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]

Haemonetics Corporation (HAE) delivered third-quarter fiscal 2025 adjusted earnings per share (EPS) of $1.19, which rose 14.4% year over year. The bottom line was on par with the Zacks Consensus Estimate. Find the latest EPS estimates and surprises on Zacks Earnings Calendar.On a GAAP basis, EPS was 74 cents compared with 61 cents in the prior-year quarter.Following the earnings announcement, shares of HAE rose 0.02% in after-market trading yesterday. HAE’s Q3 RevenuesRevenues increased 2.7% to $348.5 milli ...

Haemonetics Corporation (NYSE:HAE) Q3 2025 Earnings Conference Call February 6, 2025 8:30 AM ET Company Participants Olga Guyette - Vice President, Investor Relations and Treasury Christopher Simon - President and Chief Executive Officer James D'Arecca - EVP and Chief Financial Officer Conference Call Participants Anthony Petrone - Mizuho Financial Group Marie Thibault - BTIG David Turkaly - Citizens JMP Andrew Cooper - Raymond James Mike Matson - Needham & Company Craig Bijou - Bank of America Securities M ...

Haemonetics (HAE) reported $348.54 million in revenue for the quarter ended December 2024, representing a year-over-year increase of 3.7%. EPS of $1.19 for the same period compares to $1.04 a year ago.The reported revenue represents a surprise of -1.30% over the Zacks Consensus Estimate of $353.15 million. With the consensus EPS estimate being $1.19, the company has not delivered EPS surprise.While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expecta ...

Haemonetics (HAE) came out with quarterly earnings of $1.19 per share, in line with the Zacks Consensus Estimate. This compares to earnings of $1.04 per share a year ago. These figures are adjusted for non-recurring items.A quarter ago, it was expected that this provider blood management systems for health care providers and blood collectors would post earnings of $1.09 per share when it actually produced earnings of $1.12, delivering a surprise of 2.75%.Over the last four quarters, the company has surpasse ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: December 28, 2024 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF ☐ 1934 Commission File Number: 001-14041 HAEMONETICS CORPORATION (Exact name of registrant as specified in its charter) Massachusetts 04-2882273 (State or other jurisdiction of incorporation or organizat ...

Investor Contacts Media Contact Olga Guyette, Vice President-Investor Relations & Treasury Josh Gitelson, Sr. Director-Communications (781) 356-9763 (781) 356-9776 olga.guyette@haemonetics.com josh.gitelson@haemonetics.com | | 3rd Quarter | | 2025 | YTD 2025 | | | --- | --- | --- | --- | --- | --- | | n Revenue, increase | $349 | million, | 4% | $1,030 | million, 7% | | 1 n Organic revenue increase | | —% | | 2% | | | n Earnings per diluted share | | $0.74 | | $2.14 | | | n Adjusted earnings per diluted sha ...

Financial release accessible onlineBOSTON, Feb. 6, 2025 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE) announced that financial results for its third quarter fiscal year 2025, which ended December 28, 2024, are available on its Investor Relations website.The Company will host a conference call and webcast with investors and analysts to discuss and answer questions about the results at 8:00 a.m. ET on February 6, 2025. The conference call and webcast can be accessed with the following information: Tele ...

Investors interested in Medical - Products stocks are likely familiar with Haemonetics (HAE) and Abbott (ABT) . But which of these two companies is the best option for those looking for undervalued stocks? Let's take a closer look.Everyone has their own methods for finding great value opportunities, but our model includes pairing an impressive grade in the Value category of our Style Scores system with a strong Zacks Rank. The proven Zacks Rank puts an emphasis on earnings estimates and estimate revisions, ...