Core Insights - Artivion (AORT) reported break-even quarterly earnings per share, missing the Zacks Consensus Estimate of $0.12, and compared to earnings of $0.11 per share a year ago, resulting in an earnings surprise of -100% [1] - The company posted revenues of $97.31 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 3.56%, but showing an increase from year-ago revenues of $93.67 million [2] - Artivion shares have underperformed the market, losing about 1.2% since the beginning of the year compared to the S&P 500's gain of 2.2% [3] Earnings Outlook - The current consensus EPS estimate for the coming quarter is $0.11 on revenues of $105.2 million, and for the current fiscal year, it is $0.50 on revenues of $432.55 million [7] - The estimate revisions trend for Artivion is mixed, leading to a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Instruments industry, to which Artivion belongs, is currently in the top 33% of over 250 Zacks industries, suggesting a favorable outlook as the top 50% of Zacks-ranked industries outperform the bottom 50% by more than 2 to 1 [8] - Another company in the same industry, TransMedics (TMDX), is expected to report quarterly earnings of $0.18 per share, reflecting a year-over-year change of +50%, with revenues anticipated to be $110.38 million, up 36% from the year-ago quarter [9][10]

Revenue Performance - Total revenue for Q4 2024 was $97.3 million, a 4% increase on a GAAP basis compared to Q4 2023[5]. - Full year 2024 revenue reached $388.5 million, representing a 10% increase on a GAAP basis compared to 2023[7]. - Revenue growth in Q4 2024 was driven by On-X (10%), stent grafts (10%), and BioGlue (8%) compared to Q4 2023[3]. - Product revenues for the year ended December 31, 2024, reached $290,230,000, compared to $261,185,000 in 2023, reflecting a year-over-year increase of 11.1%[20]. - Total revenues for the three months ended December 31, 2024, were $97,308 million, representing a 3% increase from $93,670 million in the prior year[30]. - Aortic stent grafts revenue increased by 8% to $30,145 million from $27,437 million year-over-year[30]. - North America revenue for the year ended December 31, 2024, was $197,940 million, a 6% increase from $187,603 million in 2023[30]. - Europe, the Middle East, and Africa revenue increased by 13% to $131,518 million for the year ended December 31, 2024, compared to $114,814 million in 2023[30]. - Latin America revenue for the year ended December 31, 2024, increased by 26% to $21,877 million from $18,010 million in the prior year[30]. Profitability and Loss - Adjusted EBITDA for Q4 2024 increased by 15% to $17.6 million, while full year adjusted EBITDA rose by 32% to $71.3 million[3]. - Net loss for Q4 2024 was $(16.5) million, or $(0.39) per fully diluted share, compared to a net loss of $(4.0) million in Q4 2023[6]. - The net loss for the year ended December 31, 2024, was $13,359,000, compared to a net loss of $30,690,000 in 2023, representing an improvement of 56.4%[20]. - For the three months ended December 31, 2024, the net loss was $16,483 million, compared to a net loss of $3,975 million for the same period in 2023, representing a significant increase in losses[34]. - The diluted loss per common share for the year ended December 31, 2024, was $0.32, compared to $0.75 for the year ended December 31, 2023, indicating a reduction in loss per share[34]. - Adjusted net income for the year ended December 31, 2024, was $10,768 million, up from $8,426 million in 2023, reflecting a year-over-year increase of approximately 27.7%[34]. Expenses and Costs - Operating income for the year ended December 31, 2024, was $38,874,000, a decrease from $5,742,000 in 2023, showing a significant decline[20]. - Research and development expenses for the year ended December 31, 2024, totaled $28,452,000, slightly down from $28,707,000 in 2023[20]. - The company incurred a cybersecurity incident expense of $4,583 million in 2024, which was not present in 2023, highlighting a new challenge faced by the company[34]. - Business development, integration, and severance expenses totaled $29,269 million for the year ended December 31, 2023, compared to a gain of $6,102 million in 2024, indicating a significant shift in expenses[34]. - The company reported a non-cash interest expense of $3,866 million for the year ended December 31, 2024, compared to $1,858 million in 2023, indicating a rise in interest-related costs[34]. - The total income tax expense for the year ended December 31, 2024, was $5,845 million, down from $9,104 million in 2023, reflecting a decrease in tax obligations[34]. Cash and Assets - Cash and cash equivalents at the end of the year on December 31, 2024, were $53,463,000, down from $58,940,000 at the end of 2023, a decrease of 8.4%[26]. - Total current assets increased to $290,080,000 as of December 31, 2024, compared to $280,668,000 in 2023, reflecting a growth of 3.0%[22]. - Total liabilities as of December 31, 2024, were $512,901,000, compared to $510,617,000 in 2023, indicating a slight increase of 0.4%[24]. Future Outlook - The company expects 2025 revenues to be between $420 million and $435 million, indicating a growth of 10% to 14% on a constant currency basis compared to 2024[9]. - Adjusted EBITDA for 2025 is projected to grow between 18% and 28%, resulting in an expected range of $84 million to $91 million[10]. - The company anticipates that the November 2024 cybersecurity incident will not significantly impact its business for the full year 2025[4]. - The company received a Humanitarian Device Exemption from the FDA for the AMDS Hybrid Prosthesis, facilitating its market entry[4].

Core Insights - Artivion, Inc. reported strong financial performance for 2024, with total revenues reaching $388.5 million, a 10% increase on a GAAP basis compared to 2023 [7][14]. - The company achieved a net loss of $(13.4) million for the full year, an improvement from a net loss of $(30.7) million in 2023 [8][14]. - Artivion expects revenue growth for 2025 to be between $420 million and $435 million, representing a 10% to 14% increase on a constant currency basis compared to 2024 [9][19]. Financial Performance - Fourth quarter revenues for 2024 were $97.3 million, a 4% increase on a GAAP basis compared to the same quarter in 2023 [5][14]. - The company reported a net loss of $(16.5) million in Q4 2024, compared to a net loss of $(4.0) million in Q4 2023 [6][14]. - Adjusted EBITDA for Q4 2024 increased by 15% to $17.6 million, compared to $15.3 million in Q4 2023 [14][27]. Product and Market Highlights - Revenue growth in Q4 was driven by a 10% increase in On-X mechanical heart valves and stent grafts, and an 8% increase in BioGlue compared to Q4 2023 [3][14]. - Latin America showed significant revenue strength, growing 26% in Q4 2024 on a constant currency basis compared to the previous year [3][14]. - The company received a Humanitarian Device Exemption from the FDA for the AMDS Hybrid Prosthesis, allowing it to deliver its technology to patients while pursuing PMA approval [4][14]. Operational Developments - Artivion submitted the second module of the PMA application to the FDA for the AMDS Hybrid Prosthesis [4][14]. - The company generated $22.2 million in operating cash flow and $11.0 million in non-GAAP free cash flow for the full year 2024 [14][26]. - The company is confident in its ability to drive sustained double-digit revenue growth and adjusted EBITDA growth at twice the pace of constant currency revenue growth in 2025 [4][10].

Core Viewpoint - Artivion, Inc. will release its fourth quarter and full year 2024 financial results on February 24, 2025, after market close, followed by a teleconference to discuss the results [1]. Financial Results Announcement - The financial results will be announced on February 24, 2025, after market close [1]. - A teleconference call and live webcast will take place at 4:30 p.m. ET on the same day [1]. Teleconference Details - To participate in the live teleconference, interested parties should dial 201-689-8261 a few minutes before the start time [2]. - A replay of the teleconference will be available approximately one hour after the event, accessible via toll-free number 877-660-6853 or 201-612-7415, using conference number 13749878 [2]. Webcast and Earnings Release - The live webcast and replay can be accessed on the Investors section of Artivion's website [3]. - A copy of the earnings press release, containing financial and statistical information, will also be available on the Investors section of the website [3]. Company Overview - Artivion, Inc. is headquartered in suburban Atlanta, Georgia, and focuses on developing solutions for cardiac and vascular surgeons dealing with aortic diseases [4]. - The company offers four major product groups: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues [4]. - Artivion markets its products in over 100 countries worldwide [4].

Core Insights - Artivion, Inc. announced positive one-year outcomes from the AMDS PERSEVERE clinical trial for treating acute DeBakey Type I aortic dissections complicated by malperfusion [1][3][5] Clinical Trial Data - The PERSEVERE trial involved 93 participants and demonstrated a sustained benefit of the AMDS device, with 80% of patients surviving through one year [3][6] - Key findings include a 20.4% all-cause mortality rate at one year, compared to 42.7% in historical controls, and a significant reduction in major adverse events (MAEs) [4][6] - The trial reported zero occurrences of distal anastomotic new entry (DANE) tears, which are common complications in similar procedures [4][7] Device Overview - The AMDS is the first aortic arch remodeling device designed for acute DeBakey Type I aortic dissections, allowing for rapid deployment during standard surgical procedures [7] - The device aims to improve patient outcomes by addressing complications associated with traditional hemiarch repairs, such as downstream true lumen expansion and false lumen treatment [8] Market Opportunity - Approximately 48,000 patients experience acute DeBakey Type I aortic dissections annually, representing a market opportunity of $150 million in the U.S. and $540 million globally [8] - The AMDS device is currently available in the U.S. under a Humanitarian Device Exemption (HDE) and is expected to receive premarket approval (PMA) by late 2025 [5][9]

Core Insights - Three stocks with strong momentum and buy rank are highlighted for investors: NextNav Inc., Vertex, Inc., and Artivion, Inc. [1][2][3] Company Summaries - **NextNav Inc. (NN)**: - Zacks Rank 1 - Current year earnings estimate increased by 7.5% over the last 60 days - Shares gained 72.1% over the last three months, outperforming the S&P 500's 3.9% increase - Momentum Score of A [1] - **Vertex, Inc. (VERX)**: - Zacks Rank 1 - Current year earnings estimate increased by 8.6% over the last 60 days - Shares gained 26.0% over the last three months, also outperforming the S&P 500's 3.9% increase - Momentum Score of A [2] - **Artivion, Inc. (AORT)**: - Zacks Rank 1 - Current year earnings estimate increased by 68.2% over the last 60 days - Shares gained 8.3% over the last three months, again outperforming the S&P 500's 3.9% increase - Momentum Score of A [3]

Group 1 - Artivion, Inc. (AORT) has seen a 68.2% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - Vertex, Inc. (VERX) has experienced an 8.6% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - NextNav Inc. (NN) has recorded a 7.5% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [2] - Immunocore Holdings plc (IMCR) has seen a 48.6% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [2] - EverQuote, Inc. (EVER) has experienced a 19.7% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [3]

Financial Performance - The company reported Q3 2024 revenue of $95.8 million, reflecting a 10% year-over-year growth in constant currency, and adjusted EBITDA increased by 28% year-over-year [9][33] - Adjusted EBITDA margin improved to 18.5%, a 270 basis point increase from the previous year, driven by a reduction in general, administrative, and marketing expenses as a percentage of sales [33] Product Line Performance - On-X revenues grew by 15% year-over-year in constant currency, attributed to market share gains and clinical benefits [10][34] - BioGlue experienced a 14% increase in revenue on a constant currency basis, marking the second consecutive quarter of double-digit growth [11][34] - Stent graft revenues rose by 13% year-over-year in constant currency, supported by a differentiated product portfolio [12][34] - Tissue processing revenues grew by 2% year-over-year, impacted by lower donor allograft volumes [14][34] Geographic Performance - Revenue growth in Latin America was 32% and 23% in Asia Pacific, driven by regulatory approvals and commercial expansion [18][36] - EMEA revenues increased by 15%, while North America saw a modest growth of 2% [36] Company Strategy and Industry Competition - The company is focused on expanding its product portfolio and regulatory approvals, with significant growth opportunities in the U.S. and Japan markets for stent grafts [13][19] - The company anticipates FDA approval for AMDS in Q4 2025, which could open a $150 million market with no competitive alternatives [19][49] - The recent regulatory approval for BioGlue in China is expected to create a significant market opportunity, with commercialization anticipated in the second half of 2025 [20][21] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in sustaining double-digit revenue growth and driving EBITDA growth at twice the rate of revenue [31][48] - The company expects to maintain gross margins similar to 2023 levels and anticipates continued leverage from its global sales force [44][88] - For 2025, the company expects similar growth dynamics as in 2024, with no significant revenue from AMDS anticipated until 2026 [46][73] Other Important Information - Free cash flow for Q3 2024 was $7.8 million, with expectations for positive free cash flow for the full year [39] - The company’s net leverage decreased to 3.9x, down from 5.3x in the prior year, with expectations for further reduction [41] Q&A Session Summary Question: Insights on aortic stent graft business performance - Management noted strong double-digit growth across multiple products in the aortic stent graft segment, with significant market presence in Europe, Asia, and Latin America [53][54] Question: Market share gains for On-X - The company holds approximately 30% global market share and 55% in the U.S., with expectations for continued growth driven by clinical data showing reduced bleeding [55][57] Question: Long-term growth for SynerGraft - Management highlighted the challenge of donor constraints impacting growth, but ongoing improvements in donor yields are expected to support mid-single-digit growth in the long term [60][61] Question: Launch strategy for AMDS - A soft launch is anticipated in Q4 2025 following FDA approval, with a gradual ramp-up as surgeons are trained and hospitals are onboarded [70][73] Question: BioGlue market opportunity in China - The estimated market opportunity remains around $20 million, with a gradual rollout expected over several years post-approval [80][82] Question: Impact of PerClot manufacturing agreement - The agreement is expected to create a slight headwind of less than 1 percentage point in revenue, with minimal impact on EBITDA [84]

Revenue Performance - Artivion reported quarterly revenues of $95.8 million for the three months ended September 30, 2024, representing a 9% increase from $87.9 million in the same period of 2023[107]. - Revenues from aortic stent grafts increased by 12% to $28.6 million for the three months ended September 30, 2024, compared to $25.5 million in 2023[113]. - On-X product revenues rose by 15% to $21.5 million for the three months ended September 30, 2024, up from $18.7 million in the prior year[113]. - Surgical sealants revenues increased by 14% to $18.4 million for the three months ended September 30, 2024, compared to $16.2 million in 2023[113]. - Constant currency revenues increased by 10% for the three months ended September 30, 2024, compared to the same period in 2023[120]. - Total revenues for the nine months ended September 30, 2024, were $291.2 million, a 12% increase from $260.3 million in the same period of 2023[114]. - Preservation services revenues increased by 11% to $75.7 million for the nine months ended September 30, 2024, compared to $68.3 million in 2023[114]. - Aortic stent grafts accounted for 32% of total revenues for the nine months ended September 30, 2024[114]. Cost and Expenses - Cost of products increased 13% for the three months ended September 30, 2024, compared to the same period in 2023, driven by an increase in the volume of all products shipped[144]. - General, administrative, and marketing expenses decreased 2% for the three months ended September 30, 2024, compared to the same period in 2023, primarily due to a decrease in business development expenses[151]. - Research and development expenses increased by 3% to $6.605 million for the three months ended September 30, 2024, compared to $6.421 million for the same period in 2023, while remaining flat at $21.048 million for the nine months ended September 30, 2024, compared to $21.062 million in 2023[153]. Profitability and Loss - The company incurred a net loss of $2.288 million for the three months ended September 30, 2024, compared to a net loss of $9.801 million for the same period in 2023[158]. - The effective income tax rate was 81% for the three months ended September 30, 2024, compared to 4% for the same period in 2023, primarily due to changes in anticipated pre-tax operating results[159]. Cash Flow and Liquidity - As of September 30, 2024, net cash provided by operating activities was $12.1 million, compared to $8.0 million for the same period in 2023, representing a 51.25% increase[181]. - Net cash used in investing activities was $16.8 million for the nine months ended September 30, 2024, compared to net cash provided of $2.2 million for the same period in 2023[184]. - Net cash provided by financing activities was $2.0 million for the nine months ended September 30, 2024, down from $2.5 million in 2023[185]. - The company believes its cash from operations and existing cash and cash equivalents will meet its current operational liquidity needs for at least the next twelve months[170]. Debt and Financing - Interest expense rose to $8.4 million and $24.5 million for the three and nine months ended September 30, 2024, respectively, compared to $6.6 million and $19.1 million for the same periods in 2023, primarily due to increased interest rates from debt refinancing[155]. - A loss on extinguishment of debt of $3.7 million was recorded during the nine months ended September 30, 2024, related to the extinguishment of a previously existing term loan[156]. - The company entered into a credit and guaranty agreement for $350.0 million on January 18, 2024, which includes a $190.0 million secured term loan facility and a $60.0 million secured revolving credit facility[171]. - The company has $100.3 million in scheduled principal payments and $4.3 million in anticipated interest payments related to Convertible Senior Notes[186]. - Loans under the Term Loan Facilities bear interest at a floating annual rate with a margin of 5.50%, which may step down based on the total net leverage ratio[175]. Foreign Exchange Impact - Artivion's sales are impacted by foreign exchange fluctuations, with the US Dollar strengthening against major currencies affecting revenue translation for the three months ended September 30, 2024[122]. - A 10% adverse change in exchange rates could impact the company's financial position or cash flows by approximately $9.0 million[195]. Other Financial Metrics - Gross margin increased 8% for the three months ended September 30, 2024, compared to the same period in 2023, attributed to an increase in volume and favorable pricing of surgical sealants and On-X products[148]. - Domestic revenues from On-X products accounted for 59% of total On-X revenues for the three months ended September 30, 2024, down from 61% in the same period in 2023[131]. - Other revenues decreased 17% for the three months ended September 30, 2024, primarily due to a decrease in PerClot product revenues[138]. - The fair value of the Convertible Senior Notes as of September 30, 2024, was approximately $125.4 million with an effective interest rate of 5.05%[176]. - Approximately 38% of cash and cash equivalents were held in foreign jurisdictions as of September 30, 2024[179].

Artivion (AORT) came out with quarterly earnings of $0.12 per share, beating the Zacks Consensus Estimate of $0.03 per share. This compares to earnings of $0.02 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 300%. A quarter ago, it was expected that this biological medical device maker would post earnings of $0.03 per share when it actually produced earnings of $0.07, delivering a surprise of 133.33%.Over the last four quarte ...