vnda-20240930

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-Q

(Mark One)


☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2024


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 001-34186

VANDA PHARMACEUTICALS INC.

(Exact name of registrant as specified in its charter)


Delaware						03-0491827
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)

2200 Pennsylvania Avenue NW, Suite 300E

Washington, DC 20037

(202) 734-3400

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Exchange Act:


Title of Each Class	Trading Symbol(s)	Name of Exchange on Which Registered
Common Stock, par value $0.001 per share	VNDA	The Nasdaq Global Market
Series A Junior Participating Preferred Stock Purchase Right, par value $0.001 per share	-	The Nasdaq Global Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

☐

Accelerated filer

Non-accelerated filer

☐

Smaller reporting company

☐

Emerging growth company

☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No x

As of October 31, 2024, there were 58,308,144 shares of the registrant’s common stock issued and outstanding.

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Vanda Pharmaceuticals Inc.

Quarterly Report on Form 10-Q

For the Quarter Ended September 30, 2024

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		Page
PART I – FINANCIAL INFORMATION

ITEM 1	Financial Statements (Unaudited)	5

	Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023	5

	Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2024 and 2023	6

	Condensed Consolidated Statements of Comprehensive Income (Loss) for the three and nine months ended September 30, 2024 and 2023	7

	Condensed Consolidated Statements of Changes in Stockholders’ Equity for the three and nine months ended September 30, 2024 and 2023	8

	Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2024 and 2023	10

	Notes to Condensed Consolidated Financial Statements	11

ITEM 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	26

ITEM 3	Quantitative and Qualitative Disclosures about Market Risk	37

ITEM 4	Controls and Procedures	38

PART II – OTHER INFORMATION

ITEM 1	Legal Proceedings	38

ITEM 1A	Risk Factors	38

ITEM 2	Unregistered Sales of Equity Securities and Use of Proceeds	39

ITEM 3	Defaults Upon Senior Securities	39

ITEM 4	Mine Safety Disclosures	39

ITEM 5	Other Information	39

ITEM 6	Exhibits	40

Signatures		41

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This quarterly report on Form 10-Q (Quarterly Report) contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (Exchange Act). Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “project,” “target,” “goal,” “likely,” “will,” “would,” and “could,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. If the risks, changes in circumstances or uncertainties materialize or the assumptions prove incorrect, the results of Vanda Pharmaceuticals Inc. (we, our, the Company or Vanda) may differ materially from those expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements in this Quarterly Report may include, but are not limited to, statements about:

•our ability to commercialize Fanapt® (iloperidone) oral tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder;

•our ability to continue to generate United States (U.S.) sales of Fanapt® oral tablets for the treatment of schizophrenia;

•our ability to continue to commercialize HETLIOZ® (tasimelteon) capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in the U.S., in light of existing and potential generic competition, and Europe and HETLIOZ® capsules and oral suspension (HETLIOZ LQ®) for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in the U.S.;

•our ability to obtain approval from the U.S. Food and Drug Administration (FDA) for HETLIOZ® beyond the currently approved indications;

•our ability to increase market awareness of Non-24 and SMS and market acceptance of HETLIOZ®;

•our ability to commercialize PONVORY® (ponesimod) tablets for the treatment of adults with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease in the U.S. and Canada and our ability to transition regulatory and manufacturing responsibility to us;

•our ability to obtain approval from the FDA for PONVORY® beyond the currently approved indications;

•our ability to obtain regulatory approval for tradipitant from the FDA;

•our level of success in commercializing Fanapt® and HETLIOZ® in new markets;

•our ability to overcome the continued reimbursement and patient access challenges we face as a result of third-party payor coverage;

•the impact of public health crises, epidemics, pandemics or similar events on our business and operations, including our revenue, our supply chain, our commercial activities, our ongoing and planned clinical trials and our regulatory activities;

•our dependence on third-party manufacturers to manufacture Fanapt®, HETLIOZ®, HETLIOZ LQ® and PONVORY® in sufficient quantities and quality;

•our ability to prepare, file, prosecute, defend and enforce any patent claims and other intellectual property rights;

•our ability to maintain rights to develop and commercialize our products under our license agreements;

•our ability to obtain and maintain regulatory approval of our products, and the labeling for any approved products;

•our expectations regarding the timing and success of preclinical studies and clinical trials;

•the safety and efficacy of our products;

•regulatory developments in the U.S., Europe and other jurisdictions;

•limitations on our ability to utilize some or all of our prior net operating losses and orphan drug and research and development credits;

•our expectations regarding the size and growth of the current and potential markets for our products and our ability to serve those markets;

•our expectations regarding trends with respect to our revenues, costs, expenses, liabilities and cash, cash equivalents and marketable securities;

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•our ability to identify or obtain rights to new products;

•our ability to attract and retain key scientific or management personnel;

•our expectations regarding the cost, time frame, outcome, insurance coverage and effects of any litigation or other dispute;

•our ability to obtain the capital necessary to fund our research and development or commercial activities;

•potential losses incurred from product liability claims made against us; and

•the use of our existing cash, cash equivalents and marketable securities.

All forward-looking statements in this report are expressly qualified in their entirety by the cautionary statements contained throughout this report. We caution you not to rely too heavily on such forward-looking statements. Each forward-looking statement speaks only as of the date of this Quarterly Report, and we undertake no obligation, and specifically decline any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

We encourage you to read Management’s Discussion and Analysis of Financial Condition and Results of Operations and our unaudited condensed consolidated financial statements contained in this Quarterly Report. In addition to the risks described in Part I, Item 1A, Risk Factors, of our annual report on Form 10-K (Annual Report) for the fiscal year ended December 31, 2023 and Item 1A, Risk Factors, of this Quarterly Report, other unknown or unpredictable factors also could affect our results. Therefore, the information in this report should be read together with other reports and documents that we file with the Securities and Exchange Commission from time to time, including on Form 10-Q and Form 8-K, which may supplement, modify, supersede or update those risk factors. As a result of these factors, we cannot assure you that the forward-looking statements in this report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all.

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Part I — FINANCIAL INFORMATION


ITEM 1			Financial Statements (Unaudited)

VANDA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)


(in thousands, except for share and per share amounts)	September 30, 2024		December 31, 2023
ASSETS
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
LIABILITIES AND STOCKHOLDERS’ EQUITY
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	—		—
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

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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VANDA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)


	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
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	$	(0.09)	$	0.00	$	(0.24)	$	0.09
Diluted	$	(0.09)	$	0.00	$	(0.24)	$	0.09
Weighted average shares outstanding:
Basic	58,261,961		57,519,031		58,095,566		57,329,969
Diluted	58,261,961		57,595,344		58,095,566		57,512,225

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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VANDA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (Unaudited)


	Three Months Ended				Nine Months Ended
(in thousands)	September 30, 2024		September 30, 2023		September 30, 2024		September 30, 2023
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

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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VANDA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (Unaudited)


	Common Stock			Additional Paid-in Capital		Accumulated Other Comprehensive Income (Loss)		Accumulated Deficit		Total
(in thousands, except for share amounts)	Shares	Par Value
Balances at December 31, 2023	57,534,499	$	58	$	700,274	$	(30)	$	(155,392)	$	544,910

Issuance of common stock from the exercise of stock options and settlement of restricted stock units	662,024	—		—		—		—		—
Stock-based compensation expense	—	—		3,584		—		—		3,584
Net loss	—	—		—		—		(4,146)		(4,146)
Other comprehensive loss, net of tax	—	—		—		(353)		—		(353)
Balances at March 31, 2024	58,196,523	$	58	$	703,858	$	(383)	$	(159,538)	$	543,995

Issuance of common stock from the exercise of stock options and settlement of restricted stock units	90,785	—		—		—		—		—
Stock-based compensation expense	—	—		2,986		—		—		2,986
Net loss	—	—		—		—		(4,518)		(4,518)
Other comprehensive income, net of tax	—	—		—		53		—		53
Balances at June 30, 2024	58,287,308	$	58	$	706,844	$	(330)	$	(164,056)	$	542,516

Issuance of common stock from the exercise of stock options and settlement of restricted stock units	18,836	—		—		—		—		—
Stock-based compensation expense	—	—		2,999		—		—		2,999
Net loss	—	—		—		—		(5,324)		(5,324)
Other comprehensive income, net of tax	—	—		—		1,032		—		1,032
Balances at September 30, 2024	58,306,144	$	58	$	709,843	$	702	$	(169,380)	$	541,223

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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VANDA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (Unaudited) (Continued)


	Common Stock			Additional Paid-in Capital		Accumulated Other Comprehensive Loss		Accumulated Deficit		Total
(in thousands, except for share amounts)	Shares	Par Value
Balances at December 31, 2022	56,783,764	$	57	$	686,235	$	(1,193)	$	(157,901)	$	527,198

Issuance of common stock from the exercise of stock options and settlement of restricted stock units	657,228	—		—		—		—		—
Stock-based compensation expense	—	—		4,351		—		—		4,351
Net income	—	—		—		—		3,252		3,252
Other comprehensive income, net of tax	—	—		—		938		—		938
Balances at March 31, 2023	57,440,992	$	57	$	690,586	$	(255)	$	(154,649)	$	535,739

Issuance of common stock from the exercise of stock options and settlement of restricted stock units	55,921	—		—		—		—		—
Stock-based compensation expense	—	—		3,249		—		—		3,249
Net income	—	—		—		—		1,520		1,520
Other comprehensive loss, net of tax	—	—		—		(610)		—		(610)
Balances at June 30, 2023	57,496,913	$

SEC Form 10-Q filed by Vanda Pharmaceuticals Inc.