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Anteris Technologies Global Corp.

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Business Summary

Anteris Technologies Global Corp. is a structural heart company focused on developing and commercializing science-driven advancements to restore heart valve patients to healthy function. The company's core business model revolves around its lead product, the DurAVR® THV System, designed to treat aortic stenosis, a life-threatening condition. Anteris generates revenue primarily from the sale of regenerative tissue products, historically to 4C Medical Technologies, Inc. and LeMaitre Vascular, Inc., though the latter agreement expired in January 2025 and the former will terminate in June 2026. The company is currently in a development stage, incurring net losses and generating small amounts of revenue insufficient to cover its research, development, and operational activities . The total global market opportunity for Transcatheter Aortic Valve Replacement (TAVR) in relation to severe aortic stenosis and valve-in-valve (ViV) procedures is projected to reach $9.9 billion and $2.5 billion, respectively, by 2028 . North America and Europe are key target markets, expected to reach $5.5 billion and $3.7 billion for severe aortic stenosis, and $1.5 billion and $0.8 billion for ViV procedures, respectively, by 2028 .

The company's primary product is the DurAVR® THV System, a balloon-expandable transcatheter heart valve. This system consists of a single-piece, biomimetic valve made with proprietary ADAPT® tissue-enhancing technology and deployed with the ComASUR® Delivery System. The ADAPT® tissue engineering process transforms xenograft tissue (bovine heart tissue) into a durable bioscaffold, clinically demonstrated to be calcium-free for up to 10 years post-procedure , and has been used in over 55,000 patients globally in other indications . The ComASUR® Delivery System is designed for controlled deployment and accurate placement, aiming for precise alignment with the heart’s native commissures . As of December 2025, over 130 patients worldwide have been implanted with the DurAVR® THV . The DurAVR® THV is classified as a Class III medical device by the FDA .

Anteris also holds a 30% interest in v2vmedtech, inc., a company developing an innovative heart valve repair device for the minimally invasive treatment of mitral and tricuspid valve regurgitation . Under a development agreement, Anteris provides engineering, clinical, regulatory, marketing, and executive management resources to v2vmedtech. The R&D contributions (excluding general and administration expenses) paid by Anteris under Stage 1 of this agreement were $2.2 million . Total eligible development and operational contributions paid by Anteris under the v2v Agreements as of December 31, 2025, amounted to $6.2 million .

For the fiscal year ended December 31, 2025, Anteris reported net sales of $1.913 million , a decrease of 29% from $2.703 million in 2024 . The cost of products sold was $0.569 million , a 60% decrease from $1.437 million in 2024 . Research and development (R&D) expense increased by 34% to $69.120 million in 2025 from $51.451 million in 2024 . Selling, general and administrative (SG&A) expense decreased by 7% to $26.118 million in 2025 from $28.187 million in 2024 . The operating loss for 2025 was $93.894 million , a 20% increase from $78.372 million in 2024 . Net loss after income tax was $94.225 million in 2025 , compared to $75.967 million in 2024 . Basic and diluted loss per share was $2.55 in 2025 , compared to $3.68 in 2024 . Net cash used in operating activities was $77.803 million in 2025 , an increase of 27% from $61.241 million in 2024 . As of December 31, 2025, cash and cash equivalents were $12.576 million , down from $70.458 million at December 31, 2024 . Total current liabilities were $21.373 million , and total non-current liabilities were $1.877 million . The company had an accumulated deficit of $370.532 million as of December 31, 2025 .

The decrease in net sales and cost of products sold in 2025 was primarily due to the expiration of the LeMaitre Transition Services Agreement in January 2025, partly offset by increased demand for other higher-yielding tissue products . The significant increase in R&D expenses was mainly driven by a $19.8 million increase related to upscaling manufacturing and quality capabilities, including process design and validation activities and an increase in R&D headcount . Additionally, $5.5 million was attributed to PARADIGM Trial preparatory activities, including clinical costs and scaling of the field-based clinical team, and $1.0 million for expanding medical affairs activities . These increases were partially offset by a $9.5 million reduction in DurAVR® THV product research costs as the focus shifted to clinical, regulatory, and manufacturing activities . The decrease in SG&A expenses was primarily due to a $0.5 million decline in stock-based payment expenses, a $0.6 million reduction in travel and entertainment costs, and a $1.5 million reduction related to a settled claim in 2024 .

During 2025, Anteris advanced regulatory activities in Europe, securing the first European regulatory approval in Denmark in October 2025, which initiated the PARADIGM Trial . In November 2025, the FDA granted Investigational Device Exemption (IDE) approval for the PARADIGM Trial, authorizing enrollment of the first 200 patients . The company also strengthened its operational infrastructure, advancing quality management system buildout for ISO 13485 certification and progressing manufacturing scale-up activities, including expanding clean room capacity . In April 2023, Anteris invested in and entered into a development agreement with v2vmedtech, inc. for a heart valve repair device . The 4C Agreement, a supply and license agreement with 4C Medical Technologies, Inc., was not renewed and will terminate on June 1, 2026 .

Business Outlook

Anteris expects to continue incurring losses for the foreseeable future and does not anticipate generating significant revenue until regulatory approval for its products is obtained and sales commence . The company will require substantial additional funds to achieve its long-term goals and complete the R&D of its current products .

The primary growth area for Anteris is the commercialization of its DurAVR® THV System. The company expects data from the ongoing PARADIGM Trial to provide the clinical evidence required for regulators to approve commercialization, including premarket approval in the United States and CE Mark approval in Europe . The PARADIGM Trial is a global, prospective, randomized, controlled multicenter study comparing DurAVR® THV to commercially available THVs, with its primary endpoint being a composite of all-cause mortality, all stroke, and cardiovascular hospitalizations at 1-year post-procedure . The FDA granted IDE approval for a staged enrollment of the first 200 patients in the PARADIGM Trial in November 2025 . The total global market opportunity for TAVR in relation to severe aortic stenosis and ViV procedures is expected to reach $9.9 billion and $2.5 billion, respectively, by 2028 . North America and Europe are initially targeted, with projected market opportunities of $5.5 billion and $3.7 billion for severe aortic stenosis, and $1.5 billion and $0.8 billion for ViV procedures, respectively, by 2028 . These forecasts assume a projected CAGR of 14.9% for the global market, 16.2% for North America, and 14.0% for Europe .

Another growth vector is the co-development with v2vmedtech, inc. of an innovative heart valve repair device for mitral and tricuspid valve regurgitation. Development is currently in Stage 2, having reached concept lock on the clips and coupler . Anteris provides engineering, clinical, regulatory, marketing, and executive management resources for this development . The R&D contributions (excluding general and administration expenses) for Stage 2 are expected to be $0.4 million to $0.8 million, for Stage 3 $0.8 million to $1.8 million, for Stage 4 $0.7 million to $1.6 million, and for Stage 5 $1.0 million to $2.2 million . After the earlier of the completion of Stage 5 or the incurrence of $10.0 million of development and operational contributions, Anteris's ownership stake in v2vmedtech will increase from 30% to between 58% and 60% .

Operationally, Anteris continued strengthening its infrastructure in 2025, advancing quality management system buildout to support upcoming clinical activities and future ISO 13485 certification . Manufacturing scale-up activities progressed, including cross-training of inspection personnel, expansion of clean room capacity, and ongoing process development initiatives . The company plans to source ADAPT® tissue for the DurAVR® THV from both the United States and Australia to mitigate supply chain risks . The company had approximately 174 full-time equivalent employees as of December 31, 2025 .

Anteris will require substantial additional future financing to fund its operations and R&D programs . Subsequent to December 31, 2025, the company completed a public offering of 40,000,000 shares of Common Stock for gross proceeds of approximately $230.0 million , and a private placement to Medtronic plc of 15,652,173 shares of Common Stock for gross proceeds of approximately $90.0 million . These transactions collectively generated gross proceeds of approximately $320 million . Based on this increased liquidity, the company expects its current cash on hand to be sufficient to fund operations for at least 12 months following December 31, 2025 . The company does not anticipate paying cash dividends in the foreseeable future, intending to retain future earnings to finance business development .

Risk Factors

Anteris faces several material risks, including a history of operating losses and negative cash flows, with a net loss of $94.2 million and negative cash flows from operating activities of $77.8 million for the year ended December 31, 2025 . The company's ability to achieve profitability is uncertain and depends on successful clinical trials, regulatory approvals, and commercialization of products like the DurAVR® THV System. Unfavorable or inconsistent clinical data, or delays in trials, could significantly harm prospects. The medical technology industry is highly competitive and rapidly changing, with competitors potentially having greater resources and established market shares. Anteris relies on third parties for clinical trials, preclinical studies, and supply of materials, including several single-source suppliers, which exposes it to risks of delays, increased costs, and production failures. International operations present risks such as currency fluctuations, differing regulatory standards, and geopolitical tensions, including the ongoing conflict in Ukraine which could disrupt the EMBARK study in Tbilisi, Georgia . Cybersecurity threats, including those from emerging AI technologies, could disrupt operations and lead to data corruption or breaches. Compliance with evolving data privacy laws (e.g., GDPR, CCPA) and healthcare regulations (e.g., Anti-Kickback Statute, False Claims Act) is complex and non-compliance could result in significant penalties. Product liability claims are an inherent risk in medical product sales and testing. Changes in healthcare policy, particularly reimbursement determinations by government and third-party payors, could adversely impact product demand and pricing. Medtronic plc beneficially owns approximately 16.1% of Anteris's Common Stock as of January 22, 2026 , and its interests may conflict with those of other stockholders. The company will require substantial additional future financing, and any equity or debt financing could be dilutive or impose restrictive covenants. As of December 31, 2025, Anteris had United States federal net operating loss (NOL) carryforwards of $158.8 million and Australian net operating and capital loss (NOCL) carryforwards of $74.5 million , which may be subject to limitations if ownership changes occur, potentially increasing future tax liabilities.

Management Priorities

Management emphasizes Anteris's dedication to revolutionizing cardiac care through science-driven advancements, with a primary focus on the DurAVR® THV System. They acknowledge the company's development stage status and history of operating losses, but express belief in significant growth potential within the large, underpenetrated, and growing TAVR market. Key strategic priorities include advancing the DurAVR® THV System through clinical development, particularly the global pivotal PARADIGM Trial, and securing regulatory approvals in the United States and Europe. Management also highlights strengthening operational infrastructure, including quality management systems and manufacturing capacity, to support clinical activities and future commercialization. They note the successful completion of the 2026 Public Offering and Medtronic Private Placement in January 2026, which generated gross proceeds of approximately $320 million , and state that this significantly strengthened liquidity is expected to fund operations for at least 12 months following December 31, 2025 .

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business — Overview
  2. [2] Item 1, Business — Overview
  3. [3] Item 1, Business — Market Opportunity
  4. [4] Item 1, Business — Overview
  5. [5] Item 1, Business — Overview
  6. [6] Item 1, Business — Overview
  7. [7] Item 1, Business — Overview
  8. [8] Item 1, Business — Government Regulation
  9. [9] Item 1, Business — Collaborations
  10. [10] Item 1, Business — Collaborations
  11. [11] Item 1, Business — Collaborations
  12. [12] Item 7, MD&A — Results of Operations
  13. [13] Item 7, MD&A — Net Sales
  14. [14] Item 7, MD&A — Results of Operations
  15. [15] Item 7, MD&A — Cost of Products Sold
  16. [16] Item 7, MD&A — Results of Operations
  17. [17] Item 7, MD&A — Results of Operations
  18. [18] Item 7, MD&A — Results of Operations
  19. [19] Item 7, MD&A — Results of Operations
  20. [20] Item 7, MD&A — Results of Operations
  21. [21] Item 7, MD&A — Results of Operations
  22. [22] Item 8, Note 14 — Loss Per Share
  23. [23] Item 8, Note 14 — Loss Per Share
  24. [24] Item 7, MD&A — Cash Flows
  25. [25] Item 7, MD&A — Operating Activities
  26. [26] Item 7, MD&A — Capital Requirements and Sources of Liquidity
  27. [27] Item 7, MD&A — Capital Requirements and Sources of Liquidity
  28. [28] Item 8, Consolidated Balance Sheets
  29. [29] Item 8, Consolidated Balance Sheets
  30. [30] Item 7, MD&A — Capital Requirements and Sources of Liquidity
  31. [31] Item 7, MD&A — Net Sales
  32. [32] Item 7, MD&A — R&D Expense
  33. [33] Item 7, MD&A — R&D Expense
  34. [34] Item 7, MD&A — R&D Expense
  35. [35] Item 7, MD&A — Selling, General and Administrative Expense
  36. [36] Item 1, Business — Overview
  37. [37] Item 1, Business — Overview
  38. [38] Item 1, Business — Overview
  39. [39] Item 1, Business — Overview
  40. [40] Item 7, MD&A — Revenue and Other Income
  41. [41] Item 7, MD&A — Capital Requirements and Sources of Liquidity
  42. [42] Item 7, MD&A — Capital Requirements and Sources of Liquidity
  43. [43] Item 1, Business — Overview
  44. [44] Item 1, Business — Overview
  45. [45] Item 1, Business — Overview
  46. [46] Item 1, Business — Market Opportunity
  47. [47] Item 1, Business — Market Opportunity
  48. [48] Item 1, Business — Market Opportunity
  49. [49] Item 1, Business — Collaborations
  50. [50] Item 1, Business — Collaborations
  51. [51] Item 1, Business — Collaborations
  52. [52] Item 1, Business — Collaborations
  53. [53] Item 1, Business — Overview
  54. [54] Item 1, Business — Overview
  55. [55] Item 7, MD&A — R&D Expense
  56. [56] Item 1, Business — Human Capital
  57. [57] Item 1A, Risk Factors — We will require substantial additional future financing
  58. [58] Item 1, Business — 2026 Public Offering
  59. [59] Item 1, Business — Medtronic Private Placement
  60. [60] Item 7, MD&A — Financial Overview
  61. [61] Item 7, MD&A — Capital Requirements and Sources of Liquidity
  62. [62] Item 5, Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities — Dividend Policy
  63. [63] Item 1A, Risk Factors — We have a history of operating losses and may not achieve or maintain profitability in the future.
  64. [64] Item 1A, Risk Factors — Unstable market and economic conditions, including as a result of geopolitical events, including current and potential conflicts, may have serious adverse consequences on our business, financial condition, results of operations or liquidity, either directly or through adverse impacts on certain of the third parties on which we rely to conduct certain aspects of our preclinical studies or clinical trials.
  65. [65] Item 1A, Risk Factors — Medtronic beneficially owns a significant equity interest in us and its interests may conflict with our or your interests.
  66. [66] Item 8, Note 6 — Operating loss carryforwards
  67. [67] Item 23, Subsequent Events — 2026 Public Offering and Medtronic Private Placement
  68. [68] Item 3, Going Concern

Analysis on 5/22/2026