Newron announces agreement with the European Investment Bank (EIB) to extend the near-term tranche repayment dates of its 2018 Finance Contract

Newron Pharmaceuticals S.p.A.

/ Key word(s): Financing/Agreement

Newron announces agreement with the European Investment Bank (EIB) to extend the near-term tranche repayment dates of its 2018 Finance Contract

19.03.2026 / 07:00 CET/CEST

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


Newron announces agreement with the European Investment Bank (EIB) to extend the near-term tranche repayment dates of its 2018 Finance Contract

Parties agreed to extend the maturity date of all outstanding tranches under the Finance Contract to June 28, 2028

Amendments subject to execution of definitive agreements

Milan, Italy, and Morristown, NJ, USA, March 19, 2026, 07:00 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), today reported that EIB and Newron have agreed to amend certain terms of the 2018 Finance Contract and Options Rights Agreement, as previously amended in 2024.

In particular, the parties agreed to extend the maturity date of all outstanding tranches under the Finance Contract to June 28, 2028. The agreement contains further terms and conditions. The agreed amendments are subject to execution by the parties of definitive agreements. Details of the 2018 Finance Contract, as amended in 2024, can be found in Newron’s 2024 Annual Report, which is posted on the Company’s website here.

Roberto Galli, Newron’s CFO, commented: “We appreciate the support of the EIB in helping us align the contractual obligations of our loan agreement to the potential timing of certain upcoming significant value inflection points presented by our lead drug candidate evenamide, which is currently developed in the global pivotal ENIGMA-TRS Phase III program for the treatment of patients suffering from treatment-resistant schizophrenia.”
 

About Newron Pharmaceuticals
Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of innovative therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso near Milan, Italy, the Company has a strong track record of advancing neuroscience-based treatments from discovery to market. Newron’s lead compound, evenamide, is a first-in-class glutamate modulator and has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently developed in the global pivotal ENIGMA-TRS Phase III development program. Clinical trial results to date demonstrate the benefits of this drug candidate in the TRS as well as poorly responding patient population, with significant improvements across key efficacy measures increasing over time, as well as a favorable safety profile, which is uncommon for available antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron’s first marketed product, Xadago®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea. The product is commercialized by Newron’s partner Zambon, with Supernus Pharmaceuticals holding marketing rights in the U.S., and Meiji Seika responsible for development and commercialization in Japan and other key Asian territories. For more information, please visit: www.newron.com

For more information, please contact:

Newron
Stefan Weber – CEO; +39 02 6103 46 26, pr@newron.com

UK/Europe
Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting; +44 20 3727 1000, SCnewron@fticonsulting.com  

Switzerland
Valentin Handschin, IRF; +41 43 244 81 54, handschin@irf-reputation.ch

Germany/Europe
Anne Hennecke / Maximilian Schur, MC Services; +49 211 52925227, newron@mc-services.eu

USA
Paul Sagan, LaVoieHealthScience; +1 617 865 0041, psagan@lavoiehealthscience.com
 

Important Notices
This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.


19.03.2026 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: Newron Pharmaceuticals S.p.A.
via Antonio Meucci 3
20091 Bresso
Italy
Phone: +39 02 610 3461
Fax: +39 02 610 34654
E-mail: pr@newron.com
Internet: www.newron.com
ISIN: IT0004147952
WKN: A0LF18
Listed: Regulated Unofficial Market in Dusseldorf (Primärmarkt); SIX
EQS News ID: 2294008

 
End of News EQS News Service

2294008  19.03.2026 CET/CEST

DocMorris achieves 2025 targets – focus on profitability, growth and expansion of digital health platform

DocMorris AG / Key word(s): Annual Results

DocMorris achieves 2025 targets – focus on profitability, growth and expansion of digital health platform

19-March-2026 / 06:58 CET/CEST

Release of an ad hoc announcement pursuant to Art. 53 LR

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


Frauenfeld, 19 March 2026

Press release
Ad hoc announcement pursuant to Art. 53 LR

DocMorris achieves 2025 targets – focus on profitability, growth and expansion of digital health platform

  • Revenue and earnings targets for 2025 met with growth across all business units
  • Continued structural EBITDA improvement in the second half of 2025
  • Cash and cash equivalents of CHF 160 million
  • Partnership with Google to accelerate the implementation of the “AI First” platform strategy
  • Closure of the logistics site in Ludwigshafen and integration into Heerlen
  • Outlook: Management reaffirms EBITDA breakeven in the course of 2026

CEO Walter Hess says: “In the 2025 financial year, we deliberately concentrated on qualitative growth, increasing our operational efficiency, and technological differentiation. The evolution from a transaction-oriented online pharmacy business to a digital, AI-powered health platform is being further accelerated by our partnership with Google. With our AI health companion and the use of Gemini models as well as Google for Health assets, we can increase customer loyalty and address their health needs in a more personalised way. This solidifies our role as a driver of innovation and reinforces the technological foundation for sustainable profitability.”

CFO Daniel Wüest adds: “We achieved our revenue and earnings targets for 2025 and have a strong liquidity position. Particularly pleasing is the continuous structural improvement of our EBITDA in recent months, driven among other factors by the increase in marketing efficiency to support healthy Rx growth. We remain committed to our clear objective of reaching EBITDA break-even in the course of 2026 and positive free cash flow in the course of 2027.”

Structural earnings improvement in 2025

  • External revenue[1] increased by 11.1 per cent in local currency to CHF 1,185.7 million. Consolidated revenue rose by 12.4 per cent in local currency to CHF 1,124.5 million.
  • All segments and business units contributed to the revenue growth.
  • Despite additional marketing expenses of over CHF 11 million for Rx in the first three quarters, adjusted EBITDA improved slightly from minus CHF 48.6 million to minus CHF 48.2 million, with a continuous structural improvement throughout the year. Simultaneously, the gross margin increased by 0.9 percentage points to 22.2 per cent.
  • The number of active customers rose to 12.2 million in 2025, including an increase from 10.3 million to 11.0 million in the online pharmacy[2] and from 0.9 million to 1.2 million at TeleClinic.

Segment Germany grows double-digit

  • External revenue in the segment Germany grew by 11.7 per cent in local currency to CHF 1,122.5 million.
  • The significant revenue drivers were Rx and Digital Services.
  • Rx rose by 33.2 per cent in local currency, representing a 1.8-fold increase compared to the period before the CardLink introduction in April 2024.
  • The OTC business grew by 4.8 per cent in local currency – despite the discontinuation of the Zur Rose brand in Germany at the end of 2024.
  • Revenue with the core brand DocMorris increased disproportionately by more than 20 per cent.
  • Digital Services, including TeleClinic, Retail Media, and Marketplace, achieved a significant positive earnings contribution with revenue growth of 110 per cent in local currency.
  • Adjusted EBITDA in the segment Germany improved to minus CHF 46.3 million (previous year: minus CHF 47.2 million).
  • In 2026, growth in local currency of around 20 per cent for Rx, in the mid-single-digit percentage range for OTC, and in the mid-double-digit percentage range for Digital Services is targeted.

TeleClinic achieves dynamic, profitable growth

  • As Germany’s leading telemedicine platform, TeleClinic also recorded dynamic growth in 2025 with an increase of 124 per cent in local currency to CHF 25 million.
  • Over 6,500 established doctors in Germany use the platform. To date, over 4 million treatments have been carried out – 2 million of which were in 2025 alone, representing an increase of over 50 per cent compared to the previous year.
  • Given a telemedicine market penetration in Germany of still under 0.5 per cent, there remains substantial growth potential.
  • For 2026, revenue growth in the mid-double-digit percentage range and an increase in the EBITDA margin are expected for TeleClinic.

Successful Retail Media

  • With its subsidiary dmr Advertising, DocMorris has established itself as the leading healthcare retail media platform.
  • In 2025, the retail media business recorded revenue in the double-digit million range with a high EBITDA margin.
  • DocMorris expects continued strong, profitable growth dynamics for the coming years.

Focus on profitability and growth in the segment Europe

  • DocMorris increased its revenue in the Southern European marketplace business by 1.7 per cent in local currency to CHF 63.1 million.
  • Despite an increase in gross margin of 0.4 percentage points, adjusted EBITDA amounted to minus CHF 1.9 million.
  • Marketing mix was further optimised, and direct procurement for more than 950 brands on the platform was consolidated.

Partnership with Google to accelerate the implementation of the “AI First” platform strategy

  • DocMorris is accelerating the expansion of its AI-powered health platform through the partnership with Google (cf. press releases from DocMorris and Google dated 19 March 2026).
  • The partnership focuses on four core areas: AI health companion, AI-enhanced online pharmacy, operational efficiency, as well as cloud and data security.
  • In doing so, DocMorris is setting new standards for the patient journey and significantly enhancing operational performance.

Digital health and AI expert Angeli Möller joins DocMorris

  • David Masó, who has been with DocMorris since 2018 and most recently served as Chief AI Health Officer, is leaving the company in April 2026 to pursue a new professional challenge. The Board of Directors and the Executive Committee thank him sincerely for his many years of valuable contribution. The Executive Committee will be reduced from six to five members.
  • His duties will be assumed by Dr Angeli Möller as Chief Digital Health Officer and member of the extended Executive Committee. The PhD molecular biologist and AI expert brings extensive leadership experience from Roche and Bayer and is a co-founder of the “Alliance for Artificial Intelligence in Healthcare”.

Closure of Ludwigshafen site

  • DocMorris will close the Ludwigshafen site by the end of June 2026. Logistics will be integrated into the highly automated facility in Heerlen.
  • This relocation will increase efficiency, leading to a sustainable annual EBITDA improvement of over EUR 2 million from 2027 onwards.
  • The closure will result in one-off, extraordinary costs of EUR 3-4 million in 2026.
  • DocMorris is voluntarily making individual redundancy offers to the approximately 100 employees affected by the closure.

CO2e emissions reduced by 49 per cent

  • In 2025, DocMorris reduced CO2e emissions by 49 per cent (Scopes 1 and 2) through several measures.
  • Since 2022 (base year), the total CO2e reduction amounts to 87.5 per cent, meaning the medium-term target of 85 per cent by 2030 has already been exceeded.
  • Further measures to reduce CO2e emissions until Net Zero is achieved are planned (see TCFD report in the annual report).

Outlook

  • DocMorris has started according to plan into the new financial year.
  • Management reaffirms the EBITDA break-even in the course of 2026 and the free cash flow break-even in the course of 2027, as communicated last year.
  • Against this background, DocMorris provides the following guidance for 2026:
    • External revenue growth in the mid-single-digit to low teens percentage range;
    • Adjusted EBITDA of minus CHF 10 million to minus CHF 25 million;
    • Capital expenditure of around CHF 30 million.
  • Medium-term targets:
    • External revenue growth rate of around 15 per cent[3] (previously 20 per cent);
    • Capital expenditure of around CHF 30 million per year (previously around CHF 35 million);
    • EBITDA margin of around 8 per cent (as before).

The annual report published today, including the integrated sustainability report, can be downloaded here.

 

Key financials, in million CHF 2025 2024
External revenue) 1,185.7 1,085.0
Year-on-year-change of external revenue in % in local currency 11.1% 6.7%
Year-on-year change of external revenue in % 9.3% 4.6%
Net revenue 1,124.5 1,017.0
Year-on-year change of net revenue in % 10.6% 4.9%
Gross margin in % of net revenue 22.2% 21.3%
 
Earnings before interest, taxes, depreciation and amortisation adjusted (EBITDA adjusted)
-48.2 -48.6
in % of net revenue -4.3% -4.8%
Earnings before interest, taxes, depreciation and amortisation (EBITDA) -49.8 -43.9
in % of net revenue -4.4% -4.3%
Earnings before interest and taxes (EBIT) -96.9 -89.8
in % of net revenue -8.6% -8.8%
Net income / (loss) -134.4 -97.3
in % of net revenue -12.0% -9.6%
Equity 409.1 340.1
in % of total assets 49.6% 43.7%
Capital expenditure 27.3 28.6
Cash and cash equivalents (including current financial assets) 159.5 95.4
Number of employees in full-time equivalents 1’418 1’454

 

Conference call for analysts and the media at 11 am
Speakers: Walter Hess (CEO) and Daniel Wüest (CFO)

To register for the conference call, please use this link:
https://webcast.meetyoo.de/reg/oG1Cfib5tEMM
After registration, participants will receive a confirmation e-mail with personal dial-in details.
Please dial in approx. 5 minutes before the conference call begins.

To follow the livestream, please use this link:
https://www.webcast-eqs.com/docmorris-2025-fy
Sound and presentation in the web browser. Participants on the phone please mute the browser sound.
The playback can be viewed after the conference under the same link.

 

Investors and analyst contact
Moritz Stahlhut, Investor Relations Manager
Email: ir@docmorris.com, phone: +41 52 560 58 10

Media contact
Torben Bonnke, Director Communications
Email: media@docmorris.com, phone: +49 171 864 888 1

Agenda

16 April 2026 Q1/2026 Trading update
12 May 2026 Annual General Meeting, Zurich
19 August 2026 2026 Half-year results (conference call/webcast)
15 October 2026 Q3/2026 Trading update
4th quarter 2026 Capital Markets Day

 

DocMorris
The Swiss-based DocMorris AG is a leading company in the fields of online pharmacy, telemedicine and marketplace with strong brands in Germany and other European countries. Deliveries are mainly from the highly automated logistics centre in Heerlen, the Netherlands. TeleClinic is Germany’s largest telemedicine platform, connecting patients with more than 6,000 doctors. DocMorris operates leading marketplaces for health and personal care products in Southern Europe. With its broad range of products and services, DocMorris is pursuing its vision of becoming the leading digital health companion for everyone to manage their health in one click. Around 1,600 employees in Germany, the Netherlands, Spain, France, Portugal and Switzerland generated an external revenue of CHF 1,186 million serving over 12 million active customers in 2025. The shares of DocMorris AG are listed on the SIX Swiss Exchange (securities number 4261528, ISIN CH0042615283, ticker DOCM). For further information, please visit corporate.docmorris.com.
 

Disclaimer
This announcement contains certain forward-looking statements about DocMorris AG and its business, either explicitly or implicitly. Such statements involve known and unknown risks, uncertainties and other factors that could cause the actual results, financial position, performance or achievements of DocMorris AG to differ materially from the future results, performance or achievements expressed or implied by such forward-looking statements. DocMorris AG is making this announcement available as of today’s date and undertakes no obligation to update the forward-looking statements contained herein as a result of new information, future events or for any other reason.

 

[1] External revenue consists of the consolidated revenue of DocMorris plus online revenues of pharmacies supplied by DocMorris, less the consolidated revenue from supplying them.

[2] Customers supplied by DocMorris, either directly or through its partners.

[3] Back-end loaded due to increasing relative weight of Rx and Digital Services


End of Inside Information


Language: English
Company: DocMorris AG
Walzmühlestrasse 49
8500 Frauenfeld
Switzerland
ISIN: CH0042615283
Listed: SIX Swiss Exchange
EQS News ID: 2294036

 
End of Announcement EQS News Service

2294036  19-March-2026 CET/CEST

Innate Pharma Announces Conference Call and Webcast for Full Year 2025 Financial Results

Innate Pharma Announces Conference Call and Webcast for Full Year 2025 Financial Results




Innate Pharma Announces Conference Call and Webcast for Full Year 2025 Financial Results

MARSEILLE, France–(BUSINESS WIRE)–#Biotech–Regulatory News:


Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”), today announces that the Company will hold a conference call on Thursday, March 26, 2026 at 2 p.m. CET / 9 a.m. EDT, following the release of its financial results for the full year ending December 31, 2025.

Participants during the call will be:

  • Jonathan Dickinson, Chief Executive Officer
  • Sonia Quaratino, Executive Vice President, Chief Medical Officer
  • Yannis Morel, Executive Vice President, Chief Operating Officer
  • Stéphanie Cornen, Vice President, Investor Relations, Communication and Commercial Strategy
  • Frédéric Lombard, Senior Vice President, Chief Financial Officer

Details for the Virtual Event

The live webcast will be available at the following link:

https://events.q4inc.com/attendee/704730270

Participants may also join via telephone using the following registration link: https://events.q4inc.com/analyst/704730270?pwd=usHLLD39

This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event.

About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Leveraging its expertise on antibody-engineering and innovative target identification, Innate Pharma is developing innovative and differentiated next-generation antibody therapeutics.

Innate Pharma is advancing a portfolio of differentiated potential first and/or best-in-class assets, focused on areas of high unmet medical need, including IPH4502, a differentiated Nectin-4 ADC developed in solid tumors, lacutamab, an anti-KIR3DL2 antibody developed in cutaneous T cell lymphomas and peripheral T cell lymphomas, and monalizumab, an anti-NKG2A antibody developed in collaboration with AstraZeneca in non-small cell lung cancer.

Innate Pharma has established collaborations with leading biopharmaceutical companies, including Sanofi and AstraZeneca, as well as renowned academic and research institutions, to advance innovation in immuno-oncology.

Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.

Information about Innate Pharma shares

ISIN code
Ticker code
LEI

FR0010331421

Euronext: IPH Nasdaq: IPHA

9695002Y8420ZB8HJE29

Disclaimer on forward-looking information and risk factors

For a discussion of risks and uncertainties, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Contacts

For additional information, please contact:
Investors & Media Relations
Innate Pharma
Stéphanie Cornen

stephanie.cornen@innate-pharma.fr

Investor Relations
investors@innate-pharma.fr

Media
communication@innate-pharma.fr

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 longform 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 6K. The Form 6K should not be read together with, or construed as referring to, the supplemental longform 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 LinkedInFacebookInstagram, 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 longform 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 6K. The Form 6K should not be read together with, or construed as referring to, the supplemental longform 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 LinkedInFacebookInstagram, 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.