Zevra Therapeutics Reports Second Quarter 2024 Financial Results and Corporate Highlights
Zevra Therapeutics (NASDAQ: ZVRA) reported Q2 2024 financial results and corporate highlights. Key points include:
1. FDA advisory committee voted favorably on arimoclomol's effectiveness for NPC treatment; PDUFA date set for September 21, 2024.
2. Pro forma cash position of $113.8 million as of June 30, 2024, including recent public offering.
3. Q2 2024 net revenue of $4.4 million, down from $8.5 million in Q2 2023.
4. Net loss of $19.9 million ($0.48 per share) in Q2 2024, compared to $2.6 million ($0.08 per share) in Q2 2023.
5. Cash runway extended into Q1 2027, excluding potential arimoclomol revenue.
Zevra Therapeutics (NASDAQ: ZVRA) ha riportato i risultati finanziari e i punti salienti aziendali del secondo trimestre del 2024. Punti chiave includono:
1. Il comitato consultivo della FDA ha votato favorevolmente sull'efficacia dell'arimoclomolo per il trattamento della NPC; la data PDUFA è fissata per il 21 settembre 2024.
2. La posizione di cassa pro forma ammonta a 113,8 milioni di dollari al 30 giugno 2024, inclusa l'offerta pubblica recente.
3. Le entrate nette del secondo trimestre del 2024 sono state di 4,4 milioni di dollari, in calo rispetto agli 8,5 milioni di dollari del secondo trimestre del 2023.
4. La perdita netta è stata di 19,9 milioni di dollari (0,48 dollari per azione) nel secondo trimestre del 2024, rispetto ai 2,6 milioni di dollari (0,08 dollari per azione) del secondo trimestre del 2023.
5. Il cash runway è stato esteso fino al primo trimestre del 2027, escludendo i potenziali ricavi dall'arimoclomolo.
Zevra Therapeutics (NASDAQ: ZVRA) informó sobre los resultados financieros y los aspectos destacados corporativos del segundo trimestre de 2024. Puntos clave incluyen:
1. El comité asesor de la FDA votó favorablemente sobre la efectividad del arimoclomol para el tratamiento de NPC; la fecha PDUFA se estableció para el 21 de septiembre de 2024.
2. La posición de efectivo pro forma es de 113,8 millones de dólares al 30 de junio de 2024, incluida la reciente oferta pública.
3. Los ingresos netos del segundo trimestre de 2024 fueron de 4,4 millones de dólares, una disminución desde los 8,5 millones de dólares del segundo trimestre de 2023.
4. La pérdida neta fue de 19,9 millones de dólares (0,48 dólares por acción) en el segundo trimestre de 2024, en comparación con 2,6 millones de dólares (0,08 dólares por acción) en el segundo trimestre de 2023.
5. La proyección de efectivo se ha extendido hasta el primer trimestre de 2027, excluyendo los ingresos potenciales de arimoclomol.
제브라 치료제(Zevra Therapeutics, NASDAQ: ZVRA)는 2024년 2분기 재무 결과 및 기업 하이라이트를 보고했습니다. 주요 사항은 다음과 같습니다:
1. FDA 자문위원회가 NPC 치료를 위한 아리모클로몰의 효과에 대해 긍정적으로 투표했습니다; PDUFA 날짜는 2024년 9월 21일로 설정되었습니다.
2. 최근 공개를 포함하여 2024년 6월 30일 기준으로 프로포르마 현금 보유액이 1억 1,380만 달러입니다.
3. 2024년 2분기 순수익은 440만 달러로, 2023년 2분기의 850만 달러에서 감소했습니다.
4. 2024년 2분기 순손실은 1,990만 달러(주당 0.48달러)로, 2023년 2분기의 260만 달러(주당 0.08달러)와 비교되었습니다.
5. 아리모클로몰의 잠재적 수익을 제외하고 현금 실행 기간이 2027년 1분기까지 연장되었습니다.
Zevra Therapeutics (NASDAQ: ZVRA) a rapporté les résultats financiers et les points saillants de l'entreprise pour le deuxième trimestre de 2024. Les points clés incluent :
1. Le comité consultatif de la FDA a voté favorablement sur l'efficacité de l'arimoclomol pour le traitement de la NPC ; la date PDUFA est fixée au 21 septembre 2024.
2. La position de trésorerie pro forma s'élève à 113,8 millions de dollars au 30 juin 2024, y compris l'offre publique récente.
3. Le revenu net du deuxième trimestre de 2024 s'élève à 4,4 millions de dollars, en baisse par rapport à 8,5 millions de dollars au deuxième trimestre de 2023.
4. La perte nette s'est élevée à 19,9 millions de dollars (0,48 dollar par action) au deuxième trimestre de 2024, contre 2,6 millions de dollars (0,08 dollar par action) au deuxième trimestre de 2023.
5. La durée de trésorerie a été prolongée jusqu'au premier trimestre de 2027, sans tenir compte des revenus potentiels de l'arimoclomol.
Zevra Therapeutics (NASDAQ: ZVRA) hat die finanziellen Ergebnisse und Unternehmenshighlights für das zweite Quartal 2024 bekannt gegeben. Wichtige Punkte sind:
1. Der Beraterkreis der FDA stimmte positiv über die Wirksamkeit von Arimoclomol zur Behandlung von NPC ab; das PDUFA-Datum ist auf den 21. September 2024 festgelegt.
2. Die pro forma Barposition beträgt zum 30. Juni 2024 113,8 Millionen US-Dollar, einschließlich des jüngsten öffentlichen Angebots.
3. Die Nettoumsätze im zweiten Quartal 2024 betrugen 4,4 Millionen US-Dollar, ein Rückgang von 8,5 Millionen US-Dollar im zweiten Quartal 2023.
4. Der Nettoverlust betrug im zweiten Quartal 2024 19,9 Millionen US-Dollar (0,48 US-Dollar pro Aktie), im Vergleich zu 2,6 Millionen US-Dollar (0,08 US-Dollar pro Aktie) im zweiten Quartal 2023.
5. Die Cash-Runs sind bis ins erste Quartal 2027 verlängert worden, ohne die potenziellen Einnahmen aus Arimoclomol zu berücksichtigen.
- FDA advisory committee voted favorably on arimoclomol's effectiveness for NPC treatment
- Pro forma cash position strengthened to $113.8 million
- Secured $100 million credit facility with Perceptive Advisors and Healthcare Royalty Partners
- Increased OLPRUVA reimbursement coverage to 75% of covered lives
- Presented positive topline data from Phase 2 study of KP1077 in idiopathic hypersomnia
- Cash runway extended into Q1 2027
- Q2 2024 net revenue decreased to $4.4 million from $8.5 million in Q2 2023
- Net loss increased to $19.9 million in Q2 2024 from $2.6 million in Q2 2023
- R&D expenses increased to $10.5 million from $7.4 million year-over-year
- SG&A expenses rose to $12.6 million from $6.6 million year-over-year
- $3.2 million obsolescence reserve recognized against OLPRUVA inventory
Insights
Zevra Therapeutics' Q2 2024 results reveal a mixed financial picture. Revenue declined to
However, the company's cash position improved significantly post-quarter end. With the recent
The increased R&D and SG&A expenses reflect investments in clinical trials and commercial infrastructure, which could pay off if arimoclomol receives FDA approval. Overall, while current financials show pressure, the improved cash position and potential near-term catalysts present a more optimistic outlook.
The favorable FDA advisory committee vote for arimoclomol in Niemann-Pick disease type C (NPC) is a significant milestone. While non-binding, it often influences final FDA decisions. The PDUFA date of September 21, 2024, is a important near-term catalyst that could transform Zevra's market position in rare diseases.
The company's pipeline progress is noteworthy. Positive topline data from the Phase 2 study of KP1077 in idiopathic hypersomnia, presented at SLEEP 2024, sets the stage for the upcoming end-of-Phase 2 FDA meeting. This could accelerate the path to a pivotal Phase 3 trial.
The restart of the Phase 3 DiSCOVER trial for celiprolol in Vascular Ehlers-Danlos Syndrome (VEDS) adds another potential value driver to Zevra's portfolio. These advancements across multiple rare disease indications demonstrate a robust and diversified clinical development strategy, potentially mitigating risk and enhancing long-term value creation.
Zevra's commercial strategy for OLPRUVA shows promise, with increased reimbursement coverage to
The company's focus on rare diseases positions it in a high-value, less competitive market segment. The potential approval of arimoclomol could leverage the existing commercial infrastructure, potentially improving operational efficiency and market reach.
Zevra's ability to attract institutional investors through recent financing rounds, including the
FDA advisory committee voted favorably that the data support arimoclomol as effective treatment for patients with NPC; PDUFA date of September 21, 2024
Pro forma June 30, 2024, cash, cash equivalents, investments and net proceeds from underwritten public offering total
Conference call scheduled for today, August 13, 2024, at 4:30 p.m. ET
CELEBRATION, Fla., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the second quarter ended June 30, 2024.
“During the second quarter, we made steady progress executing on our strategic objectives,” said Neil F. McFarlane, President and Chief Executive Officer of Zevra. “We are encouraged by favorable vote from the FDA’s Genetic Metabolic Diseases Advisory Committee, that data presented support that arimoclomol is effective in the treatment in patients with Niemann Pick disease type C. While the vote is non-binding, we believe it is an important factor as the FDA completes its consideration for approval. Additionally, we continue the launch of OLPRUVA with a keen focus on driving patient awareness and intend to use the same commercial team to launch arimoclomol, if approved. Additionally, we expect to meet with the FDA to discuss the design of a pivotal Phase 3 trial to study KP1077 in idiopathic hypersomnia at the end of third quarter.”
“We continue to be prudent in our capital allocation as we focus on creating long-term value for stockholders,” said R. LaDuane Clifton, Zevra’s Chief Financial Officer and Treasurer. “Our recent underwritten offering provided net proceeds to the Company of
Q2 2024 Corporate Highlights:
- Arimoclomol
- On August 2, 2024, the U.S. Food and Drug Administration’s (FDA) newly formed Genetic Metabolic Diseases Advisory Committee (the “GeMDAC”) convened for the first time and discussed the benefits and risks of arimoclomol.
- The GeMDAC reviewed comments received from independent experts, NPC patients, and patient advocacy group representatives, and voted favorably that arimoclomol is effective in the treatment of NPC.
- On Friday, August 9, 2024, the Company received the first round of labeling comments, and is working closely with the FDA.
- On August 2, 2024, the U.S. Food and Drug Administration’s (FDA) newly formed Genetic Metabolic Diseases Advisory Committee (the “GeMDAC”) convened for the first time and discussed the benefits and risks of arimoclomol.
- OLPRUVA
- On June 18, 2024, announced transition of specialty pharmacy partner to Orsini.
- Increased OLPRUVA reimbursement coverage to
75% of covered lives and improved preferred status on formulary plans. - Added nine (9) new patient enrollments during Q2 2024, which is defined as a prescription for a patient on the Quick Start program or receiving a paid dispense of OLPRUVA.
- On June 18, 2024, announced transition of specialty pharmacy partner to Orsini.
- KP1077
- On June 3, 2024, presented positive topline data from its Phase 2 study in patients with idiopathic hypersomnia (IH) at the SLEEP 2024 Annual Meeting.
- The Company submitted a briefing book to the FDA for an end-of-Phase 2 meeting to be held at the end of Q3 2024.
- On June 3, 2024, presented positive topline data from its Phase 2 study in patients with idiopathic hypersomnia (IH) at the SLEEP 2024 Annual Meeting.
- Celiprolol
- Restarted recruitment for the Phase 3 DiSCOVER trial of celiprolol in patients with Vascular Ehler-Danlos Syndrome (VEDS).
- Restarted recruitment for the Phase 3 DiSCOVER trial of celiprolol in patients with Vascular Ehler-Danlos Syndrome (VEDS).
- Corporate
- On April 5, 2024, the Company entered into a
$100 million credit facility with leading biotech investors, Perceptive Advisors and Healthcare Royalty Partners. - On June 25, 2024, the Company announced the appointment of Rahsaan Thompson as Chief Legal Officer, Secretary and Compliance Officer, and Alison Peters as Chief People Officer, bringing expertise that will support the next phase of the Company’s growth.
- On April 5, 2024, the Company entered into a
Overview of Q2 2024 Financial Results:
Net revenue for Q2 2024 was
Research and development (R&D) expenses were
Selling, general and administrative (SG&A) expenses were
Net loss for Q2 2024 was (
As of June 30, 2024, total cash, cash equivalents, and investments were
As of June 30, 2024, total shares of common stock outstanding were 41,991,464, and fully diluted common shares were 57,324,496, which included 5,483,537 shares issuable upon exercise of warrants.
On April 5, 2024, the Company announced the refinancing of its existing debt with up to
On August 12, 2024, the Company completed an underwritten public offering, further strengthening its balance sheet. The underwriters fully exercised their overallotment option, resulting in the issuance of approximately 10.6 million shares at a price of
Following the closing of the underwritten public offering on August 12, 2024, pro forma June 30, 2024, common shares and fully diluted shares outstanding were 52,606,849 and 67,939,881, respectively. No warrants were issued as part of the underwritten public offering.
Based on our current operating plan, available cash, cash equivalents, and investments, including proceeds from the underwritten offering closed in August, are expected to extend our cash runway into the first quarter of 2027, subject to continuing compliance with our debt covenants.
- Cash runway forecast includes: revenue from the expected sales of OLPRUVA, ongoing reimbursements from the French EAP for arimoclomol, ongoing royalties under the AZSTARYS license agreement, and investments into the incremental commercial activities needed to support the launch of arimoclomol, if approved.
- Cash runway forecast does not include commercial revenue from arimoclomol which could follow a potential FDA approval or the potential sale of the Priority Review Voucher which would be received upon approval.
Conference Call Information
Zevra will host a conference call and audio webcast today at 4:30 p.m. ET, to discuss its corporate and financial results for Q2 2024.
The audio webcast will be accessible via the Investor Relations section of the Company’s website, http://investors.zevra.com/. An archive of the audio webcast will be available for ninety (90) days beginning at approximately 5:30 p.m. ET, on August 13, 2024.
Additionally, interested participants and investors may access the conference call by dialing either:
- (800) 225-9448 (United States)
- +1 (203) 518- 9708 (International)
- Conference ID: ZVRAQ224
About Urea Cycle Disorders
UCDs are a group of rare, genetic disorders that can cause harmful ammonia to build up in the blood, potentially resulting in brain damage and neurocognitive impairments if ammonia levels are not controlled.i Any increase in ammonia over time is serious. Therefore, it is important to adhere to any dietary protein restrictions and have alternative medication options to help control ammonia levels.
About OLPRUVA®
OLPRUVA (sodium phenylbutyrate) was approved for the treatment of certain UCDs in December 2022 and has recently been marketed under the brand name, OLPRUVA®. OLPRUVA (sodium phenylbutyrate) for oral suspension is a prescription medicine used along with certain therapies, including changes in diet, for the long-term management of adults and children weighing 44
Important Safety Information
Certain medicines may increase the level of ammonia in your blood or cause serious side effects when taken during treatment with OLPRUVA. Tell your doctor about all the medicines you or your child take, especially if you or your child take corticosteroids, valproic acid, haloperidol, and/or probenecid.
OLPRUVA can cause serious side effects, including: 1) nervous system problems (neurotoxicity). Symptoms include sleepiness, tiredness, lightheadedness, vomiting, nausea, headache, confusion, 2) low potassium levels in your blood (hypokalemia) and 3) conditions related to swelling (edema). OLPRUVA contains salt (sodium), which can cause swelling from salt and water retention. Tell your doctor right away if you or your child get any of these symptoms. Your doctor may do certain blood tests to check for side effects during treatment with OLPRUVA. If you have certain medical conditions such as heart, liver or kidney problems, are pregnant/planning to get pregnant or breast-feeding, your doctor will decide if OLPRUVA is right for you.
The most common side effects of OLPRUVA include absent or irregular menstrual periods, decreased appetite, body odor, bad taste or avoiding foods you ate prior to getting sick (taste aversion). These are not all of the possible side effects of OLPRUVA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
About Niemann-Pick Disease Type C (NPC)
Niemann-Pick disease type C (NPC) is an ultra-rare, progressive, and neurodegenerative lysosomal storage disorder characterized by an inability of the body to transport cholesterol and other lipids within the cell, leading to an accumulation of these substances in various tissue areas, including brain tissue. The disease is caused by mutations in the NPC1 or NPC2 genes, which are responsible for making lysosomal proteins. Both children and adults can be affected by NPC with varying clinical presentations. Those living with NPC lose independence due to physical and cognitive limitations, with key neurological impairments presenting in speech, cognition, swallowing, ambulation, and fine motor skills. Disease progression is irreversible and can be fatal within months or take years to be diagnosed and advance in severity.
About Arimoclomol
Arimoclomol, Zevra’s orally-delivered, investigational drug product candidate for the treatment of NPC, has been granted Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, and Rare Pediatric Disease designation by the FDA, and Orphan Medicinal Product designation for the treatment of NPC by the European Medicines Agency (EMA). The FDA has accepted the resubmission of the NDA for arimoclomol and has set a user fee action date (PDUFA date) of September 21, 2024.
About Idiopathic Hypersomnia (IH)
Idiopathic hypersomnia (IH) is a rare sleep disorder characterized by excessive daytime sleepiness (EDS). Patients with IH experience daytime lapses into sleep, or an irrepressible need to sleep that persists even with adequate or prolonged nighttime sleep. Additionally, those with IH have extreme difficulty waking, otherwise known as sleep inertia, severe brain fog, and often fall asleep unintentionally or at inappropriate times. These symptoms of IH often lead to further, even more debilitating problems such as memory lapses, difficulty maintaining focus, and depression.
It is estimated, based on claims data, that approximately 37,000 patients in the United States are currently diagnosed with IH, although the total patient population may be much larger due to some patients who have not yet been diagnosed, have been misdiagnosed, or are not currently seeking treatment.
About KP1077
KP1077 (serdexmethylphenidate, or SDX) is Zevra’s proprietary prodrug of d-methylphenidate (d-MPH) and its sole active pharmaceutical ingredient (API). KP1077 has been granted Orphan Drug Designation by the FDA, and by the European Commission, for the treatment of IH. The U.S. Drug Enforcement Agency (DEA) has classified SDX, the sole API in KP1077, as a Schedule IV controlled substance based on evidence suggesting SDX has a lower potential for abuse when compared to d-MPH, a Schedule II controlled substance. In addition, KP1077 has intellectual property protection though 2037 and potentially beyond.
About Celiprolol
Celiprolol is an investigational clinical candidate for the treatment of Vascular Ehlers-Danlos Syndrome (VEDS). Celiprolol has been granted Orphan Drug and Breakthrough Therapy Designations by the FDA. Zevra recently restarted enrollment in the Phase 3 trial, known as the DiSCOVER trial being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Celiprolol’s mechanism of action is designed to reduce the mechanical stress on collagen fibers within the arterial wall through vascular dilation and smooth muscle relaxation.
About Vascular Ehlers-Danlos Syndrome
Vascular Ehlers-Danlos syndrome is a rare genetic cardiovascular disorder which impairs collagen 3 rich connective tissue and leads to vascular and hollow organ ruptures.
It is estimated that approximately 7,500 patients in the United States are currently diagnosed patients with VEDS. There remains an unmet need with no approved treatment in the United States. Celiprolol is currently the standard of care in Europe.
About Zevra Therapeutics
Zevra Therapeutics is a rare disease company combining science, data, and patient needs to create transformational therapies for diseases with limited or no treatment options. Our mission is to bring life-changing therapeutics to people living with rare diseases. With unique, data-driven development and commercialization strategies, the Company is overcoming complex drug development challenges to make new therapies available to the rare disease community.
For more information, please visit www.zevra.com or follow us on X and LinkedIn.
Cautionary Note Concerning Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation statements regarding the promise and potential impact of our preclinical or clinical trial data; the initiation, timing and results of any clinical trials or readouts, the content, information used for, timing or results of any NDA submissions or resubmissions for arimoclomol or any other product candidates for any specific disease indication or at any dosage; the potential benefits of any of our products or product candidates for any specific disease or at any dosage; the impact of meetings or communications with the FDA or any advisory committee; decisions by the FDA or any other entity for arimoclomol or any other product candidates; our strategic and product development objectives, including with respect to becoming a leading, commercially focused rare disease company; the potential benefits of our debt facility;, our our financial position, including our cash balance: our corporate governance objectives; potential revenues from our arimoclomol expanded access program; the potential for royalty and milestone contributions, the presentation of data at conferences; and the timing of any of the foregoing. Forward-looking statements are based on information currently available to Zevra and its current plans or expectations. They are subject to several known and unknown uncertainties, risks, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the “Risk Factors” section of Zevra’s Annual Report on Form 10-K for the year ended December 31, 2023, Zevra’s Quarterly Report on Form 10-Q for the three months ended June 30, 2024, and Zevra’s other filings with the Securities and Exchange Commission. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we cannot assure that such expectations will prove correct. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this press release.
________________________
i Ah Mew N, et al. Urea cycle disorders overview [updated June 22, 2017]. In: Adam MP, Ardinger HH, Pagon RA, et al, eds. GeneReviews® [Internet]. University of Washington; 1993-2022. Accessed March 20, 2022.
Zevra Contact
Nichol Ochsner
+1 (732) 754-2545
nochsner@zevra.com
Russo Partners Contacts
Adanna G. Alexander, Ph.D.
+1 (646) 942-5603
adanna.alexander@russopartnersllc.com
| ZEVRA THERAPEUTICS, INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share amounts) | ||||||||||||||||
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue, net | $ | 4,449 | $ | 8,470 | $ | 7,874 | $ | 11,646 | ||||||||
| Cost of product revenue (excluding | 3,573 | 677 | 3,748 | 802 | ||||||||||||
| Intangible asset amortization | 1,546 | — | 3,074 | — | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 10,521 | 7,433 | 22,798 | 16,088 | ||||||||||||
| Selling, general and administrative | 12,604 | 6,612 | 22,535 | 13,839 | ||||||||||||
| Total operating expenses | 23,125 | 14,045 | 45,333 | 29,927 | ||||||||||||
| Loss from operations | (23,795 | ) | (6,252 | ) | (44,281 | ) | (19,083 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest expense | (2,110 | ) | (197 | ) | (2,845 | ) | (379 | ) | ||||||||
| Fair value adjustment related to warrant and CVR liability | 5,779 | 2,118 | 9,406 | 575 | ||||||||||||
| Fair value adjustment related to investments | 1 | 131 | (26 | ) | 327 | |||||||||||
| Interest and other income (expense), net | 270 | 1,553 | 1,199 | 2,593 | ||||||||||||
| Total other income | 3,940 | 3,605 | 7,734 | 3,116 | ||||||||||||
| Loss before income taxes | (19,855 | ) | (2,647 | ) | (36,547 | ) | (15,967 | ) | ||||||||
| Income tax benefit | (70 | ) | 74 | — | 177 | |||||||||||
| Net loss | $ | (19,925 | ) | $ | (2,573 | ) | $ | (36,547 | ) | $ | (15,790 | ) | ||||
| Basic and diluted net loss per share of common stock: | ||||||||||||||||
| Net loss | $ | (0.48 | ) | $ | (0.08 | ) | $ | (0.87 | ) | $ | (0.46 | ) | ||||
| Weighted average number of shares of common stock outstanding: | ||||||||||||||||
| Basic and diluted | 41,899,087 | 33,898,233 | 41,839,582 | 34,180,818 | ||||||||||||
| ZEVRA THERAPEUTICS, INC. 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 | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock: | ||||||||
| Undesignated preferred stock, | — | — | ||||||
| Common stock, | 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 | ||||
FAQ
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