ZEVRA THERAPEUTICS INC
For the period ended Jun 30, 2024. Filed Aug 14, 2024.
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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.
Jun 30, 2024 · Filed Aug 14, 2024
Extracted filing text, with the paragraph anchors used by the comparison.
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Table of Contents
INDEX
FORM 10-Q
| Page | ||
|---|---|---|
| PART I — FINANCIAL INFORMATION | ||
| Item 1. · unaudited CondeNSed CONSOLIDaTED Financial Statements | ||
| UNAUDITED Condensed CONSOLIDATED Balance Sheets as of JUNE 30, 2024, and December 31, 2023 | 4 | |
| UNAUDITED Condensed CONSOLIDATED Statements of Operations for the three AND SIX Months ended JUNE 30, 2024, and 2023 | 5 | |
| UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2024, AND 2023 | 6 | |
| UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2024, AND 2023 | 7 | |
| Unaudited condensed CONSOLIDATED Statements of Cash Flows for the SIX months ended JUNE 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 | 41 |
| Item 4. | Controls and Procedures | 41 |
| PART II — OTHER INFORMATION | ||
| Item 1. | Legal Proceedings | 42 |
| Item 1A. | Risk Factors | 42 |
| Item 2. | Unregistered Sales of Equity Securities AND Use of Proceeds | 43 |
| Item 3. | Defaults Upon Senior Securities | 43 |
| Item 4. | Mine Safety Disclosures | 43 |
| Item 5. | Other Information | 43 |
| Item 6. | Exhibits | 44 |
| Signatures | 45 | |
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)
| June 30, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| Assets | ||
| Current assets: | ||
| Cash and cash equivalents | $39,260 | $43,049 |
| Securities at fair value | 9,998 | 24,688 |
| Accounts and other receivables | 8,947 | 17,377 |
| Prepaid expenses and other current assets | 2,686 | 1,824 |
| Total current assets | 60,891 | 86,938 |
| Inventories | 10,198 | 9,841 |
| Property and equipment, net | 678 | 736 |
| Operating lease right-of-use assets | 911 | 790 |
| Goodwill | 4,701 | 4,701 |
| Intangible assets, net | 66,154 | 69,227 |
| Other long-term assets | 875 | 94 |
| Total assets | $144,408 | $172,327 |
| Liabilities and stockholders' equity | ||
| Current liabilities: | ||
| Accounts payable and accrued expenses | $20,452 | $28,403 |
| Line of credit payable | — | 37,700 |
| Current portion of operating lease liabilities | 596 | 543 |
| Current portion of discount and rebate liabilities | 6,768 | 4,550 |
| Other current liabilities | 2,633 | 2,524 |
| Total current liabilities | 30,449 | 73,720 |
| Long-term debt | 58,328 | 5,066 |
| Warrant liability | 7,856 | 16,100 |
| Operating lease liabilities, less current portion | 544 | 456 |
| Discount and rebate liabilities, less current portion | 8,115 | 7,663 |
| Other long-term liabilities | 6,638 | 7,458 |
| Total liabilities | 111,930 | 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 June 30, 2024, or December 31, 2023 | — | — |
| Common stock, $0.0001 par value, 250,000,000 shares authorized, 43,567,156 shares issued and 41,991,464 shares outstanding as of June 30, 2024; 43,110,360 shares issued and 41,534,668 shares outstanding as of December 31, 2023 | 4 | 4 |
| Additional paid-in capital | 479,361 | 472,664 |
| Treasury stock, at cost | (10,983) | (10,983) |
| Accumulated deficit | (436,325) | (399,778) |
| Accumulated other comprehensive income (loss) | 421 | (43) |
| Total stockholders' equity | 32,478 | 61,864 |
| Total liabilities and stockholders' equity | $144,408 | $172,327 |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.