8-K
Anteris Technologies Global Corp. (AVR)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 12, 2025
Anteris Technologies Global Corp.
(Exact name of registrant as specified in its charter)
| Delaware | 001-42437 | 99-1407174 |
|---|---|---|
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
| Toowong Tower, Level 3, Suite 302<br><br> <br>9 Sherwood Road<br><br> <br>Toowong, QLD<br><br> <br>Australia | 4066 | |
| --- | --- | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s telephone number, including area code: +61 7 3152 3200
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br><br> <br>Symbol(s) | Name of each exchange<br><br> <br>on which registered |
|---|---|---|
| Common Stock, par value $0.0001 per share | AVR | The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 2.02. | Results of Operations and Financial Condition. |
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On March 12, 2025 USA ET (March 13, 2025 AEST), Anteris Technologies Global Corp. (the “Company”) (i) lodged a financial report (the “Results Announcement”) with the Australian Securities Exchange (“ASX”) and (ii) issued an ASX Announcement regarding the Company’s financial results for the fiscal year ended December 31, 2024, both of which include audited and other historical financial information for the fiscal year ended December 31, 2024. The Results Announcement has been prepared for the purpose of complying with the reporting requirements of the ASX. Copies of the Results Announcement and the ASX Announcement are attached as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K.
The information in this Item 2.02, including Exhibits 99.1 and 99.2 attached hereto, is being furnished and shall not be deemed to be filed for the purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or incorporated by reference into any filing under the Securities Act of 1933 (the “Securities Act”) or the Exchange Act, unless such subsequent filing specifically references this Current Report on Form 8-K.
| Item 9.01. | Financial Statements and Exhibits. |
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(d) Exhibits.
The following exhibits are filed with this Current Report on Form 8-K:
| Exhibit<br><br> <br>No. | Description |
|---|---|
| 99.1 | Results Announcement, as filed with the ASX, for the fiscal year ended December 31, 2024 |
| 99.2 | ASX Announcement regarding financial results for the fiscal year ended December 31, 2024 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Anteris Technologies Global Corp. | ||
|---|---|---|
| Date: March 12, 2025 | ||
| By: | /s/ Wayne Paterson | |
| Name: | Wayne Paterson | |
| Title: | Vice Chairman and Chief Executive Officer |
Exhibit 99.1
Results Announcement
| Name of entity: | Anteris Technologies Global Corp. |
|---|---|
| ARBN: | 677 960 235 |
| Reporting period: | For the year ended December 31, 2024 |
The consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”) and are denominated in U.S. dollars.
The Company’s results for announcement to the market are as follows:
| December 31, 2024<br><br> <br>$’000 | December 31, 2023<br><br> $’000 | Change<br><br> $’000 | Change<br><br> % | |
|---|---|---|---|---|
| Revenues from ordinary activities | 2,703 | 2,735 | (32) | (1%) |
| Loss from ordinary activities after tax | (75,967) | (46,764) | (29,203) | 62% |
| Loss for the period attributable to members | (76,291) | (46,022) | (30,269) | 66% |
| • | Results of Operations | |||
| --- | --- |
Refer to the attached “Anteris Reports 2024 Financial Results and Provides Corporate Update”.
| • | Net Tangible Asset Backing: |
|---|
Net tangible assets is calculated as net assets (including Right-of-Use assets) less intangible assets. The net tangible asset backing per share was $1.74 and $1.04 as of December 31, 2024 and December 31, 2023, respectively.
| • | Dividends: |
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No dividends were proposed, declared, or issued during the year ended December 31, 2024.
| • | Annual financial statements: |
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The consolidated annual financial statements on which this report is based have been audited by KPMG. The Independent Auditor’s opinion is not modified but includes an Emphasis of Matter that the Company has suffered losses from operations that raise substantial doubt about its ability to continue as a going concern.
| • | Changes in control over entities: |
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Anteris Technologies Global Corp. (“ATGC”) was incorporated in Delaware on January 29, 2024. ATGC was formed for the purpose of reorganizing the operations of Anteris Technologies Ltd (“ATL”), an Australian public company originally registered in Western Australia, Australia and listed on the ASX, into a structure whereby the ultimate parent company would be a Delaware corporation. On December 16, 2024, ATGC received all the issued and outstanding shares of ATL pursuant to a scheme of arrangement under Australian law between ATL and its shareholders under Part 5.1 of the Corporations Act 2001 (Cth). In accordance with ASC 805 Business Combinations, when ATGC acquired ATL, the transaction was accounted for as a reverse recapitalization. The substance of the transaction was that the pre-transaction shareholders of ATL (the accounting acquirer) had effectively obtained control of ATGC. Under reverse recapitalization accounting, the consolidated financial statements are issued under the name of the legal parent (being ATGC) but, with the exception of stockholder’s equity, the financial statements represent a continuation of ATL’s financial information.
| • | Details of associates or joint ventures: |
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On April 18, 2023, the Group acquired 30% of the shares of v2vmedtech, inc. Since acquisition date, the entity has been treated as a controlled entity for accounting purposes. There have been no changes in the holding percentage since acquisition date.
| • | Use of funds: |
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On December 13, 2024 ATGC released a prospectus for an initial public offering of 14,800,000 shares of Common Stock to be sold at an initial public offering price of $6.00 per share. The prospectus included detail of the intended use of the net proceeds being:
| • | approximately $74.4 million for the ongoing development of DurAVR® THV and the preparation and enrolment of the Pivotal Trial of DurAVR® Transcatheter Heart Valve ("THV") for treating severe aortic stenosis; and |
|---|---|
| • | the remaining for working capital and other general corporate purposes determined from time to time, including the repayment of amounts owed under the Convertible Note Facility (refer to note 11 Debt<br> Obligations of the annual financial report). |
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There were no material variances in the use of funds during the fourth quarter of 2024. The convertible notes totalling $5.7 million were repaid on December 19, 2024, and the facility was terminated in February 2025.
| • | Aggregate amount of payments to related parties and their associates: |
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During the fourth quarter of 2024, the aggregate amount of payments for director fees, ATL Company secretarial fees and Chief Executive Officer remuneration was $374 thousand.
| • | Details of audit disputes or audit qualification: |
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None.
Additional 4E disclosure requirements and commentary on these results are contained in the Form 10-K Annual Report for the year ended December 31, 2024.
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Exhibit 99.2
Anteris Reports Full Year 2024 Financial Results and Provides Corporate Update
Eagan, USA and Brisbane, Australia, 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 $88.8 million (AUD $139.3 million) before costs and commissions and excluding the underwriters option, which completed the Company’s re-domiciliation to the<br> 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<br> 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. |
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| • | Performed first two cases of the DurAVR^®^THV’s European Early Feasibility Study (“EU-EFS”) at Structural Heart Copenhagen in Denmark (January 2025). |
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| • | Increased awareness of the DurAVR^®^THV system in the global medical community including multiple high profile podium presentations at key congresses such New York Valves and the 36^th^ TCT Conference. |
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| • | Finalized design optimization of the balloon-expandable ComASUR^®^ delivery system and expanded manufacturing scale-up in Malaga, AU and Minneapolis, US to support planned Pivotal Trial. |
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| • | Concluded 2024 with a strong cash position of $70.5 million (AUD $113.3 million). |
| --- | --- |
“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 Commercialisation 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 36^th^ 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, US 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 compared to December 31, 2023 are reviewed below. All amounts in $ refer to US dollars.
| • | Net Sales for 2024 were $2.7 million |
|---|---|
| • | Net Loss after Income Tax for 2024 was $76.0 million |
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| • | Closing cash balance at December 31, 2024 was $70.5 million |
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In 2024, Net Sales were $2.7 million relating to sales of our tissue product. In line with contractual arrangements, the manufacture of products for LeMaitre ceased in January 2025.
In 2024, the Net Loss after Income Tax of $76.0 million, was driven by operating expenses principally related to research and development to support the planned launch of the Pivotal Trial in 2025 and increased selling, general and administrative expenses which includes the re-domiciliation, Nasdaq listing and the US IPO.
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 $25.0 million secured convertible note facility (the “Bridging Facility”) with Obsidian Global Partners, LLC (“Obsidian”) to provide funding, primarily for the period prior to the US IPO. In total AUD $7.5 million was drawn down under the Bridging Facility. The Bridging Facility was subsequently terminated in February 2025.
In December 2024, Anteris completed its US IPO, through the offering of 14,800,000 shares of common stock (the “Common Stock”) in the U.S. at a price of $6.00 per share (the “Offering”) raising $79.6 million after costs and commissions. Anteris Common Stock were then listed on the Nasdaq Global Market from 13 December 2024 and on 17 December 2024, Anteris listed its CHESS Depositary Interests (CDIs) on a 1 CDI-for-1 share of Common Stock basis, on the ASX.
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 $6.00 per share, less underwriting discounts and commissions, to raise a further $0.4 million.
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, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients.
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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 December 10, 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 |
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