Additional Phase 2 Data of AL-S Pharma’s Lead Program AP-101 Further Demonstrate Clinically Meaningful Disease Modification and Prolonged Survival in ALS

Additional Phase 2 Data of AL-S Pharma’s Lead Program AP-101 Further Demonstrate Clinically Meaningful Disease Modification and Prolonged Survival in ALS




Additional Phase 2 Data of AL-S Pharma’s Lead Program AP-101 Further Demonstrate Clinically Meaningful Disease Modification and Prolonged Survival in ALS

Results supported by key neuroaxonal injury biomarkers pNfH and NfL after six months of treatment

AP-101 is an investigational human-derived antibody therapeutic that selectively targets the misfolded, toxic form of SOD1 to disrupt progressive spread of ALS

Data featured in oral presentation at the AD/PD™ 2026 International Conference on Alzheimer’s and Parkinson’s Diseases

Preparations underway to advance AP-101 into confirmatory Phase 3 clinical trial with initiation aimed for late 2026

ZURICH–(BUSINESS WIRE)–AL-S Pharma AG, a clinical-stage biotechnology company discovering and developing human antibodies that target misfolded proteins implicated in amyotrophic lateral sclerosis (ALS), today announced the presentation of new clinical data from the global Phase 2 clinical trial (AP-101-02) evaluating the company’s lead program, AP-101, in patients with ALS. AP-101 is an investigational human-derived antibody directed against misfolded superoxide dismutase 1 (SOD1). AP-101 is designed to inhibit the spread of SOD1 pathology in the central nervous system of people living with ALS, helping the body’s immune system clear these harmful proteins.1


The global Phase 2 clinical trial met its primary endpoint related to safety and tolerability. New results provide additional evidence of clinically meaningful disease modification and prolonged survival supported by reductions in key neuroaxonal injury biomarkers, serum neurofilament light chain (NfL) and cerebrospinal fluid phosphorylated neurofilament heavy chain (pNfH) after six months of treatment. Adverse events were comparable to placebo, and no AP-101-induced antibody responses were reported.

The AP-101-02 clinical trial results will be featured in an oral presentation at the AD/PD™ 2026 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders. The presentation will be delivered by Angela Genge, M.D., chief medical officer of AL-S Pharma, today at 8:40AM CET in Hall A2 (Session 5210).

“These data show something we rarely see in ALS – objective evidence of clinically meaningful disease modification that tracks directly with prolonged survival,” said Dr. Genge. “The Phase 2 study results with AP-101 are consistent with the hypothesis that targeting misfolded SOD1 is a disease-modifying approach in ALS.2 At AL-S Pharma, we believe AP-101 could fundamentally transform the treatment of ALS. We look forward to continue advancing the AP-101 clinical program so that we can bring a much-needed new treatment option to people living with ALS rapidly.”

The prespecified analysis of an exploratory composite endpoint revealed that early treatment with AP-101 prolonged survival and delayed ventilatory support in comparison to study participants receiving placebo for six months followed by six months of treatment with AP-101. Positive treatment effects were observed in both the sporadic ALS cohort (p = 0.013) and the SOD1 mutation carrier cohort (p = 0.036). Effects on survival were accompanied by disease stabilization as measured by King’s staging. Functional decline measured by ALSFRS-R was reduced in study participants with elevated misfolded SOD1 at baseline and in SOD1 mutation carriers.

AL-S Pharma is currently preparing for a confirmatory Phase 3 clinical trial of AP-101 in ALS aimed to initiate end of 2026. AP-101 received Orphan Drug designations from the U.S. Food and Drug Administration, the European Medicines Agency, and Swissmedic.

About AP-101-02

The AP-101-02 clinical trial (NCT05039099) was a global, randomized, double-blind, placebo-controlled Phase 2 study evaluating the safety, tolerability, pharmacodynamic markers, and pharmacokinetics (PK) of AP-101 in 73 patients with sporadic ALS and in patients with mutations in the superoxide dismutase 1 (SOD1) gene. Study participants with sporadic (n=52) or mutant SOD1 ALS (n=21) were stratified and randomized 2:1 to intravenous AP-101 or placebo every three weeks. Key assessments included survival and ventilation endpoints, slow vital capacity, neurofilament levels, misfolded SOD1, PK, and anti-drug antibodies. After 24 weeks all participants entered a 24-week open-label extension with continued AP-101 treatment, followed by a 16-week safety follow-up period.

AP-101-02 was conducted in the U.S., Canada, the U.K., European Union, and South Korea. More information about the clinical trial can be accessed on www.clinicaltrials.gov.

About Amyotrophic Lateral Sclerosis and SOD1

Amyotrophic lateral sclerosis (ALS) is a relentless and progressive neurodegenerative disease that affects the motor neurons of the brain and spinal cord. Symptoms vary from person to person. Some forms of ALS begin with limb weakness, while others start with bulbar symptoms. All forms ultimately lead to loss of independence and a markedly shortened lifespan. Median survival remains three-to-five years, and diagnosis is often delayed.

Despite this diversity, many patients share common downstream pathologies involving axonal injury, inflammation, and protein misfolding. Superoxide dismutase 1 (SOD1) is a protective enzyme that helps cells manage oxidative stress. In ALS, structural changes can cause SOD1 to lose its proper function and misfold, taking on toxic conformations that disrupt cellular function. Such misfolded SOD1 can injure motor neurons, damage mitochondria, and impair axonal transport. Pathology can spread by the seeding of SOD1 misfolding.

Misfolded SOD1 represents a powerful therapeutic opportunity. Across different presentations of ALS, misfolded SOD1 can amplify axonal injury and accelerate disease progression, making these toxic conformations an important target for intervention.

About AL-S Pharma AG

AL-S Pharma is a clinical-stage biotech company developing AP-101 for the treatment of amyotrophic lateral sclerosis (ALS). Founded and co-owned by Neurimmune and TVM Capital Life Science, AL-S Pharma brings together a seasoned team of biotech and pharmaceutical leaders with expertise spanning drug discovery, translational research, and clinical development. AL-S Pharma is based in Zurich, Switzerland. For more information, visit www.al-spharma.com.

1 Maier M et al., Sci Transl Med. 2018;10(470).

2 Marlow TR et al., Neurobiol Dis. 2025;216:107124.

Contacts

Investor Contact

AL-S Pharma

Fabian Buller, Ph.D.

Chief Business Officer

fabian.buller@al-spharma.com

Media Contact(s)

AL-S Pharma

Kathy Vincent

Corporate Affairs

kathy.vincent@al-spharma.com

MC Services AG

Brittney Sojeva

al-spharma@mc-services.eu

Dr. Myung Ju Lee of VIP Plastic Surgery Receives Minister of Health and Welfare Award at Medical Korea 2026

Dr. Myung Ju Lee of VIP Plastic Surgery Receives Minister of Health and Welfare Award at Medical Korea 2026




Dr. Myung Ju Lee of VIP Plastic Surgery Receives Minister of Health and Welfare Award at Medical Korea 2026

National honor recognizes Dr. Lee’s leadership in advancing Korea’s global healthcare standards and excellence in facial plastic surgery

SEOUL, Korea, March 19, 2026 (GLOBE NEWSWIRE) — Myung Ju Lee, MD, PhD, founder of VIP Plastic Surgery Korea, was honored today with the 2026 Medical Korea Global Healthcare – Minister of Health and Welfare Award. The national distinction was presented at the Asem Ballroom in COEX, Seoul, recognizing Dr. Lee’s significant contributions to advancing South Korea’s international medical standing.

Award-winning Korean plastic surgeon Dr. Myung Ju Lee recognized by the Ministry of Health and Welfare for contributions to global healthcare.

The award, sanctioned by the Ministry of Health and Welfare, is reserved for healthcare leaders who enhance the country’s clinical standards and global competitiveness. Dr. Lee was specifically cited for his role in positioning Korea as a premier destination for complex aesthetic and reconstructive surgery.

Dr. Lee’s practice is renowned for high-precision procedures, including Deep Plane Facelifts and complex Revision Rhinoplasty. His clinical philosophy integrates individualized surgical planning with long-term outcome tracking, a combination that has attracted patients from over 50 countries.

“It is a great honor to receive this recognition from the Ministry,” said Dr. Lee. “Our goal has always been to provide a seamless, medically supervised environment where international patients feel both safe and cared for throughout their entire surgical journey.”

VIP Plastic Surgery Korea, located in Jeju, is noted for its “all-in-one” medical tourism system, which provides surgical care, luxury accommodation, and post-operative recovery within a single integrated facility.

ABOUT DR. MYUNG JU LEE

Myung Ju Lee, MD, PhD, is the founder and lead surgeon of VIP Plastic Surgery Korea. A board-certified surgeon with extensive expertise in complex facial procedures, Dr. Lee specializes in deep plane facelifts and advanced revision rhinoplasty. Having treated patients from over 50 countries, he is a recognized leader in international healthcare and is dedicated to advancing surgical education through global mentorship and clinical research.

ABOUT VIP PLASTIC SURGERY KOREA

Located in Jeju, South Korea, VIP Plastic Surgery Korea is a premier aesthetic and reconstructive center specializing in comprehensive facial rejuvenation. The clinic is renowned for its “all-in-one” medical tourism system, which integrates world-class surgical care, on-site luxury accommodation, and 24/7 medically supervised aftercare. VIP Plastic Surgery is committed to the highest standards of safety, patient privacy, and natural-looking clinical outcomes.

MEDIA CONTACT

Jessica Rhee
Media Relations Manager,
VIP Plastic Surgery Korea
Email: info@vipps.kr
Phone: +82-64-713-1007
Website: www.vippskorea.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9a1eb0e8-01f2-44e9-8e5d-f04f76a02dff.

Positive VAX-31 Phase 1/2 Adult Data Published in The Lancet Infectious Diseases Highlight Best-in-Class Potential of Vaxcyte’s 31-Valent Pneumococcal Conjugate Vaccine (PCV) Candidate

Positive VAX-31 Phase 1/2 Adult Data Published in The Lancet Infectious Diseases Highlight Best-in-Class Potential of Vaxcyte’s 31-Valent Pneumococcal Conjugate Vaccine (PCV) Candidate




Positive VAX-31 Phase 1/2 Adult Data Published in The Lancet Infectious Diseases Highlight Best-in-Class Potential of Vaxcyte’s 31-Valent Pneumococcal Conjugate Vaccine (PCV) Candidate

Based on the Strength of Unprecedented Results from the Positive Phase 1/2 Study in Adults Aged 50 and Older, Vaxcyte Advanced VAX-31 High Dose into Comprehensive Phase 3 Adult Program; Topline Data from the OPUS-1 Pivotal Noninferiority Trial Expected in the Fourth Quarter of 2026

At All Doses Studied, VAX-31 Demonstrated Robust Opsonophagocytic Activity and Immunoglobulin G Immune Responses for All 31 Serotypes and Was Observed to be Well Tolerated with a Safety Profile Similar to Prevnar 20®

Results Further Validate Potential of Vaxcyte’s Carrier-Sparing Platform to Deliver Broadest-Spectrum PCV Candidates that Provide Protection Against Both Currently Circulating and Historically Prevalent Serotypes

VAX-31 is Designed to Cover ~95% of Invasive Pneumococcal Disease (IPD) and ~88% of Pneumococcal Pneumonia in U.S. Adults Aged 50 and Older, with Potential to Provide an Incremental 14-34% Broader IPD Coverage and 19-31% Broader Pneumonia Coverage than Standard-of-Care Vaccines

SAN CARLOS, Calif., March 18, 2026 (GLOBE NEWSWIRE) — Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company, today announced the publication of results from the positive VAX-31 adult Phase 1/2 clinical study in the journal The Lancet Infectious Diseases. The study evaluated the safety, tolerability and immunogenicity of VAX-31, the Company’s next-generation 31-valent pneumococcal conjugate vaccine (PCV) candidate, for the prevention of invasive pneumococcal disease (IPD) and pneumonia compared to one of the current standard-of-care vaccines, Prevnar 20® (PCV20), in healthy adults aged 50 years and older. Based on the positive results of this Phase 1/2 study, VAX-31 is currently being evaluated in the OPUS Phase 3 adult program.

The study results showed that VAX-31 was observed to be well tolerated and demonstrated a safety profile similar to PCV20 through the full six-month evaluation period at all doses studied. At all doses studied, VAX-31 demonstrated robust opsonophagocytic activity (OPA) and immunoglobulin G (IgG) immune responses, with high geometric mean concentrations (GMCs) across all 31 serotypes. The VAX-31 High Dose, which is currently being evaluated in the OPUS Phase 3 program, met or exceeded the OPA response non-inferiority criteria¹ for all 20 serotypes common with PCV20 and met the superiority criteria² for the 11 incremental serotypes unique to VAX-31 and not in PCV20. The VAX-31 High Dose average OPA immune responses were greater for 18 of 20 serotypes compared to PCV20 (geometric mean ratio (GMR) greater than 1.0), with seven of these serotypes achieving statistically higher immune responses3 compared to PCV20.

“The publication of these data, including both the OPA and IgG results, in The Lancet Infectious Diseases further affirms the potential of our site-specific, carrier-sparing platform to deliver the broadest-spectrum PCVs to provide protection against both currently circulating and historically prevalent serotypes,” said Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte. “Based on the strength of the unprecedented results from this study, we advanced VAX-31 into a comprehensive Phase 3 adult program and believe we are uniquely positioned to set a new standard by which future adult pneumococcal vaccines will be measured. Through the OPUS Phase 3 trials, we are aiming to expand the breadth of disease and serotype coverage while ensuring immunogenicity levels remain high to ensure durable protection and deliver a next-generation PCV with a best-in-class profile.”

“The published results provide validation of VAX-31’s safety profile and robust immune responses across all 31 serotypes,” said Jim Wassil, Executive Vice President and Chief Operating Officer of Vaxcyte. “These data directly informed the design of our comprehensive OPUS Phase 3 program, including the decision to advance the VAX-31 High Dose and the structure of our pivotal, noninferiority trial that includes head-to-head comparisons of VAX-31 to both PCV20 and Capvaxive® (PCV21). This OPUS Phase 3 program is intended to support a planned Biologics License Application, subject to study outcomes.”

About the VAX-31 Phase 1/2 Adult Study
The VAX-31 Phase 1/2 clinical study was a randomized, observer-blind, active-controlled, dose-finding study that evaluated the safety, tolerability and immunogenicity of a single injection of VAX-31 at three dose levels (Low, Middle and High) compared to PCV20 in 1,015 healthy adults aged 50 years and older. The High Dose is currently being evaluated in the comprehensive OPUS Phase 3 adult clinical program.

Safety and Tolerability Findings:

  • VAX-31 was observed to be well tolerated and demonstrated a safety profile similar to PCV20 at all doses studied.
  • Frequently reported local and systemic reactions were generally mild-to-moderate, resolving within several days of vaccination, with no meaningful differences observed across the cohorts. No serious adverse events were considered to be related to study vaccines.

Immunogenicity Findings:

  • VAX-31 demonstrated robust OPA immune responses for all 31 serotypes at all doses studied, and all three doses were considered advanceable to Phase 3.
  • At the High and Middle Doses, VAX-31 met or exceeded regulatory immunogenicity criteria for all 31 serotypes and, at the Low Dose, for 29 of 31 serotypes.
  • For the 20 serotypes common with PCV20 (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F):
    • High Dose: All 20 serotypes met OPA response non-inferiority criteria; 18 of 20 serotypes had a GMR greater than 1.0 and seven serotypes achieved statistically higher immune responses compared to PCV20.
    • Middle Dose: All 20 serotypes met OPA response non-inferiority criteria; 13 of 20 serotypes had a GMR greater than 1.0 and five serotypes achieved statistically higher immune responses compared to PCV20.
    • Low Dose: 18 of 20 serotypes met OPA response non-inferiority criteria; eight of 20 serotypes had a GMR greater than 1.0 and three serotypes achieved statistically higher immune responses compared to PCV20.
  • For all 11 additional serotypes unique to VAX-31 (2, 7C, 9N, 15A, 16F, 17F, 20B, 23A, 23B, 31, 35B), and not in PCV20, all three doses met superiority criteria.
  • At all doses studied, VAX-31 demonstrated high IgG GMCs across all 31 serotypes, and IgG GMC responses were consistent with the immune response profile observed in the OPA analyses.

About Pneumococcal Disease
Pneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae bacteria. It can result in IPD, including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media and sinusitis. In the United States, pneumococcal pneumonia is estimated to result in approximately 225,000 adult hospitalizations each year. Streptococcus pneumoniae is among the World Health Organization’s top antibiotic-resistant pathogens to be urgently addressed, and the U.S. CDC lists drug-resistant Streptococcus pneumoniae as a “serious threat.” In children under five, Streptococcus pneumoniae is the leading cause of vaccine-preventable deaths globally. Pneumococci also cause over 50% of all cases of bacterial meningitis in the United States. Antibiotics are used to treat PD, but some strains of the bacteria have developed resistance to treatments. The morbidity and mortality due to PD are significant, particularly for young children and older adults, underscoring the need for a broader-spectrum vaccine.

About VAX-31
VAX-31, a 31-valent PCV candidate being evaluated in the OPUS Phase 3 adult clinical program and in a Phase 2 infant clinical program, is designed to prevent serious and sometimes fatal infections caused by Streptococcus pneumoniae, including IPD, pneumonia and otitis media. Specifically, IPD is associated with high case-fatality rates, antibiotic resistance and meningitis. VAX-31 is the broadest-spectrum PCV candidate in the clinic today and has the potential to provide protection against both currently circulating and historically prevalent serotypes. VAX-31 is designed to increase coverage, in a single vaccine, to approximately 95% of IPD and approximately 88% of pneumococcal pneumonia circulating in adults in the United States aged 50 and older. This disease coverage has the potential to result in VAX-31 providing an incremental 14-34% of coverage for IPD and an incremental 19-31% of coverage for pneumococcal pneumonia over current standard-of-care adult PCVs. In U.S. children, it is designed to cover approximately 92% of IPD4 and approximately 96% of acute otitis media5 due to Streptococcus pneumoniae. This disease coverage has the potential to result in VAX-31 providing an incremental 23-44% of coverage for IPD and an incremental 35-62% of coverage for otitis media over current standard-of-care infant PCVs.

In May 2025, the FDA expanded the Breakthrough Therapy designation (BTD) for VAX-31 to include the prevention of pneumonia caused by Streptococcus pneumoniae in addition to the prevention of IPD in adults based on the positive topline results from the VAX-31 adult Phase 1/2 study indicating that VAX-31 may demonstrate substantial improvement over existing therapies.

About Vaxcyte 
Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. VAX-31, a 31-valent PCV candidate being evaluated in the OPUS Phase 3 adult clinical program and in a Phase 2 infant clinical program, is being developed for the prevention of IPD and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, a 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market. VAX-31 and VAX-24 are designed to improve upon standard-of-care PCVs by covering the serotypes in circulation that cause a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains. VAX-XL, in earlier-stage development, also leverages the Company’s carrier-sparing, site-specific conjugation technology with the aim of further expanding coverage to deliver the broadest-spectrum candidate in the Company’s PCV franchise.

Vaxcyte is re-engineering the way highly complex vaccines are made through XpressCF®, its cell-free protein synthesis platform exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to develop high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections, and VAX-GI, a vaccine candidate designed to prevent Shigella. For more information, visit www.vaxcyte.com.

Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the potential benefits of Vaxcyte’s carrier-sparing platform and PCV candidates, including breadth of coverage, the ability to deliver potentially best-in-class PCVs, the ability to improve upon the standard-of-care, and the ability to significantly reduce the burden of disease by expanding coverage against currently and historically circulating strains while maintaining robust immune response; the design, timing of initiation, progress and expected results of Vaxcyte’s clinical trials and regulatory plans; the demand for Vaxcyte’s vaccine candidates; and other statements that are not historical fact. The words “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “on track,” “potential,” “should,” “would” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte’s current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte’s product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; and sufficiency of cash and other funding to support Vaxcyte’s development programs and other operating expenses. These and other risks are described more fully in Vaxcyte’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K filed with the SEC on February 24, 2026 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date, and readers should not rely upon the information in this press release as current or accurate after its publication date. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date.

Contacts:

Patrick Ryan, Executive Director, Corporate Affairs
Vaxcyte, Inc.
415-606-5135
media@vaxcyte.com

Jeff Macdonald, Executive Director, Investor Relations
Vaxcyte, Inc.
917-371-0940
investors@vaxcyte.com

1Lower bound of the 2-sided 95% confidence interval of the OPA geometric mean ratio is greater than 0.5.
2Lower bound of the 2-sided 95% confidence interval of the difference in the proportions of participants with a ≥4-fold increase from Day 1 to Month 1 is greater than 10%, and lower bound of the 2-sided 95% confidence interval of the OPA geometric mean ratio is greater than 2.0.
3Lower bound of the 2-sided 95% confidence interval of the OPA geometric mean ratio is greater than 1.0.
4In U.S. children under five years of age: CDC 2023 Active Bacterial Core (ABC) Surveillance data.
5In U.S. children five years of age or under: Grant LR et al., FrontPediatr.2024;12:1383748. Serotype percentages reflect 2017–2021 data (Supplemental Table 1). 

2026 MAP Awards presented to 20 organizations for high performance in revenue cycle

2026 MAP Awards presented to 20 organizations for high performance in revenue cycle




2026 MAP Awards presented to 20 organizations for high performance in revenue cycle

CHICAGO, March 18, 2026 (GLOBE NEWSWIRE) — The Healthcare Financial Management Association (HFMA) announced the 2026 winners of the MAP Award for High Performance in Revenue Cycle, including three integrated delivery systems, eight hospital systems, four individual hospitals, two critical access hospitals and three physician practices.

“We want to congratulate these award winners for their dedicated efforts to strengthen the delivery and support of our healthcare system,” said HFMA President and CEO C. Ann Jordan, JD. “High performance in revenue cycle means these teams are building strong financial foundations, and that translates to protecting patient access and care. The MAP Awards are about more than metrics. They are about recognizing organizations that are moving the industry forward.”

HFMA’s MAP Award for High Performance in Revenue Cycle recognizes providers that have excelled in meeting industry standard revenue cycle benchmarks (MAP Keys®), implemented the patient-centered recommendations and best practices embodied in HFMA’s Healthcare Dollars & Sense® initiatives, focused their efforts on improving price transparency and achieved outstanding patient satisfaction. Award recipients are acknowledged as industry leaders and share proven strategies with their colleagues.

Winners of the 2026 MAP Award for High Performance include the following organizations.

Winning hospital systems:

  • Roper St. Francis Healthcare, Charleston, S.C.
  • Bon Secours Mercy Health, Blue Ash, Ohio
  • St. Elizabeth Healthcare, Edgewood, Ky.
  • Adena Health System, Chillicothe, Ohio
  • Valley Health System, Winchester, Va.
  • Ballad Health, Johnson City, Tenn.
  • Cottage Health, Santa Barbara, Calif.
  • Covenant Health, Andover, Mass.

Winning individual hospitals:

  • The Christ Hospital Health Network, Cincinnati, Ohio
  • Corewell Health Reed City, Reed City, Mich.
  • AnMed, Anderson, S.C.
  • The University of Texas MD Anderson Cancer Center, Houston, Texas

Winning critical access hospitals:

  • Ozark Health, Inc., Clinton, Ark.
  • Alice Peck Day Memorial Hospital, Dartmouth Health, Lebanon, N.H.

Winning physician practices:

  • Catalpa Health, Appleton, Wis.
  • Cottage Health – Cottage Medical Group, Santa Barbara, Calif.
  • Privia Health, Arlington, Va.

Winning integrated delivery systems:

  • Baptist Health Care, Pensacola, Fla.
  • Ardent Health Services, Brentwood, Tenn.
  • Baylor Scott & White Health, Dallas, Texas

The awards were presented March 18 at the HFMA Revenue Cycle Conference in Arlington, Texas.

About HFMA

The Healthcare Financial Management Association (HFMA) equips its more than 140,000 members to navigate a complex healthcare landscape. Finance professionals in the full range of work settings, including hospitals, health systems, physician practices and health plans, trust HFMA to provide the guidance and tools to help them lead their organizations, and the industry, forward. HFMA is a not-for-profit, nonpartisan organization that advances healthcare by collaborating with other key stakeholders to address industry challenges and providing guidance, education, practical tools and solutions, and thought leadership. We lead the financial management of healthcare.

Press inquiries should be directed to:
Brad Dennison
Healthcare Financial Management Association
630-386-2945
bdennison@hfma.org

VitalHub Reports Fourth Quarter 2025 Results

VitalHub Reports Fourth Quarter 2025 Results




VitalHub Reports Fourth Quarter 2025 Results

Annual Recurring Revenue (“ARR”)⁽¹⁾ up 35% YoY to $96.1 million
Total Revenue up 52% YoY to $31.4 million
Adjusted EBITDA⁽¹⁾ up 47% YoY to $7.4 million

TORONTO, March 18, 2026 (GLOBE NEWSWIRE) — Vitalhub Corp. (TSX:VHI) (OTCQX:VHIBF) (the “Company” or “VitalHub”) announced today it has filed its Consolidated Financial Statements and Management’s Discussion and Analysis report for the year ended December 31, 2025 with the Canadian securities authorities. These documents may be viewed under the Company’s profile at www.sedarplus.com.

“2025 was a milestone year for VitalHub, surpassing $100 million in revenue. In the fourth quarter, we achieved 10% annual organic ARR⁽¹⁾ growth and 24% adjusted EBITDA as a percentage of revenue⁽¹⁾,” said Dan Matlow, CEO of VitalHub. “We made significant acquisitions and filled in gaps in our portfolio that support our cross-selling activities globally. Our adjusted EBITDA as a percentage of revenue improved quarter over quarter as we commenced integration of the new acquisitions and we expect to realise further improvement in 2026. We are leveraging AI in our product roadmap and internally from a productivity perspective, as we continue to optimize the organization as one global team. We have a strong balance sheet as we consider acquisition opportunities of all sizes in our core and adjacent geographies. We are excited for the year ahead.”

VitalHub’s quarterly investor conference call will take place on Thursday, March 19, 2026, at 8:00am EST. To register for the conference call please visit: https://us06web.zoom.us/webinar/register/WN_k8_Av320RimXFXW0CFzQEA

Fourth Quarter 2025 Highlights

  • ARR⁽¹⁾ as at December 31, 2025 was $96,149,750 as compared to $93,693,789 at September 30, 2025, an increase of $2,455,961 or 3%.
    Over the previous quarter, ARR movement in Q4 2025 from Q3 2025 was attributable to the following:
    • Organic growth of $1,881,405 or 2%.
    • Gain of $574,556 due to fluctuations in foreign exchange rates.
  • Revenue of $31,390,374 as compared to $20,590,779 in the equivalent prior year period, an increase of $10,799,595 or 52%.
  • Gross profit as a percentage of revenue was 79% in Q4 2025 as compared to 81% in the equivalent prior year period.
  • Net income before income taxes of $750,087 as compared to $173,000 in the equivalent prior year period.
  • Net income of $4,067,533 as compared to $787,244 in the equivalent prior year period.
  • EBITDA⁽¹⁾ of $3,285,082 as compared to $1,875,370 in the equivalent prior year period.
  • Adjusted EBITDA⁽¹⁾ of $7,428,508 or 24% of revenue, as compared to $5,046,758 or 25% of revenue in the equivalent prior year period, an increase of $2,381,750 or 47%.

Annual 2025 Highlights

  • ARR⁽¹⁾ as at December 31, 2025 was $96,149,750 as compared to $71,054,210 at December 31, 2024, an increase of $25,095,540 or 35%.
    Over the previous year, ARR movement in Q4 2025 from Q4 2024 was attributable to the following:
    • Organic growth of $7,231,031 or 10%.
    • Acquisition growth of $15,870,000 or 22%.
    • Gain of $1,994,509 due to fluctuations in foreign exchange rates.
  • Revenue of $108,966,918 as compared to $68,594,310 in the equivalent prior year period, an increase of $40,372,608 or 59%.
  • Gross profit as a percentage of revenue was 80% compared to 81% in the prior year.
  • Net income before income taxes of $5,901,401 as compared to $5,895,758 in the equivalent prior year period.
  • Net income of $6,110,963 as compared to $2,999,045 in the equivalent prior year period
  • EBITDA⁽¹⁾ of $14,634,782 as compared to $9,950,872 in the prior year.
  • Adjusted EBITDA⁽¹⁾ of $26,554,099 or 24% of revenue, as compared to $17,840,272 or 26% of revenue in the equivalent prior year period, an increase of $8,713,827 or 49%.
  • Cash on hand and short-term investments as at December 31, 2025 was $119,180,625 compared to $56,574,904 as at December 31, 2024.

(1) Non-IFRS or supplementary financial measure.

Selected Financial Information

  Three months ended Year ended
  December 31,
2025
% Revenue December 31,
2024
%
Revenue
Change December 31,
2025
%
Revenue
December 31,
2024
%
Revenue
Change
  $   $   % $   $   %
Revenue 31,390,374   100 % 20,590,779   100 % 52 % 108,966,918   100 % 68,594,310   100 % 59 %
                     
Cost of sales 6,486,447   21 % 3,841,539   19 % (69 %) 21,378,557   20 % 13,099,877   19 % (63 %)
                     
Gross profit 24,903,927   79 % 16,749,240   81 % 49 % 87,588,361   80 % 55,494,433   81 % 58 %
                     
Operating expenses                    
General and administrative 6,024,677   19 % 5,442,656   26 % (11 %) 22,458,560   21 % 15,451,016   23 % (45 %)
Sales and marketing 2,672,840   9 % 1,685,221   8 % (59 %) 10,281,531   9 % 6,766,434   10 % (52 %)
Research and development 8,459,901   27 % 4,189,941   20 % (102 %) 28,950,760   27 % 15,227,119   22 % (90 %)
Depreciation of property and equipment 165,796   1 % 123,147   1 % (35 %) 713,788   1 % 375,838   1 % (90 %)
Depreciation of right-of-use assets 156,655   0 % 111,156   1 % (41 %) 557,770   1 % 438,068   1 % (27 %)
Share-based compensation 500,277   2 % 684,034   3 % 27 % 2,557,812   2 % 2,344,464   3 % (9 %)
Deferred share-based compensation 0   0 % 0   0 % 0 % 90,000   0 % 0   0 % (100 %)
Foreign currency loss (gain) 316,191   1 % 384,805   2 % 18 % (662,469 ) (1 %) 209,733   0 % 416 %
                     
Other expenses (income)                    
Amortization of intangible assets 3,135,396   10 % 1,730,224   8 % (81 %) 9,809,967   9 % 5,149,018   8 % (91 %)
Business acquisition, restructuring and integration costs 2,173,149   7 % 2,588,292   13 % 16 % 8,811,007   8 % 5,213,044   8 % (69 %)
(Gain) loss on change in fair value of contingent consideration 1,470,000   5 % (100,938 ) (0 %) 1,556 % 460,498   0 % 331,892   0 % (39 %)
Interest income (net of interest expense) (939,481 ) (3 %) (270,367 ) (1 %) 247 % (2,418,490 ) (2 %) (1,950,815 ) (3 %) 24 %
Interest expense from lease liabilities 16,629   0 % 8,210   0 % (103 %) 70,346   0 % 43,005   0 % (64 %)
Loss on disposal of property and equipment 1,810   0 % (141 ) (0 %) 1,384 % 5,880   0 % (141 ) (0 %) 4,270 %
                     
Current and deferred income taxes (recoverable) (3,317,446 ) (11 %) (614,244 ) (3 %) (440 %) (209,562 ) (0 %) 2,896,713   4 % 107 %
                     
Net income (loss) 4,067,533   13 % 787,244   4 % 417 % 6,110,963   6 % 2,999,045   4 % 104 %
                     
EBITDA 3,285,082   10 % 1,875,370   9 % 75 % 14,634,782   13 % 9,950,872   15 % 47 %
                     
Adjusted EBITDA 7,428,508   24 % 5,046,758   25 % 47 % 26,554,099   24 % 17,840,272   26 % 49 %
                     
Annual recurring revenue 96,149,750     71,054,210     35 % 96,149,750     71,054,210     35 %
                     
Term licences, maintenance and support revenue 23,577,363   75 % 17,673,596   86 % 33 % 85,442,864   78 % 57,070,350   83 % 50 %
                     
                     
        As at          
        December 31,
2025
December 31,
2024
         
        $ $          
  Cash and short-term investments balance 119,180,625   56,574,904            
                     
  Deferred revenue   45,434,654   35,636,002            
                     

About VitalHub

VitalHub is a leading software company dedicated to empowering health and human services providers globally. VitalHub’s comprehensive product suite includes electronic health records, operational intelligence, and workforce automation solutions that serve over 1,300 clients across the UK, Canada, and other geographies. The Company has a robust two-pronged growth strategy, targeting organic opportunities within its product suite and pursuing an aggressive M&A plan. VitalHub is headquartered in Toronto with over 700 employees globally, across key regions and the VitalHub Innovations Lab in Sri Lanka. For more information about VitalHub (TSX:VHI) (OTCQX:VHIBF), please visit www.vitalhub.com and LinkedIn.

Contact Information

Christian Sgro, CPA, CA, CFA
Head of IR and M&A Specialist
(365) 363-6433
christian.sgro@vitalhub.com

Dan Matlow
Chief Executive Officer, Director
(416) 727-9061
dan.matlow@vitalhub.com

Cautionary Statement

Certain statements contained in this news release may constitute “forward-looking information” or “financial outlook” within the meaning of applicable securities laws that involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information or financial outlook. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of each entity and are based on assumptions and subject to risks and uncertainties. Although the management of each entity believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

Non-IFRS and Other Measures

VitalHub uses certain financial and operating performance measures that management believes provide meaningful information in assessing the Company’s underlying performance. Readers are cautioned that these measures may not have a standardized meaning prescribed by IFRS and therefore may not be comparable to similar measures presented by other issuers. Accordingly, non-IFRS and supplementary financial measures should not be considered in isolation or as a substitute for measures of performance prepared in accordance with IFRS. Definitions, reconciliations, and an explanation of how the Company’s non-IFRS and supplementary financial measures provide useful information to an investor are included below.

Annual recurring revenue (“ARR”)

Annual recurring revenue is a supplementary financial measure defined as annual renewable software license fees and maintenance services. The Company defines ARR as the recurring revenue that is expected based on yearly subscriptions of the renewable software license fees and maintenance services.

Earnings before interest, taxation, depreciation, and amortization (“EBITDA”)

EBITDA is a non-IFRS measure used by management to evaluate operational performance. It is also a common measure that is reported on and used by investors in determining a company’s ability to incur and service debt, as well as a valuation methodology. EBITDA is a non-IFRS measure and should not be considered an alternative to operating income or net income (loss) in measuring the Company’s performance. The following chart reflects the calculation of the Company’s EBITDA:

            Three months ended Year ended
            December 31,
2025
December 31,
2024
December 31,
2025
December 31,
2024
            $ $ $ $
Net income         4,067,533   787,244   6,110,963   2,999,045  
Add: Interest         (922,852 ) (262,157 ) (2,348,144 ) (1,907,810 )
Add: Depreciation and amortization       3,457,847   1,964,527   11,081,525   5,962,924  
Add: Current and deferred tax expense       (3,317,446 ) (614,244 ) (209,562 ) 2,896,713  
EBITDA         3,285,082   1,875,370   14,634,782   9,950,872  
                   

Adjusted EBITDA and Adjusted EBITDA as a percentage of revenue

Adjusted EBITDA is a non-IFRS measure used by management to evaluate cash flows and the Company’s ability to service debt. Adjusted EBITDA is a non-IFRS measure and should not be considered an alternative to operating income or net income (loss) in measuring the Company’s performance. Adjusted EBITDA as a percentage of revenue expresses Adjusted EBITDA as a percentage of total revenue. The following chart reflects the Company’s calculation of Adjusted EBITDA:

            Three months ended Year ended
            December 31,
2025
December 31,
2024
December 31,
2025
December 31,
2024
            $ $ $ $
EBITDA           3,285,082   1,875,370   14,634,782   9,950,872  
Add: Share and deferred-based compensation expense     500,277   684,034   2,647,812   2,344,464  
Add: Business acquisition, restructuring and integration costs     2,173,149   2,588,292   8,811,007   5,213,044  
Add: (Gain) loss on change in fair value of contingent consideration   1,470,000   (100,938 ) 460,498   331,892  
Adjusted EBITDA         7,428,508   5,046,758   26,554,099   17,840,272  
                   

Alvotech Q4 2025 and Full Year 2025 Financial Results

Alvotech Q4 2025 and Full Year 2025 Financial Results




Alvotech Q4 2025 and Full Year 2025 Financial Results

REYKJAVIK, Iceland, March 18, 2026 (GLOBE NEWSWIRE) —

Alvotech (NASDAQ US: ALVO, ICELAND: ALVO, STOCKHOLM: ALVO SDB)

Financial Highlights 

A supplemental long‑form earnings release providing additional operational details and business update for Q4 2025 and the full year is available at: https://investors.alvotech.com/earnings-calendar The supplemental document is provided solely for reference and is not part of this SEC Form 6‑K. The Form 6‑K should not be read together with, or construed as referring to, the supplemental long‑form release.

Q4 2025 Highlights

  • Total revenues1 were $173 million, up 13% Year-on-Year (YoY)
  • Adjusted EBITDA1 was $69 million with Gross Margin at 66%
  • AVT05 was approved as a biosimilar to Simponi® in the UK and European Economic Area (EEA)
  • AVT03 was approved as a biosimilar to Prolia® and Xgeva® in the EEA
  • The EMA accepted for review a marketing application for AVT23, referencing Xolair®
  • After the end of the quarter, Alvotech entered into supply and commercialization agreements with Sandoz, covering multiple biosimilars candidates in Canada, Australia and New Zealand

FY 2025 Highlights

  • Total revenues1 were $593 million, up 21% YoY
  • Adjusted EBITDA1 was $137 million, up 27% YoY, with Gross Margin at 61%
  • The cash balance on December 31, 2025, was $172 million
  • Second biosimilar in the US, Selarsdi™ referencing Stelara® launched by commercial partner Teva
  • Three new biosimilars were approved in multiple markets, including the UK, EEA and Japan
  • Alvotech acquired Xbrane’s R&D organization in Sweden and Ivers-Lee Group in Switzerland
  • The company listed its shares on Nasdaq Stockholm and raised new equity
  • Linda Jonsdottir was appointed Chief Financial Officer, Dr. Balaji V. Prasad was appointed Chief Strategy Officer, while Joseph McClellan transitioned into the role of Chief Operating Officer and Anthony Maffia into the role of Chief Regulatory and Quality Officer

________________________________
1 Figures are adjusted to exclude items that are not indicative of our ongoing operating performance. Please see the disclaimer on ‘Non IFRS Financial Measures’ at the end of this press release. As a foreign private issuer, Alvotech is not required to, and does not, prepare or file quarterly financial statements under IFRS or with the SEC. The financial information included in this Form 6-K reflects management’s current estimates and is presented for the purpose of providing an interim business update.

Comments by Chairman of the Board and Outgoing CEO, Róbert Wessman:

“Last year we continued to expand our dedicated end-to-end biosimilars platform, advancing our pipeline with the launches of three newly approved biosimilars, expanding our R&D operation and adding a centralized assembly and packaging unit through acquisitions, while also strengthening our global network through new commercial partnerships.

“We now have five approved and on-market biosimilars supported by our global partners which provide Alvotech with commercial reach into 90 countries worldwide. We have an industry leading pipeline of 30 biosimilars in development and continue adding to it at an accelerated pace.

“During the year we further strengthened our financial position, raising close to $300 million from capital markets to support continued investment in our development programs and manufacturing platform. We broadened our investor base through the listing of shares on Nasdaq Stockholm, providing better access to Nordic and European investors.

“At the same time, we addressed the regulatory observations following the FDA inspection of our Reykjavik manufacturing facility and we implemented a comprehensive improvement program. Based on the progress made so far, we expect to resubmit the affected applications to the FDA during the second quarter of 2026. We have addressed regulatory observations before, and we know how to resolve them. Our focus has been on strengthening the operational platform so that we can continue to scale the business globally.

“We have strengthened the leadership team, with Lisa Graver’s appointment as Chief Executive Officer, and all the key management of the company is now located onsite in Iceland. Lisa and I have worked together for over twenty years, and she is ideally positioned to lead the company through this next stage. She knows the company very well, having been a board member since 2022, which gives her a deep understanding of our strategy, our platform and our global partnerships.

“As Executive Chairman of the Board I will continue to be actively engaged in the business, and I am looking forward working closely with Lisa and the leadership team as we continue building Alvotech into a leading biosimilars company.”

Outlook for 2026

Management reaffirms its outlook for 2026. With continued focus on robust cash flow and margin expansion by delivering solid sales growth and driving operational efficiencies across the company, management anticipates total revenues in the range of $650-700 million in 2026, reflecting continued double-digit sales growth. Adjusted EBITDA is expected to increase to $180-220 million, supported by higher volumes of commercialized products and launches of newly approved products in Europe, the UK and Japan.

Alvotech anticipates receiving U.S. approval by late 2026 for four Biologics License Applications from the U.S. Food and Drug Administration, with minimal impact on the topline. The lower end of the revenue range assumes no revenues from new launches into the U.S. market in 2026.

Invitation to Q4 2025 and Full Year 2025 management presentation:

Join us to listen to the live audio webcast at 8:00 AM EST (12:00 GMT, 13:00 CET) on Thursday, March 19, 2026.

The audio webcast will be accessible via the following link:
https://edge.media-server.com/mmc/p/u2p8ged8/

To participate via telephone in the Q&A session, please register using this link to obtain your PIN:
https://register-conf.media-server.com/register/BI1c565f9bbee94c928c676ea73f178077

Presentation slides for the webcast and other materials are available on the company’s website: https://investors.alvotech.com/earnings-calendar

For further information, please contact:

Media – alvotech.media@alvotech.com
Benedikt Stefansson
Sarah MacLeod

Investors – alvotech.ir@alvotech.com
Dr. Balaji V Prasad (US)
Patrik Ling (SE)
Benedikt Stefansson (IS)

The information was submitted for publication through the agency of the contact persons.

Financial calendar:

Annual or interim results will be released on the dates specified below, after the close of U.S. markets. An earnings call is held on the following day, after release of the results. Please note that all dates are subject to change.

Quarter Date of release Date of earnings call
Q1 2026 May 6, 2026 May 7, 2026
Q2 2026 August 19, 2026 August 20, 2026
Q3 2026 November 11, 2026 November 12, 2026
Q4 2026 March 10, 2027 March 11, 2027


About Alvotech

Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube.

Forward Looking Statements

Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

Non IFRS Financial Measures

This Presentation may include projections of certain financial measures not presented in accordance with International Financial Reporting Standards (“IFRS”) including, but not limited to, Adjusted Revenues, EBITDA and certain ratios and other metrics derived therefrom. These non-IFRS financial measures are not measures of financial performance in accordance with IFRS and may exclude items that are significant in understanding and assessing the Company’s financial results. Therefore, these measures should not be considered in isolation or as an alternative to net income, cash flows from operations or other measures of profitability, liquidity or performance under IFRS. You should be aware that the Company’s presentation of these measures may not be comparable to similarly-titled measures used by other companies. The Company believes these non-IFRS measures of financial results provide useful information to management and investors regarding certain financial and business trends relating to the Company’s financial condition and results of operations. The Company believes that the use of these non-IFRS financial measures provide an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company’s financial measures with other similar companies, many of which present similar non-IFRS financial measures to investors. These non-IFRS financial measures are subject to inherent limitations as they reflect the exercise of judgments by management about which expense and income are excluded or included in determining these non-IFRS financial measures. Due to the high variability and difficulty in making accurate forecasts and projections of some of the information excluded from these projected measures, together with some of the excluded information not being ascertainable or accessible, the Company is unable to quantify certain amounts that would be required to be included in the most directly comparable IFRS financial measures without unreasonable effort. Consequently, no disclosure of estimated comparable IFRS measures is included and no reconciliation of the forward-looking non-IFRS financial measures is included. For the same reasons, the Company is unable to address the probable significance of the unavailable information, which could be material to future results.

Alvotech Q4 2025 and Full Year 2025 Financial Results

Alvotech Q4 2025 and Full Year 2025 Financial Results




Alvotech Q4 2025 and Full Year 2025 Financial Results

A supplemental long‑form earnings release providing additional operational details and business update for Q4 2025 and the full year is available at: https://investors.alvotech.com/earnings-calendar The supplemental document is provided solely for reference and is not part of this SEC Form 6‑K. The Form 6‑K should not be read together with, or construed as referring to, the supplemental long‑form release.

Financial Highlights 

Q4 2025 Highlights

  • Total revenues1 were $173 million, up 13% Year-on-Year (YoY)
  • Adjusted EBITDA1 was $69 million with Gross Margin at 66%
  • AVT05 was approved as a biosimilar to Simponi® in the UK and European Economic Area (EEA)
  • AVT03 was approved as a biosimilar to Prolia® and Xgeva® in the EEA
  • The EMA accepted for review a marketing application for AVT23, referencing Xolair®
  • After the end of the quarter, Alvotech entered into supply and commercialization agreements with Sandoz, covering multiple biosimilars candidates in Canada, Australia and New Zealand

FY 2025 Highlights

  • Total revenues1 were $593 million, up 21% YoY
  • Adjusted EBITDA1 was $137 million, up 27% YoY, with Gross Margin at 61%
  • The cash balance on December 31, 2025, was $172 million
  • Second biosimilar in the US, Selarsdi™ referencing Stelara® launched by commercial partner Teva
  • Three new biosimilars were approved in multiple markets, including the UK, EEA and Japan
  • Alvotech acquired Xbrane’s R&D organization in Sweden and Ivers-Lee Group in Switzerland
  • The company listed its shares on Nasdaq Stockholm and raised new equity
  • Linda Jonsdottir was appointed Chief Financial Officer, Dr. Balaji V. Prasad was appointed Chief Strategy Officer, while Joseph McClellan transitioned into the role of Chief Operating Officer and Anthony Maffia into the role of Chief Regulatory and Quality Officer

Comments by Chairman of the Board and Outgoing CEO, Róbert Wessman:

“Last year we continued to expand our dedicated end-to-end biosimilars platform, advancing our pipeline with the launches of three newly approved biosimilars, expanding our R&D operation and adding a centralized assembly and packaging unit through acquisitions, while also strengthening our global network through new commercial partnerships.

“We now have five approved and on-market biosimilars supported by our global partners which provide Alvotech with commercial reach into 90 countries worldwide. We have an industry leading pipeline of 30 biosimilars in development and continue adding to it at an accelerated pace.

“During the year we further strengthened our financial position, raising close to $300 million from capital markets to support continued investment in our development programs and manufacturing platform. We broadened our investor base through the listing of shares on Nasdaq Stockholm, providing better access to Nordic and European investors.

“At the same time, we addressed the regulatory observations following the FDA inspection of our Reykjavik manufacturing facility and we implemented a comprehensive improvement program. Based on the progress made so far, we expect to resubmit the affected applications to the FDA during the second quarter of 2026. We have addressed regulatory observations before, and we know how to resolve them. Our focus has been on strengthening the operational platform so that we can continue to scale the business globally.

“We have strengthened the leadership team, with Lisa Graver’s appointment as Chief Executive Officer, and all the key management of the company is now located onsite in Iceland. Lisa and I have worked together for over twenty years, and she is ideally positioned to lead the company through this next stage. She knows the company very well, having been a board member since 2022, which gives her a deep understanding of our strategy, our platform and our global partnerships.

“As Executive Chairman of the Board I will continue to be actively engaged in the business, and I am looking forward working closely with Lisa and the leadership team as we continue building Alvotech into a leading biosimilars company.”

Outlook for 2026

Management reaffirms its outlook for 2026. With continued focus on robust cash flow and margin expansion by delivering solid sales growth and driving operational efficiencies across the company, management anticipates total revenues in the range of $650-700 million in 2026, reflecting continued double-digit sales growth. Adjusted EBITDA is expected to increase to $180-220 million, supported by higher volumes of commercialized products and launches of newly approved products in Europe, the UK and Japan.

Alvotech anticipates receiving U.S. approval by late 2026 for four Biologics License Applications from the U.S. Food and Drug Administration, with minimal impact on the topline. The lower end of the revenue range assumes no revenues from new launches into the U.S. market in 2026.

Invitation to Q4 2025 and Full Year 2025 management presentation:

Join us to listen to the live audio webcast at 8:00 AM EST (12:00 GMT, 13:00 CET) on Thursday, March 19, 2026.

The audio webcast will be accessible via the following link:
https://edge.media-server.com/mmc/p/u2p8ged8/

To participate via telephone in the Q&A session, please register using this link to obtain your PIN:
https://register-conf.media-server.com/register/BI1c565f9bbee94c928c676ea73f178077

Presentation slides for the webcast and other materials are available on the company’s website: https://investors.alvotech.com/earnings-calendar

For further information, please contact:

Media – alvotech.media@alvotech.com
Benedikt Stefansson
Sarah MacLeod

Investors – alvotech.ir@alvotech.com
Dr. Balaji V Prasad (US)
Patrik Ling (SE)
Benedikt Stefansson (IS)

The information was submitted for publication through the agency of the contact persons.

Financial calendar:

Annual or interim results will be released on the dates specified below, after the close of U.S. markets. An earnings call is held on the following day, after release of the results. Please note that all dates are subject to change.

Quarter Date of release Date of earnings call
Q1 2026 May 6, 2026 May 7, 2026
Q2 2026 August 19, 2026 August 20, 2026
Q3 2026 November 11, 2026 November 12, 2026
Q4 2026 March 10, 2027 March 11, 2027

About Alvotech

Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube.

Forward Looking Statements

Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

Non IFRS Financial Measures

This Presentation may include projections of certain financial measures not presented in accordance with International Financial Reporting Standards (“IFRS”) including, but not limited to, Adjusted Revenues, EBITDA and certain ratios and other metrics derived therefrom. These non-IFRS financial measures are not measures of financial performance in accordance with IFRS and may exclude items that are significant in understanding and assessing the Company’s financial results. Therefore, these measures should not be considered in isolation or as an alternative to net income, cash flows from operations or other measures of profitability, liquidity or performance under IFRS. You should be aware that the Company’s presentation of these measures may not be comparable to similarly-titled measures used by other companies. The Company believes these non-IFRS measures of financial results provide useful information to management and investors regarding certain financial and business trends relating to the Company’s financial condition and results of operations. The Company believes that the use of these non-IFRS financial measures provide an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company’s financial measures with other similar companies, many of which present similar non-IFRS financial measures to investors. These non-IFRS financial measures are subject to inherent limitations as they reflect the exercise of judgments by management about which expense and income are excluded or included in determining these non-IFRS financial measures. Due to the high variability and difficulty in making accurate forecasts and projections of some of the information excluded from these projected measures, together with some of the excluded information not being ascertainable or accessible, the Company is unable to quantify certain amounts that would be required to be included in the most directly comparable IFRS financial measures without unreasonable effort. Consequently, no disclosure of estimated comparable IFRS measures is included and no reconciliation of the forward-looking non-IFRS financial measures is included. For the same reasons, the Company is unable to address the probable significance of the unavailable information, which could be material to future results.


1 Figures are adjusted to exclude items that are not indicative of our ongoing operating performance. Please see the disclaimer on ‘Non IFRS Financial Measures’ at the end of this press release. As a foreign private issuer, Alvotech is not required to, and does not, prepare or file quarterly financial statements under IFRS or with the SEC. The financial information included in this Form 6-K reflects management’s current estimates and is presented for the purpose of providing an interim business update.

aap successfully completes MDR certification: All existing products approved according to MDR – market access in the EU and CE-relevant markets secured in the long term

aap Implantate AG

/ Key word(s): Miscellaneous

aap successfully completes MDR certification: All existing products approved according to MDR – market access in the EU and CE-relevant markets secured in the long term

18.03.2026 / 22:00 CET/CEST

The issuer is solely responsible for the content of this announcement.


  • MDR certificate for quality management system and Class IIa products received on
    January 27, 2025
  • MDR certificate for the last product group (Class IIb) successfully issued – so that MDR certificates are available for all existing products

With the MDR certificate for Class IIb products, MDR certification is completed for all existing products

aap Implantate AG (“aap” or “Company”) has received the MDR certificate for Class IIb products (plates and screws) from its Notified Body and has thus successfully completed the MDR certification process for all existing products. The transition from the previous MDD (Medical Device Directive 93/42/EEC) to the MDR (Medical Device Regulation (EU) 2017/745) is a prerequisite for the marketing of medical devices in the European Union after the expiry of the respective transition periods. With the completion of the MDR certification, the risk of missing the relevant transition periods for the existing portfolio is eliminated. At the same time, aap can secure market access in the EU as well as in CE-relevant markets in the long term. On this basis, the company is once again focusing more strongly on the further development of the portfolio and the introduction of new products. The first further developments of the LOQTEQ® product family are to be launched in the second half of 2026 and will provide positive impact for sales development from 2027 onwards.

——————————————————————————————————————————————-

aap Implantate AG (ISIN DE0005066609) – General Standard/Regulated Market – All German Stock Exchanges –

 

 

About aap Implantate AG

aap Implantate AG is a global medical technology company headquartered in Berlin. The company develops and markets products for traumatology. In addition to the innovative anatomical plate system LOQTEQ®, the patent-protected portfolio includes a wide range of perforated screws. In addition, aap Implantate AG has an innovative pipeline of promising development projects, such as an antibacterial silver coating technology. This technology addresses critical and so far insufficiently solved problems of wound infections after surgery (SSI) in traumatology and is also applicable in other medical technological areas. In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and affiliated clinics. Internationally, it mainly uses a broad network of distributors in around 41 countries. In the USA, the company and its subsidiary aap Implants Inc. rely on a network of agents and a selective direct sales strategy. The shares of aap Implantate AG are listed in the General Standard of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For more information, please visit our website at www.aap.de.

There may be technical rounding differences in the figures presented in this press release, which do not affect the overall statement.

Forward-Looking Statements

This release may contain forward-looking statements based on the current expectations, assumptions and forecasts of the Management Board and information currently available to it. The forward-looking statements are not to be understood as guarantees of future developments and results referred to therein. Various known and unknown risks, uncertainties and other factors could cause the actual results, financial condition, development or performance of the Company to differ materially from the estimates given herein. These factors also include those described by aap in published reports. Forward-looking statements therefore speak only as of the date on which they are made. We undertake no obligation to update the forward-looking statements made in this release or to conform them to future events or developments.

If you have any questions, please contact: aap Implantate AG; Rubino Di Girolamo; Chairman of the Board of Directors/CEO; Lorenzweg 5; 12099 Berlin

Phone: +49 (0)30 75019 – 141; Fax: +49 (0)30 75019 – 170; Email : r.digirolamo@aap.de


18.03.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Language: English
Company: aap Implantate AG
Lorenzweg 5
12099 Berlin
Germany
Phone: +49 (0) 30 75 019-0
Fax: +49 (0) 30 75 019-111
E-mail: info@aap.de
Internet: www.aap.de
ISIN: DE000A3H2101
WKN: A3H210
Listed: Regulated Market in Frankfurt (General Standard); Regulated Unofficial Market in Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate BSX
EQS News ID: 2293984

 
End of News EQS News Service

2293984  18.03.2026 CET/CEST

Extendicare Announces Proposed Changes to Board of Directors

Extendicare Announces Proposed Changes to Board of Directors




Extendicare Announces Proposed Changes to Board of Directors

MARKHAM, Ontario, March 18, 2026 (GLOBE NEWSWIRE) — Extendicare Inc. (“Extendicare” or the “Company”) (TSX: EXE) today announced that its board of directors (“Board of Directors” or “Board”) has nominated Josh Blair and Leslee Thompson for election as new Board members at the Company’s upcoming annual meeting of shareholders to be held on April 16, 2026 (the “Meeting”).

Extendicare also announced that current Board members Alan Torrie, Chair of the Board, and Donna Kingelin will not stand for re-election at the Meeting following over 10 years of service.

Alan’s leadership and vision during his nine years as Chair enabled the transition of Extendicare from its real estate focus to a new business model focused on health services. Donna chaired the HR Committee and subsequently the Quality and Risk Committee during her tenure, building pivotal capabilities that are core to the Company’s health services mandate. Extendicare and the Board express their deepest appreciation and gratitude to Alan and Donna for their outstanding service, invaluable contributions, and dedication during their tenures as directors of Extendicare.

The remaining seven current members of the Board, each of whom is an incumbent director, will stand for re-election at the Meeting, as further described in the Company’s management information and proxy circular dated March 5, 2026.

Assuming his re-election at the Meeting, it is expected that current director Samir Manji will be appointed as Chair of the Board immediately following the Meeting. Mr. Manji is the Executive Chair of RFA Financial Inc. and founder and CEO of Sandpiper Group, a Vancouver-based real estate private equity firm. Mr. Manji has been involved in over $10 billion in hospitality, seniors’ housing and multifamily residential real estate transactions and has over 30 years of experience in real estate and seniors’ housing, including as founder, Chairman and CEO of Amica Mature Lifestyles Inc. Mr. Manji has been a member of the Board and major shareholder of Extendicare since 2019.

Mr. Blair is the Co-Founder and Chief Executive Officer of Impro.AI, a high-tech company that enables corporations and their employees to accelerate their growth through AI-powered workforce insights and performance mentoring. He brings more than 30 years of experience in executive and board roles within the public and private capital markets across multiple industries, including AI and data services, health care and telecommunications. From 1995 through 2019, Mr. Blair served in senior leadership roles at TELUS Corporation, including as Group President overseeing TELUS Digital, TELUS Health, TELUS Business, TELUS Agriculture and TELUS Ventures.

Ms. Thompson is a corporate director, independent consultant and health care expert. She most recently served as President and CEO of Health Standards Organization and Accreditation Canada (2016–2026), two global not-for-profit organizations that certify and promote quality across Canada and in health organizations in 45 countries. Starting out as an ICU nurse, Ms. Thompson has led multiple organizations in both public and private sectors and has served on public and private boards. She was CEO of Kingston General Hospital (2009–2016), and served as a senior executive at Medtronic Canada, Cancer Care Ontario, Sunnybrook Health Sciences Centre, University Health Network and the Capital Health Authority in Edmonton.

“It has been very gratifying to play a part in transitioning Extendicare to a new business model that has enabled its emergence as a leading health services company in Canada,” said Alan Torrie, outgoing Chair of the Board. “I am confident that Samir and the rest of the Board will continue our track record of good governance practices to shepherd Extendicare’s strategy to expand access to care in the community.”

About Extendicare 
Extendicare is a leading provider of care and services for seniors across Canada, operating under the Extendicare, ParaMed, Extendicare Assist, and SGP Purchasing Network brands. We are committed to delivering quality care to meet the needs of the growing seniors’ population, inspired by our mission to provide people with the care they need, wherever they call home. We operate a network of 99 long-term care homes (59 owned, 40 under management contracts), deliver approximately 14.0 million hours of home health care services annually, and provide group purchasing services to third parties representing approximately 153,600 beds across Canada. Extendicare proudly employs approximately 23,000 individuals and manages an additional 5,000 individuals through its joint ventures, all of whom are highly qualified, trained and dedicated team members who are passionate about providing high-quality care and services to help people live better.

Extendicare contact:
David Bacon, Executive Vice President and Chief Financial Officer
T: (905) 470-4000
E: david.bacon@extendicare.com
www.extendicare.com

FDA Approves BRAVECTO® QUANTUM (fluralaner for extended-release injectable suspension) from Merck Animal Health to Treat and Control Asian Longhorned Tick and Gulf Coast Tick for 12 Months in Dogs

FDA Approves BRAVECTO® QUANTUM (fluralaner for extended-release injectable suspension) from Merck Animal Health to Treat and Control Asian Longhorned Tick and Gulf Coast Tick for 12 Months in Dogs




FDA Approves BRAVECTO® QUANTUM (fluralaner for extended-release injectable suspension) from Merck Animal Health to Treat and Control Asian Longhorned Tick and Gulf Coast Tick for 12 Months in Dogs

Expanded label for once-yearly parasiticide treatment for dogs now includes Haemaphysalis longicornis (Asian longhorned tick) and Amblyomma maculatum (Gulf Coast tick) for 12 months

RAHWAY, N.J.–(BUSINESS WIRE)–Merck Animal Health, known as MSD Animal Health outside the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), today announced the U.S. Food and Drug Administration (FDA) approved an expanded label for BRAVECTO® QUANTUM (fluralaner for extended-release injectable suspension) in dogs. The updated indication adds treatment and control of Asian longhorned tick (H. longicornis) and Gulf Coast tick (A. maculatum) for 12 months, when administered as a single, veterinarian‑delivered injection.


BRAVECTO QUANTUM was approved in the U.S. on July 10, 2025, and continues to be indicated to kill adult fleas, for the treatment and prevention of flea infestations, and for the treatment and control of Ixodes scapularis, Dermacentor variabilis, and Rhipicephalus sanguineus infestations for 12 months and A. americanum infestations for 8 months in dogs and puppies 6 months of age and older.

“For more than a decade, BRAVECTO has set the benchmark for extended‑duration flea and tick protection, and today’s label expansion reinforces our leadership in parasiticide innovation,” said Meg Conlon, DVM, executive director, U.S. Companion Animal Veterinary Services, Merck Animal Health. “With BRAVECTO QUANTUM, Merck Animal Health continues to deliver the longest‑lasting protection available in a single dose – now covering an even broader range of clinically important tick species. This advancement reflects our unwavering commitment to help veterinarians protect dogs with the most comprehensive, convenient, and science‑driven solutions on the market.”

Key Information:

  • What’s new: BRAVECTO QUANTUM is now approved to provide 12 months of treatment and control for two additional tick species – Asian longhorned tick (H. longicornis) and Gulf Coast tick (A. maculatum) – following a single injection administered by a veterinarian. This approval expands the product’s already robust label, reinforcing BRAVECTO’s position as the longest‑lasting flea and tick protection available for dogs in the United States.
  • Complete Parasite Protection Profile: BRAVECTO QUANTUM is indicated to kill adult fleas and for treatment and prevention of flea infestations. BRAVECTO QUANTUM also provides 12 months of protection against Asian longhorned ticks, Gulf Coast ticks, black‑legged ticks, American dog ticks, and brown dog ticks, along with 8 months of protection against lone star ticks following a single veterinarian administered‑injection.
  • Why this matters: The extended‑release injectable formulation offers veterinarians and pet owners a simple, once‑yearly approach that supports improved compliance and consistent, uninterrupted protection. This label update helps veterinarians address the evolving parasite landscape, as both Asian longhorned and Gulf Coast ticks continue to expand geographically and present risks to canine health.
  • Where it’s available: BRAVECTO QUANTUM remains available exclusively through licensed veterinarians, ensuring appropriate in‑clinic administration, guidance, and support.

The expanded indication underscores Merck Animal Health’s continued leadership in delivering innovative, extended‑duration parasite protection solutions. With BRAVECTO QUANTUM, veterinarians have an unmatched, once‑yearly option that now defends dogs against an even broader range of ticks – supporting year‑round protection and helping meet the evolving needs of pets and the people who care for them. For more information, visit us.bravecto.com or follow BRAVECTO on Instagram @bravecto.us.

About BRAVECTO®

Since its introduction in 2014, BRAVECTO has provided longer-lasting flea and tick protection, with more than 450 million doses distributed in 100 countries over eight years. BRAVECTO is available in a variety of formulations, including products for both dogs and cats.

The flea lifecycle can last as long as 12 weeks, and monthly treatments may leave gaps in protection. Providing pets with continuous flea and tick protection is essential – whether the pet goes outside or not. Contrary to popular belief among pet owners, fleas and ticks are not only active in the spring and summer months and are a year-round risk. Fleas and ticks can easily latch onto dogs and cats and can spread serious diseases. Fleas are the most common external parasite found on pets. BRAVECTO products are available through licensed veterinarians.

About Merck Animal Health

Merck Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is a global animal health business committed to The Science of Healthier Animals™. For more than 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. For more information, visit www.merck-animal-health.com and connect with us on LinkedIn, Facebook, X (formerly Twitter) and Instagram.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

FAQ:

  • What changed with today’s approval?

    • The BRAVECTO QUANTUM label now includes treatment and control of H. longicornis (Asian longhorned tick) and A. maculatum (Gulf Coast tick) for 12 months following a single injection administered by a veterinarian, in addition to existing indications (fleas and other listed tick species) and the 8‑month indication for A. americanum (lone star tick).
  • Why focus on Asian longhorned and Gulf Coast ticks?

    • These ticks are clinically relevant and expanding in geographic range. Adding them strengthens year‑round, single‑dose tick control options for more dogs across more U.S. regions.
  • How is BRAVECTO QUANTUM administered?

    • BRAVECTO QUANTUM is administered via a single subcutaneous injection delivered by a licensed veterinarian.
  • Is this the same BRAVECTO formulation that was introduced in 2025?

    • Yes. BRAVECTO QUANTUM remains the once‑yearly fluralaner extended‑release injectable. Today’s update expands the label’s tick species coverage.
  • Is BRAVECTO QUANTUM safe?

    • BRAVECTO QUANTUM has undergone extensive safety testing. In fact, safety was demonstrated when dosed at 5 times the recommended dose every 4 months for a total of 6 doses. In a U.S. field study with client owned dogs, 0.9% (2 out of 225 dogs) experienced seizures. This rate is consistent with estimates reported in the general dog population. BRAVECTO QUANTUM (fluralaner) is a member of the isoxazoline class, which has been associated with neurologic adverse reactions, including tremors, ataxia, and seizures. Use with caution in dogs with a history of seizures or neurologic disorders.
  • Where can veterinarians find full prescribing information?

  • Can cats receive BRAVECTO QUANTUM?

    • No. BRAVECTO QUANTUM is approved only for dogs and puppies 6 months of age and older and must be administered by a licensed veterinarian. It is not approved for use in cats. For cats, Merck Animal Health offers BRAVECTO® Plus, a topical formulation that provides broad‑spectrum, extended‑duration protection against fleas, ticks, and internal parasites.

IMPORTANT SAFETY INFORMATION:

BRAVECTO (fluralaner) Chews for Dogs: The most commonly reported adverse reactions include vomiting, lethargy, diarrhea, anorexia and pruritus. In some cases, adverse events have been reported following use in breeding females. BRAVECTO Chews has not been shown to be effective for 12-weeks’ duration in puppies less than 6 months of age. BRAVECTO Chews is not effective against lone star ticks beyond 8 weeks of dosing. Indicated for dogs 6 months of age and older. BRAVECTO 1-MONTH (fluralaner) Chews: The most commonly reported adverse reactions include itching, diarrhea, vomiting, decreased appetite, elevated ALT, lethargy, and weight loss. Not effective against lone star ticks in puppies less than 6 months of age. Indicated for dogs 8 weeks of age and older. BRAVECTO (fluralaner topical solution) for Dogs: The most commonly reported adverse reactions include vomiting, hair loss, diarrhea, lethargy, decreased appetite, and moist dermatitis/rash. BRAVECTO Topical Solution for Dogs has not been shown to be effective for 12-weeks’ duration in puppies less than 6 months of age. BRAVECTO Topical Solution for Dogs is not effective against lone star ticks beyond 8 weeks of dosing. For topical use only. Avoid oral ingestion. Indicated for dogs 6 months of age and older. BRAVECTO QUANTUM (fluralaner for extended-release injectable suspension) for Dogs: The most commonly reported adverse reactions in a US field study included lethargy, decreased appetite, vomiting, diarrhea, elevated liver enzymes and pruritus. BRAVECTO QUANTUM is not effective against lone star ticks beyond 8 months of dosing. Indicated for dogs 6 months of age and older.

BRAVECTO (fluralaner topical solution) for Cats: The most commonly reported adverse reactions include vomiting, itching, diarrhea, hair loss, decreased appetite, lethargy, and scabs/ulcerated lesions. BRAVECTO Topical Solution for Cats is not effective against American dog ticks beyond 8 weeks of dosing. BRAVECTO Topical Solution for Cats has not been shown to be effective for 12-weeks’ duration in kittens less than 6 months of age. The safety of BRAVECTO Topical Solution for Cats have not been established in breeding, pregnant and lactating cats. For topical use only. Avoid oral ingestion. Indicated for cats 6 months of age and older. BRAVECTO PLUS (fluralaner and moxidectin topical solution) for Cats: The most commonly reported adverse reactions include vomiting, hair loss, itching, diarrhea, lethargy, dry skin, elevated ALT, and hypersalivation. BRAVECTO PLUS has not been shown to be effective for 2 months in kittens less than 6 months of age. Use with caution in cats that are heartworm positive. The effectiveness of BRAVECTO PLUS to prevent heartworm disease after bathing or water immersion has not been evaluated. The safety of BRAVECTO PLUS have not been established in breeding, pregnant and lactating cats. Indicated for cats 6 months of age and older.

All BRAVECTO products contain fluralaner, which is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. Neurologic adverse reactions have been reported in cats receiving isoxazoline class drugs, even in cats without a history of neurologic disorders. Use with caution in cats with a history of neurologic disorders.

Contacts

Media Contact:

Laurel Sawicki

(908) 872-9783

laurel.mundth@merck.com

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

peter.dannenbaum@merck.com

Hayley Kasko

(732) 594-4237

hayley.kasko@merck.com