of sales
Research and development
Selling, general and administrative
Total operating expenses
Income from operations
Interest and other income
Income before income taxes
Income tax expense
Net income
Other comprehensive income:
Net unrealized (loss) gain on available-for-sale investments, net of tax impact of $198, $15
and $(104)
Foreign currency translation (loss) gain, net of tax
Total comprehensive income
Basic net income per share
Diluted net income per share
Year Ended December 31,
2020
2021
2019
$
365,978 $
353,874 $
306,486
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 $
(621)
(21)
111,870 $
(50)
204
106,165 $
0.97 $
0.92 $
0.89 $
0.85 $
5,504
89,017
100,359
194,880
111,606
5,070
116,676
22,495
94,181
327
4
94,512
0.82
0.77
$
$
$
$
Weighted average shares outstanding used in computing net income per share
Basic
Diluted
115,653
125,963
115,412
124,194
114,349
122,566
The accompanying notes are an integral part of these consolidated financial statements.
5
CORCEPT THERAPEUTICS INCORPORATED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
Cash flows from operating activities:
Net income
Adjustments to reconcile net income to net cash provided by operations:
Stock-based compensation
Amortization (accretion) of interest income
Depreciation and amortization of property and equipment
Deferred income taxes
Non-cash amortization of right-of-use asset
Others
Changes in operating assets and liabilities:
Trade receivables
Inventory
Prepaid expenses and other current assets
Other assets
Accounts payable
Accrued clinical expenses
Accrued and other liabilities
Long-term accrued income taxes
Operating lease liability
Net cash provided by operating activities
Cash flows from investing activities:
Purchases of property and equipment
Proceeds from maturities of marketable securities
Proceeds from sales of marketable securities
Purchases of marketable securities
Net cash provided by (used in) investing activities
Cash flows from financing activities:
Proceeds from exercise of stock options, 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 the net settlement of cashless
option exercises
Net cash (used in) provided by financing activities
Net increase (decrease) in cash and cash equivalents
Cash and cash equivalents, at beginning of period
Cash and cash equivalents, at end of period
Supplemental disclosure:
Income taxes paid
Cost of shares repurchased for net settlement of cashless option exercise
Recognition of right-of-use asset and lease liability
6
Year Ended December 31,
2020
2021
2019
$
112,512 $
106,011 $
94,181
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)
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)
(22,835)
(302,591)
1,427
76,190
77,617 $
(1,067)
12,214
44,921
31,269
76,190 $
29,313
(1,738)
703
16,877
1,468
—
(2,340)
(1,044)
1,696
(3,398)
(735)
2,956
(517)
147
(1,452)
136,117
(1,088)
182,295
—
(299,035)
(117,828)
8,419
—
(30,975)
(6,089)
(28,645)
(10,356)
41,625
31,269
9,104 $
15,796 $
— $
10,856 $
2,079 $
775 $
6,744
1,983
4,913
$
$
$
$
The accompanying notes are an integral part of these consolidated financial statements
7
CORCEPT THERAPEUTICS INCORPORATED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(In thousands)
Common Stock
Additional
Paid-in
Capital
Treasury
Stock
Accumulated
Other
Comprehensive
Income (Loss)
Retained Earnings
(Accumulated
Deficit)
Total
Stockholders'
Equity
Balance at December 31, 2018
Issuance of common stock upon exercise of options
Shares tendered to satisfy cost and statutory withholding
requirements for net settlement of cashless option exercises
Stock-based compensation related to employee and director
options
Stock-based compensation related to non-employee options
Other comprehensive loss, net of tax
Purchase of treasury stock
Net income
Balance at December 31, 2019
Issuance of common stock upon exercise of options
Shares tendered to satisfy cost and statutory withholding
requirements for net settlement of cashless option exercises
Stock-based compensation related to employee and director
options
Other comprehensive income, net of tax
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 related to employee and director
options
Other comprehensive income, 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
Shares
115,031
2,929
$
(631)
—
—
—
(2,780)
—
114,549
2,819
(154)
—
—
(479)
—
116,735
4,632
(1,560)
—
—
(3,867)
(10,000)
—
105,940
$
Amount
117
3
—
—
—
—
—
—
120
2
—
—
—
—
—
122
5
—
—
—
—
—
—
127
$
417,228
10,399
$
(23,657)
—
$
—
(8,072)
29,201
232
—
—
—
457,060
25,303
—
—
—
(30,975)
—
(62,704)
—
—
(3,146)
33,777
—
—
—
516,140
32,041
43,168
—
—
—
—
591,349
$
—
—
(9,945)
—
(75,795)
—
(38,631)
—
—
(88,485)
(207,500)
—
(410,411)
$
$
275,882
10,402
(8,072)
29,201
232
331
(30,975)
94,181
371,182
25,305
(3,146)
33,777
154
(9,945)
106,011
523,338
32,046
(38,631)
43,168
(642)
$
(117,736)
—
$
—
—
—
—
—
94,181
(23,555)
—
—
—
—
—
106,011
82,456
—
—
—
—
(70)
—
—
—
—
331
—
—
261
—
—
—
154
—
—
415
—
—
—
(642)
—
—
—
(227)
$
—
—
112,512
194,968
$
(88,485)
(207,500)
112,512
375,806
The accompanying notes are an integral part of these consolidated financial statements
8
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 is a commercial-stage pharmaceutical company engaged in the discovery and development of medications that
treat severe metabolic, oncologic and neuropsychiatric disorders by modulating the effect 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 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 statement of comprehensive income.
9
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 incurred any
credit losses.
Inventory and Cost of Sales
Regulatory approval of product candidates is uncertain. Because product manufactured prior to regulatory approval may not be sold unless
regulatory approval is obtained, we record the cost of manufacturing our product candidates as research and development expense at the time such costs are
incurred. We capitalize to inventory manufacturing costs related to Korlym.
We value inventory at the lower of cost or net realizable value and determine the cost of inventory we sell using the specific identification method,
which approximates a first-in, first-out basis. We assess our inventory levels at each reporting period and write down inventory that is either expected to be
at risk of expiration prior to sale, has a cost basis in excess of its expected net realizable value, or for which there are inventory quantities in excess of
expected requirements. We destroy expired inventory and recognize the related costs as cost of sales in that period’s statement of comprehensive income.
Cost of sales also includes the cost of manufacturing Korlym, including materials, third-party manufacturing costs and indirect personnel and other
overhead costs, based on the number of Korlym tablets for which we recognize revenue, as well as costs of stability testing, logistics and distribution.
We classify inventory we do not expect to sell 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,
2021, 2020 and 2019.
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
10
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 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, 2021,
2020 and 2019:
Balance at December 31, 2018:
Provision related to current period sales
Provision related to prior period sales
Credit or payments made during the period
Balance at December 31, 2019:
Provision related to current period sales
Provision related to prior period sales
Credit or payments made during the period
Balance at December 31, 2020:
Provision related to current period sales
Provision related to prior period sales
Credit or payments made during the period
Balance at December 31, 2021:
Chargebacks
Government
Rebates
(in thousands)
Total
$
$
346 $
783
—
(852)
277
519
(3)
(630)
163
394
(29)
(478)
50 $
11,133 $
24,374
(95)
(27,203)
8,209
27,698
(631)
(25,864)
9,412
33,709
(1,047)
(30,900)
11,174 $
11,479
25,157
(95)
(28,055)
8,486
28,217
(634)
(26,494)
9,575
34,103
(1,076)
(31,378)
11,224
11
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 comprehensive income on a straight-line basis
over the lease term.
Operating leases are reflected on our consolidated balance sheets as operating lease right-of-use assets, short-term operating lease liabilities and
long-term operating lease liabilities.
We begin recognizing operating lease expense when the lessor makes the underlying asset available to us. We recognize operating lease expense
under our operating leases on a straight-line basis. Variable lease payments are expensed as incurred.
The Company did not have any finance leases at either December 31, 2021 or 2020.
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 account for stock-based compensation under the fair value method, based on the value of the award at the grant date. To date, our stock-based
compensation has consisted entirely of option grants, which we value using the Black-Scholes model. We recognize stock-based compensation expense
over the applicable vesting period, net of estimated forfeitures. If actual forfeitures differ from our estimates, we adjust stock-based compensation expense
accordingly.
Income Taxes
We account for income taxes in accordance with ASC 740, Income Taxes (“ASC 740”), which requires recognition of deferred tax assets and
liabilities for the expected tax consequences of our future financial and operating activities. Under ASC 740, we determine deferred tax assets and liabilities
based on the temporary difference between the financial statement and tax bases of assets and liabilities using the tax rates in effect for the year in which
we expect such differences to reverse. If we determine that it is more likely than not that we will not generate sufficient taxable income to realize the value
of some or all of
12
CORCEPT THERAPEUTICS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued
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.
Recently Adopted Accounting Pronouncements
In December 2019, the FASB issued ASU No. 2019-12 (ASC Topic 740), “Simplifying the Accounting for Income Taxes.” This standard simplifies
and clarifies existing guidance, and is effective for fiscal years, and interim periods within those years, beginning after December 15, 2020. We adopted this
standard on January 1, 2021. The adoption had no impact on our consolidated financial statements.
2. Significant Agreements
Commercial Agreements
In August 2017, we entered into a distribution services agreement with an independent third party, Optime, to provide exclusive specialty pharmacy
and patient services programs for Korlym beginning August 10, 2017. Under the terms of this agreement, Optime acts as the exclusive specialty pharmacy
distributor of Korlym in the United States, subject to certain exceptions. Optime provides services related to pharmacy operations; patient intake, access
and reimbursement; patient support; claims management and accounts receivable; and data and reporting. We provide Korlym to Optime, which it
dispenses to patients. Optime does not purchase Korlym from us and it does not take title to the product. Title passes directly from us to the patient at the
time the patient receives the medicine.
The initial term of our agreement with Optime is five years, unless terminated earlier by us upon 90 days’ notice. The agreement contains additional
customary termination provisions, representations, warranties and covenants. Subject to certain limitations, we have agreed to indemnify Optime for certain
third-party claims related to the product, and we have each agreed to indemnify the other for certain breaches of representations, warranties, covenants and
other specified matters.
Manufacturing Agreements Related to Korlym
We purchase all of our API for Korlym from PCAS. On July 25, 2018, we amended our agreement with PCAS to add a second manufacturing site
and extend its term to December 31, 2021, with two one-year automatic renewals, unless either party provides 12 months advance written notice of its
intent not to renew. The agreement was renewed through December 31, 2022. The amendment provides exclusivity between PCAS and Corcept. In the
event PCAS cannot meet our requirements, we may purchase API from another supplier. As of December 31, 2021, we had non-cancelable commitments
to purchase $2.0 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.
13
CORCEPT THERAPEUTICS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued
3. Available for Sale Securities and Fair Value Measurements
The available-for-sale securities in our Consolidated Balance Sheets are as follows:
Cash equivalents
Short-term marketable securities
Long-term marketable securities
Total marketable securities
Year Ended December 31,
2020
2021
(in thousands)
$
$
45,088 $
145,918
112,277
303,283 $
50,524
364,506
36,196
451,226
The following table presents our available-for-sale securities grouped by asset type:
December 31, 2021
December 31, 2020
Fair Value
Hierarchy
Level
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Estimated Fair
Value
Amortized
Cost
(in thousands)
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Estimated Fair
Value
Corporate bonds
Commercial paper
Asset-backed securities
U.S. Treasury securities
Money market funds
Total Marketable securities
Level 2
Level 2
Level 2
Level 1
Level 1
$
$
125,370
30,963
57,801
44,473
45,088
303,695
$
$
3
—
—
—
—
3
$
$
(276)
—
(67)
(72)
—
(415)
$
$
125,097
30,963
57,734
44,401
45,088
303,283
$
$
96,999
139,791
39,243
124,461
50,524
451,018
$
$
74
—
15
131
—
220
$
$
(9)
—
(1)
(2)
—
(12)
$
$
97,064
139,791
39,257
124,590
50,524
451,226
We estimate the fair value of marketable securities classified as Level 1 using quoted market prices for these or identical investments obtained from
a commercial pricing service. We estimate the fair value of marketable securities classified as Level 2 using inputs that may include benchmark yields,
reported trades, broker/dealer quotes and issuer spreads.
We periodically review our debt securities to determine if any of our investments is impaired due to credit-related or other issues. If the fair value of
our investment in any debt security is less than our amortized cost basis, we determine whether an allowance for credit losses is appropriate by assessing
quantitative and subjective factors including, but not limited to, the nature of security, changes in credit ratings, analyst reports concerning the security’s
issuer and industry, interest rate fluctuations and general market conditions.
Unrealized losses on our available-for-sale debt securities as of December 31, 2021 were not material. Accordingly, we have not recorded an
allowance for credit losses associated with these investments.
During the three months ended December 31, 2021, we sold $50.5 million of investments to fund the tender offer. We recognized realized losses of
less than $0.1 million from these sales. We do not intend to sell our remaining investments that are currently in an unrealized loss position, and it is highly
unlikely that we will be required to sell the investments before recovery of their amortized cost basis, which may be at maturity.
We classified accrued interest on our marketable securities of $1.4 million and $1.3 million as of December 31, 2021 and 2020, respectively, as
prepaid and other current assets on our consolidated balance sheets.
As of December 31, 2021, all our marketable securities had original maturities of less than two years. The weighted-average maturity of our
holdings was eight months. As of December 31, 2021, our long-term marketable securities had remaining maturities ranging from 13 to 19 months. None
of our marketable securities changed from one fair value hierarchy to another during the year ended December 31, 2021.
14
CORCEPT THERAPEUTICS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued
4. Composition of Certain Balance Sheet Items
Inventory
Raw materials
Work in progress
Finished goods
Total inventory
Less strategic inventory classified as non-current
Total inventory classified as current
Year Ended December 31,
2020
2021
(in thousands)
— $
11,450
6,500
17,950
(12,962)
4,988 $
1,685
12,916
6,556
21,157
(16,247)
4,910
$
$
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
Furniture and equipment
Software
Leasehold improvements
Less accumulated depreciation
Property and equipment, net of accumulated depreciation
Accrued and other liabilities
Accrued compensation
Government rebates
Accrued selling and marketing costs
Legal fees
Income taxes payable
Professional fees
Other
Total accrued and other liabilities
Other assets
Year Ended December 31,
2020
2021
(in thousands)
1,157 $
1,508
1,262
3,927
(2,925)
1,002 $
Year Ended December 31,
2020
2021
(in thousands)
13,339 $
11,174
1,351
842
513
150
296
27,665 $
810
1,485
1,233
3,528
(1,853)
1,675
10,144
9,412
665
612
—
151
202
21,186
$
$
$
$
As of December 31, 2021 and 2020, other assets included $2.9 million and $4.8 million of deposits for clinical trials, respectively.
15
CORCEPT THERAPEUTICS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued
5. Leases
We lease our office facilities in Menlo Park, California. In October 2019, we amended the lease to extend its term from March 31, 2020 to March 31,
2022 and to add more space beginning April 1, 2020. In June 2020, we amended our lease commencement date for additional space to June 15, 2020. As a
result of this amendment, we recognized an additional right-of-use asset and corresponding lease liability of $0.8 million. The right-of-use asset and lease
liability recognized equals the present value of the remaining payments due under our amended lease.
As the operating lease for our facilities does not include an expressly stated interest rate, we calculated the present value of remaining lease
payments using a discount rate equal to the interest rate we would pay on a 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, 2021, 2020 and 2019 was approximately $2.1 million, $1.9 million and $1.5 million,
respectively.
Our right-of-use assets and related lease liabilities were as follows:
Cash paid for operating lease liabilities
Right-of-use assets obtained in connection with operating lease obligations
Weighted-average remaining lease term (months)
Weighted-average discount rate
Year Ended December 31,
2021
2020
(in thousands)
$
$
$
$
2,104
—
3 months
4.8 %
1,840
775
15 months
4.8 %
As of December 31, 2021, future minimum lease payments under non-cancelable operating leases were as follows (in thousands):
2022
Less imputed interest
Total operating lease liabilities
6. Related Party Transactions
$
$
530
530
(4)
526
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, 2021, 2020, and 2019.
7. Preferred Stock and Stockholders’ Equity
Preferred Stock
Our Board of Directors is authorized, subject to any limitations prescribed by law, without stockholder approval, to issue up to an aggregate of
10,000,000 shares of preferred stock at $0.001 par value in one or more series and to fix the rights, preferences, privileges and restrictions granted to or
imposed upon the preferred stock, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences. The rights
of the holders of common stock will be subject to the rights of holders of any preferred stock that may be issued in the future. As of December 31, 2021 and
2020, we had no outstanding shares of preferred stock.
16
CORCEPT THERAPEUTICS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued
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 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.
During the year ended December 31, 2019, we purchased 2.8 million shares of common stock at a cost of $31.0 million under a stock repurchase
program that expired on June 30, 2019.
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.
During the years ended December 31, 2021, 2020 and 2019, we issued 4.6 million, 2.8 million and 2.9 million shares, respectively, of our common
stock upon the exercise of stock options.
We have never declared or paid any dividends.
Shares of common stock reserved for future issuance as of December 31, 2021 are as follows:
Common stock:
Exercise of outstanding options
Shares available for grant under stock option plans
(in thousands)
24,453
9,571
34,024
On February 4, 2021, our Board of Directors authorized an increase of 4.7 million shares in the number of shares available under the 2012 Equity
Incentive Plan (the “2012 Plan”), which was equivalent to 4% of the shares of our common stock outstanding at December 31, 2020. On December 2,
2021, our Board of Directors authorized, effective January 1, 2022, an additional increase of 4.2 million shares available under the 2012 Plan, which is
equivalent to 4% of the shares of our common stock outstanding at December 31, 2021.
Stock Option Plans
We have two stock option plans – the 2004 Equity Incentive Plan (the “2004 Plan”) and the 2012 Plan.
In 2004, our Board of Directors and stockholders approved the 2004 Plan, which became effective upon the completion of our initial public offering.
Under the 2004 Plan, options, stock purchase and stock appreciation rights and restricted stock awards can be issued to our employees, officers, directors
and consultants. The 2004 Plan provided that the exercise price for incentive stock options will be no less than 100% of the fair value of the Company’s
common stock, as of the date of grant. Options granted under the 2004 Plan vest over periods ranging from one year to five years. The vesting period of the
options is generally equivalent to the requisite service period.
In 2012, our Board of Directors and stockholders approved the 2012 Plan. As of the effective date of the 2012 Plan, 5.3 million shares that remained
available for issuance of new grants under the 2004 Plan were transferred to the 2012 Plan. After that date, no additional options were or will be issued
under the 2004 Plan. Vested options under the 2004 Plan that are not exercised within the remaining contractual life and any options under the 2004 Plan
that do not vest because of terminations after the effective date of the 2012 Plan will be added to the pool of shares available for future grants under the
2012 Plan.
17
CORCEPT THERAPEUTICS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued
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.
Upon exercise of options, new shares are issued.
Option activity during 2021
The following table summarizes all activity under the 2004 Plan and the 2012 Plan:
Outstanding Options
Shares
Available For
Future Grant
(in thousands)
Options
Shares
Subject to
Options
Outstanding
(in thousands)
Weighted-
Average
Exercise
Price
Weighted-
Average
Remaining
Contractual
Life
(in years)
Aggregate
Intrinsic
Value
(in thousands)
9,041
4,669
(5,460)
—
1,321
9,571
24,946 $
—
5,460 $
(4,632) $
(1,321) $
24,453 $
16,532 $
9.62
26.75
6.92
18.07
13.50
10.20
6.39 $
188,820
5.33 $
165,487
23,868 $
13.31
6.34 $
187,250
Balance at December 31, 2020
Increase in shares authorized for grant
Shares granted
Shares exercised
Shares canceled and forfeited
Balance at December 31, 2021
Options exercisable at December 31, 2021
Options fully vested and expected to vest
at December 31, 2021
The total intrinsic value of options exercised during the years ended December 31, 2021, 2020 and 2019 was $78.9 million, $28.8 million and $26.6
million, respectively, based on the difference between the closing price of our common stock on the date of exercise of the options and the exercise price.
The total fair value of options that vested during the years ended December 31, 2021, 2020 and 2019 was $40.4 million, $34.0 million and $30.2
million, respectively.
Stock-Based Compensation related to Employee and Director Options
The following table summarizes the weighted-average assumptions and resultant fair value-based measurements for options granted to employees
and directors.
Weighted-average assumptions for stock options granted:
Risk-free interest rate
Expected term
Expected volatility of stock price
Dividend rate
Weighted-average grant date fair value-based measurement
18
Year Ended December 31,
2020
2021
2019
0.76%
6.3 years
60.7%
0%
$15.06
1.20%
6.0 years
59.1%
0%
$7.55
2.34%
6.0 years
67.4%
0%
$7.09
CORCEPT THERAPEUTICS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued
The expected term of options reflected in the table above has been based on a formula that considers the expected service period and expected post-
vesting termination behavior depending on whether the option holder is an employee, officer or director.
The expected volatility of our stock used in determining the fair value-based measurement of option grants to employees, officers and directors is
based on the volatility of our stock price. The volatility is based on historical data of the price for our common stock for periods of time equal to the
expected term of these grants.
We calculate employee stock-based compensation expense using the number of options we expect to vest, based on our estimate of the option
grantees’ average length of employment, and reduced by our estimate of option forfeitures. We estimate forfeitures at the time of option grant and revise
this estimate in subsequent periods if actual forfeitures differ from our estimates.
As of December 31, 2021, we had $80.0 million of unrecognized compensation expense for employee and director options outstanding, which had a
weighted-average remaining vesting period of 2.76 years.
Summary of Stock-based Compensation
The following table presents a summary of stock-based compensation by financial statement classification.
Stock-based compensation capitalized in inventory
Cost of sales
Research and development
Selling, general and administrative
Total stock-based compensation
8. Net Income Per Share
2021
Year Ended December 31,
2020
(in thousands)
2019
$
$
237 $
59
14,106
28,766
43,168 $
238 $
66
11,222
22,251
33,777 $
120
144
9,541
19,628
29,433
We compute basic and diluted net income per share by dividing our net income by the weighted-average number of common shares outstanding
during the period. We used the treasury stock method to determine the number of dilutive shares of common stock resulting from the potential exercise of
stock options. The statements of consolidated comprehensive income show the computation of net income per share for each period, including the number
of weighted-average shares outstanding.
The following table shows the computation of net income per share for each period:
2021
Year Ended December 31,
2020
(in thousands, except per share data)
2019
Numerator:
Net income
Denominator:
Weighted-average shares used to compute basic net income per share
Dilutive effect of employee stock options
Weighted-average shares used to compute diluted net income per share
Net income per share
Basic
Diluted
$
$
$
112,512 $
106,011 $
94,181
115,653
10,310
125,963
115,412
8,782
124,194
0.97 $
0.89 $
0.92 $
0.85 $
114,349
8,217
122,566
0.82
0.77
19
CORCEPT THERAPEUTICS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued
Because including them would have reduced dilution, we excluded from the computation of diluted net income per share, on a weighted-average
basis 4.5 million, 11.2 million and 9.9 million stock options outstanding during the years ended December 31, 2021, 2020, and 2019, respectively,
9. Income Taxes
The domestic and foreign components of income before income taxes were as follows:
Domestic
Foreign
Income before income taxes
2021
Year Ended December 31,
2020
(in thousands)
2019
$
$
126,308 $
(1,302)
125,006 $
131,634 $
(32)
131,602 $
116,676
—
116,676
The income tax expense for the years ended December 31, 2021, 2020, and 2019 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
2021
Year Ended December 31,
2020
(in thousands)
2019
$
$
$
$
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 $
1,716
15,944
17,660
3,900
935
4,835
—
—
—
22,495
20
CORCEPT THERAPEUTICS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial
reporting purposes and the amounts used for income tax purposes. Significant components of our deferred tax assets are as follows:
Deferred tax assets:
Federal and state net operating losses
Capitalized research and patent costs
Research credits
Stock-based compensation costs
Operating lease liability
Other
Total deferred tax assets
Valuation allowance
Deferred tax liabilities
Operating lease right-of-use asset
Total deferred tax liabilities
Net deferred tax assets
Year Ended December 31,
2020
2021
(in thousands)
5,377 $
3,412
9,953
17,831
130
3,851
40,554
(12,972)
(127)
(127)
27,455 $
5,412
5,139
15,107
14,043
630
3,473
43,804
(11,581)
(620)
(620)
31,603
$
$
Each quarter, we assess the likelihood that we will generate sufficient taxable income to use our federal and state deferred tax assets. If we believe
that recovery of these deferred tax assets is not more likely than not, we will establish a valuation allowance. Significant judgment is required in
determining any valuation allowance recorded against deferred tax assets. In assessing the need for a valuation allowance, we consider all available
evidence, including recent operating results, projections of future taxable income, our ability to utilize net operating losses and tax credit carryforwards,
and the feasibility of tax planning strategies. Other than valuation allowances against our California net deferred tax assets, we have determined that it is
more likely than not we will realize the benefit related to all other deferred tax assets. If we increase a valuation allowance, we will include an expense of
equal amount in the Condensed Consolidated Statement of Comprehensive Income in the period in which such determination is made.
The valuation allowance increased by $1.4 million, $0.2 million and $0.2 million for the years ended December 31, 2021, 2020 and 2019,
respectively.
At December 31, 2021, we had California net operating loss carryforwards of $75.2 million, which will begin to expire in the year 2031, and net
operating loss carryforwards from other states of $2.2 million, which will begin to expire in the year 2035 if not utilized. On June 29, 2020, the California
governor signed Assembly Bill 85 (“AB 85”) into law. AB 85 limits the use of business incentive tax credits and suspends the use of California net
operating losses for 2020, 2021 and 2022 for companies with California-sourced taxable income of $1 million or more. AB 85 will not have a material
impact on our consolidated financial statements.
At December 31, 2021, we also had federal research and development tax credits of $5.7 million and orphan drug tax credits of $3.8 million,
respectively, and California research and development credits of $10.5 million. The federal research credits will expire in the years 2040 through 2041 and
the California research credits have no expiration date.
21
CORCEPT THERAPEUTICS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued
The following table presents a reconciliation from the statutory federal income tax rate to the effective rate.
U.S. federal taxes at statutory rate
R&D and other credits
State income taxes, net of federal benefit
Non-deductible compensation
Stock-based compensation
Other
Total
2021
Year Ended December 31,
2020
(in thousands)
2019
$
$
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 $
24,502
(4,504)
3,819
657
(2,107)
128
22,495
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
2021
Year Ended December 31,
2020
(in thousands)
2019
$
$
7,471 $
103
—
1,663
—
9,237 $
6,029 $
158
—
1,284
—
7,471 $
4,756
261
—
1,012
—
6,029
As of December 31, 2021, the amount of unrecognized tax benefits that would favorably impact the effective tax rate were approximately $7.5
million, and approximately $1.7 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 immaterial
amounts of accrued interest and no accrued penalties related to unrecognized tax benefits as of December 31, 2021, 2020 and 2019. 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 2021 remain open and
subject to tax examination by the appropriate federal or state taxing authorities.
10. Commitments and contingencies
We have entered into a number of agreements to purchase API for the manufacturing of relacorilant, miricorilant and exicorilant. We have also
entered into agreements to perform clinical studies on miricorilant and dazucorilant (formerly, “CORT113176”). 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 150 kilograms of API
from PCAS for a total price of $2.0 million. As of December 31, 2021, there remained a $2.0 million obligation in connection with this purchase
commitment.
22
CORCEPT THERAPEUTICS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, Continued
In January 2022, we committed to purchase an additional 75 kilograms of API from PCAS for a total price of $0.9 million.
In the ordinary course of business, we may be subject to legal claims and regulatory actions that could have a material adverse effect on our business
or financial position. We assess our potential liability in such situations by analyzing the possible outcomes of various litigation, regulatory and settlement
strategies. If we determine a loss is probable and its amount can be reasonably estimated, we accrue an amount equal to the estimated loss.
No losses and no provision for a loss contingency have been recorded to date.
23
Exhibit 10.1
William Guyer
Re: Offer of Employment at Corcept Therapeutics Incorporated
Dear Bill:
We are very pleased to invite you to join Corcept Therapeutics Incorporated (the “Company”) in the role of Chief Development Officer,
contingent upon the satisfactory completion of a background check.
Duties and Responsibilities. Your initial assignment will be as Chief Development Officer reporting to Joseph K. Belanoff, M.D., Chief
Executive Officer. This offer is for a full-time position starting September 7, 2021, or such other date as we mutually agree.
Salary. Your initial annual base salary will be $550,000 for full-time employment, payable in accordance with the Company's customary payroll
practice. Salary is subject to periodic review and adjustment by the Company's management.
Bonus. You will be eligible for an at-risk, target bonus of 45% of your base salary, payable in accordance with the Company's customary payroll
practices.
Stock Options. You will receive an option to purchase up to 500,000 shares of the Company’s Common Stock under the terms of the Company's
2012 Incentive Award Plan with an exercise price equal to the closing price of the Company’s stock on October 1, 2021 and that will vest according to the
following schedule: 25 percent of the option shares after one year of continuous full-time employment and an additional 1/48th of the option shares each
succeeding month of full-time employment during the term of the option. (If at any time in the future your employment status changes from full-time to
parttime, there may be a proportionate reduction of the option shares that have not yet vested at the time of such change in status)
Medical, Dental and Insurance Benefits. You will be eligible to receive the Company's standard employee benefits package. Enclosed is a
summary sheet outlining the Company’s current benefit plans. For more specific information regarding our current benefit plans please contact me.
Vacation and Holidays. You will be entitled to take all paid holidays under the Company’s then-current schedule. In addition, it is expected that
you will take an appropriate amount of paid vacation, commensurate with your seniority and your job responsibilities.
Location. As a general rule, you will work at the Company’s principal offices in Menlo Park. Your position may also require travel to other
locations as may be necessary to fulfill your responsibilities. The Company will reimburse your reasonable and necessary travel expenses under its standard
travel reimbursement policy.
Confidential Information; Employee Confidential Information and Inventions Agreement. To enable the Company to safeguard its
proprietary and confidential information, it is a condition of employment that you agree to sign the Company's standard form of “Employee Confidential
Information and Inventions Agreement.” A copy of this agreement is enclosed. Please review, sign and return to us on your first day of employment. We
understand that you may have signed similar agreements with prior employers and wish to impress upon you that Corcept does not want to receive the
confidential or proprietary information of others. We will support you in respecting your lawful obligations to prior employers. If you have any questions
about this, do not hesitate to ask.
At-Will Employment. While we look forward to a long and mutually beneficial relationship, should you decide to accept our offer you will be an
“at-will” employee of the Company. This means that either you or the Company may terminate the employment relationship with or without cause at any
time. Participation in any stock option, benefit or incentive program does not assure continuing employment for any particular period of time.
Severance Agreement and Indemnification. Pursuant to separate agreements, you will receive payments equivalent to those received by
Corcept’s other executive officers in the event of your voluntary or involuntary termination as well as equivalent indemnification protections.
Authorization to Work. Federal government regulations require that all prospective employees present documentation of their identity and
demonstrate that they are authorized to work in the United States. Enclosed is the federal Form I-9 you must complete to satisfy this requirement. Please
bring with you to Corcept on your start date the proof of identity / work status required by Form I-9. We also require that you provide a certification
confirming that you have been vaccinated against the virus that causes COVID-19.
Complete Offer and Agreement. This letter contains our complete understanding of the terms of your employment by the Company. We have
with you no other, different or prior agreements or understandings on this or related subjects. Changes to the terms of your employment can be made only
in a writing signed by you and an authorized executive of the Company.
Start Date; Acceptance of Offer. We hope that you will accept this offer. If it is acceptable to you, sign in the space below and return this letter to
me at crobb@corcept.com. If you have any questions, please feel free to call me.
Very truly yours,
Signature:
Name
Title
/s/ Charlie Robb
Charlie Robb
Chief Business Officer
I accept the offer of employment by Corcept Therapeutics Incorporated on the terms described in this letter.
Signature:
Date:
/s/ Bill Guyer
07/02/2021
Exhibit 10.2
SEVERANCE AND CHANGE IN CONTROL AGREEMENT
THIS SEVERANCE AND CHANGE IN CONTROL AGREEMENT (“Agreement”) dated as of February 9, 2022 (the “Effective Date”) is
entered into by and between William Guyer, Chief Development Officer (“OFFICER”) and Corcept Therapeutics Incorporated, a Delaware corporation
(the “Company”).
WITNESSETH:
WHEREAS, OFFICER is a senior executive of the Company and is expected to continue to make major contributions to the short and long term
profitability, growth and financial strength of the Company;
WHEREAS, the Company recognizes that, as is the case for most publicly held companies, the possibility of a Change in Control (as defined
below) exists;
WHEREAS, the Company desires to assure itself of both present and future continuity of management;
WHEREAS, the Company wishes to ensure that OFFICER is not practically disabled from discharging his duties in respect of a proposed or
actual transaction involving a Change in Control; and
WHEREAS, the Company desires to provide additional inducement for OFFICER to continue to remain in the employ of the Company.
NOW, THEREFORE, in exchange for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the
Company and OFFICER agree as follows:
1. Certain Defined Terms. In addition to terms defined elsewhere herein, the following terms have the following meanings when used in this
Agreement with initial capital letters:
a.
“Board” shall mean the Board of Directors of the Company.
b.
“Cause” shall mean (i) OFFICER’s gross negligence or willful misconduct in the performance of his duties to the Company where
such gross negligence or willful misconduct has resulted or is likely to result in material damage to the Company or its subsidiaries; (ii)
OFFICER’s willful and habitual neglect of his or her duties of consulting or employment; (iii) OFFICER’s commission of any act of
fraud with respect to the Company; (iv) OFFICER’s conviction of or plea of guilty or nolo contendere to felony criminal conduct or any
crime involving moral turpitude; or (v) OFFICER’s violation of any noncompetition or confidentiality agreement that OFFICER has
entered into with the Company.
c. The term “Change in Control” shall mean: (i) the liquidation, dissolution or winding up of the Company; (ii) any consolidation or
merger of the Company with or into any other corporation or other entity or person, or any other corporate reorganization in which the
Company’s stockholders immediately prior to such transaction do not hold more than fifty percent (50%) of the voting power of the
surviving or acquiring entity (or its parent) immediately following such transaction (taking into account only voting power resulting from
stock held by such stockholders prior to such transaction); (iii) any transaction or series of related transactions to which the Company is a
party in which in excess of fifty percent (50%) of the Company’s voting power outstanding before such transaction is transferred or (iv) a
sale, conveyance or other disposition of all or substantially all of the assets of the Company (including without limitation a license of all
or substantially all of the Company’s intellectual property that is either exclusive or otherwise structured in a manner that constitutes a
license of all or substantially all of the assets of the Company); provided that a Change in Control shall not include (A) a merger or
consolidation with a wholly-owned subsidiary of the Company, (B) a merger effected exclusively for the purpose of changing the
domicile of the Company or (C) any transaction or series of related transactions principally for bona fide equity financing purposes.
d.
“Good Reason” shall mean any of the following events which OFFICER provides written notice to the Company of within 90 days
of such event having occurred and which is not cured by the Company within 30 days after such written notice thereof is provided to the
Company by OFFICER: (i) any reduction of OFFICER’s base salary or target annual bonus; (ii) any involuntary relocation of
OFFICER’s principal workplace to a location more than 35 miles in any direction from OFFICER’s current principal workplace, (iii) a
substantial and material adverse change, without OFFICER’s written consent, in OFFICER’s title, authority, responsibility or duties; or
(iv) any material breach by the Company of any provision of this
Agreement or any other employment agreement, after written notice delivered to the Company of such breach and the Company’s failure
to cure such breach; provided, however, in the context of a Change in Control, OFFICER shall not have Good Reason to resign in
connection with a reorganization of the Company in which the executive would retain substantially similar title, authority, duties, base
pay and bonus but might have greater or lesser reporting responsibilities. In order to constitute a termination of employment for Good
Reason, OFFICER’s employment must be terminated no later than 180 days following the initial occurrence of any events set forth
above.
2. Terminations Without Cause or for Good Reason. If OFFICER’s employment shall terminate involuntarily without Cause or for Good Reason, the
Company shall provide OFFICER with severance payments and benefits pursuant to this Section 2.
a. Terminations Not in Connection with a Change in Control. If OFFICER’s employment shall terminate involuntarily without Cause or for
Good Reason, prior to a Change in Control or more than eighteen (18) months following a Change in Control, the Company shall provide
OFFICER with the following severance payments and benefits in lieu of any severance benefits to which the OFFICER may otherwise be
entitled to under any severance plan or program maintained by the Company:
i.
ii.
Severance Payments: Pay to OFFICER an amount equal to twelve (12) months then current base salary, payable in substantially
equal installments in accordance with the Company’s customary payroll practices and procedures. The continuation of your base
salary shall be paid beginning on the sixtieth (60th) day following the date of termination, all payments deferred pursuant to this
sentence shall be paid in a lump sum to OFFICER and any remaining payments due under this paragraph shall be paid as
otherwise provided herein.
Continued Benefits. If OFFICER elects to continue his health insurance coverage under the Consolidated Omnibus Budget
Reconciliation Act of 1985, as amended (“COBRA”) following such termination, then the Company shall pay OFFICER’s
monthly COBRA premium for continued health insurance coverage for OFFICER and OFFICER’s eligible dependents until the
earlier of (i) twelve (12) months following the termination date, or (ii) the date upon which OFFICER and his eligible
dependents become eligible for comparable coverage under a group health insurance plan maintained by subsequent employer.
b. Terminations in Connection with a Change in Control. If OFFICER’s employment shall terminate involuntarily without Cause or for
Good Reason, within eighteen (18) months following a Change in Control, the Company shall provide OFFICER with the following
severance payments and benefits in lieu of any severance benefits to which the OFFICER may otherwise be entitled to under any
severance plan or program maintained by the Company:
i.
ii.
iii.
Severance Payments: Pay to OFFICER an amount equal to twelve (12) months then current base salary, payable in a lump sum
on the sixtieth (60th) day following the termination of employment.
Continued Benefits. If OFFICER elects to continue his health insurance coverage under COBRA following such termination,
then the Company shall pay OFFICER’s monthly COBRA premium for continued health insurance coverage for OFFICER and
OFFICER’s eligible dependents until the earlier of (i) twelve (12) months following the termination date, or (ii) the date upon
which OFFICER and his eligible dependents become eligible for comparable coverage under a group health insurance plan
maintained by subsequent employer.
Equity Awards. Notwithstanding any provision to the contrary in any equity award agreement or equity compensation plan, the
Company shall cause all outstanding equity awards then held by OFFICER (including, without limitation, stock options, stock
appreciation rights, phantom shares, restricted stock or similar awards) to become fully vested and, if applicable, exercisable
with respect to all the shares subject thereto effective immediately prior to the date of termination. In all other respects, such
awards will continue to be subject to the terms and conditions of the plans, if any, under which they were granted and any
applicable agreements between the Company and OFFICER.
c. Notwithstanding anything to the contrary in this Section 2, in the event that the Company, or its successor, requests OFFICER to continue
to serve in the same position following a Change in Control for a six (6)-month (or shorter) transition period (“Transition Period”),
OFFICER shall not have Good Reason to resign pursuant to Section 1(d)(iii) during such Transition Period regardless if OFFICER’s title,
authority,
responsibility or duties have been materially reduced; provided that during such Transition Period OFFICER continues to be paid the
same salary and be provided with the same bonus opportunity, if any, as in effect immediately prior to such Change in Control and
OFFICER’s principal workplace is not relocated more than 35 miles from its location immediately prior to such Change in Control.
Following the Transition Period, OFFICER may resign for Good Reason pursuant to Section 1(d)(iii) and be entitled to the benefits set
forth in Section 2(b).
3. Conditions to Receipt of Severance.
a. Separation Agreement and Release of Claims. The receipt of any severance pursuant to Section 2 will be subject to OFFICER signing
and not revoking a separation agreement and release of claims in a form reasonably acceptable to the Company within sixty (60) days
following OFFICER’s termination of employment. No severance pursuant to Section 2 will be paid or provided until the separation
agreement and release of claims becomes effective.
b. Section 409A. Notwithstanding anything contained in this Agreement to the contrary, to the maximum extent permitted by applicable
law, amounts payable to OFFICER pursuant to Section 2 shall be made in reliance upon Treas. Reg. Section 1.409A-1(b)(9) (Separation
Pay Plans) or Treas. Reg. Section 1.409A-1(b)(4) (Short-Term Deferrals). For this purpose each installment or monthly payment to which
OFFICER is entitled under Section 2 shall be considered a separate and distinct payment. In addition, (i) no amount deemed deferred
compensation subject to Section 409A shall be payable pursuant to Section 2 unless the OFFICER’s termination of employment
constitutes a “separation from service” within the meaning of Treas. Reg. Section 1.409A-1(h) and (ii) if the OFFICER is deemed at the
time of his separation from service to be a “specified employee” for purposes of Section 409A(a)(2)(B)(i) of the Code, then to the extent
delayed commencement of any portion of the termination benefits to which OFFICER is entitled under this Agreement is required in
order to avoid a prohibited distribution under Section 409A(a)(2)(B)(i) of the Code, such portion of OFFICER’s termination benefits
shall not be provided to OFFICER prior to the earlier of (A) the expiration of the six-month period measured from the date of the
OFFICER’s “separation from service” with the Company (as such term is defined in the Treasury Regulations issued under Section 409A
of the Code) or (B) the date of OFFICER’s death. Upon the earlier of such dates, all payments deferred pursuant to this Section 3(b) shall
be paid in a lump sum to OFFICER, and any remaining payments due under the Agreement shall be paid as otherwise provided herein.
The determination of whether OFFICER is a “specified employee” for purposes of Section 409A(a)(2)(B)(i) of the Code as of the time of
his separation from service shall be made by the Company in accordance with the terms of Section 409A of the Code and applicable
guidance thereunder (including without limitation Treas. Reg. Section 1.409A-1(i) and any successor provision thereto). The
reimbursement of any expense under this Agreement shall be made no later than December 31 of the year following the year in which the
expense was incurred. The amount of expenses reimbursed in one year shall not affect the amount eligible for reimbursement in any
subsequent year.
4. Successors and Binding Agreement.
a. The Company will require any successor (whether direct or indirect, by purchase, merger, consolidation, reorganization or otherwise,
including, without limitation, any successor due to a Change in Control) to the business or assets of the Company, by agreement in form
and substance reasonably satisfactory to OFFICER, expressly to assume and agree to perform this Agreement in the same manner and to
the same extent the Company would be required to perform if no such succession had taken place. This Agreement will be binding upon
and inure to the benefit of the Company and any successor to the Company, including, without limitation, any persons directly or
indirectly acquiring the business or assets of the Company in a transaction constituting a Change in Control (and such successor shall
thereafter be deemed the “Company” for the purpose of this Agreement), but will not otherwise be assignable, transferable or delegable
by the Company.
b. This Agreement will inure to the benefit of and be enforceable by OFFICER’s personal or legal representatives, executors,
administrators, successors, heirs, distributees and legatees.
c. This Agreement is personal in nature and neither of the parties hereto shall, without the consent of the other, assign, transfer or delegate
this Agreement or any rights or obligations hereunder except as expressly provided in Sections 4(a) and 4(b). Without limiting the
generality or effect of the foregoing, OFFICER’s right to receive payments hereunder will not be assignable, transferable or delegable,
whether by pledge, creation of a security interest, or otherwise, other than by a transfer by OFFICER’s will or by the laws of descent and
distribution and, in the event of any attempted assignment or transfer contrary to this Section
4(c), the Company shall have no liability to pay any amount so attempted to be assigned, transferred or delegated.
5. Amendment or Termination of Agreement. This Agreement may be changed or terminated only upon the mutual written consent of the Company
and OFFICER. The written consent of the Company to a change or termination of this Agreement must be signed by an executive officer of the
Company after such change or termination has been approved by the Board.
6. Notices. For all purposes of this Agreement, all communications, including without limitation notices, consents, requests or approvals, required or
permitted to be given hereunder will be in writing and will be deemed to have been duly given when hand delivered or dispatched by electronic
facsimile transmission (with receipt thereof orally confirmed), or five business days after having been mailed by United States registered or
certified mail, return receipt requested, postage prepaid, or three business days after having been sent by a nationally recognized overnight courier
service such as FedEx, UPS, or DHL, addressed to the Company (to the attention of the Secretary of the Company) at its principal executive office
and to OFFICER at his principal residence, or to such other address as any party may have furnished to the other in writing and in accordance
herewith, except that notices of changes of address shall be effective only upon receipt.
7. Validity. If any provision of this Agreement or the application of any provision hereof to any person or circumstances is held invalid,
unenforceable or otherwise illegal, the remainder of this Agreement and the application of such provision to any other person or circumstances
will not be affected, and the provision so held to be invalid, unenforceable or otherwise illegal will be reformed to the extent (and only to the
extent) necessary to make it enforceable, valid or legal.
8. Governing Law; Jurisdiction. The laws of the state of California shall govern the interpretation, validity and performance of the terms of this
Agreement, regardless of the law that might be applied under principles of conflicts of law. Any suit, action or proceeding against OFFICER, with
respect to this Agreement, or any judgment entered by any court in respect of any of such, may be brought in any court of competent jurisdiction
in the State of California, and OFFICER hereby submits to the jurisdiction of such courts for the purpose of any such suit, action, proceeding or
judgment.
9. Miscellaneous. No provision of this Agreement may be modified, waived or discharged unless such waiver, modification or discharge is agreed to
in writing signed by OFFICER and the Company. No waiver by either party hereto at any time of any breach by the other party hereto or
compliance with any condition or provision of this Agreement to be performed by such other party will be deemed a waiver of similar or
dissimilar provisions or conditions at the same or at any prior or subsequent time. This Agreement constitutes the entire agreement of the parties
with respect to the subject matter hereof and supersedes any and all prior agreements of the parties with respect to such subject matter. No
agreements or representations, oral or otherwise, expressed or implied with respect to the subject matter hereof have been made by either party
which are not set forth expressly in this Agreement. References to Sections are to references to Sections of this Agreement.
10. Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemed to be an original but all of which
together will constitute one and the same agreement.
11. Interpretation. The parties acknowledge and agree that, to the extent applicable, this Agreement shall be interpreted in accordance with, and the
parties agree to use their best efforts to achieve timely compliance with, Section 409A of the Code, and the Department of Treasury Regulations
and other interpretive guidance issued thereunder, including, without limitation, any such regulations or other guidance that may be issued after
the Effective Date. Notwithstanding any provision of this Agreement to the contrary, in the event that the Company determines that any amounts
payable hereunder would otherwise be taxable to OFFICER under Section 409A, the Company may adopt such limited amendments to this
Agreement and appropriate policies and procedures, including amendments and policies with retroactive effect, that the Company reasonably
determines are necessary or appropriate to comply with the requirements of Section 409A and thereby avoid the application of taxes under such
Section.
IN WITNESS WHEREOF, the parties have caused this Agreement to be duly executed and delivered as of the date first above written.
CORCEPT THERAPEUTICS INCORPORATED
/s/ Joseph K. Belanoff
Joseph K. Belanoff, M.D.
Chief Executive Officer
/s/ William Guyer
William Guyer
Chief Development Officer
CORCEPT THERAPEUTICS INCORPORATED
2012 INCENTIVE AWARD PLAN
STOCK OPTION GRANT NOTICE
Exhibit 10.14
Corcept Therapeutics Incorporated, a Delaware corporation, (the “Company”), pursuant to its 2012 Incentive Award Plan, as it may be amended from time
to time (the “Plan”), hereby grants to the holder listed below (“Participant”), an option to purchase the number of shares of the Company’s common stock,
par value $0.001 (“Stock”), set forth below (the “Option”). This Option is subject to all of the terms and conditions set forth herein, as well as in the Plan,
the Stock Option Agreement attached hereto as Exhibit A (the “Stock Option Agreement”), and the Special Provisions for Stock Options Granted to
Participants Outside the U.S. (as applicable) attached hereto as Exhibit B (the “Non-U.S. Provisions”), each of which are incorporated herein by reference.
Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Grant Notice, the Stock Option Agreement and
the Non-U.S. Provisions.
Participant:
Grant Date:
Vesting Start Date:
Exercise Price per Share:
[ ]
[ ]
[ ]
$ [ ]
Total Number of Shares Subject to the Option:
[ ] shares
Expiration Date:
Vesting Schedule:
Type of Option:
[ ]
[To be specified in individual agreements]
[ ] Incentive Stock Option [ ] Nonstatutory Stock Option
By his or her signature and the Company’s signature below, Participant agrees to be bound by the terms and conditions of the Plan, the Stock Option
Agreement, the Non-U.S. Provisions and this Grant Notice. Participant has reviewed the Stock Option Agreement, the Plan, the Non-U.S. Provisions and
this Grant Notice in their entirety, has had an opportunity to obtain the advice of counsel prior to executing this Grant Notice and fully understands all
provisions of this Grant Notice, the Stock Option Agreement, the Non-U.S. Provisions and the Plan. Participant hereby agrees to accept as binding,
conclusive and final all decisions or interpretations of the Administrator upon any questions arising under the Plan, this Grant Notice, the Non-U.S.
Provisions or the Stock Option Agreement.
CORCEPT THERAPEUTICS INCORPORATED:
PARTICIPANT:
By:
Print Name:
Title:
Address:
By:
Print Name:
Address:
EXHIBIT A
TO STOCK OPTION GRANT NOTICE
CORCEPT THERAPEUTICS INCORPORATED STOCK OPTION AGREEMENT
Pursuant to the Stock Option Grant Notice (the “Grant Notice”) to which this Stock Option Agreement (this “Agreement”) is attached, Corcept
Therapeutics Incorporated, a Delaware corporation (the “Company”), has granted to Participant an Option under the Company’s 2012 Incentive Award
Plan, as it may be amended from time to time (the “Plan”), to purchase the number of shares of Stock indicated in the Grant Notice.
ARTICLE 1.
GENERAL
1.1 Defined Terms. Capitalized terms not specifically defined herein shall have the meanings specified in the Plan and the Grant Notice.
1.2 Incorporation of Terms of Plan. The Option is subject to the terms and conditions of the Plan which are incorporated herein by reference. In
the event of any inconsistency between the Plan and this Agreement, the terms of the Plan shall control.
ARTICLE 2.
GRANT OF OPTION
2.1 Grant of Option. In consideration of Participant’s past and/or continued employment with or service to the Company or a Subsidiary and for
other good and valuable consideration, effective as of the Grant Date set forth in the Grant Notice (the “Grant Date”), the Company grants to Participant the
Option to purchase any part or all of an aggregate of the number of shares of Stock set forth in the Grant Notice, upon the terms and conditions set forth in
the Plan and this Agreement, subject to adjustments as provided in Section 13.2 of the Plan. Unless designated as a Nonstatutory Stock Option in the Grant
Notice, the Option shall be an Incentive Stock Option to the maximum extent permitted by law.
2.2 Exercise Price. The exercise price per share of Stock subject to the Option shall be as set forth in the Grant Notice, without commission or
other charge; provided, however, that the exercise price per share of the Stock subject to the Option shall not be less than 100% of the Fair Market Value of
a share of Stock on the Grant Date. Notwithstanding the foregoing, if this Option is designated as an Incentive Stock Option and Participant owns (within
the meaning of Section 424(d) of the Code) more than 10% of the total combined voting power of all classes of stock of the Company or any “subsidiary
corporation” of the Company or any “parent corporation” of the Company (each within the meaning of Section 424 of the Code), the price per share of the
shares of Stock subject to the Option shall not be less than 110% of the Fair Market Value of a share of Stock on the Grant Date.
2.3 Consideration to the Company. In consideration of the grant of the Option by the Company, Participant agrees to render faithful and efficient
services to the Company or any Subsidiary. Nothing in the Plan or this Agreement shall confer upon Participant any right to continue in the employ or
service of the Company or any Subsidiary or shall interfere with or restrict in any way the rights of the Company and its Subsidiaries, which rights are
hereby expressly reserved, to discharge or terminate the services of Participant at any time for any reason whatsoever, with or without cause, except to the
extent expressly provided otherwise in a written agreement between the Company or a Subsidiary and Participant.
ARTICLE 3.
PERIOD OF EXERCISABILITY
3.1 Commencement of Exercisability.
(a) Subject to Sections 3.2, 3.3, 5.10 and 5.16 hereof, the Option shall become vested and exercisable in such amounts and at such times
as are set forth in the Grant Notice. In the event of a change in Participant’s employment status wherein there is a reduction in the number of his or
her hours per week, the Administrator may amend the vesting schedule of the Option, including but not limited to reducing the shares to be vested
on each following vesting date, without the consent of Participant, in the Administrator’s sole discretion.
(b) No portion of the Option which has not become vested and exercisable at the date of Participant’s Termination of Service shall
thereafter become vested and exercisable, except as may be otherwise provided by the Administrator or as set forth in a written agreement
between the Company and Participant.
(c) Notwithstanding Sections 3.1(a) hereof and the Grant Notice, but subject to Section 3.1(b) hereof, pursuant to Section 13.2 of the
Plan, the Option shall become fully vested and exercisable with respect to all shares of Stock covered thereby in the event of a Change in Control,
in connection with which the successor corporation does not assume the Option or substitute an equivalent right for the Option. Should the
successor corporation assume the Option or substitute an equivalent right, then no such acceleration shall apply. [In the event the Option is
assumed or substituted for an equivalent right, and the surviving or successor corporation terminates Participant’s employment or service without
Cause upon or within 12 months of a Change in Control, then the Participant shall be fully vested and exercisable in the assumed or substituted
1
Option.]
1
The bracketed sentence should be used for general employees. If Participant is a consultant, delete the bracketed sentence and replace with the following: “For the
avoidance of doubt, in the event the Option is assumed or substituted for an equivalent right, and the surviving or successor corporation terminates Participant’s service
without Cause, no acceleration shall apply to the Option”. If Participant is an officer, delete the bracketed sentence and replace with the following: “In the event the Option
is assumed or substituted for an equivalent right, and (i) the surviving or successor corporation terminates Participant’s employment or service without Cause or (ii)
Participant resigns for Good Reason (as defined below) upon or within 18 months of a Change in Control, then Participant shall be fully vested and exercisable in the
assumed or substituted Option. For purposes of this Agreement, “Good Reason” shall mean any of the following events which Participant provides written notice to the
surviving or successor corporation of within ninety (90) days of such event having occurred and which is not cured by the surviving or successor corporation within thirty
(30) days after such written notice thereof is provided to the surviving or successor corporation by Participant: (i) any reduction of Participant’s base salary or target annual
bonus; (ii) any involuntary relocation of Participant’s principal workplace to a location more than thirty five (35) miles in any direction from Participant’s current principal
workplace, (iii) a substantial and material adverse change, without Participant’s written consent, in Participant’s title, authority, responsibility or duties; or (iv) any material
breach by the surviving or successor corporation of any provision of this Agreement or any other agreement between the surviving or successor corporation and Participant,
after written notice delivered to the surviving or successor corporation of such breach and the surviving or successor corporation’s failure to cure such breach; provided,
however, Participant shall not have Good Reason to resign if Participant would retain substantially similar title, authority, duties, base pay and bonus but might have greater
or lesser reporting responsibilities. In order to constitute a termination of employment for Good Reason, Participant’s employment must be terminated no later than one
hundred eighty (180) days following the initial occurrence of any events set forth above.”
(d) Notwithstanding any provisions in this Agreement or the Plan to the contrary, if there is a conflict between Section 3.1(c) hereof and a
written agreement by and between Participant and the Company that contains a provision providing for the acceleration of the vesting of
Participant’s stock options in the event of a “change in control” or other similar term or a termination of employment or service within a certain
period of time following a “change in control,” then such provision in the written agreement shall control only with regard to the treatment of
Participant’s stock options in the event of a “change in control” or a termination of employment or service within a certain period of time
following a “change in control.”
3.2 Duration of Exercisability. The installments provided for in the vesting schedule set forth in the Grant Notice are cumulative. Each such
installment which becomes vested and exercisable pursuant to the vesting schedule set forth in the Grant Notice shall remain vested and exercisable until it
becomes unexercisable under Section 3.3 hereof.
3.3 Expiration of Option. The Option may not be exercised to any extent by anyone after the first to occur of the following events:
(a) The Expiration Date set forth in the Grant Notice, which shall in no event be more than ten (10) years from the Grant Date;
(b) If this Option is designated as an Incentive Stock Option and Participant owned (within the meaning of Section 424(d) of the Code),
at the time the Option was granted, more than 10% of the total combined voting power of all classes of stock of the Company or any “subsidiary
corporation” of the Company or any “parent corporation” of the Company (each within the meaning of Section 424 of the Code), the expiration of
five (5) years from the Grant Date;
(c) The expiration of three (3) months from the date of Participant’s Termination of Service, unless such termination occurs by reason of
Participant’s death or disability or as provided in Section 3.3(e) below; or
(d) The expiration of one (1) year from the date of Participant’s Termination of Service by reason of Participant’s death or disability or as
provided in Section 3.3(e) below.
(e) The expiration of three (3) years from the date of Participant’s Termination of Service in the event Participant is either (i) fifty-five
(55) years old or older and has five (5) years or more of service with the Company upon voluntary termination of service (e.g., retirement) or (ii) is
involuntarily terminated and has five (5) years or more of service with the Company upon Termination of Service, regardless of age.
3.4 Special Tax Consequences. Participant acknowledges that, to the extent that the aggregate Fair Market Value (determined as of the time the
Option is granted) of all shares of Stock with respect to which Incentive Stock Options, including the Option (if applicable), are exercisable for the first
time by Participant in any calendar year exceeds $100,000, the Option
and such other options shall be Nonstatutory Stock Options to the extent necessary to comply with the limitations imposed by Section 422(d) of the Code.
Participant further acknowledges that the rule set forth in the preceding sentence shall be applied by taking the Option and other “incentive stock options”
into account in the order in which they were granted, as determined under Section 422(d) of the Code and the Treasury Regulations thereunder. Participant
also acknowledges that an Incentive Stock Option exercised more than three (3) months after Participant’s termination of employment, other than by reason
of death or disability, will be taxed as a Nonstatutory Stock Option.
3.5 Tax Indemnity.
(a) The Participant agrees to indemnify and keep indemnified the Company, any Subsidiary and his/her employing company, if different,
from and against any liability for or obligation to pay any Tax Liability (a “Tax Liability” being any liability for income tax, withholding tax and
any other employment related taxes or social security contributions in any jurisdiction, including, if applicable, employee’s and employer’s
National Insurance contributions) that is attributable to (1) the grant or exercise of, or any benefit derived by the Participant from, the Option, (2)
the acquisition by the Participant of the Stock on exercise of the Option, or (3) the disposal of any Stock.
(b) The Option cannot be exercised until the Participant has made such arrangements as the Company may require for the satisfaction of
any Tax Liability that may arise in connection with the exercise of the Option and/or the acquisition of the Stock by the Participant. The Company
shall not be required to issue, allot or transfer Stock until the Employee has satisfied this obligation.
ARTICLE 4.
EXERCISE OF OPTION
4.1 Person Eligible to Exercise. During the lifetime of Participant, only Participant may exercise the Option or any portion thereof. After the death
of Participant, any exercisable portion of the Option may, prior to the time when the Option becomes unexercisable under Section 3.3 hereof, be exercised
by Participant’s personal representative or by any person empowered to do so under the deceased Participant’s will or under the then applicable laws of
descent and distribution.
4.2 Partial Exercise. Any exercisable portion of the Option or the entire Option, if then wholly exercisable, may be exercised in whole or in part at
any time prior to the time when the Option or portion thereof becomes unexercisable under Section 3.3 hereof.
4.3 Manner of Exercise. The Option, or any exercisable portion thereof, may be exercised solely by delivery to the Secretary of the Company (or
any third party administrator or other person or entity designated by the Company), during regular business hours, of all of the following prior to the time
when the Option or such portion thereof becomes unexercisable under Section 3.3 hereof:
(a) An exercise notice in a form specified by the Administrator, stating that the Option or portion thereof is thereby exercised, such notice
complying with all applicable rules established by the Administrator;
(b) The receipt by the Company of full payment for the shares of Stock with respect to which the Option or portion thereof is exercised,
including payment of any applicable withholding tax, which shall be made by deduction from other compensation payable to Participant or in such
other form of consideration permitted under Section 4.4 hereof that is acceptable to the Company;
(c) Any other written representations as may be required in the Administrator’s reasonable discretion to evidence compliance with the
Securities Act or any other applicable law, rule or regulation; and
(d) In the event the Option or portion thereof shall be exercised pursuant to Section 4.1 hereof by any person or persons other than
Participant, appropriate proof of the right of such person or persons to exercise the Option.
Notwithstanding any of the foregoing, the Company shall have the right to specify all conditions of the manner of exercise, which conditions may vary by
country and which may be subject to change from time to time.
4.4 Method of Payment. Payment of the exercise price shall be by any of the following, or a combination thereof, at the election of Participant:
(a) Cash or check;
(b) With the consent of the Administrator, surrender of shares of Stock (including, without limitation, shares of Stock otherwise issuable
upon exercise of the Option) held for such period of time as may be required by the Administrator in order to avoid adverse accounting
consequences and having a Fair Market Value on the date of delivery equal to the aggregate exercise price of the Option or exercised portion
thereof; or
(c) Other property acceptable to the Administrator (including, without limitation, through the delivery of a notice that Participant has
placed a market sell order with a broker with respect to shares of Stock then issuable upon exercise of the Option, and that the broker has been
directed to pay a sufficient portion of the net proceeds of the sale to the Company in satisfaction of the Option exercise price; provided that
payment of such proceeds is then made to the Company at such time as may be required by the Company, but in any event not later than the
settlement of such sale).
4.5 Conditions to Issuance of Stock. The shares of Stock deliverable upon the exercise of the Option, or any portion thereof, may be either
previously authorized but unissued shares of Stock or issued shares of Stock which have then been reacquired by the Company. Such shares of
Stock shall be fully paid and nonassessable. The Company shall not be required to issue or deliver any shares of Stock purchased upon the
exercise of the Option or portion thereof prior to fulfillment of all of the following conditions:
(a) The admission of such shares of Stock to listing on all stock exchanges on which such Stock is then listed;
(b) The completion of any registration or other qualification of such shares of Stock under any state or federal law or under rulings or
regulations of the Securities and Exchange Commission or of any other governmental regulatory body, which the Administrator shall, in its
absolute discretion, deem necessary or advisable;
(c) The obtaining of any approval or other clearance from any state or federal governmental agency which the Administrator shall, in its
absolute discretion, determine to be necessary or advisable;
(d) The receipt by the Company of full payment for such shares of Stock, including payment of any applicable withholding tax, which
may be in one or more of the forms of consideration permitted under Section 4.4 hereof; and
(e) The lapse of such reasonable period of time following the exercise of the Option as the Administrator may from time to time establish
for reasons of administrative convenience.
4.6 Rights as Stockholder. The holder of the Option shall not be, nor have any of the rights or privileges of, a stockholder of the Company,
including, without limitation, voting rights and rights to dividends, in respect of any shares of Stock purchasable upon the exercise of any part of the Option
unless and until such shares of Stock shall have been issued by the Company and held of record by such holder (as evidenced by the appropriate entry on
the books of the Company or of a duly authorized transfer agent of the Company). No adjustment will be made for a dividend or other right for which the
record date is prior to the date the shares of Stock are issued, except as provided in Section 13.2 of the Plan.
ARTICLE 5
OTHER PROVISIONS
5.1 Administration. The Administrator shall have the power to interpret the Plan and this Agreement and to adopt such rules for the
administration, interpretation and application of the Plan as are consistent therewith and to interpret, amend or revoke any such rules. All actions taken and
all interpretations and determinations made by the Administrator in good faith shall be final and binding upon Participant, the Company and all other
interested persons. No member of the Committee or the Board shall be personally liable for any action, determination or interpretation made in good faith
with respect to the Plan, this Agreement or the Option.
5.2 Whole Shares. The Option may only be exercised for whole shares of Stock.
5.3 Option Not Transferable. Subject to Section 4.1 hereof, the Option may not be sold, pledged, assigned or transferred in any manner other than
by will or the laws of descent and distribution, unless and until the shares of Stock underlying the Option have been issued, and all restrictions applicable to
such shares of Stock have lapsed. Neither the Option nor any interest or right therein shall be liable for the debts, contracts or engagements of Participant or
his or her successors in interest or shall be subject to disposition by transfer, alienation, anticipation, pledge, encumbrance, assignment or any other means
whether such disposition be voluntary or involuntary or by operation of law by judgment, levy, attachment, garnishment or any other legal or equitable
proceedings (including bankruptcy), and any attempted disposition thereof shall be null and void and of no effect, except to the extent that such disposition
is permitted by the preceding sentence.
5.4 Binding Agreement. Subject to the limitation on the transferability of the Option contained herein, this Agreement will be binding upon and
inure to the benefit of the heirs, legatees, legal representatives, successors and assigns of the parties hereto.
5.5 Adjustments Upon Specified Events. The Administrator may accelerate the vesting of the Option in such circumstances as it, in its sole
discretion, may determine. In addition, upon the occurrence of certain events relating to the Stock contemplated by Section 13.2 of the Plan (including,
without limitation, an extraordinary cash dividend on such Stock), the Administrator shall make such adjustments the Administrator deems appropriate in
the number of shares of Stock subject to the
Option, the exercise price of the Option and the kind of securities that may be issued upon exercise of the Option. Participant acknowledges that the Option
is subject to adjustment, modification and termination in certain events as provided in this Agreement and Section 13.2 of the Plan.
5.6 Notices. Any notice to be given under the terms of this Agreement to the Company shall be addressed to the Company in care of the Secretary
of the Company at the Company’s principal office, and any notice to be given to Participant shall be addressed to Participant at Participant’s last address
reflected on the Company’s records. By a notice given pursuant to this Section 5.6, either party may hereafter designate a different address for notices to be
given to that party. Any notice which is required to be given to Participant shall, if Participant is then deceased, be given to the person entitled to exercise
his or her Option pursuant to Section 4.1 hereof by written notice under this Section 5.6. Any notice shall be deemed duly given when sent via email or
when sent by certified mail (return receipt requested) and deposited (with postage prepaid) in a post office or branch post office regularly maintained by the
United States Postal Service.
5.7 Titles. Titles are provided herein for convenience only and are not to serve as a basis for interpretation or construction of this Agreement.
5.8 Governing Law. The laws of the State of Delaware shall govern the interpretation, validity, administration, enforcement and performance of
the terms of this Agreement regardless of the law that might be applied under principles of conflicts of laws.
5.9 Conformity to Securities Laws. Participant acknowledges that the Plan and this Agreement are intended to conform to the extent necessary
with all provisions of the Securities Act and the Exchange Act and any and all regulations and rules promulgated by the Securities and Exchange
Commission thereunder, and state securities laws and regulations. Notwithstanding anything herein to the contrary, the Plan shall be administered, and the
Option is granted and may be exercised, only in such a manner as to conform to such laws, rules and regulations. To the extent permitted by applicable law,
the Plan and this Agreement shall be deemed amended to the extent necessary to conform to such laws, rules and regulations.
5.10 Amendments, Suspension and Termination. To the extent permitted by the Plan, this Agreement may be wholly or partially amended or
otherwise modified, suspended or terminated at any time or from time to time by the Committee or the Board; provided that, except as may otherwise be
provided by the Plan, no amendment, modification, suspension or termination of this Agreement shall adversely affect the Option in any material way
without the prior written consent of Participant.
5.11 Successors and Assigns. The Company may assign any of its rights under this Agreement to single or multiple assignees, and this Agreement
shall inure to the benefit of the successors and assigns of the Company. Subject to the restrictions on transfer herein set forth in Section 5.3 hereof, this
Agreement shall be binding upon Participant and his or her heirs, executors, administrators, successors and assigns.
5.12 Notification of Disposition. If this Option is designated as an Incentive Stock Option, Participant shall give prompt notice to the Company of
any disposition or other transfer of any shares of Stock acquired under this Agreement if such disposition or transfer is made (a) within two (2) years from
the Grant Date with respect to such shares of Stock or (b) within one (1) year after the transfer of such shares of Stock to Participant. Such notice shall
specify the date of such disposition or other transfer and the amount realized, in cash, other property, assumption of indebtedness or other consideration, by
Participant in such disposition or other transfer.
5.13 Limitations Applicable to Section 16 Persons. Notwithstanding any other provision of the Plan or this Agreement, if Participant is subject to
Section 16 of the Exchange Act, the Plan, the Option and this Agreement shall be subject to any additional limitations set forth in any applicable exemptive
rule under Section 16 of the Exchange Act (including any amendment to Rule 16b-3 of the Exchange Act) that are requirements for the application of such
exemptive rule. To the extent permitted by applicable law, this Agreement shall be deemed amended to the extent necessary to conform to such applicable
exemptive rule.
5.14 Not a Contract of Employment. Nothing in this Agreement or in the Plan shall confer upon the Participant any right to continue to serve as an
employee or other service provider of the Company or any of its Subsidiaries.
5.15 Entire Agreement. The Plan, the Grant Notice and this Agreement (including all Exhibits thereto) constitute the entire agreement of the
parties and supersede in their entirety all prior undertakings and agreements of the Company and Participant with respect to the subject matter hereof.
5.16 Section 409A. This Option is not intended to constitute “nonqualified deferred compensation” within the meaning of Section 409A of the
Code (together with any Department of Treasury regulations and other interpretive guidance issued thereunder, including without limitation any such
regulations or other guidance that may be issued after the date hereof, “Section 409A”). However, notwithstanding any other provision of the Plan, the
Grant Notice or this Agreement (or any Exhibits hereto), if at any time the Administrator determines that the Option (or any portion thereof) may be subject
to Section 409A, the Administrator shall have the right in its sole discretion (without any obligation to do so or to indemnify Participant or
any other person for failure to do so) to adopt such amendments to the Plan, the Grant Notice or this Agreement (or any Exhibits hereto), or adopt other
policies and procedures (including amendments, policies and procedures with retroactive effect), or take any other actions, as the Administrator determines
are necessary or appropriate either for the Option to be exempt from the application of Section 409A or to comply with the requirements of Section 409A.
5.17 Limitation on Participant’s Rights. Participation in the Plan confers no rights or interests other than as herein provided. This Agreement
creates only a contractual obligation on the part of the Company as to amounts payable and shall not be construed as creating a trust. Neither the Plan nor
any underlying program, in and of itself, has any assets. Participant shall have only the rights of a general unsecured creditor of the Company with respect
to amounts credited and benefits payable, if any, with respect to the Option, and rights no greater than the right to receive the Stock as a general unsecured
creditor with respect to options, as and when exercised pursuant to the terms hereof.
5.18 Consent to Personal Data Use. The Participant acknowledges and agrees that the Company is permitted to collect, hold, store, process,
modify, transfer, lock or delete certain personal (and sensitive) data in any medium about Participant (i.e., name, home address, telephone number, e-mail
address, date of birth, tax identification number and payroll information) as a part of its personnel and other business records in the course of its business,
including for the-purpose of tracking stock option grants, processing stock option exercises and subsequent share transfers and sales, arranging for
appropriate tax reporting and withholding and regulatory tracking and reporting purposes and the Company may disclose such information to third parties
in the event that such disclosure is in the Company’s view required in the course of its business, including for the proper tracking of stock option grants,
processing stock option exercises and subsequent share transfers and sales, arranging for appropriate tax reporting and withholding and regulatory tracking.
This personal data will be transferred to other locations, including locations outside of the European Union and in so-called insecure third-party countries
that do not guarantee the data privacy protection level of the European Union.
The Company will hold, collect and otherwise process certain personal data as set out in the Company’s privacy notice, which is available on the
Company’s website. All personal data will be treated in accordance with applicable data protection laws and regulations.
5.19 Special Provisions for Stock Options Granted to Participants Outside the U.S. The Option shall be subject to the special provisions, if any, for
the Participant’s country of residence, as set forth in the Special Provisions for Stock Options Granted to Participants Outside the U.S. attached to the Grant
Notice as Exhibit B (the “Non-U.S. Provisions”).
(a) If Participant relocates to one of the countries included in the Non-U.S. Provisions during the life of the Option, the special provisions
for such country shall apply to Participant, to the extent the Company determines that the application of such provisions is necessary or advisable
in order to comply with local law or facilitate the administration of the Plan.
(b) The Company reserves the right to impose other requirements on the Option and the shares of Stock purchased upon exercise of the
Option, to the extent the Company determines it is necessary or advisable in order to comply with local laws or facilitate the administration of the
Plan, and to require Participant to sign any additional agreements or undertakings that may be necessary to accomplish the foregoing.
EXHIBIT B
TO STOCK OPTION GRANT NOTICE
SPECIAL PROVISIONS FOR STOCK OPTIONS
GRANTED TO PARTICIPANTS OUTSIDE THE U.S.
This Exhibit B to the Corcept Therapeutics Incorporated 2012 Incentive Award Plan (the “Plan”) Stock Option Grant Notice (“Grant Notice”) includes
special terms and conditions applicable to Participants in the countries below. These terms and conditions are in addition to those set forth in the Stock
Option Agreement (the “Agreement”) and the Grant Notice. In the event of any inconsistency between the Agreement, the Grant Notice or the Plan and
terms in this Exhibit B, the terms of this Exhibit B shall control. Any capitalized term used in this Exhibit B without definition shall have the meaning
ascribed to such term in the Plan, the Grant Notice or the Agreement, as applicable.
This Exhibit B also includes information relating to exchange control and other issues of which Participant should be aware with respect to participation in
the Plan. The information is based on the exchange control, securities and other laws in effect in the respective countries as of January 2012. Such laws are
often complex and change frequently. As a result, the Company strongly recommends that Participant not rely on the information herein as the only source
of information relating to the consequences of participation in the Plan because the information may be out of date at the time the Option is exercised or
shares of Stock acquired under the Plan are sold.
In addition, the information is general in nature and may not apply to the particular situation of Participant, and the Company is not in a position to assure
Participant of any particular result. Accordingly, Participant is advised to seek appropriate professional advice as to how the relevant laws in Participant’s
country may apply to Participant’s individual situation. Finally, if Participant is a citizen or resident of a country other than the one in which he or she is
currently working, the information contained herein may not be applicable to Participant.
UNITED KINGDOM
Service Providers. The Agreement as amended pursuant to this Exhibit B forms the rules of the employee share scheme applicable to the United Kingdom
based Participants of the Company and any Subsidiaries. Only Employees of the Company or any subsidiary or affiliate of the Company are eligible to be
granted Options under the Agreement. Other Service Providers who are not Employees are not eligible to receive Options under the Agreement in the
United Kingdom.
Section 3.4 of the Agreement. Section 3.4 of the Agreement shall not apply.
Scope of Option Grant. The grant of an Option does not form part of the Participant’s entitlement to remuneration or benefits in terms of his employment
with the Company or any subsidiary or affiliate.
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 Statement (Form S-8 Nos. 333-183284, 333-187316, 333-194663, 333-202753, 333-210076, 333-216658, 333-223318, 333-
229857, 333-236601 and 333-253413) 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 15, 2022, 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, 2021.
/s/ Ernst & Young LLP
Redwood City, California
February 15, 2022
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, 2021 of Corcept Therapeutics Incorporated;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))
for the registrant and have:
(a)
(b)
(c)
(d)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles;
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent
fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant's internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a)
(b)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
/s/ Joseph K. Belanoff
Joseph K. Belanoff, M.D.
Chief Executive Officer and President
February 15, 2022
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, 2021 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
February 15, 2022
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, 2021, as
filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Joseph K. Belanoff, M.D., Chief Executive Officer of the
Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
/s/ Joseph K. Belanoff
Joseph K. Belanoff, M.D.
Chief Executive Officer and President
February 15, 2022
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, 2021, 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
February 15, 2022
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.