zvra20250331

zvra20250331_10q.htm

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 March 31, 2025

☐	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: 001-36913

Zevra Therapeutics, Inc.

(Exact Name of Registrant as Specified in Its Charter)

Delaware		20-5894398
(State or Other Jurisdiction of Incorporation or Organization)		(I.R.S. Employer Identification No.)

1180 Celebration Boulevard, Suite 103, Celebration, FL		34747
(Address of Principal Executive Offices)		(Zip Code)

(321) 939-3416

(Registrant’s Telephone Number, Including Area Code)

(Former Name, Former Address, and Former Fiscal Year if Changed Since Last Report)

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

Title of each class

Trading Symbol

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

ZVRA

The Nasdaq Stock Market LLC

(Nasdaq Global Select 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 ☒ No ☐

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 during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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. ☐

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

As of May 9, 2025, the registrant had 54,679,641 shares of common stock outstanding.

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INDEX

ZEVRA THERAPEUTICS, INC.

FORM 10-Q

		Page

PART I — FINANCIAL INFORMATION

Item 1.	unaudited CondeNSed CONSOLIDaTED Financial Statements
	UNAUDITED Condensed CONSOLIDATED Balance Sheets as of March 31, 2025, and December 31, 2024	4
	UNAUDITED Condensed CONSOLIDATED Statements of Operations for the three Months ended march 31, 2025, and 2024	5
	UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS FOR THE THREE MONTHS ENDED MARCH 31, 2025, AND 2024	6
	UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY FOR THE THREE MONTHS ENDED MARCH 31, 2025, AND 2024	7
	Unaudited condensed CONSOLIDATED Statements of Cash Flows for the THREE months ended MARCH 31, 2025, and 2024	9
	Notes to unaudited Condensed CONSOLIDATED Financial Statements	10
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	24
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	36
Item 4.	Controls and Procedures	36

PART II — OTHER INFORMATION

Item 1.	Legal Proceedings	37
Item 1A.	Risk Factors	37
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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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, including the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” contains forward-looking statements regarding future events and our future results that are subject to the safe harbors created under the Securities Act of 1933, as amended, or the Securities Act, and the Securities Exchange Act of 1934, as amended, or the Exchange Act. Forward-looking statements relate to future events or our future financial performance. We generally identify forward-looking statements by terminology such as “may,” “will,” “would,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “assume,” “intend,” “potential,” “continue” or other similar words or the negative of these terms. We have based these forward-looking statements largely on our current expectations about future events and financial trends that we believe may affect our business, financial condition and results of operations. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties and other factors described in “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 12, 2025 (the “Annual Report on Form 10-K”), and elsewhere in this report. Accordingly, you should not place undue reliance upon these forward-looking statements. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, the timing of events and circumstances and actual results could differ materially from those anticipated in the forward-looking statements. Forward-looking statements contained in this report include, but are not limited to, statements about:

	●	our ability to commercialize and the timing of commercializing our products and product candidates, if approved;

	●	the potential therapeutic benefits and effectiveness of our products and product candidates;

	●	the progress of, timing of and expected amount of expenses associated with our commercialization, research, and development activities;

	●	the size and characteristics of the markets that may be addressed by our products and product candidates;

	●	the expected timing of our clinical trials for our product candidates and the availability of data and results of those trials;

	●	the progress of, outcome of and timing of any regulatory approval for any of our product candidates and the expected amount or timing of any payment related thereto under any of our collaboration agreements;

	●	our expectations regarding federal, state and foreign legal and regulatory requirements;

	●	our intention to seek to establish, and the potential benefits to us from, any strategic collaborations or partnerships for the development or sale of our products and product candidates, if approved;

	●	our expectations as to future financial performance, expense levels and liquidity sources;

	●	the sufficiency of our cash resources to fund our operating expenses and capital investment requirements for any period;

	●	our ability to raise additional funds on commercially reasonable terms, or at all, in order to support our continued operations;

	●	senior leadership and board member transitions and refreshments; and

	●	other factors discussed elsewhere in this report.

The forward-looking statements made in this report relate only to events as of the date on which the statements are made. We have included or made reference to important factors in the cautionary statements included in this report, particularly in the section entitled “Risk Factors” where we make reference to Part I, Item 1A. “Risk Factors” of our Annual Report on Form 10-K, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. Except as required by law, we do not assume any intent to update any forward-looking statements after the date on which the statement is made, whether as a result of new information, future events or circumstances or otherwise.

Note Regarding Company Reference

Unless the context otherwise requires, we use the terms “Zevra,” “Company,” “we,” “us” and “our” in this Quarterly Report on Form 10-Q to refer to Zevra Therapeutics, Inc. We have proprietary rights to a number of trademarks and service marks used in this Quarterly Report on Form 10-Q that are important to our business, including LAT^®, OLPRUVA^® and its related logo, MIPLYFFA^® and its related logo, and the Zevra companies' logos. All other trademarks, trade names and service marks appearing in this Quarterly Report on Form 10-Q are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Quarterly Report on Form 10-Q are referred to without the ^® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.

On August 30, 2023, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Acer Therapeutics Inc. (“Acer”). On November 17, 2023 (the “Closing Date”), Zevra completed the acquisition of Acer (the “Merger”). Pursuant to the Merger Agreement, on the Closing Date, Acer continued as the surviving entity and as a wholly-owned subsidiary of Zevra.

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PART I — FINANCIAL INFORMATION

Item 1.

unaudited condensed CONSOLIDATED Financial Statements

ZEVRA THERAPEUTICS, INC.

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and par value amounts)

	*March 31,*			*December 31,*
	*2025*			*2024*
Assets
Current assets:
Cash and cash equivalents	$	37,340		$	33,785
Securities at fair value, current		25,291			35,711
Accounts and other receivables		12,617			10,509
Prepaid expenses and other current assets		3,766			4,052
Inventories, current		2,559			1,970
Total current assets		81,573			86,027
Securities at fair value, noncurrent		6,091			6,010
Inventories, noncurrent		10,615			10,999
Property and equipment, net		422			356
Operating lease right-of-use assets		1,636			657
Goodwill		4,701			4,701
Intangible assets, net		67,377			68,993
Other long-term assets		293			384
Total assets	$	172,708		$	178,127

Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued expenses	$	17,819		$	25,456
Current portion of operating lease liabilities		589			420
Current portion of discount and rebate liabilities		5,167			4,989
Other current liabilities		3,401			3,200
Total current liabilities		26,976			34,065
Long-term debt		60,090			59,504
Warrant liability		13,030			17,804
Income tax payable		16,166			14,431
Operating lease liabilities, less current portion		1,158			372
Discount and rebate liabilities, less current portion		9,389			7,655
Other long-term liabilities		4,876			4,630
Total liabilities		131,685			138,461

Commitments and contingencies (Note M)

Stockholders’ equity:
Preferred stock:
Undesignated preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of March 31, 2025, or December 31, 2024		—			—
Common stock, $0.0001 par value, 250,000,000 shares authorized, 56,255,055 shares issued and 54,679,363 shares outstanding as of March 31, 2025; 55,246,401 shares issued and 53,670,709 shares outstanding as of December 31, 2024		5			5
Additional paid-in capital		560,471			555,302
Treasury stock, at cost		(10,983	)		(10,983	)
Accumulated deficit		(508,388	)		(505,289	)
Accumulated other comprehensive (loss) income		(82	)		631
Total stockholders' equity		41,023			39,666
Total liabilities and stockholders' equity	$	172,708		$	178,127

See accompanying notes to unaudited condensed consolidated financial statements.

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ZEVRA THERAPEUTICS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

	*Three months ended March 31,*
	*2025*			*2024*
Revenue, net	$	20,401		$	3,425
Cost of product revenue (excluding $1,615 and $1,528 in intangible asset amortization for the three months ended March 31, 2025, and March 31, 2024, respectively, shown separately below)		1,345			175
Intangible asset amortization		1,615			1,528
Operating expenses:
Research and development		3,258			12,277
Selling, general and administrative		19,545			9,931
Total operating expenses		22,803			22,208
Loss from operations		(5,362	)		(20,486	)
Other income (expense):
Interest expense		(1,969	)		(735	)
Fair value adjustment related to warrant and CVR liability		4,874			3,627
Fair value adjustment related to investments		(3	)		(27	)
Interest and other income, net		543			929
Total other income		3,445			3,794
Income (loss) before income taxes		(1,917	)		(16,692	)
Income tax (expense) benefit		(1,182	)		70
Net loss	$	(3,099	)	$	(16,622	)

Basic and diluted net loss per share of common stock:
Net loss	$	(0.06	)	$	(0.40	)

Weighted average number of shares of common stock outstanding:
Basic and diluted		54,095,543			41,778,774

See accompanying notes to unaudited condensed consolidated financial statements.

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ZEVRA THERAPEUTICS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(in thousands)

	*Three months ended March 31,*
	*2025*			*2024*
Net loss	$	(3,099	)	$	(16,622	)
Other comprehensive (loss) income:
Foreign currency translation adjustment		(713	)		184
Other comprehensive (loss) income		(713	)		184
Comprehensive loss	$	(3,812	)	$	(16,438	)

See accompanying notes to unaudited condensed consolidated financial statements.

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ZEVRA THERAPEUTICS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(in thousands)

			*Additional*		*Treasury*						*Other*			*Total*
	*Common*		*Paid-in*		*Stock,*			*Accumulated*			*Comprehensive*			*Stockholders'*
	*Stock*		*Capital*		*at cost*			*Deficit*			*Income (Loss)*			*Equity*
Balance as of January 1, 2025	$	5	$	555,302	$	(10,983	)	$	(505,289	)	$	631		$	39,666
Net loss		—		—		—			(3,099	)		—			(3,099	)
Stock-based compensation expense		—		3,052		—			—			—			3,052
Issuance of common stock in exchange for consulting services		—		75		—			—			—			75
Issuance of common stock as part of the Employee Stock Purchase Plan		—		63		—			—			—			63
Issuance of common stock for options exercised or released		—		1,979		—			—			—			1,979
Other comprehensive loss		—		—		—			—			(713	)

SEC Form 10-Q filed by Zevra Therapeutics Inc.