Anteris Technologies Global Corp.
For the period ended Jun 30, 2025. Filed Aug 11, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 11, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-13.
0001140361-25-018701
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-11.
0001140361-25-030146
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 88 previous paragraphs and 90 current paragraphs.
54 unchanged; 26 reworded; 9 added; 8 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 2 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
In the first quarter of 2025, an investigational device exemption (“IDE”) for the PARADIGM Trial was submitted to the FDA. It is anticipated that the primary end point of the PARADIGM Trial will be to demonstrate non-inferiority of the DurAVR®THV system compared with commercially available TAVR systems (SAPIEN or Evolut series THV) for treatment of subjects with severe calcific aortic stenosis. We anticipate that the design of the PARADIGM Trial will be a prospective, randomized, controlled multicenter, international study wherein subjects will be randomized to receive either TAVR using the DurAVR®THV or TAVR using a commercially available and approved THV from competitors. We anticipate that the subjects will include a broad array of risk profiles. We anticipate that subjects with a failed surgical bioprosthesis in need of a valve-in-valve TAVR will be enrolled in a separate parallel registry. If we obtain IDE approval from the FDA, we intend to perform site activation and seek Institutional Review Board (“IRB”) approval for commencement of the study at each site. Subject to the foregoing, we anticipate enrollment to begin in the third quarter of 2025. Such a trial would be designed to provide the primary clinical evidence on which the FDA could base a decision for the Premarket Approval (“PMA”) that is required for commercialization of the DurAVR®THV system in the United States. We anticipate CE Mark approval will progress in parallel to the PMA.
Current report
In the second quarter of 2025, the Anteris team made considerable progress strengthening its clinical infrastructure and manufacturing capabilities in preparation for the PARADIGM Trial. A key focus was the qualification of trial sites, including feasibility assessments to confirm each site’s access to a suitable aortic stenosis patient population and their capacity to conduct the PARADIGM Trial to the highest standards. Preparatory activities, including site contracting with planned centers across the U.S., Europe and Canada, are well advanced, with 79 sites now qualified to participate. Ongoing collaborative work with the FDA to progress the IDE application has been a major focus this quarter, in addition to proactively scaling the manufacturing of all key products to meet the anticipated inventory demands of the upcoming PARADIGM Trial.
Current report
In the second quarter of 2025, the qualification of trial sites was a key focus, including feasibility assessments to confirm each site’s access to a suitable aortic stenosis patient population and their capacity to conduct the PARADIGM Trial to the highest standards. Preparatory activities, including site contracting with planned centers across the U.S., Europe and Canada, are well advanced, with 79 sites now qualified to participate. Ongoing collaborative work with the FDA to progress the IDE application has been a major focus this quarter, in addition to proactively scaling the manufacturing of all key products to meet the anticipated inventory demands of the upcoming PARADIGM Trial.
Current report
Cost of products sold during the three months ended June 30, 2025 was$0.1 million, a decrease of $0.2 million (53%), compared to $0.3 million for the same period in the prior year. Cost of products sold during the six months ended June 30, 2025 was$0.4 million, a decrease of $0.4 million (55%), compared to $0.8 million for the same period in the prior year. The movements in each period are primarily due to a reduction in net sales following the LeMaitre Transition Services Agreement expiring in January 2025, partly offset by increased demand for other higher-yielding tissue products in 2025.
Current report
R&D expenses during the six months ended June 30, 2025 were $32.8 million, an increase of $8.6 million (36%), compared to $24.2 million for the same period in the prior year. This is primarily due to an increase of $9.1 million relating to the upscaling of manufacturing and quality capabilities including process design and validation activities and the expansion of headcount, and a further $2.5 million relating to preparatory activities linked to the PARADIGM Trial, including clinical costs associated with the enrollment of additional patients and the scaling of our field based clinical team. These variances were partly offset by lower DurAVR® product research costs of $3.1 million in the first six months of 2025 as we shift our focus to clinical, regulatory and manufacturing activities ahead of the PARADIGM Trial.
Current report
Selling, general and administrative expenses during the three months ended June 30, 2025 were $5.0 million, a decrease of $1.1 million (19%) compared to $6.2 million for the same period in the prior year, primarily due to a reduction of $0.5 million in share-based payment expenses associated with directors and executive management and $0.4 million lower marketing spend. Expenses relating to legal, tax and compliance were relatively flat and included additional fees related to compliance with dual listing requirements and other operational matters in 2025 compared to 2024, which included costs related to our re-domiciliation, listing of our common stock on Nasdaq and conducting our initial public offering.
Current report
Selling, general and administrative expenses during the six months ended June 30, 2025 were $10.7 million, a decrease of $2.0 million (16%) compared to $12.7 million for the same period in the prior year, primarily due to a $1.0 million decline in share-based payment expenses associated with directors and executive management, $0.6 million lower marketing spend and a $0.1 million decrease in legal, tax and compliance costs, which included additional fees related to compliance with dual listing requirements and other operational matters in 2025, and in 2024 included costs related to re-domiciliation, listing of our common stock on Nasdaq and conducting our initial public offering.
Current report
The locations and uses of our material properties are as follows:
Current report
(1) Predominantly used for R&D, manufacturing of the DurAVR® valve and regulatory compliance teams. On April 30, 2025, we cancelled our sublease of the building without incurring a termination fee and entered into a new 5-year lease agreement directly with the landlord. As a result, we recognized a right-of-use asset and a corresponding lease liability of $1.6 million on the lease commencement date. This change provides longer-term access to the premises.
Removed paragraphs (8)
Previous report
Cost of products sold during the three months ended March 31, 2025 was$0.2 million, a decrease of $0.3 million (56%), compared to $0.5 million for the same period in the prior year, primarily due to a reduction in net sales and a change in the mix of products manufactured and sold.
Previous report
Selling, general and administrative expenses during the three months ended March 31, 2025 were $5.7 million, a decrease of $0.8 million (13%) compared to $6.5 million for the same period in the prior year, primarily due to a reduction of $1.2 million relating to costs incurred in the first quarter of 2024 associated with our plans to re-domicile, list on Nasdaq and conduct our initial public offering, partly offset by a $0.8 million increase in legal, tax and compliance costs linked to dual listing requirements and other operational matters. There was also a decline in share based payment expense of $0.5 million.
Previous report
Other non-operating income, net
Previous report
Other non-operating income, net during the three months ended March 31, 2025 was $0.1 million, a decrease of $0.3 million (78%) compared to $0.4 million for the same period in the prior year, primarily due to the recognition of additional government grants relating to the Australian Research and Development Tax Incentive income in the first quarter of 2024.
Previous report
Loss Before Income Taxes from Continuing Operations
Previous report
Loss before income taxes from continuing operations was $21.9 million for the three months ended March 31, 2025, an increase of $5.8 million (36%) compared to $16.2 million for the same period in the prior year.
Previous report
Net Income/(Loss) Attributable to Non-Controlling Interests
Previous report
Net loss attributable to non-controlling interests (“NCI”) was $0.1 million for the three months ended March 31, 2025, an increase of $0.3 million (134%) compared to a $0.2 million gain for the same period in the prior year. This change primarily reflects the impact of applying the hypothetical liquidation at book value (HLBV) method to measure the NCI interest.
Reworded paragraphs (26)
Previous wording
We clinically developed our DurAVR® THV system over several years with significant physician input with the goal of addressing hemodynamic limitations of the current standard-of-care products. As of March 31, 2025, a total of over 100 patients have been treated with the DurAVR® THV system across the United States, Canada and Europe.
Current wording
We clinically developed our DurAVR® THV system over several years with significant physician input with the goal of addressing hemodynamic limitations of the current standard-of-care products. As of June 2025, a total of 130 patients have been treated with the DurAVR®THV worldwide. In November 2021, we commenced our first-in-human (“FIH”) study at the Tbilisi Heart and Vascular Clinic in Tbilisi, Georgia.
Previous wording
On December 12, 2024, our Registration Statement relating to our initial public offering became effective pursuant to which we issued and sold 14,800,000 shares of Common Stock at a public offering price of $6.00 per share. On January 16, 2025, TD Cowen, Barclays and Cantor (the Underwriters’ Representatives) partially exercised the over-allotment option granted by the Company in respect of 78,481 shares of Common Stock at the purchase price of $6.00 per share. We received net proceeds of $80.0 million for the IPO and subsequent over-allotment option, after deducting the underwriting discounts, commissions and offering expenses.
Current wording
On December 12, 2024, our Registration Statement relating to our initial public offering (the “IPO”) became effective pursuant to which we issued and sold 14,800,000 shares of Common Stock at a public offering price of $6.00 per share. On January 14,2025, TD Cowen, Barclays and Cantor (the underwriters’ representatives) partially exercised the over-allotment option granted by the Company, pursuant to which we issued and sold an additional 78,481 shares of Common Stock at the purchase price of $6.00 per share. We received net proceeds of $80.0 million for the IPO and subsequent over-allotment option, after deducting the underwriting discounts, commissions and offering expenses.
Previous wording
As a development-stage company, we have incurred significant losses since our inception. We anticipate that we will continue to incur significant losses for the foreseeable future and there can be no assurance that we will ever achieve or maintain profitability.
Current wording
As a development-stage company, we have incurred losses since our inception. We anticipate that we will continue to incur losses for the foreseeable future and there can be no assurance that we will ever achieve or maintain profitability.
Previous wording
The condensed consolidated financial statements include the accounts for our company, our wholly-owned subsidiaries, and entities for which we have a controlling financial interest, and for periods prior to the series of reorganization transactions we completed prior to our U.S. initial public offering (the “Reorganization”), the accounts of Anteris Technologies Ltd (“ATL”), its wholly-owned subsidiaries, and entities for which ATL has a controlling financial interest. Intercompany transactions, balances and unrealized gains and losses on transactions between such entities are eliminated.
Current wording
The condensed consolidated financial statements include the accounts for our company, our wholly-owned subsidiaries, and entities for which we have a controlling financial interest, and for periods prior to the series of reorganization transactions we completed prior to our U.S. initial public offering (the “Reorganization”), the accounts of Anteris Technologies Pty Ltd (“ATPL”, formerly Anteris Technologies Ltd), its wholly-owned subsidiaries, and entities for which ATPL had a controlling financial interest. Intercompany transactions, balances and unrealized gains and losses on transactions between such entities are eliminated.
Previous wording
We currently derive revenue from the sale of regenerative tissue products. Such sales are made principally to 4C Medical Technologies, Inc. (“4C”) and to LeMaitre Vascular, Inc. (“LeMaitre”), a distributor of medical products, to whom we sold our CardioCel™ and VascuCel™ patch business in 2019 in order to focus on development of our proprietary ADAPT® tissue for the DurAVR® THV system. Concurrent with such sale, we entered into a Transition Services Agreement pursuant to which we manufacture and sell CardioCel™ and VascuCel™ products to LeMaitre. The Transition Services Agreement with LeMaitre expired in January 2025. We do not expect to receive any significant future revenues from LeMaitre. The initial term of our Supply and License Agreement with 4C, expires on June 1, 2025, at which time it automatically renews for successive one-year terms. Either we or 4C may terminate the 4C Agreement upon 180 days written notice to the other party at the end of the initial term or any renewal term or in the event of an uncured breach or if the other party becomes insolvent, files a petition for bankruptcy or upon the occurrence of similar events.
Current wording
We currently derive revenue from the sale of regenerative tissue products. Such sales have historically been made principally to 4C Medical Technologies, Inc. (“4C”) and to LeMaitre Vascular, Inc. (“LeMaitre”), a distributor of medical products, to whom we sold the distribution rights for CardioCel™ and VascuCel™ in 2019 in order to focus on development of our proprietary ADAPT® tissue for the DurAVR® THV system. Concurrent with such sale, we entered into a Transition Services Agreement pursuant to which we manufactured and sold CardioCel™ and VascuCel™ products to LeMaitre. The Transition Services Agreement with LeMaitre expired in January 2025. We do not expect to receive any significant future revenues from LeMaitre. The Supply and License Agreement with 4C, which had an initial seven-year term that ended on June 1, 2025, and was automatically renewed for a one-year term in accordance with its renewal provisions. Successive one-year terms automatically renew under the Transition Services Agreement absent prior indication to the contrary. Either we or 4C may terminate the 4C Agreement upon 180 days written notice to the other party at the end of the initial term or any renewal term or in the event of an uncured breach or if the other party becomes insolvent, files a petition for bankruptcy or upon the occurrence of similar events.
Previous wording
During the First Quarter, the Anteris team continued to expand global manufacturing capacity to scale for the PARADIGM Trial. All production (DurAVR® THV, ComASUR® Delivery System, crimper, E-sheath) is being scaled into new ISO Qualified Clean Room facilities, increasing manufacturing capacity to at least three times the 2024 capacity levels. The transition to the new facilities aims for a reliable and scaled inventory supply to support the anticipated commencement of the PARADIGM Trial. In addition, the gold-standard ADAPT® tissue for the DurAVR® THV will be sourced from both the U.S. and Australia moving forward to help mitigate supply chain risks. This progress reflects the strategic deployment of capital into infrastructure that supports operational readiness and long-term growth capacity for clinical and commercial success.
Current wording
During the first and secound quarters of 2025, the Anteris team continued to expand global manufacturing capacity to scale for the PARADIGM Trial. All production (DurAVR® THV, ComASUR® Delivery System, crimper, E-sheath) is being scaled into new ISO Qualified Clean Room facilities, increasing manufacturing capacity to at least three times the 2024 capacity levels. The transition to the new facilities aims for a reliable and scaled inventory supply to support the anticipated commencement of the PARADIGM Trial. In addition, the gold-standard ADAPT® tissue for the DurAVR® THV will be sourced from both the U.S. and Australia moving forward to help mitigate supply chain risks. This progress reflects the strategic deployment of capital into infrastructure that supports operational readiness and long-term growth capacity for clinical and commercial success.
Previous wording
We believe that we have the ability to raise additional funds. Notwithstanding the above factors, the future success of the Company is dependent on our ability to attract additional capital and, ultimately, on our ability to develop future profitable operations. If we do not receive sufficient cash inflows, there is substantial doubt as to whether we will be able to continue as a going concern.
Current wording
We believe that we have the ability to raise additional funds. Notwithstanding the above factors, our future success is dependent on our ability to attract additional capital and, ultimately, on our ability to develop future profitable operations. If we do not receive sufficient cash inflows, there is substantial doubt as to whether we will be able to continue as a going concern.
Previous wording
The audit report covering the December 31, 2024 and 2023 consolidated financial statements contains a paragraph that states that the Company’s recurring losses from operations raise substantial doubt about our ability to continue as a going concern. See Note 3 Going Concernto the consolidated financial statements included in our Annual Report and Note 3 Going Concernto the condensed consolidated financial statements included in this Quarterly Report.
Current wording
The audit report covering the December 31, 2024 and 2023 consolidated financial statements contains a paragraph that states that our recurring losses from operations raise substantial doubt about our ability to continue as a going concern. See Note 3 Going Concernto the consolidated financial statements included in our Annual Report and Note 3 Going Concernto the condensed consolidated financial statements included in this Quarterly Report.
Previous wording
On December 12, 2024, our registration statement on Form S-1 (File No. 333-283414) (the “Registration Statement”) relating to our initial public offering became effective pursuant to which we issued and sold 14,878,481 shares of Common Stock at a public offering price of $6.00 per share. We received net proceeds of $80.0 million, after deducting the underwriting discounts, commissions and offering expenses and giving effect to the exercise of the underwriters’ option to purchase additional shares. None of the expenses associated with the initial public offering were paid to directors, officers, persons owning 10% or more of any class of equity securities, or to our affiliates.
Current wording
On December 12, 2024, our registration statement on Form S-1 (File No. 333-283414) (the “Registration Statement”) relating to our IPO became effective pursuant to which we issued and sold 14,878,481 shares of Common Stock at a public offering price of $6.00 per share. We received net proceeds of $80.0 million, after deducting the underwriting discounts, commissions and offering expenses and giving effect to the exercise of the underwriters’ option to purchase additional shares. None of the expenses associated with the IPO were paid to directors, officers, persons owning 10% or more of any class of equity securities, or to our affiliates.
Previous wording
Prior to the consummation of the initial public offering, we completed the Reorganization pursuant to which we received all of the issued and outstanding shares of ATL, which was formerly an Australian public company originally registered in Western Australia, Australia and listed on the ASX, pursuant to a scheme of arrangement under Australian law between ATL and its shareholders (the “Scheme”) under Part 5.1 of the Australian Corporations Act 2001 (Cth) (the “Corporations Act”). Contemporaneously with implementation of the Scheme, ATL also cancelled all existing options it had on issue in exchange for our company issuing replacement options to acquire Common Stock pursuant to a scheme of arrangement between ATL and its optionholders (the “Option Scheme”) under Part 5.1 of the Corporations Act. The Scheme was approved by ATL’s shareholders at a general meeting of shareholders, which was held on December 3, 2024. The Option Scheme was approved by ATL’s optionholders at a general meeting of optionholders held on the same day. ATL obtained approval of the Scheme and the Option Scheme by the Supreme Court of Queensland on December 4, 2024. As a result of the Reorganization, ATL became a wholly owned subsidiary of our company and the shareholders of ATL immediately prior to the consummation of the initial public company became holders of the either one share of Common Stock for every ordinary share of ATL or one CDI for every one ordinary share of ATL for each share held as of the record date.
Current wording
Prior to the consummation of the IPO, we completed the Reorganization pursuant to which we received all of the issued and outstanding shares of ATPL, which was formerly an Australian public company originally registered in Western Australia, Australia and listed on the ASX, pursuant to a scheme of arrangement under Australian law between ATPL and its shareholders (the “Scheme”) under Part 5.1 of the Australian Corporations Act 2001 (Cth) (the “Corporations Act”). Contemporaneously with implementation of the Scheme, ATPL also cancelled all existing options it had on issue in exchange for our company issuing replacement options to acquire Common Stock pursuant to a scheme of arrangement between ATPL and its optionholders (the “Option Scheme”) under Part 5.1 of the Corporations Act. The Scheme was approved by ATPL’s shareholders at a general meeting of shareholders, which was held on December 3, 2024. The Option Scheme was approved by ATPL’s optionholders at a general meeting of optionholders held on the same day. ATPL obtained approval of the Scheme and the Option Scheme by the Supreme Court of Queensland on December 4, 2024. As a result of the Reorganization, ATPL became a wholly owned subsidiary of our company and the shareholders of ATPL immediately prior to the consummation of the IPO became holders of either one share of Common Stock for every ordinary share of ATPL or one CDI for every one ordinary share of ATPL for each share held as of the record date.
Previous wording
In connection with the Reorganization, on December 16, 2024, we issued (i) 21,139,816 shares of Common Stock to shareholders of ATL, 20,360,496 of which are represented by CDIs, pursuant to the Scheme and (ii) 6,118,807 options to purchase shares of Common Stock pursuant to the Option Scheme. The foregoing issuances were made pursuant to an exemption from registration under Section 3(a)(10) of the Securities Act. Each option is exercisable into one share of Common Stock, including as represented by a CDI, upon the payment of the relevant exercise price.
Current wording
In connection with the Reorganization, on December 16, 2024, we issued (i) 21,139,816 shares of Common Stock to shareholders of ATPL, 20,360,496 of which were represented by CDIs, pursuant to the Scheme and (ii) 6,118,807 options to purchase shares of Common Stock pursuant to the Option Scheme. The foregoing issuances were made pursuant to an exemption from registration under Section 3(a)(10) of the Securities Act. Each option is exercisable into one share of Common Stock, including as represented by a CDI, upon the payment of the relevant exercise price.
Previous wording
The following tables set forth our results of operations for the three months ended March 31, 2025 and 2024 (in thousands, except percentages).
Current wording
The following tables set forth our results of operations (in thousands, except percentages).
Previous wording
Net sales during the three months ended March 31, 2025 was $0.6 million, a decrease of $0.2 million (27%), compared to $0.8 million for the same period in the prior year, primarily due to lower demand for tissue products in 2025.
Current wording
Net sales during the three months ended June 30, 2025 was $0.6 million, compared to $0.6 million for the same period in the prior year. Net sales during the six months ended June 30, 2025 was $1.2 million, a decrease of $0.2 million (16%), compared to $1.4 million for the same period in the prior year. The movements in each period are primarily due to the Transition Services Agreement with LeMaitre, which included sales of CardioCel™ and VascuCel™ products, expiring in January 2025, partly offset by increased demand for other higher-yielding tissue products in 2025.
Previous wording
R&D expenses during the three months ended March 31, 2025 were $16.5 million, an increase of $4.9 million (42%) compared to $11.6 million for the same period in the prior year. This is primarily due to $3.5 million relating to the upscaling of manufacturing capabilities including process design and validation activities and the expansion of headcount; and $1.5 million relating to preparatory activities linked to the Pivotal Trial, including clinical costs associated with the enrollment of additional patients.
Current wording
R&D expenses during the three months ended June 30, 2025 were $16.3 million, an increase of $3.7 million (29%), compared to $12.6 million for the same period in the prior year. This is primarily due to an increase of $5.0 million relating to the upscaling of manufacturing and quality capabilities, including process design and validation activities and the expansion of headcount, and a further $0.6 million related to preparatory activities linked to the PARADIGM Trial, including clinical costs associated with the enrollment of additional patients and the scaling of our field based clinical team. These variances were partly offset by reduced DurAVR® product research costs of $2.2 million in the second quarter of 2025 as we shift our focus to clinical, regulatory and manufacturing activities ahead of the PARADIGM Trial.
Previous wording
Net foreign exchange losses during the three months ended March 31, 2025 were $0.2 million compared to $1.2 million of net foreign exchange gains for the same period in the prior year, a change of $1.5 million (118%), primarily due to the change in foreign exchange rates on intercompany and cash balances. In the first quarter of 2025, the United States dollar depreciated by 1% relative to the Australian dollar (“AUD $”). In the first quarter of 2024, the United States dollar appreciated by 5% relative to the AUD $.
Current wording
Net foreign exchange losses during the six months ended June 30, 2025 were $0.5 million compared to $0.8 million of net foreign exchange gains for the same period in the prior year, a change of $1.4 million (163%), primarily due to the change in foreign exchange rates on intercompany and cash balances. In the first half of 2025, the United States dollar depreciated by 5% relative to the Australian dollar. In the first half of 2024, the United States dollar appreciated by 3% relative to the Australian dollar.
Previous wording
We have experienced significant recurring operating losses and negative cash flows from operating activities since inception. As of March 31, 2025 and December 31, 2024, we had an accumulated deficit of $298.3 million and $276.4 million, respectively.
Current wording
We have experienced recurring operating losses and cash outflows from operating activities since inception. As of June 30, 2025 and December 31, 2024, we had an accumulated deficit of $319.1 million and $276.4 million, respectively.
Previous wording
In recent years, our operations have mainly been financed through the issuance of capital stock, including in our initial public offering on the Nasdaq Global Market, convertible notes, sales of regenerative tissue products and R&D tax incentives from the Australian government. Additional funding has been derived from interest earned from cash deposits. As of March 31, 2025 and December 31, 2024, we had cash and cash equivalents of $49.0 million and $70.5 million, respectively. As of March 31, 2025 and December 31, 2024, we had capital commitments relating to the lease of properties of $1.3 million and $1.4 million, respectively,. We did not have any other material capital expenditure commitments or contingent liabilities as of March 31, 2025 or December 31, 2024. We do not believe that our current cash on hand would fund our cash needs for the 12 months following March 31, 2025. We will need additional capital to fund our operations. However, our forecast of the period of time through which our financial resources will be adequate to support our operations involves risks and uncertainties, and actual results could vary materially.
Current wording
In recent years, our operations have mainly been financed through the issuance of capital stock, including in the IPO on the Nasdaq Global Market, debt financing, convertible notes, sales of regenerative tissue products and R&D tax incentives from the Australian government. Additional funding has been derived from interest earned from cash deposits. As of June 30, 2025 and December 31, 2024, we had cash, cash equivalents and restricted cash of $28.4 million and $70.5 million, respectively. As of June 30, 2025 and December 31, 2024, we had capital commitments relating to the lease of properties of $2.4 million and $1.4 million, respectively. We did not have any other material capital expenditure commitments or contingent liabilities as of June 30, 2025 or December 31, 2024. We do not believe that our current cash on hand would fund our cash needs for the 12 months following June 30, 2025. We will need additional capital to fund our operations. However, our forecast of the period of time through which our financial resources will be adequate to support our operations involves risks and uncertainties, and actual results could vary materially.
Previous wording
We anticipate that we will require substantial additional funds in order to achieve our long-term goals and complete the R&D of our current products. We do not expect to generate significant revenue until we obtain regulatory approval to market and sell our products and sales of our products have commenced. We therefore expect to continue to incur substantial losses in the near future. In order to address our short-term capital needs, we intend to raise funds through the issuance of our capital stock or other securities.
Current wording
We anticipate that we will require additional funds in order to achieve our long-term goals including completing the research and development of our current products and commercialization thereof. We do not expect to generate significant revenue until we obtain regulatory approval to market and sell our products and sales of our products have commenced. We therefore expect to continue to incur losses in the near future. In order to address our short-term capital needs, we intend to raise funds through the issuance of our capital stock or other securities.
Previous wording
● the costs of preparing and completing the Pivotal Trial of our DurAVR® THV system;
Current wording
the costs of preparing and completing the PARADIGM Trial of our DurAVR® THV system;
Previous wording
Net cash used in operating activities during the three months ended March 31, 2025 was $21.5 million, an increase of $6.0 million (38%), compared to $15.5 million in the same period in the prior year, primarily due to an increase in R&D expenses relating to the upscaling of manufacturing capabilities including process design and validation activities, preparatory activities linked to the Pivotal Trial including clinical costs associated with the enrollment of additional patients and an increase in salaries and wages linked to growth in headcount.
Current wording
Net cash used in operating activities during the six months ended June 30, 2025 was $41.0 million, an increase of $12.1 million (42%), compared to $28.9 million in the same period in the prior year, primarily due to an increase in R&D expenses relating to the upscaling of manufacturing capabilities including process design and validation activities, preparatory activities linked to the PARADIGM Trial, clinical costs associated with the enrollment of additional patients and an increase in salaries and wages linked to growth in headcount. This increase was partly offset by a reduction in selling, general and administrative expenses relating to lower marketing spending and a decrease in legal, tax and compliance costs linked to a reduction in costs from 2024, which included our re-domiciliation, listing of our common stock on Nasdaq and conducting our initial public offering, relative to 2025, which included additional costs related to compliance with dual listing requirements and other operational matters.
Previous wording
Net cash provided by investing activities during the three months ended March 31, 2025 was $1.1 million, a change of $1.8 million (255%), compared to cash outflows of $0.7 million in the same period in the prior year. This is primarily due to the receipt of $1.4 million deferred proceeds from LeMaitre relating to the sale of distribution rights in 2019. We did not have a corresponding cash inflow in 2024.
Current wording
Net cash provided by investing activities during the six months ended June 30, 2025 was $0.6 million, a change of $1.9 million (142%), compared to cash outflows of $1.4 million in the same period in the prior year. This is primarily due to the receipt of $1.4 million deferred proceeds from LeMaitre relating to the sale of distribution rights in 2019. We did not have a corresponding cash inflow in 2024. Investing cash outflows for plant and equipment were $0.6 million lower than in the same period in 2024.
Previous wording
Net cash used in financing activities during the three months ended March 31, 2025 was $1.1 million, a change of $2.6 million (170%), compared to cash inflows of $1.6 million in the same period in the prior year. In the first quarter of 2025, we received net cash proceeds of $0.6 million relating to shares issued during the quarter offset by net cash outflows of $1.2 million in transaction costs relating toour U.S. public offering, which were paid during the quarter. $0.5 million cash outflows were associated with supplier financing arrangements to fund our annual insurance premiums. In the first quarter of 2024, net cash provided by financing activities was $1.6 million, primarily due to the exercise of options over new shares in ATL.
Current wording
Net cash used in financing activities during the six months ended June 30, 2025 was $1.5 million, a change of $17.5 million (110%), compared to cash inflows of $15.9 million in the same period in the prior year. In the first half of 2025, we received net cash proceeds of $0.6 million from the issuance of shares of Common Stock, offset by net cash outflows of $1.2 million in transaction costs relating to our U.S. initial public offering, completed in December 2024, which were paid during the period. $0.9 million cash outflows were associated with supplier financing arrangements to fund our annual insurance premiums, which was an increase of $0.5 million on the same period in the prior year. In the first half of 2024, net cash provided by financing activities was $15.9 million relating to proceeds from share issuances including the exercise of options for new shares in ATPL of $17.4 million, partly offset by $1.1 million in related transaction costs.
Previous wording
We lease laboratory facilities and offices. The leases typically include options to renew at which time the lease payments are subject to market adjustments and/or set price increases. Extension and termination options are included in a number of the leases to allow for flexibility in terms of corporate growth and managing the assets used in our operations. The leases expire between June 2025 and 2029 and some include options to extend. At March 31, 2025, we had contractual commitments (on an undiscounted basis) for property leases of $1.6 million, which were recognized on a discounted basis at $1.3 million.
Current wording
We lease laboratory and manufacturing facilities and offices. The leases typically include options to renew at which time the lease payments are subject to market adjustments and/or set price increases. Extension and termination options are included in a number of the leases to allow for flexibility in terms of corporate growth and managing the assets used in our operations. The leases expire between April 2026 and April 2030 and some include options to extend. At June 30, 2025, we had contractual commitments (on an undiscounted basis) for property leases of $3.0 million, which were recognized on a discounted basis at $2.4 million.
Previous wording
The preparation of condensed consolidated financial statements in conformity with United States GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts in the consolidated financial statements and accompanying notes thereto. Management continually evaluates its judgments and estimates in relation to assets, liabilities, contingent liabilities, revenue and expenses. Management bases its judgments, estimates and assumptions on historical experience and on other various factors, including expectations regarding future events that management believes to be reasonable under the circumstances. Actual results could differ from those estimates due to risks and uncertainties and may be material.
Current wording
The preparation of condensed consolidated financial statements in conformity with United States GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts in the condensed consolidated financial statements and accompanying notes thereto. Management continually evaluates its judgments and estimates in relation to assets, liabilities, contingent liabilities, revenue and expenses. Management bases its judgments, estimates and assumptions on historical experience and on other various factors, including expectations regarding future events that management believes to be reasonable under the circumstances. Actual results could differ from those estimates due to risks and uncertainties and may be material.
Previous wording
Our significant accounting policies are discussed in Note 2, “Basis of Preparation and Summary of Significant Accounting Policies” in our Annual Report. There were no significant changes to these policies during the three months ended March 31, 2025.
Current wording
Our significant accounting policies are discussed in Note 2, “Basis of Preparation and Summary of Significant Accounting Policies” in our Annual Report. There were no significant changes to these policies during the six months ended June 30, 2025.
Previous wording
We determined that v2vmedtech is a VIE and that we are the primary beneficiary of v2vmedtech. This determination is based on our having both power over the most significant activities of v2vmedtech, primarily through holding a majority of the positions on v2vmedtech’s board of directors (although v2v’s non-Anteris shareholder representative on the v2v board of directors presently maintains certain veto rights), controlling the appointment of the chief executive officer and chief financial officer roles, being the exclusive partner to develop v2vmedtech’s products, and benefits through equity ownership.
Current wording
We determined that v2vmedtech, inc. (“v2v”) is a VIE and that we are the primary beneficiary of v2v. This determination is based on our having both power over the most significant activities of v2v, primarily through holding a majority of the positions on v2v’s board of directors (although v2v’s non-Anteris shareholder representative on the v2v board of directors presently maintains certain veto rights), controlling the appointment of the chief executive officer and chief financial officer roles, being the exclusive partner to develop v2v’s products, and benefits through equity ownership.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Net foreign exchange losses during the three months ended June 30, 2025 were $0.3 million compared to $0.4 million of net foreign exchange losses for the same period in the prior year, a decrease of $0.1 million (23%), primarily due to the change in foreign exchange rates on intercompany and cash balances. In the second quarter of 2025, the United States dollar depreciated by 4% relative to the Australian dollar. In the second quarter of 2024, the United States dollar depreciated by 1% relative to the Australian dollar.