Omnicell Announces Fiscal Year and Fourth Quarter 2025 Financial Results




Omnicell Announces Fiscal Year and Fourth Quarter 2025 Financial Results

Omnicell delivers solid fourth quarter 2025 financial results

Announces major step toward autonomous medication management with the launch of its next generation dispensing system, Titan XT, at the American Society of Health-System Pharmacists (ASHP) 2025 Midyear Clinical Meeting & Exhibition

FORT WORTH, Texas–(BUSINESS WIRE)–Omnicell, Inc. (NASDAQ:OMCL) (“Omnicell,” “we,” “our,” “us,” “management,” or the “Company”), a leading healthcare technology provider focused on empowering autonomous medication management, today announced results for its fiscal year and fourth quarter ended December 31, 2025.

“We finished 2025 with solid fourth quarter financial results, delivering full year 2025 total revenues, product bookings and annual recurring revenues (‘ARR’) all above the mid-point of our previously issued guidance ranges,” stated Randall Lipps, chairman, president, chief executive officer, and founder of Omnicell. “As we look ahead, we are focused on delivering long-term, sustainable, and profitable growth. The launch of Titan XT intends to address a significant need for an enhanced and more efficient medication management experience that combines proven automation with powerful intelligence and extends beyond the pharmacy into nursing care areas. We believe that our innovation roadmap continues to resonate with our customers, and I am optimistic for what the future holds for Omnicell in 2026 and beyond.”

Financial Results

Total revenues for the fourth quarter of 2025 were $314 million, up $7 million, or 2%, from the fourth quarter of 2024. The quarter-over-quarter increase in total revenues was driven by strength in our technical service offerings and SaaS and Expert Services revenues, as well as increases in our consumables revenues. Total revenues for the year ended December 31, 2025 were $1.185 billion, up $73 million, or 7%, from the year ended December 31, 2024. The year-over-year increase in total revenues was driven by strength in our connected devices and technical service offerings, as well as increases in our SaaS and Expert Services and consumables revenues.

Total GAAP net loss for the fourth quarter of 2025 was $2 million, or $0.05 per diluted share. This compares to GAAP net income of $16 million, or $0.34 per diluted share, for the fourth quarter of 2024. Total GAAP net income for the year ended December 31, 2025 was $2 million, or $0.04 per diluted share. This compares to GAAP net income of $13 million, or $0.27 per diluted share, for the year ended December 31, 2024.

Total non-GAAP net income for the fourth quarter of 2025 was $18 million, or $0.40 per diluted share. This compares to non-GAAP net income of $28 million, or $0.60 per diluted share, for the fourth quarter of 2024. Total non-GAAP net income for the year ended December 31, 2025 was $75 million, or $1.62 per diluted share. This compares to non-GAAP net income of $79 million, or $1.71 per diluted share, for the year ended December 31, 2024.

Total non-GAAP EBITDA for the fourth quarter of 2025 was $37 million. This compares to non-GAAP EBITDA of $46 million for the fourth quarter of 2024. Total non-GAAP EBITDA for the year ended December 31, 2025 was $140 million. This compares to non-GAAP EBITDA of $136 million for the year ended December 31, 2024.

Product Bookings, Product Backlog and Annual Recurring Revenue

We utilize product bookings⁽¹⁾ and Annual Recurring Revenue (“ARR”), each as further described below, as key performance metrics for our business. For the year ended December 31, 2025, product bookings were $535 million compared to $558 million for the year ended December 31, 2024, or a decrease of 4% year-over-year, as we are in the late stage of the XT upgrade cycle. The chart below summarizes our total product backlog ⁽²⁾ and ARR ⁽³⁾:

Balance Sheet

As of December 31, 2025, Omnicell’s balance sheet reflected cash and cash equivalents of $197 million, total debt (net of unamortized debt issuance costs) of $168 million, and total assets of $1.97 billion. Cash flows provided by operating activities in the fourth quarter of 2025 totaled $30 million. This compares to cash flows provided by operating activities totaling $56 million in the fourth quarter of 2024.

As of December 31, 2025, the Company had $350 million of availability under its revolving credit facility with no outstanding balance.

Corporate Highlights

• In December 2025, the Company announced Omnicell Titan XT, a transformational, enterprise version of automated dispensing systems (ADS). Designed to unify proven automation and powerful intelligence, Titan XT is built to deliver an enhanced and more efficient medication management experience to support a growing health system. With this launch, the power of OmniSphere is meant to extend to nursing care areas, designed to deliver greater control of medication inventory management for pharmacy, while providing nurses with more confidence when administering medications.

• More than 4,000 pharmacy leaders connected with Omnicell during December’s American Society of Health-System Pharmacists (ASHP) Midyear 2025 Clinical Meeting and Exhibition, where they had the opportunity to explore how Omnicell is working to empower autonomous medication management to drive intelligent outcomes, deliver a better clinician experience, expand visibility and oversight for pharmacy enterprise, enhance safety and accuracy in the IV cleanroom, and transform outpatient care delivery.

• Omnicell was once again recognized as one of the Top 50 Healthcare Technology Companies by the Healthcare Technology Report for continuous focus on innovation designed to help healthcare organizations deliver better, more precise care. Randall Lipps was also named one of the Top Healthcare Technology CEOs of 2025 by the Healthcare Technology Report.

2026 Guidance

The table below summarizes Omnicell’s first quarter and full year 2026 guidance:

The Company does not provide guidance for GAAP net income or GAAP earnings per share, nor a reconciliation of any forward-looking non-GAAP financial measures to the most directly comparable GAAP financial measures on a forward-looking basis because it is unable to predict certain items contained in the GAAP measures without unreasonable efforts. These forward-looking non-GAAP financial measures do not include certain items, which may be significant, including, but not limited to, unusual gains and losses, costs associated with future restructurings, acquisition-related expenses, and certain tax and litigation outcomes.

Omnicell Conference Call Information

Omnicell will hold a conference call today, Thursday, February 5, 2026, at 8:30 a.m. ET to discuss fiscal year and fourth quarter 2025 financial results. The conference call can be monitored by dialing (800) 715-9871 in the U.S. or (646) 307-1963 in international locations. The Conference ID is 4203777. A link to the live and archived webcast will also be available on the Investor Relations section of Omnicell’s website at https://ir.omnicell.com/events-and-presentations/.

About Omnicell

Since 1992, Omnicell has been committed to delivering innovative, outcomes-centric pharmacy and nursing solutions for all settings of care. As an intelligent medication management technology company, Omnicell empowers autonomous medication management by unifying automation and AI-enabled intelligence, optimized by expert services, to drive clinical and business outcomes that are helping to improve efficiency and enhance patient safety for healthcare facilities worldwide. Learn more at omnicell.com.

From time to time, Omnicell may use the Company’s investor relations website and other online social media channels, including its LinkedIn page www.linkedin.com/company/omnicell, and Facebook page www.facebook.com/omnicellinc, to disclose material non-public information and comply with its disclosure obligations under Regulation Fair Disclosure (“Reg FD”).

OMNICELL and the Omnicell logo are registered trademarks of Omnicell, Inc. or one of its subsidiaries. This press release may also include the trademarks and service marks of other companies. Such trademarks and service marks are the marks of their respective owners.

Forward-Looking Statements

To the extent any statements contained in this press release deal with information that is not historical, these statements are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, statements including the words “expect,” “intend,” “may,” “will,” “should,” “would,” “could,” “plan,” “potential,” “anticipate,” “believe,” “forecast,” “guidance,” “outlook,” “goals,” “target,” “estimate,” “seek,” “predict,” “project,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements are subject to the occurrence of many events outside Omnicell’s control. Such statements include, but are not limited to, Omnicell’s projected product bookings, revenues, including product, service, technical services and SaaS and Expert Services revenues, annual recurring revenue, non-GAAP EBITDA, and non-GAAP earnings per share; expectations regarding our products and services and developing new or enhancing existing products and solutions and the related objectives and expected benefits (and any implied financial impact); our customers’ receptivity to our innovation roadmap; our ability to deliver innovations that are designed to provide an enhanced and more efficient medication management experience extending beyond the pharmacy into nursing care areas; our customers’ expectations regarding tariffs and regulations; our ability to deliver sustainable and profitable growth, and statements about Omnicell’s strategy, plans, objectives, promise and purpose, vision, goals, opportunities, and market or Company outlook. Actual results and other events may differ significantly from those contemplated by forward-looking statements due to numerous factors that involve substantial known and unknown risks and uncertainties. These risks and uncertainties include, among other things, (i) unfavorable general economic and market conditions, including the impact and duration of inflationary pressures, (ii) Omnicell’s ability to take advantage of growth opportunities and develop and commercialize new solutions and enhance existing solutions, (iii) reduction in demand in the capital equipment market or reduction in the demand for or adoption of our solutions, systems, or services, (iv) delays in installations of our medication management solutions or our more complex medication packaging systems, (v) our international operations may subject us to additional risks, including from the impact of tariffs, (vi) risks related to Omnicell’s investments in new business strategies or initiatives, including its transition to selling more products and services on a subscription basis, and its ability to acquire companies, businesses, or technologies and successfully integrate such acquisitions, (vii) risks related to failing to maintain expected service levels when providing our SaaS and Expert Services or retaining our SaaS and Expert Services customers, (viii) Omnicell’s ability to meet the demands of, or maintain relationships with, its institutional, retail, and specialty pharmacy customers, (ix) risks related to climate change, legal, regulatory or market measures to address climate change and related emphasis on ESG matters by various stakeholders, (x) changes to the 340B Program, (xi) risks related to the incorporation of artificial intelligence technologies, including generative or agentic AI technologies, into our products, services and processes or our vendors offerings, (xii) Omnicell’s substantial debt, which could impair its financial flexibility and access to capital, (xiii) covenants in our credit agreement could restrict our business and operations, (xiv) continued and increased competition from current and future competitors in the medication management automation solutions market and the medication adherence solutions market, (xv) risks presented by government regulations, legislative changes, fraud and anti-kickback statues, products liability claims, the outcome of legal proceedings, and other legal obligations related to healthcare, privacy, data protection, and information security, and the costs of compliance with, and potential liability associated with, our actual or perceived failure to comply with such obligations, including any potential governmental investigations and enforcement actions, litigation, fines and penalties, exposure to indemnification obligations or other liabilities, and adverse publicity related to the same; (xvi) any disruption in Omnicell’s information technology systems and breaches of data security or cyber-attacks on its systems or solutions, including the previously disclosed ransomware incident and any potential adverse legal, reputational, and financial effects that may result from it and/or additional cybersecurity incidents, as well as the effectiveness of business continuity plans during any future cybersecurity incidents, (xvii) risks associated with operating in foreign countries, (xviii) Omnicell’s ability to recruit and retain skilled and motivated personnel, (xix) Omnicell’s ability to protect its intellectual property, (xx) risks related to the availability and sources of raw materials and components or price fluctuations, shortages, or interruptions of supply, (xxi) Omnicell’s dependence on a limited number of suppliers for certain components, equipment, and raw materials, as well as technologies provided by third-party vendors, (xxii) fluctuations in quarterly and annual operating results may make our future operating results difficult to predict, (xxiii) failing to meet (or significantly exceeding) our publicly announced financial guidance, and (xxiv) other risks and uncertainties further described in the “Risk Factors” section of Omnicell’s most recent Annual Report on Form 10-K, as well as in Omnicell’s other reports filed with or furnished to the United States Securities and Exchange Commission (“SEC”), available at www.sec.gov. Forward-looking statements should be considered in light of these risks and uncertainties. Readers are encouraged to review this press release in conjunction with our most recent Annual Report on Form 10-K and our other reports filed with or furnished to the SEC. Investors and others are cautioned not to place undue reliance on forward-looking statements. All forward-looking statements contained in this press release speak only as of the date of this press release. Omnicell assumes no obligation to update any such statements publicly, or to update the reasons actual results could differ materially from those expressed or implied in any forward-looking statements, whether as a result of changed circumstances, new information, future events, or otherwise, except as required by law.

Use of Non-GAAP Financial Information

This press release contains financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”). Management evaluates and makes operating decisions using various performance measures. In addition to Omnicell’s GAAP results, we also consider non-GAAP product gross profit, non-GAAP product gross margin, non-GAAP service gross profit, non-GAAP service gross margin, non-GAAP gross profit, non-GAAP gross margin, non-GAAP operating expenses, non-GAAP income from operations, non-GAAP operating margin, non-GAAP net income, non-GAAP net income per diluted share, non-GAAP diluted shares, non-GAAP EBITDA, non-GAAP EBITDA margin, and non-GAAP free cash flow. These non-GAAP results and metrics should not be considered as an alternative to revenues, product gross profit, service gross profit, gross profit, operating expenses, income from operations, net income, net income per diluted share, diluted shares, net cash provided by operating activities, or any other performance measure derived in accordance with GAAP. We present these non-GAAP results and metrics because management considers them to be important supplemental measures of Omnicell’s performance and refers to such measures when analyzing Omnicell’s strategy and operations.

Our non-GAAP product gross profit, non-GAAP product gross margin, non-GAAP service gross profit, non-GAAP service gross margin, non-GAAP gross profit, non-GAAP gross margin, non-GAAP operating expenses, non-GAAP income from operations, non-GAAP operating margin, non-GAAP net income, non-GAAP net income per diluted share, non-GAAP EBITDA, and non-GAAP EBITDA margin are exclusive of certain items to facilitate management’s review of the comparability of Omnicell’s core operating results on a period-to-period basis because such items are not related to Omnicell’s ongoing core operating results as viewed by management. We define our “core operating results” as those revenues recorded in a particular period and the expenses incurred within such period that directly drive operating income in such period. Management uses these non-GAAP financial measures in making operating decisions because, in addition to meaningful supplemental information regarding operating performance, the measures give us a better understanding of how we believe we should invest in research and development, fund infrastructure growth, and evaluate the effectiveness of marketing strategies. In calculating the above non-GAAP results: non-GAAP product gross profit and non-GAAP product gross margin exclude from their GAAP equivalents items a), b), and f) below; non-GAAP service gross profit, non-GAAP service gross margin, non-GAAP gross profit and non-GAAP gross margin exclude from their GAAP equivalents items a), b), e), and f) below; non-GAAP operating expenses, non-GAAP income from operations and non-GAAP operating margin exclude from their GAAP equivalents items a), b), c), e), f), g), h), and i) below; and non-GAAP net income and non-GAAP net income per diluted share exclude from their GAAP equivalents items a) through j) below.

Contacts

Kathleen Nemeth

Senior Vice President, Investor Relations

650-435-3318

Kathleen.Nemeth@Omnicell.com

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Real Chemistry Strengthens Global Presence with New International Leadership Appointments and Expanded Regional Hubs




Real Chemistry Strengthens Global Presence with New International Leadership Appointments and Expanded Regional Hubs

Latest investment marks key milestone in the company’s global growth strategy, supporting clients across an increasingly complex healthcare landscape

LONDON–(BUSINESS WIRE)–Real Chemistry, a global leader in AI- and insights-driven healthcare communications, today provided an update on the company’s global growth strategy with the appointment of four senior international leaders and an expanded regional hub presence.

These updates reflect Real Chemistry’s continued focus on delivering greater consistency, efficiency and seasoned counsel for healthcare clients and brands navigating increasingly complex, multi-market environments. The company’s strategy includes further strengthening its presence across key international markets – including Europe, the Middle East, Asia Pacific and Latin America – through a combination of regional hubs and an expanded affiliate network. Initial investments include new hub offices in Munich, Zurich and Dubai, with additional hub enhancements and in-market team expansion planned later this year.

“Healthcare companies today are operating in a far more complex, multi-market environment, and they need partners who can think and act globally, while delivering locally,” said Suzanne Jacobs, Head of International Markets & Group President, Medical Communications. “By expanding our international leadership and strengthening our regional hub model, we are deepening our ability to support clients across borders – from molecule to market – with the consistency and integrated expertise required to drive meaningful impact worldwide.”

The new executive appointments include:

• Kath Harrison, Group President, International Growth (based in Dubai), will lead international growth and delivery of end-to-end capabilities across global markets. Harrison will also serve as General Manager of the Dubai office, strengthening Real Chemistry’s presence in the Middle East and its ability to support clients into Asia Pacific and beyond. Most recently, Harrison served as President, International Markets at GCI Health, where she helped lead the company’s expansion across Europe, Asia and the Middle East.
• Brandon Pletsch, President, Europe (based in Germany), will lead cross-functional teams and services across Europe. Pletsch was most recently a Managing Partner within Real Chemistry’s Medical Communications group and is founder of the company’s scientific visualization division, Rad Science, where he led creative scientific storytelling, interactive experiential learning and AI innovation.
• Louise Clark, President, Integrated Communications, Global (based in UK), will support the global expansion of Real Chemistry’s Integrated Communications business. Clark spent the majority of her career working in-house at Novartis and Pfizer in a variety of communication leadership positions, and most recently at Edelman, where she oversaw international health portfolios.
• Eleanor Read, PhD, President, Integrated Communications, Europe (based in UK), will support the European expansion of Real Chemistry’s Integrated Communications business. Read spent the last two decades at Edelman, most recently as Managing Director of Health. She began her career at IMS Health.

These leaders bring decades of experience advising global pharmaceutical companies, scaling international agency operations and building integrated teams across dynamic, regulated markets.

“Real Chemistry was built to solve the unique challenges of healthcare, and that focus has become even more critical as our clients operate across increasingly nuanced and interconnected global marketplaces,” said Shankar Narayanan, Chief Executive Officer, Real Chemistry. “By investing in global leadership, regional infrastructure, AI and best-shore capabilities, we are uniquely positioned to deliver expertise, innovative solutions and efficiencies to meet our clients’ needs today and in the future.”

Since 2023, the company’s global team (ex-US) has grown 25% with more than 300 employees currently working in key international markets outside the United States.

This latest strategy update follows Real Chemistry’s recent announcement of RC Resolve, the company’s new healthcare advisory practice. Comprised of some of the industry’s most influential and trusted advisors and leaders, the practice is designed to address healthcare’s most critical business, regulatory and value inflection points where science, business, economics, policy and risk management intersect.

About Real Chemistry: 25 Years of Future-Focused Healthcare

Celebrating its 25th anniversary this year, Real Chemistry is a tier-one partner to the world’s most innovative life sciences and healthcare companies. As a leading provider of AI-powered audience analytics and insights, Real Chemistry helps the healthcare industry better understand, reach and engage critical audiences to improve the healthcare experience for all. Anchored by a culture of innovation and creativity, Real Chemistry’s 2,000+ global experts across life sciences, marketing communications and technology are singularly focused on navigating the complexities of bringing scientific advances to market, and, most importantly, to the people who need them.

Real Chemistry is the largest independent agency focused solely on healthcare. In 2025, Real Chemistry was named Healthcare Network of the Year by Medical Marketing + Media (MM+M), and Independent Healthcare Network of the Year by the London International Awards (LIA). Real Chemistry has been recertified as a Great Place to Work® for four consecutive years and recognized on Fortune’s Best Places to Work in Advertising & Marketing.

Real Chemistry operates through wholly-owned offices across North America, Europe and the Middle East, complemented by a strategic partner network in Asia Pacific, Latin America and Africa – partnerships that have long enabled the company to support clients wherever they operate. Learn more at www.realchemistry.com.

Contacts

Media Contact:

media@realchemistry.com

SynGenSys Introduces Liver.SET Synthetic Promoter Library for Liver-specific Gene Expression for in vivo Gene Therapies




SynGenSys Introduces Liver.SET Synthetic Promoter Library for Liver-specific Gene Expression for in vivo Gene Therapies

Validated, tissue-specific library enables customisable and controllable liver-targeted gene expression with high specificity and minimal off-target activity in muscle tissue

SHEFFIELD, England–(BUSINESS WIRE)–SynGenSys, a biotechnology company designing synthetic gene promoter systems to address critical bottlenecks in biopharma manufacturing and enhance cell and gene therapy development, today announced the launch of its Liver.SET™ library of liver-specific synthetic promoters. Developed using SynGenSys’ proprietary informatics and computational design platform, the Liver.SET library comprises a range of compact, patentable synthetic promoters for liver-targeted gene expression for in vivo gene therapies.

Liver.SET overcomes key challenges in cell and gene therapy development by enabling tissue-specific, precise transgene expression with minimal off-target activity in muscle tissue. Validated both in vitro and in vivo for target specificity, the promoters display a marked increase in activity and design flexibility in comparison to natural liver promoters with fixed activity profiles, sizes, and regulatory behaviours. The promoters exhibit low levels of activity in HEK293, avoiding viral vector manufacturing issues linked to therapeutic gene expression during packaging, while the modular architecture of the promoters further supports rapid customisation alongside compact sequence lengths yielding enhanced compatibility with AAV payloads.

Following the launch of SynGenSys’ first tissue-type specific library, NK.SET¹, which supports the development of natural killer cell therapies, Liver.SET further demonstrates the ability to design tissue-specific promoters with customisable designs for therapeutic applications. The demonstrated specificity of SynGenSys’ promoters provides a foundation for the development of promoter libraries designed to target and de-target tissues including muscle, retina and CNS. The commercialisation of the validated libraries also demonstrates SynGenSys’ capabilities for tailored promoter design for targeted therapeutics, facilitating the development of safer, more effective cell and gene therapies.

Dr Mike Daniels, Chief Commercial Officer, SynGenSys, commented: “The launch of Liver.SET™ represents another significant milestone for SynGenSys, demonstrating that our platform can deliver synthetic promoter solutions for real gene therapy development needs. We see this as a key enabler for in vivo gene therapies, and a reliable, validated starting point for deeper collaboration with developers seeking to design novel therapeutics with enhanced precision and safety.”

For further information please visit: https://tinyurl.com/liverSET

References:

1. https://www.syngensys.com/resources/nk

Contacts

Media
Katie Odgaard

katie.odgaard@zymecommunications.com

Quantum Motion Expands Global Presence by Opening European Offices in Spain




Quantum Motion Expands Global Presence by Opening European Offices in Spain

SAN SEBASTIAN, Spain–(BUSINESS WIRE)–#HPC–Quantum Motion today announced the opening of its offices in Spain, establishing a permanent base for quantum system development, integration and deployment in the European Union. The new site, which is located in the newly inaugurated nanoGUNE Quantum Tower, supports Quantum Motion’s scale-up of silicon-based quantum computing systems and strengthens the collaboration across Europe’s semiconductor, academic and industrial ecosystems.

The nanoGUNE Quantum Tower was officially inaugurated on February 4^th, 2026. The opening ceremony was attended by the president of the Basque Government, Imanol Pradales; the head of the regional government of Gipuzkoa, Eider Mendoza; the mayor of San Sebastian, Jon Insausti; the president and director-general of nanoGUNE, Javier Martínez-Ojinaga and Jose M. Pitarke respectively; the Basque minister of Science, Universities and Innovation; and other representatives from principal institutions, research centers and the European quantum industry.

“Our expansion in Europe demonstrates our continued commitment to global collaborations and partnerships,” said James Palles-Dimmock, CEO of Quantum Motion. “The state-of-the-art technology infrastructure available in the new Quantum Tower and our collaboration with the Basque government, academia and experts at CIC nanoGUNE provide a huge advantage as we advance our ability to deliver commercially useful, silicon-spin quantum systems at scale.”

“The scale and ambition of this project are such that we decided to expand our facilities with the construction of the new Quantum Tower to provide dedicated space to our Quantum Hardware research group and laboratories and to Quantum Motion,” said Jose M. Pitarke, nanoGUNE’s director-general. “We look forward to advancing the future of quantum computing in collaboration with Quantum Motion.”

Quantum Motion and CIC nanoGUNE are jointly collaborating on initiatives focused on delivering fault-tolerant, utility-scale quantum systems in Europe, including:

• QuDos – A prestigious European Research Council (ERC) Consolidator Grant project awarded to Gonzalez-Zalba focused on using semiconductor quantum dots as the basis for building ultra-low-power microwave qubit control and readout electronics for quantum computers.
• SPINS Consortium – The Semiconducting Pilot Line for Industrial quantum nanoSystems, which is bringing together leading European research and technology organizations to deliver semiconductor quantum chips with high manufacturing and technology readiness levels. Quantum Motion, in collaboration with nanoGUNE, is focusing on the integration of quantum and classical electronics on a monolithic chip.

“The Basque Country has one of the strongest ecosystems globally when it comes to the development of quantum technologies,” said Fernando Gonzalez-Zalba, principal engineer at Quantum Motion and Ikerbasque research professor at CIC nanoGUNE. “We look forward to building the next generation of quantum processing units based on silicon manufactured in industrial 300 mm wafer lines, as well as deploying and servicing systems throughout Europe.”

About CIC nanoGUNE

The Nanoscience Cooperative Research Center (CIC) nanoGUNE, located in the Basque city of San Sebastian, was established with the mission of conducting world-class nanoscience research for the competitive growth of the Basque Country. nanoGUNE is recognized by the Spanish Research Agency as a Maria-de-Maeztu center of excellence.

www.nanogune.eu

About Quantum Motion

Quantum Motion develops and deploys full-stack quantum computers manufactured using industry standard 300mm CMOS wafer technology with the goal of delivering commercially viable, utility scale, fault tolerant systems. A key part of this approach is the development of cryoelectronics, integrating qubits with classical control circuits capable of operating at deep cryogenic temperatures, which enables extreme scaling of quantum processors. Fault-tolerant quantum computing will enable the most powerful quantum algorithms, targeting solutions to currently intractable problems in fields as diverse as chemistry, materials science, medicine and artificial intelligence. The company employs over 100 people across the UK, US, Australia and Europe and comprises specialists in quantum theory, hardware and system engineering and software. Learn more at www.quantummotion.com.

Contacts

Press inquiries:
Debbie Caldwell or Chris Gibbs

media@quantummotion.com

Fujirebio and Sysmex Begin Sales Collaboration for Dementia Testing




Fujirebio and Sysmex Begin Sales Collaboration for Dementia Testing

MINATO-KU, TOKYO, Japan & KOBE, Japan–(BUSINESS WIRE)–#IVD–Fujirebio Holdings, Inc. (HQ: Minato-ku, Tokyo; President & CEO: Goki Ishikawa; “Fujirebio”), a consolidated subsidiary of H.U. Group Holdings, Inc. (HQ: Minato-ku, Tokyo; Chairman, President and Group CEO: Shigekazu Takeuchi) and Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano, “Sysmex”) have agreed on a sales collaboration for dementia testing. This agreement follows continued discussions based on the Basic Agreement on Business Collaboration in the Field of Immunoassay concluded in October 2023.¹ Sysmex will exclusively sell Fujirebio’s fully automated Lumipulse^® immunoassay systems and dementia-related reagents (“the Products”) in regions and countries mutually agreed upon by both companies. Going forward, Fujirebio and Sysmex will collaborate to meet the growing testing needs accompanying the wider adoption of therapeutic drugs and will gradually expand the countries where the Products are sold.

Since entering into the Basic Agreement on Business Collaboration in October 2023, the two companies have engaged in ongoing discussions aimed at accelerating the development of immunoassays and their global expansion. In November 2023, they concluded a Contract Development and Manufacturing Organization (CDMO) agreement² for reagents in the field of neurodegenerative diseases, including Alzheimer’s disease. Furthermore, in December 2023, they signed a basic agreement for the supply of reagent raw materials owned by each company,³ and have promoted specific initiatives to accelerate the mutual development of new reagents.

With the aging of the global population, the number of patients with neurodegenerative diseases is rapidly increasing. In particular, Alzheimer’s disease⁴ is a serious medical and social issue. In recent years, new therapeutic drugs to slow the progression of Alzheimer’s disease have emerged, leading to a growing demand for wider access to the testing necessary for their effective use.

Fujirebio has strong reagent development and manufacturing capabilities, while Sysmex has a global sales and service network as well as extensive experience in regulatory applications. By combining these respective strengths, Fujirebio and Sysmex will commence sales of the Products in Brazil, and plan to progressively expand into Central and South America, the Middle East, Asia, and other regions. By leveraging the strengths of Fujirebio’s Products together with Sysmex’s fully automated immunoassay systems, the HISCL™ Series, the two companies will contribute to the early adoption of testing in the field of dementia.

* Lumipulse^® is a registered trademark of Fujirebio Inc. All rights reserved.

* HISCL™ is a trademark of Sysmex Corporation.

References

About Fujirebio

Fujirebio is a diagnostics company with over 75 years of experience delivering innovative solutions to healthcare providers, pharmaceutical companies, and IVD partners worldwide. Leveraging world-class expertise in neurology, oncology, infectious diseases, and beyond, and assays available on the robust Lumipulse^® platform, Fujirebio’s open business model accelerates access to breakthrough diagnostics through strategic partnerships across the life science industry. Part of H.U. Group, Fujirebio combines strong R&D capabilities, regulatory expertise, and scalable manufacturing to deliver high-impact diagnostic solutions. Fujirebio’s flexible CDMO model helps its diagnostic partners bring validated solutions to the market faster— driving better decisions, treatments, and patient outcomes.

For more information about Fujirebio, please visit www.fujirebio.com.

About Sysmex Corporation

Sysmex Corporation, headquartered in Kobe, Japan, is a global leader in in vitro diagnostics. Since its foundation in 1968, Sysmex has focused on diagnostics as the core of its business, and today, it supports the health of people in over 190 countries and regions worldwide. Sysmex continues to innovate in diagnostics, and to collaboratively create unique values in the areas of personalized medicine and novel treatments, under its long-term vision of “Together for a better healthcare journey.” Through its unique technology, solutions, and co-creation with various partners, Sysmex delivers new value and addresses the universal desire of people to live longer and healthier lives.

*”Healthcare journey” is a trademark of Sysmex Corporation, registered in Japan.

For more information about Sysmex, please visit www.sysmex.co.jp/en/.

Contacts

For media:

Public Relations Section, Public Relations/Sustainability Department,

H.U. Group Holdings, Inc.

Phone: +81-3-6279-0884

E-mail: pr@hugp.com

For investors and analysts:

IR/SR Dept.

Phone: +81-3-5909-3337

E-mail: ir@hugp.com

Invivoscribe® Launches LeukoStrat® KMT2A + MRD Assay to Advance High-Sensitivity Leukemia Testing in Clinical Trials and Patient Management Worldwide




Invivoscribe® Launches LeukoStrat® KMT2A + MRD Assay to Advance High-Sensitivity Leukemia Testing in Clinical Trials and Patient Management Worldwide

SAN DIEGO–(BUSINESS WIRE)–Invivoscribe, a leader in precision medicine and measurable residual disease (MRD) testing, today announced the addition of the LeukoStrat^® KMT2A + MRD Assay and Software to its industry-leading oncology portfolio. The assay leverages digital PCR (dPCR) to support both screening and precise longitudinal MRD monitoring for KMT2A rearrangements in acute myeloid leukemia (AML) subjects. This quantitative test is currently available for research use in clinical trials and as a stand-alone kit for purchase by our global customers, and will soon be available as a service in our regional LabPMM^® laboratories worldwide.

The assay is available to detect key AML-associated KMT2A rearrangements, which account for the vast majority of KMT2A fusion partners in AML¹ and those most commonly targeted in menin-inhibitor clinical development programs. Later this year, the assay will be enhanced with four additional KMT2A rearrangements which are frequently found in acute lymphocytic leukemia (ALL), expanding its utility across leukemias.

The LeukoStrat KMT2A + MRD Assay accurately identifies and quantifies common KMT2A rearrangements that drive KMT2A-translocated acute leukemias, offering translational researchers and biopharmaceutical partners a critical tool to assess MRD and to evaluate therapeutic response. With unprecedented sensitivity down to 0.005% (5×10^-5) and precise quantitation through normalization against a control gene, the assay enables far more rapid turnaround time and more sensitive detection of low-level KMT2A rearrangements that traditional cytogenetics and FISH methods miss. The LeukoStrat^® KMT2A + MRD Assay and Software streamline both initial screening and longitudinal MRD monitoring from a single workflow, facilitating efficient implementation both in research laboratories and as a service supporting clinical research.

“Invivoscribe is setting a new standard for how researchers and biopharmaceutical partners can identify, monitor and understand disease response,” said Jeff Miller, CEO and CSO at Invivoscribe. “Our LeukoStrat KMT2A + MRD Assay provides partners with a powerful tool for exploratory and pivotal analyses in menin-inhibitor trials, offering precise insights into subject response throughout treatment. This assay builds on our international reputation as the ideal partner for pharmaceuticals looking to accelerate KMT2A trials using MRD as a surrogate endpoint and for companion diagnostic development as these therapies advance toward approval.”

The assay integrates with LeukoStrat^® KMT2A + MRD Software for rapid, objective analysis, enabling labs and biopharmaceutical partners to unlock complex molecular insights. When paired with Invivoscribe’s globally standardized LabPMM^® network and regulatory expertise, it supports the full development pathway from early-phase trials through CDx validation and commercialization.

For a comprehensive approach to therapy development, biopharmaceutical partners can combine the LeukoStrat KMT2A + MRD Assay for treatment monitoring with Invivoscribe’s established myeloid portfolio of IVDR and research use only LeukoStrat CDx and MRD assays, including prognostic biomarkers such as FLT3 and NPM1.^2,3,4,5 Invivoscribe’s proven track record in companion diagnostics (CDx) development and successful global regulatory submissions positions the company as a trusted strategic partner for menin-inhibitor programs progressing toward approval.

About Invivoscribe

Invivoscribe^® is a global, vertically integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics^®. For over thirty years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with pharmaceutical companies interested in clinical trial testing via our global lab network located in the U.S., Germany, Japan and China, and in developing and commercializing companion diagnostics, with our rigorous expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM^®), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization. For more information, please visit www.invivoscribe.com, contact inquiry@invivoscribe.com, or follow Invivoscribe on LinkedIn.

References

1. Meyer, C., et al. Leukemia 2023; 37, 988–1005. DOI: 10.1038/s41375-023-01877-1
2. Dillon, L. et al. JAMA. 2023; 329(9):745-755. DOI: 10.1001/jama.2023.1363
3. Dillon, L. et al. JAMA Oncology. 2024; 10(8)1104-1110. DOI: 10.1001/jamaoncol.2024.0985
4. Levis, M. et al. Blood. 2025; 145(19):2138-2148. DOI: 10.1182/blood.2024025154
5. Al-Ali, R. et al. Bone Marrow Transplantation. 2025; DOI: 10.1038/s41409-025-02757-1

Contacts

inquiry@invivoscribe.com

JCR Pharmaceuticals’ Research Presentations at WORLDSymposium™ 2026 Showcase Data from Its Investigational Treatments for Lysosomal Storage Disorders




JCR Pharmaceuticals’ Research Presentations at WORLDSymposium™ 2026 Showcase Data from Its Investigational Treatments for Lysosomal Storage Disorders

– Presentations Highlight Potential Benefits of Therapies Incorporating J-Brain Cargo^®, JCR’s Proprietary, Blood-Brain Barrier-Penetrating Technology –

HYOGO, Japan–(BUSINESS WIRE)–JCR Pharmaceuticals Co., Ltd. (TSE 4552; “JCR”), a global specialty biopharmaceutical company dedicated to developing therapies for rare and genetic diseases, today announced the presentation of four datasets demonstrating the potential benefits of its investigational therapies for lysosomal storage disorders (LSDs) at the 22^nd Annual WORLDSymposium^TM 2026. Researchers are presenting new data from two of its programs that apply the J-Brain Cargo^® platform, a proprietary technology developed by JCR to deliver medicines across the blood-brain barrier (BBB), through four poster presentations this week.

“Lysosomal storage disorders are a group of rare diseases that have been notoriously difficult to treat due to the inability to deliver a therapy across the blood-brain barrier into the central nervous system. With our J-Brain Cargo^® platform technology, we have the potential to address the progressive neurological symptoms associated with these devastating and life-limiting diseases, many of which have inadequate treatment options or no approved therapies available,” said Shin Ashida, Chairman, President and CEO of JCR Pharmaceuticals. “The data presented at the WORLDSymposium™ demonstrate the growing body of safety and efficacy evidence of JR-141 in people with Hunter syndrome and highlight the potential of JR-471 for individuals affected by fucosidosis. We believe that our proprietary J-Brain Cargo^® platform technology could be the foundation for therapies for lysosomal storage disorders. We wish to express our gratitude to the patients who have participated in our clinical programs, as well as their families, clinical investigators, and other collaborators who have supported us throughout the process.”

The first dataset highlights pre-clinical data from the JR-471 clinical development program. JR-471 is an investigational BBB-penetrating α-L-fucosidase (rDNA origin) enzyme replacement therapy (ERT) that JCR is developing for the treatment of individuals affected by fucosidosis, in partnership with MEDIPAL HOLDINGS CORPORATION.

The other three datasets focus on the long-term efficacy and cognitive and adaptive behavioral effects of JR-141 (pabinafusp alfa) for mucopolysaccharidosis type II (MPS II, or Hunter syndrome). JR-141 is a recombinant iduronate-2-sulfatase (I2S) ERT that was approved in March 2021 by the Ministry of Health, Labour and Welfare (MHLW) in Japan, where it is marketed as IZCARGO™ for the treatment of people with MPS II.

JR-471 Dataset (Fucosidosis)

This poster presentation provides pre-clinical data from the JR-471 clinical development program investigating fucosidosis:

A transferrin receptor-targeted α-L-fucosidase, JR-471, reduced core-fucosylated glycoasparagine in the brain and preserved motor function in a murine model of Fucosidosis (Poster Number 246)

Presenter: Tomomi Masuda, Ph.D. (JCR Pharmaceuticals)

Researchers reported pre-clinical data on JR-471, a fusion protein of anti-human transferrin receptor 1 (TfR) antibody and human α-L-fucosidase (FUCA1) designed to cross the BBB by leveraging the mechanism of receptor-mediated transcytosis of transferrin. Researchers administered JR-471 intravenously once every week or once every other week for 26 weeks to human TfR knock-in and FUCA1 knockout (hTfR-KI/Fuca1-KO) mice, an animal model of fucosidosis. Researchers performed a rotarod test and an active avoidance test to evaluate the motor coordination and learning/memory function, respectively.

JR-471 treatment with either regimen reduced the Fuc-GlcNAc-Asn accumulated in central nervous system (CNS) tissues (e.g., the brain and cerebrospinal fluid), as well as in peripheral tissues by more than 95% at the maximum. Moreover, researchers found that there was a strong positive linear correlation between the Fuc-GlcNAc-Asn concentrations in the brain and cerebrospinal fluid (CSF). Concomitant with the effectiveness against substrate concentration in the brain, JR-471 treatment prevented a loss of Purkinje cells in the cerebellum. Researchers concluded that JR-471 may be a promising candidate for the treatment of fucosidosis due to its ability to cross the BBB, reduce accumulated substrate in central and peripheral organs, and limit the decline in motor coordination and learning/memory functions.

JR-141 Datasets (MPS II)

The following three poster presentations provide additional evidence and context for the use of JR-141 in the treatment of MPS II:

Sustained cognitive and adaptive behavior outcomes of long-term treatment with pabinafusp alfa in patients with severe or attenuated mucopolysaccharidosis type II (Poster Number 133)

Presenter: Roberto Giugliani, M.D., Ph.D. (Federal University of Rio Grande do Sul, Brazil)

In a longitudinal, pooled, post hoc analysis of patients with MPS II receiving pabinafusp alfa across five open-label trials, researchers reported on sustained cognitive and adaptive behavior outcomes of long-term treatment with pabinafusp alfa in patients with severe or attenuated MPS II. Sixty patients with MPS II were included (18 attenuated [mean age 20.8 years (range: 3–44); 15 received prior idursulfase ERT]; 42 severe [mean age 7.4 years (range: 0–23); 31 received prior idursulfase ERT]). Researchers determined neurocognition and adaptive behavior using the Bayley Scales of Infant and Toddler Development, third edition (BSID-III), the Kyoto Scale of Psychological Development (KSPD), and the Vineland Adaptive Behavior Scales, second edition (VABS-II).

Researchers observed cognitive improvement in patients with severe disease with baseline developmental quotient ≥55 (n=7) and patients with attenuated disease (BSID-III mean change from baseline to Week 260: +14.7 and +2.5, respectively). Adaptive behavior remained stable in severe patients; researchers observed improvements in patients with severe disease with baseline developmental quotient ≥55 and in patients with attenuated disease (VABS-II total raw mean change from baseline to Week 260: +152 and +33, respectively); they also noticed improvements across all VABS-II subdomains in these patients. Researchers concluded that long-term treatment with pabinafusp alfa was well tolerated and associated with stabilization or continued skill acquisition in many patients with severe or attenuated MPS II. These results suggest that, with timely initiation prior to the onset of irreversible neurodegeneration, treatment with pabinafusp alfa may provide a benefit to patients with MPS II.

Long-term somatic efficacy of pabinafusp alfa across a broad spectrum of age groups and phenotypes in patients with mucopolysaccharidosis type II (Poster Number 245)

Presenter: Ana Maria Martins, M.D., Ph.D. (Federal University of São Paulo)

In a longitudinal, pooled, post hoc analysis of patients with MPS II receiving pabinafusp alfa in open-label trials, researchers reported on the somatic effects of pabinafusp alfa in a heterogenous population of patients with MPS II who initiated treatment at different ages. Of 65 patients with MPS II, 42 had severe disease phenotype and 18 had attenuated disease phenotype.

In treatment-naïve patients (n=17), serum dermatan sulfate (DS) and serum heparan sulfate (HS) rapidly decreased following treatment with pabinafusp alfa (geometric mean change from baseline [gmCFB], Week 104: DS −65%; HS −77%), while levels were maintained in previously treated patients (n=47) through the end of follow-up. Researchers observed a similar pattern across patients treated at all ages and disease phenotype. In treatment-naïve patients, liver and spleen volumes (adjusted by body weight) decreased (gmCFB Week 104: −32% and −39%, respectively) and the left ventricular mass index (LVMI) stabilized by Week 52. In previously treated patients, there was a decreasing trend in liver and spleen volumes while LVMI remained stable (gmCFB, Week 104: −7%, −6%, and -3%, respectively). Researchers observed positive trends in somatic efficacy irrespective of prior ERT exposure and age at treatment initiation, with the greatest improvements observed in ERT treatment-naïve patients. They concluded that long-term treatment with pabinafusp alfa was well tolerated and provided positive somatic effects to a broad spectrum of patients with MPS II.

Infusion rate adjustment in enzyme replacement therapy with pabinafusp alfa for mucopolysaccharidosis II (Poster Number 310)

Presenter: Norio Sakai, M.D., Ph.D. (ISEIKAI International General Hospital, Osaka, Japan)

In this post hoc, retrospective pharmacodynamic analysis, researchers reviewed 260-week data from 27 Japanese patients with MPS II enrolled in a Phase II/III clinical trial and extension study of pabinafusp alfa to assess if a shorter infusion duration impacts the long-term efficacy and safety of ERT with pabinafusp alfa in patients with MPS II. Researchers evaluated pharmacodynamics using HS and DS levels in CSF, serum, and urine, along with neurocognitive development (KSPD), and liver and spleen volumes. Infusion duration was ≥3 hours (≤33mL/h) until Week 52; thereafter rates could be increased at physician discretion. Patients were retrospectively grouped by infusion speed as “fast” (n=18; ≥66% of pabinafusp alfa infusions during the extension period were administered at a rate of >33 mL/h (infusion duration predominantly <3 hours)) or “slow” (n=9; <66% of pabinafusp alfa infusions during the extension period were administered at a rate of >33 mL/h (infusion duration predominantly >3 hours)).

Shorter infusion times did not appear to correlate with increased infusion-associated reactions or other adverse events. Changes in HS and DS concentrations in CSF, serum and urine, as well as liver and spleen volumes, were similar regardless of infusion rate. These findings suggest that clinicians may safely consider shorter infusion durations when using pabinafusp alfa to treat MPS II to accommodate clinical circumstances or individual patient needs, potentially improving quality of life and treatment compliance in pediatric patients.

About the Annual WORLDSymposium™

The WORLDSymposium™ is designed for basic, translational and clinical researchers, patient advocacy groups, clinicians, and all others who are interested in learning more about the latest discoveries related to lysosomal diseases and the clinical investigation of these advances. For additional information on the 22^nd Annual WORLDSymposium™, please visit https://worldsymposia.org/.

About the J-Brain Cargo^® Platform Technology

JCR Pharmaceuticals has developed a proprietary blood-brain barrier (BBB)-penetrating technology, J-Brain Cargo^®, to bring biotherapeutics into the central nervous system (CNS). The first drug developed based on this technology is IZCARGO™ (INN: pabinafusp alfa), which is approved in Japan for the treatment of a lysosomal storage disorder (LSD). With J-Brain Cargo^®, JCR seeks to address the unresolved clinical challenges of LSDs by delivering the enzyme to both the body and the brain.

About Pabinafusp Alfa

Pabinafusp alfa is a recombinant fusion protein of an antibody against the human transferrin receptor and iduronate-2-sulfatase, the enzyme that is missing or malfunctioning in subjects with Hunter syndrome. It incorporates J-Brain Cargo^®, JCR’s proprietary blood-brain barrier (BBB)-penetrating technology, to cross the BBB through transferrin receptor-mediated transcytosis, and its uptake into cells is mediated through the mannose-6-phosphate receptor. This novel mechanism of action is expected to make IZCARGO^TM effective against the central nervous system (CNS) symptoms of Hunter syndrome.

In pre-clinical trials, JCR has confirmed both high-affinity binding of pabinafusp alfa to transferrin receptors and passage across the BBB into neuronal cells. In addition, JCR has confirmed enzyme uptake in various brain tissues. The company has also confirmed a reduction of substrate accumulation in the CNS and peripheral organs in an animal model of Hunter syndrome.^1,2

In several clinical trials of pabinafusp alfa, JCR obtained evidence of reducing heparan sulfate (HS) concentrations in the cerebrospinal fluid (CSF), a biomarker for assessing effectiveness against CNS symptoms; these results were consistent with those obtained in pre-clinical studies.³ Clinical studies have also demonstrated the positive effects of pabinafusp alfa on CNS symptoms.^4,5,6

Pabinafusp alfa was approved in Japan by the Ministry of Health, Labour and Welfare and marketed since May 2021 under the brand name “IZCARGO™ I.V. Infusion 10mg.”

Important Safety Information

INDICATION:

IZCARGO™ is indicated for the treatment of mucopolysaccharidosis type II (MPS II), which is also known as Hunter syndrome. IZCARGO™ is approved in Japan only.

CONTRAINDICATION:

IZCARGO™ is contraindicated in patients with a history of anaphylactic shock to its components.

WARNINGS AND PRECAUTIONS:

Warnings

Since serious anaphylaxis and shock may occur with use of IZCARGO™, adequate emergency measures should be made ready for execution before initiation of administration, and the patient should be closely monitored during and after the administration. If a serious infusion associated reaction (IAR) occurs, administration of IZCARGO™ should be discontinued, and appropriate actions should be taken.

When IZCARGO™ is administered to patients with severe respiratory failure or acute respiratory disease, an IAR may lead to acute exacerbation of symptoms. A patient’s condition should be closely monitored, and appropriate actions should be taken as needed.

Precautions for Use

IZCARGO™ is a protein medicinal product and may cause anaphylactic shock, for which close monitoring is required. If any signs of anaphylaxis are noted, discontinue the infusion, and take appropriate actions. Considering the onset of such symptoms, emergency measures should be made ready for execution.

IZCARGO™ may cause IARs such as headache, chills, syncope, fatigue, dizziness, pyrexia, rash, erythema, urticaria, or other symptoms. If an IAR occurs, reduce the rate or temporarily discontinue the infusion, and initiate appropriate drug treatment (e.g., corticosteroids, antihistamines, antipyretic analgesics, anti-inflammatory drugs) or emergency procedures (e.g., oxygen administration, securing of airway, adrenaline administration). Premedication with antihistamines, corticosteroids, etc., should be considered for the subsequent infusion of IZCARGO™.

ADVERSE REACTIONS:

The most commonly reported adverse reactions were pyrexia and urticaria.

About Mucopolysaccharidosis Type II (Hunter Syndrome)

Mucopolysaccharidosis type II (MPS II, or Hunter syndrome) is an X-linked recessive lysosomal storage disorder caused by a deficiency of iduronate-2-sulfatase, an enzyme that breaks down complex carbohydrates called glycosaminoglycans (GAGs, also known as mucopolysaccharides) in the body. Hunter syndrome, which affects an estimated 2,000-3,000 individuals worldwide (according to JCR research), gives rise to a wide range of somatic and neurological symptoms. The current standard of care for Hunter syndrome is enzyme replacement therapy. Central nervous system symptoms related to MPS II have been unmet medical needs so far.

About JR-471

JR-471 is a recombinant fusion protein of α-L-fucosidase and J-Brain Cargo^®, JCR’s proprietary blood-brain barrier (BBB)-penetrating technology. JCR and MEDIPAL HOLDINGS CORPORATION are developing JR-471 for the treatment of fucosidosis, which is currently in the pre-clinical stage.

About Fucosidosis

Fucosidosis is a lysosomal storage disorder that is inherited in an autosomal recessive manner. Mutations result in malfunction of a glycoprotein-metabolizing enzyme (α- L-fucosidase) which causes glycans and glycoproteins to accumulate throughout the body. Patients with fucosidosis display a variety of symptoms, including psychomotor symptoms, muscle hypotonia, visceromegaly, and skeletal abnormalities. Fucosidosis is classified into type I and type II according to the age of onset, and fewer than 120 cases have been reported worldwide, making it an ultra-rare disease. There is no approved therapy available for this disease.

About JCR Pharmaceuticals Co., Ltd.

JCR Pharmaceuticals Co., Ltd. (TSE 4552) is a global specialty pharmaceutical company that develops treatments that go beyond rare diseases to solve the world’s most complex healthcare challenges. We continue to build upon our 50-year legacy in Japan while expanding our global footprint into the U.S., Europe, and Latin America. We improve patients’ lives by applying our scientific expertise and unique technologies to research, develop, and deliver next-generation therapies. Our approved products in Japan include therapies for the treatment of growth disorder, MPS II (Hunter syndrome), Fabry disease, acute graft-versus host disease, and renal anemia. Our investigational products in development worldwide are aimed at treating rare diseases including MPS I (Hurler, Hurler-Scheie and Scheie syndrome), MPS II, MPS IIIA and B (Sanfilippo syndrome type A and B), and more. Our core values – Putting people first, Forging our own path, Always advancing, and Committed to excellence – mean that the work we do benefits all our stakeholders, including partners, patients and employees. We strive to expand the possibilities for patients while accelerating medical advancement at a global level. For more information, please visit JCR’s global website: https://jcrpharm.com/.

Cautionary Statement Regarding Forward-Looking Statements

This document contains forward-looking statements that are subject to known and unknown risks and uncertainties, many of which are outside our control. Forward-looking statements often contain words such as “believe,” “estimate,” “anticipate,” “intend,” “plan,” “will,” “would,” “target” and similar references to future periods. All forward-looking statements regarding our plans, outlook, strategy and future business, financial performance and financial condition are based on judgments derived from the information available to us at this time. Factors or events that could cause our actual results to be materially different from those expressed in our forward-looking statements include, but are not limited to, a deterioration of economic conditions, a change in the legal or governmental system, a delay in launching a new product, impact on competitors’ pricing and product strategies, a decline in marketing capabilities relating to our products, manufacturing difficulties or delays, an infringement of our intellectual property rights, an adverse court decision in a significant lawsuit and regulatory actions.

This document involves information on pharmaceutical products (including those under development). However, it is not intended for advertising or providing medical advice. Furthermore, it is intended to provide information on our company and businesses and not to solicit investment in securities we issue.

Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the factors that could cause actual results to differ materially, even if new information becomes available in the future.

References

1: Sonoda, et al. A blood-brain-barrier-penetrating anti-human transferrin receptor antibody fusion protein for neuronopathic mucopolysaccharidosis II. Mol. Ther. 2018; 26(5):1366-1374.

2: Morimoto, et al. Clearance of heparin sulfate in the brain prevents neurodegeneration and neurocognitive impairment in MPS II mice. Mol. Ther. 2021; 29(5): 1853-1861.

3: Okuyama, et al. Iduronate-2-sulfatase with Anti-human Transferrin Receptor Antibody for Neuropathic Mucopolysaccharidosis II: A Phase 1/2 Trial. Mol Ther. 2020; 27(2): 456-464.

4: Okuyama, et al. A Phase 2/3 Trial of Pabinafusp Alfa, IDS Fused with Anti-Human Transferrin Receptor Antibody, Targeting Neurodegeneration in MPS-II. Mol Ther. 2021; 29(2): 671-679.

5: Giugliani, et al. Iduronate-2-sulfatase fused with anti-human transferrin receptor antibody, pabinafusp alfa, for treatment of neuronopathic and non-neuronopathic mucopolysaccharidosis II: Report of a phase 2 trial in Brazil. Mol Ther. 2021; 29(7): 2378-2386.

6: Giugliani, et al. Enzyme Replacement Therapy with Pabinafusp Alfa for Neuronopathic Mucopolysaccharidosis II; an Integrated Analysis of Preclinical and Clinical Data. Int. J. Mol. Sci. 2021, Volume 22, Issue 20, 10938.

Contacts

Investors & Media:

JCR Pharmaceuticals Co., Ltd.

Corporate Communications

ir-info@jp.jcrpharm.com

Veracyte to Release Fourth Quarter and Full-Year 2025 Financial Results on February 25, 2026




Veracyte to Release Fourth Quarter and Full-Year 2025 Financial Results on February 25, 2026

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, announced today that it will release financial results for the fourth quarter and full-year 2025 after the close of market on Wednesday, February 25, 2026. Company management will host a conference call and webcast to discuss financial results and provide a general business update at 4:30 p.m. Eastern Time on the same day.

The conference call will be webcast live from the company’s website and will be available via the following link: https://edge.media-server.com/mmc/p/motsphxv. A webcast replay will be available following the conclusion of the live broadcast and will be accessible on the company’s website at https://investor.veracyte.com/events-presentations.

The conference call dial-ins can be accessed by registering via this link.

About Veracyte

Veracyte (Nasdaq: VCYT) is a global diagnostics company whose vision is to transform cancer care for patients all over the world. We empower clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Our Veracyte Diagnostics Platform delivers high-performing cancer tests that are fueled by broad genomic and clinical data, deep bioinformatic and AI capabilities, and a powerful evidence-generation engine, which ultimately drives durable reimbursement and guideline inclusion for our tests, along with new insights to support continued innovation and pipeline development. For more information, please visit www.veracyte.com or follow us on LinkedIn or X (Twitter).

Contacts

Investors
Shayla Gorman

investors@veracyte.com
(619) 393-1545

Media
Karen Possemato

media@veracyte.com

Travere Therapeutics to Present at the Guggenheim Emerging Outlook Biotech Summit




Travere Therapeutics to Present at the Guggenheim Emerging Outlook Biotech Summit

SAN DIEGO–(BUSINESS WIRE)–Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that company management will present at the Guggenheim Emerging Outlook: Biotech Summit 2026 on Wednesday, February 11, 2026, at 4:00 p.m. ET.

A live webcast will be accessible on the Investor page of Travere’s website at ir.travere.com/events-and-presentations, and a replay will be available for up to 30 days following the event.

About Travere Therapeutics

At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families, and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop, and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit travere.com.

Contacts

Investors:

888-969-7879

IR@travere.com

Media:

888-969-7879

mediarelations@travere.com

Phibro Animal Health Corporation Reports Second Quarter Results, Updates Financial Guidance




Phibro Animal Health Corporation Reports Second Quarter Results, Updates Financial Guidance

TEANECK, N.J.–(BUSINESS WIRE)–Phibro Animal Health Corporation (Nasdaq: PAHC) (“Phibro” or the “Company”) today announced financial results for its second quarter ended December 31, 2025, and its updated financial guidance for the year ending June 30, 2026.

Highlights for the three months ended December 31, 2025 (compared to the three months ended December 31, 2024):

• Net sales of $373.9 million, an increase of $64.6 million, or 21%
• Net income of $27.5 million, an increase of $24.3 million
• Diluted earnings per share of $0.67, an increase of $0.59
• Adjusted EBITDA of $68.1 million, an increase of $19.9 million, or 41%
• Adjusted net income of $35.7 million, an increase of $13.5 million, or 60%
• Adjusted diluted EPS of $0.87, an increase of $0.32, or 58%

We have raised our fiscal year 2026 guidance, which includes:

• Net sales of $1.45 billion to $1.50 billion
• Adjusted EBITDA of $245 million to $255 million

COMMENTARY

“This was a strong quarter for us, and I’m really proud of how our teams are executing around the world,” stated Jack Bendheim, President and Chief Executive Officer. “We’re seeing faster than expected uptake of our newly integrated MFA portfolio, which is already giving our results a real lift. At the same time, our nutritional specialty and vaccine offerings continue to deliver strong, sustained growth across key markets. With this momentum and the progress we’re making across the business, we feel confident raising our full year guidance. Even with some of the challenges in the global environment, our people continue to show resilience and stay focused on delivering for our customers. With the strategy we have in place and the dedication of our teams, I feel very good about where we’re headed.”

QUARTERLY RESULTS

Net sales

Net sales of $373.9 million for the three months ended December 31, 2025 increased $64.6 million, or 21%, as compared to the three months ended December 31, 2024. Animal Health increased $60.6 million, Mineral Nutrition increased $5.7 million, and Performance Products decreased $1.6 million.

Animal Health

Net sales of $290.0 million for the three months ended December 31, 2025 increased $60.6 million, or 26%. Net sales of MFAs and other increased $51.8 million, or 34%, due to incremental revenues of $57.5 million from sales of products from the MFA portfolio acquired on October 31, 2024, partially offset by the timing of purchases by a large customer.

Net sales of nutritional specialty products increased $4.3 million, or 9%, primarily due to increased North American demand for dairy.

Net sales of vaccines increased $4.5 million, or 13%, primarily due to continued growth of poultry products in Latin America and an increase in international demand, particularly in Southeast Asia.

Mineral Nutrition

Net sales of $68.9 million for the three months ended December 31, 2025 increased $5.7 million, or 9%, due to an increase in demand for trace minerals and zinc.

Performance Products

Net sales of $15.0 million for the three months ended December 31, 2025 decreased $1.6 million, or 10%, as a result of lower demand for the ingredients used in personal care products.

Gross profit

Gross profit of $132.7 million for the three months ended December 31, 2025 increased $30.8 million, or 30%, as compared to the three months ended December 31, 2024. Gross margin increased 260 basis points to 35.5% of net sales for the three months ended December 31, 2025, as compared to 32.9% for the three months ended December 31, 2024. The comparison of gross profit to the prior year includes a net decrease of $0.8 million for acquisition-related cost of goods sold related to the purchase accounting for the MFA acquisition. Excluding this purchase accounting item, gross profit increased $30.0 million, or 29%, and gross margin increased 220 basis points to 35.7% of net sales due to increased sales, favorable product mix, and increases in average selling prices, partially offset by higher input and distribution costs and the unfavorable impact of changes in foreign currency exchange rates.

Animal Health gross profit, excluding the purchase accounting item discussed above, increased $29.8 million, primarily driven by increased sales, favorable product mix, and increases in average selling prices, partially offset by higher input and distribution costs and the unfavorable impact of changes in foreign currency exchange rates. Mineral Nutrition gross profit increased $0.8 million, driven by increased sales volume. Performance Products gross profit decreased $0.6 million, primarily as a result of lower demand.

Selling, general and administrative expenses (“SG&A”)

SG&A of $82.3 million for the three months ended December 31, 2025 increased $6.0 million, or 8%, as compared to the three months ended December 31, 2024. SG&A for the three months ended December 31, 2025 included $3.6 million of costs associated with Phibro Forward income growth initiatives, $0.2 million for acquisition-related costs, and $0.2 million of stock-based compensation expense related to awards granted to certain named executive officers in fiscal year 2024. SG&A for the three months ended December 31, 2024 included $8.8 million of acquisition-related costs, $1.7 million of costs associated with Phibro Forward income growth initiatives, and $0.2 million of stock-based compensation expense, partially offset by $1.3 million related to an insurance settlement gain. Excluding these items, SG&A increased $11.4 million, or 17%.

Animal Health SG&A, excluding the non-recurring Animal Health related items discussed above, increased $7.1 million, primarily due to an increase in employee-related costs due in part to the incremental headcount added as part of the MFA acquisition. Mineral Nutrition SG&A increased $0.2 million, and Performance Products SG&A increased $0.4 million. Corporate costs, excluding the non-recurring Corporate related items discussed above, increased $3.7 million due to an increase in employee-related costs.

Interest expense, net

Interest expense, net of $11.8 million for the three months ended December 31, 2025 increased $2.8 million, as compared to the three months ended December 31, 2024, due to higher average debt levels associated with the financing of the MFA acquisition, as well as the expiration of a favorable interest rate swap agreement on $300.0 million of notional debt principal.

Foreign currency losses, net

Foreign currency losses, net for the three months ended December 31, 2025 were $2.1 million, as compared to $11.7 million of net losses for the three months ended December 31, 2024. Current period gains/losses were driven by fluctuations in certain currencies related to the U.S. dollar, most prominently, in the Argentine Peso and the Israeli New Shekel. Prior year period losses were driven in large part by fluctuations in the Brazil Real.

Provision for income taxes

The provision for income taxes was $9.0 million and $1.7 million for the three months ended December 31, 2025 and 2024, respectively. The effective income tax rate was 24.6% and 34.2% for the three months ended December 31, 2025 and 2024, respectively.

The effective income tax rate in the current year was higher than the federal statutory rate of 21% due to the impact of Global Intangible Low-Tax Income tax expense and state and local income taxes. The provision for income taxes in the current year was also impacted by other taxes, primarily driven by the mix of foreign income.

The effective income tax rate in the current period included among other items (i) a $0.2 million expense from changes in uncertain tax positions related to prior years and (ii) certain other charges, including acquisition-related costs, foreign currency losses, and certain stock-based compensation, which had lower tax rates. The effective income tax rate in the prior year included (i) various exchange rate losses, (ii) changes in uncertain tax positions related to prior years, and (iii) certain other charges, including acquisition-related costs. Excluding these items, the effective income tax rate was 23.7% and 26.3% for the three months ended December 31, 2025 and 2024, respectively.

Net income

Net income of $27.5 million for the three months ended December 31, 2025 increased $24.3 million, as compared to net income of $3.2 million for the three months ended December 31, 2024. Operating income increased $24.8 million, driven by favorable gross profit, partially offset by higher SG&A. Gross profit increased $30.8 million primarily as a result of higher sales in the Animal Health segment, driven in part by incremental revenues associated with sales from the MFA portfolio acquired on October 31, 2024. SG&A increased $6.0 million due to higher employee-related costs and a net increase of $1.9 million of costs associated with Phibro Forward income growth initiatives. Interest expense, net increased $2.8 million due to higher debt levels, due in part to the financing of the MFA acquisition and the expiration of an interest rate swap agreement. Foreign currency losses, net decreased $9.6 million. Income tax expense increased $7.3 million.

Adjusted EBITDA

Adjusted EBITDA of $68.1 million for the three months ended December 31, 2025, increased $19.9 million, or 41%, as compared to the three months ended December 31, 2024. Animal Health Adjusted EBITDA increased $24.0 million due to higher sales and gross profit, partially offset by increased SG&A. Mineral Nutrition Adjusted EBITDA increased $0.7 million, due to higher sales and gross profit. Performance Products Adjusted EBITDA decreased $1.1 million due to lower sales and higher SG&A. Corporate expenses increased $3.7 million due to higher employee-related costs.

Adjusted provision for income taxes

The adjusted effective income tax rates for the three months ended December 31, 2025 and 2024, were 23.7% and 26.3%, respectively.

Adjusted net income

Adjusted net income of $35.7 million for the three months ended December 31, 2025 increased $13.5 million, or 60%, as compared to the prior year period. The increase was driven by higher gross profit, partially offset by higher SG&A expenses and higher interest expense. The higher gross profit resulted from higher sales. SG&A expenses increased due to higher employee-related costs. Interest expense increased due to higher debt levels associated with the financing of the MFA acquisition and the expiration of an interest rate swap agreement.

Adjusted diluted earnings per share

Adjusted diluted earnings per share was $0.87 for the quarter, an increase of $0.32, or 58%, as compared to the adjusted diluted earnings per share of $0.55 in the prior year period.

BALANCE SHEET AND CASH FLOWS

• Free cash flow was $47.3 million for the twelve months ended December 31, 2025 (Free cash flow equals cash flow from operating activities less capital expenditures).
• 3.1x gross leverage ratio as of December 31, 2025
  • $737.0 million total debt
  • $234.8 million Adjusted EBITDA for the twelve months ended December 31, 2025
  • Cash and short-term investments of $74.5 million as of December 31, 2025

FISCAL YEAR 2026 FINANCIAL GUIDANCE

Our updated fiscal year 2026 financial guidance is as shown below. Year-over-year percentages are calculated using the midpoint of the guidance ranges.

• Net sales of $1.45 billion to $1.50 billion, 14% growth
• Net income of $85 million to $95 million, 86% growth
• Diluted EPS of $2.08 to $2.32, 85% growth
• Adjusted EBITDA of $245 million to $255 million, 36% growth
• Adjusted net income of $120 million to $127 million, 45% growth
• Adjusted diluted EPS of $2.93 to $3.10, 44% growth
• Adjusted effective tax rate of ~25%

Guidance for GAAP measures assumes no additional foreign exchange (gains) losses for the year ending June 30, 2026.

WEBCAST & CONFERENCE CALL DETAILS

Phibro Animal Health Corporation will host a webcast and conference call during which the Company will review its financial results and respond to questions.

NOTE: To join this conference call, all participants will be required to provide the Conference ID number.

A replay of the webcast will be archived and made available on Phibro’s website.

DISCLOSURE NOTICES

Forward-Looking Statements: This communication contains forward-looking statements that are subject to risks and uncertainties, including with respect to any future debt and leverage levels. All statements other than statements of historical or current fact included in this report are forward-looking statements. Forward-looking statements discuss our current expectations and projections relating to our financial condition, results of operations, plans, objectives, future performance and business. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as “aim,” “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “outlook,” “potential,” “project,” “projection,” “plan,” “intend,” “seek,” “may,” “could,” “would,” “will,” “should,” “can,” “can have,” “likely,” the negatives thereof and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events. These statements are not guarantees of future performance or actions. If one or more of these risks or uncertainties materialize, or if management’s underlying assumptions prove to be incorrect, actual results may differ materially from those contemplated by a forward-looking statement. Forward-looking statements speak only as of the date on which they are made. Phibro expressly disclaims any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. A further list and description of risks, uncertainties and other matters can be found in our Quarterly Report on Form 10-Q and Annual Report on Form 10-K, including in the sections thereof captioned “Forward-Looking Statements” and “Risk Factors.” These filings and subsequent filings are available online at www.sec.gov, www.pahc.com, or on request from Phibro.

Non-GAAP Financial Information: We use non-GAAP financial measures, such as adjusted EBITDA, adjusted net income, adjusted diluted EPS and free cash flow to assess and analyze our operational results and trends and to make financial and operational decisions. Management uses adjusted EBITDA as its primary operating measure. We report adjusted net income to portray the results of our operations prior to considering certain income statement elements. We believe these non-GAAP financial measures are also useful to investors because they provide greater transparency regarding our operating performance. The non-GAAP financial measures included in this communication should not be considered alternatives to measurements required by GAAP, such as net income, operating income and earnings per share, and should not be considered measures of liquidity. These non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Reconciliation of non-GAAP financial measures and GAAP financial measures are included in the tables accompanying this communication and/or our Quarterly Report on Form 10-Q and Annual Report on Form 10-K.

We are not providing a reconciliation of forward-looking guidance of non-GAAP financial measures to the most directly comparable GAAP financial measures because of the uncertainty regarding, and the potential variability of, certain of the items required for a reconciliation; accordingly, a reconciliation of the non-GAAP financial measure to the corresponding GAAP financial measure is not available without unreasonable effort. These items are uncertain, depend on various factors and may have a material impact on our future GAAP results.

Internet Posting of Information: We routinely post information that may be important to investors in the “Investors” section of our website at www.pahc.com. We encourage investors and potential investors to consult our website regularly for important information about us.

Amounts and percentages may reflect rounding adjustments.

* Calculation not meaningful

Amounts and percentages may reflect rounding adjustments.

* Calculation not meaningful

Contacts

Phibro Animal Health Corporation

Glenn C. David

Chief Financial Officer

+1-201-329-7300

Or

investor.relations@pahc.com

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