ZEVRA THERAPEUTICS INC

For the period ended Sep 30, 2024. Filed Nov 13, 2024.

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2024 · Filed Nov 13, 2024

ZVRA$11.59+10.1%Stored close · as of Nov 6, 2026

Extracted filing text, with the paragraph anchors used by the comparison.

See the whole filing, with its images and exhibits

Contents

INDEX

FORM 10-Q

Page
PART I — FINANCIAL INFORMATION
Item 1. · unaudited CondeNSed CONSOLIDaTED Financial Statements
	UNAUDITED Condensed CONSOLIDATED Balance Sheets as of SEPTEMBER 30, 2024, and December 31, 2023	4
	UNAUDITED Condensed CONSOLIDATED Statements of Operations for the three AND NINE Months ended SEPTEMBER 30, 2024, and 2023	5
	UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2024, AND 2023	6
	UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2024, AND 2023	7
	Unaudited condensed CONSOLIDATED Statements of Cash Flows for the NINE months ended SEPTEMBER 30, 2024, and 2023	9
	Notes to unaudited Condensed CONSOLIDATED Financial Statements	10
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	27
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	40
Item 4.	Controls and Procedures	40
PART II — OTHER INFORMATION
Item 1.	Legal Proceedings	41
Item 1A.	Risk Factors	41
Item 2.	Unregistered Sales of Equity Securities AND Use of Proceeds	42
Item 3.	Defaults Upon Senior Securities	42
Item 4.	Mine Safety Disclosures	42
Item 5.	Other Information	42
Item 6.	Exhibits	43
	Signatures	44

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 Part II, Item 1A. "Risk Factors" and elsewhere in this Quarterly Report on Form 10-Q and**Part I, Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on April 1, 2024. 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 integrate Acer (as defined below) into our business successfully or realize the anticipated synergies and related benefits of the Merger (as defined below);
●	the progress of, outcome or 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 ability to continue as a going concern;
●	the progress of, timing of and expected amount of expenses associated with our research, development and commercialization activities;
●	our ability to raise additional funds on commercially reasonable terms, or at all, in order to support our continued operations;
●	the sufficiency of our cash resources to fund our operating expenses and capital investment requirements for any period;
●	the expected timing of our clinical trials for our product candidates and the availability of data and results of those trials;
●	our expectations regarding federal, state and foreign regulatory requirements;
●	the potential therapeutic benefits and effectiveness of our products and product candidates;
●	the size and characteristics of the markets that may be addressed by our products and product candidates;
●	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 timing of commercializing our products and product candidates, if approved;
●	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 for the fiscal year ended December 31, 2023, filed with the SEC on April 1, 2024, 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., formerly known as KemPharm, Inc. prior to February 21, 2023. We have proprietary rights to a number of trademarks used in this Quarterly Report on Form 10-Q that are important to our business, including LAT® and the Zevra logo. 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, the Company and Aspen Z Merger Sub, Inc., an indirect wholly-owned subsidiary of Zevra (“Merger Sub”) entered into an Agreement and Plan of Merger (the“Merger Agreement”) with Acer Therapeutics Inc. ("Acer"). On November 17, 2023 (the "Closing Date"), we completed**the acquisition of Acer. Pursuant to the Merger Agreement, on the Closing Date, Merger Sub was merged with and into Acer (the "Merger"), with Acer continuing as the surviving entity and as a wholly-owned subsidiary of Zevra.

PART I — FINANCIAL INFORMATION

Item 1.	unaudited condensed CONSOLIDATED Financial Statements

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and par value amounts)

	September 30,	December 31,
	2024	2023
Assets
Current assets:
Cash and cash equivalents	$54,039	$43,049
Securities at fair value, current	35,337	24,688
Accounts and other receivables	7,790	17,377
Prepaid expenses and other current assets	2,276	1,824
Total current assets	99,442	86,938
Inventories	8,756	9,841
Securities at fair value, long-term	6,105	—
Property and equipment, net	607	736
Operating lease right-of-use assets	820	790
Goodwill	4,701	4,701
Intangible assets, net	70,608	69,227
Other long-term assets	512	94
Total assets	$191,551	$172,327
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued expenses	$24,464	$28,403
Line of credit payable	—	37,700
Current portion of operating lease liabilities	540	543
Current portion of discount and rebate liabilities	8,547	4,550
Other current liabilities	930	2,524
Total current liabilities	34,481	73,720
Long-term debt	58,904	5,066
Warrant liability	13,902	16,100
Operating lease liabilities, less current portion	483	456
Discount and rebate liabilities, less current portion	8,490	7,663
Other long-term liabilities	5,521	7,458
Total liabilities	121,781	110,463
Commitments and contingencies (Note D)
Stockholders’ equity:
Preferred stock:
Undesignated preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of September 30, 2024, or December 31, 2023	—	—
Common stock, $0.0001 par value, 250,000,000 shares authorized, 54,803,056 shares issued and 53,227,364 shares outstanding as of September 30, 2024; 43,110,360 shares issued and 41,534,668 shares outstanding as of December 31, 2023	5	4
Additional paid-in capital	550,413	472,664
Treasury stock, at cost	(10,983)	(10,983)
Accumulated deficit	(469,550)	(399,778)
Accumulated other comprehensive income (loss)	(115)	(43)
Total stockholders' equity	69,770	61,864
Total liabilities and stockholders' equity	$191,551	$172,327

** ZEVRA THERAPEUTICS, INC.**

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

	Three months ended September 30,		Nine months ended September 30,
	2024	2023	2024	2023
Revenue, net	$3,695	$2,895	$11,569	$14,541
Cost of product revenue (excluding $1,545 and $4,619 in intangible asset amortization for the three and nine months ended September 30, 2024, respectively shown separately below)	2,303	144	6,051	946
Intangible asset amortization	1,545	—	4,619	—
Operating expenses:
Research and development	10,945	12,297	33,743	28,385
Selling, general and administrative	16,208	5,818	38,743	19,657
Total operating expenses	27,153	18,115	72,486	48,042
Loss from operations	(27,306)	(15,364)	(71,587)	(34,447)
Other (expense) income:
Interest expense	(2,312)	(366)	(5,157)	(745)
Fair value adjustment related to warrant and CVR liability	(4,746)	3,678	4,660	4,253
Fair value adjustment related to investments	90	124	64	451
Interest and other income (expense), net	1,049	1,738	2,248	4,331
Total other (expense) income	(5,919)	5,174	1,815	8,290
Loss before income taxes	(33,225)	(10,190)	(69,772)	(26,157)
Income tax expense	—	(177)	—	—
Net loss	$(33,225)	$(10,367)	$(69,772)	$(26,157)
Basic and diluted net loss per share of common stock:
Net loss	$(0.69)	$(0.30)	$(1.59)	$(0.76)
Weighted average number of shares of common stock outstanding:
Basic and diluted	47,808,817	34,724,614	43,843,851	34,364,075

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

	Three months ended September 30,		Nine months ended September 30,
	2024	2023	2024	2023
Net loss	$(33,225)	$(10,367)	$(69,772)	$(26,157)
Other comprehensive (loss) income:
Foreign currency translation adjustment	(536)	5	(72)	(333)
Other comprehensive (loss) income	(536)	5	(72)	(333)
Comprehensive loss	$(33,761)	$(10,362)	$(69,844)	$(26,490)

See accompanying notes to unaudited condensed consolidated financial**statements.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

Additional · Treasury · Other · Total
	Common	Paid-in	Stock,	Accumulated	Comprehensive	Stockholders'
	Stock	Capital	at cost	Deficit	Income (Loss)	Equity
Balance as of January 1, 2024	$4	$472,664	$(10,983)	$(399,778)	$(43)	$61,864
Net loss	—	—	—	(16,622)	—	(16,622)
Stock-based compensation expense	—	2,119	—	—	—	2,119
Issuance of common stock in exchange for consulting services	—	56	—	—	—	56
Issuance of common stock as part of the Employee Stock Purchase Plan	—	71	—	—	—	71
Issuance of common stock for options exercised	—	1,146	—	—	—	1,146
Other comprehensive income	—	—	—	—	184	184
Balance as of March 31, 2024	$4	$476,056	$(10,983)	$(416,400)	$141	$48,818
Net loss	—	—	—	(19,925)	—	(19,925)
Stock-based compensation expense	—	2,632	—	—	—	2,632
Issuance of common stock in exchange for consulting services	—	193	—	—	—	193
Issuance of common stock as part of the Employee Stock Purchase Plan	—	480	—	—	—	480
Other comprehensive income	—	—	—	—	280	280
Balance as of June 30, 2024	$4	$479,361	$(10,983)	$(436,325)	$421	$32,478
Net loss	—	—	—	(33,225)	—	(33,225)
Stock-based compensation expense	—	6,137	—	—	—	6,137
Issuance of common stock in public offering	1	64,516	—	—	—	64,517
Issuance of common stock in exchange for consulting services	—	150	—	—	—	150
Issuance of common stock as part of the Employee Stock Purchase Plan	—	92	—	—	—	92
Issuance of common stock for options exercised	—	157	—	—	—	157
Other comprehensive loss	—	—	—	—	(536)	(536)
Balance as of September 30, 2024	$5	$550,413	$(10,983)	$(469,550)	$(115)	$69,770

See accompanying notes to unaudited condensed consolidated financial**statements.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY, CONTINUED

Additional · Other · Total
	Common	Paid-in	Treasury	Accumulated	Comprehensive	Stockholders'
	Stock	Capital	Stock, at cost	Deficit	Income (Loss)	Equity
Balance as of January 1, 2023	$3	$436,269	$(7,536)	$(353,729)	$113	$75,120
Net loss	—	—	—	(13,217)	—	(13,217)
Stock-based compensation expense	—	945	—	—	—	945
Shares repurchased as part of the Share Repurchase Program	—	—	(3,447)	—	—	(3,447)
Issuance of common stock in exchange for consulting services	—	42	—	—	—	42
Other comprehensive loss	—	—	—	—	(176)	(176)
Balance as of March 31, 2023	$3	$437,256	$(10,983)	$(366,946)	$(63)	$59,267
Net income	—	—	—	(2,573)	—	(2,573)
Stock-based compensation expense	—	2,151	—	—	—	2,151
Issuance of common stock in exchange for consulting services	—	25	—	—	—	25
Issuance of common stock as part of the Employee Stock Purchase Plan	—	165	—	—	—	165
Other comprehensive loss	—	—	—	—	(162)	(162)
Balance as of June 30, 2023	$3	$439,597	$(10,983)	$(369,519)	$(225)	$58,873
Net loss	—	—	—	(10,367)	—	(10,367)
Stock-based compensation expense	—	1,440	—	—	—	1,440
Issuance of common stock in connection with the Merger (Note L)	—	11,500	—	—	—	11,500
Issuance of common stock in exchange for consulting services	—	71	—	—	—	71
Other comprehensive income	—	—	—	—	5	5
Balance as of September 30, 2023	$3	$452,608	$(10,983)	$(379,886)	$(220)	$61,522

ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.

About this filing

Table of Contents