0001628280-24-045970 | 10-Q | XBRL Viewer | Vanda Pharmaceuticals INC

Accounts Payable and Accrued Liabilities

9 Months Ended

Sep. 30, 2024

Accounts Payable and Accrued Liabilities

The following is a summary of the Company’s accounts payable and accrued liabilities as of September 30, 2024 and December 31, 2023:


(in thousands)	September 30, 2024		December 31, 2023
Research and development expenses	$	12,861	$	15,691
Consulting and other professional fees	10,013		4,404
Compensation and employee benefits	6,687		6,413
Operating lease liabilities	2,454		2,398
Royalties payable	1,480		2,409

Accounts payable and other accrued liabilities	5,809		7,145
Total accounts payable and accrued liabilities	$	39,304	$	38,460

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2024
Accounting Policies [Abstract]
Business Organization	Vanda Pharmaceuticals Inc. (the Company or Vanda) 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 three products, Fanapt® for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the treatment of schizophrenia, HETLIOZ® for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) and for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS), and PONVORY® for the treatment of relapsing forms of multiple sclerosis (MS) to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, in adults. HETLIOZ® is the first product approved by the United States Food and Drug Administration (FDA) for patients with Non-24 and for patients with SMS. In addition, the Company has a number of drugs in development, including: •Milsaperidone (VHX-896), the active metabolite of Fanapt® (iloperidone), for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia and major depressive disorder; •Fanapt® (iloperidone) long acting injectable (LAI) formulation for the treatment of schizophrenia; •HETLIOZ® (tasimelteon) for the treatment of jet lag disorder, insomnia, pediatric insomnia, delayed sleep phase disorder (DSPD) and pediatric Non-24; •PONVORY® (ponesimod) for the treatment of psoriasis and ulcerative colitis; •Tradipitant (VLY-686), a small molecule neurokinin-1 (NK-1) receptor antagonist, for the treatment of gastroparesis, motion sickness and atopic dermatitis; •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; •VTR-297, a small molecule histone deacetylase (HDAC) inhibitor for the treatment of onychomycosis and hematologic malignancies and with potential use as a treatment for several oncology indications; •VQW-765, a small molecule nicotinic acetylcholine receptor partial agonist, for the treatment of social/performance anxiety and psychiatric disorders; and •Antisense oligonucleotide (ASO) molecules, including VCA-894A for the treatment of Charcot-Marie-Tooth Disease, Type 2S (CMT2S), caused by cryptic slice site variants within the IGHMBP2 gene.
Basis of Presentation	The accompanying unaudited condensed consolidated financial statements include 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, 2023. The financial information as of September 30, 2024 and for the three and nine months ended September 30, 2024 and 2023 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, 2023 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	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.
Major Customers	Fanapt® is available in the U.S. for distribution through a limited number of wholesalers and is available in retail pharmacies. HETLIOZ® is available in the United States (U.S.) for distribution through a limited number of specialty pharmacies and is not available in retail pharmacies. PONVORY® is available in the U.S. for distribution primarily through specialty distributors and specialty pharmacies. The Company invoices and records revenue when its customers, wholesalers, specialty pharmacies and specialty distributors, receive product from the third-party logistics warehouse, which is the point at which control is transferred to the customer. Outside the U.S., the Company has a distribution agreement for the commercialization of Fanapt® in Israel and sells HETLIOZ® in Germany. There were four major customers that each accounted for more than 10% of total revenues and, as a group, represented 68% of total revenues for the nine months ended September 30, 2024. There were four major customers that each accounted for more than 10% of accounts receivable and, as a group, represented 60% of total accounts receivable at September 30, 2024. 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	In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which is intended to provide enhanced segment disclosures. The standard will require disclosures about significant segment expenses and other segment items and identifying the Chief Operating Decision Maker and how they use the reported segment profitability measures to assess segment performance and allocate resources. These enhanced disclosures are required for all entities on an interim and annual basis, even if they have only a single reportable segment. The standard is effective for years beginning after December 15, 2023, and interim periods within annual periods beginning after December 15, 2024 and early adoption is permitted. The Company is evaluating this standard to determine the enhanced disclosures that will be required upon adoption in its Annual Report for the year ending December 31, 2024. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which is intended to provide enhancements to annual income tax disclosures. The standard will require more detailed information in the rate reconciliation table and for income taxes paid, among other enhancements. The standard is effective for years beginning after December 15, 2024 and early adoption is permitted. The Company is evaluating this standard to determine if adoption will have a material impact on the Company’s consolidated financial statements. In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Topic 220-40), which addresses the disaggregation of income statement expenses. This standard is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. The Company is currently evaluating this standard to determine if adoption will have a material impact on the Company's consolidated financial statements.
Marketable Securities	The Company’s assets classified in Level 1 and Level 2 as of September 30, 2024 and December 31, 2023 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	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, as calculated using the treasury stock method.

Commitments and Contingencies - Purchase Commitments - Narrative (Details)	9 Months Ended
	Sep. 30, 2024
Commitments and Contingencies Disclosure [Abstract]
Agreements for clinical and marketing services, termination notice period	90 days

Stock-Based Compensation - Schedule of RSU Activity (Details) - Restricted Stock Units (RSUs)	9 Months Ended
	Sep. 30, 2024 $ / shares shares
Number of Shares
Beginning balance (in shares) \| shares	1,905,310
Granted (in shares) \| shares	1,638,903
Forfeited (in shares) \| shares	(47,872)
Vested (in shares) \| shares	(772,645)
Ending balance (in shares) \| shares	2,723,696
Weighted Average Grant Date Fair Value
Beginning balance (in dollars per share) \| $ / shares	$ 10.87
Granted (in dollars per share) \| $ / shares	4.47
Forfeited (in dollars per share) \| $ / shares	10.15
Vested (in dollars per share) \| $ / shares	11.53
Ending balance (in dollars per share) \| $ / shares	$ 6.84

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (Unaudited) - USD ($) $ in Thousands	Total	Common Stock	Additional Paid-in Capital	Accumulated Other Comprehensive Income (Loss)	Accumulated Deficit
Beginning balance (in shares) at Dec. 31, 2022		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 loss (income)	3,252				3,252
Other comprehensive (loss) income, net of tax	938			938
Ending balance (in shares) at Mar. 31, 2023		57,440,992
Ending balance at Mar. 31, 2023	535,739	$ 57	690,586	(255)	(154,649)
Beginning balance (in shares) at Dec. 31, 2022		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]
Net loss (income)	4,909
Other comprehensive (loss) income, net of tax	226
Ending balance (in shares) at Sep. 30, 2023		57,529,499
Ending balance at Sep. 30, 2023	543,100	$ 58	697,001	(967)	(152,992)
Beginning balance (in shares) at Mar. 31, 2023		57,440,992
Beginning balance at Mar. 31, 2023	535,739	$ 57	690,586	(255)	(154,649)
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)		55,921
Stock-based compensation expense	3,249		3,249
Net loss (income)	1,520				1,520
Other comprehensive (loss) income, net of tax	(610)			(610)
Ending balance (in shares) at Jun. 30, 2023		57,496,913
Ending balance at Jun. 30, 2023	539,898	$ 57	693,835	(865)	(153,129)
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)		32,586
Issuance of common stock from the exercise of stock options and settlement of restricted stock units	0	$ 1	(1)
Stock-based compensation expense	3,167		3,167
Net loss (income)	137				137
Other comprehensive (loss) income, net of tax	(102)			(102)
Ending balance (in shares) at Sep. 30, 2023		57,529,499
Ending balance at Sep. 30, 2023	$ 543,100	$ 58	697,001	(967)	(152,992)
Beginning balance (in shares) at Dec. 31, 2023	57,534,499	57,534,499
Beginning balance at Dec. 31, 2023	$ 544,910	$ 58	700,274	(30)	(155,392)
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)		662,024
Stock-based compensation expense	3,584		3,584
Net loss (income)	(4,146)				(4,146)
Other comprehensive (loss) income, net of tax	(353)			(353)
Ending balance (in shares) at Mar. 31, 2024		58,196,523
Ending balance at Mar. 31, 2024	$ 543,995	$ 58	703,858	(383)	(159,538)
Beginning balance (in shares) at Dec. 31, 2023	57,534,499	57,534,499
Beginning balance at Dec. 31, 2023	$ 544,910	$ 58	700,274	(30)	(155,392)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss (income)	(13,988)
Other comprehensive (loss) income, net of tax	$ 732
Ending balance (in shares) at Sep. 30, 2024	58,306,144	58,306,144
Ending balance at Sep. 30, 2024	$ 541,223	$ 58	709,843	702	(169,380)
Beginning balance (in shares) at Mar. 31, 2024		58,196,523
Beginning balance at Mar. 31, 2024	543,995	$ 58	703,858	(383)	(159,538)
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)		90,785
Stock-based compensation expense	2,986		2,986
Net loss (income)	(4,518)				(4,518)
Other comprehensive (loss) income, net of tax	53			53
Ending balance (in shares) at Jun. 30, 2024		58,287,308
Ending balance at Jun. 30, 2024	542,516	$ 58	706,844	(330)	(164,056)
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)		18,836
Stock-based compensation expense	2,999		2,999
Net loss (income)	(5,324)				(5,324)
Other comprehensive (loss) income, net of tax	$ 1,032			1,032
Ending balance (in shares) at Sep. 30, 2024	58,306,144	58,306,144
Ending balance at Sep. 30, 2024	$ 541,223	$ 58	$ 709,843	$ 702	$ (169,380)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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Legal Matters	9 Months Ended
Legal Matters	Sep. 30, 2024
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 Current Report on Form 8-K filed with the Securities and Exchange Commission 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. In January 2023, MSN and its commercial partner, Amneal Pharmaceuticals, Inc. (Amneal), informed the Company of their belief that such circumstances have occurred and have since launched their generic version. The Company disagreed with this position and sought to defend its legal rights to exclusivity for HETLIOZ®. The consolidated lawsuits against the remaining HETLIOZ® Defendants were tried in March 2022. In December 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. In May 2023, a three-judge panel of the Federal Circuit affirmed the Delaware District Court’s ruling, and in June 2023, the Company requested a rehearing or rehearing en banc from the Federal Circuit. In August 2023, the Federal Circuit denied the Company’s petition for a rehearing. In January 2024, the Company filed a petition for a writ of certiorari with the U.S. Supreme Court to review the Federal Circuit’s decision. In April 2024, the U.S. Supreme Court denied the Company’s petition for a writ of certiorari. In December 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. In April 2023, Teva and Apotex moved for judgment on the pleadings. In June 2024, the Delaware District Court denied those motions, allowing the Company’s lawsuit to proceed. The Company’s lawsuit remains 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 December 2023, the case was transferred to the Delaware District Court. The Company’s lawsuit remains pending. 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. The labeling and packaging for HETLIOZ® includes Braille, but Teva’s generic version 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 generic HETLIOZ® product. In February 2023, Teva intervened in the lawsuit as a defendant. In September 2023, the Company amended its lawsuit to request that the DC District Court set aside the FDA’s July 2023 denial of the Company’s citizen petition, originally filed with the FDA in January 2023. In April 2024, the Company filed a motion for summary judgment. The Company’s lawsuit remains pending. In September 2023, the Company filed a lawsuit in the DC District Court against the FDA challenging the FDA’s approval of MSN’s ANDA for its generic version of HETLIOZ® capsules under the APA, the FDCA, FDA regulations and the Appointments Clause of the U.S. Constitution. The Company believes that MSN’s underlying approval data, particularly its bioequivalence studies, are faulty. On this basis, the Company asked the DC District Court to, among other things, vacate the FDA’s approval of MSN’s ANDA, declare that the approval of the ANDA was unlawful, arbitrary, and capricious, is unconstitutional under the Appointments Clause, and compel the FDA to order MSN to recall its generic HETLIOZ® product. In December 2023, the Company filed a motion for summary judgment. In January 2024, the FDA opposed the Company’s motion and moved to waive the administrative record, following which the court held an oral argument on the cross-motions. The DC District Court issued an order compelling the FDA to serve the administrative record and has set deadlines for further proceedings. In April 2024, the Company filed a motion for summary judgment. In July 2024, the DC District Court held an oral argument on the motion to dismiss that the FDA filed in January 2024, which the Company opposed in February 2024. In September 2024, the DC District Court granted in part the FDA’s motion to dismiss as to the Company’s APA claims and denied the FDA’s motion to dismiss as to the Company’s claims under the Appointments Clause. The Company’s lawsuit remains pending. In April 2024, the Company filed a lawsuit in the Delaware District Court against MSN, Amneal, and Impax alleging claims for false advertising in violation of the Lanham Act and unfair competition under several state laws as well as claims for breach of express representation and fraudulent inducement of a license agreement. In July 2024, the defendants filed a motion to dismiss and in September 2024, the Company opposed the motion. The Company’s lawsuit remains pending. HETLIOZ LQ®. In July 2024, the Company filed a Hatch-Waxman lawsuit against MSN in the Delaware District Court asserting that U.S. Patent Nos. 10,179,119, 11,266,622, 11,285,129, 11,850,229, 10,610,510, 10,980,770, and 11,759,446 (together, the Asserted Patents) will be infringed by MSN’s generic version of HETLIOZ LQ® for which MSN is seeking FDA approval. The Company has asked the Delaware District Court to, among other things, enter judgment that MSN has infringed at least one claim of each of the Asserted Patents by submitting or causing to be submitted its ANDA to obtain FDA approval for the commercial manufacture, use, import, offer for sale and/or sale in the U.S. of its generic version of HETLIOZ LQ® before the expiration of each of the Asserted Patents, enter judgment that the use of MSN’s generic version of HETLIOZ LQ® in the U.S. before the expiration of each of the Asserted Patents will directly infringe at least one claim of each of the Asserted Patents, order that the effective date of any approval by the FDA of MSN’s generic version of HETLIOZ LQ® be a date that is no earlier than the expiration of the last expiring Asserted Patent(s), or such later date as the Court may determine, enjoin MSN from the commercial manufacture, use, import, offer for sale and/or sale of its generic version of HETLIOZ LQ® until the expiration of each of the Asserted Patents or such later date as the Court may determine, and award monetary damages, to the extent applicable. The Company’s lawsuit remains pending. Other Matters. From April 2022 to July 2024, the Company filed eighteen lawsuits in the DC District Court against the FDA to compel the FDA to produce records under the Freedom of Information Act (FOIA) regarding, among other matters: the FDA’s denial of the Company’s supplemental New Drug Application (sNDA) for HETLIOZ® in the treatment of jet lag disorder; 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, HETLIOZ® and Fanapt®; a warning letter that the FDA sent to the Company concerning its webpages for HETLIOZ® and Fanapt®; the FDA’s removal of a clinical trials design presentation from its website; discipline reviews relating to the FDA’s evaluations of the Company’s sNDA for HETLIOZ® and a third-party sNDA for jet lag; internal standard operating procedures or guidance relating to the FDA’s processing of incoming FOIA requests; and bioequivalence and other study reports submitted relating to the FDA’s consideration of tasimelteon ANDAs. Five of these lawsuits have since been resolved in the Company’s favor, one is pending resolution and the other twelve remain outstanding. The FDA has failed to respond and provide the requested documents within the statutory timeframe with respect to each of these twelve outstanding 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 (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. In April 2023, the Company appealed the ruling to the U.S. Court of Appeals for the Fourth Circuit (Fourth Circuit). In January 2024, the Fourth Circuit held an oral argument. In April 2024, the Fourth Circuit ruled against the Company. In September 2024, the Company filed a petition for a writ of certiorari with the U.S. Supreme Court to review the Fourth Circuit’s decision. 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 August 2023, the DC District Court ruled against the Company. In September 2023, the Company appealed the ruling to the U.S. Court of Appeals for the District of Columbia Circuit and in September 2024, the Court of Appeals held an oral argument. The Company's lawsuit remains pending. 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 non-discretionary obligations under the FDCA and its implementing regulations: an obligation to publish a notice of an opportunity for a hearing on the Company’s sNDA for HETLIOZ® in the treatment of jet lag disorder 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 January 2024, the DC District Court held an oral argument on dispositive cross-motions, following which the DC District Court granted in part the Company’s motion for summary judgment. The DC District Court ruled that the FDA violated the statute and ordered the FDA to either finally resolve the Company’s application or commence a hearing on or before March 5, 2024. In March 2024, the Company and the FDA filed a consent motion for entry of final judgment in the Company’s favor on its Administrative Procedure Act claim for the FDA’s unreasonable delay in resolving the hearing request. 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. The federal government filed a motion to dismiss the complaint, which the Company opposed. In January 2024, the Federal Claims Court held an oral argument on the motion to dismiss, following which the Federal Claims Court issued a decision denying in part the government’s motion, allowing the Company’s takings claim to proceed. The Company’s lawsuit remains pending. In February 2024, the Company filed a lawsuit in the DC District Court against the FDA to compel the FDA to comply with its statutory obligations under the FDCA and its implementing regulations, and to challenge the FDA’s complete response letter and 60-day filing regulations, which the Company believes do not absolve the FDA of its statutory responsibilities. Under the FDCA, the FDA has an obligation to either approve the Company’s sNDA for HETLIOZ® in the treatment of insomnia characterized by difficulties with sleep initiation within 180 days of the filing of the sNDA or give the Company a notice of an opportunity for a hearing. The Company submitted the sNDA on May 4, 2023. The Company has asked the DC District Court to, among other things, compel the FDA to comply with its obligations, declare that its lack of compliance violates the FDCA and the FDA regulations and declare the FDA’s complete response letter and 60-day filing regulations unlawful. In June 2024, the Company filed a motion for summary judgment and the FDA published a notice of opportunity for a hearing. In July 2024, the FDA opposed the Company’s motion for summary judgment. In September 2024, the DC District Court held an oral argument on the dispositive cross motions. The Company's lawsuit remains pending. In March 2024, the Company filed a petition for review in the U.S. Court of Appeals for the District of Columbia Circuit (DC Circuit) seeking review of the FDA’s final order refusing to hold a hearing or to approve the Company’s sNDA for HETLIOZ® in the treatment of jet lag disorder. Under the FDCA, the FDA has an obligation to either approve an sNDA or to hold a hearing on the application’s approvability. The Company’s petition asks the DC Circuit to set aside the FDA’s order refusing to hold a hearing and refusing approval. The Company’s petition remains pending. On April 22, 2024, a purported stockholder of the Company filed a lawsuit in the Court of Chancery of the State of Delaware (Delaware Chancery Court) against the members of the Company’s board of directors and the Rights Agent, along with the Company as nominal defendant (collectively, the Defendants), captioned Steamfitters Local 449 Pension Fund v. Mihael H. Polymeropoulos, et al., CA No. 2024-0416-KSJM. The lawsuit contended, among other things, that the members of the Company’s board of directors breached their fiduciary duties in adopting the Rights Agreement. The lawsuit sought relief declaring, in part, that provisions of the Rights Agreement be deemed unenforceable and sought to enjoin the use of such provisions as well as damages, costs, and other remedies, and also sought to enjoin for 30 days the Company’s 2024 Annual Meeting of Stockholders (the Annual Meeting) that was held on May 17, 2024. At a hearing on May 7, 2024, the Delaware Chancery Court denied the plaintiff’s request to enjoin the Annual Meeting. A three-day trial in the case was scheduled to begin on November 4, 2024. On August 7, 2024, the Company amended the Rights Agreement to, among other things, clarify certain of the provisions that were the subject of the lawsuit. On August 12, 2024, the parties filed with the Delaware Chancery Court a stipulation and order dismissing the lawsuit with prejudice, pursuant to which, the plaintiff agreed that the amendment to the Rights Agreement mooted the plaintiff’s claims. The plaintiff filed a petition in the Delaware Chancery Court for an award of attorney’s fees and reimbursement of expenses, which the Company intends to oppose. The Company does not anticipate that this litigation will have a material adverse effect on its business, results of operations or financial condition and the Company believes it is entitled to coverage under its relevant insurance policies, subject to a retention, but coverage could be denied or prove to be insufficient to cover any such award. In August 2024, the Company filed a lawsuit against the FDA in the DC District Court challenging FDA decisionmakers’ authority under the Appointments Clause of the U.S. Constitution to render a decision on Vanda’s new drug application for tradipitant to treat symptoms of gastroparesis. In September 2024, the Company filed a motion for a preliminary injunction to enjoin the FDA from subjecting Vanda’s NDA for tradipitant for the treatment of symptoms of gastroparesis to a final decision prior to the PDUFA target date of September 18, 2024. In September 2024, the DC District Court denied the motion. The Company’s lawsuit remains pending.

Accumulated Other Comprehensive Income (Loss) (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Equity [Abstract]
Foreign currency translation	$ 35	$ 21
Unrealized gain (loss) on marketable securities	667	(51)
Accumulated other comprehensive income (loss)	$ 702	$ (30)

- Definition

Amount, after tax, of accumulated increase (decrease) in equity from transaction and other event and circumstance from nonowner source.

+ References + Details

Business Organization and Presentation (Details)	9 Months Ended
Business Organization and Presentation (Details)	Sep. 30, 2024 segment product
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Number of operating segments	1
Number of reportable segments	1
Number of products in portfolio \| product	3

Earnings per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Numerator:
Net income (loss)	$ (5,324)	$ (4,518)	$ (4,146)	$ 137	$ 1,520	$ 3,252	$ (13,988)	$ 4,909
Denominator:
Weighted average shares outstanding, basic (in shares)	58,261,961			57,519,031			58,095,566	57,329,969
Effect of dilutive securities (in shares)	0			76,313			0	182,256
Weighted average shares outstanding, diluted (in shares)	58,261,961			57,595,344			58,095,566	57,512,225
Net income (loss) per share, basic and diluted:
Basic (in dollars per share)	$ (0.09)			$ 0.00			$ (0.24)	$ 0.09
Diluted (in dollars per share)	$ (0.09)			$ 0.00			$ (0.24)	$ 0.09
Antidilutive securities excluded from calculations of diluted net income (loss) per share (in shares)	6,383,154			6,724,127			6,603,367	6,526,562

Stock-Based Compensation

9 Months Ended

Sep. 30, 2024

Share-Based Payment Arrangement [Abstract]

Stock-Based Compensation

As of September 30, 2024, there were 7,648,463 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 15,690,000 shares of common stock authorized for issuance under the 2016 Plan, 4,655,745 shares of which remained available for future grant as of September 30, 2024.

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 September 30, 2024, $3.8 million of unrecognized compensation costs related to unvested service option awards are expected to be recognized over a weighted average period of 0.9 years. No option awards are classified as a liability as of September 30, 2024.

A summary of option activity under the Plans for the nine months ended September 30, 2024 follows:


(in thousands, except for share and per share amounts)	Number of Shares	Weighted Average Exercise Price at Grant Date		Weighted Average Remaining Term (Years)	Aggregate Intrinsic Value
Outstanding at December 31, 2023	4,792,506	$	12.95	6.00	$	—
Granted	190,514	5.41

Expired	(58,253)	11.39

Outstanding at September 30, 2024	4,924,767	12.67		5.48	—
Exercisable at September 30, 2024	3,973,865	13.65		4.81	—
Vested and expected to vest at September 30, 2024	4,856,293	12.75		5.44	—

The weighted average grant date fair value of options granted was $2.95 and $3.53 per share for the nine months ended September 30, 2024 and 2023. There were no proceeds from the exercise of stock options for the nine months ended September 30, 2024 and 2023.

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 and new directors upon their election vest in four equal annual installments. Subsequent annual service RSUs granted to directors vest on the first anniversary of the date of grant. 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. Service RSUs granted to directors provide for accelerated vesting if there is a change in control of the Company.

As of September 30, 2024, $13.9 million of unrecognized compensation costs related to unvested service RSUs are expected to be recognized over a weighted average period of 1.6 years. No RSUs are classified as a liability as of September 30, 2024.

A summary of RSU activity for the Plans for the nine months ended September 30, 2024 is as follows:


	Number of Shares	Weighted Average Grant Date Fair Value
Unvested at December 31, 2023	1,905,310	$	10.87
Granted	1,638,903	4.47
Forfeited	(47,872)	10.15
Vested	(772,645)	11.53
Unvested at September 30, 2024	2,723,696	6.84

The grant date fair value for the 772,645 shares underlying RSUs that vested during the nine months ended September 30, 2024 was $8.9 million.

Stock-Based Compensation Expense

Stock-based compensation expense recognized for the three and nine months ended September 30, 2024 and 2023 was comprised of the following:


	Three Months Ended				Nine Months Ended
(in thousands)	September 30, 2024		September 30, 2023		September 30, 2024		September 30, 2023
Research and development	$	703	$	739	$	2,241	$	2,538
Selling, general and administrative	2,296		2,428		7,328		8,229
Total stock-based compensation expense	$	2,999	$	3,167	$	9,569	$	10,767

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 nine months ended September 30, 2024 and 2023 were as follows:


	Nine Months Ended
	September 30, 2024		September 30, 2023
Expected dividend yield	0	%	0	%
Weighted average expected volatility	50	%	47	%
Weighted average expected term (years)	6.27		6.16
Weighted average risk-free rate	4.52	%	3.89	%

Fair Value Measurements - Narrative (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Assets measured at fair value	$ 275,764	$ 316,211
Cash Equivalents
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Assets measured at fair value	$ 0	$ 63,800

Intangible Assets

9 Months Ended

Sep. 30, 2024

Goodwill and Intangible Assets Disclosure [Abstract]

Intangible Assets

HETLIOZ®. In January 2014, the Company announced that the FDA had approved the 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.

PONVORY®. On December 7, 2023, the Company acquired the U.S. and Canadian rights to PONVORY® from Janssen. The total purchase price was allocated to the acquired intangible asset for the U.S. and Canadian rights to PONVORY®. See Note 3, PONVORY® Acquisition, for additional details. The PONVORY® intangible asset is being amortized on a straight-line basis over the estimated economic useful life of the related product rights. During the first quarter of 2024, the estimated useful life

for the PONVORY® intangible asset was changed from 2035 to 2042 based on a change in the estimated economic useful life of the related product rights.

The following is a summary of the Company’s amortizing intangible assets as of September 30, 2024:


		September 30, 2024
(in thousands)	Estimated Useful Life	Gross Carrying Amount		Accumulated Amortization		Net Carrying Amount
HETLIOZ®	2035	$	33,000	$	17,034	$	15,966

PONVORY®	2042	104,894		5,012		99,882
Total amortizing intangible assets		$	137,894	$	22,046	$	115,848

The following is a summary of the Company’s amortizing intangible assets as of December 31, 2023:


		December 31, 2023
(in thousands)	Estimated Useful Life	Gross Carrying Amount		Accumulated Amortization		Net Carrying Amount
HETLIOZ®	2035	$	33,000	$	15,937	$	17,063

PONVORY®	2035	104,894		588		104,306
Total amortizing intangible assets		$	137,894	$	16,525	$	121,369

As of September 30, 2024 and December 31, 2023, 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 $1.8 million and $0.4 million for the three months ended September 30, 2024 and 2023, respectively. Amortization expense was $5.5 million and $1.1 million for the nine months ended September 30, 2024 and 2023, respectively. The following is a summary of the future intangible asset amortization schedule as of September 30, 2024:


(in thousands)	Total		2024		2025		2026		2027		2028		Thereafter
HETLIOZ®	$	15,966	$	365	$	1,463	$	1,463	$	1,463	$	1,463	$	9,749
PONVORY®	99,882		1,387		5,544		5,544		5,544		5,544		76,319
Total amortizing intangible assets	$	115,848	$	1,752	$	7,007	$	7,007	$	7,007	$	7,007	$	86,068

Commitments and Contingencies - Other Agreements - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions	4 Months Ended
	Dec. 31, 2022	Sep. 30, 2024	Aug. 31, 2024	Apr. 17, 2024	Dec. 31, 2023
Commitments and Contingencies [Line Items]
Number of rights (in shares)				1
Preferred stock, par value (in dollars per share)		$ 0.001			$ 0.001
Lease fixed payments			$ 5.5
Lease, term of contract			3 years
Series A Junior Participating Preferred Stock Purchase Right, par value $0.001 per share
Commitments and Contingencies [Line Items]
Class of warrant or right, number of securities called by each warrant or right (in shares)				0.001
Preferred stock, par value (in dollars per share)				$ 0.001
Exercise price (in dollars per share)				$ 25.00
Ownership acquired percentage				10.00%
OliPass Corporation \| Additional Funding Agreement Terms
Commitments and Contingencies [Line Items]
Consideration for entering into the arrangement	$ 3.0

Accounts Payable and Accrued Liabilities (Tables)

9 Months Ended

Sep. 30, 2024

Payables and Accruals [Abstract]

Schedule of Accounts Payable and Accrued Liabilities

The following is a summary of the Company’s accounts payable and accrued liabilities as of September 30, 2024 and December 31, 2023:


(in thousands)	September 30, 2024		December 31, 2023
Research and development expenses	$	12,861	$	15,691
Consulting and other professional fees	10,013		4,404
Compensation and employee benefits	6,687		6,413
Operating lease liabilities	2,454		2,398
Royalties payable	1,480		2,409

Accounts payable and other accrued liabilities	5,809		7,145
Total accounts payable and accrued liabilities	$	39,304	$	38,460

Fair Value Measurements (Tables)

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Abstract]

Schedule of 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 September 30, 2024, as follows:


			Fair Value Measurement as of September 30, 2024 Using
	Total Fair Value		Quoted Prices in Active Markets for Identical Assets		Significant Other Observable Inputs		Significant Unobservable Inputs
(in thousands)			(Level 1)		(Level 2)		(Level 3)
U.S. Treasury and government agencies	$	173,246	$	173,246	$	—	$	—
Corporate debt	102,518		—		102,518		—

Total assets measured at fair value	$	275,764	$	173,246	$	102,518	$	—

The Company held certain assets that are required to be measured at fair value on a recurring basis as of December 31, 2023, as follows:


			Fair Value Measurement as of December 31, 2023 Using
	Total Fair Value		Quoted Prices in Active Markets for Identical Assets		Significant Other Observable Inputs		Significant Unobservable Inputs
(in thousands)			(Level 1)		(Level 2)		(Level 3)
U.S. Treasury and government agencies	$	209,103	$	209,103	$	—	$	—
Corporate debt	107,108		—		107,108		—

Total assets measured at fair value	$	316,211	$	209,103	$	107,108	$	—

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

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)	September 30, 2024		September 30, 2023
Cash and cash equivalents	$	100,497	$	183,186


Restricted cash included in non-current inventory and other	469		469
Total cash, cash equivalents and restricted cash	$	100,966	$	183,655

Revenue from Net Product Sales

The Company’s net product sales consist of sales of Fanapt®, HETLIOZ® and PONVORY®. Net sales by product for the three and nine months ended September 30, 2024 and 2023 were as follows:


	Three Months Ended				Nine Months Ended
(in thousands)	September 30, 2024		September 30, 2023		September 30, 2024		September 30, 2023
Fanapt® net product sales	$	23,919	$	21,315	$	67,648	$	68,274
HETLIOZ® net product sales	17,870		17,500		56,631		79,095
PONVORY® net product sales	5,862		—		21,308		—
Total net product sales	$	47,651	$	38,815	$	145,587	$	147,369

The Company’s HETLIOZ® net product sales as reported for the three months ended March 31, 2023 reflected 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 at March 31, 2023. During the remainder of 2023, although there was continued destocking at specialty pharmacy customers, inventory levels remained elevated relative to inventory levels prior to the entrance of generic competition and remained elevated at March 31, 2024, June 30, 2024 and September 30, 2024. Going forward, HETLIOZ® net product sales may reflect lower unit sales as a result of reduction of the elevated inventory levels at specialty pharmacy customers or may be variable depending upon when specialty pharmacy customers need to purchase again. Further, HETLIOZ® net product sales will likely decline in future periods, potentially significantly, related to continued generic competition in the U.S. The Company constrained HETLIOZ® net product sales for the three and nine months ended September 30, 2024 and 2023 to an amount not probable of significant revenue reversal. The amount of revenue recognized during the three months ended September 30, 2024 and 2023 related to changes in estimates on revenue constrained during the second quarter of 2024 and 2023 was $0.8 million and $0.3 million, respectively. The amount of revenue recognized during the nine months ended September 30, 2024 related to changes in estimates on revenue constrained during the year ended December 31, 2023 was $1.4 million. HETLIOZ® net product sales could experience variability in future periods as the remaining uncertainties associated with variable consideration related to inventory stocking by specialty pharmacy customers are resolved.

Major Customers

Fanapt® is available in the U.S. for distribution through a limited number of wholesalers and is available in retail pharmacies. HETLIOZ® is available in the United States (U.S.) for distribution through a limited number of specialty pharmacies and is not available in retail pharmacies. PONVORY® is available in the U.S. for distribution primarily through specialty distributors and

specialty pharmacies. The Company invoices and records revenue when its customers, wholesalers, specialty pharmacies and specialty distributors, receive product from the third-party logistics warehouse, which is the point at which control is transferred to the customer. Outside the U.S., the Company has a distribution agreement for the commercialization of Fanapt® in Israel and sells HETLIOZ® in Germany. There were four major customers that each accounted for more than 10% of total revenues and, as a group, represented 68% of total revenues for the nine months ended September 30, 2024. There were four major customers that each accounted for more than 10% of accounts receivable and, as a group, represented 60% of total accounts receivable at September 30, 2024. 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

In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which is intended to provide enhanced segment disclosures. The standard will require disclosures about significant segment expenses and other segment items and identifying the Chief Operating Decision Maker and how they use the reported segment profitability measures to assess segment performance and allocate resources. These enhanced disclosures are required for all entities on an interim and annual basis, even if they have only a single reportable segment. The standard is effective for years beginning after December 15, 2023, and interim periods within annual periods beginning after December 15, 2024 and early adoption is permitted. The Company is evaluating this standard to determine the enhanced disclosures that will be required upon adoption in its Annual Report for the year ending December 31, 2024.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which is intended to provide enhancements to annual income tax disclosures. The standard will require more detailed information in the rate reconciliation table and for income taxes paid, among other enhancements. The standard is effective for years beginning after December 15, 2024 and early adoption is permitted. The Company is evaluating this standard to determine if adoption will have a material impact on the Company’s consolidated financial statements.

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Topic 220-40), which addresses the disaggregation of income statement expenses. This standard is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. The Company is currently evaluating this standard to determine if adoption will have a material impact on the Company's consolidated financial statements.

Intangible Assets - Narrative (Details) - USD ($) $ in Thousands	1 Months Ended		3 Months Ended		9 Months Ended		12 Months Ended	248 Months Ended
	Apr. 30, 2018	Jan. 31, 2014	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2018	Sep. 30, 2024	Dec. 31, 2023
Finite-Lived Intangible Assets [Line Items]
Fully amortized intangible assets			$ 137,894		$ 137,894			$ 137,894	$ 137,894
Fully amortized intangible assets, amortization			22,046		22,046			22,046	16,525
Intangible asset amortization			1,751	$ 380	5,521	$ 1,137
HETLIOZ®
Finite-Lived Intangible Assets [Line Items]
Acquisition of intangible assets		$ 8,000					$ 25,000	37,500
Cumulative worldwide sales milestone	$ 250,000
Fully amortized intangible assets			33,000		33,000			33,000	33,000
Fully amortized intangible assets, amortization			17,034		17,034			17,034	15,937
Fanapt®
Finite-Lived Intangible Assets [Line Items]
Fully amortized intangible assets			27,900		27,900			27,900	27,900
Fully amortized intangible assets, amortization			$ 27,900		$ 27,900			$ 27,900	$ 27,900

Stock-Based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	$ 2,999	$ 3,167	$ 9,569	$ 10,767
Research and development
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	703	739	2,241	2,538
Selling, general and administrative
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	$ 2,296	$ 2,428	$ 7,328	$ 8,229

Summary of Significant Accounting Policies - Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023	Sep. 30, 2023	Dec. 31, 2022
Accounting Policies [Abstract]
Cash and cash equivalents	$ 100,497	$ 135,821	$ 183,186
Restricted cash included in non-current inventory and other	469		469
Total cash, cash equivalents and restricted cash	$ 100,966	$ 136,290	$ 183,655	$ 135,498

Inventory - Schedule of Inventory (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets
Work-in-process	$ 52	$ 27
Finished goods	1,562	1,330
Total inventory, current	1,614	1,357
Non-Current assets
Raw materials	934	934
Work-in-process	6,496	7,177
Finished goods	494	737
Total inventory, non-current	7,924	8,848
Total inventory	$ 9,538	$ 10,205

Inventory (Tables)

9 Months Ended

Sep. 30, 2024

Inventory Disclosure [Abstract]

Schedule of Inventory

Inventory consisted of the following as of September 30, 2024 and December 31, 2023:


(in thousands)	September 30, 2024		December 31, 2023
Current assets
Work-in-process	$	52	$	27
Finished goods	1,562		1,330
Total inventory, current	$	1,614	$	1,357
Non-Current assets
Raw materials	$	934	$	934
Work-in-process	6,496		7,177
Finished goods	494		737
Total inventory, non-current	7,924		8,848
Total inventory	$	9,538	$	10,205

Fair Value Measurements

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Abstract]

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 September 30, 2024 and December 31, 2023 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 September 30, 2024, as follows:


			Fair Value Measurement as of September 30, 2024 Using
	Total Fair Value		Quoted Prices in Active Markets for Identical Assets		Significant Other Observable Inputs		Significant Unobservable Inputs
(in thousands)			(Level 1)		(Level 2)		(Level 3)
U.S. Treasury and government agencies	$	173,246	$	173,246	$	—	$	—
Corporate debt	102,518		—		102,518		—

Total assets measured at fair value	$	275,764	$	173,246	$	102,518	$	—

The Company held certain assets that are required to be measured at fair value on a recurring basis as of December 31, 2023, as follows:


			Fair Value Measurement as of December 31, 2023 Using
	Total Fair Value		Quoted Prices in Active Markets for Identical Assets		Significant Other Observable Inputs		Significant Unobservable Inputs
(in thousands)			(Level 1)		(Level 2)		(Level 3)
U.S. Treasury and government agencies	$	209,103	$	209,103	$	—	$	—
Corporate debt	107,108		—		107,108		—

Total assets measured at fair value	$	316,211	$	209,103	$	107,108	$	—

Total assets measured at fair value as of September 30, 2024 include no cash equivalents. Total assets measured at fair value as of December 31, 2023 include $63.8 million 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.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Accumulated Other Comprehensive Income (Loss) (Tables)

9 Months Ended

Sep. 30, 2024

Equity [Abstract]

Schedule of Accumulated Balances Related to Each Component of Other Comprehensive Income (Loss)

The accumulated balances related to each component of other comprehensive income (loss), net of taxes, were as follows as of September 30, 2024 and December 31, 2023:


(in thousands)	September 30, 2024		December 31, 2023
Foreign currency translation	$	35	$	21
Unrealized gain (loss) on marketable securities	667		(51)
Accumulated other comprehensive income (loss)	$	702	$	(30)

Commitments and Contingencies - Fanapt - Narrative (Details) - Fanapt®		60 Months Ended
	Dec. 31, 2014	Dec. 31, 2019
Commitments and Contingencies [Line Items]
Royalty payable percentage on net sales	6.00%	3.00%
Royalty payment period	10 years

Stock-Based Compensation - Restricted Stock Units - Narrative (Details) $ in Millions	9 Months Ended
	Sep. 30, 2024 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 \| $	$ 13.9
Unrecognized compensation expenses, weighted average period	1 year 7 months 6 days
Grant date fair value of common stock granted (in shares) \| shares	772,645
Grant date fair value of common stock vested \| $	$ 8.9

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure
Net income (loss)	$ (5,324)	$ (4,518)	$ (4,146)	$ 137	$ 1,520	$ 3,252	$ (13,988)	$ 4,909

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
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)	58,306,144	57,534,499
Common stock, shares outstanding (in shares)	58,306,144	57,534,499

Commitments and Contingencies - CFTR Activators and Inhibitors - Narrative (Details) - CFTR Activators and Inhibitors - USD ($) $ in Millions	9 Months Ended	91 Months Ended
	Sep. 30, 2024	Sep. 30, 2024
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	33.0
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

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Revenues:
Net product sales	$ 47,651	$ 38,815	$ 145,587	$ 147,369
Total revenues	47,651	38,815	145,587	147,369
Operating expenses:
Cost of goods sold excluding amortization	2,551	3,063	8,724	11,336
Research and development	16,776	16,600	54,591	52,484
Selling, general and administrative	37,573	24,767	107,132	89,270
Intangible asset amortization	1,751	380	5,521	1,137
Total operating expenses	58,651	44,810	175,968	154,227
Loss from operations	(11,000)	(5,995)	(30,381)	(6,858)
Other income	4,756	5,875	13,957	14,858
Income (loss) before income taxes	(6,244)	(120)	(16,424)	8,000
Provision (benefit) for income taxes	(920)	(257)	(2,436)	3,091
Net income (loss)	$ (5,324)	$ 137	$ (13,988)	$ 4,909
Net income (loss) per share:
Basic (in dollars per share)	$ (0.09)	$ 0.00	$ (0.24)	$ 0.09
Diluted (in dollars per share)	$ (0.09)	$ 0.00	$ (0.24)	$ 0.09
Weighted average shares outstanding:
Basic (in shares)	58,261,961	57,519,031	58,095,566	57,329,969
Diluted (in shares)	58,261,961	57,595,344	58,095,566	57,512,225

Accounts Payable and Accrued Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Payables and Accruals [Abstract]
Research and development expenses	$ 12,861	$ 15,691
Consulting and other professional fees	10,013	4,404
Compensation and employee benefits	6,687	6,413
Operating lease liabilities	2,454	2,398
Royalties payable	1,480	2,409
Accounts payable and other accrued liabilities	5,809	7,145
Total accounts payable and accrued liabilities	$ 39,304	$ 38,460

Stock-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2024

Share-Based Payment Arrangement [Abstract]

Schedule of Option Activity

A summary of option activity under the Plans for the nine months ended September 30, 2024 follows:


(in thousands, except for share and per share amounts)	Number of Shares	Weighted Average Exercise Price at Grant Date		Weighted Average Remaining Term (Years)	Aggregate Intrinsic Value
Outstanding at December 31, 2023	4,792,506	$	12.95	6.00	$	—
Granted	190,514	5.41

Expired	(58,253)	11.39

Outstanding at September 30, 2024	4,924,767	12.67		5.48	—
Exercisable at September 30, 2024	3,973,865	13.65		4.81	—
Vested and expected to vest at September 30, 2024	4,856,293	12.75		5.44	—

Schedule of RSU Activity

A summary of RSU activity for the Plans for the nine months ended September 30, 2024 is as follows:


	Number of Shares	Weighted Average Grant Date Fair Value
Unvested at December 31, 2023	1,905,310	$	10.87
Granted	1,638,903	4.47
Forfeited	(47,872)	10.15
Vested	(772,645)	11.53
Unvested at September 30, 2024	2,723,696	6.84

Schedule of Stock-Based Compensation Expense

Stock-based compensation expense recognized for the three and nine months ended September 30, 2024 and 2023 was comprised of the following:


	Three Months Ended				Nine Months Ended
(in thousands)	September 30, 2024		September 30, 2023		September 30, 2024		September 30, 2023
Research and development	$	703	$	739	$	2,241	$	2,538
Selling, general and administrative	2,296		2,428		7,328		8,229
Total stock-based compensation expense	$	2,999	$	3,167	$	9,569	$	10,767

Schedule of 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 nine months ended September 30, 2024 and 2023 were as follows:


	Nine Months Ended
	September 30, 2024		September 30, 2023
Expected dividend yield	0	%	0	%
Weighted average expected volatility	50	%	47	%
Weighted average expected term (years)	6.27		6.16
Weighted average risk-free rate	4.52	%	3.89	%

Income Taxes (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Income Taxes (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Income Tax Disclosure [Abstract]
Income tax (benefit) provision	$ (920)	$ (257)	$ (2,436)	$ 3,091
Discrete income tax expense	$ 200	$ 200	$ 1,000	$ 2,100

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References + Details

Summary of Significant Accounting Policies - Major Customers - Narrative (Details) - USD ($) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024
Summary Of Significant Accounting Policies [Line Items]
Amount of net product sales recognized related to a change in estimate	$ 0.8	$ 0.3	$ 1.4
Customer Concentration Risk \| Sales Revenue, Net \| Four Major Customers
Summary Of Significant Accounting Policies [Line Items]
Concentration risk, percentage			68.00%
Credit Concentration Risk \| Accounts Receivable \| Four Major Customers
Summary Of Significant Accounting Policies [Line Items]
Concentration risk, percentage			60.00%

Commitments and Contingencies - Tradipitant - Narrative (Details) - Tradipitant - USD ($) $ in Millions	9 Months Ended	12 Months Ended	150 Months Ended
	Sep. 30, 2024	Dec. 31, 2023	Sep. 30, 2024
Commitments and Contingencies [Line Items]
Future percentage of royalty payments based net sales	low double digits
Development and milestone obligations paid to third party			$ 5.0
Pre-NDA Approval Milestones
Commitments and Contingencies [Line Items]
Development and milestone obligations paid to third party		$ 2.0
Regulatory Approval Milestone \| U.S.
Commitments and Contingencies [Line Items]
Possible future milestone payment	$ 10.0
Regulatory Approval Milestone \| E.U.
Commitments and Contingencies [Line Items]
Possible future milestone payment	5.0
Sales Milestone
Commitments and Contingencies [Line Items]
Possible future milestone payment	$ 80.0

Cover - shares	9 Months Ended
Cover - shares	Sep. 30, 2024	Oct. 31, 2024
Document Information [Line Items]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2024
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
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		58,308,144
Entity Central Index Key	0001347178
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
Amendment Flag	false
Common Stock, par value $0.001 per share
Document Information [Line Items]
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	VNDA
Security Exchange Name	NASDAQ
Series A Junior Participating Preferred Stock Purchase Right, par value $0.001 per share
Document Information [Line Items]
Title of 12(b) Security	Series A Junior Participating Preferred Stock Purchase Right, par value $0.001 per share
No Trading Symbol Flag	true
Security Exchange Name	NASDAQ

Earnings per Share

9 Months Ended

Sep. 30, 2024

Earnings Per Share [Abstract]

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, as calculated using the treasury stock method.

The following table presents the calculation of basic and diluted net income (loss) per share of common stock for the three and nine months ended September 30, 2024 and 2023:


	Three Months Ended				Nine Months Ended
(in thousands, except for share and per share amounts)	September 30, 2024		September 30, 2023		September 30, 2024		September 30, 2023
Numerator:
Net income (loss)	$	(5,324)	$	137	$	(13,988)	$	4,909
Denominator:
Weighted average shares outstanding, basic	58,261,961		57,519,031		58,095,566		57,329,969
Effect of dilutive securities	—		76,313		—		182,256
Weighted average shares outstanding, diluted	58,261,961		57,595,344		58,095,566		57,512,225
Net income (loss) per share, basic and diluted:
Basic	$	(0.09)	$	0.00	$	(0.24)	$	0.09
Diluted	$	(0.09)	$	0.00	$	(0.24)	$	0.09
Antidilutive securities excluded from calculations of diluted net income (loss) per share	6,383,154		6,724,127		6,603,367		6,526,562

The Company incurred a net loss for the three and nine months ended September 30, 2024 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.

Commitments and Contingencies	9 Months Ended
Commitments and Contingencies	Sep. 30, 2024
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. 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. 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 September 30, 2024, 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 7, 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 decreased from 10% to 5% in December 2022. This U.S. royalty ended 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®. 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 September 30, 2024, the Company has paid Lilly $5.0 million in upfront fees and development milestones. These payments for upfront fees and development milestones include a $2.0 million milestone paid to Lilly during the year ended December 31, 2023 for the filing of the first application for marketing authorization for tradipitant in either the U.S. or European Union (E.U.). As of September 30, 2024, remaining milestone obligations include $10.0 million and $5.0 million milestones 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, 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 September 30, 2024, the Company has paid UCSF $1.6 million in upfront fees and development milestones. As of September 30, 2024, 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 Olipass. 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 in 2022. The Company is funding the research and development activities and has the option to license jointly developed intellectual property upon successful development. Shareholder Rights Plan. On April 17, 2024, the Company’s board of directors authorized and declared a dividend distribution of one right (each, a Right) for each outstanding share of common stock of the Company to stockholders of record as of the close of business on April 29, 2024 (the Record Date). Each Right entitles the registered holder to purchase from the Company, subject to certain conditions which have not yet occurred, one one-thousandth of a share of Series A Junior Participating Preferred Stock, par value $0.001 per share (the Preferred Stock), of the Company at an exercise price of $25.00 (the Exercise Price), subject to adjustment. The complete terms of the Rights are set forth in a Rights Agreement, dated as of April 17, 2024, between the Company and Equiniti Trust Company, LLC, as rights agent (the Rights Agent), as amended by that certain Amendment No. 1 to the Rights Agreement, and that certain Amendment No. 2 to the Rights Agreement, each, by and between the Company and the Rights Agent (as amended, the Rights Agreement). In general terms, subject to certain enumerated exceptions, the Rights Agreement works by imposing a significant penalty upon any person or group that acquires beneficial ownership of 10% or more of the shares of common stock without the prior approval of the board of directors. In general, any person will be deemed to beneficially own any securities (a) as to which such person has any agreement, arrangement or understanding with another person for the purpose of acquiring, holding, voting or disposing of any shares of Common Stock or (b) that are the subject of a derivative transaction or constitute a derivative security. As a result, the overall effect of the Rights Agreement and the issuance of the Rights may be to render more difficult or discourage a merger, tender or exchange offer or other business combination involving the Company that is not approved by the board of directors. However, neither the Rights Agreement nor the Rights should interfere with any merger, tender or exchange offer or other business combination approved by the board of directors. Lease Agreements. In August 2024, the Company entered into a master lease agreement for vehicles to be utilized by the Company's sales force. As of September 30, 2024, none of the individual vehicle leases had been executed, none of the vehicles had been delivered, and no amounts have been paid pertaining to the vehicle leases. The individual car leases will commence upon delivery of the vehicles, which is expected to begin in the fourth quarter of 2024. Total fixed payments under this contract are estimated to total $5.5 million, payable over initial terms of three years, and subject to change upon finalization of each vehicle lease contract. For further information regarding the Company's lease agreements, see Note 8, Leases, to the condensed consolidated financial statements included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023. 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 primarily relate to commitments for data services. 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.

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Sep. 30, 2024
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

Stock-Based Compensation - Narrative (Details)	Sep. 30, 2024 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)	7,648,463
2016 Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of shares of common stock authorized for issuance (in shares)	15,690,000
Number of shares of common stock available for future grant (in shares)	4,655,745

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash flows from operating activities
Net income (loss)	$ (13,988)	$ 4,909
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
Depreciation of property and equipment	638	715
Stock-based compensation	9,569	10,767
Amortization of premiums and accretion of discounts on marketable securities	(5,479)	(7,053)
Loss on sale of marketable securities	0	655
Intangible asset amortization	5,521	1,137
Deferred income taxes	(4,568)	6,198
Other non-cash adjustments, net	1,643	2,772
Changes in operating assets and liabilities:
Accounts receivable	(8,581)	4,129
Prepaid expenses and other assets	(3,179)	1,333
Inventory	78	(344)
Accounts payable and other liabilities	3,835	(14,315)
Product revenue allowances	571	5,630
Net cash provided by (used in) operating activities	(13,940)	16,533
Cash flows from investing activities
Asset acquisition	(4,229)	0
Purchases of property and equipment	(276)	(130)
Purchases of marketable securities	(272,369)	(457,628)
Sales and maturities of marketable securities	255,451	489,485
Net cash provided by (used in) investing activities	(21,423)	31,727
Effect of exchange rate changes on cash, cash equivalents and restricted cash	39	(103)
Net change in cash, cash equivalents and restricted cash	(35,324)	48,157
Cash, cash equivalents and restricted cash
Beginning of period	136,290	135,498
End of period	$ 100,966	$ 183,655

Commitments and Contingencies - HETLIOZ - Narrative (Details) - HETLIOZ® - USD ($)	1 Months Ended		9 Months Ended	11 Months Ended	12 Months Ended	248 Months Ended
	Dec. 31, 2022	Jan. 31, 2014	Sep. 30, 2024	Nov. 30, 2022	Dec. 31, 2018	Sep. 30, 2024
Commitments and Contingencies [Line Items]
Acquisition of intangible assets		$ 8,000,000.0			$ 25,000,000.0	$ 37,500,000
Intangible assets capitalized						$ 33,000,000.0
Possible future milestone payment			$ 0
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			5.00%
U.S.
Commitments and Contingencies [Line Items]
Royalty payable percentage on net sales	5.00%			10.00%

Stock-Based Compensation - Stock Option - Narrative (Details)	9 Months Ended
	Sep. 30, 2024 USD ($) installment $ / shares	Sep. 30, 2023 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	25.00%
Portion of initial stock options granted to employees and new directors that vests ratably over three years after completion of first year of service	75.00%
Number of vesting equal installments \| installment	36
Options granted, weighted average fair value per share (in dollars per share) \| $ / shares	$ 2.95	$ 3.53
Proceeds from exercise of 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	$ 3,800,000
Unrecognized compensation expenses, weighted average period	10 months 24 days

Intangible Assets - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Finite-Lived Intangible Assets [Line Items]
Gross Carrying Amount	$ 137,894	$ 137,894
Accumulated Amortization	22,046	16,525
Net Carrying Amount	115,848	121,369
HETLIOZ®
Finite-Lived Intangible Assets [Line Items]
Gross Carrying Amount	33,000	33,000
Accumulated Amortization	17,034	15,937
Net Carrying Amount	15,966	17,063
PONVORY®
Finite-Lived Intangible Assets [Line Items]
Gross Carrying Amount	104,894	104,894
Accumulated Amortization	5,012	588
Net Carrying Amount	$ 99,882	$ 104,306

Summary of Significant Accounting Policies - Schedule of Net Product Sales (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Revenue from External Customer [Line Items]
Total net product sales	$ 47,651	$ 38,815	$ 145,587	$ 147,369
Fanapt® net product sales
Revenue from External Customer [Line Items]
Total net product sales	23,919	21,315	67,648	68,274
HETLIOZ® net product sales
Revenue from External Customer [Line Items]
Total net product sales	17,870	17,500	56,631	79,095
PONVORY® net product sales
Revenue from External Customer [Line Items]
Total net product sales	$ 5,862	$ 0	$ 21,308	$ 0

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 924
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 11.L)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479941/924-10-S99-1

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
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-Section 50
-Paragraph 5
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-URI https://asc.fasb.org//1943274/2147479806/606-10-50-5

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
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-Paragraph 30
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-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-30

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
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-Name Accounting Standards Codification
-Section 50
-Paragraph 42
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-42

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Section 50
-Paragraph 22
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-22

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
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-Name Accounting Standards Codification
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-Paragraph 32
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-32

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
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-Name Accounting Standards Codification
-Section 50
-Paragraph 40
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-40

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
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-Name Accounting Standards Codification
-Section 50
-Paragraph 22
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-22

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-32

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
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-Name Accounting Standards Codification
-Section 50
-Paragraph 41
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-41

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
-Paragraph 4
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479806/606-10-50-4

+ Details

Earnings per Share (Tables)

9 Months Ended

Sep. 30, 2024

Earnings Per Share [Abstract]

Schedule of 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 and nine months ended September 30, 2024 and 2023:


	Three Months Ended				Nine Months Ended
(in thousands, except for share and per share amounts)	September 30, 2024		September 30, 2023		September 30, 2024		September 30, 2023
Numerator:
Net income (loss)	$	(5,324)	$	137	$	(13,988)	$	4,909
Denominator:
Weighted average shares outstanding, basic	58,261,961		57,519,031		58,095,566		57,329,969
Effect of dilutive securities	—		76,313		—		182,256
Weighted average shares outstanding, diluted	58,261,961		57,595,344		58,095,566		57,512,225
Net income (loss) per share, basic and diluted:
Basic	$	(0.09)	$	0.00	$	(0.24)	$	0.09
Diluted	$	(0.09)	$	0.00	$	(0.24)	$	0.09
Antidilutive securities excluded from calculations of diluted net income (loss) per share	6,383,154		6,724,127		6,603,367		6,526,562

CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 100,497	$ 135,821
Marketable securities	275,764	252,443
Accounts receivable, net	42,753	34,155
Inventory	1,614	1,357
Prepaid expenses and other current assets	11,759	9,170
Total current assets	432,387	432,946
Property and equipment, net	2,178	2,037
Operating lease right-of-use assets	6,016	7,103
Intangible assets, net	115,848	121,369
Deferred tax assets	79,363	75,000
Non-current inventory and other	9,323	9,985
Total assets	645,115	648,440
Current liabilities:
Accounts payable and accrued liabilities	39,304	38,460
Product revenue allowances	49,786	49,237
Total current liabilities	89,090	87,697
Operating lease non-current liabilities	5,486	7,006
Other non-current liabilities	9,316	8,827
Total liabilities	103,892	103,530
Commitments and contingencies (Notes 9 and 14)
Stockholders’ equity:
Preferred stock, $0.001 par value; 20,000,000 shares authorized, and no shares issued or outstanding at September 30, 2024 and December 31, 2023	0	0
Common stock, $0.001 par value; 150,000,000 shares authorized; 58,306,144 and 57,534,499 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively	58	58
Additional paid-in capital	709,843	700,274
Accumulated other comprehensive income (loss)	702	(30)
Accumulated deficit	(169,380)	(155,392)
Total stockholders’ equity	541,223	544,910
Total liabilities and stockholders’ equity	$ 645,115	$ 648,440

Inventory - Narrative (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Inventory [Line Items]
Inventory	$ 9,538	$ 10,205
Fanapt®
Inventory [Line Items]
Inventory	2,100	3,000
HETLIOZ®
Inventory [Line Items]
Inventory	$ 7,300	$ 7,200

PONVORY® Acquisition (Details) $ in Millions	Dec. 07, 2023 USD ($)
PONVORY Acquisition
Asset Acquisition [Line Items]
Total consideration	$ 104.9

Intangible Assets - Schedule of Future Intangible Asset Amortization (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Finite-Lived Intangible Assets [Line Items]
Net Carrying Amount	$ 115,848	$ 121,369
2024	1,752
2025	7,007
2026	7,007
2027	7,007
2028	7,007
Thereafter	86,068
HETLIOZ®
Finite-Lived Intangible Assets [Line Items]
Net Carrying Amount	15,966	17,063
2024	365
2025	1,463
2026	1,463
2027	1,463
2028	1,463
Thereafter	9,749
PONVORY®
Finite-Lived Intangible Assets [Line Items]
Net Carrying Amount	99,882	$ 104,306
2024	1,387
2025	5,544
2026	5,544
2027	5,544
2028	5,544
Thereafter	$ 76,319

Inventory

9 Months Ended

Sep. 30, 2024

Inventory Disclosure [Abstract]

Inventory

Inventory consisted of the following as of September 30, 2024 and December 31, 2023:


(in thousands)	September 30, 2024		December 31, 2023
Current assets
Work-in-process	$	52	$	27
Finished goods	1,562		1,330
Total inventory, current	$	1,614	$	1,357
Non-Current assets
Raw materials	$	934	$	934
Work-in-process	6,496		7,177
Finished goods	494		737
Total inventory, non-current	7,924		8,848
Total inventory	$	9,538	$	10,205

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 the risk of excess inventory and product expiry by evaluating current and future product demand relative to product shelf life, taking into account all possible alternative uses for the inventory available in the ordinary course of business. 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 included $2.1 million and $3.0 million of Fanapt® product and $7.3 million and $7.2 million of HETLIOZ® product as of September 30, 2024 and December 31, 2023, respectively.

Commitments and Contingencies - VQW-765 - Narrative (Details)	9 Months Ended
	Sep. 30, 2024
VQW-765
Commitments and Contingencies [Line Items]
Future percentage of royalty payments based net sales	mid-teens

Stock-Based Compensation - Schedule of Option Activity (Details) - 2006 Plan and 2016 Plan - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Number of Shares
Beginning balance (in shares)	4,792,506
Granted (in shares)	190,514
Expired (in shares)	(58,253)
Ending balance (in shares)	4,924,767	4,792,506
Exercisable at end of period (in shares)	3,973,865
Vested and expected to vest at end of period (in shares)	4,856,293
Weighted Average Exercise Price at Grant Date
Beginning balance (in dollars per share)	$ 12.95
Granted (in dollars per share)	5.41
Expired (in dollars per share)	11.39
Ending balance (in dollars per share)	12.67	$ 12.95
Exercisable at end of period (in dollars per share)	13.65
Vested and expected to vest at end of period (in dollars per share)	$ 12.75
Weighted Average Remaining Term (Years)
Outstanding	5 years 5 months 23 days	6 years
Exercisable at end of period	4 years 9 months 21 days
Vested and expected to vest at end of period	5 years 5 months 8 days
Aggregate Intrinsic Value
Beginning balance	$ 0
Ending balance	0	$ 0
Exercisable at end of period	0
Vested and expected to vest at end of period	$ 0

Marketable Securities (Tables)

9 Months Ended

Sep. 30, 2024

Investments, Debt and Equity Securities [Abstract]

Schedule of Available-for-Sale Marketable Securities

The following is a summary of the Company’s available-for-sale marketable securities as of September 30, 2024, which all have contractual maturities of less than two years:


	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Fair Market Value
(in thousands)
U.S. Treasury and government agencies	$	172,505	$	797	$	(56)	$	173,246
Corporate debt	102,412		108		(2)		102,518

Total marketable securities	$	274,917	$	905	$	(58)	$	275,764

The following is a summary of the Company’s available-for-sale marketable securities as of December 31, 2023, which all have contractual maturities of less than two years:


	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Fair Market Value
(in thousands)
U.S. Treasury and government agencies	$	185,168	$	227	$	(280)	$	185,115
Corporate debt	67,352		2		(26)		67,328

Total marketable securities	$	252,520	$	229	$	(306)	$	252,443

- Definition

Tabular disclosure of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale).

+ References

Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481800/320-10-50-9

Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
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-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481800/320-10-50-3

Reference 3: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
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-Name Accounting Standards Codification
-Section 50
-Paragraph 2
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-URI https://asc.fasb.org//1943274/2147481800/320-10-50-2

Reference 4: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
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-Name Accounting Standards Codification
-Section 50
-Paragraph 2
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-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481800/320-10-50-2

Reference 5: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
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-Section 50
-Paragraph 2
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-URI https://asc.fasb.org//1943274/2147481800/320-10-50-2

Reference 6: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 7: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 8: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
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-URI https://asc.fasb.org//1943274/2147481800/320-10-50-3

+ Details

Marketable Securities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Debt Securities, Available-for-sale [Line Items]
Amortized Cost	$ 274,917	$ 252,520
Gross Unrealized Gains	905	229
Gross Unrealized Losses	(58)	(306)
Fair Market Value	275,764	252,443
U.S. Treasury and government agencies
Debt Securities, Available-for-sale [Line Items]
Amortized Cost	172,505	185,168
Gross Unrealized Gains	797	227
Gross Unrealized Losses	(56)	(280)
Fair Market Value	173,246	185,115
Corporate debt
Debt Securities, Available-for-sale [Line Items]
Amortized Cost	102,412	67,352
Gross Unrealized Gains	108	2
Gross Unrealized Losses	(2)	(26)
Fair Market Value	$ 102,518	$ 67,328

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
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-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481800/320-10-50-2

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+ Details

Fair Value Measurements - Schedule of Assets Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total assets measured at fair value	$ 275,764	$ 316,211
U.S. Treasury and government agencies
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total assets measured at fair value	173,246	209,103
Corporate debt
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total assets measured at fair value	102,518	107,108
Quoted Prices in Active Markets for Identical Assets (Level 1)
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total assets measured at fair value	173,246	209,103
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]
Total assets measured at fair value	173,246	209,103
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]
Total 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]
Total assets measured at fair value	102,518	107,108
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]
Total 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]
Total assets measured at fair value	102,518	107,108
Significant Unobservable Inputs (Level 3)
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total 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]
Total 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]
Total assets measured at fair value	$ 0	$ 0

Business Organization and Presentation	9 Months Ended
Business Organization and Presentation	Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Business Organization and Presentation	Business Organization and Presentation Business Organization Vanda Pharmaceuticals Inc. (the Company or Vanda) 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 three products, Fanapt® for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the treatment of schizophrenia, HETLIOZ® for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) and for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS), and PONVORY® for the treatment of relapsing forms of multiple sclerosis (MS) to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, in adults. HETLIOZ® is the first product approved by the United States Food and Drug Administration (FDA) for patients with Non-24 and for patients with SMS. In addition, the Company has a number of drugs in development, including: •Milsaperidone (VHX-896), the active metabolite of Fanapt® (iloperidone), for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia and major depressive disorder; •Fanapt® (iloperidone) long acting injectable (LAI) formulation for the treatment of schizophrenia; •HETLIOZ® (tasimelteon) for the treatment of jet lag disorder, insomnia, pediatric insomnia, delayed sleep phase disorder (DSPD) and pediatric Non-24; •PONVORY® (ponesimod) for the treatment of psoriasis and ulcerative colitis; •Tradipitant (VLY-686), a small molecule neurokinin-1 (NK-1) receptor antagonist, for the treatment of gastroparesis, motion sickness and atopic dermatitis; •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; •VTR-297, a small molecule histone deacetylase (HDAC) inhibitor for the treatment of onychomycosis and hematologic malignancies and with potential use as a treatment for several oncology indications; •VQW-765, a small molecule nicotinic acetylcholine receptor partial agonist, for the treatment of social/performance anxiety and psychiatric disorders; and •Antisense oligonucleotide (ASO) molecules, including VCA-894A for the treatment of Charcot-Marie-Tooth Disease, Type 2S (CMT2S), caused by cryptic slice site variants within the IGHMBP2 gene. Basis of Presentation The accompanying unaudited condensed consolidated financial statements include 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, 2023. The financial information as of September 30, 2024 and for the three and nine months ended September 30, 2024 and 2023 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, 2023 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.

Stock-Based Compensation - Schedule of Black-Scholes-Merton Option Pricing Model for Employee and Director Stock Options Granted (Details)	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Share-Based Payment Arrangement [Abstract]
Expected dividend yield	0.00%	0.00%
Weighted average expected volatility	50.00%	47.00%
Weighted average expected term (years)	6 years 3 months 7 days	6 years 1 month 28 days
Weighted average risk-free rate	4.52%	3.89%

Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash


(in thousands)	September 30, 2024		September 30, 2023
Cash and cash equivalents	$	100,497	$	183,186


Restricted cash included in non-current inventory and other	469		469
Total cash, cash equivalents and restricted cash	$	100,966	$	183,655

Schedule of Net Product Sales

Net sales by product for the three and nine months ended September 30, 2024 and 2023 were as follows:


	Three Months Ended				Nine Months Ended
(in thousands)	September 30, 2024		September 30, 2023		September 30, 2024		September 30, 2023
Fanapt® net product sales	$	23,919	$	21,315	$	67,648	$	68,274
HETLIOZ® net product sales	17,870		17,500		56,631		79,095
PONVORY® net product sales	5,862		—		21,308		—
Total net product sales	$	47,651	$	38,815	$	145,587	$	147,369

Income Taxes	9 Months Ended
Income Taxes	Sep. 30, 2024
Income Tax Disclosure [Abstract]
Income Taxes	Income Taxes For the three months ended September 30, 2024 and 2023, the Company recorded an income tax benefit of $0.9 million and $0.3 million, respectively. The income tax benefit for the three months ended September 30, 2024 and 2023 was primarily driven by the estimated effective tax rate for the year, as well as discrete income tax expense of $0.2 million. For the nine months ended September 30, 2024 and 2023, the Company recorded an income tax benefit of $2.4 million and a provision for income taxes of $3.1 million, respectively. The income tax expense (benefit) for the nine months ended September 30, 2024 and 2023 was primarily driven by the estimated effective tax rate for the year, as well as discrete income tax expense of $1.0 million and $2.1 million, respectively. The Company assesses the need for a valuation allowance against its deferred tax asset each quarter through the review of all available positive and negative evidence. Deferred tax assets are reduced by a tax valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. The analysis is highly dependent upon historical and projected pretax income. As of September 30, 2024, after considering all available positive and negative evidence, including but not limited to cumulative income in recent periods, historical, current and future projected results and significant risks and uncertainties related to forecasts, the Company concluded, consistent with prior periods, that it was more likely than not that substantially all of its deferred tax assets in the U.S. are realizable in future periods. The Company maintains a valuation allowance against certain state net deferred tax assets. The Company generated a pretax loss for the nine months ended September 30, 2024. If the Company continues to generate pretax losses and if the Company's projections indicate pretax losses in future periods, the conclusion about the appropriateness of the valuation allowance could change in a future period. An increase in the valuation allowance would result in a non-cash income tax expense during the period of change. The potential timing and amount of any future valuation allowance has yet to be determined and requires an analysis that is highly dependent upon historical and future projected earnings, among other factors. Any such adjustment could have a material impact on the Company’s results of operations but not a material impact on the Company's cash position.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
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+ Details

Intangible Assets (Tables)

9 Months Ended

Sep. 30, 2024

Goodwill and Intangible Assets Disclosure [Abstract]

Schedule of Intangible Assets

The following is a summary of the Company’s amortizing intangible assets as of September 30, 2024:


		September 30, 2024
(in thousands)	Estimated Useful Life	Gross Carrying Amount		Accumulated Amortization		Net Carrying Amount
HETLIOZ®	2035	$	33,000	$	17,034	$	15,966

PONVORY®	2042	104,894		5,012		99,882
Total amortizing intangible assets		$	137,894	$	22,046	$	115,848

The following is a summary of the Company’s amortizing intangible assets as of December 31, 2023:


		December 31, 2023
(in thousands)	Estimated Useful Life	Gross Carrying Amount		Accumulated Amortization		Net Carrying Amount
HETLIOZ®	2035	$	33,000	$	15,937	$	17,063

PONVORY®	2035	104,894		588		104,306
Total amortizing intangible assets		$	137,894	$	16,525	$	121,369

Schedule of Future Intangible Asset Amortization

The following is a summary of the future intangible asset amortization schedule as of September 30, 2024:


(in thousands)	Total		2024		2025		2026		2027		2028		Thereafter
HETLIOZ®	$	15,966	$	365	$	1,463	$	1,463	$	1,463	$	1,463	$	9,749
PONVORY®	99,882		1,387		5,544		5,544		5,544		5,544		76,319
Total amortizing intangible assets	$	115,848	$	1,752	$	7,007	$	7,007	$	7,007	$	7,007	$	86,068

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Statement of Comprehensive Income [Abstract]
Net income (loss)	$ (5,324)	$ 137	$ (13,988)	$ 4,909
Other comprehensive income (loss):
Net foreign currency translation gain (loss)	36	(18)	14	(6)
Change in net unrealized gain (loss) on marketable securities	1,283	(109)	924	301
Tax benefit (provision) on other comprehensive income (loss)	(287)	25	(206)	(69)
Other comprehensive income (loss), net of tax	1,032	(102)	732	226
Comprehensive income (loss)	$ (4,292)	$ 35	$ (13,256)	$ 5,135

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

- Definition

Amount after tax and reclassification adjustments of other comprehensive income (loss).

+ References

+ Details

- Definition

Amount of tax expense (benefit) allocated to other comprehensive income (loss).

+ References

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+ Details

PONVORY® Acquisition	9 Months Ended
PONVORY® Acquisition	Sep. 30, 2024
Business Combination and Asset Acquisition [Abstract]
PONVORY® Acquisition	PONVORY® Acquisition On December 7, 2023, the Company entered into an Asset Purchase Agreement (the Purchase Agreement) to acquire the U.S. and Canadian rights to PONVORY® from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company, and the closing of the transaction took place simultaneously with signing. PONVORY® is a once-daily oral selective sphingosine-1-phosphate receptor 1 modulator, indicated to treat adults with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The total consideration for the acquisition was $104.9 million consisting of cash paid to Janssen and acquisition-related transaction costs. The Purchase Agreement includes customary representations, warranties and covenants, as well as standard mutual indemnities covering losses arising from any material breach of the Purchase Agreement or inaccuracy of representations and warranties. Janssen has agreed to indemnify the Company against losses arising from its activities prior to the closing, and the Company has agreed to indemnify Janssen against losses arising from the Company’s activities pertaining to PONVORY® after the closing. Simultaneously and in connection with the Purchase Agreement, the parties also entered into certain supporting agreements, including a customary transition agreement, pursuant to which, during a transition period, Janssen will continue PONVORY® operations. The Company announced in May 2024 that ownership of the U.S. New Drug Application (NDA) and Investigational New Drug applications for PONVORY® had been transferred to Vanda from a Johnson & Johnson Company, fully allowing the Company to commercialize PONVORY® in the U.S. The acquisition of PONVORY® has been accounted for as an asset acquisition in accordance with ASC 805-50 because substantially all of the fair value of the assets acquired is concentrated in a single asset, the PONVORY® product rights. The PONVORY® products rights consist of certain patents and trademarks, regulatory approvals, marketing assets, and other records, and are considered a single asset as they are inextricably linked. The total consideration of $104.9 million was fully allocated to the acquired intangible asset for the U.S. and Canadian rights to PONVORY®. The straight-line method is used to amortize the intangible asset, as disclosed in Note 7, Intangible Assets.

Accumulated Other Comprehensive Income (Loss)

9 Months Ended

Sep. 30, 2024

Equity [Abstract]

Accumulated Other Comprehensive Income (Loss)

The accumulated balances related to each component of other comprehensive income (loss), net of taxes, were as follows as of September 30, 2024 and December 31, 2023:


(in thousands)	September 30, 2024		December 31, 2023
Foreign currency translation	$	35	$	21
Unrealized gain (loss) on marketable securities	667		(51)
Accumulated other comprehensive income (loss)	$	702	$	(30)

Marketable Securities

9 Months Ended

Sep. 30, 2024

Investments, Debt and Equity Securities [Abstract]

Marketable Securities

The following is a summary of the Company’s available-for-sale marketable securities as of September 30, 2024, which all have contractual maturities of less than two years:


	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Fair Market Value
(in thousands)
U.S. Treasury and government agencies	$	172,505	$	797	$	(56)	$	173,246
Corporate debt	102,412		108		(2)		102,518

Total marketable securities	$	274,917	$	905	$	(58)	$	275,764

The following is a summary of the Company’s available-for-sale marketable securities as of December 31, 2023, which all have contractual maturities of less than two years:


	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Fair Market Value
(in thousands)
U.S. Treasury and government agencies	$	185,168	$	227	$	(280)	$	185,115
Corporate debt	67,352		2		(26)		67,328

Total marketable securities	$	252,520	$	229	$	(306)	$	252,443