Zevra Reports Full Year 2024 and Fourth Quarter Financial Results
Zevra Therapeutics (ZVRA) reported FY 2024 financial results with net revenue of $23.6 million, including $12.0 million in Q4 2024. The company posted a net loss of $105.5 million ($2.28 per share) for 2024, compared to $46.0 million loss in 2023.
Key highlights include the successful commercial launch of MIPLYFFA following FDA approval in September 2024, with 109 prescription enrollment forms received by year-end. The company entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million.
Cash position stood at $75.5 million as of December 31, 2024. With current operating forecast and excluding PRV sale proceeds, Zevra projects cash runway into 2029. The Phase 3 DiSCOVER trial for celiprolol enrolled 27 total patients, and the company plans to file for EU marketing authorization for MIPLYFFA in H2 2025.
Zevra Therapeutics (ZVRA) ha riportato i risultati finanziari per l'anno fiscale 2024 con un fatturato netto di 23,6 milioni di dollari, inclusi 12,0 milioni di dollari nel quarto trimestre del 2024. L'azienda ha registrato una perdita netta di 105,5 milioni di dollari (2,28 dollari per azione) per il 2024, rispetto a una perdita di 46,0 milioni di dollari nel 2023.
I punti salienti includono il lancio commerciale di successo di MIPLYFFA dopo l'approvazione della FDA nel settembre 2024, con 109 moduli di iscrizione a prescrizione ricevuti entro la fine dell'anno. L'azienda ha stipulato un accordo per vendere il suo Voucher di Revisione Prioritaria per Malattie Pediatriche Rare (PRV) per 150 milioni di dollari.
La posizione di cassa si attestava a 75,5 milioni di dollari al 31 dicembre 2024. Con l'attuale previsione operativa ed escludendo i proventi dalla vendita del PRV, Zevra prevede di avere liquidità fino al 2029. Il trial di fase 3 DiSCOVER per il celiprololo ha arruolato un totale di 27 pazienti, e l'azienda prevede di presentare domanda per l'autorizzazione al marketing nell'UE per MIPLYFFA nel secondo semestre del 2025.
Zevra Therapeutics (ZVRA) reportó resultados financieros para el año fiscal 2024 con ingresos netos de 23,6 millones de dólares, incluyendo 12,0 millones de dólares en el cuarto trimestre de 2024. La compañía registró una pérdida neta de 105,5 millones de dólares (2,28 dólares por acción) para 2024, en comparación con una pérdida de 46,0 millones de dólares en 2023.
Los aspectos destacados incluyen el exitoso lanzamiento comercial de MIPLYFFA tras la aprobación de la FDA en septiembre de 2024, con 109 formularios de inscripción de recetas recibidos a finales de año. La compañía firmó un acuerdo para vender su Voucher de Revisión Prioritaria para Enfermedades Pediátricas Raras (PRV) por 150 millones de dólares.
La posición de efectivo se situó en 75,5 millones de dólares al 31 de diciembre de 2024. Con la proyección operativa actual y excluyendo los ingresos de la venta del PRV, Zevra proyecta tener liquidez hasta 2029. El ensayo de fase 3 DiSCOVER para el celiprolol incluyó un total de 27 pacientes, y la compañía planea presentar una solicitud de autorización de comercialización en la UE para MIPLYFFA en la segunda mitad de 2025.
제브라 테라퓨틱스 (ZVRA)는 2024 회계연도의 재무 결과를 보고하며, 순수익이 2360만 달러에 달하고, 2024년 4분기에는 1200만 달러를 포함한다고 발표했습니다. 이 회사는 2024년 동안 1억 550만 달러 (주당 2.28달러)의 순손실을 기록했으며, 이는 2023년의 4600만 달러 손실과 비교됩니다.
주요 하이라이트로는 2024년 9월 FDA 승인을 받은 MIPLYFFA의 성공적인 상업 출시가 있으며, 연말까지 109개의 처방 등록 양식이 접수되었습니다. 회사는 1억 5000만 달러에 희귀 소아 질병 우선 검토 바우처 (PRV)를 판매하기로 계약했습니다.
2024년 12월 31일 기준 현금 보유액은 7550만 달러였습니다. 현재 운영 예측과 PRV 판매 수익을 제외하고, 제브라는 2029년까지 현금 유동성을 유지할 것으로 예상합니다. 셀리프로롤에 대한 3상 DiSCOVER 시험에는 총 27명의 환자가 등록되었으며, 회사는 2025년 하반기에 MIPLYFFA의 EU 마케팅 승인을 신청할 계획입니다.
Zevra Therapeutics (ZVRA) a annoncé ses résultats financiers pour l'exercice 2024 avec un chiffre d'affaires net de 23,6 millions de dollars, dont 12,0 millions de dollars au quatrième trimestre 2024. L'entreprise a enregistré une perte nette de 105,5 millions de dollars (2,28 dollars par action) pour 2024, contre une perte de 46,0 millions de dollars en 2023.
Parmi les faits marquants, on trouve le lancement commercial réussi de MIPLYFFA suite à l'approbation de la FDA en septembre 2024, avec 109 formulaires d'inscription de prescription reçus d'ici la fin de l'année. L'entreprise a conclu un accord pour vendre son Voucher de Révision Prioritaire pour les Maladies Pédiatriques Rares (PRV) pour 150 millions de dollars.
La position de liquidité s'élevait à 75,5 millions de dollars au 31 décembre 2024. Avec les prévisions opérationnelles actuelles et sans compter les produits de la vente du PRV, Zevra prévoit une liquidité jusqu'en 2029. L'essai de phase 3 DiSCOVER pour le célibrolo a inclus un total de 27 patients, et l'entreprise prévoit de déposer une demande d'autorisation de mise sur le marché pour MIPLYFFA dans l'UE au second semestre 2025.
Zevra Therapeutics (ZVRA) berichtete über die finanziellen Ergebnisse für das Geschäftsjahr 2024 mit einem Nettoumsatz von 23,6 Millionen Dollar, einschließlich 12,0 Millionen Dollar im vierten Quartal 2024. Das Unternehmen verzeichnete einen Nettoverlust von 105,5 Millionen Dollar (2,28 Dollar pro Aktie) für 2024, im Vergleich zu einem Verlust von 46,0 Millionen Dollar im Jahr 2023.
Zu den wichtigsten Punkten gehört der erfolgreiche kommerzielle Start von MIPLYFFA nach der FDA-Zulassung im September 2024, mit 109 eingegangenen Rezeptanmeldungen bis zum Jahresende. Das Unternehmen hat eine Vereinbarung zur Verkauf seines Priority Review Voucher (PRV) für seltene pädiatrische Krankheiten für 150 Millionen Dollar getroffen.
Die Liquiditätsposition betrug zum 31. Dezember 2024 75,5 Millionen Dollar. Mit der aktuellen Betriebsvorhersage und ohne die Erlöse aus dem PRV-Verkauf rechnet Zevra mit einer Liquidität bis 2029. Die Phase-3-Studie DiSCOVER für Celiprolol hat insgesamt 27 Patienten eingeschlossen, und das Unternehmen plant, im zweiten Halbjahr 2025 einen Antrag auf Marktzulassung für MIPLYFFA in der EU zu stellen.
- Secured $150M PRV sale agreement, providing significant cash injection
- Extended cash runway into 2029 based on current operations
- Successfully launched MIPLYFFA with 109 prescription enrollments by year-end
- OLPRUVA maintains strong market access at 76% of covered lives
- Q4 2024 revenue of $12.0M, primarily driven by MIPLYFFA sales
- Net loss increased to $105.5M in 2024 from $46.0M in 2023
- Operating expenses rose to $97.0M, up from previous year
- OLPRUVA recorded $5.7M inventory obsolescence reserve expense
- Revenue declined to $23.6M in 2024 from $27.5M in 2023
- French EAP reimbursements decreased by $0.7M in Q4 2024 vs Q4 2023
Insights
Zevra's financial report shows a transformative year with significant strategic developments. The standout element is the
FY 2024 revenue of
The widened net loss of
With
Zevra's evolution into a commercial-stage rare disease company marks a critical inflection point. The successful launch of MIPLYFFA for Niemann-Pick disease type C represents one of only a handful of FDA-approved therapies for ultra-rare lysosomal storage disorders. The 109 prescription enrollment forms collected in just the first six weeks of commercial availability (Nov 21-Dec 31) demonstrates strong initial uptake in a disease with an estimated US prevalence of only 500-600 patients.
The commercial execution appears well-orchestrated, with the company achieving commercial availability at the early end of their guidance. The mention that patients are receiving authorization through both direct formulary coverage and medical exceptions indicates the company is navigating the complex rare disease reimbursement landscape effectively during this launch phase.
Pipeline progress continues with the Phase 3 DiSCOVER trial for celiprolol in Vascular Ehlers-Danlos Syndrome (VEDS), another ultra-rare indication with high unmet need. With 27 patients now enrolled, recruitment pace appears modest but steady in this genetically-confirmed population.
The planned EU regulatory filing for MIPLYFFA in second half 2025 presents a significant expansion opportunity. European approval would substantially increase the addressable patient population and revenue potential. Meanwhile, the company's strategic evaluation of KP1077 for rare sleep disorders suggests appropriate portfolio prioritization rather than stretching resources across too many programs.
FY 2024 net revenue of
Entered into asset purchase agreement for sale of PRV for
Company to host conference call and webcast today, Mar. 11, 2025, at 4:30 p.m. ET
CELEBRATION, Fla., March 11, 2025 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare disease, today reported its financial results for the fourth quarter and full year ended Dec. 31, 2024.
“2024 was a transformational year for Zevra. We emerged as a commercial stage company and are executing on the opportunity to positively impact the lives of people living with rare diseases,” said Neil F. McFarlane, Zevra’s President and Chief Executive Officer. “We are starting 2025 from a position of strength. Our priorities are guided by Zevra’s strategic plan, unveiled during our third quarter call and categorized under four actionable pillars: commercial excellence, pipeline and innovation, talent and culture, and corporate foundation.”
Commercial Excellence
- Initiated commercial launch of MIPLYFFA immediately following U.S. FDA approval on Sep. 20, 2024, and organized U.S. commercial availability on Nov. 21, 2024, at the early end of the company’s guidance.
- As of Dec. 31, 2024, Zevra received 109 total prescription enrollment forms for MIPLYFFA, including all active U.S. Expanded Access Program (EAP) participants. To date in this early phase of the launch, patients have received payor authorization through direct formulary coverage or via the medical exception process as Zevra’s market access team continues to engage with payors to formalize coverage.
- OLPRUVA® had 4 new patient enrollments during Q4 2024 as the team began to execute on its strategy to target adult UCD patients with an active lifestyle where enhanced portability and ease of administration is an important benefit; market access remains consistent at
76% of covered lives.
Pipeline and Innovation
- With receipt of the U.S. approval for MIPLYFFA, regulatory approval in the EU is a key priority. Filing of the Marketing Authorisation Application with the European Medicines Agency (EMA) is targeted for the second half of 2025.
- New data presented during the WORLDSymposium included eight (8) poster presentations, with one poster highlighting safety and tolerability outcomes of MIPLYFFA in NPC patients aged 6 months to <24 months from a pediatric sub-study.
- As of Dec. 31, 2024, eight additional patients enrolled in the Phase 3 DiSCOVER trial of celiprolol for the treatment of Vascular Ehlers-Danlos Syndrome (VEDS), bringing the total patients enrolled to 27. Zevra is focused on expanding its recruitment efforts through direct outreach with providers and clinics that treat genetically confirmed COL3A1 patients.
- Zevra continues its evaluation of strategic alternatives to advance the clinical development and potential future commercialization of KP1077 for the treatment of rare sleep disorders.
Talent and Culture
- In Q4 2024, Zevra consolidated its development and scientific functions under the leadership of Adrian Quartel, M.D. FFPM, Zevra’s Chief Medical Officer, for success with continuity of leadership and the appropriate span of control to achieve objectives.
Corporate Foundation
- On Feb. 27, 2025, Zevra entered into an asset purchase agreement for the sale of a Rare Pediatric Disease Priority Review Voucher (PRV), issued by the U.S. FDA upon the approval of MIPLYFFA, for
$150 million .
FY 2024 Financial Highlights
- Revenue, Net:
$23.6 million , comprised of$10.1 million in MIPLYFFA net revenue,$0.1 million in OLPRUVA net revenue,$9.1 million in in net reimbursements from the French expanded access program (EAP) for arimoclomol, and$4.3 million in royalties and other reimbursements under the AZSTARYS® license agreement. For full year 2023, net revenue was$27.5 million , which was primarily driven by$18.8 million in royalties, net sales milestone payments and other reimbursements under the AZSTARYS license agreement and included$15 million in one-time net sales milestone payments, and$8.7 million in net reimbursements under the French EAP for arimoclomol. - Cost of Goods Sold:
$13.7 million , which includes$6.2 million of non-cash intangible asset amortization, and$5.7 million in inventory obsolescence reserve expense related to OLPRUVA inventory during the year. - Operating Expense:
$97.0 million , which includes non-cash stock compensation expense of$14.9 million , of which$2.4 million was accelerated vesting related to severance arrangements, and severance expense of$2.7 million which was recognized as part of both R&D and SG&A expenses during the year.- R&D expenses were
$42.1 million , which was an increase of$2.3 million compared to FY 2023 due to an increase of$6.3 million in personnel-related costs offset by a decrease of$3.6 million in third party costs primarily as a result of the completion of the KP1077 phase 2 trial. - SG&A expenses were
$54.9 million for 2024, compared to$34.3 million for 2023, which reflects the commercial team fully in place and actively engaged in commercial launch activities.
- R&D expenses were
- Net Loss: (
$105.5) million , or ($2.28) per basic and diluted share for 2024, compared to a net loss of ($46.0) million , or ($1.30) per basic and diluted share for 2023. - Cash Position: Cash, cash equivalents and investments were
$75.5 million as of Dec. 31, 2024. On Feb. 26, 2025, we entered into an agreement to sell the PRV for$150 million in gross proceeds, which upon closing is expected to provide net proceeds of$148.3 million , after fees.
- Cash Runway Forecast: Given our execution to date on the MIPLYFFA and OLPRUVA commercial launches and the sale of the PRV, our Form 10-K will not include a Going Concern disclosure. Based on our current operating forecast, existing resources extend our cash runway into 2029. The cash runway forecast does not include proceeds from the sale of the PRV, but it does include anticipated net revenue from MIPLYFFA and OLPRUVA sales, net reimbursements from the French EAP for arimoclomol, royalties under the AZSTARYS license agreement, and continued investments into our development pipeline.
- Common and Fully Diluted Shares O/S: As of Dec. 31, 2024, total shares of common stock outstanding were 53,670,709, and fully diluted common shares were 66,943,904, which included 7,789,658 issuable from outstanding awards under equity incentive plans, and 5,483,537 shares issuable upon exercise of warrants.
Q4 2024 Financial Highlights
- Revenue, Net:
$12.0 million for Q4 2024, which includes$10.1 million of MIPLYFFA net revenue,$0.1 million of OLPRUVA net revenue,$1.1 million in net reimbursements from the French EAP for arimoclomol, which was a decrease of$0.7 million compared to Q4 2023 due to a true-up in program access fees, and royalties and other reimbursements of$0.7 million under the AZSTARYS License Agreement. Net revenue for Q4 2023 was$13.2 million and included a one-time net sales milestone payment of$10 million under the AZSTARYS License Agreement. - Cost of Goods Sold:
$3.0 million for Q4 2024, which includes$1.6 million of non-cash intangible asset amortization.
Operating Expense:$24.5 million for Q4 2024, which includes non-cash stock compensation expense of$4.0 million , of which$2.1 million was accelerated vesting expense related to severance arrangements, and severance expense of$1.6 million .
- R&D expenses were
$8.4 million for Q4 2024, which was a decrease of$3.0 million compared to Q4 2023 due primarily to a decrease in third party costs upon completion of the KP1077 phase 2 trial, offset in part by an increase in personnel-related costs due to recognition of$2.1 million of non-cash stock compensation expense related to severance arrangements, and$1.6 million of severance expense during the quarter. - SG&A expenses were
$16.1 million for Q4 2024, which was an increase of$1.4 million compared to$14.7 million for Q4 2023, due primarily to an increase in personnel-related costs for the commercial team being fully in place and actively engaged in commercial launch activities and patient services initiatives.
- R&D expenses were
- Net Loss: (
$35.7) million , or ($0.67) per basic and diluted share for Q4 2024, compared to a net loss of ($19.6) million , or ($0.51) per basic and diluted share in Q4 2023.
Upcoming Events
- Zevra will participate in a fireside chat at the 37th Annual ROTH Conference, on Monday, Mar. 17, 2025, at 2:00 p.m. PT. Management will be available for one-on-one meetings with registered attendees.
Conference Call Information
Zevra will host a conference call and audio webcast today at 4:30 p.m. ET to discuss its corporate update and financial results for the fourth quarter and full year 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 Mar. 11, 2025.
Additionally, interested participants and investors may access the conference call by dialing either:
- (800) 245-3047 (United States)
- +1 (203) 518-9765 (International)
- Conference ID: ZVRAQ424
About MIPLYFFA™ (arimoclomol)
MIPLYFFA (arimoclomol) is Zevra’s approved therapy for the treatment of Niemann-Pick disease type C (NPC). Approved by the U.S. Food and Drug Administration on Sep. 20, 2024, MIPLYFFA (arimoclomol) increases the activation of the transcription factors EB (TFEB) and E3 (TFE3) resulting in the upregulation of coordinated lysosomal expression and regulation (CLEAR) genes. MIPLYFFA has also been shown to reduce unesterified cholesterol in the lysosomes of human NPC fibroblasts. The clinical significance of these findings is not fully understood. In the pivotal phase 3 trial, MIPLYFFA halted disease progression compared to placebo over the one-year duration of the trial when measured by the only validated disease progression measurement tool, the NPC Clinical Severity Scale. MIPLYFFA has also received Orphan Medicinal Product designation by the European Medicines Agency (EMA) for the treatment of NPC.
INDICATIONS AND USAGE
MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years of age and older.
IMPORTANT SAFETY INFORMATION
Hypersensitivity Reactions:
Hypersensitivity reactions such as urticaria and angioedema have been reported in patients treated with MIPLYFFA during Trial 1: two patients reported both urticaria and angioedema (
Embryofetal Toxicity:
MIPLYFFA may cause embryofetal harm when administered during pregnancy based on findings from animal reproduction studies. Advise pregnant females of the potential risk to the fetus and consider pregnancy planning and prevention for females of reproductive potential.
Increased Creatinine without Affecting Glomerular Function:
Across clinical trials of MIPLYFFA, mean increases in serum creatinine of
During MIPLYFFA treatment, use alternative measures that are not based on creatinine to assess renal function. Increases in creatinine reversed upon MIPLYFFA discontinuation.
The most common adverse reactions in Trial 1 (≥
Three (
To report SUSPECTED ADVERSE REACTIONS, contact Zevra Therapeutics, Inc. at toll-free phone 1-844-600-2237 or FDA at 1‑800-FDA-1088 or www.fda.gov/medwatch.
Drug Interaction(s):
Arimoclomol is an inhibitor of the organic cationic transporter 2 (OCT2) transporter and may increase the exposure of drugs that are OCT2 substrates. When MIPLYFFA is used concomitantly with OCT2 substrates, monitor for adverse reactions and reduce the dosage of the OCT2 substrate.
Use in Females and Males of Reproductive Potential:
Based on animal findings, MIPLYFFA may impair fertility and may increase post-implantation loss and reduce maternal, placental, and fetal weights.
Renal Impairment:
The recommended dosage of MIPLYFFA, in combination with miglustat, in patients with an eGFR ≥15 mL/minute to <50 mL/minute is lower than the recommended dosage (less frequent dosing) in patients with normal renal function.
MIPLYFFA capsules for oral use are available in the following strengths: 47 mg, 62 mg, 93 mg, and 124 mg.
About OLPRUVA®
OLPRUVA (sodium phenylbutyrate) is Zevra’s approved treatment for the treatment of certain UCDs. 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 U.S. FDA at 1-800-FDA-1088.
About Celiprolol
Celiprolol is Zevra’s investigational clinical candidate for the treatment of Vascular Ehlers-Danlos Syndrome (VEDS). Celiprolol has been granted Orphan Drug and Breakthrough Therapy designations by the U.S. FDA. Zevra recently restarted enrollment in the DiSCOVER trial, a Phase 3 trial being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. 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 KP1077
KP1077 is Zevra’s product candidate intended for the treatment of rare sleep disorders, and is comprised of serdexmethylphenidate (SDX), Zevra’s proprietary prodrug of d-methylphenidate (d-MPH) and is the sole active pharmaceutical ingredient of KP1077. KP1077 has been granted Orphan Drug designation by the U.S. Food and Drug Administration, and by the European Commission, for the treatment of Idiopathic Hypersomnia (IH). The U.S. Drug Enforcement Agency has classified SDX 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.
About Zevra Therapeutics, Inc.
Zevra Therapeutics, Inc. is a commercial-stage rare disease company combining science, data, and patient need 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.
Expanded access programs are made available by Zevra Therapeutics, Inc. and its affiliates and are subject to the Company's Expanded Access Program (EAP) policy, as published on its website. Participation in these programs is subject to the laws and regulations of each jurisdiction under which each respective program is operated. Eligibility for participation in any such program is at the treating physician's discretion.
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 sale of the PRV and anticipated proceeds therefrom; 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 any products or 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; future research and development activities; 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 financial position, including our cash balance and anticipated cash runway; potential revenues from MIPLYFFA sales; potential revenues from our arimoclomol expanded access program in France; 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, including that the PRV sale is subject to conditions and may not close in the timeframe expected or at all. 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, 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.
Zevra Contact
Nichol Ochsner
+1 (732) 754-2545
nochsner@zevra.com
ZEVRA THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share amounts) | |||||||
Year Ended December 31, | |||||||
2024 | 2023 | ||||||
Revenue, net | $ | 23,612 | $ | 27,461 | |||
Cost of product revenue (excluding | 7,417 | 2,173 | |||||
Intangible asset amortization | 6,235 | 772 | |||||
Operating expenses: | |||||||
Research and development | 42,095 | 39,806 | |||||
Selling, general and administrative | 54,868 | 34,314 | |||||
Total operating expenses | 96,963 | 74,120 | |||||
Loss from operations | (87,003 | ) | (49,604 | ) | |||
Other (expense) income: | |||||||
Interest expense | (7,351 | ) | (1,501 | ) | |||
Fair value adjustment related to warrant and CVR liability | 2,057 | (98 | ) | ||||
Fair value adjustment related to investments | (18 | ) | 613 | ||||
Interest and other income, net | 2,175 | 4,541 | |||||
Total other (expense) income | (3,137 | ) | 3,555 | ||||
Loss before income taxes | (90,140 | ) | (46,049 | ) | |||
Income tax (expense) benefit | (15,371 | ) | - | ||||
Net loss | $ | (105,511 | ) | $ | (46,049 | ) | |
Basic and diluted net loss per share of common stock: | |||||||
Net loss | $ | (2.28 | ) | $ | (1.30 | ) | |
Weighted average number of shares of common stock outstanding: | |||||||
Basic and diluted | 46,251,239 | 35,452,460 | |||||
ZEVRA THERAPEUTICS, INC. CONSOLIDATED BALANCE SHEETS (in thousands, except share and par value amounts) | |||||||
December 31, | |||||||
2024 | 2023 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 33,785 | $ | 43,049 | |||
Securities at fair value, current | 35,711 | 24,688 | |||||
Accounts and other receivables | 10,509 | 17,377 | |||||
Prepaid expenses and other current assets | 4,052 | 1,824 | |||||
Inventories, current | 1,970 | - | |||||
Total current assets | 86,027 | 86,938 | |||||
Inventories, noncurrent | 10,999 | 9,841 | |||||
Securities at fair value, noncurrent | 6,010 | - | |||||
Property and equipment, net | 356 | 736 | |||||
Operating lease right-of-use assets | 657 | 790 | |||||
Goodwill | 4,701 | 4,701 | |||||
Intangible assets, net | 68,993 | 69,227 | |||||
Other long-term assets | 384 | 94 | |||||
Total assets | $ | 178,127 | $ | 172,327 | |||
Liabilities and stockholders’ equity | |||||||
Current liabilities: | |||||||
Accounts payable and accrued expenses | $ | 25,456 | $ | 28,403 | |||
Line of credit payable | - | 37,700 | |||||
Current portion of operating lease liabilities | 420 | 543 | |||||
Current portion of discount and rebate liabilities | 4,989 | 4,550 | |||||
Other current liabilities | 3,200 | 2,524 | |||||
Total current liabilities | 34,065 | 73,720 | |||||
Long-term debt | 59,504 | 5,066 | |||||
Derivative and warrant liability | 17,804 | 16,100 | |||||
Income tax payable, noncurrent | 14,431 | - | |||||
Operating lease liabilities, less current portion | 372 | 456 | |||||
Discount and rebate liabilities, less current portion | 7,655 | 7,663 | |||||
Other long-term liabilities | 4,630 | 7,458 | |||||
Total liabilities | 138,461 | 110,463 | |||||
Commitments and contingencies | |||||||
Stockholders' equity: | |||||||
Preferred stock: | |||||||
Undesignated preferred stock, | - | - | |||||
Common stock, | 5 | 4 | |||||
Additional paid-in capital | 555,302 | 472,664 | |||||
Treasury stock, at cost | (10,983 | ) | (10,983 | ) | |||
Accumulated deficit | (505,289 | ) | (399,778 | ) | |||
Accumulated other comprehensive income | 631 | (43 | ) | ||||
Total stockholders' equity | 39,666 | 61,864 | |||||
Total liabilities and stockholders' equity | $ | 178,127 | $ | 172,327 |
