Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2023 | Apr. 27, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-34186 | |
Entity Registrant Name | VANDA PHARMACEUTICALS INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 03-0491827 | |
Entity Address, Address Line One | 2200 Pennsylvania Avenue NW | |
Entity Address, Address Line Two | Suite 300E | |
Entity Address, City or Town | Washington | |
Entity Address, State or Province | DC | |
Entity Address, Postal Zip Code | 20037 | |
City Area Code | 202 | |
Local Phone Number | 734-3400 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | VNDA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 57,444,139 | |
Entity Central Index Key | 0001347178 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 354,171 | $ 135,029 |
Marketable securities | 147,325 | 331,830 |
Accounts receivable, net | 24,513 | 33,512 |
Inventory | 1,105 | 1,194 |
Prepaid expenses and other current assets | 6,593 | 17,727 |
Total current assets | 533,707 | 519,292 |
Property and equipment, net | 2,333 | 2,573 |
Operating lease right-of-use assets | 8,097 | 8,400 |
Intangible assets, net | 18,186 | 18,565 |
Deferred tax assets | 71,747 | 74,039 |
Non-current inventory and other | 10,462 | 11,378 |
Total assets | 644,532 | 634,247 |
Current liabilities: | ||
Accounts payable and accrued liabilities | 35,092 | 45,551 |
Product revenue allowances | 58,702 | 45,885 |
Total current liabilities | 93,794 | 91,436 |
Operating lease non-current liabilities | 8,387 | 8,813 |
Other non-current liabilities | 6,612 | 6,800 |
Total liabilities | 108,793 | 107,049 |
Commitments and contingencies (Notes 8 and 13) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 20,000,000 shares authorized, and no shares issued or outstanding at March 31, 2023 and December 31, 2022 | 0 | 0 |
Common stock, $0.001 par value; 150,000,000 shares authorized; 57,440,992 and 56,783,764 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | 57 | 57 |
Additional paid-in capital | 690,586 | 686,235 |
Accumulated other comprehensive loss | (255) | (1,193) |
Accumulated deficit | (154,649) | (157,901) |
Total stockholders’ equity | 535,739 | 527,198 |
Total liabilities and stockholders’ equity | $ 644,532 | $ 634,247 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Stockholders’ equity: | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 20,000,000 | 20,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 150,000,000 | 150,000,000 |
Common stock, shares issued (in shares) | 57,440,992 | 56,783,764 |
Common stock, shares outstanding (in shares) | 57,440,992 | 56,783,764 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenues: | ||
Net product sales | $ 62,498 | $ 60,192 |
Total revenues | 62,498 | 60,192 |
Operating expenses: | ||
Cost of goods sold excluding amortization | 4,774 | 5,665 |
Research and development | 19,237 | 20,969 |
Selling, general and administrative | 36,104 | 40,848 |
Intangible asset amortization | 379 | 379 |
Total operating expenses | 60,494 | 67,861 |
Income (loss) from operations | 2,004 | (7,669) |
Other income | 3,524 | 105 |
Income (loss) before income taxes | 5,528 | (7,564) |
Provision (benefit) for income taxes | 2,276 | (1,134) |
Net income (loss) | $ 3,252 | $ (6,430) |
Net income (loss) per share: | ||
Basic (in dollars per share) | $ 0.06 | $ (0.11) |
Diluted (in dollars per share) | $ 0.06 | $ (0.11) |
Weighted average shares outstanding: | ||
Basic (in shares) | 57,011,396 | 56,105,239 |
Diluted (in shares) | 57,400,152 | 56,105,239 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Statement of Comprehensive Income [Abstract] | ||
Net income (loss) | $ 3,252 | $ (6,430) |
Other comprehensive income (loss): | ||
Net foreign currency translation gain (loss) | 9 | (16) |
Change in net unrealized gain (loss) on marketable securities | 1,206 | (1,475) |
Tax benefit (provision) on other comprehensive income (loss) | (277) | 338 |
Other comprehensive income (loss), net of tax | 938 | (1,153) |
Comprehensive income (loss) | $ 4,190 | $ (7,583) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2021 | 55,900,855 | ||||
Beginning balance at Dec. 31, 2021 | $ 504,928 | $ 56 | $ 669,223 | $ (175) | $ (164,176) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock from the exercise of stock options and settlement of restricted stock units (in shares) | 585,857 | ||||
Stock-based compensation expense | 4,778 | 4,778 | |||
Net income (loss) | (6,430) | (6,430) | |||
Other comprehensive income (loss), net of tax | (1,153) | (1,153) | |||
Ending balance (in shares) at Mar. 31, 2022 | 56,486,712 | ||||
Ending balance at Mar. 31, 2022 | $ 502,123 | $ 56 | 674,001 | (1,328) | (170,606) |
Beginning balance (in shares) at Dec. 31, 2022 | 56,783,764 | 56,783,764 | |||
Beginning balance at Dec. 31, 2022 | $ 527,198 | $ 57 | 686,235 | (1,193) | (157,901) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock from the exercise of stock options and settlement of restricted stock units (in shares) | 657,228 | ||||
Stock-based compensation expense | 4,351 | 4,351 | |||
Net income (loss) | 3,252 | 3,252 | |||
Other comprehensive income (loss), net of tax | $ 938 | 938 | |||
Ending balance (in shares) at Mar. 31, 2023 | 57,440,992 | 57,440,992 | |||
Ending balance at Mar. 31, 2023 | $ 535,739 | $ 57 | $ 690,586 | $ (255) | $ (154,649) |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities | ||
Net income (loss) | $ 3,252 | $ (6,430) |
Adjustments to reconcile net income (loss) to net cash provided by operating activities: | ||
Depreciation of property and equipment | 291 | 323 |
Stock-based compensation | 4,351 | 4,778 |
Amortization of premiums and accretion of discounts on marketable securities | (2,288) | 77 |
Loss on sale of marketable securities | 655 | 0 |
Intangible asset amortization | 379 | 379 |
Deferred income taxes | 2,014 | 4,417 |
Other non-cash adjustments, net | 1,109 | 552 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 8,901 | 1,957 |
Prepaid expenses and other assets | 11,345 | (13,360) |
Inventory | 74 | (1,179) |
Accounts payable and other liabilities | (10,791) | 13,426 |
Product revenue allowances | 12,511 | (894) |
Net cash provided by operating activities | 31,803 | 4,046 |
Cash flows from investing activities | ||
Purchases of property and equipment | (51) | (75) |
Purchases of marketable securities | (163,045) | (79,134) |
Sales and maturities of marketable securities | 350,390 | 90,075 |
Net cash provided by investing activities | 187,294 | 10,866 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | 45 | (57) |
Net change in cash, cash equivalents and restricted cash | 219,142 | 14,855 |
Cash, cash equivalents and restricted cash | ||
Beginning of period | 135,498 | 52,590 |
End of period | $ 354,640 | $ 67,445 |
Business Organization and Prese
Business Organization and Presentation | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business Organization and Presentation | Business Organization and Presentation Business Organization Vanda Pharmaceuticals Inc. (the Company) is a global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. The Company commenced its operations in 2003 and operates in one reporting segment. The Company’s commercial portfolio is currently comprised of two products, HETLIOZ ® for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) and Fanapt ® for the treatment of schizophrenia. HETLIOZ ® is the first product approved by the United States Food and Drug Administration (FDA) for patients with Non-24 and patients with SMS. In addition, the Company has a number of drugs in development, including: • HETLIOZ ® (tasimelteon) for the treatment of jet lag disorder, insomnia, delayed sleep phase disorder (DSPD), sleep disturbances in autism spectrum disorder (ASD) and pediatric Non-24; • Fanapt ® (iloperidone) for the treatment of bipolar I disorder and Parkinson’s disease psychosis and a long acting injectable (LAI) formulation for the treatment of schizophrenia; • Tradipitant (VLY-686), a small molecule neurokinin-1 (NK-1) receptor antagonist, for the treatment of gastroparesis, motion sickness, atopic dermatitis, and COVID-19 pneumonia; • VTR-297, a small molecule histone deacetylase (HDAC) inhibitor for the treatment of hematologic malignancies and with potential use as a treatment for several oncology indications; • Portfolio of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) activators and inhibitors, including VSJ-110 for the treatment of dry eye and ocular inflammation and VPO-227 for the treatment of secretory diarrhea disorders, including cholera; • VQW-765, a small molecule nicotinic acetylcholine receptor partial agonist, for the treatment of performance anxiety and psychiatric disorders; • VHX-896, the active metabolite of iloperidone; and • Antisense oligonucleotide (ASO) molecules. Basis of Presentation |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies There have been no material changes to the significant accounting policies previously disclosed in the Annual Report. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates that affect the reported amounts of assets and liabilities at the date of the financial statements, disclosure of contingent assets and liabilities, and the reported amounts of revenue and expenses during the reporting period. Management continually re-evaluates its estimates, judgments and assumptions, and management’s evaluation could change. Actual results could differ from those estimates. Cash, Cash Equivalents and Restricted Cash For purposes of the Condensed Consolidated Balance Sheets and Condensed Consolidated Statements of Cash Flows, cash equivalents represent highly-liquid investments with a maturity date of three months or less at the date of purchase. Cash and cash equivalents include investments in money market funds with commercial banks and financial institutions, and commercial paper of high-quality corporate issuers. Restricted cash relates primarily to amounts held as collateral for letters of credit for leases for office space at the Company’s Washington, D.C. headquarters. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the Condensed Consolidated Balance Sheets to the total end of period cash, cash equivalents and restricted cash reported within the Condensed Consolidated Statements of Cash Flows: (in thousands) March 31, March 31, Cash and cash equivalents $ 354,171 $ 66,927 Restricted cash included in non-current inventory and other 469 518 Total cash, cash equivalents and restricted cash $ 354,640 $ 67,445 Revenue from Net Product Sales The Company’s net product sales consist of sales of HETLIOZ ® and Fanapt ® . Net sales by product for the three months ended March 31, 2023 and 2022 were as follows: Three Months Ended (in thousands) March 31, March 31, HETLIOZ ® net product sales $ 39,616 $ 37,031 Fanapt ® net product sales 22,882 23,161 Total net product sales $ 62,498 $ 60,192 The Company’s HETLIOZ ® net product sales for the three months ended March 31, 2023 reflect higher unit sales as compared to recent prior periods. The higher unit sales during the three months ended March 31, 2023 resulted in a significant increase of inventory stocking at specialty pharmacy customers. HETLIOZ ® net product sales will likely decline in future periods, potentially significantly, as a result of the reduction of the elevated inventory levels at specialty pharmacy customers at March 31, 2023 and as a result of continued generic competition absent removal of generic HETLIOZ ® products from the United States (U.S.) market. Additionally, the Company constrained HETLIOZ ® net product sales for the three months ended March 31, 2023 to an amount not probable of revenue reversal. HETLIOZ ® net product sales could experience variability in future periods as uncertainties associated with variable consideration related to the significant increase of inventory stocking during the three months ended March 31, 2023 are resolved. Major Customers HETLIOZ ® is available in the U.S. for distribution through a limited number of specialty pharmacies and is not available in retail pharmacies. Fanapt ® is available in the U.S. for distribution through a limited number of wholesalers and is available in retail pharmacies. The Company invoices and records revenue when its customers, specialty pharmacies and wholesalers, receive product from the third-party logistics warehouse, which is the point at which control is transferred to the customer. There were five major customers that each accounted for more than 10% of total revenues and, as a group, represented 86% of total revenues for the three months ended March 31, 2023. There were four major customers that each accounted for more than 10% of accounts receivable and, as a group, represented 88% of total accounts receivable at March 31, 2023. Receivables are carried at transaction price net of allowance for credit losses. Allowance for credit losses is measured using historical loss rates based on the aging of receivables and incorporating current conditions and forward-looking estimates. Recent Accounting Pronouncements There are no recent accounting pronouncements that are expected to have a material impact on the Company’s condensed consolidated financial statements or related disclosures. |
Marketable Securities
Marketable Securities | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities The following is a summary of the Company’s available-for-sale marketable securities as of March 31, 2023, which all have contractual maturities of less than two years: Amortized Gross Gross Fair (in thousands) U.S. Treasury and government agencies $ 138,015 $ 44 $ (397) $ 137,662 Corporate debt 9,642 21 — 9,663 Total marketable securities $ 147,657 $ 65 $ (397) $ 147,325 The following is a summary of the Company’s available-for-sale marketable securities as of December 31, 2022, which all have contractual maturities of less than two years: Amortized Gross Gross Fair (in thousands) U.S. Treasury and government agencies $ 178,351 $ — $ (1,181) $ 177,170 Corporate debt 155,017 14 (371) 154,660 Total marketable securities $ 333,368 $ 14 $ (1,552) $ 331,830 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements Authoritative guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: • Level 1 — defined as observable inputs such as quoted prices in active markets • Level 2 — defined as inputs other than quoted prices in active markets that are either directly or indirectly observable • Level 3 — defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions The Company’s assets classified in Level 1 and Level 2 as of March 31, 2023 and December 31, 2022 consist of cash equivalents and available-for-sale marketable securities. The valuation of Level 1 instruments is determined using a market approach and is based upon unadjusted quoted prices for identical assets in active markets. The valuation of Level 2 instruments is also determined using a market approach based upon quoted prices for similar assets in active markets, or other inputs that are observable for substantially the full term of the financial instrument. Level 2 securities include certificates of deposit, commercial paper and corporate notes that use as their basis readily observable market parameters. The Company held certain assets that are required to be measured at fair value on a recurring basis as of March 31, 2023, as follows: Fair Value Measurement as of March 31, 2023 Using Total Fair Value Quoted Prices in Significant Other Significant (in thousands) (Level 1) (Level 2) (Level 3) U.S. Treasury and government agencies $ 137,662 $ 137,662 $ — $ — Corporate debt 9,663 — 9,663 — Total assets measured at fair value $ 147,325 $ 137,662 $ 9,663 $ — The Company held certain assets that are required to be measured at fair value on a recurring basis as of December 31, 2022, as follows: Fair Value Measurement as of December 31, 2022 Using Total Fair Value Quoted Prices in Significant Other Significant (in thousands) (Level 1) (Level 2) (Level 3) U.S. Treasury and government agencies $ 177,170 $ 177,170 $ — $ — Corporate debt 154,660 — 154,660 — Total assets measured at fair value $ 331,830 $ 177,170 $ 154,660 $ — Total assets measured at fair value as of March 31, 2023 and December 31, 2022 include no cash equivalents. The Company also has financial assets and liabilities, not required to be measured at fair value on a recurring basis, which primarily consist of cash, accounts receivable, restricted cash, accounts payable and accrued liabilities, and product revenue allowances, the carrying values of which materially approximate their fair values. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory consisted of the following as of March 31, 2023 and December 31, 2022: (in thousands) March 31, December 31, 2022 Current assets Work-in-process $ 23 $ 23 Finished goods 1,082 1,171 Total inventory, current $ 1,105 $ 1,194 Non-Current assets Raw materials $ 1,043 $ 1,043 Work-in-process 7,504 8,212 Finished goods 1,036 1,041 Total inventory, non-current 9,583 10,296 Total inventory $ 10,688 $ 11,490 Inventory, which is recorded at the lower of cost or net realizable value, includes the cost of third-party manufacturing and other direct and indirect costs and is valued using the first-in, first-out method. The Company evaluates expiry risk by evaluating current and future product demand relative to product shelf life. The Company builds demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance, patient usage, and generic competition. The Company’s inventory balance consisted of $7.4 million and $8.0 million of HETLIOZ ® product and $3.3 million and $3.4 million of Fanapt ® product as of March 31, 2023 and December 31, 2022, respectively. |
Intangible Assets
Intangible Assets | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Intangible Assets HETLIOZ ® . In January 2014, the Company announced that the FDA had approved the New Drug Application (NDA) for HETLIOZ ® . As a result of this approval, the Company met a milestone under its license agreement with Bristol-Myers Squibb (BMS) that required the Company to make a license payment of $8.0 million to BMS. In April 2018, the Company met its final milestone under its license agreement with BMS when cumulative worldwide sales of HETLIOZ ® reached $250.0 million. As a result of the achievement of this milestone, the Company made a payment to BMS of $25.0 million in 2018. These milestone payments were determined to be additional consideration for the acquisition of HETLIOZ ® and capitalized as an intangible asset and are being amortized on a straight-line basis over the estimated economic useful life of the related product patents. The following is a summary of the Company’s intangible assets as of March 31, 2023: March 31, 2023 (in thousands) Estimated Gross Accumulated Net HETLIOZ ® March 2035 $ 33,000 $ 14,814 $ 18,186 The following is a summary of the Company’s intangible assets as of December 31, 2022: December 31, 2022 (in thousands) Estimated Gross Accumulated Net HETLIOZ ® March 2035 $ 33,000 $ 14,435 $ 18,565 As of March 31, 2023 and December 31, 2022, the Company also had $27.9 million of fully amortized intangible assets related to Fanapt ® . Intangible assets are amortized over their estimated useful economic life using the straight-line method. Amortization expense was $0.4 million for each of the three months ended March 31, 2023 and 2022. The following is a summary of the future intangible asset amortization schedule as of March 31, 2023: (in thousands) Total 2023 2024 2025 2026 2027 Thereafter HETLIOZ ® $ 18,186 $ 1,137 $ 1,516 $ 1,516 $ 1,516 $ 1,516 $ 10,985 |
Accounts Payable and Accrued Li
Accounts Payable and Accrued Liabilities | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accounts Payable and Accrued Liabilities | Accounts Payable and Accrued Liabilities The following is a summary of the Company’s accounts payable and accrued liabilities as of March 31, 2023 and December 31, 2022: (in thousands) March 31, December 31, 2022 Research and development expenses $ 11,676 $ 9,474 Consulting and other professional fees 10,713 9,241 Royalties payable 3,421 4,979 Compensation and employee benefits 3,136 6,839 Operating lease liabilities 2,346 2,328 Accounts payable and other accrued liabilities 3,800 12,690 Total accounts payable and accrued liabilities $ 35,092 $ 45,551 As of December 31, 2022, the prepaid expenses and other current assets and accounts payable and accrued liabilities balances included $11.5 million related to the case, Gordon v. Vanda Pharmaceuticals Inc. In January 2023, the settlement related to the case was fully and finally approved. As a result, the Company removed the associated prepaid and liability balances. (See Note 16, Legal Matters , in Part II, Item 8 of the Annual Report for additional information.) |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Guarantees and Indemnifications The Company has entered into a number of standard intellectual property indemnification agreements in the ordinary course of its business. Pursuant to these agreements, the Company indemnifies, holds harmless, and agrees to reimburse the indemnified party for losses suffered or incurred by the indemnified party, generally the Company’s business partners or customers, in connection with any U.S. patent or any copyright or other intellectual property infringement claim by any third party with respect to the Company’s products. The term of these indemnification agreements is generally perpetual from the date of execution of the agreement. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited. Since inception, the Company has not incurred costs to defend lawsuits or settle claims related to these indemnification agreements. The Company also indemnifies its officers and directors for certain events or occurrences, subject to certain conditions. License Agreements The Company’s rights to develop and commercialize its products are subject to the terms and conditions of licenses granted to the Company by other pharmaceutical companies. HETLIOZ ® . In February 2004, the Company entered into a license agreement with BMS under which it received an exclusive worldwide license under certain patents and patent applications, and other licenses to intellectual property, to develop and commercialize HETLIOZ ® . As of March 31, 2023, the Company has paid BMS $37.5 million in upfront fees and milestone obligations, including $33.0 million of regulatory approval and commercial milestones capitalized as intangible assets (see Note 6, Intangible Assets ). The Company has no remaining milestone obligations to BMS. Additionally, the Company is obligated to make royalty payments on HETLIOZ ® net sales to BMS. The royalty period in each territory where the Company commercializes HETLIOZ ® is 10 years following the first commercial sale in the territory. In territories outside the U.S., the royalty is 5% on net sales. In the U.S., the royalty on net sales in the U.S. decreased from 10% to 5% in December 2022. This U.S. royalty will end in April 2024. The Company is also obligated under the license agreement to pay BMS a percentage of any sublicense fees, upfront payments and milestone and other payments (excluding royalties) that it receives from a third party in connection with any sublicensing arrangement, at a rate which is in the mid-twenties. The Company is obligated to use its commercially reasonable efforts to develop and commercialize HETLIOZ ® . Fanapt ® . Pursuant to the terms of a settlement agreement with Novartis Pharma AG (Novartis), Novartis transferred all U.S. and Canadian rights in the Fanapt ® franchise to the Company on December 31, 2014. The Company paid directly to Sanofi S.A. (Sanofi) a fixed royalty of 3% of net sales through December 2019 related to manufacturing know-how. The Company is also obligated to pay Sanofi a fixed royalty on Fanapt ® net sales equal to 6% on Sanofi know-how not related to manufacturing under certain conditions for a period of up to 10 years in markets where the new chemical entity (NCE) patent has expired or was not issued. The Company is obligated to pay this 6% royalty on net sales in the U.S. through November 2026. Tradipitant. In April 2012, the Company entered into a license agreement with Eli Lilly and Company (Lilly) pursuant to which the Company acquired an exclusive worldwide license under certain patents and patent applications, and other licenses to intellectual property, to develop and commercialize an NK-1 receptor antagonist, tradipitant, for all human indications. Lilly is eligible to receive future payments based upon achievement of specified development, regulatory approval and commercialization milestones as well as tiered-royalties on net sales at percentage rates up to the low double digits. As of March 31, 2023, the Company has paid Lilly $3.0 million in upfront fees and development milestones. As of March 31, 2023 remaining milestone obligations include a $2.0 million development milestone due upon the filing of the first application for marketing authorization for tradipitant in either the U.S. or European Union (E.U.), $10.0 million and $5.0 million for the first approval of an application for marketing authorization for tradipitant in the U.S. and E.U., respectively, and up to $80.0 million for sales milestones. The Company is obligated to use its commercially reasonable efforts to develop and commercialize tradipitant. Portfolio of CFTR activators and inhibitors . In March 2017, the Company entered into a license agreement with the University of California San Francisco (UCSF), under which the Company acquired an exclusive worldwide license to develop and commercialize a portfolio of CFTR activators and inhibitors. Pursuant to the license agreement, the Company will develop and commercialize the CFTR activators and inhibitors and is responsible for all development costs under the license agreement, including current pre-investigational new drug development work. UCSF is eligible to receive future payments based upon achievement of specified development and commercialization milestones as well as single-digit royalties on net sales. As of March 31, 2023, the Company has paid UCSF $1.6 million in upfront fees and development milestones. As of March 31, 2023 remaining milestone obligations include $11.9 million for development milestones and $33.0 million for future regulatory approval and sales milestones. Included in the $11.9 million of development milestones are $1.1 million of milestone obligations due upon the conclusion of clinical studies for each licensed product but not to exceed $3.2 million in total for the CFTR portfolio. VQW-765. In connection with a settlement agreement with Novartis relating to Fanapt ® , the Company received an exclusive worldwide license under certain patents and patent applications, and other licenses to intellectual property, to develop and commercialize VQW-765, a Phase II alpha-7 nicotinic acetylcholine receptor partial agonist. Pursuant to the license agreement, the Company is obligated to use its commercially reasonable efforts to develop and commercialize VQW-765 and is responsible for all development costs. The Company has no milestone obligations; however, Novartis is eligible to receive tiered-royalties on net sales at percentage rates up to the mid-teens. Other Agreements In September 2022, the Company entered into an agreement with OliPass Corporation (OliPass) to jointly develop a set of ASO molecules based on OliPass’ proprietary modified peptide nucleic acids. As consideration for entering into the arrangement, the Company paid OliPass an upfront fee of $3.0 million, which was recorded as research and development expense during the year ended December 31, 2022. The Company is funding the research and development activities and has the option to license jointly developed intellectual property upon successful development. Purchase Commitments In the course of its business, the Company regularly enters into agreements with third-party vendors under fee service arrangements, which generally may be terminated on 90 days’ notice without incurring additional charges, other than charges for work completed or materials procured but not paid for through the effective date of termination and other costs incurred by the Company’s contractors in closing out work in progress as of the effective date of termination. The Company’s non-cancellable purchase commitments for agreements longer than one year are not material. Various other long-term agreements entered into for services with other third-party vendors, such as inventory purchase commitments, are cancellable in nature or contain variable commitment terms within the agreement. |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Loss | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Accumulated Other Comprehensive Loss | Accumulated Other Comprehensive Loss The accumulated balances related to each component of other comprehensive loss, net of taxes, were as follows as of March 31, 2023 and December 31, 2022: (in thousands) March 31, December 31, 2022 Foreign currency translation $ 2 $ (7) Unrealized loss on marketable securities (257) (1,186) Accumulated other comprehensive loss $ (255) $ (1,193) |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation As of March 31, 2023, there were 6,985,906 shares subject to outstanding options and restricted stock units (RSUs) under the 2006 Equity Incentive Plan (2006 Plan) and the Amended and Restated 2016 Equity Incentive Plan (2016 Plan, and together with the 2006 Plan, Plans). The 2006 Plan expired by its terms in April 2016, and the Company adopted the 2016 Plan. Outstanding options under the 2006 Plan remain in effect and the terms of the 2006 Plan continue to apply, but no additional awards can be granted under the 2006 Plan. In June 2016, the Company’s stockholders approved the 2016 Plan. The 2016 Plan has been amended a number of times since to increase the number of shares reserved for issuance, among other administrative changes. Each of the amendments to the 2016 Plan was approved by the Company’s stockholders. There is a total of 11,890,000 shares of common stock authorized for issuance under the 2016 Plan, 2,756,373 shares of which remained available for future grant as of March 31, 2023. Stock Options The Company has granted option awards under the Plans with service conditions (service option awards) that are subject to terms and conditions established by the compensation committee of the board of directors. Service option awards have 10-year contractual terms. Service option awards granted to employees and new directors upon their election vest and become exercisable over four years, with the first 25% of the shares subject to service option awards vesting on the first anniversary of the grant date and the remaining 75% of the shares subject to the service option awards in 36 equal monthly installments thereafter. Subsequent annual service option awards granted to directors vest and become exercisable in full on the first anniversary of the grant date. Service option awards granted to executive officers and certain other employees provide for partial acceleration of vesting if the executive officer or employee is subject to an involuntary termination, and full acceleration of vesting if the executive officer or employee is subject to an involuntary termination within 24 months after a change in control of the Company. Service option awards granted to directors provide for accelerated vesting if there is a change in control of the Company or if the director’s service terminates as a result of the director’s death or total and permanent disability. As of March 31, 2023, $8.6 million of unrecognized compensation costs related to unvested service option awards are expected to be recognized over a weighted average period of 1.4 years. No option awards are classified as a liability as of March 31, 2023. A summary of option activity under the Plans for the three months ended March 31, 2023 follows: (in thousands, except for share and per share amounts) Number of Weighted Average Weighted Average Aggregate Outstanding at December 31, 2022 4,232,210 $ 14.19 5.81 $ — Granted 774,976 7.01 Expired (5,417) 14.38 Outstanding at March 31, 2023 5,001,769 13.08 6.24 21 Exercisable at March 31, 2023 3,229,665 14.32 4.71 — Vested and expected to vest at March 31, 2023 4,670,167 13.39 6.00 14 The weighted average grant date fair value of options granted was $3.57 and $5.28 per share for the three months ended March 31, 2023 and 2022, respectively. There were no proceeds from the exercise of stock options for the three months ended March 31, 2023 and 2022. Restricted Stock Units An RSU is a stock award that entitles the holder to receive shares of the Company’s common stock as the award vests. The fair value of each RSU is based on the closing price of the Company’s stock on the date of grant. The Company has granted RSUs under the Plans with service conditions (service RSUs) that are subject to terms and conditions established by the compensation committee of the board of directors. Service RSUs granted to employees vest in four equal annual installments provided that the employee remains employed with the Company. Service RSUs granted to executive officers and certain other employees provide for accelerated vesting if the executive officer or employee is subject to an involuntary termination within 24 months after a change in control. Annual service RSUs granted to directors vest on the first anniversary of the grant date and provide for accelerated vesting if there is a change in control of the Company. As of March 31, 2023, $20.8 million of unrecognized compensation costs related to unvested service RSUs are expected to be recognized over a weighted average period of 1.8 years. No RSUs are classified as a liability as of March 31, 2023. A summary of RSU activity for the Plans for the three months ended March 31, 2023 is as follows: Number of Weighted Average Grant Date Fair Value Unvested at December 31, 2022 1,915,546 $ 14.41 Granted 765,708 7.03 Forfeited (39,492) 12.70 Vested (657,625) 15.53 Unvested at March 31, 2023 1,984,137 11.23 The grant date fair value for the 657,625 shares underlying RSUs that vested during the three months ended March 31, 2023 was $10.2 million. Stock-Based Compensation Expense Stock-based compensation expense recognized for the three months ended March 31, 2023 and 2022 was comprised of the following: Three Months Ended (in thousands) March 31, March 31, Research and development $ 1,066 $ 1,160 Selling, general and administrative 3,285 3,618 Total stock-based compensation expense $ 4,351 $ 4,778 The fair value of each option award is estimated on the date of grant using the Black-Scholes-Merton option pricing model that uses the assumptions noted in the following table. Expected volatility rates are based on the historical volatility of the Company’s publicly traded common stock and other factors. The expected terms are determined based on a combination of historical exercise data and hypothetical exercise data for unexercised stock options. The risk-free interest rates are based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. The Company has never paid cash dividends to its stockholders and does not plan to pay dividends in the foreseeable future. Assumptions used in the Black-Scholes-Merton option pricing model for employee and director stock options granted during the three months ended March 31, 2023 and 2022 were as follows: Three Months Ended March 31, 2023 March 31, 2022 Expected dividend yield 0 % 0 % Weighted average expected volatility 47 % 47 % Weighted average expected term (years) 6.15 6.05 Weighted average risk-free rate 3.92 % 1.86 % |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income TaxesFor the three months ended March 31, 2023 and 2022, the Company recorded a provision for income taxes of $2.3 million and income tax benefit of $1.1 million, respectively. The income tax expense (benefit) for the three months ended March 31, 2023 and 2022 was primarily driven by the estimated effective tax rate for the year, as well as discrete income tax expense of $1.1 million for each period. |
Earnings per Share
Earnings per Share | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Earnings per Share | Earnings per Share Basic earnings per share (EPS) is calculated by dividing the net income (loss) by the weighted average number of shares of common stock outstanding. Diluted EPS is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding, plus potential outstanding common stock for the period. Potential outstanding common stock includes stock options and shares underlying RSUs, but only to the extent that their inclusion is dilutive. The following table presents the calculation of basic and diluted net income (loss) per share of common stock for the three months ended March 31, 2023 and 2022: Three Months Ended (in thousands, except for share and per share amounts) March 31, March 31, Numerator: Net income (loss) $ 3,252 $ (6,430) Denominator: Weighted average shares outstanding, basic 57,011,396 56,105,239 Effect of dilutive securities 388,756 — Weighted average shares outstanding, diluted 57,400,152 56,105,239 Net income (loss) per share, basic and diluted: Basic $ 0.06 $ (0.11) Diluted $ 0.06 $ (0.11) Antidilutive securities excluded from calculations of diluted net income (loss) per share 6,133,050 4,263,975 The Company incurred a net loss for the three months ended March 31, 2022 causing inclusion of any potentially dilutive securities to have an anti-dilutive effect, resulting in dilutive loss per share and basic loss per share attributable to common stockholders being equivalent. |
Legal Matters
Legal Matters | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal Matters | Legal Matters HETLIOZ ® . Between April 2018 and March 2021, the Company filed numerous Hatch-Waxman lawsuits in the U.S. District Court for the District of Delaware (Delaware District Court) against Teva Pharmaceuticals USA, Inc. (Teva), MSN Pharmaceuticals Inc. and MSN Laboratories Private Limited (MSN) and Apotex Inc. and Apotex Corp. (Apotex, and collectively with Teva and MSN, the HETLIOZ ® Defendants) asserting that U.S. Patent Nos. RE46,604 (‘604 Patent), 9,060,995, 9,539,234, 9,549,913, 9,730,910 (‘910 Patent), 9,844,241, 10,071,977, 10,149,829 (‘829 Patent), 10,376,487 (‘487 Patent), 10,449,176, 10,610,510, 10,610,511, 10,829,465, and 10,611,744 will be infringed by the HETLIOZ ® Defendants’ generic versions of HETLIOZ ® for which they were seeking FDA approval. As initially disclosed in the Company’s Form 8-K filed with the Securities and Exchange Commission (SEC) on January 14, 2022, in January 2022, the Company entered into a license agreement with MSN and Impax Laboratories LLC (Impax) resolving the lawsuits against MSN (the MSN/Impax License Agreement). The MSN/Impax License Agreement grants MSN and Impax a non-exclusive license to manufacture and commercialize MSN’s generic version of HETLIOZ ® in the U.S. effective as of March 13, 2035, unless prior to that date the Company obtains pediatric exclusivity for HETLIOZ ® , in which case the license will be effective as of July 27, 2035. The MSN/Impax License Agreement also provides that MSN and Impax may launch a generic version of HETLIOZ ® earlier under certain limited circumstances. The consolidated lawsuits against the remaining HETLIOZ ® Defendants were tried in March 2022. On December 13, 2022, the Delaware District Court ruled that Teva and Apotex did not infringe the ‘604 Patent, and that the asserted claims of the ‘604, ‘910, ‘829 and ‘487 Patents were invalid. In December 2022, the Company appealed the Delaware District Court’s decision to the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) and an oral argument for the appeal was held in March 2023. On December 27, 2022, the Company filed patent infringement lawsuits, including Hatch-Waxman Act claims, against each of Teva and Apotex in the U.S. District Court for the District of New Jersey (NJ District Court) asserting that U.S. Patent No. 11,285,129, a method of administration patent that was not litigated in the Delaware District Court cases (‘129 Patent), will be infringed by Teva’s and Apotex’ generic versions of HETLIOZ ® , each of which was approved by the FDA. The Company asked the NJ District Court to, among other things, order that the effective date of the FDA’s approval of Teva’s and Apotex’ generic versions of HETLIOZ ® be a date that is no earlier than the expiration of the ‘129 Patent, or such later date that the NJ District Court may determine, and enjoin each of Teva and Apotex from the commercial manufacture, use, import, offer for sale and/or sale of their generic versions of HETLIOZ ® until the expiration of the ‘129 Patent, or such later date that the NJ District Court may determine. In February 2023, the case was transferred to the Delaware District Court, where it is now pending. In January 2023, the Company filed a lawsuit in the NJ District Court against Teva challenging Teva’s advertising and marketing practices related to its at-risk launch of its generic version of HETLIOZ ® for the single indication of Non-24. The Company believes that Teva’s advertising and marketing practices related to its generic version of HETLIOZ ® promote its product for uses beyond the limited labeling that Teva sought, and the FDA approved. The Company seeks to, among other things, enjoin Teva from engaging in false and misleading advertising and recover monetary damages. In March 2023, Teva filed a motion to dismiss or to transfer the case to the Delaware District Court. In January 2023, the Company filed a lawsuit in the U.S. District Court for the District of Columbia (DC District Court) against the FDA challenging the FDA’s approval of Teva’s Abbreviated New Drug Application (ANDA) for its generic version of HETLIOZ ® capsules under the Administrative Procedure Act, the Food, Drug, and Cosmetic Act (FDCA), and FDA regulations. Under the FDCA, every ANDA must contain information to show that the labeling proposed for the generic drug is the same as the labeling approved for the listed drug; additionally, the generic drug must have the same conditions of use as the listed drug. The labeling and packaging for HETLIOZ ® includes Braille, but Teva’s generic tasimelteon does not. On this basis, the Company believes that Teva’s approved labeling does not comply with applicable requirements. The Company has asked the DC District Court to, among other things, vacate the FDA’s approval of Teva’s ANDA, declare that the approval of the ANDA was unlawful, arbitrary, and capricious and compel the FDA to order Teva to recall its shipments or sales of its generic HETLIOZ ® product. In February 2023, Teva joined the lawsuit as a defendant. Other Matters . From April to December 2022, the Company filed six lawsuits in the DC District Court against the FDA to compel the FDA to produce records under the Freedom of Information Act (FOIA). The first lawsuit, in April 2022, requested certain records relating to its denial of the Company’s supplemental NDA for HETLIOZ ® in the treatment of jet lag disorder. The Company had repeatedly attempted to obtain these records from the FDA pursuant to a FOIA request submitted by the Company in December of 2019, but the FDA refused to provide them, claiming an exemption under FOIA. In March 2023, the DC District Court ruled in the Company’s favor, rejecting the FDA’s claim that the exemption applied to the records requested. The remaining lawsuits, which relate to requests for certain records regarding cases in which the FDA waived its putative requirement of a 9-month non-rodent toxicity study before drugs can be tested on human patients for extended durations; communications external to and within the FDA relating to tradipitant; and communications external to and within the FDA relating to HETLIOZ ® , are ongoing. The FDA has failed to respond and disclose the requested documents within the statutory timeframe with respect to each of these requests. The Company has asked the DC District Court to, among other things, compel the FDA to comply with its obligations and declare that its lack of compliance violates FOIA. In April 2022, the Company filed a lawsuit in the U.S. District Court for the District of Maryland (the MD District Court) against the Centers for Medicare & Medicaid Services (CMS) and the Administrator of CMS challenging CMS’ rule broadly interpreting the defined terms “line extension” and “new formulation” under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (ACA), which went into effect in January 2022 (the Rule). The Company believes that the Rule is unlawful and contrary to the intent of Congress when it passed the ACA. Under the Rule, certain of the Company’s products would be treated as line extensions and new formulations subject to enhanced rebates, despite the statutory text and CMS’ own long-standing practice, under which such products would not constitute line extensions or new formulations. In March 2023, the MD District Court ruled that CMS’ interpretation of the terms was reasonable and consistent with Congress’ intent. The Company has appealed the ruling to the U.S. Court of Appeals for the Fourth Circuit. In May 2022, the Company filed a lawsuit in the DC District Court against the FDA challenging the FDA’s denial of Fast Track designation for tradipitant. In October 2021, the Company submitted to the FDA a request for Fast Track designation for tradipitant under the Food and Drug Administration Modernization Act of 1997 (FDAMA). The FDAMA provides for expedited development and review of drugs that receive Fast Track designation from the FDA. Under the FDAMA, the FDA must designate a drug as a Fast Track product if it both (1) is intended to treat a serious or life-threatening disease or condition and (2) demonstrates the potential to address unmet medical needs for such disease or condition. Although Fast Track designation is non-discretionary when the criteria are satisfied, the FDA denied the Company’s request for Fast Track designation. The Company does not believe that the FDA based its decision on the relevant criteria. Therefore, among other reasons, the Company maintains that the FDA’s denial is unlawful. The Company has asked the DC District Court to, among other things, set aside and vacate the FDA’s denial. An oral argument was held in January 2023. In September 2022, the Company filed a lawsuit in the DC District Court against the FDA to compel the FDA to comply with two separate nondiscretionary obligations under the FDCA and its implementing regulations: an obligation to publish a notice of an opportunity for a hearing on the Company’s supplemental New Drug Application (sNDA) in the Federal Register within 180 days of the filing of the sNDA, and a separate obligation to publish the same notice within 60 days of the request for a hearing. The FDA published the notice of an opportunity for a hearing on October 11, 2022. The Company has asked the DC District Court to, among other things, compel the FDA to comply with its obligations and declare that its lack of compliance violates the FDCA and the FDA regulations. In May 2023, the Company filed a lawsuit in the U.S. Court of Federal Claims (Federal Claims Court) against the federal government for the uncompensated taking and misuse of the Company’s trade secrets and confidential information. The Company believes that the FDA violated the Fifth Amendment’s due process clause by improperly providing confidential details from the Company’s drug master files for HETLIOZ ® and Fanapt ® to generic drug manufacturers during the FDA’s review of the manufacturers’ ANDAs. The Company has asked the Federal Claims Court to, among other things, declare that the FDA’s disclosure of the Company’s confidential commercial information constitutes a taking for purposes of the Fifth Amendment and award just compensation. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of PresentationThe accompanying unaudited condensed consolidated financial statements includes the accounts of Vanda Pharmaceuticals Inc. and its wholly-owned subsidiaries and have been prepared in accordance with United States generally accepted accounting principles (GAAP) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the Company’s consolidated financial statements and accompanying notes included in the Company’s annual report on Form 10-K (Annual Report) for the fiscal year ended December 31, 2022. The financial information as of March 31, 2023 and for the three months ended March 31, 2023 and 2022 is unaudited, but in the opinion of management, all adjustments considered necessary for a fair statement of the results for these interim periods have been included. All intercompany accounts and transactions have been eliminated in consolidation. The condensed consolidated balance sheet data as of December 31, 2022 was derived from audited financial statements but does not include all disclosures required by GAAP. The results of the Company’s operations for any interim period are not necessarily indicative of the results that may be expected for any other interim period or any future year or period. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates that affect the reported amounts of assets and liabilities at the date of the financial statements, disclosure of contingent assets and liabilities, and the reported amounts of revenue and expenses during the reporting period. Management continually re-evaluates its |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted CashFor purposes of the Condensed Consolidated Balance Sheets and Condensed Consolidated Statements of Cash Flows, cash equivalents represent highly-liquid investments with a maturity date of three months or less at the date of purchase. Cash and cash equivalents include investments in money market funds with commercial banks and financial institutions, and commercial paper of high-quality corporate issuers. Restricted cash relates primarily to amounts held as collateral for letters of credit for leases for office space at the Company’s Washington, D.C. headquarters. |
Major Customers | Major Customers HETLIOZ ® is available in the U.S. for distribution through a limited number of specialty pharmacies and is not available in retail pharmacies. Fanapt ® is available in the U.S. for distribution through a limited number of wholesalers and is available in retail pharmacies. The Company invoices and records revenue when its customers, specialty pharmacies and wholesalers, receive product from the third-party logistics warehouse, which is the point at which control is transferred to the customer. There were five major customers that each accounted for more than 10% of total revenues and, as a group, represented 86% of total revenues for the three months ended March 31, 2023. There were four major customers that each accounted for more than 10% of accounts receivable and, as a group, represented 88% of total accounts receivable at March 31, 2023. Receivables are carried at transaction price net of allowance for credit losses. Allowance for credit losses is measured using historical loss rates based on the aging of receivables and incorporating current conditions and forward-looking estimates. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements There are no recent accounting pronouncements that are expected to have a material impact on the Company’s condensed consolidated financial statements or related disclosures. |
Marketable Securities | The Company’s assets classified in Level 1 and Level 2 as of March 31, 2023 and December 31, 2022 consist of cash equivalents and available-for-sale marketable securities. The valuation of Level 1 instruments is determined using a market approach and is based upon unadjusted quoted prices for identical assets in active markets. The valuation of Level 2 instruments is also determined using a market approach based upon quoted prices for similar assets in active markets, or other inputs that are observable for substantially the full term of the financial instrument. Level 2 securities include certificates of deposit, commercial paper and corporate notes that use as their basis readily observable market parameters. |
Earnings per Share | Earnings per ShareBasic earnings per share (EPS) is calculated by dividing the net income (loss) by the weighted average number of shares of common stock outstanding. Diluted EPS is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding, plus potential outstanding common stock for the period. Potential outstanding common stock includes stock options and shares underlying RSUs, but only to the extent that their inclusion is dilutive. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the Condensed Consolidated Balance Sheets to the total end of period cash, cash equivalents and restricted cash reported within the Condensed Consolidated Statements of Cash Flows: (in thousands) March 31, March 31, Cash and cash equivalents $ 354,171 $ 66,927 Restricted cash included in non-current inventory and other 469 518 Total cash, cash equivalents and restricted cash $ 354,640 $ 67,445 |
Net Product Sales | The Company’s net product sales consist of sales of HETLIOZ ® and Fanapt ® . Net sales by product for the three months ended March 31, 2023 and 2022 were as follows: Three Months Ended (in thousands) March 31, March 31, HETLIOZ ® net product sales $ 39,616 $ 37,031 Fanapt ® net product sales 22,882 23,161 Total net product sales $ 62,498 $ 60,192 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Available-for-Sale Marketable Securities | The following is a summary of the Company’s available-for-sale marketable securities as of March 31, 2023, which all have contractual maturities of less than two years: Amortized Gross Gross Fair (in thousands) U.S. Treasury and government agencies $ 138,015 $ 44 $ (397) $ 137,662 Corporate debt 9,642 21 — 9,663 Total marketable securities $ 147,657 $ 65 $ (397) $ 147,325 The following is a summary of the Company’s available-for-sale marketable securities as of December 31, 2022, which all have contractual maturities of less than two years: Amortized Gross Gross Fair (in thousands) U.S. Treasury and government agencies $ 178,351 $ — $ (1,181) $ 177,170 Corporate debt 155,017 14 (371) 154,660 Total marketable securities $ 333,368 $ 14 $ (1,552) $ 331,830 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Assets Measured at Fair Value on Recurring Basis | The Company held certain assets that are required to be measured at fair value on a recurring basis as of March 31, 2023, as follows: Fair Value Measurement as of March 31, 2023 Using Total Fair Value Quoted Prices in Significant Other Significant (in thousands) (Level 1) (Level 2) (Level 3) U.S. Treasury and government agencies $ 137,662 $ 137,662 $ — $ — Corporate debt 9,663 — 9,663 — Total assets measured at fair value $ 147,325 $ 137,662 $ 9,663 $ — The Company held certain assets that are required to be measured at fair value on a recurring basis as of December 31, 2022, as follows: Fair Value Measurement as of December 31, 2022 Using Total Fair Value Quoted Prices in Significant Other Significant (in thousands) (Level 1) (Level 2) (Level 3) U.S. Treasury and government agencies $ 177,170 $ 177,170 $ — $ — Corporate debt 154,660 — 154,660 — Total assets measured at fair value $ 331,830 $ 177,170 $ 154,660 $ — |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory consisted of the following as of March 31, 2023 and December 31, 2022: (in thousands) March 31, December 31, 2022 Current assets Work-in-process $ 23 $ 23 Finished goods 1,082 1,171 Total inventory, current $ 1,105 $ 1,194 Non-Current assets Raw materials $ 1,043 $ 1,043 Work-in-process 7,504 8,212 Finished goods 1,036 1,041 Total inventory, non-current 9,583 10,296 Total inventory $ 10,688 $ 11,490 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Summary of Intangible Assets | The following is a summary of the Company’s intangible assets as of March 31, 2023: March 31, 2023 (in thousands) Estimated Gross Accumulated Net HETLIOZ ® March 2035 $ 33,000 $ 14,814 $ 18,186 The following is a summary of the Company’s intangible assets as of December 31, 2022: December 31, 2022 (in thousands) Estimated Gross Accumulated Net HETLIOZ ® March 2035 $ 33,000 $ 14,435 $ 18,565 |
Summary of Future Intangible Asset Amortization | The following is a summary of the future intangible asset amortization schedule as of March 31, 2023: (in thousands) Total 2023 2024 2025 2026 2027 Thereafter HETLIOZ ® $ 18,186 $ 1,137 $ 1,516 $ 1,516 $ 1,516 $ 1,516 $ 10,985 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Summary of Accounts Payable and Accrued Liabilities | The following is a summary of the Company’s accounts payable and accrued liabilities as of March 31, 2023 and December 31, 2022: (in thousands) March 31, December 31, 2022 Research and development expenses $ 11,676 $ 9,474 Consulting and other professional fees 10,713 9,241 Royalties payable 3,421 4,979 Compensation and employee benefits 3,136 6,839 Operating lease liabilities 2,346 2,328 Accounts payable and other accrued liabilities 3,800 12,690 Total accounts payable and accrued liabilities $ 35,092 $ 45,551 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Loss (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Summary of Accumulated Balances Related to Each Component of Other Comprehensive Loss | The accumulated balances related to each component of other comprehensive loss, net of taxes, were as follows as of March 31, 2023 and December 31, 2022: (in thousands) March 31, December 31, 2022 Foreign currency translation $ 2 $ (7) Unrealized loss on marketable securities (257) (1,186) Accumulated other comprehensive loss $ (255) $ (1,193) |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Option Activity | A summary of option activity under the Plans for the three months ended March 31, 2023 follows: (in thousands, except for share and per share amounts) Number of Weighted Average Weighted Average Aggregate Outstanding at December 31, 2022 4,232,210 $ 14.19 5.81 $ — Granted 774,976 7.01 Expired (5,417) 14.38 Outstanding at March 31, 2023 5,001,769 13.08 6.24 21 Exercisable at March 31, 2023 3,229,665 14.32 4.71 — Vested and expected to vest at March 31, 2023 4,670,167 13.39 6.00 14 |
Summary of RSU Activity | A summary of RSU activity for the Plans for the three months ended March 31, 2023 is as follows: Number of Weighted Average Grant Date Fair Value Unvested at December 31, 2022 1,915,546 $ 14.41 Granted 765,708 7.03 Forfeited (39,492) 12.70 Vested (657,625) 15.53 Unvested at March 31, 2023 1,984,137 11.23 |
Stock-Based Compensation Expense | Stock-based compensation expense recognized for the three months ended March 31, 2023 and 2022 was comprised of the following: Three Months Ended (in thousands) March 31, March 31, Research and development $ 1,066 $ 1,160 Selling, general and administrative 3,285 3,618 Total stock-based compensation expense $ 4,351 $ 4,778 |
Black-Scholes-Merton Option Pricing Model for Employee and Director Stock Options Granted | Assumptions used in the Black-Scholes-Merton option pricing model for employee and director stock options granted during the three months ended March 31, 2023 and 2022 were as follows: Three Months Ended March 31, 2023 March 31, 2022 Expected dividend yield 0 % 0 % Weighted average expected volatility 47 % 47 % Weighted average expected term (years) 6.15 6.05 Weighted average risk-free rate 3.92 % 1.86 % |
Earnings per Share (Tables)
Earnings per Share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Basic and Diluted Net Income Per Share of Common Stock | The following table presents the calculation of basic and diluted net income (loss) per share of common stock for the three months ended March 31, 2023 and 2022: Three Months Ended (in thousands, except for share and per share amounts) March 31, March 31, Numerator: Net income (loss) $ 3,252 $ (6,430) Denominator: Weighted average shares outstanding, basic 57,011,396 56,105,239 Effect of dilutive securities 388,756 — Weighted average shares outstanding, diluted 57,400,152 56,105,239 Net income (loss) per share, basic and diluted: Basic $ 0.06 $ (0.11) Diluted $ 0.06 $ (0.11) Antidilutive securities excluded from calculations of diluted net income (loss) per share 6,133,050 4,263,975 |
Business Organization and Pre_2
Business Organization and Presentation (Details) | 3 Months Ended |
Mar. 31, 2023 segment | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of operating segments | 1 |
Number of reportable segments | 1 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 354,171 | $ 135,029 | $ 66,927 | |
Restricted cash included in non-current inventory and other | 469 | 518 | ||
Total cash, cash equivalents and restricted cash | $ 354,640 | $ 135,498 | $ 67,445 | $ 52,590 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Net Product Sales (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenue from External Customer [Line Items] | ||
Net product sales | $ 62,498 | $ 60,192 |
HETLIOZ® net product sales | ||
Revenue from External Customer [Line Items] | ||
Net product sales | 39,616 | 37,031 |
Fanapt® net product sales | ||
Revenue from External Customer [Line Items] | ||
Net product sales | $ 22,882 | $ 23,161 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Major Customers (Details) - Major Customers | 3 Months Ended |
Mar. 31, 2023 customer | |
Customer Concentration Risk | Sales Revenue, Net | |
Summary Of Significant Accounting Policies [Line Items] | |
Number of major customers that each accounted for more than 10% of total revenues | 5 |
Concentration risk, percentage | 86% |
Credit Concentration Risk | Accounts Receivable | |
Summary Of Significant Accounting Policies [Line Items] | |
Concentration risk, percentage | 88% |
Number of major customers that each accounted for more than 10% of total accounts receivable | 4 |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 147,657 | $ 333,368 |
Gross Unrealized Gains | 65 | 14 |
Gross Unrealized Losses | (397) | (1,552) |
Fair Market Value | 147,325 | 331,830 |
U.S. Treasury and government agencies | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 138,015 | 178,351 |
Gross Unrealized Gains | 44 | 0 |
Gross Unrealized Losses | (397) | (1,181) |
Fair Market Value | 137,662 | 177,170 |
Corporate debt | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 9,642 | 155,017 |
Gross Unrealized Gains | 21 | 14 |
Gross Unrealized Losses | 0 | (371) |
Fair Market Value | $ 9,663 | $ 154,660 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | $ 147,325,000 | $ 331,830,000 |
Cash Equivalents | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 0 | 0 |
U.S. Treasury and government agencies | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 137,662,000 | 177,170,000 |
Corporate debt | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 9,663,000 | 154,660,000 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 137,662,000 | 177,170,000 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | U.S. Treasury and government agencies | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 137,662,000 | 177,170,000 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Corporate debt | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 0 | 0 |
Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 9,663,000 | 154,660,000 |
Significant Other Observable Inputs (Level 2) | U.S. Treasury and government agencies | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Corporate debt | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 9,663,000 | 154,660,000 |
Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 0 | 0 |
Significant Unobservable Inputs (Level 3) | U.S. Treasury and government agencies | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Corporate debt | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | $ 0 | $ 0 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets | ||
Work-in-process | $ 23 | $ 23 |
Finished goods | 1,082 | 1,171 |
Total inventory, current | 1,105 | 1,194 |
Non-Current assets | ||
Raw materials | 1,043 | 1,043 |
Work-in-process | 7,504 | 8,212 |
Finished goods | 1,036 | 1,041 |
Total inventory, non-current | 9,583 | 10,296 |
Total inventory | $ 10,688 | $ 11,490 |
Inventory - Narrative (Details)
Inventory - Narrative (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory [Line Items] | ||
Inventory | $ 10,688 | $ 11,490 |
HETLIOZ® | ||
Inventory [Line Items] | ||
Inventory | 7,400 | 8,000 |
Fanapt® | ||
Inventory [Line Items] | ||
Inventory | $ 3,300 | $ 3,400 |
Intangible Assets - Additional
Intangible Assets - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Apr. 30, 2018 | Jan. 31, 2014 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2018 | Dec. 31, 2022 | |
Finite-Lived Intangible Assets [Line Items] | ||||||
Intangible asset amortization | $ 379 | $ 379 | ||||
HETLIOZ® | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Acquisition of intangible assets | $ 8,000 | $ 25,000 | ||||
Cumulative worldwide sales milestone | $ 250,000 | |||||
Gross Carrying Amount | 33,000 | $ 33,000 | ||||
Accumulated Amortization | 14,814 | 14,435 | ||||
Fanapt® | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Gross Carrying Amount | 27,900 | 27,900 | ||||
Accumulated Amortization | $ 27,900 | $ 27,900 |
Intangible Assets - Summary of
Intangible Assets - Summary of Intangible Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets [Line Items] | ||
Net Carrying Amount | $ 18,186 | $ 18,565 |
HETLIOZ® | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 33,000 | 33,000 |
Accumulated Amortization | 14,814 | 14,435 |
Net Carrying Amount | $ 18,186 | $ 18,565 |
Intangible Assets - Summary o_2
Intangible Assets - Summary of Future Intangible Asset Amortization (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets [Line Items] | ||
Net Carrying Amount | $ 18,186 | $ 18,565 |
HETLIOZ® | ||
Finite-Lived Intangible Assets [Line Items] | ||
Net Carrying Amount | 18,186 | $ 18,565 |
2023 | 1,137 | |
2024 | 1,516 | |
2025 | 1,516 | |
2026 | 1,516 | |
2027 | 1,516 | |
Thereafter | $ 10,985 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Mar. 31, 2023 | |
Payables And Accruals [Line Items] | ||
Research and development expenses | $ 9,474 | $ 11,676 |
Consulting and other professional fees | 9,241 | 10,713 |
Royalties payable | 4,979 | 3,421 |
Compensation and employee benefits | 6,839 | 3,136 |
Operating lease liabilities | 2,328 | 2,346 |
Accounts payable and other accrued liabilities | 12,690 | 3,800 |
Total accounts payable and accrued liabilities | 45,551 | $ 35,092 |
Accounts Payable and Accrued Liabilities | Gordon v. Vanda Pharmaceuticals Inc. | ||
Payables And Accruals [Line Items] | ||
Payments for legal settlements | 11,500 | |
Prepaid expenses and other current assets | Gordon v. Vanda Pharmaceuticals Inc. | ||
Payables And Accruals [Line Items] | ||
Payments for legal settlements | $ 11,500 |
Commitments and Contingencies -
Commitments and Contingencies - HETLIOZ - Additional Information (Details) - HETLIOZ® - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 11 Months Ended | 230 Months Ended |
Dec. 31, 2022 | Mar. 31, 2023 | Nov. 30, 2022 | Mar. 31, 2023 | |
Commitments and Contingencies [Line Items] | ||||
Development and milestone obligations paid to third party | $ 37.5 | |||
Intangible assets capitalized | $ 33 | |||
Royalty payment period | 10 years | |||
Percentage of future sublicense fees payable to third-party | mid-twenties | |||
Non-US | ||||
Commitments and Contingencies [Line Items] | ||||
Royalty payable percentage on net sales | 5% | |||
U.S. | ||||
Commitments and Contingencies [Line Items] | ||||
Royalty payable percentage on net sales | 5% | 10% |
Commitments and Contingencies_2
Commitments and Contingencies - Fanapt - Additional Information (Details) - Fanapt® | 3 Months Ended | 60 Months Ended |
Mar. 31, 2023 | Dec. 31, 2019 | |
Commitments and Contingencies [Line Items] | ||
Royalty payable percentage on net sales | 6% | 3% |
Royalty payment period | 10 years |
Commitments and Contingencies_3
Commitments and Contingencies - Tradipitant - Additional Information (Details) - Tradipitant - USD ($) $ in Millions | 3 Months Ended | 132 Months Ended |
Mar. 31, 2023 | Mar. 31, 2023 | |
Commitments and Contingencies [Line Items] | ||
Future percentage of royalty payments based net sales | low double digits | |
Development and milestone obligations paid to third party | $ 3 | |
Pre-NDA Approval Milestones | ||
Commitments and Contingencies [Line Items] | ||
Possible future milestone payment | $ 2 | |
Regulatory Approval Milestone | U.S. | ||
Commitments and Contingencies [Line Items] | ||
Possible future milestone payment | 10 | |
Regulatory Approval Milestone | E.U. | ||
Commitments and Contingencies [Line Items] | ||
Possible future milestone payment | 5 | |
Sales Milestone | ||
Commitments and Contingencies [Line Items] | ||
Possible future milestone payment | $ 80 |
Commitments and Contingencies_4
Commitments and Contingencies - CFTR Activators and Inhibitors - Additional Information (Details) - CFTR Activators and Inhibitors - USD ($) $ in Millions | 3 Months Ended | 73 Months Ended |
Mar. 31, 2023 | Mar. 31, 2023 | |
Commitments and Contingencies [Line Items] | ||
Future percentage of royalty payments based net sales | single-digit | |
Development and milestone obligations paid to third party | $ 1.6 | |
Developmental Milestone | ||
Commitments and Contingencies [Line Items] | ||
Possible future milestone payments | $ 11.9 | |
Future Regulatory Approval and Sales Milestones | ||
Commitments and Contingencies [Line Items] | ||
Possible future milestone payments | 33 | |
Development and Milestone Payment, Conclusion of Clinical Studies | ||
Commitments and Contingencies [Line Items] | ||
Possible future milestone payments | 1.1 | |
Development and Milestone Payment, Conclusion of Clinical Studies | Maximum | ||
Commitments and Contingencies [Line Items] | ||
Possible future milestone payments | $ 3.2 |
Commitments and Contingencies_5
Commitments and Contingencies - VQW-765 - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2023 | |
VQW-765 | |
Commitments and Contingencies [Line Items] | |
Future percentage of royalty payments based net sales | mid-teens |
Commitments and Contingencies_6
Commitments and Contingencies - Other Agreements (Details) $ in Millions | 1 Months Ended |
Sep. 30, 2022 USD ($) | |
OliPass Corporation | Additional Funding Agreement Terms | |
Commitments and Contingencies [Line Items] | |
Consideration for entering into the arrangement | $ 3 |
Commitments and Contingencies_7
Commitments and Contingencies - Purchase Commitments - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Agreements for clinical and marketing services, termination notice period | 90 days |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Loss (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Equity [Abstract] | ||
Foreign currency translation | $ 2 | $ (7) |
Unrealized loss on marketable securities | (257) | (1,186) |
Accumulated other comprehensive loss | $ (255) | $ (1,193) |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) | Mar. 31, 2023 shares |
2006 Plan and 2016 Plan | Outstanding Options and RSUs | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Shares subject to outstanding options and RSUs (in shares) | 6,985,906 |
2016 Plan | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares of common stock authorized for issuance (in shares) | 11,890,000 |
Number of shares of common stock available for future grant (in shares) | 2,756,373 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option - Additional Information (Details) | 3 Months Ended | |
Mar. 31, 2023 USD ($) installment $ / shares | Mar. 31, 2022 USD ($) $ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share based compensation option awards contractual term | 10 years | |
Vesting period for subsequent stock options granted to employees and new directors | 4 years | |
Portion of initial stock options granted to employees and new directors that vests on first anniversary of grant date | 25% | |
Portion of initial stock options granted to employees and new directors that vests ratably over three years after completion of first year of service | 75% | |
Number of vesting equal installments | installment | 36 | |
Options granted, weighted average fair value per share (in dollars per share) | $ / shares | $ 3.57 | $ 5.28 |
Proceeds from exercise of employee stock options | $ 0 | $ 0 |
Service option awards | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Full acceleration of vesting, employee or executive officer subject to involuntary termination, period post change of control of the Company | 24 months | |
Unrecognized compensation expenses | $ 8,600,000 | |
Unrecognized compensation expenses, weighted average period | 1 year 4 months 24 days |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Option Activity (Details) - 2006 Plan and 2016 Plan - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Number of Shares | ||
Beginning balance (in shares) | 4,232,210 | |
Granted (in shares) | 774,976 | |
Expired (in shares) | (5,417) | |
Ending balance (in shares) | 5,001,769 | 4,232,210 |
Exercisable at end of period (in shares) | 3,229,665 | |
Vested and expected to vest at end of period (in shares) | 4,670,167 | |
Weighted Average Exercise Price at Grant Date | ||
Beginning balance (in dollars per share) | $ 14.19 | |
Granted (in dollars per share) | 7.01 | |
Expired (in dollars per share) | 14.38 | |
Ending balance (in dollars per share) | 13.08 | $ 14.19 |
Exercisable at end of period (in dollars per share) | 14.32 | |
Vested and expected to vest at end of period (in dollars per share) | $ 13.39 | |
Weighted Average Remaining Term (Years) | ||
Outstanding | 6 years 2 months 26 days | 5 years 9 months 21 days |
Exercisable at end of period | 4 years 8 months 15 days | |
Vested and expected to vest at end of period | 6 years | |
Aggregate Intrinsic Value | ||
Beginning balance | $ 0 | |
Ending balance | 21 | $ 0 |
Exercisable at end of period | 0 | |
Vested and expected to vest at end of period | $ 14 |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Units - Additional Information (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2023 USD ($) installment shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of vesting equal installments | installment | 36 |
Restricted Stock Units (RSUs) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of vesting equal installments | installment | 4 |
Full acceleration of vesting, employee or executive officer subject to involuntary termination, period post change of control of the Company | 24 months |
Unrecognized compensation expenses related to unvested RSUs | $ | $ 20.8 |
Unrecognized compensation expenses, weighted average period | 1 year 9 months 18 days |
Grant date fair value of common stock granted (in shares) | shares | 657,625 |
Grant date fair value of common stock vested | $ | $ 10.2 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of RSU Activity (Details) - Restricted Stock Units (RSUs) | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Number of Shares | |
Beginning balance (in shares) | shares | 1,915,546 |
Granted (in shares) | shares | 765,708 |
Forfeited (in shares) | shares | (39,492) |
Vested (in shares) | shares | (657,625) |
Ending balance (in shares) | shares | 1,984,137 |
Weighted Average Grant Date Fair Value | |
Beginning balance (in dollars per share) | $ / shares | $ 14.41 |
Granted (in dollars per share) | $ / shares | 7.03 |
Forfeited (in dollars per share) | $ / shares | 12.70 |
Vested (in dollars per share) | $ / shares | 15.53 |
Ending balance (in dollars per share) | $ / shares | $ 11.23 |
Stock-Based Compensation - St_2
Stock-Based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 4,351 | $ 4,778 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | 1,066 | 1,160 |
Selling, general and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 3,285 | $ 3,618 |
Stock-Based Compensation - Blac
Stock-Based Compensation - Black-Scholes-Merton Option Pricing Model for Employee and Director Stock Options Granted (Details) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Expected dividend yield | 0% | 0% |
Weighted average expected volatility | 47% | 47% |
Weighted average expected term (years) | 6 years 1 month 24 days | 6 years 18 days |
Weighted average risk-free rate | 3.92% | 1.86% |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Income tax expense (benefit) | $ 2,276 | $ (1,134) |
Discrete income tax expense (benefit) | $ 1,100 | $ 1,100 |
Earnings per Share (Details)
Earnings per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Numerator: | ||
Net income (loss) | $ 3,252 | $ (6,430) |
Denominator: | ||
Weighted average shares outstanding, basic (in shares) | 57,011,396 | 56,105,239 |
Effect of dilutive securities (in shares) | 388,756 | 0 |
Weighted average shares outstanding, diluted (in shares) | 57,400,152 | 56,105,239 |
Net income (loss) per share, basic and diluted: | ||
Basic (in dollars per share) | $ 0.06 | $ (0.11) |
Diluted (in dollars per share) | $ 0.06 | $ (0.11) |
Antidilutive securities excluded from calculations of diluted net income (loss) per share (in shares) | 6,133,050 | 4,263,975 |