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ARTIVION, INC.

For the period ended Sep 30, 2026. Filed Nov 6, 2026.

View on SEC.gov

About this filing

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.

Sep 30, 2026 · Filed Nov 6, 2026

AORT$20.21-20.2%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-07.

0001628280-26-054746

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-06.

0001628280-26-071486

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 113 previous paragraphs and 114 current paragraphs.

64 unchanged; 44 reworded; 6 added; 4 removed; 1 previous and 0 current paragraphs rearranged.

Tables are not compared: 10 previous and 10 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 (6)

Current report

Revenues from the sales of aortic stent grafts increased 12% for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025. This increase was primarily due to an increase in the volume of units sold, and to a lesser extent, an increase in average sales prices.

Current report

Gross margin increased 2% and 10% for the three and nine months ended September 30, 2026, respectively, as compared to the three and nine months ended September 30, 2025.

Current report

Gain from sale of non-financial assets for the three and nine months ended September 30, 2025 consisted of a net $3.5 million gain as part of the Baxter Transaction upon Baxter's achievement of certain cumulative worldwide net sales of PerClot. See Part I, Item 1, Note 2 of the “Notes to Condensed Consolidated Financial Statements” for further discussion of the Baxter Transaction.

Current report

Under the terms of the Baxter Transaction, we made a $1.5 million payment to Starch Medical, Inc. in January 2026 in connection with the PerClot sales milestones. As of September 30, 2026 an additional $1.5 million remained payable in connection with these sales milestones. See Part I, Item 1, Note 2 – “Sale of PerClot” for additional information.
Removed paragraphs (4)

Previous report

Revenues from the sales of On-X products increased 20% for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. This increase was primarily due to an increase in the volume of units sold and an increase in average sales prices.

Previous report

Gross margin increased 10% and 14% for the three and six months ended June 30, 2026, respectively, as compared to the three and six months ended June 30, 2025.

Previous report

Other than the borrowing, related anticipated interest payments, contingent payment obligations, and payment described above, there have been no material changes outside of the ordinary course of business with respect to our material cash requirements for our contractual and other obligations as set forth in the table included in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2025.
Reworded paragraphs (44)

Previous wording

We reported quarterly revenues of $125.8 million for the three months ended June 30, 2026, an 11% increase from the three months ended June 30, 2025. The increase in revenues for the three months ended June 30, 2026 was due to an increase in revenues from all products and preservation services other than surgical sealants, which remained relatively flat. Constant currency revenues, as defined below, increased 9% for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025.

Current wording

We reported quarterly revenues of $123.8 million for the three months ended September 30, 2026, a 9% increase from the three months ended September 30, 2025. The increase in revenues for the three months ended September 30, 2026 was primarily due to increases in revenues from aortic stent grafts and On-X products, and to a lesser extent, other products, while revenues from surgical sealants and preservation services remained relatively flat. Constant currency revenues, as defined below, increased 9% for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025.

Previous wording

See the “Results of Operations” section below for additional analysis of the three and six months ended June 30, 2026.

Current wording

See the “Results of Operations” section below for additional analysis of the three and nine months ended September 30, 2026.

Previous wording

Revenues increased 11% and 14% for the three and six months ended June 30, 2026, respectively, as compared to the three and six months ended June 30, 2025. The increase in revenues for the three months ended June 30, 2026 was primarily due to an increase in revenues from aortic stent grafts and On-X products, and to a lesser extent, preservation services and other products. The increase in revenues for the six months ended June 30, 2026 was primarily due to an increase in revenues from aortic stent grafts, On-X products, and preservation services, and to a lesser extent, surgical sealants and other products.

Current wording

Revenues increased 9% and 12% for the three and nine months ended September 30, 2026, respectively, as compared to the three and nine months ended September 30, 2025. The increase in revenues for the three months ended September 30, 2026 was primarily due to an increase in revenues from aortic stent grafts and On-X products, and to a lesser extent, other products. The increase in revenues for the nine months ended September 30, 2026 was primarily due to an increase in revenues from aortic stent grafts, On-X products, and preservation services, and to a lesser extent, other products and surgical sealants.

Previous wording

A detailed discussion of the changes in product revenues and preservation services revenues for the three and six months ended June 30, 2026 is presented below.

Current wording

A detailed discussion of the changes in product revenues and preservation services revenues for the three and nine months ended September 30, 2026 is presented below.

Previous wording

Revenues from products increased 14% and 15% for the three and six months ended June 30, 2026, respectively, as compared to the three and six months ended June 30, 2025. The increase for the three months ended June 30, 2026 was primarily due to an increase in revenues from aortic stent grafts and On-X products, and to a lesser extent, other products. The increase for the six months ended June 30, 2026 was primarily due to an increase in revenues from aortic stent grafts and On-X products, and to a lesser extent, surgical sealants and other products.

Current wording

Revenues from products increased 12% and 14% for the three and nine months ended September 30, 2026, respectively, as compared to the three and nine months ended September 30, 2025. The increase for the three months ended September 30, 2026 was primarily due to an increase in revenues from aortic stent grafts and On-X products, and to a lesser extent, other products. The increase for the nine months ended September 30, 2026 was primarily due to an increase in revenues from aortic stent grafts and On-X products, and to a lesser extent, other products and surgical sealants.

Previous wording

Sales of certain products through our direct sales force and distributors across Europe and various other countries are denominated in a variety of currencies including Euros, Brazilian Reals, Polish Zlotys, British Pounds, Canadian Dollars, and Swiss Francs with a concentration denominated in Euros. Each currency is subject to exchange rate fluctuations. For the three and six months ended June 30, 2026, as compared to the three and six months ended June 30, 2025, the US Dollar weakened in comparison to major currencies, resulting in revenue increases when these foreign currency denominated transactions were translated into US Dollars. Future changes in these exchange rates could have a material, adverse effect on our revenues denominated in these currencies. Additionally, our sales to many distributors around the world are denominated in US Dollars, and although these sales are not directly impacted by currency exchange rates, we believe that some of our distributors may delay or reduce purchases of products in US Dollars depending on the relative price of these goods in their local currencies.

Current wording

Sales of certain products through our direct sales force and distributors across Europe and various other countries are denominated in a variety of currencies including Euros, Brazilian Reals, Polish Zlotys, British Pounds, Canadian Dollars, and Swiss Francs with a concentration denominated in Euros. Each currency is subject to exchange rate fluctuations. For the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, foreign currency fluctuations did not have a significant impact on revenues. For the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, the US Dollar weakened in comparison to major currencies, resulting in revenue increases when these foreign currency denominated transactions were translated into US Dollars. Future changes in these exchange rates could have a material, adverse effect on our revenues denominated in these currencies. Additionally, our sales to many distributors around the world are denominated in US Dollars, and although these sales are not directly impacted by currency exchange rates, we believe that some of our distributors may delay or reduce purchases of products in US Dollars depending on the relative price of these goods in their local currencies.

Previous wording

Aortic stent grafts include aortic arch stent grafts, abdominal stent grafts, and synthetic vascular grafts, and original equipment manufacturing (“OEM”) aortic stent graft products. Aortic arch stent grafts include our E-vita Open NEO, E-vita Open Plus, AMDS, the NEXUS family of products, and E-vita Thoracic 3G products. Abdominal stent grafts include our E-xtra Design Engineering, E-nside, Artivex, E-tegra, E-ventus BX, Tuva BX, and E-liac products. Aortic stent grafts are used in endovascular and open vascular surgery for the treatment of complex aortic arch, thoracic, and abdominal aortic diseases. Our aortic stent grafts are primarily distributed in international markets.

Current wording

Aortic stent grafts include aortic arch stent grafts, abdominal stent grafts, synthetic vascular grafts, and original equipment manufacturing (“OEM”) aortic stent graft products. Aortic arch stent grafts include our E-vita Open NEO, E-vita Open Plus, AMDS, the NEXUS family of products, and E-vita Thoracic 3G products. Abdominal stent grafts include our E-xtra Design Engineering, E-nside, Artivex, E-tegra, E-ventus BX, Tuva BX, and E-liac products. Aortic stent grafts are used in endovascular and open vascular surgery for the treatment of complex aortic arch, thoracic, and abdominal aortic diseases. Our aortic stent grafts are primarily distributed in international markets.

Previous wording

Revenues from the sales of aortic stent grafts increased 16% and 19% for the three and six months ended June 30, 2026, respectively, as compared to the three and six months ended June 30, 2025. These increases were primarily due to an increase in the volume of units sold, and to a lesser extent, the favorable effect of foreign exchange rates.

Current wording

Revenues from the sales of aortic stent grafts increased 16% for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025. This increase was primarily due to an increase in the volume of units sold, and to a lesser extent, the favorable effect of foreign exchange rates and an increase in average sales prices.

Previous wording

Constant currency revenues from the sales of aortic stent grafts increased 12% and 11% for the three and six months ended June 30, 2026, respectively, as compared to the three and six months ended June 30, 2025. These increases for the three and six months ended June 30, 2026 were primarily due to revenue increases in Europe, the Middle East, and Africa (collectively, “EMEA”) and North America. The revenue increases in EMEA for the three and six months ended June 30, 2026 were primarily due to an increase in volume of products sold within the aortic stent graft product line in direct (to hospitals) markets. The revenue increases in North America for the three and six months ended June 30, 2026 were primarily due to an increase in sales of AMDS, reflecting increased adoption following the grant of a humanitarian device exemption (“HDE”) by the FDA in December 2024 for use of the AMDS™ Hybrid Prosthesis in acute DeBakey Type I dissections in the presence of malperfusion. The HDE allowed for, subject to certain restrictions, commercial distribution of AMDS in the United States (“US”) prior to the approval of a Premarket Approval Application, which we received in June 2026, allowing for full commercial distribution of AMDS in the US. The revenue increases for the six months ended June 30, 2026 were partially offset by revenue decreases in Asia Pacific (“APAC”) and Latin America (“LATAM”), primarily due to customer buying patterns in certain markets.

Current wording

Constant currency revenues from the sales of aortic stent grafts increased 12% and 11% for the three and nine months ended September 30, 2026, respectively, as compared to the three and nine months ended September 30, 2025. Revenues for the three months ended September 30, 2026 increased in all geographies, with the most significant increase in Europe, the Middle East, and Africa (collectively, “EMEA”). The revenue increase in EMEA for the three months ended September 30, 2026 was primarily due to an increase in the volume of products sold within the aortic stent graft product line in direct (to hospitals) markets. The increase in revenues for the nine months ended September 30, 2026 was primarily due to revenue increases in EMEA and North America. The revenue increases in EMEA for the nine months ended September 30, 2026 were primarily due to an increase in the volume of products sold within the aortic stent graft product line in direct (to hospitals) markets. The revenue increases in North America for the nine months ended September 30, 2026 were primarily due to an increase in sales of AMDS, reflecting increased adoption following the grant of a humanitarian device exemption (“HDE”) by the FDA in December 2024 for use of the AMDS™ Hybrid Prosthesis in acute DeBakey Type I dissections in the presence of malperfusion. The HDE allowed for, subject to certain restrictions, commercial distribution of AMDS in the United States (“US”) prior to the approval of a Premarket Approval Application, which we received in June 2026, allowing for full commercial distribution of AMDS in the US.

Previous wording

For the three and six months ended June 30, 2026 and 2025, the substantial majority of aortic stent graft revenues were generated from geographies outside the US.

Current wording

For the three and nine months ended September 30, 2026 and 2025, the substantial majority of aortic stent graft revenues were generated from geographies outside the US.

Previous wording

Revenues from the sales of On-X products increased 19% for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. This increase was primarily due to higher average sales prices and an increase in the volume of units sold.

Current wording

Revenues from the sales of On-X products increased 13% and 17% for the three and nine months ended September 30, 2026, respectively, as compared to the three and nine months ended September 30, 2025. These increases were primarily due to higher average sales prices and an increase in the volume of units sold.

Previous wording

Constant currency revenues from the sales of On-X products increased 18% and 17% for the three and six months ended June 30, 2026, respectively, as compared to the three and six months ended June 30, 2025. The increase in revenues for the three and six months ended June 30, 2026 was primarily due to growth in North America, EMEA, and APAC, reflecting gains in market share.

Current wording

Constant currency revenues from the sales of On-X products increased 13% and 16% for the three and nine months ended September 30, 2026, respectively, as compared to the three and nine months ended September 30, 2025. The increase in revenues for the three and nine months ended September 30, 2026 was primarily due to growth in North America and, to a lesser extent, increases in EMEA and Asia Pacific (“APAC”), reflecting gains in market share.

Previous wording

Domestic revenues from the sales of On-X products accounted for 58% and 60% of total On-X revenues for the three and six months ended June 30, 2026, respectively, as compared to 61% and 63% for the three and six months ended June 30, 2025, respectively.

Current wording

Domestic revenues from the sales of On-X products accounted for 61% and 60% of total On-X revenues for the three and nine months ended September 30, 2026, respectively, as compared to 60% and 62% for the three and nine months ended September 30, 2025, respectively.

Previous wording

Revenues from the sales of surgical sealants were flat for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, primarily due to a decrease in the volume of milliliters sold, offset by favorable foreign exchange rates and, to a lesser extent, an increase in average sales prices.

Current wording

Revenues from the sales of surgical sealants were flat for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, primarily due to a decrease in the volume of milliliters sold, offset by an increase in average sales prices.

Previous wording

Revenues from the sales of surgical sealants increased 2% for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. This increase was primarily due to favorable foreign exchange rates and, to a lesser extent, an increase in average sales prices, partially offset by a decrease in the volume of milliliters sold.

Current wording

Revenues from the sales of surgical sealants increased 1% for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025. This increase was primarily due to favorable foreign exchange rates and an increase in average sales prices, partially offset by a decrease in the volume of milliliters sold.

Previous wording

Constant currency revenues from the sales of surgical sealants decreased 2% for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The decrease for the three months ended June 30, 2026 was primarily due to revenue decreases in EMEA and North America, partially offset by revenue increases in APAC and LATAM. Revenue variability across international markets primarily reflected the timing of hospital and distributor purchases and buying patterns. North America revenues decreased due to lower unit sales primarily reflecting the timing of customer orders, partially offset by higher average selling prices.

Current wording

Constant currency revenues from the sales of surgical sealants were flat for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025. This reflected revenue increases in North America and APAC, offset by revenue decreases in Latin America (“LATAM”) and EMEA. Revenue variability across international markets primarily reflected the timing of hospital and distributor purchases and buying patterns. The revenue increase in North America for the three months ended September 30, 2026 was primarily due to an increase in average sales prices, while APAC growth also benefited from increased adoption in certain markets.

Previous wording

Constant currency revenues from the sales of surgical sealants decreased 1% for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The decrease for the six months ended June 30, 2026 was primarily due to revenue decreases in LATAM and EMEA, partially offset by revenue increases in APAC and North America. Revenue variability across international markets primarily reflected the timing of hospital and distributor purchases and buying patterns, while APAC growth also benefited from increased adoption in certain markets. The revenue increase in North America for the six months ended June 30, 2026 was primarily due to an increase in average sales prices.

Current wording

Constant currency revenues from the sales of surgical sealants decreased 1% for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025. The decrease for the nine months ended September 30, 2026 was primarily due to revenue decreases in LATAM and EMEA, partially offset by revenue increases in APAC and North America. Revenue variability across international markets primarily reflected the timing of hospital and distributor purchases and buying patterns, while APAC growth also benefited from increased adoption in certain markets. The revenue increase in North America for the nine months ended September 30, 2026 was primarily due to an increase in average sales prices.

Previous wording

Domestic revenues from the sales of surgical sealants accounted for 45% and 48% of total surgical sealant revenues for the three and six months ended June 30, 2026, respectively, as compared to 48% for both the three and six months ended June 30, 2025.

Current wording

Domestic revenues from the sales of surgical sealants accounted for 45% and 47% of total surgical sealant revenues for the three and nine months ended September 30, 2026, respectively, as compared to 44% and 47% for the three and nine months ended September 30, 2025, respectively.

Previous wording

Other revenues increased 35% and 14% for the three and six months ended June 30, 2026, respectively, as compared to the three and six months ended June 30, 2025. The increase was primarily due to an increase in PerClot product revenues resulting from an increase in volume of units sold.

Current wording

Other revenues increased 93% and 39% for the three and nine months ended September 30, 2026, respectively, as compared to the three and nine months ended September 30, 2025. The increase was primarily due to an increase in PerClot product revenues resulting from an increase in volume of units sold. As discussed in Part I, Item 1, Note 2 of the “Notes to Condensed Consolidated Financial Statements,” we expect to conclude our PerClot manufacturing activities under the Transitional Manufacturing and Supply Agreement with Baxter by the end of 2026.

Previous wording

Revenues from tissue processing increased 1% for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The increase was primarily due to an increase in average sales prices, partially offset by a decrease in the volume of tissues shipped. Shipment volumes during the three months ended June 30, 2025 benefited from the release of a backlog of tissues resulting from the 2024 cybersecurity incident, which started to release during the second quarter of 2025.

Current wording

Revenues from tissue processing were flat for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025. The change was primarily due to an increase in average sales prices, partially offset by a decrease in the volume of tissues shipped. Shipment volumes during the three months ended September 30, 2025 benefited from the release of a backlog of tissues resulting from the 2024 cybersecurity incident, which started to release during the second quarter of 2025.

Previous wording

Revenues from tissue processing increased 11% for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The increase was primarily due to an increase in the volume of tissues shipped as well as an increase in average sales prices. Revenues for the three months ended March 31, 2025 were adversely affected by a backlog of tissues resulting from the 2024 cybersecurity incident. The backlog started to release during the second quarter of 2025, as discussed above.

Current wording

Revenues from tissue processing increased 7% for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025. The increase was primarily due to an increase in average sales prices as well as an increase in the volume of tissues shipped. Revenues for the three months ended March 31, 2025 were adversely affected by a backlog of tissues resulting from the 2024 cybersecurity incident. The backlog started to release during the second quarter of 2025, as discussed above.

Previous wording

Cost of products increased 20% and 19% for the three and six months ended June 30, 2026, respectively, as compared to the three and six months ended June 30, 2025. Cost of products for the three and six months ended June 30, 2026 and 2025 included costs related to aortic stent grafts, On-X products, surgical sealants, and other products.

Current wording

Cost of products increased 28% and 22% for the three and nine months ended September 30, 2026, respectively, as compared to the three and nine months ended September 30, 2025. Cost of products for the three and nine months ended September 30, 2026 and 2025 included costs related to aortic stent grafts, On-X products, surgical sealants, and other products.

Previous wording

The increase in total cost of products for the six months ended June 30, 2026 was primarily due to an increase in the volume of On-X products and aortic stent grafts shipped, and an increase in the unit cost of certain aortic stent grafts and On-X products shipped, as compared to the six months ended June 30, 2025.

Current wording

The increase in total cost of products for the three and nine months ended September 30, 2026 was primarily due to an increase in the volume of aortic stent grafts and On-X products shipped, and an increase in the unit cost of certain aortic stent grafts and On-X products shipped, as compared to the three and nine months ended September 30, 2025.

Previous wording

Cost of preservation services decreased 3% for the three months ended June 30, 2026 as compared to the three months ended June 30, 2025. Cost of preservation services increased 3% for the six months ended June 30, 2026 as compared to the six months ended June 30, 2025. Cost of preservation services included costs for cardiac and vascular tissue preservation services.

Current wording

Cost of preservation services increased 8% and 5% for the three and nine months ended September 30, 2026, respectively, as compared to the three and nine months ended September 30, 2025. Cost of preservation services included costs for cardiac and vascular tissue preservation services.

Previous wording

The decrease in total cost of preservation services for the three months ended June 30, 2026 was primarily due to a decrease in the unit cost and volume of certain tissues shipped, as compared to the three months ended June 30, 2025.

Current wording

The increase in total cost of preservation services for the three months ended September 30, 2026 was primarily due to an increase in the unit cost of tissues shipped, as compared to the three months ended September 30, 2025.

Previous wording

The increase in total cost of preservation services for the six months ended June 30, 2026 was primarily due to an increase in the volume of certain tissues shipped, partially offset by a decrease in the unit cost of certain tissues shipped, as compared to the six months ended June 30, 2025.

Current wording

The increase in total cost of preservation services for the nine months ended September 30, 2026 was primarily due to an increase in the volume of certain tissues shipped and, to a lesser extent, an increase in the unit cost of certain tissues shipped, as compared to the nine months ended September 30, 2025.

Previous wording

The increase in gross margin for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, was primarily due to higher average selling prices for certain products and tissues shipped, an increase in volume of certain products shipped, and favorable foreign currency effects for the three months ended June 30, 2026. The increase was partially offset by unfavorable cost of certain products shipped, as compared to the three months ended June 30, 2025. Gross margin as a percentage of total revenues decreased for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. Gross margin as a percentage of total revenues was negatively impacted by an unfavorable geographic mix and unfavorable costs of certain products and tissues shipped, partially offset by favorable pricing of certain products shipped, during the three months ended June 30, 2026.

Current wording

The increase in gross margin for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, was primarily due to an increase in the volume of certain products shipped and an increase in the average selling prices of products and tissues shipped. The increase was partially offset by an unfavorable mix and higher costs of certain products and tissues shipped, as compared to the three months ended September 30, 2025. Gross margin as a percentage of total revenues decreased for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025. Gross margin as a percentage of total revenues was negatively impacted by higher costs and an unfavorable mix of certain products and tissues shipped, partially offset by favorable pricing of certain products and tissues shipped during the three months ended September 30, 2026.

Previous wording

The increase in gross margin for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, was primarily due to a favorable mix of certain products and tissues shipped, an increase in the average sales price of certain products and tissues shipped, a favorable effect of foreign exchange rates, and an increase in volume of certain products and tissues shipped for the six months ended June 30, 2026. The increase was partially offset by unfavorable cost of certain products and tissues shipped, as compared to the six months ended June 30, 2025. Gross margin as a percentage of total revenues was flat for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. Gross margin as a percentage of total revenues was impacted by unfavorable costs of certain products and certain tissues shipped, offset by favorable pricing of certain products and tissues shipped during the six months ended June 30, 2026.

Current wording

The increase in gross margin for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, was primarily due to an increase in the average selling prices of certain products and tissues shipped, an increase in the volume of certain products and tissues shipped, and the favorable effect of foreign exchange rates. These increases were partially offset by higher costs of certain products and certain tissues shipped, as compared to the nine months ended September 30, 2025. Gross margin as a percentage of total revenues decreased for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025. Gross margin as a percentage of total revenues was negatively impacted by higher costs of certain products and certain tissues shipped, an unfavorable geographic mix of certain products shipped, and an unfavorable product mix of certain products and tissues shipped, partially offset by favorable pricing of certain products and tissues shipped during the nine months ended September 30, 2026.

Previous wording

General, administrative, and marketing expenses increased 38% for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, which includes the impact of the Ascyrus contingent consideration fair value adjustment loss of $8.0 million and $2.6 million for the three months ended June 30, 2026 and 2025, respectively. The remaining general, administrative, and marketing expenses for the three months ended June 30, 2026 increased $16.8 million, primarily due to $11.7 million of Endospan acquisition transaction costs, of which $10.2 million related to transaction bonuses for Endospan employees associated with the Endospan acquisition, as well as investments in sales and marketing, and increased non-cash stock compensation expenses.

Current wording

General, administrative, and marketing expenses increased 10% for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, which includes the impact of the Ascyrus contingent consideration fair value adjustment losses of $1.1 million and $2.6 million for the three months ended September 30, 2026 and 2025, respectively, and the Endospan contingent consideration fair value adjustment loss of $2.9 million for the three months ended September 30, 2026. The remaining general, administrative, and marketing expenses for the three months ended September 30, 2026 increased $4.5 million, primarily due to $1.5 million of Endospan integration-related costs, operating expenses associated with Endospan following the acquisition, as well as increased investments in sales and marketing and information technology.

Previous wording

General, administrative, and marketing expenses increased 25% for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, which includes the impact of the Ascyrus contingent consideration fair value adjustment loss of $9.7 million and gain of $0.2 million for the six months ended June 30, 2026 and 2025, respectively. The remaining general, administrative, and marketing expenses for the six months ended June 30, 2026 increased $18.4 million, primarily due to $12.5 million of Endospan acquisition transaction costs, of which $10.2 million related to transaction bonuses for Endospan employees associated with the Endospan acquisition, as well as investments in sales and marketing and information technology, and increased non-cash stock compensation expenses. These increases were partially offset by $1.5 million in net cyber insurance recoveries received.

Current wording

General, administrative, and marketing expenses increased 20% for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, which includes the impact of the Ascyrus contingent consideration fair value adjustment losses of $10.8 million and $2.4 million for the nine months ended September 30, 2026 and 2025, respectively, and the Endospan contingent consideration fair value adjustment loss of $2.9 million for the nine months ended September 30, 2026. The remaining general, administrative, and marketing expenses for the nine months ended September 30, 2026 increased $22.9 million, primarily due to $14.0 million of Endospan acquisition transaction, diligence, and integration costs, of which $10.2 million related to transaction bonuses for Endospan employees associated with the Endospan acquisition, operating expenses associated with Endospan following the acquisition, as well as investments in sales and marketing and information technology, and increased non-cash stock compensation expenses. These increases were partially offset by $1.5 million in net cyber insurance recoveries received.

Previous wording

Research and development expenses increased 28% and 30% for the three and six months ended June 30, 2026, respectively, as compared to the three and six months ended June 30, 2025. Research and development spending for the three and six months ended June 30, 2026 was primarily focused on clinical work to gain regulatory approvals for certain aortic stent grafts.

Current wording

Research and development expenses increased 21% and 27% for the three and nine months ended September 30, 2026, respectively, as compared to the three and nine months ended September 30, 2025. Research and development spending for the three and nine months ended September 30, 2026 was primarily focused on clinical work to gain regulatory approvals for certain aortic stent grafts, including $0.5 million of Endospan integration-related costs for both the three and nine months ended September 30, 2026.

Previous wording

Interest expense was $7.3 million and $12.6 million for the three and six months ended June 30, 2026, respectively, as compared to $7.3 million and $14.9 million for the three and six months ended June 30, 2025, respectively. Interest expense for the six months ended June 30, 2026 decreased primarily due to lower variable interest rates on our credit facilities and reduced interest expense as a result of the settlement of the Convertible Senior Notes, partially offset by interest incurred on the New Delayed Draw Term Loan borrowed in May 2026. See Part I, Item 1, Note 9 of the “Notes to Condensed Consolidated Financial Statements” for further discussion of the settlement of the Convertible Senior Notes and the borrowing under the New Delayed Draw Term Loan.

Current wording

Interest expense was $8.5 million and $21.1 million for the three and nine months ended September 30, 2026, respectively, as compared to $6.1 million and $21.1 million for the three and nine months ended September 30, 2025, respectively. Interest expense for the three months ended September 30, 2026 increased primarily due to interest incurred on the New Delayed Draw Term Loan borrowed in May 2026. Interest expense for the nine months ended September 30, 2026 remained relatively flat, as lower variable interest rates on our credit facilities and reduced interest expense resulting from the settlement of the Convertible Senior Notes were offset by interest incurred on the New Delayed Draw Term Loan. See Part I, Item 1, Note 9 of the “Notes to Condensed Consolidated Financial Statements” for further discussion of the settlement of the Convertible Senior Notes and the borrowing under the New Delayed Draw Term Loan.

Previous wording

During the three and six months ended June 30, 2025 we recorded a loss on inducement of convertible debt of $2.7 million in connection with the settlement of our Convertible Senior Notes. See Part I, Item 1, Note 9 of the “Notes to Condensed Consolidated Financial Statements” for further discussion of our Convertible Senior Notes.

Current wording

During the nine months ended September 30, 2025 we recorded a loss on inducement of convertible debt of $2.7 million in connection with the settlement of our Convertible Senior Notes. See Part I, Item 1, Note 9 of the “Notes to Condensed Consolidated Financial Statements” for further discussion of our Convertible Senior Notes.

Previous wording

Other income was $3.6 million and $3.3 million for the three and six months ended June 30, 2026, respectively, as compared to $5.0 million and $8.0 million of income for the three and six months ended June 30, 2025, respectively. For the three months ended June 30, 2026, other income primarily included a $4.3 million gain from fair value adjustments to loans issued in connection with our acquisition of Endospan, partially offset by a net $0.7 million loss from realized and unrealized effects of foreign currency gains and losses. Other income for the six months ended June 30, 2026 primarily included a $4.8 million gain associated with fair value adjustments to loans issued in connection with our acquisition of Endospan, partially offset by a net $1.6 million loss from realized and unrealized effects of foreign currency gains and losses.

Current wording

Other expense (income), net was $0.5 million of expense and $2.8 million of income for the three and nine months ended September 30, 2026, respectively, as compared to $0.4 million and $8.4 million of income for the three and nine months ended September 30, 2025, respectively. For the three months ended September 30, 2026, other expense (income), net primarily included $0.6 million of net realized and unrealized foreign currency losses. Other expense (income), net for the nine months ended September 30, 2026 primarily included a $5.0 million gain associated with fair value adjustments to loans issued in connection with our acquisition of Endospan, partially offset by a net $2.2 million loss from realized and unrealized effects of foreign currency gains and losses.

Previous wording

Our effective income tax rate was (15)% and (6)% for the three and six months ended June 30, 2026, respectively, as compared to 61% and 29% for the three and six months ended June 30, 2025, respectively. Our income tax rate varied from the US statutory rate of 21% predominately due to state income taxes, non-deductible executive compensation, changes in our valuation allowance for current period losses and changes in estimates of our expected recovery of net deferred tax assets, excess tax deductions on stock-based compensation, and foreign withholding taxes. The year-over-year changes to the effective income tax rate were largely attributable to the shift from pre-tax book income in each respective period in 2025 to pre-tax book losses in each respective period in 2026.

Current wording

Our effective income tax rate was (34)% and (16)% for the three and nine months ended September 30, 2026, respectively, as compared to 8% and 11% for the three and nine months ended September 30, 2025, respectively. Our income tax rate varied from the US statutory rate of 21% predominantly due to state income taxes, non-deductible executive compensation, and the impact of tax rate changes to our deferred tax liabilities, offset by changes in our valuation allowance against our net deferred tax assets, excess tax deductions on stock-based compensation, and foreign provision to return adjustments. The year-over-year changes to the effective income tax rate were largely attributable to the shift from pre-tax book income in each respective period in 2025 to pre-tax book losses in each respective period in 2026.

Previous wording

On July 4, 2025 the One Big Beautiful Bill Act (“OBBBA”) was enacted in the US. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework, and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. We have reflected the impact of the enactment in our results for the three and six months ended June 30, 2026.

Current wording

On July 4, 2025 the One Big Beautiful Bill Act (“OBBBA”) was enacted in the US. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework, and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. We have reflected the impact of the enactment in our results for the three and nine months ended September 30, 2026.

Previous wording

Our liquidity as of June 30, 2026 consisted of cash and cash equivalents of $77.3 million and unused commitments of $30.0 million under a revolving credit facility (see “Credit Facilities” below). As of June 30, 2026 approximately 28% of our cash and cash equivalents were held in foreign jurisdictions. Our practice is to maintain sufficient liquidity through cash from operations and our revolving credit facility to mitigate the impacts of any adverse financial market conditions on our operations. We believe that cash generated from operations, together with amounts available under our Credit Facilities, as defined below, will be sufficient to meet working capital requirements and anticipated capital expenditures, and other strategic uses of cash, if any, and debt payments, if any, over the next twelve months.

Current wording

Our liquidity as of September 30, 2026 consisted of cash and cash equivalents of $48.4 million and unused commitments of $30.0 million under a revolving credit facility (see “Credit Facilities” below). As of September 30, 2026 approximately 53% of our cash and cash equivalents were held in foreign jurisdictions. Our practice is to maintain sufficient liquidity through cash from operations and our revolving credit facility to mitigate the impacts of any adverse financial market conditions on our operations. We believe that cash generated from operations, together with amounts available under our Credit Facilities, as defined below, will be sufficient to meet working capital requirements and anticipated capital expenditures, and other strategic uses of cash, if any, and debt payments, if any, over the next twelve months.

Previous wording

Our future cash requirements are expected to include interest payments under our credit facilities, expenditures for clinical trials, research and development expenditures, general working capital needs, capital expenditures, other corporate purposes, and may include cash to fund other business development activities including obligations pursuant to the acquisition of Ascyrus and Endospan. In July 2026, following receipt of FDA approval of the premarket approval application for the AMDS, we made a contingent payment of $25.0 million under the Ascyrus Agreement. These items may have a significant effect on our future cash flows during the next twelve months. Subject to the terms of our credit facilities, we may seek additional borrowing capacity or financing, pursuant to our current or any future shelf registration statement, for general corporate purposes or to fund other future cash requirements. If we undertake any further significant business development activity, we may need to finance such activities by obtaining additional debt financing or using a registration statement to sell equity securities. There can be no assurance that we will be able to obtain any additional debt or equity financing at the time needed or that such financing will be available on terms that are favorable or acceptable to us.

Current wording

Our future cash requirements are expected to include interest payments under our credit facilities, expenditures for clinical trials, research and development expenditures, general working capital needs, capital expenditures, other corporate purposes, and may include cash to fund other business development activities including obligations pursuant to the acquisition of Ascyrus and Endospan. These items may have a significant effect on our future cash flows during the next twelve months. Subject to the terms of our credit facilities, we may seek additional borrowing capacity or financing, pursuant to our current or any future shelf registration statement, for general corporate purposes or to fund other future cash requirements. If we undertake any further significant business development activity, we may need to finance such activities by obtaining additional debt financing or using a registration statement to sell equity securities. There can be no assurance that we will be able to obtain any additional debt or equity financing at the time needed or that such financing will be available on terms that are favorable or acceptable to us.

Previous wording

The final scheduled maturity date of the Credit Facilities is January 18, 2031. There are no scheduled repayments of principal required to be made prior to the final maturity date. We have the right to prepay loans under the Credit Agreement in whole or in part at any time, subject to certain premium payment requirements. Amounts repaid in respect of loans under the Term Loan Facilities may not be reborrowed. The Credit Facilities currently bear interest at the Secured Overnight Financing Rate (“SOFR”) plus applicable margins. As of June 30, 2026 the stated interest rates on the Term Loan Facility, Revolving Credit Facility, and New Delayed Draw Term Loan Facility were 8.44%, 7.19%, and 8.40%, respectively. See Part I, Item 1, Note 9 of the “Notes to Condensed Consolidated Financial Statements” for further discussion of our new Ares Credit Agreement.

Current wording

The final scheduled maturity date of the Credit Facilities is January 18, 2031. There are no scheduled repayments of principal required to be made prior to the final maturity date. We have the right to prepay loans under the Credit Agreement in whole or in part at any time, subject to certain premium payment requirements. Amounts repaid in respect of loans under the Term Loan Facilities may not be reborrowed. The Credit Facilities currently bear interest at the Secured Overnight Financing Rate (“SOFR”) plus applicable margins. As of September 30, 2026 the stated interest rates on the Term Loan Facility, Revolving Credit Facility, and New Delayed Draw Term Loan Facility were 8.48%, 7.23%, and 8.51%, respectively. See Part I, Item 1, Note 9 of the “Notes to Condensed Consolidated Financial Statements” for further discussion of our new Ares Credit Agreement.

Previous wording

Net cash used in operating activities decreased by $1.8 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, as an increase in cash collected from customers and the insurance recoveries associated with the 2024 cybersecurity incident were partially offset by transaction and integration expenditures associated with our acquisition of Endospan, the $10.2 million payment for transaction bonuses for Endospan employees associated with the Endospan acquisition, and an increase in inventories to support revenue growth.

Current wording

Net cash flows from operating activities decreased by $25.0 million during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, primarily due to the $13.3 million operating portion of the $25.0 million AMDS PMA milestone payment made in July 2026, $14.5 million of Endospan acquisition transaction, diligence, and integration costs, of which $10.2 million related to transaction bonuses paid to Endospan employees, and an increase in inventories to support revenue growth, partially offset by an increase in cash collected from customers and insurance recoveries associated with the 2024 cybersecurity incident.

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Previous report — wording carried elsewhere

The increase in total cost of products for the three months ended June 30, 2026 was primarily due to an increase in the volume of aortic stent grafts and On-X products shipped, as compared to the three months ended June 30, 2025.