Document And Entity Information
Document And Entity Information | 3 Months Ended |
Mar. 31, 2020shares | |
Document and Entity Information [Abstract] | |
Document Type | 10-Q |
Document Quarterly Report | true |
Document Transition Report | false |
Document Period End Date | Mar. 31, 2020 |
Entity File Number | 001-35668 |
Entity Registrant Name | INTERCEPT PHARMACEUTICALS, INC. |
Entity Incorporation, State or Country Code | DE |
Entity Tax Identification Number | 22-3868459 |
Entity Address, Address Line One | 10 Hudson Yards, 37th Floor |
Entity Address, City or Town | New York |
Entity Address, State or Province | NY |
Entity Address, Postal Zip Code | 10001 |
City Area Code | 646 |
Local Phone Number | 747-1000 |
Title of 12(b) Security | Common Stock |
Trading Symbol | ICPT |
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 | 32,937,431 |
Entity Central Index Key | 0001270073 |
Current Fiscal Year End Date | --12-31 |
Document Fiscal Period Focus | Q1 |
Document Fiscal Year Focus | 2020 |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 41,408 | $ 70,055 |
Restricted cash | 5,011 | 4,725 |
Investment debt securities, available-for-sale | 507,628 | 582,567 |
Accounts receivable, net of allowance for credit losses of $179 and $0, respectively | 43,857 | 38,044 |
Prepaid expenses and other current assets | 30,287 | 25,924 |
Total current assets | 628,191 | 721,315 |
Fixed assets, net | 4,846 | 5,202 |
Inventory | 10,260 | 8,462 |
Security deposits | 6,644 | 6,661 |
Other assets | 12,440 | 13,246 |
Total assets | 662,381 | 754,886 |
Current liabilities: | ||
Accounts payable, accrued expenses and other liabilities | 144,518 | 153,968 |
Short-term interest payable | 5,450 | 8,037 |
Total current liabilities | 149,968 | 162,005 |
Long-term liabilities: | ||
Long-term debt | 538,968 | 532,078 |
Long-term other liabilities | 8,164 | 9,247 |
Total liabilities | 697,100 | 703,330 |
Commitments and contingencies (Note 16) | ||
Stockholders' equity: | ||
Common stock par value $0.001 per share; 45,000,000 shares authorized; 32,937,431 and 32,853,066 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively | 33 | 33 |
Additional paid-in capital | 2,185,501 | 2,176,133 |
Accumulated other comprehensive loss, net | (3,804) | (1,144) |
Accumulated deficit | (2,216,449) | (2,123,466) |
Total stockholders' (deficit) equity | (34,719) | 51,556 |
Total liabilities and stockholders' (deficit) equity | $ 662,381 | $ 754,886 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Condensed Consolidated Balance Sheets | ||
Allowance for credit losses | $ 179 | $ 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized | 45,000,000 | 45,000,000 |
Common stock, shares, issued | 32,937,431 | 32,853,066 |
Common stock, shares, outstanding | 32,937,431 | 32,853,066 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Revenue | $ 72,652 | $ 52,252 |
Operating expenses: | ||
Cost of sales | 852 | 574 |
Selling, general and administrative | 98,558 | 77,227 |
Research and development | 56,687 | 58,396 |
Total operating expenses | 156,097 | 136,197 |
Operating loss | (83,445) | (83,945) |
Other income (expense): | ||
Interest expense | (11,777) | (7,839) |
Other income, net | 2,239 | 1,514 |
Total other (expense), net | (9,538) | (6,325) |
Net loss | $ (92,983) | $ (90,270) |
Net loss per common and potential common share: | ||
Basic and diluted | $ (2.86) | $ (3.03) |
Weighted average common and potential common shares outstanding: | ||
Basic and diluted | 32,561 | 29,760 |
Product [Member] | ||
Revenue | $ 72,652 | $ 51,847 |
License [Member] | ||
Revenue | $ 405 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Condensed Consolidated Statements of Comprehensive Loss | ||
Net loss | $ (92,983) | $ (90,270) |
Net changes related to available-for-sale investment debt securities: | ||
Unrealized (losses) gains on investment debt securities | (2,163) | 803 |
Reclassification adjustment for realized gains on investment debt securities included in other income, net | 9 | 4 |
Net unrealized (losses) gains on investment debt securities | (2,154) | 807 |
Foreign currency translation (losses) gains | (512) | 283 |
Other comprehensive (loss) income | (2,666) | 1,090 |
Comprehensive loss | $ (95,649) | $ (89,180) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders' (Deficit) Equity - USD ($) shares in Thousands, $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated (Deficit) Equity [Member] | Total |
Balance at Dec. 31, 2018 | $ 30 | $ 1,800,144 | $ (2,259) | $ (1,778,785) | $ 19,130 |
Balance (in shares) at Dec. 31, 2018 | 29,694 | ||||
Stock-based compensation | 14,897 | 14,897 | |||
Net proceeds from exercise of stock options | 943 | 943 | |||
Net proceeds from exercise of stock options (in shares) | 83 | ||||
Employee withholding taxes related to stock-based awards | (791) | (791) | |||
Other comprehensive income (loss) | 1,090 | 1,090 | |||
Net loss | (90,270) | (90,270) | |||
Balance at Mar. 31, 2019 | $ 30 | 1,815,193 | (1,169) | (1,869,055) | (55,001) |
Balance (in shares) at Mar. 31, 2019 | 29,777 | ||||
Balance at Dec. 31, 2019 | $ 33 | 2,176,133 | (1,144) | (2,123,466) | 51,556 |
Balance (in shares) at Dec. 31, 2019 | 32,853 | ||||
Stock-based compensation | 12,473 | 12,473 | |||
Net proceeds from exercise of stock options | (1,783) | $ (1,783) | |||
Net proceeds from exercise of stock options (in shares) | 88 | 9 | |||
Employee withholding taxes related to stock-based awards | (1,322) | $ (1,322) | |||
Employee withholding taxes related to stock-based awards, (in shares) | (4) | ||||
Other comprehensive income (loss) | (2,660) | (2,660) | |||
Net loss | (92,983) | (92,983) | |||
Balance at Mar. 31, 2020 | $ 33 | $ 2,185,501 | $ (3,804) | $ (2,216,449) | $ (34,719) |
Balance (in shares) at Mar. 31, 2020 | 32,937 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (92,983) | $ (90,270) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 12,473 | 14,897 |
(Accretion) amortization of (discount) premium on investment debt securities | 536 | (299) |
Amortization of deferred financing costs | 614 | 406 |
Depreciation | 764 | 996 |
Non-cash operating lease cost | 1,584 | 1,404 |
Gain on lease termination | (1,995) | |
Loss on the disposal of fixed assets | 2,683 | |
Accretion of debt discount | 6,276 | 3,695 |
Provision for allowance of credit losses | 179 | |
Changes in operating assets: | ||
Accounts receivable | (6,549) | (3,746) |
Prepaid expenses and other current assets | (7,122) | 752 |
Inventory | (2,377) | (262) |
Security deposits | 50 | 883 |
Other assets | (19,716) | |
Changes in operating liabilities: | ||
Accounts payable, accrued expenses and other current liabilities | (7,899) | (800) |
Operating lease liabilities | (1,690) | (1,638) |
Interest payable | (2,587) | (3,737) |
Deferred revenue | 690 | |
Long-term other liabilities | 12,632 | |
Net cash (used in) operating activities | (98,731) | (83,425) |
Cash flows from investing activities: | ||
Purchases of investment debt securities | (34,444) | (5,212) |
Sales and maturities of investment debt securities | 106,693 | 100,412 |
Purchases of equipment, leasehold improvements, and furniture and fixtures | (432) | (733) |
Net cash provided by investing activities | 71,817 | 94,467 |
Cash flows from financing activities: | ||
Proceeds from exercise of options, net | 569 | 943 |
Payments of employee withholding taxes related to stock-based awards | (1,322) | (791) |
Net cash (used in) provided by financing activities | (753) | 152 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (694) | 282 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (28,361) | 11,476 |
Cash, cash equivalents and restricted cash at beginning of period | 74,780 | 43,248 |
Cash, cash equivalents and restricted cash at end of period | $ 46,419 | $ 54,724 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |||
Mar. 31, 2020 | Dec. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | |
Supplemental disclosure of non-cash transactions: | ||||
Right-of-use asset obtained in exchange for new operating lease obligations | $ 1,006 | |||
Reconciliation of cash, cash equivalents and restricted cash included in the consolidated balance sheets: | ||||
Cash and cash equivalents | 41,408 | $ 70,055 | $ 54,724 | |
Restricted cash | 5,011 | 4,725 | ||
Total cash, cash equivalents and restricted cash | $ 46,419 | $ 74,780 | $ 54,724 | $ 43,248 |
Overview of Business
Overview of Business | 3 Months Ended |
Mar. 31, 2020 | |
Basis of Presentation [Abstract] | |
Overview of Business | 1. Overview of Business Intercept Pharmaceuticals, Inc. (the “Company”) is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, including primary biliary cholangitis (“PBC”) and nonalcoholic steatohepatitis (“NASH”). The Company currently has one marketed product, Ocaliva (obeticholic acid or “OCA”). Founded in 2002 in New York, the Company has operations in the United States, Europe and Canada. |
Basis of Presentation
Basis of Presentation | 3 Months Ended |
Mar. 31, 2020 | |
Basis of Presentation [Abstract] | |
Basis of Presentation | 2. Basis of Presentation The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany balances and transactions have been eliminated in consolidation. Certain information that is normally required by U.S. GAAP has been condensed or omitted in accordance with rules and regulations of the Securities and Exchange Commission (“SEC”). Operating results for the three months ended March 31, 2020 are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2020. In the opinion of management, these unaudited condensed consolidated financial statements include all normal and recurring adjustments considered necessary for a fair presentation of these interim unaudited condensed consolidated financial statements. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2019, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC. Use of Estimates The preparation of these unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and judgments that affect the reported amounts of assets and liabilities, the disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from these estimates. We are not presently aware of any events or circumstances arising from the coronavirus (“COVID-19”) pandemic that would require us to update our estimates, judgments or revise the carrying value of our assets or liabilities. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2020 | |
Summary of Significant Accounting Policiies | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Credit Losses Accounts receivable The allowance for credit losses is based on the Company’s assessment of the collectibility of customer accounts. The Company regularly reviews the allowance by considering factors such as historical experience, the aging of the accounts receivable balances, credit conditions that may affect a customer’s ability to pay, current and forecast economic conditions and other relevant factors. The following table summarizes the allowance for credit losses activity on the Company’s trade receivables for the three-month period ended March 31, 2020 (in thousands): Balance at December 31, 2019 $ — Provision for credit losses 190 Write-offs (11) Balance at March 31, 2020 $ 179 Available-for-sale investment debt securities For available-for-sale investment debt securities in an unrealized loss position, the Company first assesses whether it intends to sell the security or it is more likely than not that it will be required to sell the security before recovery of its amortized cost basis. If either of the criteria regarding intent or requirement to sell is met, the amortized cost basis is written down to fair value through income. For any investment debt securities that do not meet the criteria, the Company evaluates whether the decline in fair value has resulted from credit losses or other factors. Management considers the extent in which the fair value of the security is less than amortized costs, any changes to the rating of the security by a rating agency, changes in interest rates, and any other adverse factors related to the security. If the assessment indicates a credit loss, the present value of cash flows expected to be collected are compared to the amortized cost basis of the security. If the expected present value of cash flows is less than the amortized cost basis, a credit loss exists and an allowance for credit losses is recorded, limited to the amount that the fair value is below the amortized cost basis. Any impairment not recorded through an allowance is recognized in Other comprehensive (loss) income. Changes in the allowance for credit losses are recorded as a provision for (or reversal of) credit loss expense. Losses are charged against the allowance when management believes the uncollectibility of the security is confirmed or whether either of the criteria regarding intent or requirement to sell is met. The Company excludes accrued interest from both the fair value and amortized cost basis in the assessment of credit losses on its available-for-sale investment debt securities and will instead elect to write-off any uncollectible accrued interest receivable balances in a timely manner, which is defined by the Company as when interest due becomes 90 days delinquent. Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“ In August 2018, the FASB issued ASU No. 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement” (“ASU 2018-13”), which makes a number of changes meant to add, modify or remove certain disclosure requirements associated with the movement amongst or hierarchy associated with Level 1, Level 2 and Level 3 fair value measurements. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is permitted upon issuance of the update. The Company adopted ASU 2018-13 on January 1, 2020 and its adoption did not have an impact on the Company’s condensed consolidated financial statements and related disclosures. Recent Accounting Pronouncements to be Adopted In December 2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures. |
Cash, Cash Equivalents and Inve
Cash, Cash Equivalents and Investment Debt Securities | 3 Months Ended |
Mar. 31, 2020 | |
Cash, Cash Equivalents, and Investment Debt Securities [Abstract] | |
Cash, Cash Equivalents, and Investment Debt Securities | 4. Cash, Cash Equivalents and Investment Debt Securities The following table summarizes the Company’s cash, cash equivalents and investment debt securities as of March 31, 2020 and December 31, 2019: As of March 31, 2020 Allowance Gross Gross for Credit Unrealized Unrealized Amortized Cost Losses Gains Losses Fair Value (in thousands) Cash and cash equivalents: Cash and money market funds $ 41,408 $ — $ — $ — $ 41,408 Total cash and cash equivalents 41,408 — — — 41,408 Investment debt securities: Commercial paper 18,478 — 10 — 18,488 Corporate debt securities 486,490 — 189 (1,581) 485,098 U.S. treasuries 4,018 — 24 — 4,042 Total investment debt securities 508,986 — 223 (1,581) 507,628 Total cash, cash equivalents and investment debt securities $ 550,394 $ — $ 223 $ (1,581) $ 549,036 As of December 31, 2019 Gross Gross Unrealized Unrealized Amortized Cost Gains Losses Fair Value (in thousands) Cash and cash equivalents: Cash and money market funds $ 62,557 $ — $ — $ 62,557 Commercial paper 7,498 — — 7,498 Total cash and cash equivalents 70,055 — — 70,055 Investment debt securities: Commercial paper 42,806 43 (1) 42,848 Corporate debt securities 538,965 835 (81) 539,719 Total investment debt securities 581,771 878 (82) 582,567 Total cash, cash equivalents and investment debt securities $ 651,826 $ 878 $ (82) $ 652,622 The aggregate fair value of the Company’s available-for-sale investment debt securities that have been in a continuous unrealized loss position for less than twelve months or twelve months or longer is as follows: As of March 31, 2020 Less than 12 months 12 months or longer Total (in thousands) Gross Gross Gross Unrealized Unrealized Unrealized Fair Value Losses Fair Value Losses Fair Value Losses Corporate debt securities $ 326,320 $ (1,581) $ — $ — $ 326,320 $ (1,581) Total $ 326,320 $ (1,581) $ — $ — $ 326,320 $ (1,581) As of December 31, 2019 Less than 12 months 12 months or longer Total (in thousands) Gross Gross Gross Unrealized Unrealized Unrealized Fair Value Losses Fair Value Losses Fair Value Losses Commercial paper $ 11,976 $ (1) $ — $ — $ 11,976 $ (1) Corporate debt securities 121,684 (81) — — 121,684 (81) Total $ 133,660 $ (82) $ — $ — $ 133,660 $ (82) |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Measurements [Abstract] | |
Fair Value Measurements | 5. Fair Value Measurements The carrying amounts of the Company’s receivables and payables approximate their fair value due to their short maturities. Accounting principles provide guidance for using fair value to measure assets and liabilities. The guidance includes a three-level hierarchy of valuation techniques used to measure fair value, defined as follows: ● Unadjusted Quoted Prices — The fair value of an asset or liability is based on unadjusted quoted prices in active markets for identical assets or liabilities (Level 1). ● Pricing Models with Significant Observable Inputs — The fair value of an asset or liability is based on information derived from either an active market quoted price, which may require further adjustment based on the attributes of the financial asset or liability being measured, or an inactive market transaction (Level 2). ● Pricing Models with Significant Unobservable Inputs — The fair value of an asset or liability is primarily based on internally derived assumptions surrounding the timing and amount of expected cash flows for the financial instrument. Therefore, these assumptions are unobservable in either an active or inactive market (Level 3). The Company considers an active market as one in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. Conversely, the Company views an inactive market as one in which there are few transactions for the asset or liability, the prices are not current, or price quotations vary substantially either over time or among market makers. Where appropriate, non-performance risk, or that of a counterparty, is considered in determining the fair values of liabilities and assets, respectively. The Company’s money market funds are classified within Level 1 of the fair value hierarchy because they are valued using quoted prices in active markets. Investment debt securities are classified as Level 2 instruments based on market pricing and other observable inputs. Financial assets carried at fair value are classified in the tables below in one of the three categories described above: Fair Value Measurements Using Total Level 1 Level 2 Level 3 (in thousands) March 31, 2020 Assets Cash and cash equivalents: Money market funds $ 24,773 $ 24,773 $ — $ — Available-for-sale investment debt securities: Commercial paper 18,488 — 18,488 — Corporate debt securities 485,098 — 485,098 — U.S. treasuries 4,042 — 4,042 — Total financial assets $ 532,401 $ 24,773 $ 507,628 $ — December 31, 2019 Assets Cash and cash equivalents: Money market funds $ 19,376 $ 19,376 $ — $ — Commercial paper 7,498 — 7,498 — Available-for-sale investment debt securities: Commercial paper 42,848 — 42,848 — Corporate debt securities 539,719 — 539,719 — Total financial assets $ 609,441 $ 19,376 $ 590,065 $ — The aggregate fair value of all available-for-sale investment debt securities (commercial paper, corporate debt securities and U.S. treasuries), by contractual maturity, are as follows: Fair Value as of March 31, 2020 December 31, 2019 (in thousands) Due in one year or less $ 433,013 $ 473,602 Due after one year through two years 74,615 116,463 Total investment debt securities $ 507,628 $ 590,065 Actual maturities may differ from contractual maturities because issuers may have the right to call or prepay obligations without call or prepayment penalties. |
Fixed Assets, Net
Fixed Assets, Net | 3 Months Ended |
Mar. 31, 2020 | |
Fixed Assets, Net [Abstract] | |
Fixed Assets, Net | 6. Fixed Assets, Net Fixed assets are stated at cost and depreciated or amortized using the straight-line method based on useful lives as follows: Useful lives (Years) March 31, 2020 December 31, 2019 (in thousands) Office equipment and software 3 $ 4,349 $ 4,386 Leasehold improvements Shorter of remaining lease term or useful life 10,743 10,489 Furniture and fixtures 7 4,139 4,032 Subtotal 19,231 18,907 Less: accumulated depreciation (14,385) (13,705) Fixed assets, net $ 4,846 $ 5,202 |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2020 | |
Inventory [Abstract] | |
Inventory | 7. Inventory Inventories are stated at the lower of cost or market. Inventories consisted of the following: March 31, 2020 December 31, 2019 (in thousands) Work-in-process $ 10,030 $ 8,302 Finished goods 230 160 Inventory $ 10,260 $ 8,462 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2020 | |
Operating Leases [Abstract] | |
Leases | 8. Leases The Company leases various office spaces under non-cancelable operating leases with original lease periods expiring between the third quarter of 2020 and 2024. The Company subleases one of its office spaces to a third party. The Company also enters into leases for equipment. A number of the Company’s leases include one or more options to renew, with renewal terms that can extend the lease term. The exercise of lease renewal options is typically at the sole discretion of the Company; therefore, all renewals to extend the lease terms are not included in the right-of-use (“ROU”) assets and lease liabilities as they are not reasonably certain of exercise. The Company regularly evaluates the renewal options and when they are reasonably certain of exercise, includes the renewal period in the lease term. These operating leases do not contain material variable rent payments, residual value guarantees, covenants, or other restrictions. The Company has elected the practical expedient to exclude short-term leases from its ROU assets and lease liabilities; therefore leases with an initial term of 12 months or less are not recorded on the balance sheet. The Company recognizes lease expense for these leases on a straight-line basis over the lease term. The Company elected the practical expedient not to separate non-lease components from all leases. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at the lease commencement date in determining the present value of the lease payments. The Company’s incremental borrowing rate is the estimated rate that would be required to pay for a collateralized borrowing equal to the total lease payment over the lease term. The Company estimates its incremental borrowing rate based on an analysis of publicly traded debt securities of companies with credit and financial profiles similar to its own adjusted to be commensurate with the term of the underlying lease and the Company’s secured borrowing rate. Operating lease assets and liabilities are classified on the condensed consolidated balance sheets as follows: Leases Classification March 31, 2020 December 31, 2019 Assets (in thousands) Operating lease assets Other assets $ 12,440 $ 13,246 Total leased assets $ 12,440 $ 13,246 Liabilities Current Operating lease liabilities Accounts payable, accrued expenses and other liabilities $ 6,596 $ 6,456 Noncurrent Operating lease liabilities Long-term other liabilities 8,164 9,222 Total operating lease liabilities $ 14,760 $ 15,678 Operating lease costs for the three-month periods ended March 31, 2020 and 2019, are as follows: Three Months Ended March 31, Lease Cost Classification 2020 2019 (in thousands) Operating lease cost Selling, general and administrative expenses $ 1,739 $ 1,678 Short-term lease cost Selling, general and administrative expenses 421 826 Variable lease cost Selling, general and administrative expenses 247 224 Sublease income Other income, net (120) (180) Net lease cost $ 2,287 $ 2,548 The weighted-average remaining term of the Company’s operating leases was 2.4 years and the weighted-average discount rate used to measure the present value of the Company’s operating lease liabilities was 3.9% as of March 31, 2020. Cash payments included in the measurement of the Company’s operating lease liabilities reported in operating cash flows were $1.8 million and $1.9 million for the three months ended March 31, 2020 and 2019, respectively. During the three months ended March 31, 2020, the Company obtained a ROU asset of $1.0 million in exchange for new operating lease obligations of $1.0 million. Maturities of the Company’s operating lease liabilities, which do not include short-term leases, as of March 31, 2020 are as follows: Maturity of Lease Liabilities Operating leases (in thousands) 2020 $ 5,616 2021 6,475 2022 2,340 2023 895 2024 373 Thereafter — Total lease payments 15,699 Less: Present value discount (939) Total operating lease liabilities $ 14,760 |
Accounts Payable, Accrued Expen
Accounts Payable, Accrued Expenses and Other Liabilities | 3 Months Ended |
Mar. 31, 2020 | |
Accounts Payable, Accrued Expenses and Other Liabilities [Abstract] | |
Accounts Payable, Accrued Expenses and Other Liabilities | 9. Accounts Payable, Accrued Expenses and Other Liabilities Accounts payable, accrued expenses and other liabilities consisted of the following: March 31, 2020 December 31, 2019 (in thousands) Accounts payable $ 14,977 $ 18,975 Accrued employee compensation 14,135 26,483 Accrued contracted services 76,592 74,486 Accrued rebates, discounts and other incentives 25,422 21,529 Operating lease liabilities 6,596 6,456 Other liabilities 6,796 6,039 Accounts payable, accrued expenses and other liabilities $ 144,518 $ 153,968 Research & Development Tax Credit The Company benefits from the U.K. Small and Medium-sized Enterprise R&D Tax Credit scheme, or the SME scheme, under which it can obtain a refundable credit of up to 33.4% of eligible research and development expenses incurred by the Company in the U.K.. Eligible expenses generally include employment costs for research staff, consumables, software and certain internal overhead costs incurred as part of research projects. The Company submitted a claim seeking to obtain tax credits for qualifying R&D expenses incurred in the years ended December 31, 2015 and 2016. In September 2019, the Company received a partial payment of $10.5 million from Her Majesty’s Revenue and Customs, the U.K.’s government tax authority. Given the claim review has not been finalized, the credit received is recorded as a deferred liability within Accounts payable, accrued expenses, and other liabilities. |
Long-Term Debt
Long-Term Debt | 3 Months Ended |
Mar. 31, 2020 | |
Long-Term Debt [Abstract] | |
Long-Term Debt | 10. Long-Term Debt Debt, net of discounts and deferred financing costs, consisted of the following: March 31, 2020 December 31, 2019 (in thousands) 2023 Convertible Notes $ 460,000 $ 460,000 2026 Convertible Notes 230,000 230,000 Long-term debt, gross 690,000 690,000 Less: Unamortized debt discounts and fees (151,032) (157,922) Long-term debt, net $ 538,968 $ 532,078 2019 Offering On May 14, 2019, the Company issued and sold $230.0 million aggregate principal amount of 2.00% Convertible Senior Notes due 2026 (the “2026 Convertible Notes”). The Company received net proceeds from the sale of the 2026 Convertible Notes of $223.4 million, after deducting underwriting discounts, commissions and estimated offering expenses of approximately $6.6 million. The 2026 Convertible Notes were issued pursuant to a Second Supplemental Indenture, dated as of May 14, 2019 (the “Second Supplemental Indenture”), which supplements the Indenture (the “Base Indenture”), as supplemented by a First Supplemental Indenture (the “First Supplemental Indenture” and collectively with the Base Indenture and the Second Supplemental Indenture, the “Indenture”), each dated as of July 6, 2016, by and between the Company and U.S. Bank National Association, as trustee. The 2026 Convertible Notes are senior unsecured obligations of the Company, bear interest at a fixed rate of 2.00% per annum (payable semi-annually on May 15 and November 15 of each year, beginning on November 15, 2019) and will mature on May 15, 2026, unless earlier repurchased, redeemed or converted. Holders may convert their 2026 Convertible Notes at their option at any time prior to the close of business on the business day immediately preceding February 15, 2026 only under the following circumstances: (i) during any calendar quarter (and only during such calendar quarter) commencing after the calendar quarter ended on June 30, 2019, if the last reported sale price of the Company’s common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day; (ii) during the five business day period after any five consecutive trading day period in which the trading price (as defined in the Indenture) per $1,000 principal amount of 2026 Convertible Notes for each trading day of such five consecutive trading day period was less than 98% of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day; (iii) if the Company calls any or all of the 2026 Convertible Notes for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date; or (iv) upon the occurrence of specified corporate events. On or after February 15, 2026 until the close of business on the business day immediately preceding the maturity date, holders may convert their 2026 Convertible Notes at any time, regardless of the foregoing circumstances. Upon conversion of the 2026 Convertible Notes, the Company will pay or deliver, as the case may be, cash, shares of the Company’s common stock (and cash in lieu of any fractional shares) or a combination of cash and shares of the Company’s common stock, at the Company’s election. The initial conversion rate of the 2026 Convertible Notes is 9.2123 shares of the Company’s common stock per $1,000 principal amount of 2026 Convertible Notes, which is equivalent to an initial conversion price of approximately $108.55 per share of the Company’s common stock. The conversion rate is subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date, the Company will increase the conversion rate for a holder who elects to convert its 2026 Convertible Notes in connection with such a corporate event in certain circumstances. The Company may not redeem the 2026 Convertible Notes prior to May 20, 2023. The Company may redeem for cash all or any portion of the 2026 Convertible Notes, at the Company’s option, on or after May 20, 2023, if the last reported sale price of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption at a redemption price equal to 100% of the principal amount of the 2026 Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the 2026 Convertible Notes. If the Company undergoes a fundamental change (as defined in the Indenture), holders may require the Company to repurchase for cash all or any portion of their 2026 Convertible Notes at a fundamental change repurchase price equal to 100% of the principal amount of the 2026 Convertible Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. The Indenture provides for customary events of default. In accordance with Accounting Standards Codification (“ASC”) Subtopic 470-20, “Debt with Conversion and Other Options” (“ASC 470-20”), the Company used an effective interest rate of 9.9% to determine the liability component of the 2026 Convertible Notes. This resulted in the recognition of $137.5 million as the liability component of the 2026 Convertible Notes and the recognition of the residual $85.9 million as the debt discount with a corresponding increase to additional paid-in capital for the equity component of the 2026 Convertible Notes. The underwriting discount and estimated offering expenses totaling $6.6 million were allocated between the debt and equity issuance costs in proportion to the allocation of the liability and equity components of the 2026 Convertible Notes. Accordingly, equity issuance costs of $2.5 million were recorded as an offset to additional paid-in capital and total debt issuance costs of $4.1 million were recorded on the issuance date and are reflected in the unaudited condensed consolidated balance sheet as a direct deduction from the carrying value of the associated debt liability. The debt discount and debt issuance costs will be amortized as non-cash interest expense through May 15, 2026. The fair value of the 2026 Convertible Notes was approximately $184.6 million and $294.9 million at March 31, 2020 and December 31, 2019, respectively, and was determined using Level 2 inputs based on quoted market values. 2016 Offerings On July 6, 2016, the Company issued and sold $460.0 million aggregate principal amount of 3.25% Convertible Senior Notes due 2023 (the “2023 Convertible Notes”, and together with the 2026 Convertible Notes, the “Convertible Notes”). The Company received net proceeds from the sale of the 2023 Convertible Notes of $447.6 million, after deducting underwriting discounts, commissions and estimated offering expenses of approximately $12.4 million. The Company used approximately $38.4 million of such net proceeds to fund the cost of the Capped Call Transactions (as defined below) that were entered into in connection with the issuance of the 2023 Convertible Notes. The 2023 Convertible Notes were issued pursuant to the Base Indenture, as supplemented by the First Supplemental Indenture. The 2023 Convertible Notes are senior unsecured obligations of the Company, bear interest at a fixed rate of 3.25% per year (payable semi-annually on January 1 and July 1 of each year, beginning on January 1, 2017) and will mature on July 1, 2023, unless earlier repurchased, redeemed or converted. Holders may convert their 2023 Convertible Notes at their option at any time prior to the close of business on the business day immediately preceding January 1, 2023 only under the following circumstances: (i) during any calendar quarter commencing after the calendar quarter ended on September 30, 2016, if the last reported sale price of the Company’s common stock for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day; (ii) during the five business day period after any five consecutive trading day period in which the trading price (as defined in the Indenture) per $1,000 principal amount of 2023 Convertible Notes for each trading day of such five consecutive trading day period was less than 98% of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day; (iii) if the Company calls any or all of the 2023 Convertible Notes for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date; or (iv) upon the occurrence of specified corporate events. On or after January 1, 2023 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert their 2023 Convertible Notes at any time, regardless of the foregoing circumstances. Upon conversion of the 2023 Convertible Notes, the Company will pay or deliver, as the case may be, cash, shares of the Company’s common stock (and cash in lieu of any fractional shares) or a combination of cash and shares of the Company’s common stock, at the Company’s election. The initial conversion rate of the 2023 Convertible Notes is 5.0358 shares of the Company’s common stock per $1,000 principal amount of 2023 Convertible Notes, which is equivalent to an initial conversion price of approximately $198.58 per share of the Company’s common stock. The conversion rate is subject to adjustment upon the occurrence of certain events but will not be adjusted for any accrued and unpaid interest. If the Company undergoes a fundamental change (as defined in the Indenture), holders may require the Company to repurchase for cash all or any portion of their 2023 Convertible Notes at a fundamental change repurchase price equal to 100% of the principal amount of the 2023 Convertible Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, if certain make-whole fundamental changes occur, the Company will, in certain circumstances, increase the conversion rate for any 2023 Convertible Notes converted in connection with such make-whole fundamental change. The Company may not redeem the 2023 Convertible Notes prior to July 6, 2021. The Company may redeem for cash all or part of the 2023 Convertible Notes, at its option, on or after July 6, 2021, if the last reported sale price of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption at a redemption price equal to 100% of the principal amount of the 2023 Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. The Indenture provides for customary events of default. On June 30, 2016, in connection with the pricing of the 2023 Convertible Notes, the Company entered into privately-negotiated capped call transactions (the “Base Capped Call Transactions”) with each of Royal Bank of Canada, UBS AG, London Branch, and Credit Suisse Capital LLC (the “Option Counterparties”). On July 1, 2016, in connection with the underwriters’ exercise of their over-allotment option in full, the Company entered into additional capped call transactions (the “Additional Capped Call Transactions” and, together with the Base Capped Call Transactions, the “Capped Call Transactions”) with the Option Counterparties. The Capped Call Transactions are expected generally to reduce the potential dilution with respect to the Company’s common stock and/or offset the cash payments the Company would be required to make in excess of the principal amount of converted 2023 Convertible Notes, as the case may be, upon conversion of the 2023 Convertible Notes in the event that the market price per share of the Company’s common stock, as measured under the terms of the Capped Call Transactions, is greater than the strike price of the Capped Call Transactions, which initially corresponds to the conversion price of the 2023 Convertible Notes and is subject to anti-dilution adjustments substantially similar to those applicable to the conversion rate of the 2023 Convertible Notes. The cap price of the Capped Call Transactions is initially $262.2725 per share, and is subject to certain adjustments under the terms of the Capped Call Transactions. If, however, the market price per share of the Company’s common stock, as measured under the terms of the Capped Call Transactions, exceeds the cap price of the Capped Call Transactions, there would nevertheless be dilution and/or there would not be an offset of such potential cash payments, in each case, upon conversion of the Convertible Notes to the extent that such market price exceeds the cap price of the Capped Call Transactions. In accordance with ASC 470-20, the Company used an effective interest rate of 8.4% to determine the liability component of the 2023 Convertible Notes. This resulted in the recognition of $334.4 million as the liability component of the 2023 Convertible Notes and the recognition of the residual $113.1 million as the debt discount with a corresponding increase to additional paid-in capital for the equity component of the 2023 Convertible Notes. The fair value of the 2023 Convertible Notes was approximately $372.8 million and $463.5 million at March 31, 2020 and December 31, 2019, respectively, and was determined using Level 2 inputs based on quoted market values. Interest Expense on Convertible Notes Interest expense was $11.8 million and $7.8 million for the three months ended March 31, 2020 and 2019, respectively, related to the Convertible Notes. Accrued interest on the Convertible Notes was approximately $5.5 million and $8.1 million as of March 31, 2020 and December 31, 2019, respectively. The Company recorded debt issuance costs of $19.0 million, which are being amortized using the effective interest method. As of March 31, 2020, $12.6 million of debt issuance costs are recorded on the unaudited condensed consolidated balance sheet in Long-term debt. Cash payments for interest were $7.5 million and $7.5 million for the three months ended March 31, 2020 and 2019, respectively. |
Product Revenue, Net
Product Revenue, Net | 3 Months Ended |
Mar. 31, 2020 | |
Product Revenue, Net [Abstract] | |
Product Revenue, Net | 11. Product Revenue, Net The Company recognized net sales of Ocaliva of $72.7 million and $51.8 million for the three months ended March 31, 2020 and 2019, respectively. The table below summarizes consolidated product revenue, net by region: Three Months Ended March 31, 2020 2019 (in thousands) Product revenue, net: U.S. $ 50,779 $ 37,991 ex-U.S. 21,873 13,856 Total product revenue, net $ 72,652 $ 51,847 |
License Agreement
License Agreement | 3 Months Ended |
Mar. 31, 2020 | |
License Agreement [Abstract] | |
License Agreement | 12. License Agreement Sumitomo Dainippon Pharma Co., Ltd. In March 2011, the Company entered into an exclusive license agreement (the “Original Sumitomo Agreement”) with Sumitomo Dainippon Pharma Co., Ltd. (“Sumitomo Dainippon”), pursuant to which the Company granted to Sumitomo Dainippon an exclusive license to research, develop and commercialize OCA for the treatment of PBC and NASH in Japan and China (excluding Taiwan) and an option to research, develop and commercialize OCA in certain countries outside of such territories (the “Country Option”). The Company received an upfront payment from Sumitomo Dainippon of $15.0 million under the terms of the Original Sumitomo Agreement. In October 2019, the Company and Sumitomo Dainippon mutually agreed to terminate with immediate effect the Sumitomo Agreement. In connection with the termination of the Sumitomo Agreement, Sumitomo Dainippon agreed to return to the Company the rights to develop and commercialize OCA in China and the Company agreed to forego any further milestone or royalty payments relating to the development and commercialization of OCA in China. No payment is due from the Company to Sumitomo Dainippon as a result of the termination of the Sumitomo Agreement. The Company recognized licensing revenue of $0 and $0.4 million for the three months ended March 31, 2020 and 2019, respectively, under the Sumitomo Agreement. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2020 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | 13. Stockholders’ Equity 2019 Public Offering and Concurrent Private Placement On May 14, 2019, the Company issued and sold (i) 2,760,000 shares of common stock in a registered public offering (including 360,000 shares issued and sold upon the exercise in full of the underwriters’ option to purchase additional shares), at a price to the public of $83.50 per share (the “2019 Public Offering”) and (ii) 119,760 shares of common stock (the “2019 Private Placement Shares”) in a concurrent private placement of common stock (the “2019 Concurrent Private Placement”) exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), at a purchase price per share equivalent to the price to the public set in the 2019 Public Offering and pursuant to a securities purchase agreement (the “2019 Securities Purchase Agreement”) that the Company entered into with Samsara BioCapital, L.P. (“Samsara”), one of the Company’s existing stockholders. Pursuant to the 2019 Securities Purchase Agreement, the Company granted to Samsara certain registration rights requiring the Company, upon request of Samsara on or after July 9, 2019 and subject to certain terms and conditions, to register the resale by Samsara of its 2019 Private Placement Shares. Such registration rights have since expired. |
Stock Compensation
Stock Compensation | 3 Months Ended |
Mar. 31, 2020 | |
Stock Compensation [Abstract] | |
Stock Compensation | 14. Stock Compensation The Company’s 2012 Equity Incentive Plan (“2012 Plan”) became effective upon the pricing of its initial public offering in October 2012. At the same time, the Company’s 2003 Stock Incentive Plan (“2003 Plan”) was terminated and 555,843 shares available under the 2003 Plan were added to the 2012 Plan. On January 1, 2020, the number of shares available for issuance under the 2012 Plan increased by 1,211,533 shares, as a result of the automatic increase provisions thereof. The estimated fair value of the stock options granted in the three months ended March 31, 2020 was determined utilizing a Black-Scholes option-pricing model at the date of grant. The fair value of the restricted stock units (“RSUs”) granted in the three months ended March 31, 2020 was determined utilizing the closing price of the Company’s common stock on the date of grant. The fair value of the performance restricted stock units (“PRSUs”) granted in the three months ended March 31, 2020 was determined utilizing the Monte Carlo simulation method. The following table summarizes stock option activity during the three months ended March 31, 2020: Weighted Average Number Weighted Remaining Aggregate of Options Average Contractual Intrinsic Value (in thousands) Exercise Price Term (years) (in thousands) Outstanding at December 31, 2019 1,981 $ 99.87 7.4 $ 65,662 Granted 557 $ 99.94 — $ — Exercised (9) $ 47.78 — $ — Cancelled/forfeited (63) $ 97.85 — $ — Expired (20) $ 198.78 — $ — Outstanding at March 31, 2020 2,446 $ 99.32 7.7 $ 6,106 Expected to vest 1,256 $ 92.39 9.0 $ 1,005 Exercisable 1,190 $ 106.62 6.4 $ 5,101 The aggregate intrinsic value of options is calculated as the difference between the exercise price of the underlying options and the deemed fair value of the Company’s common stock for those options that had exercise prices lower than the deemed fair value of the Company’s common stock. As of March 31, 2020, the total compensation cost related to non-vested option awards not yet recognized is approximately $66.6 million with a weighted average remaining vesting period of 1.54 years. The Company estimated the fair value of stock options granted in the periods presented utilizing a Black-Scholes option-pricing model utilizing the following assumptions: Three Months Ended March 31, 2020 2019 Volatility 61.9 - 87.1 % 87.0 - 87.2 % Expected term (in years) 6.0 6.0 Risk-free rate 0.9 - 1.7 % 2.5 - 2.9 % Expected dividend yield — % — % The following table summarizes the aggregate RSU, restricted stock award (“RSA”), PRSU and performance restricted share award (“PRSA”) activity during the three months ended March 31, 2020: Weighted Number of Average Grant Date Awards Fair Value (in thousands) Non-vested awards at December 31, 2019 709 $ 88.39 Granted 399 $ 102.82 Vested (104) $ 74.75 Forfeited (43) $ 94.43 Non-vested awards at March 31, 2020 961 $ 95.58 As of March 31, 2020, there is approximately $76.9 million of total unrecognized compensation expense related to unvested RSUs, RSAs, PRSUs and PRSAs, which is expected to be recognized over a weighted average vesting period of 1.72 years. During the three months ended March 31, 2020, the Company granted a total of 64,900 PRSUs to certain of the Company’s executive officers. The performance criterion for such PRSUs is based on the Total Shareholder Return (“TSR”) of the Company’s common stock relative to the TSR of the companies comprising the S&P Biotechnology Select Industry Index (the “TSR Peer Group”) over a 3-year performance period and is accounted for as a market condition under ASC Topic 718, Compensation – Stock Compensation The Company recorded approximately $0.6 million of stock-based compensation related to such PRSUs during the three months ended March 31, 2020. The Company accounts for all forfeitures when they occur. Ultimately, the actual expense recognized over the vesting period will be for only those shares that vest and are not forfeited. The Company has in the past, and may in the future, grant performance-based awards with vesting terms based on the achievement of specified goals. To the extent such awards do not contain a market condition, the Company recognizes no expense until achievement of the performance requirement is deemed probable. There are no awards with performance conditions outstanding as of March 31, 2020. Stock-based compensation expense has been reported in the Company’s condensed consolidated statements of operations as follows: Three Months Ended March 31, 2020 2019 (in thousands) Selling, general and administrative $ 9,723 $ 11,331 Research and development 2,750 3,566 Total stock-based compensation $ 12,473 $ 14,897 |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2020 | |
Net loss per common and potential common share: | |
Net Loss Per Share | 15. Net Loss Per Share Basic loss per share is computed by dividing net loss attributable to common stockholders (numerator) by the weighted average number of common shares outstanding (denominator) during the period. For the three-month periods ended March 31, 2020 and 2019, as the Company was in a net loss position, the diluted loss per share computations for such periods did not assume the conversion of the Convertible Notes, exercise of stock options or vesting of RSUs or PRSUs as they would have had an anti-dilutive effect on loss per share. The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding for the three-month periods ended March 31, 2020 and 2019, as the inclusion thereof would have been anti-dilutive: Three Months Ended March 31, 2020 2019 (in thousands) Shares issuable upon conversion of Convertible Notes 4,435 2,316 Options 2,446 2,224 Unvested restricted stock units 871 645 Total 7,752 5,185 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2020 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | 16. Commitments and Contingencies Legal Proceedings The Company is involved in various disputes, governmental inquiries and investigations, legal proceedings and litigation in the course of its business, including the matters described below and, from time to time, intellectual property, employment and other litigation. These matters, which could result in damages, fines or other administrative, civil or criminal remedies, liabilities or penalties, are often complex and the outcome of such matters is often uncertain. The Company may from time to time enter into settlements to resolve such matters. On September 27, 2017, a purported shareholder class action, initially styled DeSmet v. Intercept Pharmaceuticals, Inc., et al, was filed in the United States District Court for the Southern District of New York, naming the Company and certain of its officers as defendants. The Court appointed lead plaintiffs in the lawsuit on June 1, 2018, and the lead plaintiffs filed an amended complaint on July 31, 2018, captioned Hou Liu and Amy Fu v. Intercept Pharmaceuticals, Inc., et al., naming the Company and certain of its current and former officers as defendants. The lead plaintiffs claim to be suing on behalf of anyone who purchased or otherwise acquired the Company’s common stock between June 9, 2016 and September 20, 2017. This lawsuit alleges that material misrepresentations and/or omissions of material fact were made in the Company’s public disclosures during the period from June 9, 2016 to September 20, 2017, in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Rule 10b-5 promulgated thereunder. The alleged improper disclosures relate to statements regarding Ocaliva dosing, use and pharmacovigilance-related matters, as well as the Company’s operations, financial performance and prospects. The plaintiffs seek unspecified monetary damages on behalf of the putative class, an award of costs and expenses, including attorney’s fees, and rescissory damages. On September 14, 2018, the Company filed a motion to dismiss the amended complaint. On March 26, 2020, the Court granted the Company’s motion to dismiss the amended complaint in its entirety, and on March 27, 2020 the Court entered judgment in favor of the Company. On May 8, 2020, the plaintiffs filed a motion to set aside the judgment and grant leave to file a second amended complaint. Separately, on January 5, 2018, a follow-on derivative suit, styled Davis v. Pruzanski et al., was filed in New York state court by shareholder Gregg Davis based on substantially the same allegations as those set forth in the securities case. On December 1, 2017, a purported shareholder demand was made on the Company based on substantially the same allegations as those set forth in the securities case. While the Company believes that it has a number of valid defenses to the claims described above and intends to vigorously defend itself, the matters are in the early stages of litigation and no assessment can be made as to the likely outcome of the matters or whether they will be material to the Company. Accordingly, an estimate of the potential loss, or range of loss, if any, to the Company relating to the matters is not possible at this time. |
Basis of Presentation (Policy)
Basis of Presentation (Policy) | 3 Months Ended |
Mar. 31, 2020 | |
Basis of Presentation [Abstract] | |
Use of Estimates | Use of Estimates The preparation of these unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and judgments that affect the reported amounts of assets and liabilities, the disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from these estimates. We are not presently aware of any events or circumstances arising from the coronavirus (“COVID-19”) pandemic that would require us to update our estimates, judgments or revise the carrying value of our assets or liabilities. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
Summary of Significant Accounting Policiies | |
Use of Estimates | Use of Estimates The preparation of these unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and judgments that affect the reported amounts of assets and liabilities, the disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from these estimates. We are not presently aware of any events or circumstances arising from the coronavirus (“COVID-19”) pandemic that would require us to update our estimates, judgments or revise the carrying value of our assets or liabilities. |
Accounts Receivable | The allowance for credit losses is based on the Company’s assessment of the collectibility of customer accounts. The Company regularly reviews the allowance by considering factors such as historical experience, the aging of the accounts receivable balances, credit conditions that may affect a customer’s ability to pay, current and forecast economic conditions and other relevant factors. The following table summarizes the allowance for credit losses activity on the Company’s trade receivables for the three-month period ended March 31, 2020 (in thousands): Balance at December 31, 2019 $ — Provision for credit losses 190 Write-offs (11) Balance at March 31, 2020 $ 179 Available-for-sale investment debt securities For available-for-sale investment debt securities in an unrealized loss position, the Company first assesses whether it intends to sell the security or it is more likely than not that it will be required to sell the security before recovery of its amortized cost basis. If either of the criteria regarding intent or requirement to sell is met, the amortized cost basis is written down to fair value through income. For any investment debt securities that do not meet the criteria, the Company evaluates whether the decline in fair value has resulted from credit losses or other factors. Management considers the extent in which the fair value of the security is less than amortized costs, any changes to the rating of the security by a rating agency, changes in interest rates, and any other adverse factors related to the security. If the assessment indicates a credit loss, the present value of cash flows expected to be collected are compared to the amortized cost basis of the security. If the expected present value of cash flows is less than the amortized cost basis, a credit loss exists and an allowance for credit losses is recorded, limited to the amount that the fair value is below the amortized cost basis. Any impairment not recorded through an allowance is recognized in Other comprehensive (loss) income. Changes in the allowance for credit losses are recorded as a provision for (or reversal of) credit loss expense. Losses are charged against the allowance when management believes the uncollectibility of the security is confirmed or whether either of the criteria regarding intent or requirement to sell is met. The Company excludes accrued interest from both the fair value and amortized cost basis in the assessment of credit losses on its available-for-sale investment debt securities and will instead elect to write-off any uncollectible accrued interest receivable balances in a timely manner, which is defined by the Company as when interest due becomes 90 days delinquent. |
Available-for-sale investment debt securities | |
Fair Value of Financial Instruments | The carrying amounts of the Company’s receivables and payables approximate their fair value due to their short maturities. Accounting principles provide guidance for using fair value to measure assets and liabilities. The guidance includes a three-level hierarchy of valuation techniques used to measure fair value, defined as follows: ● Unadjusted Quoted Prices — The fair value of an asset or liability is based on unadjusted quoted prices in active markets for identical assets or liabilities (Level 1). ● Pricing Models with Significant Observable Inputs — The fair value of an asset or liability is based on information derived from either an active market quoted price, which may require further adjustment based on the attributes of the financial asset or liability being measured, or an inactive market transaction (Level 2). ● Pricing Models with Significant Unobservable Inputs — The fair value of an asset or liability is primarily based on internally derived assumptions surrounding the timing and amount of expected cash flows for the financial instrument. Therefore, these assumptions are unobservable in either an active or inactive market (Level 3). The Company considers an active market as one in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. Conversely, the Company views an inactive market as one in which there are few transactions for the asset or liability, the prices are not current, or price quotations vary substantially either over time or among market makers. Where appropriate, non-performance risk, or that of a counterparty, is considered in determining the fair values of liabilities and assets, respectively. The Company’s money market funds are classified within Level 1 of the fair value hierarchy because they are valued using quoted prices in active markets. Investment debt securities are classified as Level 2 instruments based on market pricing and other observable inputs. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“ In August 2018, the FASB issued ASU No. 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement” (“ASU 2018-13”), which makes a number of changes meant to add, modify or remove certain disclosure requirements associated with the movement amongst or hierarchy associated with Level 1, Level 2 and Level 3 fair value measurements. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is permitted upon issuance of the update. The Company adopted ASU 2018-13 on January 1, 2020 and its adoption did not have an impact on the Company’s condensed consolidated financial statements and related disclosures. Recent Accounting Pronouncements to be Adopted In December 2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures. |
Fair Value Measurements (Policy
Fair Value Measurements (Policy) | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Measurements [Abstract] | |
Fair Value of Financial Instruments | The carrying amounts of the Company’s receivables and payables approximate their fair value due to their short maturities. Accounting principles provide guidance for using fair value to measure assets and liabilities. The guidance includes a three-level hierarchy of valuation techniques used to measure fair value, defined as follows: ● Unadjusted Quoted Prices — The fair value of an asset or liability is based on unadjusted quoted prices in active markets for identical assets or liabilities (Level 1). ● Pricing Models with Significant Observable Inputs — The fair value of an asset or liability is based on information derived from either an active market quoted price, which may require further adjustment based on the attributes of the financial asset or liability being measured, or an inactive market transaction (Level 2). ● Pricing Models with Significant Unobservable Inputs — The fair value of an asset or liability is primarily based on internally derived assumptions surrounding the timing and amount of expected cash flows for the financial instrument. Therefore, these assumptions are unobservable in either an active or inactive market (Level 3). The Company considers an active market as one in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. Conversely, the Company views an inactive market as one in which there are few transactions for the asset or liability, the prices are not current, or price quotations vary substantially either over time or among market makers. Where appropriate, non-performance risk, or that of a counterparty, is considered in determining the fair values of liabilities and assets, respectively. The Company’s money market funds are classified within Level 1 of the fair value hierarchy because they are valued using quoted prices in active markets. Investment debt securities are classified as Level 2 instruments based on market pricing and other observable inputs. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Summary of Significant Accounting Policiies | |
Schedule of allowance for credit losses | The following table summarizes the allowance for credit losses activity on the Company’s trade receivables for the three-month period ended March 31, 2020 (in thousands): Balance at December 31, 2019 $ — Provision for credit losses 190 Write-offs (11) Balance at March 31, 2020 $ 179 |
Cash, Cash Equivalents and In_2
Cash, Cash Equivalents and Investment Debt Securities (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Cash, Cash Equivalents, and Investment Debt Securities [Abstract] | |
Cash, Cash Equivalents and Investment Debt Securities | The following table summarizes the Company’s cash, cash equivalents and investment debt securities as of March 31, 2020 and December 31, 2019: As of March 31, 2020 Allowance Gross Gross for Credit Unrealized Unrealized Amortized Cost Losses Gains Losses Fair Value (in thousands) Cash and cash equivalents: Cash and money market funds $ 41,408 $ — $ — $ — $ 41,408 Total cash and cash equivalents 41,408 — — — 41,408 Investment debt securities: Commercial paper 18,478 — 10 — 18,488 Corporate debt securities 486,490 — 189 (1,581) 485,098 U.S. treasuries 4,018 — 24 — 4,042 Total investment debt securities 508,986 — 223 (1,581) 507,628 Total cash, cash equivalents and investment debt securities $ 550,394 $ — $ 223 $ (1,581) $ 549,036 As of December 31, 2019 Gross Gross Unrealized Unrealized Amortized Cost Gains Losses Fair Value (in thousands) Cash and cash equivalents: Cash and money market funds $ 62,557 $ — $ — $ 62,557 Commercial paper 7,498 — — 7,498 Total cash and cash equivalents 70,055 — — 70,055 Investment debt securities: Commercial paper 42,806 43 (1) 42,848 Corporate debt securities 538,965 835 (81) 539,719 Total investment debt securities 581,771 878 (82) 582,567 Total cash, cash equivalents and investment debt securities $ 651,826 $ 878 $ (82) $ 652,622 |
Available-for-sale Securities, Continuous Unrealized Loss Position, Fair Value | The aggregate fair value of the Company’s available-for-sale investment debt securities that have been in a continuous unrealized loss position for less than twelve months or twelve months or longer is as follows: As of March 31, 2020 Less than 12 months 12 months or longer Total (in thousands) Gross Gross Gross Unrealized Unrealized Unrealized Fair Value Losses Fair Value Losses Fair Value Losses Corporate debt securities $ 326,320 $ (1,581) $ — $ — $ 326,320 $ (1,581) Total $ 326,320 $ (1,581) $ — $ — $ 326,320 $ (1,581) As of December 31, 2019 Less than 12 months 12 months or longer Total (in thousands) Gross Gross Gross Unrealized Unrealized Unrealized Fair Value Losses Fair Value Losses Fair Value Losses Commercial paper $ 11,976 $ (1) $ — $ — $ 11,976 $ (1) Corporate debt securities 121,684 (81) — — 121,684 (81) Total $ 133,660 $ (82) $ — $ — $ 133,660 $ (82) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Measurements [Abstract] | |
Fair Value, Marketable Securities Measured on Recurring and Nonrecurring Basis | Financial assets carried at fair value are classified in the tables below in one of the three categories described above: Fair Value Measurements Using Total Level 1 Level 2 Level 3 (in thousands) March 31, 2020 Assets Cash and cash equivalents: Money market funds $ 24,773 $ 24,773 $ — $ — Available-for-sale investment debt securities: Commercial paper 18,488 — 18,488 — Corporate debt securities 485,098 — 485,098 — U.S. treasuries 4,042 — 4,042 — Total financial assets $ 532,401 $ 24,773 $ 507,628 $ — December 31, 2019 Assets Cash and cash equivalents: Money market funds $ 19,376 $ 19,376 $ — $ — Commercial paper 7,498 — 7,498 — Available-for-sale investment debt securities: Commercial paper 42,848 — 42,848 — Corporate debt securities 539,719 — 539,719 — Total financial assets $ 609,441 $ 19,376 $ 590,065 $ — |
Schedule of Available for Sale Securities Debt Maturities | The aggregate fair value of all available-for-sale investment debt securities (commercial paper, corporate debt securities and U.S. treasuries), by contractual maturity, are as follows: Fair Value as of March 31, 2020 December 31, 2019 (in thousands) Due in one year or less $ 433,013 $ 473,602 Due after one year through two years 74,615 116,463 Total investment debt securities $ 507,628 $ 590,065 |
Fixed Assets, Net (Tables)
Fixed Assets, Net (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Fixed Assets, Net [Abstract] | |
Fixed Assets, Net | Fixed assets are stated at cost and depreciated or amortized using the straight-line method based on useful lives as follows: Useful lives (Years) March 31, 2020 December 31, 2019 (in thousands) Office equipment and software 3 $ 4,349 $ 4,386 Leasehold improvements Shorter of remaining lease term or useful life 10,743 10,489 Furniture and fixtures 7 4,139 4,032 Subtotal 19,231 18,907 Less: accumulated depreciation (14,385) (13,705) Fixed assets, net $ 4,846 $ 5,202 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Inventory [Abstract] | |
Schedule of Inventory | Inventories are stated at the lower of cost or market. Inventories consisted of the following: March 31, 2020 December 31, 2019 (in thousands) Work-in-process $ 10,030 $ 8,302 Finished goods 230 160 Inventory $ 10,260 $ 8,462 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Operating Leases [Abstract] | |
Schedule of operating lease assets and liabilities | Operating lease assets and liabilities are classified on the condensed consolidated balance sheets as follows: Leases Classification March 31, 2020 December 31, 2019 Assets (in thousands) Operating lease assets Other assets $ 12,440 $ 13,246 Total leased assets $ 12,440 $ 13,246 Liabilities Current Operating lease liabilities Accounts payable, accrued expenses and other liabilities $ 6,596 $ 6,456 Noncurrent Operating lease liabilities Long-term other liabilities 8,164 9,222 Total operating lease liabilities $ 14,760 $ 15,678 |
Schedule of operating lease costs | Operating lease costs for the three-month periods ended March 31, 2020 and 2019, are as follows: Three Months Ended March 31, Lease Cost Classification 2020 2019 (in thousands) Operating lease cost Selling, general and administrative expenses $ 1,739 $ 1,678 Short-term lease cost Selling, general and administrative expenses 421 826 Variable lease cost Selling, general and administrative expenses 247 224 Sublease income Other income, net (120) (180) Net lease cost $ 2,287 $ 2,548 |
Schedule of maturities of the company's operating lease liabilities | Maturities of the Company’s operating lease liabilities, which do not include short-term leases, as of March 31, 2020 are as follows: Maturity of Lease Liabilities Operating leases (in thousands) 2020 $ 5,616 2021 6,475 2022 2,340 2023 895 2024 373 Thereafter — Total lease payments 15,699 Less: Present value discount (939) Total operating lease liabilities $ 14,760 |
Accounts Payable, Accrued Exp_2
Accounts Payable, Accrued Expenses and Other Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Accounts Payable, Accrued Expenses and Other Liabilities [Abstract] | |
Schedule of Accounts Payable and Accrued Liabilities | Accounts payable, accrued expenses and other liabilities consisted of the following: March 31, 2020 December 31, 2019 (in thousands) Accounts payable $ 14,977 $ 18,975 Accrued employee compensation 14,135 26,483 Accrued contracted services 76,592 74,486 Accrued rebates, discounts and other incentives 25,422 21,529 Operating lease liabilities 6,596 6,456 Other liabilities 6,796 6,039 Accounts payable, accrued expenses and other liabilities $ 144,518 $ 153,968 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Long-Term Debt [Abstract] | |
Schedule of Long-term Debt Instruments | Debt, net of discounts and deferred financing costs, consisted of the following: March 31, 2020 December 31, 2019 (in thousands) 2023 Convertible Notes $ 460,000 $ 460,000 2026 Convertible Notes 230,000 230,000 Long-term debt, gross 690,000 690,000 Less: Unamortized debt discounts and fees (151,032) (157,922) Long-term debt, net $ 538,968 $ 532,078 |
Product Revenue, Net (Tables)
Product Revenue, Net (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Product Revenue, Net [Abstract] | |
Product Revenues | The table below summarizes consolidated product revenue, net by region: Three Months Ended March 31, 2020 2019 (in thousands) Product revenue, net: U.S. $ 50,779 $ 37,991 ex-U.S. 21,873 13,856 Total product revenue, net $ 72,652 $ 51,847 |
Stock Compensation (Tables)
Stock Compensation (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Stock Compensation [Abstract] | |
Schedule of Share Based Compensation Stock Options Activities | The following table summarizes stock option activity during the three months ended March 31, 2020: Weighted Average Number Weighted Remaining Aggregate of Options Average Contractual Intrinsic Value (in thousands) Exercise Price Term (years) (in thousands) Outstanding at December 31, 2019 1,981 $ 99.87 7.4 $ 65,662 Granted 557 $ 99.94 — $ — Exercised (9) $ 47.78 — $ — Cancelled/forfeited (63) $ 97.85 — $ — Expired (20) $ 198.78 — $ — Outstanding at March 31, 2020 2,446 $ 99.32 7.7 $ 6,106 Expected to vest 1,256 $ 92.39 9.0 $ 1,005 Exercisable 1,190 $ 106.62 6.4 $ 5,101 |
Schedule of Share Based Compensation Arrangement By Share Based Payment Award Grants in Period Fair Value Assumptions | The Company estimated the fair value of stock options granted in the periods presented utilizing a Black-Scholes option-pricing model utilizing the following assumptions: Three Months Ended March 31, 2020 2019 Volatility 61.9 - 87.1 % 87.0 - 87.2 % Expected term (in years) 6.0 6.0 Risk-free rate 0.9 - 1.7 % 2.5 - 2.9 % Expected dividend yield — % — % |
Schedule of Share-based Compensation, Restricted Stock Units Award Activity | The following table summarizes the aggregate RSU, restricted stock award (“RSA”), PRSU and performance restricted share award (“PRSA”) activity during the three months ended March 31, 2020: Weighted Number of Average Grant Date Awards Fair Value (in thousands) Non-vested awards at December 31, 2019 709 $ 88.39 Granted 399 $ 102.82 Vested (104) $ 74.75 Forfeited (43) $ 94.43 Non-vested awards at March 31, 2020 961 $ 95.58 |
Schedule of Stock Based Compensation Expense | Stock-based compensation expense has been reported in the Company’s condensed consolidated statements of operations as follows: Three Months Ended March 31, 2020 2019 (in thousands) Selling, general and administrative $ 9,723 $ 11,331 Research and development 2,750 3,566 Total stock-based compensation $ 12,473 $ 14,897 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Net loss per common and potential common share: | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding for the three-month periods ended March 31, 2020 and 2019, as the inclusion thereof would have been anti-dilutive: Three Months Ended March 31, 2020 2019 (in thousands) Shares issuable upon conversion of Convertible Notes 4,435 2,316 Options 2,446 2,224 Unvested restricted stock units 871 645 Total 7,752 5,185 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Allowance for credit losses) (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2020USD ($) | |
Allowance for credit losses, Rollforward | |
Balance at the beginning of period | $ 0 |
Provision for allowance of credit losses | 179 |
Provision for credit losses | 190 |
Write-offs | (11) |
Balance at the end of period | $ 179 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Narrative) (Details) | 3 Months Ended |
Mar. 31, 2020 | |
Summary of Significant Accounting Policiies | |
Period in which uncollectible interest due to become delinquent | 90 days |
Cash, Cash Equivalents and In_3
Cash, Cash Equivalents and Investment Debt Securities (Narrative) (Details) $ in Millions | Mar. 31, 2020USD ($)security |
Cash, Cash Equivalents, and Investment Debt Securities [Abstract] | |
Number of positions that were in a continuous unrealized loss position for more than twelve months | security | 90 |
Accrued investment income receivable | $ | $ 3.3 |
Cash, Cash Equivalents and In_4
Cash, Cash Equivalents and Investment Debt Securities (Cash, Cash Equivalents and Investment Debt Securities) (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Cash and cash equivalents: | ||
Cash and Cash Equivalents, Amortized Cost | $ 41,408 | $ 70,055 |
Cash and cash equivalents, Fair Value | 41,408 | 70,055 |
Investment Debt Securities Abstract | ||
Total investments, Amortized Cost | 508,986 | 581,771 |
Total cash and cash equivalents and investment debt securities, Amortized Cost | 550,394 | 651,826 |
Total investments, Gross Unrealized Gains | 223 | 878 |
Total cash and cash equivalents and investment debt securities, Gross Unrealized Gains | 223 | 878 |
Total investments, Gross Unrealized Losses | (1,581) | (82) |
Total cash and cash equivalents and investment debt securities, Gross Unrealized Losses | (1,581) | (82) |
Total investments, Fair Value | 507,628 | 590,065 |
Total Investments, Fair Value | 582,567 | |
Total cash and cash equivalents and investment debt securities, Fair Value | 549,036 | 652,622 |
Commercial Paper [Member] | ||
Cash and cash equivalents: | ||
Cash and Cash Equivalents, Amortized Cost | 7,498 | |
Cash and cash equivalents, Fair Value | 7,498 | |
Investment Debt Securities Abstract | ||
Total investments, Amortized Cost | 18,478 | 42,806 |
Total investments, Gross Unrealized Gains | 10 | 43 |
Total investments, Gross Unrealized Losses | (1) | |
Total investments, Fair Value | 18,488 | 42,848 |
Corporate Debt Securities [Member] | ||
Investment Debt Securities Abstract | ||
Total investments, Amortized Cost | 486,490 | 538,965 |
Total investments, Gross Unrealized Gains | 189 | 835 |
Total investments, Gross Unrealized Losses | (1,581) | (81) |
Total investments, Fair Value | 485,098 | 539,719 |
US Treasury Securities [Member] | ||
Investment Debt Securities Abstract | ||
Total investments, Amortized Cost | 4,018 | |
Total investments, Gross Unrealized Gains | 24 | |
Total investments, Fair Value | 4,042 | |
Cash and Money Market Funds [Member] | ||
Cash and cash equivalents: | ||
Cash and Cash Equivalents, Amortized Cost | 41,408 | 62,557 |
Cash and cash equivalents, Fair Value | $ 41,408 | $ 62,557 |
Cash, Cash Equivalents, and Inv
Cash, Cash Equivalents, and Investments (Available-for-sale Securities, Continuous Unrealized Loss Position, Fair Value) (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Total available for sale securities, Less than 12 months, Fair Value | $ 326,320 | $ 133,660 |
Total available for sale securities Less than 12 months, Gross Unrealized Holding Losses | (1,581) | (82) |
Available-for-sale securities, Total Fair Value | 326,320 | 133,660 |
Available-for-sale securities, Total Gross Unrealized Losses | (1,581) | (82) |
Commercial Paper [Member] | ||
Total available for sale securities, Less than 12 months, Fair Value | 11,976 | |
Total available for sale securities Less than 12 months, Gross Unrealized Holding Losses | (1) | |
Available-for-sale securities, Total Fair Value | 11,976 | |
Available-for-sale securities, Total Gross Unrealized Losses | (1) | |
Corporate Debt Securities [Member] | ||
Total available for sale securities, Less than 12 months, Fair Value | 326,320 | 121,684 |
Total available for sale securities Less than 12 months, Gross Unrealized Holding Losses | (1,581) | (81) |
Available-for-sale securities, Total Fair Value | 326,320 | 121,684 |
Available-for-sale securities, Total Gross Unrealized Losses | $ (1,581) | $ (81) |
Fair Value Measurements (Fair V
Fair Value Measurements (Fair Value, Marketable Securities Measured on Recurring and Nonrecurring Basis) (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Cash and cash equivalents, fair value disclosure | $ 41,408 | $ 70,055 |
Available-for-sale securities, fair value disclosure | 507,628 | 590,065 |
Total financial assets | 532,401 | 609,441 |
Fair Value, Inputs, Level 1 [Member] | ||
Total financial assets | 24,773 | 19,376 |
Fair Value, Inputs, Level 2 [Member] | ||
Total financial assets | 507,628 | 590,065 |
Money Market Funds [Member] | ||
Cash and cash equivalents, fair value disclosure | 24,773 | 19,376 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash and cash equivalents, fair value disclosure | 24,773 | 19,376 |
Commercial Paper [Member] | ||
Cash and cash equivalents, fair value disclosure | 7,498 | |
Available-for-sale securities, fair value disclosure | 18,488 | 42,848 |
Commercial Paper [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Cash and cash equivalents, fair value disclosure | 7,498 | |
Available-for-sale securities, fair value disclosure | 18,488 | 42,848 |
Corporate Debt Securities [Member] | ||
Available-for-sale securities, fair value disclosure | 485,098 | 539,719 |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Available-for-sale securities, fair value disclosure | 485,098 | $ 539,719 |
US Treasury Securities [Member] | ||
Available-for-sale securities, fair value disclosure | 4,042 | |
US Treasury Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Available-for-sale securities, fair value disclosure | $ 4,042 |
Fair Value Measurements (Schedu
Fair Value Measurements (Schedule of Available for Sale Securities Debt Maturities) (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Fair Value Measurements [Abstract] | ||
Due in one year or less | $ 433,013 | $ 473,602 |
Due after one year through two years | 74,615 | 116,463 |
Total investment debt securities | $ 507,628 | $ 590,065 |
Fixed Assets, Net (Fixed Assets
Fixed Assets, Net (Fixed Assets Stated at Cost) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Dec. 31, 2019 | |
Fixed assets | $ 19,231 | $ 18,907 |
Less: accumulated depreciation | (14,385) | (13,705) |
Fixed assets, net | 4,846 | 5,202 |
Office Equipment [Member] | ||
Fixed assets | $ 4,349 | 4,386 |
Property, Plant and Equipment, Useful Life | 3 years | |
Leasehold Improvements [Member] | ||
Fixed assets | $ 10,743 | 10,489 |
Property, Plant and Equipment, Estimated Useful Lives | Shorter of remaining lease term or useful life | |
Furniture and Fixtures [Member] | ||
Fixed assets | $ 4,139 | $ 4,032 |
Property, Plant and Equipment, Useful Life | 7 years |
Inventory (Schedule of Inventor
Inventory (Schedule of Inventory) (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Inventory [Abstract] | ||
Work-in-process | $ 10,030 | $ 8,302 |
Finished goods | 230 | 160 |
Inventory | $ 10,260 | $ 8,462 |
Leases (Details)
Leases (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Operating Leases [Abstract] | ||
Operating lease, existence of option to extend | true | |
Operating leases, weighted-average remaining term | 2 years 4 months 24 days | |
Operating leases, weighted-average discount rate | 3.90% | |
Cash payments included in the measurement of the Company's lease liabilities | $ 1,800 | $ 1,900 |
Right-of-use asset obtained in exchange for new operating lease obligations | 1,006 | |
Increase (decrease) in operating lease liability | $ 1,000 |
Leases (Assets and Liabilities)
Leases (Assets and Liabilities) (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Operating Leases [Abstract] | ||
Operating lease assets | $ 12,440 | $ 13,246 |
Other assets | us-gaap:OtherAssets | us-gaap:OtherAssets |
Total leased assets | $ 12,440 | $ 13,246 |
Operating lease liabilities, current | $ 6,596 | $ 6,456 |
Accounts payable, accrued expenses and other liabilities | us-gaap:AccountsPayableAndOtherAccruedLiabilities | us-gaap:AccountsPayableAndOtherAccruedLiabilities |
Operating lease liabilities, Noncurrent | $ 8,164 | $ 9,222 |
Long-term other liabilities | us-gaap:OtherLiabilitiesNoncurrent | us-gaap:OtherLiabilitiesNoncurrent |
Total operating lease liabilities | $ 14,760 | $ 15,678 |
Leases (Lease Cost, Term and Di
Leases (Lease Cost, Term and Discount Rate) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Lease Cost | ||
Net lease cost | $ 2,287 | $ 2,548 |
Selling, General and Administrative Expenses [Member] | ||
Lease Cost | ||
Operating lease cost | 1,739 | 1,678 |
Short-term lease cost | 421 | 826 |
Variable lease cost | 247 | 224 |
Other income, net | ||
Lease Cost | ||
Sublease income | $ (120) | $ (180) |
Leases (Maturities of Operating
Leases (Maturities of Operating Lease Liabilities and lease payments) (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Maturity of Lease Liabilities | ||
2020 | $ 5,616 | |
2021 | 6,475 | |
2022 | 2,340 | |
2023 | 895 | |
2024 | 373 | |
Total lease payments | 15,699 | |
Less: Present value discount | (939) | |
Total operating lease liabilities | $ 14,760 | $ 15,678 |
Accounts Payable, Accrued Exp_3
Accounts Payable, Accrued Expenses and Other Liabilities (Narrative) (Details) - Foreign Tax Authority [Member] - Her Majesty's Revenue and Customs (HMRC) [Member] - USD ($) $ in Millions | 1 Months Ended | 24 Months Ended |
Sep. 30, 2019 | Dec. 31, 2016 | |
Percentage of credit eligible from tax authority | 33.40% | |
Investment tax credit | $ 10.5 |
Accounts Payable, Accrued Exp_4
Accounts Payable, Accrued Expenses and Other Liabilities (Schedule of Accounts Payable and Accrued Liabilities) (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Accounts Payable, Accrued Expenses and Other Liabilities [Abstract] | ||
Accounts payable | $ 14,977 | $ 18,975 |
Accrued employee compensation | 14,135 | 26,483 |
Accrued contracted services | 76,592 | 74,486 |
Accrued rebates, discounts and other incentives | 25,422 | 21,529 |
Operating lease liabilities | 6,596 | 6,456 |
Other liabilities | 6,796 | 6,039 |
Accounts payable, accrued expenses and other liabilities | $ 144,518 | $ 153,968 |
Long-Term Debt (Narrative) (Det
Long-Term Debt (Narrative) (Details) | May 14, 2019USD ($)$ / shares | Jul. 06, 2016USD ($)$ / shares | Mar. 31, 2020USD ($)item | Mar. 31, 2019USD ($) | Dec. 31, 2019USD ($) | Jun. 30, 2016$ / shares |
Payments for capped call transactions and associated costs | $ 38,400,000 | |||||
Cap price of capped call transaction | $ / shares | $ 262.2725 | |||||
Long-term debt | $ 538,968,000 | $ 532,078,000 | ||||
Interest expense | 11,777,000 | $ 7,839,000 | ||||
Convertible Debt [Member] | ||||||
Debt issuance costs | 19,000,000 | |||||
Cash payments for interest | $ 7,500,000 | 7,500,000 | ||||
Convertible Senior Notes 3.25% [Member] | Convertible Debt [Member] | ||||||
Debt instrument, face amount | 460,000,000 | |||||
Debt instrument, interest rate, stated percentage | 3.25% | |||||
Proceeds from convertible debt | 447,600,000 | |||||
Debt issuance costs | $ 12,400,000 | $ 12,600,000 | ||||
Debt instrument convertible, percentage of conversion price | 130.00% | |||||
Average percentage of closing sale price of common stock | 98.00% | |||||
Debt instrument, convertible, conversion ratio | 5.0358 | |||||
Debt instrument, convertible, conversion price | $ / shares | $ 198.58 | |||||
Percentage of repurchase price is equal to principal amount of convertible notes | 100.00% | |||||
Debt instrument liability component effective interest rate | 8.40% | |||||
Long-term debt | $ 334,400,000 | |||||
Debt instrument, unamortized discount, noncurrent | 113,100,000 | |||||
Interest expense | 11,800,000 | $ 7,800,000 | ||||
Interest payable, current | 5,500,000 | 8,100,000 | ||||
Fair value of the Convertible Notes | $ 372,800,000 | 463,500,000 | ||||
Convertible Senior Notes 3.25% [Member] | Convertible Debt [Member] | One Hundred Thirty Percent Applicable Conversion Price [Member] | Maximum [Member] | ||||||
Debt instrument convertible consecutive trading days | 30 | |||||
Convertible Senior Notes 3.25% [Member] | Convertible Debt [Member] | One Hundred Thirty Percent Applicable Conversion Price [Member] | Minimum [Member] | ||||||
Debt instrument convertible consecutive trading days | 20 | |||||
Convertible Senior Notes 3.25% [Member] | Convertible Debt [Member] | Ninety Eight Percent Applicable Conversion Price [Member] | ||||||
Debt instrument convertible consecutive trading days | item | 5 | |||||
Convertible Senior Notes 2.00% Due 2026 [Member] | Convertible Debt [Member] | ||||||
Debt instrument, face amount | $ 230,000,000 | |||||
Debt instrument, interest rate, stated percentage | 2.00% | |||||
Proceeds from convertible debt | 223,400,000 | |||||
Debt issuance costs | $ 6,600,000 | |||||
Debt instrument convertible, percentage of conversion price | 130.00% | |||||
Average percentage of closing sale price of common stock | 98.00% | |||||
Debt instrument, convertible, conversion ratio | 9.2123 | |||||
Debt instrument, convertible, conversion price | $ / shares | $ 108.55 | |||||
Percentage of repurchase price is equal to principal amount of convertible notes | 100.00% | |||||
Debt instrument liability component effective interest rate | 9.90% | |||||
Long-term debt | $ 137,500,000 | |||||
Debt instrument, unamortized discount, noncurrent | 85,900,000 | |||||
Underwriting discounts and estimated offering expenses | 6,600,000 | |||||
Equity issuance cost | 2,500,000 | |||||
Debt issuance costs | 4,100,000 | |||||
Fair value of the Convertible Notes | $ 184,600,000 | $ 294,900,000 | ||||
Convertible Senior Notes 2.00% Due 2026 [Member] | Convertible Debt [Member] | One Hundred Thirty Percent Applicable Conversion Price [Member] | Maximum [Member] | ||||||
Debt instrument convertible consecutive trading days | 30 | |||||
Convertible Senior Notes 2.00% Due 2026 [Member] | Convertible Debt [Member] | One Hundred Thirty Percent Applicable Conversion Price [Member] | Minimum [Member] | ||||||
Debt instrument convertible consecutive trading days | 20 | |||||
Convertible Senior Notes 2.00% Due 2026 [Member] | Convertible Debt [Member] | Ninety Eight Percent Applicable Conversion Price [Member] | ||||||
Debt instrument convertible consecutive trading days | item | 5 |
Long-Term Debt (Schedule of Lon
Long-Term Debt (Schedule of Long-term Debt Instruments) (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Long-term debt, gross | $ 690,000 | $ 690,000 |
Less: Unamortized debt discounts and fees | (151,032) | (157,922) |
Long-term Debt, Total | 538,968 | 532,078 |
Long-term debt outstanding | 538,968 | 532,078 |
Convertible Senior Notes 3.25% [Member] | ||
Long-term debt, gross | 460,000 | 460,000 |
Convertible Senior Notes 2.00% Due 2026 [Member] | ||
Long-term debt, gross | $ 230,000 | $ 230,000 |
Product Revenue, Net (Narrative
Product Revenue, Net (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Product revenue, net | $ 72,652 | $ 52,252 |
Product [Member] | ||
Product revenue, net | $ 72,652 | $ 51,847 |
Product Revenue, Net (Schedule
Product Revenue, Net (Schedule of Product Revenue, Net) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Disaggregation of Revenue [Line Items] | ||
Product revenue, net | $ 72,652 | $ 52,252 |
Product [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Product revenue, net | 72,652 | 51,847 |
Product [Member] | United States [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Product revenue, net | 50,779 | 37,991 |
Product [Member] | Non-US [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Product revenue, net | $ 21,873 | $ 13,856 |
License Agreement (Narrative) (
License Agreement (Narrative) (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | |
Mar. 31, 2011 | Mar. 31, 2020 | Mar. 31, 2019 | |
Significant Agreements [Line Items] | |||
License arrangement, deferred revenue, recognized | $ 0 | $ 0.4 | |
Up-front Payment [Member] | Dainippon Sumitomo Pharma Co Ltd [Member] | |||
Significant Agreements [Line Items] | |||
License agreement payment | $ 15 |
Stockholders' Equity (Narrative
Stockholders' Equity (Narrative) (Details) | May 14, 2019$ / sharesshares |
Stock issued during period, shares, new issues | 2,760,000 |
Shares issued, price per share | $ / shares | $ 83.50 |
Private Placement [Member] | |
Stock issued during period, shares, new issues | 119,760 |
Underwriters [Member] | |
Stock issued during period, shares, new issues | 360,000 |
Stock Compensation (Narrative)
Stock Compensation (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands | Jan. 01, 2019 | Oct. 31, 2012 | Mar. 31, 2020 | Mar. 31, 2019 |
Granted - Number of Shares | 557,000 | |||
Granted - Weighted Average Fair Value | $ 102.82 | |||
Net proceeds from exercise of stock options | $ (1,783) | $ 943 | ||
Granted - Shares | 399,000 | |||
2012 Stock Plan [Member] | ||||
Additional shares available | 1,211,533 | 555,843 | ||
Stock Options [Member] | ||||
Share-based compensation not yet recognized | $ 66,600 | |||
Share-based compensation not yet recognized, period | 1 year 6 months 14 days | |||
Restricted and Performance Stock Units and Awards [Member] | ||||
Share-based compensation not yet recognized, other than options | $ 76,900 | |||
Share-based compensation not yet recognized, period | 1 year 8 months 19 days | |||
Performance Stock Units and Awards [Member] | ||||
Performance period | 3 years | |||
Share based compensation expenses | $ 600 | |||
Performance Stock Units and Awards [Member] | Minimum [Member] | ||||
Payout percentage, as percent of target award | 0.00% | |||
Performance Stock Units and Awards [Member] | Maximum [Member] | ||||
Payout percentage, as percent of target award | 150.00% | |||
Performance Stock Units (PSUs) [Member] | ||||
Shares granted during period for stock based compensation | 64,900 |
Stock Compensation (Schedule of
Stock Compensation (Schedule of Share Based Compensation Arrangement By Share Based Payment Award Grants in Period Fair Value Assumptions) (Details) - Stock Options [Member] | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Volatility, minimum | 61.90% | 87.00% |
Volatility, maximum | 87.10% | 87.20% |
Expected term (in years) | 6 years | 6 years |
Risk-free interest rate, minimum | 0.90% | 2.50% |
Risk-free interest rate, maximum | 1.70% | 2.90% |
Stock Compensation (Schedule _2
Stock Compensation (Schedule of Share Based Compensation Stock Options Activities) (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Stock Compensation [Abstract] | ||
Beginning Outstanding, Number of Shares | 1,981 | |
Granted - Number of Shares | 557 | |
Exercised - Number of Shares | (9) | |
Forfeited - Number of Shares | (63) | |
Expired - Number of Shares | (20) | |
Ending Outstanding, Number of Shares | 2,446 | 1,981 |
Expected to vest - Number of shares | 1,256 | |
Exercisable - Number of Shares | 1,190 | |
Beginning Outstanding, Weighted Average Exercise Price | $ 99.87 | |
Granted - Weighted Average Exercise Price | 99.94 | |
Exercised - Weighted Average Exercise Price | 47.78 | |
Forfeited - Weighted Average Exercise Price | 97.85 | |
Expired - Weighted Average Exercise Price | 198.78 | |
Ending Outstanding, Weighted Average Exercise Price | 99.32 | $ 99.87 |
Expected to vest - Weighted Average Exercise Price | 92.39 | |
Exercisable - Weighted Average Exercise Price | $ 106.62 | |
Options Outstanding - Weighted Average Remaining Life | 7 years 8 months 12 days | 7 years 4 months 24 days |
Expected to vest - Weighted Average Remaining Term | 9 years | |
Exercisable - Weighted Average Remaining Term | 6 years 4 months 24 days | |
Options Outstanding - Aggregate Intrinsic Value | $ 6,106 | $ 65,662 |
Expected to vest - Aggregate Intrinsic Value | 1,005 | |
Exercisable - Aggregate Intrinsic Value | $ 5,101 |
Stock Compensation (Schedule _3
Stock Compensation (Schedule of Share-based Compensation, Restricted Stock Units and Award Activity) (Details) shares in Thousands | 3 Months Ended |
Mar. 31, 2020$ / sharesshares | |
Stock Compensation [Abstract] | |
Outstanding, December 31, 2019 | shares | 709 |
Granted - Shares | shares | 399 |
Vested - Shares | shares | (104) |
Forfeited - Shares | shares | (43) |
Outstanding, March 31, 2020 | shares | 961 |
Outstanding - Weighted Average Fair Value, December 31, 2019 | $ / shares | $ 88.39 |
Granted - Weighted Average Fair Value | $ / shares | 102.82 |
Vested - Weighted Average Fair Value | $ / shares | 74.75 |
Forfeited - Weighted Average Fair Value | $ / shares | 94.43 |
Outstanding - Weighted Average Fair Value, March 31, 2020 | $ / shares | $ 95.58 |
Stock Compensation (Schedule _4
Stock Compensation (Schedule of Stock Based Compensation Expense) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Allocated stock-based compensation | $ 12,473 | $ 14,897 |
Selling, General and Administrative Expenses [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Allocated stock-based compensation | 9,723 | 11,331 |
Research and Development Expense [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Allocated stock-based compensation | $ 2,750 | $ 3,566 |
Net Loss Per Share (Schedule of
Net Loss Per Share (Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share) (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Antidilutive securities excluded from computation of earnings per share, amount | 7,752 | 5,185 |
Convertible Notes [Member] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 4,435 | 2,316 |
Stock Options [Member] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 2,446 | 2,224 |
Restricted Stock Units (RSUs) [Member] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 871 | 645 |