Financial Data and Key Metrics Changes - The company reported total revenue of $1.4 billion, reflecting a 4% growth on a reported basis and 1% organic growth, with organic growth excluding $148 million from CSL and the whole blood divestiture at 8% [7][8] - Adjusted gross margin for the fourth quarter was 60.2%, an increase of 620 basis points compared to the prior year, driven by volume growth and improved product mix [24][25] - Adjusted net income for fiscal year 2025 was $231.5 million, up $28 million or 14%, with adjusted earnings per diluted share at $4.57, a 15% increase compared to the prior year [29] Business Line Data and Key Metrics Changes - Hospital revenue grew 12% in the quarter and 24% in fiscal year 2025 on a reported basis, with organic growth of 9% respectively [11] - Blood Management Technologies revenue grew 6% in the quarter and 10% in fiscal year 2025, driven by strong utilization and share gains [11] - The Interventional Technologies franchise delivered 21% reported growth in the quarter and 46% in fiscal year 2025, with 16% organic growth respectively [13] Market Data and Key Metrics Changes - Plasma revenue declined 9% in the quarter and 6% in fiscal year 2025, but excluding CSL, plasma revenue grew 11% in the fourth quarter and 5% for fiscal year 2025 [18][20] - Blood center revenue declined 22% in the quarter and 8% in fiscal year 2025 on a reported basis due to the whole blood divestiture [21] - The company anticipates plasma revenue to decline 7% to 10% on a reported basis in fiscal year 2026, with organic growth excluding CSL expected to be 11% to 14% [20] Company Strategy and Development Direction - The company is focused on advancing its innovation agenda and reallocating resources towards higher growth opportunities following the divestiture of the whole blood business [28] - A new regional and market alignment initiative is expected to generate approximately $30 million of net savings over the next two years [28] - The company aims for both blood management technologies and interventional technologies to become billion-dollar franchises each [66] Management's Comments on Operating Environment and Future Outlook - Management remains confident in the strong growth trajectory of the hospital business, projecting reported and organic revenue growth of 8% to 11% in fiscal year 2026 [16] - The company expects adjusted operating margin to improve by 200 to 300 basis points, reaching 26% to 27% in fiscal year 2026 [33] - Management highlighted the importance of cash flow generation and expects free cash flow in fiscal year 2026 to be in the range of $160 million to $200 million [35] Other Important Information - The company executed a $150 million share buyback, repurchasing approximately 2.4 million shares, reflecting its commitment to value creation [10] - The adjusted income tax rate was 22% for the fourth quarter and 23% for fiscal year 2025, compared to 21% to 23% for the respective periods of the prior year [28] Q&A Session Summary Question: Insights on plasma collections and guidance for fiscal year 2026 - Management remains bullish on plasma, indicating that the 11% to 14% growth guidance is primarily driven by share gains and technology adoption, with modest growth expected in the first half of fiscal year 2026 [43][45] Question: Clarification on EPS guidance and operating margin drivers - The operating margin guidance of 26% to 27% is supported by continued gross margin improvement and operational leverage, with a $0.20 impact from tariffs factored into the guidance [47][49] Question: Update on vascular closure portfolio and legacy business performance - The company is focusing on driving utilization and share gains in the vascular closure market, with a dedicated team addressing both new and legacy products [55][60] Question: Changes in strategy following management transitions - The leadership changes are aimed at enhancing focus on growth in the hospital segment, with expectations for both blood management and interventional technologies to reach billion-dollar franchises [66][67] Question: Update on M&A activities and potential acquisition of VIVUSURE Medical - The company maintains a long-term appetite for strategic acquisitions, with optimism regarding the VIVUSURE opportunity, which aligns with its focus on closure and structural heart segments [74][76]

[Financial Performance Summary](index=1&type=section&id=Haemonetics%20Reports%20Fourth%20Quarter%20and%20Fiscal%202025%20Results%3B%20Provides%20Fiscal%202026%20Guidance) Haemonetics reported increased FY2025 revenue and adjusted EPS, driven by profitability and strategic growth [Q4 & Fiscal 2025 Highlights](index=1&type=section&id=Financial%20Highlights) For fiscal 2025, Haemonetics reported a 4% increase in total revenue to $1.361 billion, with a 1% organic growth, achieving a significant increase in profitability with fiscal 2025 adjusted EPS rising to $4.57, while the fourth quarter saw a revenue decrease of 4% to $331 million primarily due to divestitures and a major plasma customer contract transition Q4 & Fiscal 2025 Key Financial Metrics | Metric | 4th Quarter 2025 | Fiscal 2025 | | :--- | :--- | :--- | | **Revenue** | $331 million (-4%) | $1.361 billion (+4%) | | **Organic Revenue Growth** | —% | 1% | | **GAAP EPS (Diluted)** | $1.17 | $3.31 | | **Adjusted EPS (Diluted)** | $1.24 | $4.57 | | **Cash Flow from Operations** | $117 million | $182 million | | **Free Cash Flow** | $95 million | $145 million | [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CEO Chris Simon highlighted the company's solid earnings growth in fiscal 2025, emphasizing record margin expansion and strong cash flow, noting that key technologies like NexSys, TEG, and VASCADE are driving growth and the company is on track to meet its long-range plan goals in fiscal 2026 - The CEO emphasized **strong performance in FY2025**, citing **record margin expansion** and **robust cash flow** as indicators of business health[3](index=3&type=chunk) - Growth is being propelled by industry-leading technologies: NexSys, TEG, and VASCADE[3](index=3&type=chunk) - The company is on schedule to achieve all goals of its four-year long-range plan in the upcoming fiscal year 2026[3](index=3&type=chunk) [Detailed Financial Analysis](index=1&type=section&id=Detailed%20Financial%20Analysis) Q4 and FY2025 analysis reveals strong Hospital growth and margin expansion, offsetting other segment declines [Q4 FY2025 Performance (GAAP)](index=1&type=section&id=GAAP%20RESULTS) In Q4 FY2025, GAAP revenue decreased by 3.7% to $330.6 million, driven by declines in Plasma and Blood Center, partially offset by strong 12.2% growth in the Hospital segment, with gross margin significantly improving to 58.4% from 51.2% year-over-year, and operating income surging 138.2% to $71.3 million, primarily due to lower restructuring costs and a gain from the remeasurement of contingent consideration Q4 FY2025 GAAP Revenue by Business Unit | Business Unit | Revenue ($ millions) | Growth vs. Q4 FY2024 | | :--- | :--- | :--- | | Plasma | $126.7 | (9.1)% | | Blood Center | $56.0 | (22.2)% | | Hospital | $147.9 | 12.2% | | **Total Net Revenue** | **$330.6** | **(3.7)%** | - Gross margin increased to **58.4%** in Q4 FY2025 from **51.2%** in Q4 FY2024, driven by volume growth in high-margin Hospital products, pricing benefits, and lower restructuring costs[5](index=5&type=chunk)[6](index=6&type=chunk) - Operating income for Q4 FY2025 was **$71.3 million (21.6% margin)**, a substantial increase from **$29.9 million (8.7% margin)** in the prior year, helped by lower operating expenses[6](index=6&type=chunk) - Net income for Q4 FY2025 was **$58.0 million**, or **$1.17 per diluted share**, compared to **$20.4 million**, or **$0.40 per diluted share**, in Q4 FY2024[6](index=6&type=chunk) [Q4 FY2025 Performance (Adjusted)](index=2&type=section&id=ADJUSTED%20RESULTS) On an adjusted basis, Q4 FY2025 organic revenue saw a slight decrease of 0.2%, mainly due to the CSL U.S. disposables business transition in the Plasma segment, but the Hospital segment showed strong organic growth of 8.9%, with adjusted gross margin expanding by 620 basis points to 60.2%, and adjusted operating margin growing by 610 basis points to 24.9%, leading to a 37.8% increase in adjusted EPS to $1.24 Q4 FY2025 Organic Revenue Growth by Business Unit | Business Unit | Organic Growth vs. Q4 FY2024 | | :--- | :--- | | Plasma | (8.9)% | | Blood Center | (0.2)% | | Hospital | 8.9% | | **Total Net Revenue** | **(0.2)%** | - Adjusted gross margin increased to **60.2%**, up **620 basis points YoY**, due to volume growth in higher-margin Hospital products and pricing benefits[7](index=7&type=chunk) - Adjusted operating income rose **27.5%** to **$82.3 million**, with the adjusted operating margin reaching **24.9%**[8](index=8&type=chunk) - Adjusted net income increased **33.8%** to **$61.6 million**, resulting in adjusted EPS of **$1.24**, up **37.8% YoY**[9](index=9&type=chunk) [Full-Year FY2025 Performance by Business Unit](index=8&type=section&id=Full-Year%20FY2025%20Performance%20by%20Business%20Unit) For the full fiscal year 2025, total reported revenue grew 4.0% to $1.36 billion, driven by a strong 23.7% increase in the Hospital business, which benefited from acquisitions and 12.4% organic growth, offsetting declines in Plasma (-6.0%) and Blood Center (-7.8%), the latter impacted by the Whole Blood product line divestiture FY2025 Revenue Performance by Business Unit | Business Unit | FY2025 Revenue ($M) | Reported Growth | Organic Growth | | :--- | :--- | :--- | :--- | | Plasma | $535.4 | (6.0)% | (5.9)% | | Blood Center | $261.1 | (7.8)% | (1.5)% | | Hospital | $564.3 | 23.7% | 12.4% | | **Total Net Revenue** | **$1,360.8** | **4.0%** | **1.4%** | [Capital Allocation & Balance Sheet](index=3&type=section&id=Capital%20Allocation%20%26%20Balance%20Sheet) The company strengthened its balance sheet, completing a $300M share repurchase and authorizing a new $500M program [Share Repurchase Program](index=3&type=section&id=SHARE%20REPURCHASE%20PROGRAM%3B%20NEW%20AUTHORIZATION) Haemonetics completed its $300 million share repurchase program, buying back 2.39 million shares, and subsequently the Board of Directors approved a new, larger three-year program authorizing the repurchase of up to $500 million of common stock to offset equity grant dilution and support long-term growth plans - The company completed its previously announced **$300 million share repurchase program**, having repurchased a total of **2,386,131 shares**[10](index=10&type=chunk) - In April 2025, the Board of Directors approved a new share repurchase authorization of up to **$500 million** over the next three years[11](index=11&type=chunk) [Balance Sheet and Cash Flow](index=3&type=section&id=BALANCE%20SHEET%20AND%20CASH%20FLOW) The company ended fiscal 2025 with a strengthened balance sheet, with cash on hand increasing by $128.0 million to $306.8 million, while cash flow from operations remained stable at $181.7 million, and free cash flow for the year increased to $144.6 million from $117.3 million in the prior year, aided by proceeds from asset sales Key Balance Sheet Items (as of March 29, 2025) | Account | FY2025 ($ thousands) | FY2024 ($ thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $306,763 | $178,800 | | Total current assets | $934,975 | $768,903 | | Total assets | $2,450,948 | $2,195,591 | | Total current liabilities | $578,113 | $300,383 | | Long-term debt | $921,230 | $797,564 | | Total stockholders' equity | $820,836 | $959,959 | Fiscal Year Cash Flow Summary | Metric | Fiscal 2025 | Fiscal 2024 | | :--- | :--- | :--- | | Cash Flow from Operations | $181.7 million | $181.8 million | | Free Cash Flow | $144.6 million | $117.3 million | - The company ended fiscal 2025 with a **strengthened balance sheet**, with cash on hand increasing by **$128.0 million** to **$306.8 million**[29](index=29&type=chunk) - Cash flow from operations remained **stable at $181.7 million**, while free cash flow for the year increased to **$144.6 million** from **$117.3 million** in the prior year, aided by proceeds from asset sales[14](index=14&type=chunk)[31](index=31&type=chunk) [Fiscal 2026 Outlook](index=4&type=section&id=FISCAL%202026%20GUIDANCE) Fiscal 2026 guidance anticipates reported revenue decline due to divestitures, offset by strong organic growth and margin expansion [Revenue Guidance](index=4&type=section&id=Revenue%20Guidance) For fiscal 2026, Haemonetics projects a reported revenue decline of 3-6%, heavily influenced by the divestiture of the Whole Blood business and the CSL plasma contract transition, however, organic revenue is guided to be between -2% and +1%, and excluding the CSL impact, organic growth is expected to be a strong 6-9%, led by 11-14% growth in Plasma and 8-11% in Hospital Fiscal 2026 Revenue Growth Guidance | Category | Plasma | Blood Center | Hospital | Total Company | | :--- | :--- | :--- | :--- | :--- | | **Reported Growth** | (7 – 10%) | (23 – 26%) | 8 – 11% | **(3 – 6%)** | | **Organic Growth** | (7 – 10%) | (4 – 6%) | 8 – 11% | **(2) – 1%** | | **Organic, ex-CSL** | 11 – 14% | (4 – 6%) | 8 – 11% | **6 – 9%** | [Profitability and Cash Flow Guidance](index=4&type=section&id=Profitability%20and%20Cash%20Flow%20Guidance) The company anticipates continued margin expansion and strong earnings in fiscal 2026, guiding for an adjusted operating margin of 26-27% and adjusted earnings per diluted share between $4.70 and $5.00, with free cash flow expected to be in the range of $160 million to $200 million Fiscal 2026 Adjusted Profitability and Cash Flow Guidance | Metric | Guidance Range | | :--- | :--- | | Adjusted Operating Margin | 26 – 27% | | Adjusted EPS | $4.70 – $5.00 | | Free Cash Flow | $160M – $200M | [Appendix: Financial Statements](index=7&type=section&id=Appendix%3A%20Financial%20Statements) This appendix provides comprehensive unaudited financial statements, including income, balance sheets, cash flows, and GAAP reconciliations [Condensed Consolidated Statements of Income](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Income) This section provides the detailed unaudited consolidated statements of income for the three months and full year ended March 29, 2025, compared to the prior year periods, including breakdowns of revenues, costs, expenses, and profitability margins Condensed Consolidated Statements of Income (Year Ended) | ($ thousands, except per share) | Year Ended 3/29/2025 | Year Ended 3/30/2024 | | :--- | :--- | :--- | | Net revenues | $1,360,824 | $1,309,055 | | Gross profit | $748,958 | $691,548 | | Operating income | $221,817 | $164,883 | | Net income | $167,679 | $117,558 | | Net income per share (diluted) | $3.31 | $2.29 | [Revenue Analysis by Business Unit](index=8&type=section&id=Revenue%20Analysis%20by%20Business%20Unit) This section presents a detailed breakdown of revenue by business unit and product line for both the fourth quarter and the full fiscal year 2025, including reported growth, currency impact, acquisition/divestiture impact, and resulting organic growth rates Q4 Revenue Analysis by Business Unit ($ thousands) | Business Unit | Q4 FY2025 | Q4 FY2024 | Reported Growth | Organic Growth | | :--- | :--- | :--- | :--- | :--- | | Plasma | $126,736 | $139,479 | (9.1)% | (8.9)% | | Blood Center | $56,006 | $71,990 | (22.2)% | (0.2)% | | Hospital | $147,857 | $131,821 | 12.2% | 8.9% | | **Total** | **$330,599** | **$343,290** | **(3.7)%** | **(0.2)%** | Full Year Revenue Analysis by Business Unit ($ thousands) | Business Unit | FY2025 | FY2024 | Reported Growth | Organic Growth | | :--- | :--- | :--- | :--- | :--- | | Plasma | $535,431 | $569,535 | (6.0)% | (5.9)% | | Blood Center | $261,124 | $283,231 | (7.8)% | (1.5)% | | Hospital | $564,269 | $456,289 | 23.7% | 12.4% | | **Total** | **$1,360,824** | **$1,309,055** | **4.0%** | **1.4%** | [Condensed Consolidated Balance Sheets](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides the company's unaudited consolidated balance sheets as of March 29, 2025, compared to March 30, 2024, detailing assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets ($ thousands) | | As of 3/29/2025 | As of 3/30/2024 | | :--- | :--- | :--- | | **Assets** | | | | Total current assets | $934,975 | $768,903 | | Total assets | $2,450,948 | $2,195,591 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $578,113 | $300,383 | | Long-term debt | $921,230 | $797,564 | | Stockholders' equity | $820,836 | $959,959 | | Total liabilities & stockholders' equity | $2,450,948 | $2,195,591 | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section details the company's cash flows from operating, investing, and financing activities for the fiscal years ended March 29, 2025, and March 30, 2024, and includes a reconciliation of free cash flow Condensed Consolidated Statements of Cash Flows (Year Ended, $ thousands) | | FY2025 | FY2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $181,725 | $181,751 | | Net cash used in investing activities | ($161,895) | ($322,389) | | Net cash provided by financing activities | $108,818 | $38,157 | | Net Change in Cash and Cash Equivalents | $127,963 | ($105,666) | | **Free cash flow** | **$144,588** | **$117,265** | [Reconciliation of GAAP to Adjusted Measures](index=12&type=section&id=Reconciliation%20of%20Adjusted%20Measures) This section provides detailed reconciliations of reported GAAP financial measures to non-GAAP adjusted measures for the fourth quarter and full fiscal years 2025 and 2024, itemizing adjustments for costs such as amortization, restructuring, and acquisitions to derive adjusted gross profit, operating income, net income, and EPS Q4 FY2025 Reconciliation of Net Income and EPS | ($ thousands, except per share) | Reported (GAAP) | Adjustments | Adjusted (Non-GAAP) | | :--- | :--- | :--- | :--- | | Gross Profit | $193,050 | $6,017 | $199,067 | | Operating Income | $71,335 | $11,008 | $82,343 | | Net Income | $57,981 | $3,593 | $61,574 | | EPS (Diluted) | $1.17 | $0.07 | $1.24 | Full Year FY2025 Reconciliation of Net Income and EPS | ($ thousands, except per share) | Reported (GAAP) | Adjustments | Adjusted (Non-GAAP) | | :--- | :--- | :--- | :--- | | Gross Profit | $748,958 | $32,805 | $781,763 | | Operating Income | $221,817 | $104,487 | $326,304 | | Net Income | $167,679 | $63,830 | $231,509 | | EPS (Diluted) | $3.31 | $1.26 | $4.57 |

Core Insights - Haemonetics Corporation announced its financial results for the fourth quarter and fiscal year 2025, which ended on March 29, 2025 [1] - The company will host a conference call and webcast on May 8, 2025, at 8:00 a.m. ET to discuss the results and answer questions from investors and analysts [1][2] - Supplemental tables providing additional information on fiscal 2026 revenue growth guidance have been posted on the Investor Relations website [2] Company Overview - Haemonetics is a global medical technology company focused on improving healthcare quality, effectiveness, and efficiency [3] - The company offers innovative solutions for critical medical needs, including hospital technologies, plasma collection technologies, and products for blood centers [3]

With that in mind, let's delve into the average projections of some Haemonetics metrics that are commonly tracked and projected by analysts on Wall Street. Wall Street analysts expect Haemonetics (HAE) to post quarterly earnings of $1.22 per share in its upcoming report, which indicates a year-over-year increase of 35.6%. Revenues are expected to be $327.34 million, down 4.7% from the year-ago quarter. The consensus EPS estimate for the quarter has undergone a downward revision of 3.3% in the past 30 days, ...

Financial Results Announcement - Haemonetics Corporation plans to publish its fourth quarter and fiscal year 2025 financial results on May 8, 2025, at 6:00 am ET [1] - A conference call for investors and analysts will take place on the same day at 8:00 am ET to discuss the results and answer questions [1] Conference Call Access - Participants can access the conference call via teleconference after completing registration, which provides a dial-in number and personalized PIN [2] - It is recommended that participants join the call 10 minutes early, and a live webcast will be available on Haemonetics' investor relations website [2] - A replay of the conference call and webcast will be accessible for one year starting from May 8, 2025, at 11:00 am ET [2] Company Overview - Haemonetics is a global healthcare company focused on innovative medical products and solutions aimed at improving patient care and reducing healthcare costs [3] - The company's technology serves critical medical markets, including blood and plasma component collection, surgical suites, and hospital transfusion services [3]

Core Insights - Haemonetics Corporation's Hospital business recovery is expected to drive growth in upcoming quarters, supported by the strong uptake of the NexSys PCS system and overall financial stability [1][3][6] Financial Performance - In the past year, Haemonetics' shares have decreased by 14.5%, while the industry and S&P 500 have grown by 9% and 10%, respectively [2] - The company has a market capitalization of $3.26 billion and has beaten earnings estimates in three of the last four quarters, with an average surprise of 1.01% [2] - The Zacks Consensus Estimate for fiscal 2025 earnings has decreased by 0.2% to $4.54 per share, while the revenue estimate is $1.39 billion, indicating a 6.2% increase from the previous year [10] Business Segments - The Hospital business achieved a 24% increase in revenues in the third quarter of fiscal 2025, driven by strong market growth and share gains [4] - The Interventional Technologies business grew by 47% in the same quarter, with significant contributions from the Vascular Closure business and positive feedback for the Enzo ETM esophageal cooling device [5] Product Developments - The NexSys PCS system, which is FDA-cleared, aims to enhance plasma yield collections and improve productivity, with the proprietary Persona Technology increasing yield by 9% to 12% on average [6][7] - The rollout of the NexSys system is expected to drive meaningful improvements in 2025 as the transition from older devices continues [7] Market Challenges - Ongoing global geopolitical constraints and economic uncertainty are impacting operational results, with a 5.4% year-over-year increase in the cost of goods sold [8] - The competitive landscape poses challenges, particularly with slower-than-expected product adoption by key customers like the American Red Cross [9]

Core Insights - Haemonetics Corporation has announced changes to its Executive Leadership team, appointing Frank Chan as Executive Vice President and Chief Operating Officer, effective April 7, 2025, and Roy Galvin as Executive Vice President and Chief Commercial Officer, effective immediately [1][4] Group 1: Leadership Changes - Frank Chan will oversee research and development, regulatory affairs, global manufacturing, and supply chain operations, reporting to the President and CEO Chris Simon [2] - Roy Galvin, previously President of Global Plasma and Blood Center, will now manage the Global Hospital business and direct commercialization initiatives for the entire product portfolio [4] Group 2: Leadership Experience - Frank Chan brings over 25 years of experience in medical device and healthcare technology, having previously served as President of Acute Care & Monitoring at Medtronic, and held roles at Covidien and DePuy Orthopaedics [3] - Roy Galvin has over 25 years of experience in the global healthcare technology field, particularly in the Neuroscience and Orthopedic markets at Medtronic [4] Group 3: Company Strategy - Chris Simon emphasized that the addition of Chan and the expanded role for Galvin aligns with the company's long-range plan for growth and success [5]

Core Insights - Haemonetics Corporation will have its President and CEO, Chris Simon, participate in a fireside chat with investors at the Raymond James 46th Annual Institutional Investors Conference on March 4, 2025 [1] - The event will be accessible via a live webcast on Haemonetics' Investor Relations website, with a replay available for 90 days post-event [2] - Haemonetics is a global healthcare company focused on innovative medical products and solutions aimed at improving patient care and reducing healthcare costs, particularly in blood and plasma collection, surgical suites, and hospital transfusion services [3]

Core Insights - Takeda has received EMA approval for a new 2 mL pre-filled pen option for TAKHZYRO® (lanadelumab) aimed at adolescents (aged 12 and above) and adult patients with Hereditary Angioedema (HAE) [1][5] - This new option enhances Takeda's commitment to the HAE community by providing individualized treatment solutions to alleviate the burden of HAE and improve patients' quality of life [1][2] Company Overview - Takeda is a leading biopharmaceutical company focused on creating better health outcomes and delivering life-transforming treatments across various therapeutic areas, including rare diseases [7] - The company emphasizes innovation and patient-centric solutions, particularly for underserved communities, and has a strong historical engagement in HAE treatment [2][7] Product Information - TAKHZYRO® is a fully human monoclonal antibody that targets plasma kallikrein, indicated for the routine prevention of recurrent HAE attacks in patients aged 2 years and older [4][6] - The newly approved 300 mg solution for injection in a pre-filled pen is designed for subcutaneous administration, allowing for self-administration or caregiver administration after proper training [4][8] Market Context - HAE is a rare genetic disorder affecting approximately 1 in 50,000 people globally, often under-recognized and under-treated [2][3] - The approval of the new administration option is expected to provide additional individualized treatment choices for HAE patients aged 12 years and older, addressing a significant unmet need in the market [2][5]

Core Viewpoint - CSL Behring K.K. has received approval from Japan's Ministry of Health, Labour and Welfare for ANDEMBRY® (garadacimab) Subcutaneous Injection 200mg Pens, marking a significant advancement in the management of hereditary angioedema (HAE) [1][3] Product Overview - ANDEMBRY is the first fully human monoclonal antibody in Japan designed to inhibit activated Factor XII (Factor XIIa), which is crucial in the angioedema attack process [2] - The product is approved for the prevention of acute attacks of HAE and is the first pre-filled pen for once-monthly subcutaneous administration for long-term prophylaxis [1][6] Clinical Significance - The approval is based on the efficacy and safety data from the pivotal international Phase 3 VANGUARD trial, which included HAE patients from Japan [4][6] - HAE is a rare, chronic, debilitating genetic disorder affecting approximately 430 diagnosed patients in Japan, with a global prevalence estimated at 1 in 50,000 people [3][4] Company Commitment - CSL has a 40-year commitment to HAE research and treatment optimization, with ANDEMBRY being the first approved recombinant monoclonal antibody developed entirely by CSL [3][5] - The company emphasizes its dedication to improving the lives of those with HAE, having supported this community for over four decades [6][9] Approval Timeline - ANDEMBRY has also received approvals in Australia, the United Kingdom, and the European Union, indicating a broad acceptance of the product in multiple markets [1][7]