Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2021 | Oct. 27, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 000-50679 | |
Entity Registrant Name | CORCEPT THERAPEUTICS INC | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 77-0487658 | |
Entity Address, Address Line One | 149 Commonwealth Drive | |
Entity Address, City or Town | Menlo Park | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94025 | |
City Area Code | 650 | |
Local Phone Number | 327-3270 | |
Title of 12(b) Security | Common Stock, $0.001 par value | |
Trading Symbol | CORT | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 115,451,895 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001088856 | |
Current Fiscal Year End Date | --12-31 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 94,688 | $ 76,190 |
Short-term marketable securities | 266,643 | 364,506 |
Trade receivables, net of allowances | 26,508 | 26,198 |
Inventory | 4,994 | 4,910 |
Prepaid expenses and other current assets | 9,067 | 6,697 |
Total current assets | 401,900 | 478,501 |
Strategic inventory | 13,659 | 16,247 |
Operating lease right-of-use asset | 1,022 | 2,509 |
Property and equipment, net of accumulated depreciation | 1,226 | 1,675 |
Long-term marketable securities | 133,845 | 36,196 |
Other assets | 4,106 | 5,000 |
Deferred tax assets, net | 29,641 | 31,603 |
Total assets | 585,399 | 571,731 |
Current liabilities: | ||
Accounts payable | 6,558 | 10,554 |
Accrued clinical expenses | 12,844 | 13,704 |
Accrued and other liabilities | 24,309 | 21,186 |
Short-term operating lease liability | 1,046 | 2,050 |
Total current liabilities | 44,757 | 47,494 |
Long-term operating lease liability | 0 | 501 |
Long-term accrued income taxes | 413 | 398 |
Total liabilities | 45,170 | 48,393 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock | 0 | 0 |
Common stock | 126 | 122 |
Additional paid-in capital | 571,377 | 516,140 |
Treasury stock | (194,304) | (75,795) |
Accumulated other comprehensive income | 115 | 415 |
Retained earnings | 162,915 | 82,456 |
Total stockholders’ equity | 540,229 | 523,338 |
Total liabilities and stockholders’ equity | $ 585,399 | $ 571,731 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Statement of Comprehensive Income [Abstract] | ||||
Product revenue, net | $ 96,131 | $ 86,327 | $ 267,156 | $ 268,139 |
Operating expenses: | ||||
Cost of sales | 1,275 | 1,216 | 3,927 | 4,328 |
Research and development | 28,091 | 33,869 | 85,345 | 86,489 |
Selling, general and administrative | 30,533 | 26,523 | 90,071 | 79,630 |
Total operating expenses | 59,899 | 61,608 | 179,343 | 170,447 |
Income from operations | 36,232 | 24,719 | 87,813 | 97,692 |
Interest and other income | 72 | 622 | 457 | 3,103 |
Income before income taxes | 36,304 | 25,341 | 88,270 | 100,795 |
Income tax expense | (5,833) | (3,716) | (7,811) | (20,778) |
Net income | 30,471 | 21,625 | 80,459 | 80,017 |
Other comprehensive income: | ||||
Net unrealized gain (loss) on available-for-sale investments, net of tax effect of $8, $109, $85 and $(81), respectively | (23) | (347) | (265) | 259 |
Foreign currency translation gain (loss), net of tax | (77) | 84 | (35) | 57 |
Total comprehensive income | $ 30,371 | $ 21,362 | $ 80,159 | $ 80,333 |
Basic net income per share (in dollars per share) | $ 0.26 | $ 0.19 | $ 0.69 | $ 0.70 |
Diluted net income per share (in dollars per share) | $ 0.24 | $ 0.17 | $ 0.63 | $ 0.65 |
Weighted-average shares outstanding used in computing net income per share | ||||
Basic (in shares) | 115,791 | 115,734 | 116,297 | 115,107 |
Diluted (in shares) | 125,136 | 124,464 | 127,173 | 123,337 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Statement of Comprehensive Income [Abstract] | ||||
Net unrealized income (loss) on available-for-sale investments, tax impact | $ 8 | $ 109 | $ 85 | $ (81) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities: | ||
Net income | $ 80,459 | $ 80,017 |
Adjustments to reconcile net income to net cash provided by operations: | ||
Stock-based compensation | 32,121 | 25,109 |
Deferred income taxes | 2,047 | 11,778 |
Amortization of interest income | 3,805 | 404 |
Depreciation and amortization of property and equipment | 783 | 447 |
Non-cash amortization of right-of-use asset | 1,487 | 1,228 |
Others | 0 | 148 |
Changes in operating assets and liabilities: | ||
Trade receivables | (310) | (2,029) |
Inventory | 2,655 | 694 |
Prepaid expenses and other current assets | (2,288) | (1,882) |
Other assets | 894 | (1,562) |
Accounts payable | (3,961) | (988) |
Accrued clinical expenses | (860) | 9,055 |
Accrued and other liabilities | 3,138 | (4,315) |
Operating lease liability | (1,505) | (1,205) |
Net cash provided by operating activities | 118,465 | 116,899 |
Cash flows from investing activities: | ||
Purchases of property and equipment | (404) | (807) |
Proceeds from maturities of marketable securities | 308,864 | 193,418 |
Purchases of marketable securities | (312,805) | (323,094) |
Net cash used in investing activities | (4,345) | (130,483) |
Cash flows from financing activities: | ||
Proceeds from exercise of stock options, net of issuance costs | 13,182 | 13,240 |
Repurchase of common stock | (88,485) | (275) |
Cash paid to satisfy statutory withholding requirement for net settlement of cashless option exercises | (20,319) | (90) |
Net cash (used in) provided by financing activities | (95,622) | 12,875 |
Net increase (decrease) in cash and cash equivalents | 18,498 | (709) |
Cash and cash equivalents, at beginning of period | 76,190 | 31,269 |
Cash and cash equivalents, at end of period | 94,688 | 30,560 |
Supplemental disclosure: | ||
Cost of shares repurchased for net settlement of cashless option exercises | 9,705 | 900 |
Recognition of right-of-use asset and lease liability | $ 0 | $ 775 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Treasury Stock | Accumulated Other Comprehensive Income | Retained Earnings (Accumulated Deficit) |
Beginning balance (in shares) at Dec. 31, 2019 | 114,549 | |||||
Beginning balance at Dec. 31, 2019 | $ 371,182 | $ 120 | $ 457,060 | $ (62,704) | $ 261 | $ (23,555) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock upon exercise of options | 67 | |||||
Issuance of common stock upon exercise of options | 480 | 480 | ||||
Purchases of treasury stock (in shares) | (20) | |||||
Purchases of treasury stock | (275) | (275) | ||||
Stock-based compensation | 7,988 | 7,988 | ||||
Other comprehensive income (loss), net of tax | 49 | 49 | ||||
Net income | 30,065 | 30,065 | ||||
Ending balance (in shares) at Mar. 31, 2020 | 114,596 | |||||
Ending balance at Mar. 31, 2020 | 409,489 | $ 120 | 465,528 | (62,979) | 310 | 6,510 |
Beginning balance (in shares) at Dec. 31, 2019 | 114,549 | |||||
Beginning balance at Dec. 31, 2019 | $ 371,182 | $ 120 | 457,060 | (62,704) | 261 | (23,555) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock upon exercise of options | 1,700 | |||||
Net income | $ 80,017 | |||||
Ending balance (in shares) at Sep. 30, 2020 | 116,168 | |||||
Ending balance at Sep. 30, 2020 | 489,680 | $ 121 | 496,489 | (63,969) | 577 | 56,462 |
Beginning balance (in shares) at Mar. 31, 2020 | 114,596 | |||||
Beginning balance at Mar. 31, 2020 | 409,489 | $ 120 | 465,528 | (62,979) | 310 | 6,510 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock upon exercise of options | 1,011 | |||||
Issuance of common stock upon exercise of options | 7,639 | $ 1 | 7,638 | |||
Shares purchased to satisfy cost and statutory withholding requirements for net settlement of cashless option exercises | (54) | |||||
Shares purchased to satisfy cost and statutory withholding requirements for net settlement of cashless option exercises | (835) | (835) | ||||
Stock-based compensation | 8,548 | 8,548 | ||||
Other comprehensive income (loss), net of tax | 530 | 530 | ||||
Net income | 28,327 | 28,327 | ||||
Ending balance (in shares) at Jun. 30, 2020 | 115,553 | |||||
Ending balance at Jun. 30, 2020 | $ 453,698 | $ 121 | 481,714 | (63,814) | 840 | 34,837 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock upon exercise of options | 600 | 626 | ||||
Issuance of common stock upon exercise of options | $ 6,020 | 6,020 | ||||
Shares purchased to satisfy cost and statutory withholding requirements for net settlement of cashless option exercises | (11) | |||||
Shares purchased to satisfy cost and statutory withholding requirements for net settlement of cashless option exercises | (155) | (155) | ||||
Stock-based compensation | 8,755 | 8,755 | ||||
Other comprehensive income (loss), net of tax | (263) | (263) | ||||
Net income | 21,625 | 21,625 | ||||
Ending balance (in shares) at Sep. 30, 2020 | 116,168 | |||||
Ending balance at Sep. 30, 2020 | 489,680 | $ 121 | 496,489 | (63,969) | 577 | 56,462 |
Beginning balance (in shares) at Dec. 31, 2020 | 116,735 | |||||
Beginning balance at Dec. 31, 2020 | 523,338 | $ 122 | 516,140 | (75,795) | 415 | 82,456 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock upon exercise of options | 1,832 | |||||
Issuance of common stock upon exercise of options | 10,083 | $ 2 | 10,081 | |||
Purchases of treasury stock (in shares) | (1,282) | |||||
Purchases of treasury stock | (33,540) | (33,540) | ||||
Shares purchased to satisfy cost and statutory withholding requirements for net settlement of cashless option exercises | (808) | |||||
Shares purchased to satisfy cost and statutory withholding requirements for net settlement of cashless option exercises | (22,520) | (22,520) | ||||
Stock-based compensation | 10,142 | 10,142 | ||||
Other comprehensive income (loss), net of tax | (166) | (166) | ||||
Net income | 23,465 | 23,465 | ||||
Ending balance (in shares) at Mar. 31, 2021 | 116,477 | |||||
Ending balance at Mar. 31, 2021 | 510,802 | $ 124 | 536,363 | (131,855) | 249 | 105,921 |
Beginning balance (in shares) at Dec. 31, 2020 | 116,735 | |||||
Beginning balance at Dec. 31, 2020 | $ 523,338 | $ 122 | 516,140 | (75,795) | 415 | 82,456 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock upon exercise of options | 3,600 | |||||
Purchases of treasury stock (in shares) | (4,300) | |||||
Shares purchased to satisfy cost and statutory withholding requirements for net settlement of cashless option exercises | (1,200) | |||||
Net income | $ 80,459 | |||||
Ending balance (in shares) at Sep. 30, 2021 | 115,303 | |||||
Ending balance at Sep. 30, 2021 | 540,229 | $ 126 | 571,377 | (194,304) | 115 | 162,915 |
Beginning balance (in shares) at Mar. 31, 2021 | 116,477 | |||||
Beginning balance at Mar. 31, 2021 | 510,802 | $ 124 | 536,363 | (131,855) | 249 | 105,921 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock upon exercise of options | 855 | |||||
Issuance of common stock upon exercise of options | 6,661 | $ 1 | 6,660 | |||
Purchases of treasury stock (in shares) | (1,365) | |||||
Purchases of treasury stock | (29,170) | (29,170) | ||||
Shares purchased to satisfy cost and statutory withholding requirements for net settlement of cashless option exercises | (146) | |||||
Shares purchased to satisfy cost and statutory withholding requirements for net settlement of cashless option exercises | (3,238) | (3,238) | ||||
Stock-based compensation | 11,131 | 11,131 | ||||
Other comprehensive income (loss), net of tax | (34) | (34) | ||||
Net income | 26,523 | 26,523 | ||||
Ending balance (in shares) at Jun. 30, 2021 | 115,821 | |||||
Ending balance at Jun. 30, 2021 | $ 522,675 | $ 125 | 554,154 | (164,263) | 215 | 132,444 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock upon exercise of options | 900 | 904 | ||||
Issuance of common stock upon exercise of options | $ 6,225 | $ 1 | 6,224 | |||
Purchases of treasury stock (in shares) | (1,220) | |||||
Purchases of treasury stock | $ (25,775) | (25,775) | ||||
Shares purchased to satisfy cost and statutory withholding requirements for net settlement of cashless option exercises | (200) | (202) | ||||
Shares purchased to satisfy cost and statutory withholding requirements for net settlement of cashless option exercises | $ (4,266) | (4,266) | ||||
Stock-based compensation | 10,999 | 10,999 | ||||
Other comprehensive income (loss), net of tax | (100) | (100) | ||||
Net income | 30,471 | 30,471 | ||||
Ending balance (in shares) at Sep. 30, 2021 | 115,303 | |||||
Ending balance at Sep. 30, 2021 | $ 540,229 | $ 126 | $ 571,377 | $ (194,304) | $ 115 | $ 162,915 |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | Basis of Presentation and Summary of Significant Accounting Policies Description of Business and Basis of Presentation Corcept Therapeutics Incorporated is a commercial-stage pharmaceutical company engaged in the discovery and development of medications that treat severe metabolic, oncologic and psychiatric disorders by modulating the effect of the hormone cortisol. In 2012, the U.S. Food and Drug Administration (“FDA”) approved Korlym (“mifepristone”) 300 mg tablets, as a once-daily oral medication for the treatment of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. We have discovered 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 We have prepared the following in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X: (i) condensed consolidated balance sheet as of September 30, 2021, (ii) condensed consolidated statements of comprehensive income and stockholders’ equity for the three- and nine-month periods ended September 30, 2021 and 2020 and (iii) condensed consolidated statements of cash flows for the nine-month periods ended September 30, 2021 and 2020. These do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments considered necessary for a fair presentation (which in the applicable periods consist only of normal, recurring adjustments) have been included. Operating results for the three- and nine-month periods ended September 30, 2021 are not necessarily indicative of the results for the remainder of 2021 or any other period. These financial statements and notes should be read in conjunction with the consolidated financial statements for the year ended December 31, 2020 included in our Annual Report on Form 10-K. The December 31, 2020 consolidated balance sheet was derived from audited financial statements at that date. There have been no material changes in the significant accounting policies described in our Annual Report on Form 10-K for the year ended December 31, 2020. Recently Adopted Accounting Pronouncement 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 condensed consolidated financial statements. |
Composition of Certain Balance
Composition of Certain Balance Sheet Items | 9 Months Ended |
Sep. 30, 2021 | |
Balance Sheet Related Disclosures [Abstract] | |
Composition of Certain Balance Sheet Items | Composition of Certain Balance Sheet Items Inventory September 30, December 31, (in thousands) Raw materials $ — $ 1,685 Work in progress 13,727 12,916 Finished goods 4,926 6,556 Total inventory 18,653 21,157 Less strategic inventory classified as non-current (13,659) (16,247) Total inventory classified as current $ 4,994 $ 4,910 Because we rely on a single manufacturer to produce Korlym’s active pharmaceutical ingredient (“API”), we have purchased and hold significant quantities of API, including in our 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 September 30, December 31, (in thousands) Furniture and equipment $ 1,093 $ 810 Software 1,508 1,485 Leasehold improvements 1,261 1,233 Total property and equipment 3,862 3,528 Less accumulated depreciation (2,636) (1,853) Property and equipment, net of accumulated depreciation $ 1,226 $ 1,675 Accrued and other liabilities September 30, December 31, (in thousands) Government rebates $ 11,146 $ 9,412 Accrued compensation 10,474 10,144 Accrued selling and marketing costs 871 665 Legal fees 756 612 Professional fees 544 151 Other 518 202 Total accrued and other liabilities $ 24,309 $ 21,186 Other assets As of September 30, 2021 and December 31, 2020, other assets included $3.9 million and $4.8 million of deposits for clinical trials, respectively. |
Available-for-Sale Securities a
Available-for-Sale Securities and Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Available For Sale Securities And Fair Value Measurements [Abstract] | |
Available-for-Sale Securities and Fair Value Measurements | Available-for-Sale Securities and Fair Value Measurements The available-for-sale securities in our Condensed Consolidated Balance Sheets are as follows: September 30, December 31, (in thousands) Cash equivalents $ 73,180 $ 50,524 Short-term marketable securities 266,643 364,506 Long-term marketable securities 133,845 36,196 Total marketable securities $ 473,668 $ 451,226 The following table presents our available-for-sale securities grouped by asset type: Fair Value September 30, 2021 December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value (in thousands) Corporate bonds Level 2 $ 135,204 $ 15 $ (37) $ 135,182 $ 96,999 $ 74 $ (9) $ 97,064 Commercial paper Level 2 127,395 — — 127,395 139,791 — — 139,791 Asset-backed securities Level 2 63,220 6 (49) 63,177 39,243 15 (1) 39,257 U.S. treasury securities Level 1 74,726 9 (1) 74,734 124,461 131 (2) 124,590 Money market funds Level 1 73,180 — — 73,180 50,524 — — 50,524 Total marketable securities $ 473,725 $ 30 $ (87) $ 473,668 $ 451,018 $ 220 $ (12) $ 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 September 30, 2021 were not material. Accordingly, we have not recorded an allowance for credit losses associated with these investments. We do not intend to sell investments that currently have unrealized losses and it is highly unlikely that we will sell any investment before recovery of its amortized cost basis, which may be at maturity. We classified accrued interest on our marketable securities of $1.4 million and $1.3 million as of September 30, 2021 and December 31, 2020, respectively, as prepaid and other current assets on our condensed consolidated balance sheets. As of September 30, 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 September 30, 2021, our long-term marketable securities had remaining maturities ranging from 13 to 22 months. None of our marketable securities changed from one fair value hierarchy to another during the three and nine months ended September 30, 2021. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies There have been no material changes in our obligations under contractual agreements described in our Annual Report on Form 10-K for the year ended December 31, 2020. 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 potential outcomes under 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. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Stockholders’ Equity | Stockholders’ Equity Stock Option Plans We have two stock option plans – the 2004 Equity Incentive Plan (the “2004 Plan”) and the 2012 Incentive Award Plan (the “2012 Plan”). In February 2021, our Board of Directors authorized a 4.7 million increase in the shares available for grant under the 2012 Plan. During the three and nine months ended September 30, 2021, we issued 0.9 million and 3.6 million shares of our common stock, respectively, upon the exercise of stock options. Certain option holders exercised their options on a “net exercise” basis, pursuant to which they surrendered to us, and we purchased from them at the current market price, enough shares to cover the exercise price and tax withholding requirements arising from the exercise. During the three and nine months ended September 30, 2021, we purchased 0.2 million and 1.2 million shares, respectively, in connection with such option net exercises. In connection with the shares purchased, during the three and nine months ended September 30, 2021, we paid $2.3 million and $20.3 million, respectively, to satisfy the tax withholding obligations associated with the net-share settlement of these cashless option exercises. We recorded these shares as treasury stock on our condensed consolidated balance sheets, at cost. During the three and nine months ended September 30, 2020, we issued 0.6 million and 1.7 million shares of our common stock upon the exercise of stock options, respectively. Stock Repurchase Program In November 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 three and nine months ended September 30, 2021, we repurchased 1.2 million and 3.9 million shares of common stock under the Stock Repurchase Program in open market transactions at an average price of $21.13 and $22.88 per share, for an aggregate purchase price of $25.8 million and $88.5 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. We recorded repurchased shares as treasury stock on our condensed consolidated balance sheets, at cost. As of September 30, 2021 and December 31, 2020 we had 10.9 million and 5.3 million treasury shares outstanding, respectively. Stock-based compensation The following table summarizes our stock-based compensation by account: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 (in thousands) Stock-based compensation capitalized in inventory $ 47 $ 53 $ 151 $ 182 Cost of sales 12 13 38 51 Research and development 3,434 2,958 10,764 8,357 Selling, general and administrative 7,506 5,731 21,319 16,701 Total stock-based compensation $ 10,999 $ 8,755 $ 32,272 $ 25,291 |
Net Income Per Share
Net Income Per Share | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Net Income Per Share | Net Income Per Share 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, including potentially dilutive shares. 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 following table shows the computation of net income per share for each period: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 (in thousands) Numerator: Net income $ 30,471 $ 21,625 $ 80,459 $ 80,017 Denominator: Weighted-average shares used to compute basic net income per share 115,791 115,734 116,297 115,107 Dilutive effect of employee stock options 9,345 8,730 10,876 8,230 Weighted-average shares used to compute diluted net income per share 125,136 124,464 127,173 123,337 Net income per share Basic $ 0.26 $ 0.19 $ 0.69 $ 0.70 Diluted $ 0.24 $ 0.17 $ 0.63 $ 0.65 As of September 30, 2021 and 2020, we had 25.5 million and 26.0 million stock options outstanding, respectively. Because including them would have reduced dilution, we excluded from the computation of diluted net income per share 5.3 million and 4.1 million stock options outstanding, on a weighted-average basis, during the three and nine months ended September 30, 2021, respectively, and 10.5 million and 12.7 million stock options outstanding during the three and nine months ended September 30, 2020, respectively. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes We recorded income tax expense of $5.8 million and $7.8 million for the three and nine months ended September 30, 2021, respectively. In the three and nine months ended September 30, 2020, respectively, our income tax expense was $3.7 million and $20.8 million. The increase in income tax expense during the three months ended September 30, 2021 was primarily due to increased net income compared to the corresponding period in 2020. The decrease in income tax expense during the nine months ended September 30, 2021 compared to the corresponding period in 2020 was primarily due to increased excess tax benefits for stock option exercises. Our effective tax rate differs from the federal statutory rate due to state income taxes and the non-deductible portion of our stock-based compensation, which increased our tax expense, offset by tax benefits for research and development tax credits and the excess tax deduction arising from the exercise of employee stock options, which reduced our taxable income. During the three and nine months ended September 30, 2021, unrecognized tax benefits increased by $0.6 million and $1.4 million, respectively. As of September 30, 2021, the Company had unrecognized tax benefits of $7.2 million that, if recognized, would affect the Company’s effective tax rate and approximately $1.8 million of unrecognized tax benefits that would not impact the effective tax rate as they would be offset by a corresponding change in valuation allowance. Each quarter, we assess the likelihood that we will generate sufficient taxable income to make use of our federal and state deferred tax assets. If we believe that recovery of these deferred tax assets is not more likely than not, we establish a valuation allowance offsetting such assets on our balance sheet. Significant judgment is required in assessing the need for a valuation allowance. We consider all available evidence, including our recent operating results and our forecasts of future taxable income. 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. To the extent we increase a valuation allowance, we include an expense in the Condensed Consolidated Statement of Comprehensive Income in the period in which we make that determination. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation We have prepared the following in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X: (i) condensed consolidated balance sheet as of September 30, 2021, (ii) condensed consolidated statements of comprehensive income and stockholders’ equity for the three- and nine-month periods ended September 30, 2021 and 2020 and (iii) condensed consolidated statements of cash flows for the nine-month periods ended September 30, 2021 and 2020. These do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments considered necessary for a fair presentation (which in the applicable periods consist only of normal, recurring adjustments) have been included. Operating results for the three- and nine-month periods ended September 30, 2021 are not necessarily indicative of the results for the remainder of 2021 or any other period. These financial statements and notes should be read in conjunction with the consolidated financial statements for the year ended December 31, 2020 included in our Annual Report on Form 10-K. The December 31, 2020 consolidated balance sheet was derived from audited financial statements at that date. |
Recently Adopted Accounting Pronouncement | Recently Adopted Accounting Pronouncement 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 condensed consolidated financial statements. |
Composition of Certain Balanc_2
Composition of Certain Balance Sheet Items (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of composition of inventory, current | Inventory September 30, December 31, (in thousands) Raw materials $ — $ 1,685 Work in progress 13,727 12,916 Finished goods 4,926 6,556 Total inventory 18,653 21,157 Less strategic inventory classified as non-current (13,659) (16,247) Total inventory classified as current $ 4,994 $ 4,910 |
Schedule of composition of inventory, noncurrent | Inventory September 30, December 31, (in thousands) Raw materials $ — $ 1,685 Work in progress 13,727 12,916 Finished goods 4,926 6,556 Total inventory 18,653 21,157 Less strategic inventory classified as non-current (13,659) (16,247) Total inventory classified as current $ 4,994 $ 4,910 |
Schedule of property and equipment | Property and Equipment September 30, December 31, (in thousands) Furniture and equipment $ 1,093 $ 810 Software 1,508 1,485 Leasehold improvements 1,261 1,233 Total property and equipment 3,862 3,528 Less accumulated depreciation (2,636) (1,853) Property and equipment, net of accumulated depreciation $ 1,226 $ 1,675 |
Schedule of other accrued liabilities | Accrued and other liabilities September 30, December 31, (in thousands) Government rebates $ 11,146 $ 9,412 Accrued compensation 10,474 10,144 Accrued selling and marketing costs 871 665 Legal fees 756 612 Professional fees 544 151 Other 518 202 Total accrued and other liabilities $ 24,309 $ 21,186 |
Available-for-Sale Securities_2
Available-for-Sale Securities and Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Available For Sale Securities And Fair Value Measurements [Abstract] | |
Summary of the classification of available-for-sale securities in condensed consolidated balance sheets | The available-for-sale securities in our Condensed Consolidated Balance Sheets are as follows: September 30, December 31, (in thousands) Cash equivalents $ 73,180 $ 50,524 Short-term marketable securities 266,643 364,506 Long-term marketable securities 133,845 36,196 Total marketable securities $ 473,668 $ 451,226 |
Schedule of available-for-sale securities | The following table presents our available-for-sale securities grouped by asset type: Fair Value September 30, 2021 December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value (in thousands) Corporate bonds Level 2 $ 135,204 $ 15 $ (37) $ 135,182 $ 96,999 $ 74 $ (9) $ 97,064 Commercial paper Level 2 127,395 — — 127,395 139,791 — — 139,791 Asset-backed securities Level 2 63,220 6 (49) 63,177 39,243 15 (1) 39,257 U.S. treasury securities Level 1 74,726 9 (1) 74,734 124,461 131 (2) 124,590 Money market funds Level 1 73,180 — — 73,180 50,524 — — 50,524 Total marketable securities $ 473,725 $ 30 $ (87) $ 473,668 $ 451,018 $ 220 $ (12) $ 451,226 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Summary of stock-based compensation | The following table summarizes our stock-based compensation by account: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 (in thousands) Stock-based compensation capitalized in inventory $ 47 $ 53 $ 151 $ 182 Cost of sales 12 13 38 51 Research and development 3,434 2,958 10,764 8,357 Selling, general and administrative 7,506 5,731 21,319 16,701 Total stock-based compensation $ 10,999 $ 8,755 $ 32,272 $ 25,291 |
Net Income Per Share (Tables)
Net Income Per Share (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of computation of net income per share | The following table shows the computation of net income per share for each period: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 (in thousands) Numerator: Net income $ 30,471 $ 21,625 $ 80,459 $ 80,017 Denominator: Weighted-average shares used to compute basic net income per share 115,791 115,734 116,297 115,107 Dilutive effect of employee stock options 9,345 8,730 10,876 8,230 Weighted-average shares used to compute diluted net income per share 125,136 124,464 127,173 123,337 Net income per share Basic $ 0.26 $ 0.19 $ 0.69 $ 0.70 Diluted $ 0.24 $ 0.17 $ 0.63 $ 0.65 |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Details) | 9 Months Ended |
Sep. 30, 2021series | |
Accounting Policies [Abstract] | |
Number of series of selective cortisol modulators | 4 |
Composition of Certain Balanc_3
Composition of Certain Balance Sheet Items - Schedule of Composition of Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Balance Sheet Related Disclosures [Abstract] | ||
Raw materials | $ 0 | $ 1,685 |
Work in progress | 13,727 | 12,916 |
Finished goods | 4,926 | 6,556 |
Total inventory | 18,653 | 21,157 |
Less strategic inventory classified as non-current | (13,659) | (16,247) |
Total inventory classified as current | $ 4,994 | $ 4,910 |
Composition of Certain Balanc_4
Composition of Certain Balance Sheet Items - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 3,862 | $ 3,528 |
Less accumulated depreciation | (2,636) | (1,853) |
Property and equipment, net of accumulated depreciation | 1,226 | 1,675 |
Furniture and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 1,093 | 810 |
Software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 1,508 | 1,485 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 1,261 | $ 1,233 |
Composition of Certain Balanc_5
Composition of Certain Balance Sheet Items - Schedule of Other Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Balance Sheet Related Disclosures [Abstract] | ||
Government rebates | $ 11,146 | $ 9,412 |
Accrued compensation | 10,474 | 10,144 |
Accrued selling and marketing costs | 871 | 665 |
Legal fees | 756 | 612 |
Professional fees | 544 | 151 |
Other | 518 | 202 |
Total accrued and other liabilities | $ 24,309 | $ 21,186 |
Composition of Certain Balanc_6
Composition of Certain Balance Sheet Items - Narrative (Details) - USD ($) $ in Millions | Sep. 30, 2021 | Dec. 31, 2020 |
Balance Sheet Related Disclosures [Abstract] | ||
Deposits for clinical trials | $ 3.9 | $ 4.8 |
Available-for-Sale Securities_3
Available-for-Sale Securities and Fair Value Measurements - Summary of the classification of available-for-sale securities in condensed consolidated balance sheets (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Debt Securities, Available-for-sale [Line Items] | ||
Total marketable securities | $ 473,668 | $ 451,226 |
Cash equivalents | ||
Debt Securities, Available-for-sale [Line Items] | ||
Total marketable securities | 73,180 | 50,524 |
Short-term marketable securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Total marketable securities | 266,643 | 364,506 |
Long-term marketable securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Total marketable securities | $ 133,845 | $ 36,196 |
Available-for-Sale Securities_4
Available-for-Sale Securities and Fair Value Measurements - Schedule of Available-for-Sale Securities (Details) - Estimate of fair value measurement - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 473,725 | $ 451,018 |
Gross Unrealized Gains | 30 | 220 |
Gross Unrealized Losses | (87) | (12) |
Estimated Fair Value | 473,668 | 451,226 |
Corporate bonds | Level 2 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 135,204 | 96,999 |
Gross Unrealized Gains | 15 | 74 |
Gross Unrealized Losses | (37) | (9) |
Estimated Fair Value | 135,182 | 97,064 |
Commercial paper | Level 2 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 127,395 | 139,791 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 127,395 | 139,791 |
Asset-backed securities | Level 2 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 63,220 | 39,243 |
Gross Unrealized Gains | 6 | 15 |
Gross Unrealized Losses | (49) | (1) |
Estimated Fair Value | 63,177 | 39,257 |
U.S. treasury securities | Level 1 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 74,726 | 124,461 |
Gross Unrealized Gains | 9 | 131 |
Gross Unrealized Losses | (1) | (2) |
Estimated Fair Value | 74,734 | 124,590 |
Money market funds | Level 1 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 73,180 | 50,524 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | $ 73,180 | $ 50,524 |
Available-for-Sale Securities_5
Available-for-Sale Securities and Fair Value Measurements - Narrative (Details) - USD ($) $ in Millions | 9 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2020 | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Interest receivable, current | $ 1.4 | $ 1.3 |
Maximum maturity period (in years) | 2 years | |
Weighted average maturity period (in years) | 8 months | |
Minimum | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Long term marketable securities, remaining maturity | 13 months | |
Maximum | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Long term marketable securities, remaining maturity | 22 months |
Commitments and Contingencies (
Commitments and Contingencies (Details) | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |
Losses for contingent liability | $ 0 |
Provision for a loss contingency | $ 0 |
Stockholders' Equity - Narrativ
Stockholders' Equity - Narrative (Details) $ / shares in Units, $ in Thousands, shares in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||
Feb. 28, 2021shares | Sep. 30, 2021USD ($)$ / sharesshares | Jun. 30, 2021USD ($) | Mar. 31, 2021USD ($) | Sep. 30, 2020shares | Mar. 31, 2020USD ($) | Sep. 30, 2021USD ($)stockOptionPlan$ / sharesshares | Sep. 30, 2020USD ($)shares | Dec. 31, 2020shares | Nov. 30, 2020USD ($) | |
Shareholders Equity [Line Items] | ||||||||||
Number of stock option plans | stockOptionPlan | 2 | |||||||||
Common shares issued upon exercise of options | 0.9 | 0.6 | 3.6 | 1.7 | ||||||
Shares withheld for tax withholding obligation | 0.2 | 1.2 | ||||||||
Payment tax withholding share-based payment arrangement | $ | $ 2,300 | $ 20,319 | $ 90 | |||||||
Treasury stock shares acquired | 4.3 | |||||||||
Common stock repurchased, average price (in dollars per share) | $ / shares | $ 22.69 | |||||||||
Common shares repurchased | $ | $ 25,775 | $ 29,170 | $ 33,540 | $ 275 | ||||||
Treasury stock, value, acquired, cost method, net | $ | $ 98,200 | |||||||||
Treasury shares outstanding | 10.9 | 10.9 | 5.3 | |||||||
Stock Repurchase Program | ||||||||||
Shareholders Equity [Line Items] | ||||||||||
Stock repurchase amount | $ | $ 200,000 | |||||||||
Treasury stock shares acquired | 1.2 | 3.9 | ||||||||
Common stock repurchased, average price (in dollars per share) | $ / shares | $ 21.13 | $ 22.88 | ||||||||
Common shares repurchased | $ | $ 25,800 | $ 88,500 | ||||||||
2012 Equity Incentive Award Plan | ||||||||||
Shareholders Equity [Line Items] | ||||||||||
Increase in shares authorized for grant | 4.7 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock-Based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation capitalized in inventory | $ 47 | $ 53 | $ 151 | $ 182 |
Total stock-based compensation | 10,999 | 8,755 | 32,272 | 25,291 |
Cost of sales | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated share-based compensation expense | 12 | 13 | 38 | 51 |
Research and development | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated share-based compensation expense | 3,434 | 2,958 | 10,764 | 8,357 |
Selling, general and administrative | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated share-based compensation expense | $ 7,506 | $ 5,731 | $ 21,319 | $ 16,701 |
Net Income Per Share - Schedule
Net Income Per Share - Schedule of Computation of Net Income Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Numerator: | ||||||||
Net income | $ 30,471 | $ 26,523 | $ 23,465 | $ 21,625 | $ 28,327 | $ 30,065 | $ 80,459 | $ 80,017 |
Denominator: | ||||||||
Weighted-average shares used to compute basic net income per share | 115,791 | 115,734 | 116,297 | 115,107 | ||||
Dilutive effect of employee stock options (in shares) | 9,345 | 8,730 | 10,876 | 8,230 | ||||
Weighted-average shares used to compute diluted net income per share | 125,136 | 124,464 | 127,173 | 123,337 | ||||
Net income per share | ||||||||
Basic (in dollars per share) | $ 0.26 | $ 0.19 | $ 0.69 | $ 0.70 | ||||
Diluted (in dollars per share) | $ 0.24 | $ 0.17 | $ 0.63 | $ 0.65 |
Net Income Per Share - Narrativ
Net Income Per Share - Narrative (Details) - shares shares in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Stock options outstanding (in shares) | 25.5 | 26 | 25.5 | 26 |
Stock Options to Purchase Common Stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Weighted average options excluded from the computation of diluted net income per share (in shares) | 5.3 | 10.5 | 4.1 | 12.7 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Income Tax Disclosure [Abstract] | ||||
Income tax expense | $ 5,833 | $ 3,716 | $ 7,811 | $ 20,778 |
Unrecognized tax benefits, period increase | 600 | 1,400 | ||
Unrecognized tax benefits that would impact effective tax rate | 7,200 | 7,200 | ||
Unrecognized tax benefits that would be offset by a change in valuation allowance | $ 1,800 | $ 1,800 |