Anteris Reports 2024 Financial Results and Provides Corporate Update
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) reported its 2024 financial results and corporate updates. Key highlights include a successful U.S. IPO raising $88.8M and preparations for the DurAVR® Transcatheter Heart Valve's global pivotal study. The company completed 86 patient cases and initiated European Early Feasibility Study in Denmark.
Financial results show net sales of $2.7M and a net loss of $76.0M for 2024, ending with a cash position of $70.5M. The planned pivotal trial will be an all-risk, head-to-head TAVR registration trial involving 80 sites and 1,000-1,200 patients with severe calcific aortic stenosis.
The company advanced manufacturing scale-up in Malaga and Minneapolis facilities, presented clinical data at major conferences, and plans to submit an IDE application to FDA in Q1 2025.
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) ha riportato i risultati finanziari e gli aggiornamenti aziendali per il 2024. I punti salienti includono un IPO di successo negli Stati Uniti che ha raccolto 88,8 milioni di dollari e i preparativi per lo studio clinico globale pivotale della valvola cardiaca transcatetere DurAVR®. L'azienda ha completato 86 casi di pazienti e ha avviato uno studio di fattibilità precoce in Europa in Danimarca.
I risultati finanziari mostrano vendite nette di 2,7 milioni di dollari e una perdita netta di 76,0 milioni di dollari per il 2024, con una posizione di liquidità finale di 70,5 milioni di dollari. Il trial pivotale pianificato sarà uno studio di registrazione TAVR a rischio totale, che coinvolgerà 80 siti e da 1.000 a 1.200 pazienti con stenosi aortica calcifica severa.
L'azienda ha avanzato la scalabilità della produzione nelle strutture di Malaga e Minneapolis, ha presentato dati clinici in importanti conferenze e prevede di presentare una domanda IDE alla FDA nel primo trimestre del 2025.
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) informó sobre sus resultados financieros y actualizaciones corporativas para 2024. Los aspectos destacados incluyen una exitosa OPI en EE. UU. que recaudó 88,8 millones de dólares y los preparativos para el estudio pivotal global de la válvula cardíaca transcatéter DurAVR®. La empresa completó 86 casos de pacientes e inició un estudio de viabilidad temprana en Europa en Dinamarca.
Los resultados financieros muestran ventas netas de 2,7 millones de dólares y una pérdida neta de 76,0 millones de dólares para 2024, finalizando con una posición de efectivo de 70,5 millones de dólares. El ensayo pivotal planificado será un ensayo de registro TAVR de riesgo total, que involucrará 80 sitios y de 1.000 a 1.200 pacientes con estenosis aórtica calcificada severa.
La empresa avanzó en la escalabilidad de la producción en las instalaciones de Málaga y Minneapolis, presentó datos clínicos en conferencias importantes y planea presentar una solicitud IDE a la FDA en el primer trimestre de 2025.
안테리스 테크놀로지스 글로벌 코프. (NASDAQ: AVR, ASX: AVR)는 2024년 재무 결과 및 기업 업데이트를 보고했습니다. 주요 하이라이트에는 8,880만 달러를 모금한 성공적인 미국 IPO와 DurAVR® 경피 심장 판막의 글로벌 주요 연구 준비가 포함됩니다. 이 회사는 86명의 환자 사례를 완료하고 덴마크에서 유럽 조기 타당성 연구를 시작했습니다.
재무 결과는 270만 달러의 순매출과 7600만 달러의 순손실을 보여주며, 현금 잔고는 7050만 달러로 마감했습니다. 계획된 주요 시험은 80개 사이트와 심한 석회화 대동맥 협착증 환자 1,000~1,200명을 포함하는 모든 위험의 TAVR 등록 시험이 될 것입니다.
회사는 말라가와 미니애폴리스 시설에서 제조 규모 확대를 진행했으며, 주요 회의에서 임상 데이터를 발표하고 2025년 1분기에 FDA에 IDE 신청서를 제출할 계획입니다.
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) a publié ses résultats financiers et ses mises à jour d'entreprise pour 2024. Les points forts incluent une introduction en bourse réussie aux États-Unis ayant permis de lever 88,8 millions de dollars et les préparatifs pour l'étude pivotale mondiale de la valve cardiaque transcatheter DurAVR®. L'entreprise a complété 86 cas de patients et a lancé une étude de faisabilité précoce en Europe au Danemark.
Les résultats financiers montrent des ventes nettes de 2,7 millions de dollars et une perte nette de 76,0 millions de dollars pour 2024, se terminant avec une position de trésorerie de 70,5 millions de dollars. L'essai pivot prévu sera un essai d'enregistrement TAVR à risque total impliquant 80 sites et 1 000 à 1 200 patients souffrant de sténose aortique calcifiée sévère.
L'entreprise a avancé dans l'augmentation de la capacité de production dans ses installations de Malaga et de Minneapolis, a présenté des données cliniques lors de conférences majeures et prévoit de soumettre une demande IDE à la FDA au premier trimestre de 2025.
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) hat seine finanziellen Ergebnisse und Unternehmensupdates für 2024 veröffentlicht. Zu den wichtigsten Highlights gehören ein erfolgreicher Börsengang in den USA, der 88,8 Millionen Dollar einbrachte, sowie die Vorbereitungen für die globale Hauptstudie der DurAVR® Transkatheter-Herzklappe. Das Unternehmen hat 86 Patientenfälle abgeschlossen und eine europäische Frühstudie in Dänemark initiiert.
Die finanziellen Ergebnisse zeigen Nettoverkäufe von 2,7 Millionen Dollar und einen Nettoverlust von 76,0 Millionen Dollar für 2024, mit einer liquiden Mittelposition von 70,5 Millionen Dollar zum Jahresende. Die geplante Hauptstudie wird eine risikobehaftete, vergleichende TAVR-Zulassungsstudie sein, die 80 Standorte und 1.000 bis 1.200 Patienten mit schwerer aortaler Stenose umfasst.
Das Unternehmen hat die Produktionskapazität in den Einrichtungen in Málaga und Minneapolis ausgebaut, klinische Daten auf großen Konferenzen präsentiert und plant, im ersten Quartal 2025 einen IDE-Antrag bei der FDA einzureichen.
- Successful U.S. IPO raising $88.8M, strengthening financial position
- Strong cash position of $70.5M at year-end
- Expanded clinical experience with 86 successful patient cases
- Manufacturing scale-up progress in multiple facilities
- Net loss of $76.0M in 2024
- Low net sales of only $2.7M
- Manufacturing of LeMaitre products ceased in January 2025
Insights
Anteris's 2024 financial results highlight a $76 million net loss against modest $2.7 million revenue from tissue products. However, the company has secured substantial capital through its $88.8 million Nasdaq IPO, ending 2024 with a $70.5 million cash position. This runway should comfortably fund the pivotal trial for their DurAVR® Transcatheter Heart Valve (THV) system, scheduled for IDE submission in Q1 2025.
The company's 86 treated patients to date and the initiation of European clinical studies represent important regulatory milestones. Manufacturing scale-up in Australia and the US indicates preparation for commercial-scale operations. While burning significant capital, Anteris has executed well on its fundraising strategy by securing investor confidence, evidenced by the successful IPO and $25 million convertible note facility (subsequently repaid).
The larger strategic picture shows Anteris positioning itself within the lucrative structural heart market with its novel THV technology. Their head-to-head pivotal trial design against established players like Edwards and Medtronic demonstrates confidence in their technology's competitive advantages. The financial results reflect a typical pre-commercial medical device company profile - high cash burn funding R&D and clinical validation, with investor capital supporting the path to potential regulatory approval.
Anteris's DurAVR® THV system represents significant potential in the TAVR (Transcatheter Aortic Valve Replacement) market, with the company making substantial clinical progress. The 86 patient cases have generated valuable data supporting their upcoming IDE submission, while the first European cases in January 2025 demonstrated successful outcomes in both native valve stenosis and valve-in-valve procedures.
The planned pivotal trial design is particularly noteworthy - an all-risk, head-to-head comparison against industry leaders Edwards (SAPIEN) and Medtronic (Evolut). This 1:1 randomized study across 80 sites with 1,000-1,200 patients aims to demonstrate non-inferiority, a pragmatic regulatory approach. The parallel valve-in-valve registry suggests targeting multiple market segments simultaneously.
The company's hemodynamic performance data presentations at major conferences (TCT, EuroPCR, New York Valves) indicate positive clinical outcomes, particularly the CMR imaging showing laminar flow restoration and early left ventricular remodeling - critical functional measurements for heart valve performance. The finalized balloon-expandable ComASUR® delivery system design suggests the company has addressed one of the most technically challenging aspects of TAVR systems. While still pre-approval, the clinical progression, manufacturing scale-up, and design optimization demonstrate appropriate execution of a medical device development pathway.
EAGAN, Minn. and BRISBANE, Australia, March 12, 2025 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today reported financial results for the full year ended December 31, 2024, and provided a corporate update.
2024 Full Year Highlights & Recent Developments
- Achieved a successful U.S. Initial Public Offering (“IPO”) onto Nasdaq raising
$88.8m (AUD$139.3m ) before costs and commissions and excluding the underwriters option, which completed the Company’s re-domiciliation to the United States. - Continued preparations to initiate the DurAVR® Transcatheter Heart Valve’s (“THV”) randomized global pivotal study (the “Pivotal Trial”) – request for Investigational Device Exemption (“IDE”) on track for submission to the U.S. Food and Drug Administration (“FDA”) in the first quarter of 2025.
- Generated additional positive patient data to support IDE submission for the DurAVR® THV – 86 cases treated to date.
- Performed first two cases of the DurAVR® THV’s European Early Feasibility Study (“EU-EFS”) at Structural Heart Copenhagen in Denmark (January 2025).
- Increased awareness of the DurAVR® THV system in the global medical community including multiple high profile podium presentations at key congresses such as New York Valves and the 36th TCT Conference.
- Finalized design optimization of the balloon-expandable ComASUR® delivery system and expanded manufacturing scale-up in Malaga, AU and Minneapolis, U.S. to support planned Pivotal Trial.
- Concluded 2024 with a strong cash position of
$70.5m (AUD$113.3m ).
“This has been a transformational year for Anteris as we made advancements across all aspects of our business, which positions us well to commence the Pivotal Trial of our DurAVR® THV system in 2025.” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris.
Business & Operations
DurAVR® THV Commercialization Update:
Preparations for Pivotal Trial
During 2024, the Company executed several key activities to facilitate obtaining approval from the FDA to commence a Pivotal Trial for the Company’s lead product, the DurAVR® THV system. The approval to commence the Pivotal Trial, if granted, requires submitting an IDE application to the FDA, which is planned for the first quarter of 2025. Multiple pre-submission meetings with the FDA occurred covering topics such as reviewing the Pivotal Trial’s clinical plan and statistical rationale. Other key preparatory activities included life cycle testing, test method creation and validation, human factors validation testing with physicians, sterilization and shipping validation, and simulated use testing.
Expanded clinical experience
During 2024, Anteris advanced preparations for the DurAVR® THV’s planned EU-EFS. The first two cases were performed in January 2025 at Structural Heart Copenhagen in Denmark by Dr Ole De Backer. Excellent outcomes were achieved in a native aortic valve stenosis and a degenerated surgical valve. The EU-EFS is planned to be carried out in Denmark, Sweden, the Netherlands, France and Germany, enrolling up to 40 patients, to provide both Valve-in-Valve (“ViV”) data in a controlled setting as well as generate further feasibility and safety data in patients with severe aortic stenosis. The objective of these EU-EFS implants is to build awareness, understanding and experience with the DurAVR® THV system.
Clinical data presented at major medical conferences
Over the course of 2024, the Company attended several key industry conferences to promote awareness among clinicians of the DurAVR® THV system as a potential new treatment paradigm for aortic stenosis. These activities included podium presentations at Cardiovascular Research Technologies or CRT (March 2024), Sydney Valves (March 2024), Society for Cardiovascular Angiography & Interventions or SCAI (May 2024), Euro PCR (May 2024), New York Valves (June 2024), the 36th Annual Transcatheter Cardiovascular Therapeutics or TCT Conference (October 2024) and London Valves (Nov 2024).
Data presented during the year included US-EFS 30-day results, First-in-Human (“FIH”) 1-year results demonstrating sustained hemodynamic performance, ViV data and a post-transcatheter aortic valve replacement (“TAVR”) cardiac magnetic resonance (“CMR”) imaging study demonstrating restoration of laminar flow and early left ventricular reverse remodelling following treatment with the DurAVR® THV.
Scaled up manufacturing to support Pivotal Trial
During 2024, the Company’s team continued design optimizations to the DurAVR® THV system to optimise the procedure, support ease of use and lower manufacturing costs. Additionally, manufacturing scale-up progressed at both the Malaga, AU and Minneapolis, U.S. manufacturing facilities as well as outsourced suppliers of the key components and delivery system. Additionally, Anteris engaged a Contract Research Organisation and bolstered in-house resources to support planned requirements to initiate and manage the Pivotal Trial.
About the DurAVR® THV Pivotal Trial
This prospective Pivotal Trial is anticipated to be the first all-risk, head-to-head TAVR registration trial to date. The Pivotal Trial is expected to include up to 80 sites across the U.S. and other key markets with an estimated 1,000 to 1,200 patients having severe, calcific aortic stenosis, and subject to customary study exclusions. The Pivotal Trial will be on a 1:1 randomised basis with patients receiving either the DurAVR® THV or TAVR using a commercially available and approved THV from the SAPIEN series (Edwards Life Sciences) or the Evolut series (Medtronic). This is intended to generate the widest possible patient population from the Pivotal Trial, enabling direct comparison with existing therapy and support a claim to the FDA of non-inferiority of the DurAVR® THV. Patients with a failed surgical bio-prosthesis needing ViV TAVR will be enrolled in a separate parallel registry. This is intended to support the Company’s plans for the ViV market opportunity. To date, 86 patients have been implanted with the DurAVR® THV with an expanding dataset over one year and overall promising performance across several haemodynamic measures.
2024 Financial Results
The financial results for Anteris for the year ended December 31, 2024 are reviewed below. All amounts in $ refer to U.S. dollars.
- Net Sales for 2024 were
$2.7 million - Net Loss after Income Tax for 2024 was
$76.0 million - Closing cash balance at December 31, 2024 was
$70.5 million
In 2024, Net Sales were
In 2024, the Net Loss after Income Tax of
Anteris refers to the detailed Financial Information contained in its Form 10-K filing including the Management Discussion & Analysis and the Risks.
Corporate and Financing Activities
In October 2024, Anteris entered an AUD
In December 2024, Anteris completed its U.S IPO, through the offering of 14,800,000 shares of common stock (the “Common Stock”) in the U.S. at a price of
In January 2025, TD Cowen, Barclays and Cantor (the “IPO Underwriters”) partially exercised the underwriters’ option to purchase additional shares granted by Anteris in respect of 78,481 shares of Common Stock at the purchase price of
About Anteris®
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, U.S., Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients.
Anteris’ lead product, the DurAVR® Transcatheter Heart Valve (“THV”), was designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV system is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® delivery system.
Forward-Looking Statements
This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ registration statement filed on 10 December 2024 with the SEC and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, neither ATL or Anteris assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.
Authorisation and Additional information
This announcement was authorised for release on the ASX by the Board of Directors.
For more information:
| Investor Relations | Investor Relations (US) |
| investors@anteristech.com | mchatterjee@bplifescience.com |
| Debbie Ormsby | Malini Chatterjee, Ph.D. |
| Anteris Technologies Global Corp. | Blueprint Life Science Group |
| +61 1300 550 310 | +61 7 3152 3200 | +1 917 330 4269 |
| Website | www.anteristech.com |
| X | @AnterisTech |
| www.facebook.com/anteristech | |
| https://www.linkedin.com/company/anteristech |
FAQ
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