AVR 10-K Fiscal year ended Dec. 31, 2024

☒	ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO

Delaware		99-1407174
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

Toowong Tower, Level 3, Suite 302 9 Sherwood Road Toowong, QLD Australia		4066
(Address of principal executive offices)		(Zip Code)

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common stock, par value $0.0001 per share		AVR		The Nasdaq Global Market

Large accelerated filer		Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging growth company	☒

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“Acellularized” refers to when all cellular antigens (such as cells and cell remnants) known to initiate inflammation and interrelated calcification mechanisms have been removed.

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“ADAPT ® anti-calcification tissue” refers to the tissue produced by the ADAPT ® tissue engineering process, which transforms xenograft tissue (bovine heart tissue) into a durable bioscaffold which Anteris uses in its DurAVR ® THV to mimic human tissue in aortic valve replacement.

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“Aldehydes” refers to organic compounds.

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“Aortic stenosis” refers to the narrowing of the aortic valve restricting the flow of blood from the left ventricle (lower chamber of the heart) to the aorta (main artery).

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“Bioscaffold” refers to a durable structure engineered from biological material.

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“Biostability” refers to the ability of a material to maintain its physical and chemical integrity after implantation into a living tissue and organs.

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“Coaptation” refers to the portion of the leaflets that touch when the aortic valve is in the closed position.

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“ComASUR ® delivery system” refers to the balloon expandable system which provides controlled deployment and accurate placement of the DurAVR ® THV, designed to achieve precise alignment with the heart’s native commissures to achieve ideal valve positioning.

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“Commissure alignment” refers to the position of the transcatheter aortic valve replacement leaflets in line with the anatomical orientation of the recipient’s native valve leaflets.

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“Commissures” refers to where the valve leaflets are attached to the aortic wall inside the aortic sinus of Valsalva.

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“Cytotoxicity” refers to toxicity to cells.

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“Doppler velocity index” and “DVI” refer to the index that expresses the EOA as a proportion of valve area, with DVI representing the physical ratio of a patient’s aortic valve area to the left ventricular outflow tract area. A higher DVI indicates improved blood flow through the aortic valve. DVI is independent of the flow state (like gradient) and diameter (like EOA).

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“DurAVR ® THV” refers to a transcatheter heart valve (“THV”) developed by Anteris. It is a novel, biomimetic (meaning human-like) valve made from a single-piece of native-shaped ADAPT ® tissue and is used for the treatment of aortic stenosis. The DurAVR ® THV (new aortic valve) is placed within the diseased aortic valve via a minimally invasive procedure.

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“Effective orifice area” and “EOA” refer to the smallest cross-sectional area of the aortic valve opening that is available for blood flow. A larger EOA reduces the work the left ventricle (heart chamber) must do to pump blood through the valve. Patients with severe aortic stenosis typically have an EOA of ≤ 1 cm 2 .

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“Exercise capacity” refers to a measure of a patient’s exercise ability, measured in clinical trials by a six minute walk test (“6MWT”), which scores a person on the distance they can cover in six minutes of walking.

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“Flow displacement” and “FD” refer to a marker of flow eccentricity in the ascending aortic root. Flow in the ascending aortic root is mainly laminar with a flow displacement ranging from 6 – 15% only. A higher degree of FD reflects abnormal turbulent flow.

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“Flow reversal ratio” or “FRR” is calculated at peak systole in the ascending aorta. At this point there should be almost no backward flow, and any backward flow is considered abnormal. FRR represents the ratio of backward and forward flow at peak systole.

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“Hemodynamics” refers to how blood flows through the blood vessels.

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“Laminar flow” refers to a smooth, streamlined flow of blood. In a healthy heart, aortic flow is predominantly laminar during systole (when the left ventricle contracts and pumps blood into the aorta). Abnormal aortic flow is associated with turbulence, which can increase the risk of morbidity and increase the stress on the valve leaflets leading to increased wear and tear and subsequent structural valve deterioration.

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“Mean pressure gradient” and “MPG” refer to the average pressure across the aortic valve between the left ventricle and aorta. Patients with severe aortic stenosis have MPG ≥ 40 mmHg. Post-TAVR MPG is expected to decrease, which indicates that the left ventricle is not working as hard to pump blood through the aortic valve.

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“Transcatheter aortic valve replacement” or “TAVR” refer to a minimally invasive procedure for the treatment of aortic stenosis. A new aortic valve is placed inside the diseased valve, meaning the old, damaged valve is not removed.

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“ViV” refers to valve-in-valve.

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“Xenograft” refers to a tissue that is derived from a species that is different from the recipient of the specimen, meaning tissue from animal species.

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our current and future research and development (“R&D”) activities, including clinical testing and manufacturing and related costs and timing;

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sufficiency of our capital resources;

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our product development and business strategy, including the potential size of the markets for our products and future development and/or expansion of our products in our markets;

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our ability to commercialize products and generate product revenues;

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our ability to raise additional funding when needed;

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any statements concerning anticipated regulatory activities, including our ability to obtain regulatory clearances;

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our R&D expenses; and

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risks facing our operations and intellectual property.

Item 1.

Business.

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Novel, Biomimetic design . DurAVR ® is a novel, first in class, “biomimetic” THV. It is designed to mimic the normal anatomy with a more “human like” valve design. Novel molding of the leaflets allows for a more even coaptation area delivering larger EOAs and lower MPGs.

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Significant clinical results to date in European and United States studies . Anteris has made significant progress in advancing clinical trials, which we believe are delivering strong results and are bringing us closer to potentially achieving regulatory approvals for our DurAVR ® THV system. We believe our FIH study at the Tbilisi Heart and Vascular Clinic in Tbilisi, Georgia, and our EFS study represent key steps on our pathway to ultimately support an IDE to undertake the Pivotal Trial of our DurAVR ® THV system.

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Highly innovative physician-led R&D structure . Our DurAVR ® THV and our ComASUR ® balloon expandable delivery system have both been developed with considerable input from leading interventional cardiologists and cardiac surgeons. We believe our emphasis on involving physicians in the R&D process allows us to better serve the needs of patients and physicians alike.

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Strong intellectual property position . Anteris relies on a combination of intellectual property assets to protect our innovative technology and our brand. This includes our strong patent portfolio, which includes 51 issued patents and 53 pending patent applications, in the United States and in other countries. We also have six pending patent applications through v2vmedtech.

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Industry experienced executive team . Our management team and members of our Board of Directors (our “Board”) have extensive experience in the medical technology and health care industries. We believe that our team’s diverse experiences and track record in the medical industry will assist our efforts to obtain regulatory approval of our products in the United States and other territories and continue to grow our business.

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it is the first transcatheter aortic valve to use a patented construction of a molded single-piece of bioengineered tissue (our ADAPT ® anti-calcification tissue with molded leaflets (see “ ADAPT ® Anti-Calcification Tissue ”));

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it has fewer sutures and seams when compared with conventional valves, thereby preserving tissue integrity with the intent to reduce calcification risk to extend valve durability;

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it is uniquely shaped to emulate the performance of a healthy human valve and produce long leaflet coaptation, laminar flows and near-normal hemodynamics;

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it has large open cells in the stent frame to improve coronary access; and

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it utilizes the ComASUR ® balloon expandable delivery system (see “ ComASUR ® Delivery System ”) for controlled deployment and accurate placement.

		First, the balloon starts out as collapsed.
		The balloon is then expanded and the DurAVR ® THV is deployed.
		Finally, the balloon is deflated and removed.

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the FDA or other regulatory authorities do not approve a clinical trial protocol or a clinical trial, or place a clinical trial on hold;

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patients do not enroll in clinical trials at the rate expected;

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patients do not comply with trial protocols;

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patient follow-up is not at the rate expected;

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patients die during a clinical trial, even though their death may not be related to the products that are part of the trial;

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device malfunctions occur in unexpected ways, with unexpected frequency, or with potential adverse consequences;

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side effects or device malfunctions of similar products already in the market that change the FDA’s view toward approval of new or similar pre-market approvals or clearance of new or similar 510(k)s or de novo classification requests, or result in the imposition of new requirements or testing;

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IRBs and third-party clinical investigators may delay or reject the trial protocol;

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third-party clinical investigators decline to participate in a trial or do not perform a trial on the anticipated schedule or consistent with the clinical trial protocol, investigator agreement, investigational plan, good clinical practices, the IDE regulations, or other FDA or IRB requirements;

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we or third-party organizations do not perform data collection, monitoring and analysis in a timely or accurate manner or consistent with the clinical trial protocol or investigational or statistical plans, or otherwise fail to comply with the IDE regulations governing responsibilities, records, and reports of sponsors of clinical investigations;

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third-party clinical investigators have significant financial interests related to us or our study such that the FDA deems the study results unreliable, or we or investigators fail to disclose such interests;

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regulatory inspections of our clinical trials or manufacturing facilities, which may, among other things, require us to undertake corrective action or suspend or terminate our clinical trials;

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changes in government regulations or administrative actions;

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the interim or final results of the clinical trial are inconclusive or unfavorable as to safety or effectiveness; or

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the FDA concludes that our trial design is unreliable or inadequate to demonstrate safety and effectiveness.

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the device may not be shown to be safe or effective to the FDA’s satisfaction;

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the data from preclinical studies and/or clinical trials may be found unreliable or insufficient to support approval;

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the manufacturing process or facilities may not meet applicable requirements;

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the proposed labeling is found to be false or misleading;

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the device is not shown to conform to a required performance standard; or

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changes in FDA approval policies or adoption of new regulations may require additional data.

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establishment registration and device listing;

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the Device cGMP, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, production, control, supplier/contractor selection, complaint handling, documentation, and other quality assurance procedures during the manufacturing process;

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labeling regulations, advertising and promotion requirements, restrictions on sale, distribution or use of a device, each including the FDA general prohibition against the promotion of products for any uses other than those cleared or approved by the FDA, which are commonly known as “off label” uses;

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medical device reporting regulations requiring that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or if their device malfunctioned and the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur;

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medical device corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections or removals if undertaken to reduce a risk to health posed by a device or to remedy a violation of the FDCA that may present a risk to health;

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recall requirements, including a mandatory recall if there is a reasonable probability that the device would cause serious adverse health consequences or death;

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any order from FDA to repair, replace or refund a device;

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product export requirements;

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device tracking requirements; and

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post-market study and surveillance requirements.

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warning or untitled letters, fines, injunctions, consent decrees and civil penalties;

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unanticipated expenditures, including for repairs, replacements, or refunds of devices;

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customer notifications, voluntary or mandatory recall or seizure of our products;

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operating restrictions, partial suspension or total shutdown of production;

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delay in reviewing, or refusal to clear or approve, submissions or applications for new products or modifications to existing products;

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FDA refusal to issue certificates to foreign governments needed to export products for sale in other countries;

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suspension or withdrawal of FDA approvals or clearances that have already been granted; and

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criminal prosecution.

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United States federal healthcare fraud and abuse laws generally apply to our activities because our products are covered under federal healthcare programs such as Medicare and Medicaid. The federal Anti-Kickback Statute (the “Anti-Kickback Statute”) is particularly relevant because of its broad applicability. The Anti-Kickback Statute makes it illegal for any person, including a prescription medical device manufacturer (or a party acting on its behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration that is intended to induce or reward referrals, including the purchase, recommendation, order or prescription of a particular medical device, for which payment may be made under a federal healthcare program, such as Medicare or Medicaid. Almost any financial arrangement with a healthcare provider, patient or customer could implicate the Anti-Kickback Statute. Statutory exceptions and regulatory safe harbors protect certain arrangements if specific requirements are met. Individual states have corollaries to the federal Anti-Kickback Statute that may also apply and may be more expansive or impose additional requirements.

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Another fraud and abuse law that may be implicated by ownership and compensation arrangements with health care professionals or their families is the Physician Self-Referral Law, commonly referred to as the “Stark Law”. The Stark Law prohibits physicians from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies. While the Stark Law generally only provides to those entities that provide “designated health services” and submit claims for such services, it may nonetheless be implicated by certain ownership or compensation arrangements with health care professionals or family members. Individual states have corollaries to the federal Stark law that may also apply and may be more expansive or impose additional requirements.

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Another development affecting the medical technology industry is the increased use of the federal Civil False Claims Act (the “False Claims Act”) and, in particular, actions brought pursuant to the False Claims Act’s “whistleblower” or “qui tam” provisions. In recent years, the number of suits brought against healthcare companies by private individuals has increased dramatically. The federal civil and criminal false claims acts prohibit individuals or entities from knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. Individual states have false claims acts with respect to Medicaid spending that may also apply and may be more expansive or impose additional requirements. Additionally, some states have insurance fraud provisions that apply to commercial payors or all payors under insurance laws that have similar whistleblower or relator provisions (e.g., Insurance Fraud Prevention Act for California).

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The Civil Monetary Penalty Act of 1981 (“CMP”) allows the DHHS Office of Inspector General to seek civil monetary penalties and sometimes exclusion from participation in the government health care programs for a wide variety of conduct. For example, the CMP and implementing regulations impose penalties against any person or entity that is determined to have presented or caused to be presented a claim to a federal healthcare program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent. Other conduct that may result in violation of the CMP is offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier.

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The Health Insurance Portability and Accountability Act (“HIPAA”) prohibits executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and their implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. While HIPAA applies only to covered entities, which generally does not include device manufacturers, HIPAA and HITECH impose those same obligations to business associates under contractual terms. HIPAA may also still apply directly to the manufacturer depending on the scope and nature of data sharing arrangement or other contracting arrangements. In addition to HIPAA and its accompanying regulations, device manufacturers may be subject to additional state consumer and privacy laws which may be more expansive or restrictive on the use and protection of patient and consumer data.

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The FDCA prohibits the adulteration or misbranding of medical devices. Medical device manufacturers may also be subject to state corollaries to the FDCA.

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The federal Physician Payment Sunshine Act and its implementing regulations, which require applicable manufacturers of covered drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS and DHHS information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), non-physician healthcare professionals (such as physician assistants and nurse practitioners, among others) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

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The Foreign Corrupt Practices Act (“FCPA”) prohibits any United States individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring us to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, if any, and to devise and maintain an adequate system of internal accounting controls for international operations. On February 10, 2025, Executive Order “Pausing Foreign Corrupt Practices Act Enforcement to Further American Economic and National Security” was signed, which directs the U.S. attorney general to review and update guidelines and policies related to FCPA enforcement and to cease new FCPA investigations and enforcement actions until a new enforcement policy is implemented.

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Analogous state and foreign laws and regulations, such as state anti-kickback, anti-referral, and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state laws that require certain medical device companies to comply with the industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government and may require applicable manufacturers to disclose or report certain information related to payments and other transfers of value to health care professionals and entities or sales, marketing, pricing, clinical trials, marketing expenditures and activities, and state and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts; and state laws related to insurance fraud in the case of claims involving private insurers.

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the scope, timing, progress, costs and results of discovery, preclinical development and clinical trials for our current or future products;

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the number and size of clinical trials required for regulatory clearance and approval of our current or future products;

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the costs, timing and outcome of regulatory review of any of our current or future products;

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the costs associated with acquiring or licensing additional products, technologies or assets;

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the cost of manufacturing clinical and commercial supplies of our current or future products;

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the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending against any intellectual property-related claims, including any claims by third parties that we are infringing upon their intellectual property rights;

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our ability to maintain existing, and establish new, strategic collaborations or other arrangements and the financial terms of any such agreements;

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the costs and timing of future commercialization activities, including manufacturing, marketing, sales and end-to-end supply chain management, for any of our products for which we receive regulatory clearance and approval;

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the revenue, if any, received from commercial sales of our products for which we receive regulatory clearance and approval;

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expenses to attract, hire and retain skilled personnel;

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the costs of operating as a dual-listed public company;

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our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors;

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the effect of competing technological and market developments; and

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the extent to which we acquire or invest in additional businesses, products and technologies.

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additional clinical trials may be required beyond what we currently expect;

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the risk that our financial and other resources are not sufficient to complete the necessary clinical trials;

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regulatory authorities may disagree with our interpretation of data from our clinical trials or may require that we conduct additional trials;

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we may be unable to obtain and maintain regulatory clearance or approval of our products in any jurisdiction;

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regulatory authorities may identify deficiencies in manufacturing processes;

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regulatory authorities may lack sufficient resources to timely and completely address applications for regulatory clearance or approval of our products;

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regulatory authorities may change their clearance or approval policies or adopt new regulations;

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we, or our third-party manufacturers, may not be able to source or produce current Good Manufacturing Practice (“cGMP”) materials for the production of our products or product candidates;

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our products, if approved, may not be able to be manufactured at a cost or in quantities necessary to make commercially successful products;

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we may experience delays in the commencement of, enrollment of patients in and timing of our clinical trials;

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we may not be able to achieve and maintain compliance with all regulatory requirements applicable to our products or operations;

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we may not be able to maintain a continued acceptable safety profile of our products following clearance or approval;

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the market may not accept our products, if approved;

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we may be unable to establish and maintain an effective sales and marketing infrastructure, either through the creation of a commercial infrastructure or through strategic collaborations, and the effectiveness of our own or any future strategic collaborators’ marketing, sales and distribution strategy and operations will affect our profitability;

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we may experience competition from existing products or new products that may emerge;

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we may be unable to successfully obtain, maintain, defend and enforce intellectual property rights important to protect our products; and

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we may not be able to obtain and maintain coverage and adequate reimbursement from third-party payors.

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the timing of market introduction of our products, as well as competitive products;

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the clinical indications for which a product is approved;

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perceived benefits from our products;

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perceived cost effectiveness of our products;

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perceived safety and effectiveness of our products;

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the effectiveness of sales and marketing efforts;

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the terms of any clearances or approvals and the countries in which clearances and approvals are obtained;

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our ability to provide acceptable evidence of safety and efficacy;

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marketing, manufacturing and supply support;

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potential product liability claims;

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the willingness of patients to pay out-of-pocket in the absence of coverage by third-party payors and government authorities;

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in certain instances, reimbursement available through government and private healthcare programs for using our products; and

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introduction and acceptance of competing products or technologies.

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have significantly greater financial, manufacturing, marketing, development, technical and human resources than we do;

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develop and commercialize products that are safer, more effective, less expensive, easier to implement or have fewer or less severe side effects;

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obtain quicker regulatory clearance or approval;

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establish superior proprietary positions covering our products and technologies;

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implement more effective approaches to sales and marketing; or

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form more advantageous strategic alliances.

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IQVIA, which is a clinical research organization that provides us with clinical data monitoring, project and site management, data management, and safety reporting services for the EFS;

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CRF, which provides us with core lab services for the EFS and an independent clinical events committee; and

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QMED, which provides clinical trial support for the EU, including the provision of life science services in the areas of regulatory affairs, training, quality assurance and control, clinical trial consultancy and submission support to the EU authorities.

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general economic conditions that could adversely affect the financial viability of our vendors;

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vendors’ election to no longer service or supply medical technology companies, including due to the burdens of applicable quality requirements and regulations or for no reason at all;

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the limitation or ban of certain chemicals or other materials used in the manufacture of our products; and

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delays or shortages due to trade or regulatory embargoes.

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inability to satisfy demand for our current and future products and services;

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reduced control over delivery timing and related customer experience and product reliability;

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reduced ability to monitor the manufacturing process and components used in our products;

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limited ability to develop comprehensive manufacturing specifications that take into account any materials shortages or substitutions;

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variance in the manufacturing capability of our third-party manufacturers;

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price increases;

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failure of a significant supplier or manufacturer partner to perform its obligations to us for technical, market or other reasons;

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variance in the quality of services provided by our third-party partners;

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inability of suppliers to comply with applicable provisions of the FDA’s Device cGMP or other applicable laws enforced by the FDA, state regulatory authorities or non-United States regulatory authorities;

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inability to ensure the quality of products and components manufactured by third parties;

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production delays related to the evaluation and testing of products and components from alternative suppliers and corresponding regulatory qualifications;

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difficulties in establishing additional supplier or manufacturer partner relationships if we experience difficulties with our existing suppliers, manufacturers or logistics partners;

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shortages of materials or components;

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production shortages resulting from any events affecting raw material supply;

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misappropriation of our intellectual property;

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exposure to natural catastrophes, epidemics such as a pandemic, political unrest, terrorism, labor disputes and economic instability resulting in the disruption of trade from foreign countries in which our products or the components are sourced;

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changes in local economic conditions in the jurisdictions where our suppliers, manufacturers, and logistics partners are located;

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the imposition of new laws, including those relating to labor conditions, quality and safety standards, imports, duties, tariffs, taxes and trade restrictions; and

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insufficient warranties and indemnities on components supplied to our manufacturers or performance by our partners.

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we may not be able to control the amount and timing of resources that our strategic partners/collaborators may devote to the products;

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strategic partners/collaborators may experience financial difficulties;

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the failure to successfully collaborate with third parties may delay, prevent or otherwise impair the development or commercialization of our products or revenue expectations;

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business combinations or significant changes in a collaborator’s business strategy may adversely affect a collaborator’s willingness or ability to complete their obligations under any arrangement;

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a collaborator could independently move forward with a competing product developed either independently or in collaboration with others, including our competitors; and

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collaborative arrangements are often terminated or allowed to expire, which would delay the development of, and may increase the cost of developing, products.

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fluctuations in currency exchange rates;

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domestic and global economic conditions such as inflation or recession;

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healthcare legislation and other regulations;

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differing standards and privacy requirements for the conduct of clinical trials;

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differing procedures and standards for regulatory approval and commercialization;

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tariffs and other trade barriers;

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compliance with foreign medical device manufacturing regulations;

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challenges with obtaining required supplies of components for our devices;

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difficulty in enforcing agreements and collecting receivables through foreign legal systems;

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reduction in third-party payor reimbursement for our products;

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inability to obtain import licenses;

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the impact from health epidemics/pandemics on the global economy;

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the impact of geopolitical tensions and/or conflicts, including the war in Ukraine;

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changes in trade policies and in United States and foreign tax policies;

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possible changes in export or import restrictions;

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differing labor regulations and difficulty in staffing and managing foreign operations;

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the modification or introduction of other governmental policies with potentially adverse effects; and

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limitations on our ability under local laws to protect our intellectual property.

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decreased demand for our products;

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injury to our reputation;

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withdrawal of clinical trial participants;

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costs of related litigation;

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substantial monetary awards to patients and others;

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loss of revenues; and

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the inability to commercialize products.

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litigation, which may be expensive and time-consuming and may divert our management’s attention from our core business;

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substantial damages for infringement, which we may have to pay if a court decides that the product or technology at issue infringes on or violates the third party’s rights, and, if the court finds that the infringement was willful, we could be ordered to pay treble damages and the patent owner’s attorneys’ fees;

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a court prohibiting us from developing, manufacturing, marketing or selling our products, or from using our proprietary technologies, unless the third-party licenses its product rights to us, which it is not required to do;

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if a license is available from a third party, we may have to pay substantial royalties, upfront fees and other amounts, and/or grant cross-licenses to intellectual property rights for our products; and

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redesigning our products or processes so they do not infringe third-party intellectual property rights, which may not be possible or may require substantial monetary expenditures and time.

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Others may be able to make products that are similar to ours but that are not covered by our intellectual property rights.

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Others may independently develop similar or alternative technologies or otherwise circumvent any of our technologies without infringing our intellectual property rights.

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We or any of our collaboration partners might not have been the first to conceive and reduce to practice the inventions covered by the patents or patent applications that we own, license or will own or license.

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We or any of our collaboration partners might not have been the first to file patent applications covering certain of the patents or patent applications that we or they own or have obtained a license.

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It is possible that any pending patent applications that we have filed, or will file, will not lead to issued patents.

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Issued patents that we own may not provide us with any competitive advantage, or may be held invalid or unenforceable, as a result of legal challenges by our competitors.

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Our competitors might conduct R&D activities in countries where we do not have patent rights, or in countries where R&D safe harbor laws exist, and then use the information learned from such activities to develop competitive products for sale in our major commercial markets.

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Ownership of our patents or patent applications may be challenged by third parties

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Our patents may only be valid for a limited period of time.

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The patents of third parties or pending or future applications of third parties, if issued, may have an adverse effect on our business.

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actual or expected fluctuations in our prospects or operating results;

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announcements relating to our products, including the results of clinical trials by us or our collaborators;

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changes in the demand for our products;

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additions or departures of our key personnel;

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changes or proposed changes in laws, regulations or tax policy;

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sales or perceived potential sales of our Common Stock by us or our executive officers, directors or stockholders in the future;

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announcements or expectations concerning additional financing efforts; and

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conditions in the United States, Australian and global financial markets, or in our industry in particular, or changes in general economic or political conditions.

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the last day of the fiscal year during which we have total annual gross revenues of $1,235,000,000 (as such amount is indexed for inflation every five years by the SEC) or more;

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the last day of our fiscal year following the fifth anniversary of the closing of our initial public offering;

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the date on which we have, during the previous three-year period, issued more than $1,000,000,000 in non-convertible debt; or

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the date on which we are deemed to be a “large accelerated filer,” as defined in Rule 12b-2 of the Exchange Act.

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the ability of our Board to issue shares of preferred stock and to determine the price and other terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquirer;

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a staggered Board divided into three classes serving staggered three-year terms, such that not all members of our Board will be elected at one time;

•

allowing only our Board to fill director vacancies, which prevents stockholders from being able to fill vacancies on our Board;

•

a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders;

•

a requirement for the affirmative vote of holders of at least 75% of the voting power of all of the then-outstanding shares of the voting stock, voting together as a single class, to amend certain provisions of our Second Amended and Restated Certificate of Incorporation or our Amended and Restated Bylaws, which may inhibit the ability of an acquirer to effect such amendments to facilitate an unsolicited takeover attempt;

•

the ability of our Board to amend our Amended and Restated Bylaws, which may allow our Board to take additional actions to prevent an unsolicited takeover and inhibit the ability of an acquirer to amend the Amended and Restated Bylaws to facilitate an unsolicited takeover attempt;

•

advance notice procedures with which stockholders must comply to nominate candidates to our Board or to propose matters to be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of our company; and

•

a prohibition of cumulative voting in the election of our Board, which would otherwise allow less than a majority of stockholders to elect director candidates.

•

a limited availability of market quotations for our Common Stock;

•

a determination that our Common Stock is a “penny stock” which will require brokers trading in our Common Stock to adhere to more stringent rules, which could result in a reduced level of trading activity in the secondary trading market for our Common Stock;

•

more limited news and analyst coverage for our company; and

•

a decreased ability to issue additional securities or obtain additional financing in the future.

•

periodic risk assessments;

•

annual security assessment and penetration testing;

•

A third-party Security Operations Center (“SOC”) partner to monitor, manage and respond to cybersecurity incidents;

•

the use of external service providers, where appropriate, to assess, test or otherwise assist with aspects of our security controls;

Location of Facility		Lease expiry date
11600-11628 96th Avenue North, Maple Grove, MN 55369 (1)		December 31, 2025
26 Harris Road, Malaga WA 6090, Australia		July 31, 2026 (2)

---

•

the scope, results and timing of clinical trials;

•

the costs of preparing and completing the Pivotal Trial of our DurAVR ® THV system;

•

the costs and time required to obtain pre-market approval from the FDA for our DurAVR ® THV system; and

•

the costs of establishing marketing, sales and distribution capabilities.

		Year Ended December 31,
		2024				2023				% Change
Net Cash provided by (used in):
Operating activities		$	(61,241	)		$	(34,631	)			77	%
Investing activities			(2,280	)			(2,582	)			(12	)%
Financing activities			112,833				49,340				129	%
Effect of exchange rate movements on cash, cash equivalents and restricted cash			57				(391	)			(115	)%
Net change in cash, cash equivalents and restricted cash			49,369				11,736				321	%

•

Risk-free interest rate was based on Australian government bonds aligned to the life of the securities, with the range being 3.56% - 4.48% (year to December 31, 2024) and 3.2% - 4.4% (year to December 31, 2023).

•

The expected price volatility range of 40.0% - 65.5% (year to December 31, 2024) and 55.0% - 75.1% (year to December 31, 2023) based on our historic volatility and the remaining life of the securities, adjusted for any expected changes to future volatility due to publicly available information.

•

we will avail ourselves of the exemption from the requirement to obtain an attestation and report from our independent registered public accounting firm on the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”);

•

we will provide less extensive disclosure about our executive compensation arrangements; and

•

we will not require non-binding, advisory stockholder votes on executive compensation or golden parachute arrangements.

•

18,615,386 shares of Common Stock quoted held by 28 stockholders of record on Nasdaq;

•

17,402,911 shares of Common Stock, held by CHESS Depositary Nominees Pty Limited as Depository Nominee on behalf of 3,666 CDI holders, representing 17,402,911 CDIs quoted on the ASX;

•

6,046,558 unquoted unlisted options which entitle the holders of those securities, upon vesting of their conversion rights, to be issued shares of Common Stock (including in certain cases in the form of CDIs) held by 237 holders; and

Name of Beneficial Owner		Amount and Nature of Beneficial Ownership – Common Stock (1)								Percentage (2)
Directors and NEOs
J. Seaberg			188,358				(3	)			*
W. Paterson			837,082				(4	)			2.3	%
S. Denaro			90,555				(5	)			*
W. Gu			66,833				(6	)			*
D. St Denis			198,764				(7	)			*
M. McDonnell			95,335				(8	)			*
All directors and executive officers as a group (six persons)			1,476,927								3.9	%
5%+ Stockholders (Substantial stockholders)
L1 Capital Pty Ltd			6,741,401				(9	)			18.7	%
Sio Capital Management, LLC			3,465,005				(10	)			9.6	%
Perceptive Advisors, LLC			2,440,000				(11	)			6.8	%

Range	Number of Holders of Record	Share of Common Stock		Percentage of total Common Stock outstanding (1)
1 – 1,000	2,721	768,538		2.1%
1,001 – 5,000	656	1,489,449		4.1%
5,001 - 10,000	134	985,918		2.7%
10,001 - 100,000	136	3,347,584		9.3%
100,001 and over	19	10,811,422		30.0%
Total	3,666	17,402,911

Range	Number of Holders of Record	Units		Percentage of unquoted options
1 – 1,000	117	51,212		0.9%
1,001 – 5,000	54	137,305		2.3%
5,001 - 10,000	20	147,621		2.4%
10,001 - 100,000	32	838,933		13.9%
100,001 and over	14	4,871,487		80.6%
Round	-	-		-0.1%
Total	237	6,046,558		100.0%

Range	Number of Holders of Record	Units		Percentage of RSUs
10,001 - 100,000	1	83,333		11.1%
100,001 and over	2	666,666		88.9%
Total	3	749,999		100.0%

Item 13.

Certain Relationships and Related Transactions, and Director Independence.

Item 14.

Principal Accountant Fees and Services.

Item 15.

Exhibits, Financial Statement Schedules.

Exhibit Number	Description	Incorporated by Reference			Filed
		Form	Date	Number	Herewith
2.1 †	Scheme Implementation Deed, dated August 13, 2024, by and between Anteris Technologies Global Corp. and Anteris Technologies Ltd	S-1	11/22/2024	2.1
3.1	Second Amended and Restated Certificate of Incorporation of Anteris Technologies Global Corp.	8-K	12/16/2024	3.1
3.2	Amended and Restated Bylaws of Anteris Technologies Global Corp.	8-K	12/16/2024	3.2
4.1	Reference is made to Exhibits 3.1 through 3.2				X
4.2 †^	Convertible Securities Agreement, dated October 31, 2024, between Anteris Technologies Ltd and Obsidian Global GP, LLC	S-1	11/22/2024	4.2
4.3	Description of Registrant’s Securities				X
10.1 +	Anteris Technologies Global Corp. Equity Incentive Plan	S-1	11/22/2024	10.1
10.2 +	Admedus Ltd Employee Long Term Incentive Plan	S-8	12/16/2024	99.2
10.3 +	Anteris Technologies Ltd Employee Incentive Plan	S-8	12/16/2024	99.3
10.4+	Form of Indemnification Agreement for Directors and Officers	S-1	11/22/2024	10.2
10.5 #†^	Development Agreement, dated April 18, 2023, by and between v2vmedtech, inc. and Anteris Technologies Corporation	S-1	11/22/2024	10.3

10.6 #^	License Agreement, dated October 11, 2019, among Admedus Ltd, Admedus Regen Pty Ltd, Admedus Biomanufacturing Pty Ltd and LeMaitre Vascular, Inc.	S-1	11/22/2024	10.4
10.7 #†^	Transition Services Agreement, dated October 11, 2019, among Admedus Ltd, Admedus Regen Pty Ltd, Admedus Biomanufacturing Pty Ltd and LeMaitre Vascular, Inc.	S-1/A	12/9/2024	10.5
10.8 #	Amendment No. 1 to Transition Services Agreement, dated August 28, 2021, among Anteris Technologies Ltd, Admedus Regen Pty Ltd, Admedus Biomanufacturing Pty Ltd and LeMaitre Vascular, Inc.	S-1	11/22/2024	10.6
10.9 #	Amendment No. 2 to Transition Services Agreement, dated December 19, 2022, among Anteris Technologies Ltd, Admedus Regen Pty Ltd, Admedus Biomanufacturing Pty Ltd and LeMaitre Vascular, Inc.	S-1	11/22/2024	10.7
10.10 #^	Amendment No. 3 to Transition Services Agreement, dated September 18, 2023, among Anteris Technologies Ltd, Anteris Aus Operations Pty Ltd and LeMaitre Vascular, Inc.	S-1	11/22/2024	10.8
10.11 #†^	Supply and Quality Agreement, dated May 15, 2024, by and between Anteris Aus Operations Pty Ltd and Harvey Industries Group Pty Ltd	S-1	11/22/2024	10.9
10.12 †^	Second Amended and Restated Supply and License Agreement, dated June 1, 2018, between 4C Medical Technologies, Inc. and Admedus Corporation	S-1	11/22/2024	10.10
10.13 †^	Amendment No. 1 to Second Amended and Restated Supply and License Agreement, dated March 5, 2024, between 4C Medical Technologies, Inc. and Anteris Technologies Corporation	S-1	11/22/2024	10.11
10.14 #†^	Supply and Quality Agreement, dated November 16, 2021 between Anteris Technologies Corporation and Aran Biomedical Teoranta	S-1	11/22/2024	10.12
10.15 ^	Supplier Quality Agreement, dated February 15, 2024, between Taurus Engineering and Manufacturing, Inc. and Anteris Technologies Corporation	S-1	11/22/2024	10.13
10.16 #†^	First Amended and Restated Services Agreement, dated February 21, 2021, by and between NPX Medical, LLC and Anteris Technologies Corporation	S-1	11/22/2024	10.14

10.17	Amendment No. 1 to First Amended and Restated Services Agreement, dated March 24, 2024, by and between NPX Medical, LLC and Anteris Technologies Corporation	S-1	11/22/2024	10.15
10.18 #†^	Master Services Agreement, dated June 1, 2021, by and between Anteris Technologies Corporation and Switchback Medical LLC	S-1	11/22/2024	10.16
10.19 #†^	Sublease Agreement, dated March 1, 2022, by and between Switchback Medical LLC and Anteris Technologies Corporation	S-1	11/22/2024	10.17(a)
10.20 #^	Sublease Amending Agreement, dated February 24, 2023, by and between Switchback Medical LLC and Anteris Technologies Corporation	S-1	11/22/2024	10.17(b)
10.21  #^	Sublease Amending Agreement, dated August 18, 2023, by and between Switchback Medical LLC and Anteris Technologies Corporation	S-1	11/22/2024	10.17(c)
10.22  #^	Sublease Amending Agreement, dated May 28, 2024, by and between Switchback Medical LLC and Anteris Technologies Corporation	S-1	11/22/2024	10.17(d)
10.23 †^	Combined Bioinformatics Master Services Agreement, dated September 1, 2021, by and between Anteris Technologies Corporation and Cardiovascular Research Foundation	S-1	11/22/2024	10.18
10.24 #†^	Lease of Part 26 Harris Road, Malaga, dated February 1, 2009, by and between Giacomel Pty Ltd, Verigen Australia Pty Ltd and Genzyme Corporation	S-1	11/22/2024	10.19(a)
10.25 #†	Deed of Variation of Lease, dated June 23, 2014, among Giacomel Pty Ltd, Admedus Biomanufacturing Pty Ltd, Genzyme Corporation and Admedus Ltd	S-1	11/22/2024	10.19(b)
10.26 #	Deed of Extension and Variation, dated February 19, 2019, by and between Giacomel Pty Ltd, Admedus Biomanufactuing Pty Ltd and Admedus Ltd	S-1	11/22/2024	10.19(c)
10.27	Deed of Assignment of Lease, dated March 28, 2023 by and between Giacomel Pty Ltd, Admedus Biomanufacturing Pty Ltd, Admedus Regen Pty Ltd and Anteris Technologies Ltd	S-1	11/22/2024	10.19(d)
10.28 #	Deed of Variation of Lease, dated June 12, 2023, by and between Giamocel Pty Ltd, Anteris Aus Operations Pty Ltd and Anteris Technologies Ltd	S-1	11/22/2024	10.19(e)

10.29 #	Deed of Extension and Variation of Lease, dated February 13, 2024, among Giacomel Pty Ltd, Anteris Aus Operations Pty Ltd and Anteris Technologies Ltd	S-1	11/22/2024	10.19(f)
10.30 #†^+	Professional Services Agreement, dated September 3, 2021, between Anteris Technologies Corporation and Christopher Meduri, M.D.	S-1	11/22/2024	10.20(a)
10.31 #†+	Amendment No. 1 to Professional Services Agreement, dated May 1, 2023, between Anteris Technologies Corporation and Christopher Meduri, M.D.	S-1	11/22/2024	10.20(b)
10.32 +	Executive Service Agreement, dated December 1, 2019, between Admedus Corporation and Wayne Paterson	S-1	11/22/2024	10.21
10.33 #†+	Employee Agreement, dated December 1, 2019, between Admedus Limited ACN 088 221 078 and Matthew McDonnell	S-1	11/22/2024	10.22
10.34 †+	Executive Service Agreement, dated May 10, 2017, between Admedus Corporation and David St Denis	S-1	11/22/2024	10.23
10.35 +^	Amended and Restated Employment Agreement, dated November 18, 2024, by and between Anteris Technologies Global Corp. and Wayne Paterson	S-1	11/22/2024	10.24
10.36 +†^	Contract of Employment, dated November 19, 2024, by and between Anteris Technologies Ltd and Matthew McDonnell	S-1	11/22/2024	10.25
10.37 +^	Amended and Restated Employment Agreement, dated November 19, 2024, by and between Anteris Technologies Global Corp. and David St Denis	S-1	11/22/2024	10.26
10.38 #	Anteris Technologies Global Corp. Non-Employee Director Compensation Policy	S-1	11/22/2024	10.27
10.39  #†	Contribution and Stock Purchase Agreement, dated April 18, 2023, by and among Anteris Technologies Corporation, v2vmedtech, inc., Dr. Vinayak Bapat, Urmi Bapat, Shalaka Bapat, Susheel Kodali, Michael McDonald and Christopher Meduri	S-1/A	12/9/2024	10.28
14.1	Code of Business Conduct and Ethics				X
19.1	Insider Trading and Securities Dealing Policy				X
21.1	Subsidiaries of the Registrant	S-1	11/22/2024	21.1

23.1(a)	Consent of Independent Registered Public Accounting Firm for Anteris Technologies Global Corp.				X
23.2	Consent for Future Market Insights, Inc.				X
24.1	Power of Attorney (included in the signature page hereto)				X
31.1	Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002				X
31.2	Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002				X
32.1*	Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C.  Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002				X
97.1	Compensation Clawback Policy				X

---

*

This certification attached as Exhibit 32.1 that accompanies this Form 10-K, is deemed furnished and not filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-K, irrespective of any general incorporation language contained in such filing.

#	Certain identified information has been excluded from this exhibit pursuant to Rule 601(b)(10) of Regulation S-K because it is both (i) not material and (ii) is the type of information that the registrant treats as private or confidential.

†	Certain information in this exhibit has been redacted pursuant to Item 601(a)(6) of Regulation S-K.

^	Schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. Anteris Technologies Global Corp. agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC upon request.

+	Management contract or compensatory plan, contract or arrangement.

Item 16.

Form 10-K Summary

	Anteris Technologies Global Corp
	By:	/s/ Wayne Paterson
		Name:	Wayne Paterson
		Title:	Vice Chairman and Chief Executive Officer