Akebia Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights
Akebia Therapeutics reported its Q3 2024 financial results and recent business highlights. Key points include the commercial launch of Vafseo® (vadadustat) expected in January 2025. Approximately 60% of U.S. dialysis patients are now covered under contracts for Vafseo. The drug has been granted TDAPA reimbursement and a Level II Healthcare Common Procedure Coding System code. Akebia also partnered with U.S. Renal Care for a trial to evaluate Vafseo's outcomes in dialysis patients.
Financially, Akebia reported total revenues of $37.4 million, down from $42.0 million in Q3 2023. Net product revenues for Auryxia were $35.6 million, down from $40.1 million. The cost of goods sold decreased to $14.2 million from $18.0 million. R&D expenses fell to $8.5 million from $13.3 million, while SG&A expenses rose to $26.5 million from $22.7 million. Akebia's net loss increased to $20.0 million from $14.5 million. The company had $34.0 million in cash and cash equivalents as of September 30, 2024.
Akebia Therapeutics ha riportato i risultati finanziari del terzo trimestre del 2024 e le recenti novità aziendali. I punti chiave includono il lancio commerciale di Vafseo® (vadadustat), previsto per gennaio 2025. Circa il 60% dei pazienti in dialisi negli Stati Uniti è ora coperto da contratti per Vafseo. Il farmaco ha ricevuto il rimborso TDAPA e un codice del Livello II nel Healthcare Common Procedure Coding System. Akebia ha inoltre collaborato con U.S. Renal Care per un trial volto a valutare i risultati di Vafseo nei pazienti in dialisi.
Dal punto di vista finanziario, Akebia ha riportato entrate totali di 37,4 milioni di dollari, in calo rispetto ai 42,0 milioni del terzo trimestre del 2023. Le entrate nette da prodotti per Auryxia si sono attestate a 35,6 milioni di dollari, in diminuzione rispetto ai 40,1 milioni. Il costo delle merci vendute è sceso a 14,2 milioni di dollari da 18,0 milioni. Le spese per R&S sono diminuite a 8,5 milioni di dollari rispetto ai 13,3 milioni, mentre le spese SG&A sono aumentate a 26,5 milioni di dollari da 22,7 milioni. La perdita netta di Akebia è aumentata a 20,0 milioni di dollari da 14,5 milioni. L'azienda aveva 34,0 milioni di dollari in contante e equivalenti di cassa al 30 settembre 2024.
Akebia Therapeutics informó sus resultados financieros del tercer trimestre de 2024 y los recientes aspectos destacados de la empresa. Los puntos clave incluyen el lanzamiento comercial de Vafseo® (vadadustat) previsto para enero de 2025. Aproximadamente el 60% de los pacientes con diálisis en EE. UU. ahora están cubiertos por contratos para Vafseo. El medicamento ha recibido reembolso TDAPA y un código del Sistema de Codificación de Procedimientos Comunes de Salud de Nivel II. Akebia también se asoció con U.S. Renal Care para un ensayo destinado a evaluar los resultados de Vafseo en pacientes de diálisis.
Desde el punto de vista financiero, Akebia reportó ingresos totales de 37,4 millones de dólares, una disminución con respecto a los 42,0 millones del tercer trimestre de 2023. Los ingresos netos por productos de Auryxia fueron de 35,6 millones de dólares, en comparación con los 40,1 millones. El costo de bienes vendidos disminuyó a 14,2 millones de dólares desde 18,0 millones. Los gastos de I+D cayeron a 8,5 millones de dólares desde 13,3 millones, mientras que los gastos SG&A aumentaron a 26,5 millones de dólares desde 22,7 millones. La pérdida neta de Akebia aumentó a 20,0 millones de dólares desde 14,5 millones. La compañía tenía 34,0 millones de dólares en efectivo y equivalentes de efectivo al 30 de septiembre de 2024.
Akebia Therapeutics는 2024년 3분기 재무 결과와 최근 비즈니스 하이라이트를 발표했습니다. 주요 사항으로는 2025년 1월에 예정된 Vafseo® (vadadustat)의 상업적 출시가 포함됩니다. 현재 약 60%의 미국 투석 환자가 Vafseo에 대한 계약으로 보장을 받고 있습니다. 이 약물은 TDAPA 환급 및 수준 II 건강 보험 공통 절차 코드가 부여되었습니다. Akebia는 또한 미국 신장 치료 Center(U.S. Renal Care)와 협력하여 투석 환자에서 Vafseo의 결과를 평가하기 위한 시험을 진행했습니다.
재무적으로 Akebia는 2023년 3분기 4200만 달러에서 감소한 총 수익 3740만 달러를 보고했습니다. Auryxia의 순제품 수익은 3560만 달러로 4010만 달러에서 감소했습니다. 판매된 상품의 원가는 1800만 달러에서 1420만 달러로 감소했습니다. 연구개발 비용은 1330만 달러에서 850만 달러로 줄었고, 판매 및 관리 비용은 2270만 달러에서 2650만 달러로 증가했습니다. Akebia의 순손실은 1450만 달러에서 2000만 달러로 증가했습니다. 2024년 9월 30일 현재 회사는 3400만 달러의 현금 및 현금성 자산을 보유하고 있습니다.
Akebia Therapeutics a publié ses résultats financiers pour le troisième trimestre 2024 et les points saillants récents de l'entreprise. Les points clés comprennent le lancement commercial de Vafseo® (vadadustat), prévu pour janvier 2025. Environ 60 % des patients sous dialyse aux États-Unis sont maintenant couverts par des contrats pour Vafseo. Le médicament a été accordé remboursement TDAPA et possède un code de niveau II dans le Healthcare Common Procedure Coding System. Akebia a également établi un partenariat avec U.S. Renal Care pour un essai destiné à évaluer les résultats de Vafseo chez les patients sous dialyse.
Sur le plan financier, Akebia a rapporté des revenus totaux de 37,4 millions de dollars, en baisse par rapport à 42,0 millions de dollars au troisième trimestre 2023. Les revenus nets des produits pour Auryxia étaient de 35,6 millions de dollars, en baisse par rapport à 40,1 millions de dollars. Le coût des biens vendus a diminué à 14,2 millions de dollars contre 18,0 millions de dollars. Les dépenses de R&D ont chuté à 8,5 millions de dollars contre 13,3 millions de dollars, tandis que les dépenses SG&A ont augmenté à 26,5 millions de dollars contre 22,7 millions de dollars. La perte nette d'Akebia a augmenté à 20,0 millions de dollars contre 14,5 millions de dollars. Au 30 septembre 2024, la société disposait de 34,0 millions de dollars en espèces et équivalents de trésorerie.
Akebia Therapeutics hat seine Finanzberichte für das 3. Quartal 2024 und die aktuellen Unternehmenshighlights veröffentlicht. Zu den wichtigsten Punkten gehört die kommerzielle Einführung von Vafseo® (vadadustat), die für Januar 2025 erwartet wird. Etwa 60% der Dialysepatienten in den USA sind nun durch Verträge für Vafseo abgedeckt. Das Medikament hat TDAPA-Erstattung sowie einen Level-II-Code des Healthcare Common Procedure Coding System erhalten. Akebia hat auch eine Partnerschaft mit U.S. Renal Care für eine Studie vereinbart, um die Ergebnisse von Vafseo bei Dialysepatienten zu bewerten.
Finanziell berichtete Akebia von Gesamterlösen in Höhe von 37,4 Millionen Dollar, ein Rückgang von 42,0 Millionen Dollar im 3. Quartal 2023. Die Netto-Produktumsätze von Auryxia betrugen 35,6 Millionen Dollar, ein Rückgang von 40,1 Millionen Dollar. Die Herstellungskosten sanken auf 14,2 Millionen Dollar von 18,0 Millionen Dollar. Die F&E-Ausgaben fielen auf 8,5 Millionen Dollar von 13,3 Millionen Dollar, während die SG&A-Ausgaben auf 26,5 Millionen Dollar von 22,7 Millionen Dollar stiegen. Der Nettoverlust von Akebia stieg auf 20,0 Millionen Dollar von 14,5 Millionen Dollar. Zum 30. September 2024 hatte das Unternehmen 34,0 Millionen Dollar in bar und liquiden Mitteln.
- Vafseo expected to be available in the U.S. market in January 2025.
- 60% of U.S. dialysis patients now covered under contracts for Vafseo.
- TDAPA reimbursement granted for Vafseo.
- Cost of goods sold decreased to $14.2 million.
- Total revenues decreased to $37.4 million from $42.0 million.
- Net product revenues for Auryxia fell to $35.6 million from $40.1 million.
- Net loss increased to $20.0 million from $14.5 million.
- SG&A expenses rose to $26.5 million from $22.7 million.
Insights
The Q3 results show mixed signals with concerning revenue trends but promising commercial progress for Vafseo. Total revenue declined to
However, the commercial outlook is strengthening with contracts covering
The initiation of the VOICE trial with U.S. Renal Care represents a strategic move to build clinical evidence for Vafseo. The study's focus on mortality non-inferiority and potential
The transition from Auryxia to Vafseo will be critical, especially with Auryxia moving to bundled payments in 2025. The commercial infrastructure appears well-positioned with major dialysis provider contracts secured.
- Vafseo® (vadadustat) on track for U.S. market availability expected in January 2025
- Over 300,000 patients, representing approximately
60% of dialysis patient lives in theU.S. , now covered under dialysis provider contracts for Vafseo - Vafseo granted TDAPA reimbursement and issued a Level II Healthcare Common Procedure Coding System code
- Akebia to Host Conference Call at 8:00 a.m. ET on November 7
"Our entire organization has been diligently executing across multiple fronts on launch readiness activities as we approach Vafseo U.S. market availability expected in January. Importantly, approximately 60 percent of patients on dialysis are now covered under dialysis organization and group purchasing organization contracts for Vafseo," said John P. Butler, Chief Executive Officer of Akebia. "We expect to enter into contracts with additional dialysis providers to increase coverage over the remainder of 2024 while continuing our efforts to drive demand for Vafseo from prescribers. We also recently partnered with
Progress on Key Vafseo Business Initiatives
- Akebia has entered into commercial supply contracts for Vafseo with dialysis organizations treating over 300,000 patients, which represents approximately
60% of dialysis patients in theU.S. Recent commercial supply contracts include agreements with one of the leading dialysis organizations serving more than 200,000 dialysis patients, USRC which serves more than 36,000 patients and Renal Purchasing Group, a specialty group purchasing organization that serves many of the independent and small dialysis organizations. - In October 2024, the Center for Medicare & Medicaid Services determined that Vafseo met the criteria for Transitional Drug Add-On Payment Adjustment (TDAPA) reimbursement, which will begin on January 1, 2025. Akebia also received a Level II Healthcare Common Procedure Coding System code for Vafseo that will be utilized by dialysis organizations to help process health insurance claims for Medicare enrollees upon launch.
- In October 2024, Akebia had a strong presence at the ASN Kidney Week conference, hosting commercial and medical affairs booths, and a product theatre, as well as presenting seven scientific posters at the conference. The event was well-attended with significant participation from the nephrology community serving to help Akebia further educate the physician community and to drive prescriber demand in advance of Vafseo market availability.
- In September 2024, Akebia and USRC initiated the Vafseo Outcomes In-Center Experience (VOICE) trial. The trial will randomize patients to treatment with oral Vafseo 300 mg tablets administered three times per week or standard of care erythropoiesis-stimulating agents and will be powered to demonstrate non-inferiority for all-cause mortality and superiority for a
10% reduction in all-cause hospitalization.
Financial Results
- Revenues: Total revenues were
in the third quarter of 2024 compared to$37.4 million for the third quarter of 2023, comprised of the following components:$42.0 million - Auryxia® (ferric citrate) net product revenues were
in the third quarter of 2024 as compared to$35.6 million in the third quarter of 2023. This decrease was driven by a reduction in volume partially offset by price increases and execution of our contracting strategy with third party payors. Akebia continues to enter into commercial supply contracts for Auryxia, which is expected to be added to the bundled payment for dialysis services in January 2025.$40.1 million - License, collaboration and other revenues were
in the third quarter of 2024 compared to$1.8 million in the third quarter of 2023.$1.9 million
- Auryxia® (ferric citrate) net product revenues were
- Cost of Goods Sold: Cost of goods sold (COGS) was
in the third quarter of 2024 compared to$14.2 million in the third quarter of 2023. This decrease was driven by a$18.0 million benefit due to our ability to commercially sell inventory previously written-down as excess inventory, as well as lower year-over-year sales volume. Akebia continues to carry a non-cash intangible amortization charge of$3.7 million per quarter in COGS through the fourth quarter of 2024.$9.0 million - Research & Development Expenses: Research and development expenses were
in the third quarter of 2024 compared to$8.5 million in the third quarter of 2023. This decrease was driven by the completion of activities related to certain clinical trials, lower headcount related costs and decreased professional service and consulting expense.$13.3 million - Selling, General & Administrative Expenses: Selling, general and administrative expenses were
in the third quarter of 2024 compared to$26.5 million in the third quarter of 2023. This increase was driven by higher costs incurred in connection with preparatory activities related to Vafseo product availability in the$22.7 million U.S. , which is expected in January 2025. - Net Loss: Net loss was
in the third quarter of 2024 compared to$20.0 million in the third quarter of 2023. The increase in net loss included$14.5 million in non-cash interest expense related to the settlement royalty liability in connection with the Vifor Termination and Settlement Agreement that Akebia signed in July 2024.$4.4 million - Cash Position: Cash and cash equivalents as of September 30, 2024 were approximately
. Akebia expects its existing cash resources and cash from operations will be sufficient to fund its current operating plan, including the$34.0 million U.S. Vafseo launch, for at least two years.
Conference Call
Akebia will host a conference call on Thursday, November 7 at 8:00 a.m. Eastern Time to discuss third quarter 2024 earnings. To access the call, please register by clicking on this Registration Link, and you will be provided with dial in details. To avoid delays and ensure timely connection, we encourage dialing into the conference call 15 minutes ahead of the scheduled start time.
A live webcast of the conference call will be available via the "Investors" section of Akebia's website at: https://ir.akebia.com/. An online archive of the webcast can be accessed via the Investors section of Akebia's website at https://ir.akebia.com approximately two hours after the event.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in
About Vafseo® (vadadustat) tablets
Vafseo® (vadadustat) tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing hemoglobin and red blood cell production to manage anemia. Vafseo is approved for use in 37 countries.
INDICATION
VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.
Limitations of Use
- VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being.
- VAFSEO is not indicated for use:
- As a substitute for red blood cell transfusions in patients who require immediate correction of anemia.
- In patients with anemia due to CKD not on dialysis.
IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets
WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS. |
|
CONTRAINDICATIONS
- Known hypersensitivity to VAFSEO or any of its components
- Uncontrolled hypertension
WARNINGS AND PRECAUTIONS
- Increased Risk of Death, Myocardial Infarction (MI), Stroke, Venous Thromboembolism, and Thrombosis of Vascular Access
A rise in hemoglobin (Hb) levels greater than 1 g/dL over 2 weeks can increase these risks. Avoid in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting VAFSEO. Targeting a Hb level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events. Use the lowest effective dose to reduce the need for red blood cell (RBC) transfusions. Adhere to dosing and Hb monitoring recommendations to avoid excessive erythropoiesis. - Hepatotoxicity
Hepatocellular injury attributed to VAFSEO was reported in less than1% of patients, including one severe case with jaundice. Elevated serum ALT, AST, and bilirubin levels were observed in1.8% ,1.8% , and0.3% of CKD patients treated with VAFSEO, respectively. Measure ALT, AST, and bilirubin before treatment and monthly for the first 6 months, then as clinically indicated. Discontinue VAFSEO if ALT or AST is persistently elevated or accompanied by elevated bilirubin. Not recommended in patients with cirrhosis or active, acute liver disease. - Hypertension
Worsening of hypertension was reported in14% of VAFSEO and17% of darbepoetin alfa patients. Serious worsening of hypertension was reported in2.7% of VAFSEO and3% of darbepoetin alfa patients. Cases of hypertensive crisis, including hypertensive encephalopathy and seizures, have also been reported in patients receiving VAFSEO. Monitor blood pressure. Adjust anti-hypertensive therapy as needed. - Seizures
Seizures occurred in1.6% of VAFSEO and1.6% of darbepoetin alfa patients. Monitor for new-onset seizures, premonitory symptoms, or change in seizure frequency. - Gastrointestinal (GI) Erosion
Gastric or esophageal erosions occurred in6.4% of VAFSEO and5.3% of darbepoetin alfa patients. Serious GI erosions, including GI bleeding and the need for RBC transfusions, were reported in3.4% of VAFSEO and3.3% of darbepoetin alfa patients. Consider this risk in patients at increased risk of GI erosion. Advise patients about signs of erosions and GI bleeding and urge them to seek prompt medical care if present. - Serious Adverse Reactions in Patients with Anemia Due to CKD and Not on Dialysis
The safety of VAFSEO has not been established for the treatment of anemia due to CKD in adults not on dialysis and its use is not recommended in this setting. In large clinical trials in adults with anemia of CKD who were not on dialysis, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetin alfa. - Malignancy
VAFSEO has not been studied and is not recommended in patients with active malignancies. Malignancies were observed in2.2% of VAFSEO and3.0% of darbepoetin alfa patients. No evidence of increased carcinogenicity was observed in animal studies.
ADVERSE REACTIONS
- The most common adverse reactions (occurring at ≥
10% ) were hypertension and diarrhea.
DRUG INTERACTIONS
- Iron supplements and iron-containing phosphate binders: Administer VAFSEO at least 1 hour before products containing iron.
- Non-iron-containing phosphate binders: Administer VAFSEO at least 1 hour before or 2 hours after non-iron-containing phosphate binders.
- BCRP substrates: Monitor for signs of substrate adverse reactions and consider dose reduction.
- Statins: Monitor for statin-related adverse reactions. Limit the daily dose of simvastatin to 20 mg and rosuvastatin to 5 mg.
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm.
- Lactation: Breastfeeding not recommended until two days after the final dose.
- Hepatic Impairment: Not recommended in patients with cirrhosis or active, acute liver disease.
Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide.
Forward-Looking Statements
Statements in this press release regarding Akebia Therapeutics, Inc.'s ("Akebia's") strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the
The terms "intend," "believe," "plan," "goal," "potential," "anticipate, "estimate," "expect," "future," "will," "continue," derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: whether Vafseo will be commercially available when expected; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to, Auryxia® and Vafseo, including estimates regarding the potential market opportunity; the competitive landscape for Auryxia and Vafseo, including potential generic entrants; the ability of Akebia to attract and retain qualified personnel; Akebia's ability to implement cost avoidance measures and reduce operating expenses; decisions made by health authorities, such as the FDA, with respect to regulatory filings; the potential therapeutic benefits, safety profile, and effectiveness of Vafseo; the results of preclinical and clinical research; the direct or indirect impact of the COVID-19 pandemic on the markets and communities in which Akebia and its partners, collaborators, vendors and customers operate; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; and early termination of any of Akebia's collaborations. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and other filings that Akebia may make with the
Akebia Therapeutics® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc. and its affiliates.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
AKEBIA THERAPEUTICS, INC. | |||
Unaudited Condensed Consolidated Statements of Operations | |||
Three Months Ended September 30, | |||
(in thousands, except per share data) | 2024 | 2023 | |
Revenues | |||
Product revenue, net | $ 35,592 | $ 40,118 | |
License, collaboration and other revenue | 1,836 | 1,928 | |
Total revenues | 37,428 | 42,046 | |
Cost of goods sold | |||
Cost of product and other revenue | 5,150 | 8,998 | |
Amortization of intangible asset | 9,011 | 9,011 | |
Total cost of goods sold | 14,161 | 18,009 | |
Operating expenses | |||
Research and development | 8,487 | 13,330 | |
Selling, general and administrative | 26,516 | 22,710 | |
License | 769 | 864 | |
Restructuring | — | 169 | |
Total operating expenses | 35,772 | 37,073 | |
Loss from operations | (12,505) | (13,036) | |
Other expense, net | (6,678) | (1,453) | |
Change in fair value of warrant liability | (856) | — | |
Loss on termination of lease | — | — | |
Net loss | $ (20,039) | $ (14,489) | |
Net loss per share - basic and diluted | |||
Weighted-average number of common shares - basic and diluted | 210,348,459 | 188,306,350 |
Unaudited Selected Balance Sheet Data | |||
(in thousands) | September 30, 2024 | December 31, 2023 | |
Cash and cash equivalents | $ 34,019 | $ 42,925 | |
Working capital | $ 34,411 | $ 18,279 | |
Total assets | $ 207,142 | $ 241,703 | |
Total stockholders' (deficit) equity | $ (50,402) | $ (30,584) |
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SOURCE Akebia Therapeutics, Inc.
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