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U.S. Food and Drug Administration Approves CSL's ANDEMBRY® (garadacimab-gxii), the Only Prophylactic Hereditary Angioedema (HAE) Treatment Targeting Factor XIIa with Once-Monthly Dosing for All Patients From the Start
Prnewswire· 2025-06-16 23:48
Core Viewpoint - CSL has received FDA approval for ANDEMBRY®, a novel treatment for hereditary angioedema (HAE), marking a significant advancement in the management of this rare genetic disorder [1][3][11] Group 1: Product Overview - ANDEMBRY is the first monoclonal antibody developed entirely by CSL, targeting factor XIIa to prevent HAE attacks in patients aged 12 and older [1][3][11] - The treatment offers once-monthly subcutaneous self-injection, providing a convenient administration method [1][3] - ANDEMBRY has shown a median reduction of more than 99% in HAE attacks compared to placebo, with a least squares mean reduction of 89.2% [6][7] Group 2: Clinical Trial Data - The approval is based on data from the pivotal Phase 3 VANGUARD trial, which demonstrated the efficacy and safety of ANDEMBRY [3][12] - In the pivotal trial, 62% of patients treated with ANDEMBRY remained attack-free throughout the treatment period [7] - The most common adverse reactions reported were nasopharyngitis and abdominal pain, with injection-site reactions occurring in 14% of patients [4][7] Group 3: Market Impact and Availability - ANDEMBRY's approval expands CSL's HAE franchise and reinforces the company's commitment to innovation in the HAE community [6][8] - The product is set to launch commercially immediately, with availability expected before the end of June 2025 [9] - ANDEMBRY has also received approvals in multiple regions, including Australia, the UK, the EU, Japan, Switzerland, and the UAE [8]
Haemonetics to Present at Goldman Sachs 46th Annual Global Healthcare Conference
Prnewswire· 2025-05-30 10:00
BOSTON, May 30, 2025 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE) announced that Chris Simon, President and CEO, will participate in a fireside chat with investors at the Goldman Sachs 46th Annual Global Healthcare Conference on Monday, June 9, 2025 at 8:40 a.m. ET.The public may access a live webcast of the fireside chat at Haemonetics' Investor Relations website or at the following link: https://event.webcasts.com/starthere.jsp?ei=1721260&tp_key=3096fdc651&tp_special=8 A replay of the recorded webc ...
Haemonetics(HAE) - 2025 Q4 - Annual Report
2025-05-21 10:12
Financial Performance - Net revenues for fiscal 2025 increased by 4.0% to $1,360,824, compared to $1,309,055 in fiscal 2024 [230]. - Operating income rose by 34.5% to $221,817 in fiscal 2025, driven by operating leverage and a gain from the sale of a manufacturing facility [232]. - Gross profit increased by 8.3% to $748,958, representing 55.0% of net revenues in fiscal 2025, up from 52.8% in fiscal 2024 [242]. - Hospital revenue surged by 23.7% to $564,269, primarily due to growth in Interventional Technologies and Blood Management Technologies [241]. - Plasma revenue decreased by 6.0% to $535,431, primarily due to lower sales volumes in North America [239]. - Blood Center revenue fell by 7.8% to $261,124, driven by declines in the Whole Blood business [240]. - Research and development expenses increased by 15.2% to $62,722, reflecting increased headcount from recent acquisitions [243]. - Interest and other expenses decreased by 25.1% to $(9,746), primarily due to gains on extinguishment of convertible notes [250]. - The reported income tax rate decreased to 20.9% in fiscal 2025 from 22.6% in fiscal 2024 [251]. - For the year ended March 29, 2025, the company recorded a pre-tax income of $212.1 million and an income tax expense of $44.4 million, resulting in a reported tax rate of 20.9% [253]. Cash Flow and Financing Activities - As of March 29, 2025, the company had $306.8 million in cash and cash equivalents, an increase from $178.8 million as of March 30, 2024 [254][255]. - Net cash provided by operating activities was $181.7 million during fiscal 2025, relatively flat compared to fiscal 2024 [265]. - Net cash used in investing activities was $161.9 million during fiscal 2025, an increase of $160.5 million compared to fiscal 2024 [266]. - Net cash provided by financing activities was $108.8 million during fiscal 2025, an increase of $70.7 million compared to fiscal 2024 [267]. - The company authorized a share repurchase program of up to $500 million to offset the dilutive impact of employee equity grants [262]. - The company repurchased $150.0 million of common stock through an ASR with Goldman Sachs, completing the ASR in April 2025, and has fully funded a $300.0 million Share Repurchase Authorization [205]. Acquisitions and Divestitures - The company completed the divestiture of its Whole Blood product line for total cash consideration of up to $65.8 million, including $43.3 million upfront and up to $22.5 million in contingent consideration based on sales growth over the next three years [204]. - The acquisition of Attune Medical was completed for total consideration of $187.7 million, enhancing the Hospital business unit's presence in electrophysiology [210][211]. - The acquisition of OpSens was finalized for approximately $254.5 million, expanding the Hospital business unit portfolio in interventional cardiology [212][213]. - The company completed the acquisition of Attune Medical for a purchase price of $187.7 million, including contingent consideration with an initial fair value of $25.3 million [300]. - The fair value of identified intangible assets from the acquisition totaled $105.8 million, primarily consisting of developed technology [301]. Market and Operational Insights - The company has seen declining transfusion rates in mature markets due to minimally invasive procedures, impacting growth in the Blood Center market [218]. - The Vascular Closure market continues to grow with the launch of VASCADE MVP in Japan and CE mark clearance for VASCADE systems in fiscal 2023 [221]. - Advanced hemostasis testing is increasingly utilized in clinical decision-making, with TEG systems achieving high market penetration in North America and Europe [224][226]. - The company expanded its market presence in the U.K. with SafeTraceTX, addressing operational efficiency and cybersecurity needs [229]. - Approximately 42% of the company's revenue during fiscal 2025 was generated by its ten largest customers, indicating a concentration of credit risk [269]. - 25.7% of the company's sales in fiscal 2025 were generated outside the U.S., primarily in foreign currencies, with significant exposure to Japanese Yen, Euro, and Chinese Yuan [273]. Debt and Financial Instruments - As of March 29, 2025, total outstanding debt under the senior unsecured term loan was $245.3 million with an effective interest rate of 5.7% [293]. - The company has scheduled principal payments of $6.3 million during fiscal 2026 related to its term loan [261]. - The company utilizes interest rate swaps to convert variable rate borrowings to fixed rates, with a notional amount of $204.5 million as of March 29, 2025 [293]. - A 10% strengthening of the U.S. Dollar would result in a $5.6 million increase in the fair value of forward contracts, while a 10% weakening would lead to a $6.8 million decrease [292]. - The company has a program to mitigate foreign currency exchange rate exposure using derivative financial instruments, including forward foreign currency contracts [275]. Accounting and Valuation - The consolidated financial statements present fairly the financial position of the company as of March 29, 2025, in conformity with U.S. generally accepted accounting principles [295]. - The fair value of contingent consideration in business combinations is recorded at fair value and remeasured at each reporting period based on changes in underlying assumptions [289]. - The company reviews intangible assets for impairment at least annually, considering factors such as market size declines and increased competition [282]. - The income tax provision process involves assessing temporary differences and maintaining a valuation allowance for deferred tax assets that are not more-likely-than-not realizable [285]. - Sensitivity analyses were performed to evaluate changes in fair value resulting from changes in significant assumptions [303].
Here's What Key Metrics Tell Us About Haemonetics (HAE) Q4 Earnings
ZACKS· 2025-05-10 01:30
Core Insights - Haemonetics reported revenue of $330.6 million for the quarter ended March 2025, a decrease of 3.7% year-over-year, but exceeded the Zacks Consensus Estimate by 1.00% [1] - The company's EPS for the quarter was $1.24, up from $0.90 in the same quarter last year, representing a surprise of 1.64% over the consensus estimate of $1.22 [1] Revenue Breakdown - Plasma segment net revenues were $126.74 million, slightly below the estimated $127.03 million, reflecting an 8.6% decline year-over-year [4] - Hospital segment net revenues reached $147.86 million, surpassing the average estimate of $147.41 million, with a year-over-year increase of 14.5% [4] - Blood Center segment net revenues were $56.01 million, exceeding the estimated $53.14 million, but showed a significant decline of 20.3% compared to the previous year [4] Stock Performance - Haemonetics shares have returned +14.8% over the past month, outperforming the Zacks S&P 500 composite's +13.7% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the broader market in the near term [3]
Haemonetics (HAE) Q4 Earnings and Revenues Surpass Estimates
ZACKS· 2025-05-08 14:20
Company Performance - Haemonetics reported quarterly earnings of $1.24 per share, exceeding the Zacks Consensus Estimate of $1.22 per share, and up from $0.90 per share a year ago [1] - The company posted revenues of $330.6 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 1%, but down from $343.29 million year-over-year [3] - The earnings surprise for this quarter was 1.64%, and Haemonetics has surpassed consensus EPS estimates two times over the last four quarters [2] Stock Performance - Haemonetics shares have declined approximately 17.7% since the beginning of the year, compared to a decline of 4.3% for the S&P 500 [4] - The current Zacks Rank for Haemonetics is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [7] Future Outlook - The current consensus EPS estimate for the upcoming quarter is $1.07 on revenues of $315.05 million, and for the current fiscal year, it is $4.98 on revenues of $1.32 billion [8] - The estimate revisions trend for Haemonetics is mixed, and changes in earnings expectations may occur following the recent earnings report [5][7] Industry Context - The Medical - Products industry, to which Haemonetics belongs, is currently ranked in the bottom 32% of over 250 Zacks industries, indicating potential challenges ahead [9]
Haemonetics(HAE) - 2025 Q4 - Earnings Call Transcript
2025-05-08 13:02
Haemonetics (HAE) Q4 2025 Earnings Call May 08, 2025 08:00 AM ET Company Participants Olga Guyette - VP - Investor Relations & TreasurerChristopher Simon - CEO, President & DirectorJames D'Arecca - Executive VP & CFORohin Patel - Vice PresidentMarie Thibault - Managing DirectorAndrew Cooper - VP - Equity ResearchJoanne Wuensch. - Managing DirectorAnthony Petrone - Managing Director Conference Call Participants Mike Matson - Senior Equity Research AnalystMike Petusky - Research AnalystCraig Bijou - Equity Re ...
Haemonetics(HAE) - 2025 Q4 - Earnings Call Transcript
2025-05-08 13:00
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]
Haemonetics(HAE) - 2025 Q4 - Annual Results
2025-05-08 10:03
Exhibit 99.1 Investor Contacts Media Contact Olga Guyette, Vice President-Investor Relations & (781) 356-9763 (781) 356-9776 olga.guyette@haemonetics.com josh.gitelson@haemonetics.com Treasury Josh Gitelson, Sr. Director-Global Communications David Trenk, Manager-Investor Relations (203) 733-4987 david.trenk@haemonetics.com 1 Haemonetics Reports Fourth Quarter and Fiscal 2025 Results; Provides Fiscal 2026 Guidance Boston, MA, May 8, 2025 - Haemonetics Corporation (NYSE: HAE) reported financial results for i ...
Haemonetics 4th Quarter and Fiscal Year 2025 Earnings Release Available on Investor Relations Website
Prnewswire· 2025-05-08 10:00
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]
Gear Up for Haemonetics (HAE) Q4 Earnings: Wall Street Estimates for Key Metrics
ZACKS· 2025-05-07 14:21
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, ...