|
☒
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☐
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
77-0487658
|
(State or other jurisdiction of
incorporation or organization)
|
(I.R.S. Employer
Identification No.)
|
Large accelerated filer
|
☒
|
|
Accelerated filer
|
☐
|
Non-accelerated filer
|
☐
|
|
Smaller reporting company
|
☐
|
|
|
|
Emerging growth company
|
☐
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common Stock, $0.001 par value
|
CORT
|
The Nasdaq Capital Market
|
|
|
March 31,
2019 |
|
December 31,
2018 |
||||
|
(Unaudited)
|
|
(See Note 1)
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
49,650
|
|
|
$
|
41,625
|
|
Short-term marketable securities
|
137,255
|
|
|
165,135
|
|
||
Trade receivables, net of allowances
|
19,218
|
|
|
17,588
|
|
||
Inventory
|
5,000
|
|
|
4,732
|
|
||
Prepaid expenses and other current assets
|
5,741
|
|
|
7,740
|
|
||
Total current assets
|
216,864
|
|
|
236,820
|
|
||
Strategic inventory
|
10,360
|
|
|
11,510
|
|
||
Operating lease right-of-use asset
|
1,465
|
|
|
—
|
|
||
Property and equipment, net of accumulated depreciation
|
925
|
|
|
655
|
|
||
Long-term marketable securities
|
28,842
|
|
|
—
|
|
||
Other assets
|
75
|
|
|
50
|
|
||
Deferred tax assets, net
|
61,681
|
|
|
62,659
|
|
||
Total assets
|
$
|
320,212
|
|
|
$
|
311,694
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
9,330
|
|
|
$
|
8,266
|
|
Accrued clinical expenses
|
4,537
|
|
|
3,521
|
|
||
Other accrued liabilities
|
18,830
|
|
|
23,786
|
|
||
Operating lease liability
|
1,521
|
|
|
—
|
|
||
Total current liabilities
|
34,218
|
|
|
35,573
|
|
||
Long-term accrued income taxes
|
239
|
|
|
239
|
|
||
Total liabilities
|
34,457
|
|
|
35,812
|
|
||
Commitments and contingencies (Note 5)
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock
|
—
|
|
|
—
|
|
||
Common stock
|
118
|
|
|
117
|
|
||
Additional paid-in capital
|
427,317
|
|
|
417,228
|
|
||
Treasury stock
|
(42,312
|
)
|
|
(23,657
|
)
|
||
Accumulated other comprehensive gain (loss)
|
94
|
|
|
(70
|
)
|
||
Accumulated deficit
|
(99,462
|
)
|
|
(117,736
|
)
|
||
Total stockholders’ equity
|
285,755
|
|
|
275,882
|
|
||
Total liabilities and stockholders’ equity
|
$
|
320,212
|
|
|
$
|
311,694
|
|
|
Three Months Ended March 31,
|
||||||
|
2019
|
|
2018
|
||||
Product revenue, net
|
$
|
64,829
|
|
|
$
|
57,659
|
|
Operating expenses:
|
|
|
|
||||
Cost of sales
|
1,240
|
|
|
1,174
|
|
||
Research and development
|
20,244
|
|
|
17,050
|
|
||
Selling, general and administrative
|
24,389
|
|
|
18,440
|
|
||
Total operating expenses
|
45,873
|
|
|
36,664
|
|
||
Income from operations
|
18,956
|
|
|
20,995
|
|
||
Interest and other income
|
1,097
|
|
|
294
|
|
||
Income before income taxes
|
20,053
|
|
|
21,289
|
|
||
Income tax expense
|
(1,779
|
)
|
|
(3,830
|
)
|
||
Net income
|
$
|
18,274
|
|
|
$
|
17,459
|
|
Other comprehensive income (loss):
|
|
|
|
||||
Net unrealized income (loss) on available-for-sale investments, net of tax impact of $(52) and $48, respectively
|
164
|
|
|
(152
|
)
|
||
Total comprehensive income
|
$
|
18,438
|
|
|
$
|
17,307
|
|
|
|
|
|
||||
Basic net income per share
|
$
|
0.16
|
|
|
$
|
0.15
|
|
|
|
|
|
||||
Diluted net income per share
|
$
|
0.15
|
|
|
$
|
0.14
|
|
|
|
|
|
||||
Weighted-average shares outstanding used in computing net
income per share |
|
|
|
||||
Basic
|
114,844
|
|
|
114,882
|
|
||
Diluted
|
123,895
|
|
|
127,733
|
|
|
Three Months Ended March 31,
|
||||||
|
2019
|
|
2018
|
||||
Cash flows from operating activities:
|
|
|
|
||||
Net income
|
$
|
18,274
|
|
|
$
|
17,459
|
|
Adjustments to reconcile net income to net cash generated from operations:
|
|
|
|
||||
Stock-based compensation
|
6,696
|
|
|
4,954
|
|
||
Deferred income taxes
|
926
|
|
|
3,169
|
|
||
Excess tax benefits from stock option activity
|
—
|
|
|
54
|
|
||
Accretion of interest income
|
(634
|
)
|
|
(198
|
)
|
||
Depreciation and amortization of property and equipment
|
96
|
|
|
48
|
|
||
Amortization of right-of-use asset
|
413
|
|
|
—
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Trade receivables
|
(1,630
|
)
|
|
(1,961
|
)
|
||
Other receivable
|
—
|
|
|
12,876
|
|
||
Inventory
|
910
|
|
|
590
|
|
||
Prepaid expenses and other current assets
|
1,999
|
|
|
(635
|
)
|
||
Other assets
|
(25
|
)
|
|
(23
|
)
|
||
Accounts payable
|
953
|
|
|
(759
|
)
|
||
Accrued clinical expenses
|
1,016
|
|
|
1,239
|
|
||
Other accrued liabilities
|
(4,956
|
)
|
|
(2,383
|
)
|
||
Operating lease liability
|
(357
|
)
|
|
—
|
|
||
Net cash provided by operating activities
|
23,681
|
|
|
34,430
|
|
||
Cash flows from investing activities:
|
|
|
|
||||
Purchases of property and equipment
|
(257
|
)
|
|
(77
|
)
|
||
Proceeds from maturities of marketable securities
|
70,825
|
|
|
16,650
|
|
||
Purchases of marketable securities
|
(70,935
|
)
|
|
(50,866
|
)
|
||
Cash used in investing activities
|
(367
|
)
|
|
(34,293
|
)
|
||
Cash flows from financing activities:
|
|
|
|
||||
Proceeds from issuance of common stock upon exercise of options, net of issuance costs
|
2,435
|
|
|
1,922
|
|
||
Repurchase of common stock
|
(13,555
|
)
|
|
—
|
|
||
Cash paid to satisfy statutory withholding requirement for net settlement of cashless option exercise
|
(4,169
|
)
|
|
—
|
|
||
Net cash (used in) provided by financing activities
|
(15,289
|
)
|
|
1,922
|
|
||
Net increase in cash and cash equivalents
|
8,025
|
|
|
2,059
|
|
||
Cash and cash equivalents, at beginning of period
|
41,625
|
|
|
31,062
|
|
||
Cash and cash equivalents, at end of period
|
$
|
49,650
|
|
|
$
|
33,121
|
|
|
|
|
|
||||
Supplemental disclosure:
|
|
|
|
||||
Exercise price of shares tendered in net settlement of cashless option exercise
|
$
|
931
|
|
|
$
|
—
|
|
Recognition of right-of-use asset and lease liability
|
$
|
1,878
|
|
|
$
|
—
|
|
|
|
Common Stock
|
|
Additional
Paid-in Capital |
|
Treasury Stock
|
|
Accumulated
Other Comprehensive Loss |
|
Accumulated
Deficit |
|
Total
Stockholders' Equity |
|||||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance at December 31, 2017
|
|
114,717
|
|
|
$
|
115
|
|
|
$
|
384,074
|
|
|
$
|
—
|
|
|
$
|
(75
|
)
|
|
$
|
(193,146
|
)
|
|
$
|
190,968
|
|
Issuance of common stock upon exercise of options
|
|
479
|
|
|
—
|
|
|
1,922
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,922
|
|
||||||
Stock-based compensation related to employee and director options
|
|
—
|
|
|
—
|
|
|
4,954
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,954
|
|
||||||
Net unrealized gain on marketable securities, net of tax
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(77
|
)
|
|
—
|
|
|
(77
|
)
|
||||||
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
17,459
|
|
|
17,459
|
|
||||||
Balance at March 31, 2018
|
|
115,196
|
|
|
$
|
115
|
|
|
$
|
390,950
|
|
|
$
|
—
|
|
|
$
|
(152
|
)
|
|
$
|
(175,687
|
)
|
|
$
|
215,226
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance at December 31, 2018
|
|
115,031
|
|
|
$
|
117
|
|
|
$
|
417,228
|
|
|
$
|
(23,657
|
)
|
|
$
|
(70
|
)
|
|
$
|
(117,736
|
)
|
|
$
|
275,882
|
|
Issuance of common stock upon exercise of options
|
|
1,497
|
|
|
1
|
|
|
3,365
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,366
|
|
||||||
Shares tendered to satisfy cost and statutory withholding requirements for net settlement of cashless option exercise
|
|
(428
|
)
|
|
—
|
|
|
—
|
|
|
(5,100
|
)
|
|
—
|
|
|
—
|
|
|
(5,100
|
)
|
||||||
Stock-based compensation related to employee and director options
|
|
—
|
|
|
—
|
|
|
6,724
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,724
|
|
||||||
Net unrealized gain on marketable securities, net of tax
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
164
|
|
|
—
|
|
|
164
|
|
||||||
Purchases of treasury stock
|
|
(1,168
|
)
|
|
—
|
|
|
—
|
|
|
(13,555
|
)
|
|
—
|
|
|
—
|
|
|
(13,555
|
)
|
||||||
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
18,274
|
|
|
18,274
|
|
||||||
Balance at March 31, 2019
|
|
114,932
|
|
|
$
|
118
|
|
|
$
|
427,317
|
|
|
$
|
(42,312
|
)
|
|
$
|
94
|
|
|
$
|
(99,462
|
)
|
|
$
|
285,755
|
|
|
March 31,
2019 |
|
December 31,
2018 |
||||
|
(in thousands)
|
||||||
Raw materials
|
$
|
2,055
|
|
|
$
|
4,195
|
|
Work in progress
|
6,936
|
|
|
5,624
|
|
||
Finished goods
|
6,369
|
|
|
6,423
|
|
||
Total inventory
|
15,360
|
|
|
16,242
|
|
||
Less strategic inventory classified as non-current
|
(10,360
|
)
|
|
(11,510
|
)
|
||
Total inventory classified as current
|
$
|
5,000
|
|
|
$
|
4,732
|
|
|
March 31,
2019 |
|
December 31,
2018 |
||||
|
(in thousands)
|
||||||
Government rebates
|
$
|
10,829
|
|
|
$
|
11,132
|
|
Accrued compensation
|
3,296
|
|
|
7,879
|
|
||
Income taxes payable
|
2,462
|
|
|
1,542
|
|
||
Legal fees
|
531
|
|
|
314
|
|
||
Professional fees
|
493
|
|
|
240
|
|
||
Accrued selling and marketing costs
|
699
|
|
|
261
|
|
||
Accrued manufacturing costs
|
70
|
|
|
2,032
|
|
||
Other
|
450
|
|
|
386
|
|
||
Total other accrued liabilities
|
$
|
18,830
|
|
|
$
|
23,786
|
|
|
Fair Value
Hierarchy
Level
|
|
Estimated Fair Value
|
||||||
|
|
March 31,
2019 |
|
December 31,
2018 |
|||||
|
|
|
(in thousands)
|
||||||
Corporate bonds
|
Level 2
|
|
$
|
70,545
|
|
|
$
|
54,469
|
|
Commercial paper
|
Level 2
|
|
35,738
|
|
|
67,906
|
|
||
Asset-backed securities
|
Level 2
|
|
28,951
|
|
|
10,965
|
|
||
Repurchase agreements
|
Level 2
|
|
15,000
|
|
|
15,000
|
|
||
U.S. treasury securities
|
Level 1
|
|
30,863
|
|
|
39,287
|
|
||
Money market funds
|
Level 1
|
|
12,364
|
|
|
4,583
|
|
||
Total Marketable securities
|
|
|
$
|
193,461
|
|
|
$
|
192,210
|
|
|
|
|
|
|
|
||||
Classified as:
|
|
|
|
|
|
||||
Cash equivalents
|
|
|
$
|
27,364
|
|
|
$
|
27,075
|
|
Short-term marketable securities
|
|
|
137,255
|
|
|
165,135
|
|
||
Long-term marketable securities
|
|
|
28,842
|
|
|
—
|
|
||
Total marketable securities
|
|
|
$
|
193,461
|
|
|
$
|
192,210
|
|
|
|
Three Months Ended March 31, 2019
|
||
|
|
(in thousands)
|
||
Cash paid for operating lease liability
|
|
$
|
379
|
|
Right-of-use assets obtained in exchange for new operating lease liability
|
|
$
|
1,878
|
|
Weighted-average remaining lease term
|
|
1 year
|
|
|
Weighted-average discount rate
|
|
5.0
|
%
|
2019 (remainder)
|
|
$
|
1,172
|
|
2020
|
|
391
|
|
|
|
|
1,563
|
|
|
Less imputed interest
|
|
(42
|
)
|
|
Total lease liability
|
|
$
|
1,521
|
|
|
Three Months Ended
March 31, |
||||||
|
2019
|
|
2018
|
||||
|
(in thousands)
|
||||||
Stock-based compensation capitalized in inventory
|
$
|
28
|
|
|
$
|
—
|
|
Cost of sales
|
28
|
|
|
—
|
|
||
Research and development
|
1,979
|
|
|
1,464
|
|
||
Selling, general and administrative
|
4,689
|
|
|
3,490
|
|
||
Total stock-based compensation
|
$
|
6,724
|
|
|
$
|
4,954
|
|
|
Three Months Ended
March 31, |
||||||
|
2019
|
|
2018
|
||||
|
(in thousands)
|
||||||
Numerator:
|
|
|
|
||||
Net income
|
$
|
18,274
|
|
|
$
|
17,459
|
|
Denominator:
|
|
|
|
||||
Weighted-average shares used to compute basic net income per share
|
114,844
|
|
|
114,882
|
|
||
Dilutive effect of employee stock options
|
9,051
|
|
|
12,851
|
|
||
Weighted-average shares used to compute diluted net income per share
|
123,895
|
|
|
127,733
|
|
||
Net income per share
|
|
|
|
||||
Basic
|
$
|
0.16
|
|
|
$
|
0.15
|
|
Diluted
|
$
|
0.15
|
|
|
$
|
0.14
|
|
|
Three Months Ended
March 31, |
||||||
|
2019
|
|
2018
|
||||
Project
|
(in thousands)
|
||||||
Development programs:
|
|
|
|
||||
Oncology
|
$
|
5,214
|
|
|
$
|
3,401
|
|
Endocrinology
|
6,846
|
|
|
4,145
|
|
||
Pre-clinical and clinical selective cortisol modulators
|
3,559
|
|
|
6,542
|
|
||
Unallocated activities, including pre-clinical, manufacturing and
regulatory activities
|
2,646
|
|
|
1,498
|
|
||
Stock-based compensation
|
1,979
|
|
|
1,464
|
|
||
Total research and development expense
|
$
|
20,244
|
|
|
$
|
17,050
|
|
•
|
the preference of some physicians for off-label treatments for Cushing’s syndrome, such as ketoconazole;
|
•
|
competition from non-medical treatments, such as surgery and radiation;
|
•
|
the potential introduction of a competitor for Korlym, including a generic version of Korlym;
|
•
|
the lack of availability of adequate private and government insurance coverage;
|
•
|
negative publicity and political concerns about Korlym, RU-486, Mifeprex
®
or mifepristone; and
|
•
|
rapid technological change that makes Korlym obsolete.
|
•
|
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. 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 payors 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;
|
•
|
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 PPACA on drug manufacturers regarding any “transfer of value” made or distributed to prescribers and other health care providers, 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;
|
•
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and their respective implementing regulations, which impose obligations on covered healthcare providers, health plans, and healthcare clearinghouses, as well as their business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
|
•
|
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 payor, 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; 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; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
|
•
|
delays obtaining regulatory permission to start a trial or changes to the size or design or regulatory requirements with respect to a trial already underway;
|
•
|
inability to secure acceptable terms with vendors and clinical trial sites;
|
•
|
delays or inability to obtain institutional review board (“IRB”) approval at prospective trial sites;
|
•
|
slow patient enrollment;
|
•
|
failure of patients or investigators to comply with the clinical trial protocol;
|
•
|
negative or inconclusive trial results; and
|
•
|
negative findings of inspections of clinical sites or manufacturing operations by us, the FDA or other authorities.
|
•
|
manage our sales and marketing efforts, clinical trials, research and development activities and supply chain effectively;
|
•
|
hire additional management, clinical development, administrative and sales and marketing personnel; and
|
•
|
develop our administrative, accounting and management information systems and controls.
|
•
|
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’ potential development programs, including the announcement of ANDA filings seeking approval to market generic versions of Korlym and developments in ANDA litigation;
|
•
|
disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
|
•
|
Short selling of our common stock, the publication of speculative opinions about our business or other market manipulation activities by third parties that are intended to lower our stock price or increase its volatility;
|
•
|
changes in estimates or recommendations by securities analysts or the failure of our performance to meet the published expectations of those analysts or any public guidance we have provided;
|
•
|
actual or anticipated regulatory approvals of our product candidates or of competing products;
|
•
|
purchases or sales of our common stock by our officers, directors or stockholders;
|
•
|
purchases of our common stock pursuant to our Stock Repurchase Program or changes to that program;
|
•
|
changes in laws or regulations applicable to our product candidates or our competitors’ products;
|
•
|
announcements of technological innovations by us, our collaborators or our competitors;
|
•
|
trading volume of our common stock;
|
•
|
conditions or trends in the biotechnology and pharmaceutical industries, including the market valuations of companies similar to Corcept;
|
•
|
general market and economic conditions;
|
•
|
additions or departures of key personnel;
|
•
|
announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments;
|
•
|
our cash and short-term investment position; and
|
•
|
additional financing activities.
|
Fiscal Period
|
|
Total Number of Shares Purchased As
Part of a Publicly Announced Program
(1)
|
|
Average Price Paid Per Share
|
|
Approximate Dollar Amount of Shares
That May Yet be Purchased Under the Program
(2)
|
|||||
January 1, 2019 to January 31, 2019
|
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
February 1, 2019 to February 28, 2019
|
|
438
|
|
|
10.49
|
|
|
71,752
|
|
||
March 1, 2019 to March 31, 2019
|
|
730
|
|
|
12.27
|
|
|
62,789
|
|
||
Total
|
|
1,168
|
|
|
$
|
11.61
|
|
|
$
|
62,789
|
|
|
CORCEPT THERAPEUTICS INCORPORATED
|
|
|
Date: May 9, 2019
|
/s/ Joseph K. Belanoff
|
|
Joseph K. Belanoff, M.D.
Chief Executive Officer
|
|
|
Date: May 9, 2019
|
/s/ G. Charles Robb
|
|
G. Charles Robb
|
|
Chief Financial Officer
|
|
CORCEPT THERAPEUTICS INCORPORATED
|
|
/s/ Charlie Robb
|
Charlie Robb, Chief Financial Officer
|
|
/s/ Andrea Grauer
|
Andreas Grauer, M.D., Chief Medical Officer
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q for the period ended
March 31, 2019
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 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 we have:
|
(a)
|
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;
|
(b)
|
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;
|
(c)
|
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
|
(d)
|
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 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)
|
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
|
(b)
|
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
|
May 9, 2019
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q for the period ended
March 31, 2019
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 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 we have:
|
(a)
|
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;
|
(b)
|
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;
|
(c)
|
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
|
(d)
|
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 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)
|
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
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ G. Charles Robb
|
G. Charles Robb
|
Chief Financial Officer and Secretary
|
May 9, 2019
|
(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
|
May 9, 2019
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ G. Charles Robb
|
G. Charles Robb
|
Chief Financial Officer and Secretary
|
May 9, 2019
|