Medical Gas Market Trends and Forecast Report 2025-2033 | Home Healthcare Trends, Chronic Disease Burden, and Medical Tech Advancements Drive Growth – ResearchAndMarkets.com




Medical Gas Market Trends and Forecast Report 2025-2033 | Home Healthcare Trends, Chronic Disease Burden, and Medical Tech Advancements Drive Growth – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Medical Gas Market Share Analysis and Size – Growth Trends and Forecast Report 2025-2033” report has been added to ResearchAndMarkets.com’s offering.

The Global Medical Gas Market is expected to reach US$ 28.61 billion by 2033 from US$ 14.41 billion in 2024, with a CAGR of 7.92% from 2025 to 2033. Some of the key reasons driving the market are the growing tendency toward home healthcare and telemedicine, the prevalence of chronic illnesses including respiratory and cardiovascular diseases (CVDs), and many developments in medical technology.

Global Medical Gas Industry Overview

The aging population, rising rates of chronic respiratory conditions, and improvements in healthcare infrastructure are all contributing to the substantial expansion of the worldwide medical gas market. Medical gases, such as carbon dioxide, nitrous oxide, and oxygen, are necessary for a number of therapeutic and diagnostic uses in ambulatory surgery centers, home healthcare settings, and hospitals. The need for portable medical gas solutions, such oxygen concentrators, has increased due to the growing demand for home healthcare services.

Due to growing healthcare sectors and government expenditures in medical infrastructure, the Asia-Pacific region is expected to develop at the highest rate, while North America already has a significant market share. The availability and distribution of medical gases may be impacted by supply chain interruptions and strict regulatory restrictions, which provide difficulties for the sector.

The need for medicinal gases is also being fueled by the increasing incidence of asthma. The Australian Institute of Health and Welfare (AIHW) estimates that in 2023, asthma accounted for 35% of the entire burden related to all respiratory disorders and 2.5% of the overall illness burden. Nitrous oxide, carbon dioxide, nitrogen, oxygen, and medical air are some of the most often utilized medical gases in hospitals.

One of the leading companies, Air Liquide Healthcare, provides medicinal gases to 20,000 hospitals and new healthcare facilities, and assists over 2 million people in managing chronic illnesses. Medical gases including heliox, oxygen, and lung gas mixes are widely employed in the diagnosis and treatment of certain respiratory conditions.

Additionally, the need for portable medical gases, such as oxygen concentrators, is rising as more people choose home-based healthcare. In order to ensure that chronic patients receive the oxygen therapy they require at home, this change places an emphasis on convenience and continuity of care. Home healthcare has become increasingly popular in recent years and is predicted to continue to grow. Many medical illnesses may now be successfully treated at home, including those that require ventilator assistance, mixed gas therapies, and long-term oxygen therapy.

Additionally, it is anticipated that rising home healthcare reimbursement would support market expansion throughout the projection period. The Firesafe Cannula Valve, for example, was formally covered by Iowa Medicaid in November 2023 and was given the HCPCS number E0700 for reimbursement. In the event that the oxygen tubing downstream burns, this novel mechanism functions as a thermal fuse and instantly stops the oxygen supply. Thermal fuses must be installed in all home oxygen systems in the United Kingdom. Interestingly, the US has a 20-fold greater risk of death from oxygen-related flames than England, where installing firebreaks has been required since 2006.

Growth Drivers for the Medical Gas Market

Numerous Medical Technology Advancements

Laparoscopy and endoscopy are examples of minimally invasive (MI) surgical techniques that have been made possible by technological breakthroughs. Surgeons can execute treatments with fewer incisions, quicker patient recovery, and less tissue stress when medical gases like carbon dioxide are utilized to provide a clean operating field. Furthermore, more specialized and individualized treatment for respiratory problems is now possible because to developments in respiratory therapy equipment.

The World Health Organization reports that asthma and other chronic respiratory diseases (CRDs) are on the rise worldwide, with 3.2 million deaths from COPD and 262 million cases of asthma in 2019. Advanced oxygen treatment equipment, such as portable oxygen delivery systems and oxygen concentrators, are used to supply medical gases like oxygen. Additionally, a number of developments in dermatology and cryosurgery have increased the use of medicinal gases, such as liquid nitrogen, to freeze and remove sick or aberrant tissue. The market is being driven by the regulated and focused treatment that cryotherapy equipment provides, which minimizes harm to nearby healthy tissue.

Growing Preference for Telemedicine and Home Healthcare

Medical gases, such as oxygen, are frequently given to patients in their homes as part of home healthcare. To control their symptoms and enhance their quality of life, patients with long-term respiratory diseases like COPD need oxygen treatment. Medical oxygen gases are in greater demand as a result of the shift toward home healthcare, which enables patients to obtain oxygen therapy without the need for extended hospital stays. Furthermore, nebulization, pain relief, and respiratory therapies are only a few of the uses for medical gases that go beyond oxygen therapy. As a result of this trend, fewer extended hospital stays are required, which raises the requirement for medical oxygen.

Additionally, as cardiovascular disorders are thought to cause 17.9 million deaths worldwide each year, medicinal gases – such as oxygen – are essential for treating associated ailments, which raises the need for at-home therapies. The need for medical gases is further increased by the growth of telemedicine and home healthcare, which enables patients to receive a greater variety of medical gas treatments in the convenience of their own homes.

Rising Rates of Chronic Conditions, Including Heart and Respiratory Conditions

Medical gases like oxygen are necessary for respiratory support because to the rising prevalence of respiratory conditions such asthma, interstitial lung disorders, and chronic obstructive pulmonary disease (COPD). Chronic respiratory disorders (CRDs), such as asthma, interstitial lung diseases, and chronic obstructive pulmonary disease (COPD), are on the rise, according to the World Health Organization (WHO). According to the Global Asthma Report, asthma affects an estimated 262 million people globally, and COPD alone was responsible for almost 3.2 million deaths in 2019.

Oxygen treatment is necessary for patients who have trouble breathing in order to keep their blood oxygen levels sufficient and to relieve their symptoms. Furthermore, medicinal gases are frequently needed for diagnostic and therapeutic purposes in cardiovascular illnesses, such as heart failure, coronary artery disease, and hypertension. In order to ensure patient comfort and stability during cardiovascular procedures, nitrous oxide is used as an anesthetic agent. Additionally, medicinal gases are essential for palliative care for individuals with chronic illnesses that have progressed.

Challenges in the Medical Gas Market

Stringent Regulatory Compliance

Because medical gases are essential to patient care and safety, the market is subject to strict regulatory compliance. To guarantee that medical gases fulfill therapeutic needs, regulatory agencies impose stringent criteria for purity, labeling, packing, and transportation. Operational complexity can be further increased by the constant monitoring, certification procedures, and thorough paperwork that are frequently required to comply with these rules. To maintain compliance, manufacturers must spend more on qualified staff and sophisticated quality control systems, which raises prices. Furthermore, managing disparate regional restrictions might make international distribution plans more difficult. Although these regulations guarantee patient safety and product dependability, they also place a financial and logistical strain on manufacturers, particularly newly established smaller businesses.

High Production and Storage Costs

Complex infrastructure and procedures are needed to produce and store medicinal gases, which raises supply chain costs. To guarantee purity and safety, the gases need to be produced under exacting circumstances, which calls for cutting-edge technology and strict adherence to regulations. Energy-intensive systems are needed for compression and liquefaction, and storage facilities need to be built to withstand temperature changes, pollution, and leakage.

Specialized, frequently temperature-controlled containers that adhere to stringent rules are also necessary for the transportation of these gases. Long-term costs are further increased by continuing storage system monitoring and maintenance. These elements work together to make medical gases far more expensive to produce, handle, and distribute than many other medical supplies, which puts a strain on both healthcare providers and suppliers.

Key Players Analyzed: Overview, Key Persons, Recent Development & Strategies, Revenue Analysis

• Air Liquide
• Linde PLC
• Atlas Copco Group
• INOX-Air Products Inc.
• TAIYO NIPPON SANSO CORPORATION
• MATHESON TRI-GAS, INC.
• HORIBA Group
• SOL India Private Limited

Key Attributes:

Key Topics Covered:

1. Introduction

2. Research Methodology

2.1 Data Source

2.1.1 Primary Sources

2.1.2 Secondary Sources

2.2 Research Approach

2.2.1 Top-Down Approach

2.2.2 Bottom-Up Approach

2.3 Forecast Projection Methodology

3. Executive Summary

4. Market Dynamics

4.1 Growth Drivers

4.2 Challenges

5. Global Medical Gas Market

5.1 Historical Market Trends

5.2 Market Forecast

6. Medical Gas Market Share Analysis

6.1 By Product

6.2 By Application

6.3 By End Use

6.4 By Countries

7. Product

7.1 Pure Gases

7.2 Gas Mixtures

8. Application

8.1 Therapeutics

8.2 Diagnostics

8.3 Others

9. End Use

9.1 Hospitals

9.2 Pharmaceutical & Biotechnology Companies

9.3 Ambulatory Surgical Centers

9.4 Diagnostic & Research Laboratories

9.5 Academic & Research Institutes

9.6 Home Healthcare

10. Countries

10.1 North America

10.1.1 United States

10.1.2 Canada

10.2 Europe

10.2.1 France

10.2.2 Germany

10.2.3 Italy

10.2.4 Spain

10.2.5 United Kingdom

10.2.6 Belgium

10.2.7 Netherlands

10.2.8 Turkey

10.3 Asia-Pacific

10.3.1 China

10.3.2 Japan

10.3.3 India

10.3.4 South Korea

10.3.5 Thailand

10.3.6 Malaysia

10.3.7 Indonesia

10.3.8 Australia

10.3.9 New Zealand

10.4 Latin America

10.4.1 Brazil

10.4.2 Mexico

10.4.3 Argentina

10.5 Middle East & Africa

10.5.1 Saudi Arabia

10.5.2 UAE

10.5.3 South Africa

11. Porter’s Five Forces Analysis

11.1 Bargaining Power of Buyers

11.2 Bargaining Power of Suppliers

11.3 Degree of Rivalry

11.4 Threat of New Entrants

11.5 Threat of Substitutes

12. SWOT Analysis

12.1 Strength

12.2 Weakness

12.3 Opportunity

12.4 Threat

13. Key Players Analysis

For more information about this report visit https://www.researchandmarkets.com/r/er19ws

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Devonian Announces Closing of a Private Placement of Units




Devonian Announces Closing of a Private Placement of Units

Not for distribution to United States newswire services or for dissemination in the United States

QUEBEC CITY–(BUSINESS WIRE)–Devonian Health Group Inc. (“Devonian” or the “Corporation”) (TSXV: GSD; OTCQB: DVHGF), a clinical stage corporation focused on developing unique solutions to inflammatory diseases, announces that it has closed its non-brokered private placement for aggregate gross proceeds of $2,272,999.85 (the “Offering”). The Offering consisted of the issuance of 15,153,332 units of the Corporation (the “Units”) at a price of $0.15 per Unit. Each Unit consists of one subordinate voting share of the Corporation (a “Share”) and one Share purchase warrant (a “Warrant”). Each Warrant entitles the holder thereof to purchase one Share at an exercise price of $0.20 per Share for a period of 24 months from the date of issuance thereof.

The proceeds of the Offering will primarily be used to finance working capital related to the Corporation’s corporate overhead and research and development activities.

A total of $2,700.00 cash finder’s fees were paid in connection with this Offering. The Shares and the Warrants issued pursuant to this Offering are subject to a restricted hold period of four months and one day, ending on December 8, 2025, under applicable Canadian securities laws. The Offering remains subject to the final approval of the TSX Venture Exchange.

About Devonian

Devonian Health Group Inc. is a clinical stage pharmaceutical company specializing in the development of drugs for various auto-immune inflammatory conditions with novel therapeutic approaches to targeting unmet medical needs. Devonian’s core strategy is to develop prescription drugs for the treatment of inflammatory autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian’s focus is further supported by a U.S. Food and Drug Administration set of regulatory guidelines favoring a more efficient drug development pathway for prescription botanical drug products over those of traditional prescription medicines.

Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian also owns a commercialization subsidiary, Altius Healthcare Inc., focused on selling prescription pharmaceutical products in Canada, under license from brand name pharmaceutical companies.

Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Québec, Canada where it owns a state-of-the art extraction facility with full traceability ‘from the seed to the pill’. Devonian is traded publicly on the TSX Venture Exchange (the “Exchange”) (TSXV: GSD) and on OTCQB exchange (OTCQB: DVHGF).

For more information, visit www.groupedevonian.com

Cautionary Note Regarding Forward-Looking Statements

All statements, other than statements of historical fact, contained in this press release including, but not limited to those relating to the intended use of proceeds, the final approval of the TSX Venture Exchange in connection with the Offering and generally, the above “About Devonian” paragraph, which essentially describes the Corporation’s outlook, constitute “forward-looking information” or “forward-looking statements” within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release.

Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Corporation as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect. Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that these assumptions will prove to be correct and there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.

By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. Readers are cautioned not to place undue reliance on these forward-looking statements as a number of important risk factors and future events could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates, assumptions and intentions expressed in such forward-looking statements. All of the forward-looking statements made in this press release are qualified by these cautionary statements and those made in our other filings with the applicable securities regulators of Canada. The Corporation disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) and may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and applicable state securities laws. “United States” and “U.S. person” are as defined in Regulation S under the U.S. Securities Act.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contacts

Dr André P. Boulet, PhD

Chairman and Chief Executive Officer

Devonian Health Group inc.

Telephone: (450) 979-2916

Email: investors@groupedevonian.com

Viridian Therapeutics Highlights Recent Progress and Reports Second Quarter 2025 Financial Results




Viridian Therapeutics Highlights Recent Progress and Reports Second Quarter 2025 Financial Results

– Robust execution with multiple upcoming near-term milestones, including planned Biologics License Application (BLA) submission for veligrotug on track in 2H 2025 and expected U.S. commercial launch in 2026 –

– Breakthrough Therapy Designation (BTD) for veligrotug announced in May 2025, a designation granted by the Food and Drug Administration (FDA) to drug candidates where clinical evidence shows they may offer substantial improvement over existing therapies –

– Veligrotug showed a strong durability of proptosis response and continued to be generally well-tolerated at 52 weeks in THRIVE –

– Announced exclusive license agreement with Kissei Pharmaceutical to develop and commercialize veligrotug and VRDN-003 in Japan for $70 million upfront and potential future milestones up to $315 million and royalties –

– Cash position of $563.4 million as of June 30, 2025, supporting cash runway into 2H 2027 –

WALTHAM, Mass.–(BUSINESS WIRE)–Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing and commercializing potential best-in-class medicines for serious and rare diseases, today reported recent business highlights and financial results for the second quarter ended June 30, 2025.

“Veligrotug’s recent Breakthrough Therapy Designation as well as the continued and consistent performance of veligrotug across all of the endpoints and timepoints in our pivotal clinical trials, including the latest update on durability of response, showcase the momentum Viridian is building as we approach our planned BLA filing and expected commercial launch,” said Steve Mahoney, Viridian’s President and CEO. “We are making extraordinary progress on our commercial preparation and we plan to be launch-ready on a Priority Review designation timeline, if we receive it. In parallel to U.S. commercial launch planning, the recently announced license agreement with Kissei to develop and commercialize veligrotug and VRDN-003 in Japan further validates the value of our TED programs and the potential broad global opportunities in front of us. Overall, we are very pleased with our progress across our portfolio, including continuing to advance our FcRn inhibitors, VRDN-006 and VRDN-008, and look forward to sharing the outcomes from our upcoming milestones.”

Recent Business Highlights

Veligrotug for Active and Chronic Thyroid Eye Disease

• Positive Pivotal Trial Readouts. Veligrotug achieved all primary and secondary endpoints across proptosis, Clinical Activity Score (CAS), and diplopia in each of its two pivotal phase 3 clinical trials, THRIVE and THRIVE-2 for patients with active and chronic TED respectively.
• Robust Clinical Profile. This is the first and only drug candidate in chronic TED to demonstrate statistically significant and clinically meaningful improvement and resolution of diplopia in a global phase 3 clinical trial to date.
• Generally Well Tolerated Safety Profile. Veligrotug was generally well-tolerated in its pivotal phase 3 clinical trials, THRIVE and THRIVE-2.
• Breakthrough Therapy Designation. The FDA granted Breakthrough Therapy Designation (BTD) to veligrotug for the treatment of TED.
  • Our application was based on veligrotug’s (i) consistent and robust improvement and resolution of diplopia in chronic TED, and (ii) rapid onset of proptosis response.
  • BTD supports eligibility for Priority Review which, if received, could accelerate our timing for veli commercial launch.
• Durability of Response. Demonstrated positive long-term durability data in THRIVE, with 70% of proptosis responders at 15 weeks maintaining that response at 52 weeks, which is 40 weeks after patients received their last dose in the clinical trial.
• Biologics License Application. Viridian is on track to submit a BLA to the U.S. FDA in the second half of 2025 and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the first half of 2026.

VRDN-003 for Active and Chronic Thyroid Eye Disease

• Topline Data – Pivotal Clinical Trials. Anticipate topline data from both REVEAL-1 and REVEAL-2 in the first half of 2026; BLA submission planned for year-end 2026.
• Planned Commercial Profile. Plan to launch VRDN-003, if approved, with a commercially validated, low-volume autoinjector designed for patients to infrequently self-administer at home.

Japan Licensing with Kissei Pharmaceutical

• As announced in July, Viridian entered into an exclusive license agreement with Kissei Pharmaceutical to develop and commercialize veligrotug and VRDN-003 in Japan.
  • Viridian will receive an upfront cash payment of $70 million, with the potential to receive an additional $315 million in development, regulatory, and commercial milestones.
  • Viridian also receives tiered royalties on net sales in Japan with percentages ranging from the 20s to mid-30s.
  • Kissei will be responsible for all development, regulatory, and commercialization activities, and associated costs, in Japan.

FcRn Inhibitor Portfolio

• VRDN-006 Healthy Volunteer Data. Viridian expects data from the VRDN-006 phase 1 clinical trial in healthy volunteers in Q3 2025, including proof-of-concept IgG reduction
• VRDN-008 Investigational New Drug (IND). Submission on track for year-end 2025
  • As previously disclosed, after a single, high dose in non-human primates, VRDN-008 showed a longer half-life head-to-head versus efgartigimod and a more sustained IgG reduction.

Expected Upcoming Milestones

• Veligrotug
  • BLA submission in second half 2025
  • U.S. commercial launch in 2026, if approved
  • MAA submission in first half 2026
• VRDN-003
  • Topline data in first half 2026
• VRDN-006
  • Healthy volunteer clinical data in Q3 2025
• VRDN-008
  • IND submission year-end 2025

Financial Results

• Cash Position: Cash, cash equivalents, and short-term investments were $563.4 million as of June 30, 2025, compared with $636.6 million as of March 31, 2025. The company believes that its current cash, cash equivalents, and short-term investments will be sufficient to fund its currently planned operations into the second half of 2027.

• R&D Expenses: Research and development expenses were $86.6 million during the three months ended June 30, 2025, compared to $56.2 million during the three months ended June 30, 2024. The increase in research and development expenses was driven by increased costs associated with conducting more clinical trials than the same period last year, including multiple ongoing phase 3 clinical trials for both veligrotug and VRDN-003 and a phase 1 clinical trial for VRDN-006, as well as increased personnel-related costs as a result of increased headcount.

• G&A Expenses: General and administrative expenses were $20.2 million during the three months ended June 30, 2025, compared to $16.1 million during the three months ended June 30, 2024. The increase was driven by increased costs associated with preparatory commercial activities for veligrotug, as well as increased legal, accounting, and other professional service costs and personnel-related costs to support the growing organization.

• Shares Outstanding: As of June 30, 2025, Viridian had 100,320,386 shares of common stock outstanding on an as-converted basis, which included 81,651,186 shares of common stock and an aggregate 18,669,200 shares of common stock issuable upon the conversion of 134,864 and 145,160 shares of Series A and Series B preferred stock, respectively.

About Viridian Therapeutics

Viridian is a biopharmaceutical company focused on discovering, developing, and commercializing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas.

Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED) and a portfolio of inhibitors to the neonatal Fc receptor (FcRn). In TED, the company is conducting a pivotal program for veligrotug, including two global phase 3 clinical trials (THRIVE and THRIVE-2), to evaluate its efficacy and safety in patients with active and chronic TED. Both THRIVE and THRIVE-2 reported positive topline data, meeting all the primary and secondary endpoints of each study. For the FcRn portfolio, Viridian is developing VRDN-006, a Fc fragment that inhibits FcRn, and VRDN-008, a half-life extended FcRn inhibitor.

About Veligrotug

Veligrotug is an intravenously delivered, anti-insulin-like growth factor-1 receptor (IGF-1R) antibody in phase 3 development for thyroid eye disease, with the potential to be the IV treatment-of-choice for active and chronic TED patients. Based on clinical data to date, veligrotug has demonstrated robust clinical activity and was generally well-tolerated.

In its pivotal phase 3 clinical trials, THRIVE and THRIVE-2, veligrotug demonstrated a rapid onset of treatment effect and statistically significant and clinically meaningful reduction and resolution of diplopia. Both THRIVE and THRIVE-2 reported positive topline data, meeting all the primary and secondary endpoints of each study. This is the first data set from a global phase 3 clinical trial in chronic TED patients to demonstrate statistically significant diplopia response and resolution.

About VRDN-003

VRDN-003 is a subcutaneously delivered, half-life extended, potential best-in-class anti-IGF-1R antibody. VRDN-003 has the same binding domain as veligrotug and was engineered to have a longer half-life. In a phase 1 healthy volunteer clinical trial, VRDN-003 showed a half-life of 40-50 days, 4-5x that of veligrotug. Pharmacokinetics modeling predicted that VRDN-003 exposure levels after Q4W and Q8W dosing achieve the range of veligrotug exposures that showed robust clinical activity in a two-infusion phase 2 clinical trial in TED. Viridian is conducting a pivotal program for VRDN-003, including two phase 3 clinical trials assessing VRDN-003 dosed Q4W and Q8W in active and chronic TED, REVEAL-1 and REVEAL-2, respectively.

About VRDN-006 and VRDN-008

VRDN-006 is a highly selective Fc fragment which inhibits FcRn and is designed to be a convenient subcutaneous and self-administered option for patients. Viridian is studying VRDN-006 in a first-in-human phase 1 clinical trial in healthy volunteers.

VRDN-008 is a half-life extended FcRn inhibitor comprising an Fc fragment and an albumin-binding domain designed to prolong IgG suppression and provide a potentially best-in-class subcutaneous option for patients. VRDN-008 showed a longer half-life than efgartigimod and led to a more sustained IgG reduction after a single, high dose in non-human primates.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, “anticipate,” “believe,” “become,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “might,” “on track,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: preclinical development, clinical development, and anticipated commercialization of Viridian’s product candidates veligrotug (formerly VRDN-001), VRDN-003, VRDN-006, and VRDN-008; anticipated data results and timing of their disclosure, including VRDN-003 topline data from the REVEAL-1 and REVEAL-2 trials in the first half of 2026 and anticipated VRDN-006 clinical data, including proof-of-concept IgG reduction data, in the third quarter of 2025; regulatory interactions and anticipated timing of regulatory submissions, including the anticipated BLA submissions for veligrotug in the second half of 2025 and VRDN-003 by year-end 2026, MAA submission for veligrotug in the first half of 2026, and IND submission for VRDN-008 by year-end 2025, pending data; the impact of Breakthrough Therapy Designation, including eligibility for Priority Review, or any other FDA designations; the potential utility, efficacy, potency, safety, clinical benefits, clinical response, convenience, and number of indications of veligrotug, VRDN-003, VRDN-006, and VRDN-008, including Viridian’s view of the strength of the THRIVE durability and safety resolution data and veligrotug’s robust clinical profile; veligrotug’s potential to be the IV treatment-of-choice for active and chronic TED; potential market sizes and market opportunities, including for Viridian’s product candidates; Viridian’s product candidates potentially being best-in-class; Viridian’s expectations regarding the potential commercialization of veligrotug and VRDN-003, if approved, including the anticipated U.S. launch of veligrotug in 2026, plans to launch VRDN-003 with a low-volume autoinjector, and in Japan under the agreement with Kissei; Viridian’s partnership with Kissei, including that it supports the potential for broad global opportunities; Viridian’s ability to receive development, regulatory, and commercial milestone payments and receive royalties on the commercial sale of our product candidates, if approved, pursuant to the agreement with Kissei; and that Viridian’s cash, cash equivalents and short-term investments will be sufficient to fund its operations into the second half of 2027.

New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: potential utility, efficacy, potency, safety, clinical benefits, clinical response, and convenience of Viridian’s product candidates; that results or data from completed or ongoing clinical trials may not be representative of the results of ongoing or future clinical trials; that preliminary data may not be representative of final data; the timing, progress and plans for our ongoing or future research, preclinical, and clinical development programs; changes to trial protocols for ongoing or new clinical trials; expectations and changes regarding the timing for regulatory filings; regulatory interactions; expectations and changes regarding the timing for enrollment and data; uncertainty and potential delays related to clinical drug development; the duration and impact of regulatory delays in our clinical programs; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates; manufacturing risks; competition from other therapies or products; estimates of market size; other matters that could affect the sufficiency of existing cash, cash equivalents, and short-term investments to fund operations; our financial position and projected cash runway; our future operating results and financial performance; Viridian’s intellectual property position; the timing of preclinical and clinical trial activities and reporting results from same; that our product candidates may not be commercially successful, if approved; and other risks described from time to time in the “Risk Factors” section of our filings with the Securities and Exchange Commission (SEC), including those described in our most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as applicable, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date hereof.

Contacts

IR@viridiantherapeutics.com
Media@viridiantherapeutics.com

Cencora Reports Fiscal 2025 Third Quarter Results




Cencora Reports Fiscal 2025 Third Quarter Results

Revenue of $80.7 billion for the Third Quarter, an 8.7 percent Increase Year-Over-Year

Third Quarter GAAP Diluted EPS of $3.52 and Adjusted Diluted EPS of $4.00

Adjusted Diluted EPS Guidance Range Raised to $15.85 to $16.00 for Fiscal 2025

CONSHOHOCKEN, Pa.–(BUSINESS WIRE)–Cencora, Inc. (NYSE: COR) reported that in its fiscal year 2025 third quarter ended June 30, 2025, revenue increased 8.7 percent year-over-year to $80.7 billion. On the basis of U.S. generally accepted accounting principles (GAAP), diluted earnings per share (EPS) was $3.52 for the third quarter of fiscal 2025 compared to $2.42 in the prior year third quarter. Adjusted diluted EPS, which is a non-GAAP financial measure that excludes items described below, increased 19.8 percent to $4.00 in the fiscal third quarter from $3.34 in the prior year third quarter.

Cencora is updating its outlook for fiscal year 2025. The Company does not provide forward-looking guidance on a GAAP basis as discussed below in Fiscal Year 2025 Expectations. Adjusted diluted EPS guidance has been raised from the previous range of $15.70 to $15.95 to a range of $15.85 to $16.00.

“Cencora delivered strong financial results in the third fiscal quarter, driven by our pharmaceutical-centric strategy and focus on our growth priorities,” said Robert P. Mauch, President and Chief Executive Officer of Cencora.

“Our teams are fueling our growth as they identify opportunities and customer-centric solutions that strengthen our value proposition as the partner of choice,” Mauch continued. “We are guided by our purpose and focused on our strategic drivers of digital transformation, investing in our talent and culture, prioritizing growth-oriented investments and increasing productivity.”

Third Quarter Fiscal Year 2025 Summary Results

Below, Cencora presents descriptive summaries of the Company’s GAAP and adjusted (non-GAAP) quarterly results. In the tables that follow, GAAP results and GAAP to non-GAAP reconciliations are presented. For more information related to non-GAAP financial measures, including adjustments made in the periods presented, please refer to the “Supplemental Information Regarding Non-GAAP Financial Measures” following the tables.

Third Quarter GAAP Results

• Revenue: In the third quarter of fiscal 2025, revenue was $80.7 billion, up 8.7 percent compared to the same quarter in the previous fiscal year, due to an 8.5 percent increase in revenue within the U.S. Healthcare Solutions segment and a 10.5 percent increase in revenue within the International Healthcare Solutions segment.

• Gross Profit: Gross profit in the third quarter of fiscal 2025 was $2.9 billion, a 20.6 percent increase compared to the same quarter in the previous fiscal year, primarily due to the increase in gross profit in both reportable segments and a LIFO credit in the current year quarter in comparison to LIFO expense in the prior year quarter, offset in part by lower gains from antitrust litigation settlements in the current year quarter. Gross profit as a percentage of revenue was 3.60 percent, an increase of 35 basis points from the prior year quarter due to the increase in U.S. Healthcare Solutions gross profit margin, driven primarily from the January 2025 acquisition of Retina Consultants of America (RCA).

• Operating Expenses: In the third quarter of fiscal 2025, operating expenses were $2.0 billion, a 17.3 percent increase compared to the same quarter in the previous fiscal year, primarily driven by an increase in distribution, selling, and administrative expenses as a result of the January 2025 acquisition of RCA and to support our revenue growth.

• Operating Income: In the third quarter of fiscal 2025, operating income was $0.9 billion, an increase of 29.0 percent compared to the same quarter in the previous fiscal year due to the increase in gross profit, offset in part by the increase in operating expenses. Operating income as a percentage of revenue was 1.08 percent in the third quarter of fiscal 2025 compared to 0.91 percent in the prior year quarter.

• Interest Expense, Net: In the third quarter of fiscal 2025, net interest expense was $81.8 million, an increase of $50.5 million from the prior year quarter primarily due to an increase in interest expense as a result of our issuance of senior notes and a variable-rate term loan to finance a portion of the January 2025 acquisition of RCA, and increased revolving credit facility borrowings to cover short-term working capital needs.

• Effective Tax Rate: The effective tax rate was 23.0 percent for the third quarter of fiscal 2025 compared to 22.4 percent in the prior year quarter.

• Diluted Earnings Per Share: Diluted earnings per share was $3.52 in the third quarter of fiscal 2025, a 45.5 percent increase compared to $2.42 in the previous fiscal year’s third quarter.

• Diluted Shares Outstanding: Diluted weighted average shares outstanding for the third quarter of fiscal 2025 were 195.2 million, a decrease of 2.4 percent versus the prior year third quarter primarily due to share repurchases.

Third Quarter Adjusted (non-GAAP) Results

• Revenue: No adjustments were made to the GAAP presentation of revenue. In the third quarter of fiscal 2025, revenue was $80.7 billion, up 8.7 percent compared to the same quarter in the previous fiscal year, due to an 8.5 percent increase in revenue within the U.S. Healthcare Solutions segment and a 10.5 percent increase in revenue within the International Healthcare Solutions segment.

• Adjusted Gross Profit: Adjusted gross profit in the third quarter of fiscal 2025 was $2.9 billion, a 20.7 percent increase compared to the same quarter in the previous fiscal year due to the increase in gross profit in both reportable segments. Adjusted gross profit as a percentage of revenue was 3.55 percent in the fiscal 2025 third quarter, an increase of 36 basis points from the prior year quarter due to the increase in U.S. Healthcare Solutions gross profit margin, driven primarily from the January 2025 acquisition of RCA.

• Adjusted Operating Expenses: In the third quarter of fiscal 2025, adjusted operating expenses were $1.8 billion, a 20.8 percent increase compared to the same quarter in the previous fiscal year, primarily driven by an increase in distribution, selling, and administrative expenses as a result of the January 2025 acquisition of RCA and to support our revenue growth.

• Adjusted Operating Income: In the third quarter of fiscal 2025, adjusted operating income was $1.1 billion, a 20.6 percent increase compared to the same quarter in the prior fiscal year due to the increase in gross profit, offset in part by the increase in operating expenses. Adjusted operating income as a percentage of revenue was 1.31 percent in the fiscal 2025 third quarter, an increase of 13 basis points when compared to the prior year quarter.

• Interest Expense, Net: No adjustments were made to the GAAP presentation of net interest expense. In the third quarter of fiscal 2025, net interest expense was $81.8 million, an increase of $50.5 million from the prior year quarter primarily due to an increase in interest expense as a result of our issuance of senior notes and a variable-rate term loan to finance a portion of the January 2025 acquisition of RCA, and increased revolving credit facility borrowings to cover short-term working capital needs.

• Adjusted Effective Tax Rate: The adjusted effective tax rate was 20.7 percent for the third quarter of fiscal 2025 compared to 21.0 percent in the prior year quarter.

• Adjusted Diluted Earnings Per Share: Adjusted diluted earnings per share was $4.00 in the third quarter of fiscal 2025, a 19.8 percent increase compared to $3.34 in the previous fiscal year’s third quarter.

• Diluted Shares Outstanding: No adjustments were made to the GAAP presentation of diluted shares outstanding. Diluted weighted average shares outstanding for the third quarter of fiscal 2025 were 195.2 million, a decrease of 2.4 percent versus the prior year third quarter primarily due to share repurchases.

Segment Discussion

The Company is organized geographically based upon the products and services it provides to its customers under two reportable segments: U.S. Healthcare Solutions and International Healthcare Solutions.

U.S. Healthcare Solutions

U.S. Healthcare Solutions revenue was $72.9 billion in the third quarter of fiscal 2025, an increase of 8.5 percent compared to the same quarter in the previous fiscal year due to overall market growth primarily driven by unit volume growth, including increased sales of products labeled for diabetes and/or weight loss in the GLP-1 class and specialty products to physician practices and health systems. Segment operating income of $0.9 billion in the third quarter of fiscal 2025 was up 29.1 percent compared to the same quarter in the previous fiscal year primarily due to the increase in gross profit, as a result of increased product sales and the January 2025 acquisition of RCA, offset in part by the increase in operating expenses.

International Healthcare Solutions

International Healthcare Solutions revenue was $7.8 billion in the third quarter of fiscal 2025, an increase of 10.5 percent compared to the previous fiscal year’s third quarter. Segment operating income in the third quarter of fiscal 2025 was $156.2 million, a decrease of 12.9 percent, primarily due to lower operating income at our global specialty logistics business and our specialized consulting services business. On a constant currency basis, International Healthcare Solutions revenue increased by 8.8 percent in the third quarter of fiscal 2025 compared to the previous fiscal year’s third quarter, while segment operating income decreased by 16.2 percent.

Recent Company Highlights & Milestones

• Good Neighbor Pharmacy, Cencora’s national franchise for independent pharmacies, brought together in July 2025 more than 4,000 community pharmacy owners, industry experts and partners for its 14^th annual ThoughtSpot, the flagship tradeshow and conference serving as a celebration of Good Neighbor Pharmacy and its member pharmacies.

Fiscal Year 2025 Expectations

The Company does not provide forward-looking guidance on a GAAP basis as to certain financial information, where the probable significance of the information cannot be determined, is not available or cannot be reasonably estimated. Please refer to the Supplemental Information Regarding Non-GAAP Financial Measures following the tables for additional information.

Fiscal Year 2025 Expectations on an Adjusted (non-GAAP) Basis

Cencora is now updating its fiscal year 2025 financial guidance primarily to reflect stronger earnings growth in the U.S. Healthcare Solutions segment. The Company now expects:

• Revenue growth to be approximately 9 percent, from the previous range of 8 to 10 percent;
  • U.S. Healthcare Solutions segment revenue growth to be in the range of 9 to 10 percent, from the previous range of 9 to 11 percent;
  • International Healthcare Solutions segment revenue growth to be in the range of 6 to 7 percent, from the previous range of 3 to 4 percent;
    • On a constant currency basis, International Healthcare Solutions segment revenue growth to be in the range of 7 to 8 percent, from the previous range of 6 to 8 percent; and
• Adjusted diluted EPS to be in the range of $15.85 to $16.00, from the previous range of $15.70 to $15.95.

Additional expectations now include:

• Adjusted consolidated operating income growth to be in the range of 15 to 16 percent, from the previous range of 13.5 to 15.5 percent;
  • U.S. Healthcare Solutions segment operating income growth to be in the range of 20 to 21 percent, from the previous range of 17.5 to 19.5 percent;
  • International Healthcare Solutions segment operating income decline of approximately 6 percent, from the previous range of a decline of 1 to 4 percent;
    • On a constant currency basis, International Healthcare Solutions segment operating income decline of approximately 5 percent, from the previous range of a decline of 3 percent to flat; and
• Adjusted effective tax rate to be in the range of 20.5 to 21 percent, from the prior expectation of approximately 21 percent.

All other previously communicated aspects of the Company’s fiscal year 2025 consolidated financial guidance and assumptions remain the same.

Dividend Declaration

The Company’s Board of Directors declared a quarterly cash dividend of $0.55 per common share, payable September 3, 2025, to stockholders of record at the close of business on August 15, 2025.

Conference Call & Slide Presentation

The Company will host a conference call to discuss its operating results at 8:30 a.m. ET on August 6, 2025. A slide presentation for investors has also been posted on the Company’s website at investor.cencora.com. Participating in the conference call will be:

• Robert P. Mauch, President & Chief Executive Officer
• James F. Cleary, Executive Vice President & Chief Financial Officer

The dial-in number for the live call will be +1 (833) 470-1428. From outside the United States and Canada, dial +1 (404) 975-4839. The access code for the call will be 015103. The live call will also be webcast via the Company’s website at investor.cencora.com. Users are encouraged to log on to the webcast approximately 10 minutes in advance of the scheduled start time of the call.

Replays of the call will be made available via telephone and webcast. A replay of the webcast will be posted on investor.cencora.com approximately one hour after the completion of the call and will remain available for one year. The telephone replay will also be available approximately one hour after the completion of the call and will remain available for seven days. To access the telephone replay from within the U.S. and Canada, dial +1 (866) 813-9403. From outside the United States, dial +1 (929) 458-6194. The access code for the replay is 676245.

Upcoming Investor Events

Cencora management will be attending the following investor events in the coming months:

• Wells Fargo Healthcare Conference, September 5, 2025;
• Baird Healthcare Conference, September 9, 2025;
• Morgan Stanley Global Healthcare Conference, September 10, 2025; and
• Nephron Healthcare Summit, September 16, 2025.

Please check the website for updates regarding the timing of the live presentation webcasts, if any, and for replay information.

About Cencora

Cencora is a leading global pharmaceutical solutions organization centered on improving the lives of people and animals around the world. We partner with pharmaceutical innovators across the value chain to facilitate and optimize market access to therapies. Care providers depend on us for the secure, reliable delivery of pharmaceuticals, healthcare products, and solutions. Our 51,000+ worldwide team members contribute to positive health outcomes through the power of our purpose: We are united in our responsibility to create healthier futures. Cencora is ranked #10 on the Fortune 500 and #18 on the Global Fortune 500 with more than $290 billion in annual revenue. Learn more at investor.cencora.com

Cencora’s Cautionary Note Regarding Forward-Looking Statements

Certain of the statements contained in this press release are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Securities Exchange Act”). Words such as “aim,” “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “on track,” “opportunity,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “strive,” “sustain,” “synergy,” “target,” “will,” “would” and similar expressions are intended to identify such forward-looking statements, but the absence of these words does not mean the statement is not forward-looking. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances and speak only as of the date hereof. These statements are not guarantees of future performance and are based on assumptions and estimates that could prove incorrect or could cause actual results to vary materially from those indicated. A more detailed discussion of the risks and uncertainties that could cause our actual results to differ materially from those indicated is included (i) in the “Risk Factors” and “Management’s Discussion and Analysis” sections in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2024 and elsewhere in that report and (ii) in other reports filed by the Company pursuant to the Securities Exchange Act. The Company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by the federal securities laws.

Contacts

Bennett S. Murphy
Senior Vice President, Head of Investor Relations and Treasury
bennett.murphy@cencora.com

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BeOne Medicines Announces Second Quarter 2025 Financial Results and Business Updates




BeOne Medicines Announces Second Quarter 2025 Financial Results and Business Updates

• Second quarter total revenues increased 42% to $1.3 billion versus second quarter 2024
• Global BRUKINSA revenues increased 49% to $950 million versus second quarter 2024
• Reported diluted GAAP Earnings per American Depositary Share (ADS) of $0.84, non-GAAP diluted Earnings per ADS of $2.25
• Anticipate 20+ milestones in next 18 months across hematology and solid tumor pipeline

SAN CARLOS, Calif.–(BUSINESS WIRE)–$ONC #BeOne—BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced financial results and corporate updates from the second quarter of 2025.

“Our strong second quarter performance reinforces our trajectory as a global oncology powerhouse and underscores our proven ability to deliver sustainable, long-term growth,” said John V. Oyler, Co-Founder, Chairman and CEO of BeOne. “We are executing with purpose and advancing our mission to deliver transformative medicines to more patients worldwide. BRUKINSA, the backbone of our hematology franchise, continues to set the standard as the best-in-class BTK inhibitor with the most approved indications and market leader in the US, a position earned from superior efficacy, favorable safety, and positive patient outcomes across its five indications. Building on this momentum, our two additional Phase 3 hematology assets, BCL2 inhibitor sonrotoclax and BTK CDAC BGB-16673, have the potential to further expand our franchise leadership with pivotal data readouts and new trial initiations anticipated in the near-term. At our recent Investor R&D Day, we outlined a bold path forward with more than 20 expected R&D milestones in the next 18 months. This includes potentially promising advances across our expansive solid tumor pipeline, where we are building future global franchises targeting a range of highly prevalent cancers.”

(Amounts in thousands of U.S. dollars and unaudited)

Second Quarter 2025 Financial Results

Revenue for the second quarter of 2025 was $1.3 billion, compared to $929 million in the prior-year period driven primarily by growth in BRUKINSA (zanubrutinib) product sales in the U.S. and Europe.

Product Revenue totaled $1.3 billion for the second quarter of 2025 compared to $921 million in the prior-year period. The increase in product revenue was primarily attributable to increased sales of BRUKINSA. The U.S. continued to be the Company’s largest market, with product revenue of $685 million compared to $479 million in the prior-year period. In-licensed products from Amgen and TEVIMBRA (tislelizumab) also contributed to product revenue growth.

• U.S. sales of BRUKINSA totaled $684 million in the second quarter of 2025, representing growth of 43% over the prior-year period driven primarily by robust demand growth across all indications and modest benefit due to net pricing. BRUKINSA continues to maintain its leading new patient share across the BTKi class due to its differentiated, best-in-class clinical profile. BRUKINSA sales in Europe totaled $150 million in the second quarter of 2025, representing growth of 85% compared to the prior-year period, driven by increased market share across all major European markets, including Germany, Italy, Spain, France and the UK.
• Sales of TEVIMBRA totaled $194 million in the second quarter of 2025, representing growth of 22% compared to the prior-year period.

Gross Margin as a percentage of global product sales for the second quarter of 2025 was 87.4% compared to 85.0% in the prior-year period on a GAAP basis. The gross margin percentage increased due to a proportionally higher sales mix of global BRUKINSA compared to other products in our portfolio. Gross margin also benefited from cost of sales productivity improvements for both BRUKINSA and TEVIMBRA. On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of product sales increased to 88.1% for the second quarter of 2025, compared to 85.4% in the prior-year period.

Operating Expenses

The following table summarizes operating expenses for the second quarter of 2025:

The following table summarizes operating expenses for the first half of 2025:

Research and Development (R&D) Expenses increased for the second quarter of 2025 compared to the prior-year period on both a GAAP and adjusted basis primarily due to advancing preclinical programs into the clinic and early clinical programs into late stage, and offset by lower development upfront and milestone fees. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled $0.5 million and $12 million in the second quarter of 2025 and 2024, respectively.

Selling, General and Administrative (SG&A) Expenses increased for the second quarter of 2025 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment in global commercial expansion, primarily in the U.S. and Europe. SG&A expenses as a percentage of product sales were 41% for the second quarter of 2025, compared to 48% in the prior-year period.

Net Income/(Loss) and GAAP/Non-GAAP Earnings Per Share

GAAP net income for the second quarter of 2025 was $94 million, an increase of $215 million over the prior-year period loss, primarily attributable to revenue growth and improved operating leverage.

For the second quarter of 2025, basic and diluted earnings per share was $0.07 and $0.06 per share and $0.87 and $0.84 per American Depositary Share (ADS), respectively, compared to basic loss of $0.09 per share and $1.15 per ADS in the prior-year period.

Free Cash Flow for the second quarter of 2025 was $220 million, an increase of $425 million over the prior-year period.

For further details on BeOne’s Second Quarter 2025 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the second quarter of 2025 filed with the U.S. Securities and Exchange Commission.

Full Year 2025 Guidance

BeOne has updated its full year 2025 revenue guidance and maintained its expense guidance. Guidance is summarized below:

BeOne’s total revenue guidance for full year 2025 of $5.0 billion to $5.3 billion includes expectations for strong revenue growth driven by BRUKINSA’s U.S. leadership position and continued global expansion in both Europe and other important rest of world markets. Gross margin percentage is expected to be in the mid- to high-80% range due to mix and production efficiencies as compared to 2024. BeOne’s guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth in both commercial and research at a pace that continues to deliver meaningful operating leverage. Non-GAAP operating expenses, which exclude costs related to share-based compensation, depreciation and amortization expense, are expected to track with GAAP operating expenses, with reconciling items unchanged from existing practice. Operating expense guidance does not assume any potential new, material business development activity or unusual/non-recurring items.

Second Quarter Business Highlights

Core Marketed Products

BRUKINSA (zanubrutinib)

• BRUKINSA is now approved in 75 markets globally with five new or expanded reimbursements in the quarter.
• Received U.S. Food and Drug Administration (FDA) approval and a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of a new film-coated tablet formulation for all approved indications.

TEVIMBRA (tislelizumab)

• TEVIMBRA is now approved in 47 markets globally with 20 new reimbursements in the quarter, including in Japan, Europe and Australia.
• Received European Commission (EC) approval in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma.
• Received EC approval for the treatment of first-line extensive-stage small cell lung cancer.
• Received a positive CHMP opinion recommending approval of TEVIMBRA in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence.
• Received FDA approval of alternative dosing regimens of 150 Q2W and 300 Q4W for the treatment of first-line gastric cancer and second-line esophageal squamous cell carcinoma.

Select Clinical-Stage Programs

Hematology

• Sonrotoclax (BCL2 inhibitor):

• Achieved acceptance of submissions in China with priority reviews for the treatment of relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and R/R mantle cell lymphoma (MCL).
• Achieved first subject enrolled in global Phase 3 trial in combination with CD20 antibody for the treatment of R/R CLL.
  

• BGB-16673 (BTK CDAC):

• Received EMA PRIority MEdicines (PRIME) designation for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor.
• Achieved first subject enrolled for global Phase 3 BGB-16673-302 trial for the treatment of R/R CLL.
• Achieved first subject enrolled for China Phase 3 BGB-16673-303 trial for the treatment of R/R/ CLL.
• Initiated enrollment of potentially registration enabling Phase 2 trial for the treatment of R/R WM.

Lung Cancer

• Tarlatamab (AMG 757):
  • Achieved acceptance of BLA and priority review in China for the treatment of 3L+ small cell lung cancer (SCLC).
  • Achieved acceptance of BLA in China for the treatment of 2L SCLC.

GI Cancers

• Zanidatamab (HER2-targeting bispecific antibody): Received regulatory approval and achieved commercial launch in China for the treatment of second-line HER2-high-expression biliary tract cancer.

Inflammation & Immunology

• BGB-45035 (IRAK4 CDAC): Achieved first subject enrolled in Phase 1b trial for the treatment of atopic dermatitis and prurigo nodularis.
• BGB-16673 (BTK CDAC): Achieved first subject enrolled in Phase 1 trial for the treatment of chronic spontaneous urticaria.

Anticipated R&D Milestones

Other Highlights

• Completed renaming to BeOne Medicines Ltd., and redomiciliation to Switzerland.

Conference Call and Webcast

The Company’s earnings conference call for the second quarter 2025 will be broadcast via webcast at 8:00 a.m. ET on Wednesday, August 6, 2025, and will be accessible through the Investors section of BeOne’s website at www.beonemedicines.com. Supplemental information in the form of a slide presentation and a replay of the webcast will also be available.

About BeOne

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding: upcoming R&D milestones to be achieved by BeOne; the timing of clinical developments and data readouts; BeOne’s expectations regarding continued global expansion and investment to support growth; BeOne’s ability to bring transformative medicines to more patients worldwide; BeOne’s future revenue, operating income, cash flow, free cash flow, operating expenses, and gross margin percentage; and BeOne’s plans, commitments, aspirations and goals under the caption “About BeOne”. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. BeOne’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties.

Note Regarding Use of Non-GAAP Financial Measures

BeOne provides certain non-GAAP financial measures, including Adjusted Operating Expenses, Adjusted Operating Loss, Adjusted Net Income, Adjusted Earnings Per Share and certain other non-GAAP income statement line items, each of which include adjustments to GAAP figures. These non-GAAP financial measures are intended to provide additional information on BeOne’s operating performance. Adjustments to BeOne’s GAAP figures exclude, as applicable, non-cash items such as share-based compensation, depreciation and amortization. Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred. Non-GAAP adjustments are tax effected to the extent there is U.S. GAAP current tax expense. The Company currently records a valuation allowance on its net deferred tax assets, so there is no net impact recorded for deferred tax effects. BeOne maintains an established non-GAAP policy that guides the determination of what costs will be excluded in non-GAAP financial measures and the related protocols, controls and approval with respect to the use of such measures. BeOne believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of BeOne’s operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of BeOne’s historical and expected financial results and trends and to facilitate comparisons between periods and with respect to projected information. In addition, these non-GAAP financial measures are among the indicators BeOne’s management uses for planning and forecasting purposes and measuring BeOne’s performance.

Contacts

Investor Contact
Liza Heapes

+1 857-302-5663

ir@beonemed.com

Media Contact
Kyle Blankenship

+1 667-351-5176

media@beonemed.com

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Lysoway Therapeutics Awarded Grant from The Michael J. Fox Foundation to Advance TRPML1 Agonist to Treat Parkinson’s Disease




Lysoway Therapeutics Awarded Grant from The Michael J. Fox Foundation to Advance TRPML1 Agonist to Treat Parkinson’s Disease

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Lysoway Therapeutics, Inc., a biopharmaceutical company developing small molecule modulators of lysosomal ion channels, today announced that it has received a research grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF). Support comes from MJFF’s Parkinson’s Disease Therapeutics Pipeline Program, which focuses on candidates with strong potential to slow or halt disease progression or alleviate burdensome symptoms for those living with Parkinson’s disease. Lysoway Therapeutics funding of $2.93 million will support the preclinical and translational development of Lysoway’s novel, highly brain-penetrant small molecule TRPML1 agonist.

The study aims to investigate whether activating TRPML1 by a novel, small molecule modulator, will enhance the lysosomal membrane calcium ion channel to restore lysosomal function and help with clearance of alpha-synuclein, the protein that is linked to the disease.

“We are honored to receive this generous grant from The Michael J. Fox Foundation,” said Valerie Cullen, PhD, Principal Investigator and SVP of Research and Translation at Lysoway. “TRPML1 is a high value target due to its pivotal role in sensing and responding to cellular stress. By activating this ion channel, we can engage multiple beneficial pathways that restore autophagy/lysosomal homeostasis and bolster cellular resilience. Our lead development candidate is both orally bioavailable and highly brain-penetrant, offering strong potential to modify disease progression in Parkinson’s Disease.”

Yongchang Qiu, PhD, Founder and Chief Executive Officer of Lysoway Therapeutics, added “This funding underscores growing confidence in TRPML1 as a compelling target for Parkinson’s disease. It will allow us to accelerate development of our lead TRPML1 agonist and to establish key biomarkers for target engagement, with the goal of initiating first-in-human clinical trials early next year.”

About Lysoway Therapeutics, Inc.

Based in Cambridge, MA, Lysoway Therapeutics is a leader in developing therapeutically viable lysosomal ion channel modulators. The company is advancing a pipeline of small molecule activators targeting these channels to treat neurodegenerative diseases. Learn more at www.lysoway.com

Contacts

Media contact: Info@lysoway.com

Polpharma Biologics and Fresenius Kabi Sign Licensing Agreement for Proposed Vedolizumab Biosimilar PB016




Polpharma Biologics and Fresenius Kabi Sign Licensing Agreement for Proposed Vedolizumab Biosimilar PB016

AMSTERDAM, ZUG, Switzerland & GDAŃSK, Poland–(BUSINESS WIRE)–Polpharma Biologics S.A. (“Polpharma Biologics”) announces a global (except for Middle East & North Africa) licensing agreement with Fresenius Kabi for the commercialization of PB016, a proposed biosimilar to vedolizumab, an integrin receptor antagonist, (reference product: Entyvio®*), a biologic therapy indicated for moderate to severe ulcerative colitis and Crohn’s disease.

Under the terms of the agreement, Polpharma Biologics will lead development and manufacturing of PB016, while Fresenius Kabi will hold exclusive commercialization rights worldwide, excluding Middle East & North Africa.

“This partnership reinforces our mission to broaden access to high-quality biologics that improve patient outcomes globally,” said Konstantin Matentzoglu, Supervisory Board Member of Polpharma Biologics Group. “Fresenius Kabi’s deep commercialization experience and commitment to biosimilars make them an ideal partner for bringing PB016 to patients worldwide. Together, we are taking an important step toward addressing the rising burden of chronic inflammatory diseases.”

The agreement builds on Polpharma Biologics’ growing biosimilar portfolio and proven development capabilities. The company has previously brought forward multiple biosimilars — including ranibizumab and natalizumab — across global markets in partnership with leading pharmaceutical companies.

This strategic collaboration strengthens both companies’ commitments to expanding global access to affordable biologic medicines while supporting healthcare system sustainability.

*Entyvio® is a registered trademark of Takeda.

About Polpharma Biologics:

Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Using patented solutions and state-of-the-art platform technologies, Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas.

Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production preparing drugs for future commercial partnerships with global pharmaceutical organizations. The expertise of Polpharma Biologics lies in the development and manufacture of medicines based on microbial and mammalian expression systems. With its cell line development center in the Netherlands and two centers of development and manufacturing in Poland, Polpharma Biologics creates growth and development opportunities for biotechnology specialists.

Learn more at www.polpharmabiologics.com

About Fresenius Kabi:

As part of the global healthcare company Fresenius, Fresenius Kabi specializes in (bio)pharmaceuticals, medical technologies and nutrition products for critical and chronic conditions. The company’s products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies. For more information, please visit www.fresenius-kabi.com.

Important Note

This press release is for informational purposes only and does not constitute promotional material for PB016 in Poland or any other jurisdiction. The commercialization of proposed vedolizumab biosimilar PB016 is solely the responsibility of Fresenius Kabi, the marketing authorization holder, in accordance with all applicable laws and regulations.

Disclaimer

This press release is issued from Polpharma Biologics Group and is intended to provide worldwide information to healthcare professionals, media and (potential) investors about our global business in relation to drug development and manufacturing expertise. Although Polpharma Biologics Group is not a public company as of this date, recipients should understand that this press release contains certain forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). These statements involve inherent risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the approval and commercialization of the medicinal product, market reception, competition, changes in economic conditions and applicable laws, global regulatory developments, contractual risks and dependencies from third parties. Polpharma Biologics undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release. Moreover, Polpharma Biologics wishes to emphasize that this press release is for informational purposes only and shall not be construed as making any representation, warranties, or guarantees, either express or implied, regarding the potential approval, market reception, commercialization, or success of the medicinal product or any other product or therapy.

Contacts

Media contacts
Natalia Kwiecień

natalia.kwiecien@polpharmabiologics.com

Ethris Doses First Patient in Phase 2a Clinical Trial of Lead mRNA Candidate ETH47 for Asthma




Ethris Doses First Patient in Phase 2a Clinical Trial of Lead mRNA Candidate ETH47 for Asthma

MUNICH–(BUSINESS WIRE)–Ethris GmbH, a clinical-stage biotechnology company pioneering next-generation RNA therapeutics and vaccines, today announced that the first patient has been treated in a Phase 2a clinical trial investigating ETH47, Ethris’ lead mRNA-based antiviral candidate. The study will assess the ability of intranasal ETH47 to reduce asthma-related symptoms following a rhinovirus challenge in adults with asthma. ETH47 encodes interferon lambda (IFNλ), a protein crucial for viral immunity in the airways. It is designed to target viral triggers of asthma exacerbations, one of the most common causes of acute symptoms in patients with asthma.

The start of the Phase 2a clinical trial (ISRCTN21576805) builds on positive data from the Phase 1 trial (ISRCTN15391202) where ETH47 demonstrated favorable safety and tolerability at all tested doses in healthy volunteers. The trial confirmed targeted activity in the respiratory tract, with robust local induction of IFNλ and activation of antiviral genes, with no systemic exposure to mRNA, IFNλ, or the lipidoid nanoparticle, thereby minimizing the risk of off-target effects.

“Dosing the first patient in our Phase 2a trial for ETH47 marks a defining moment for Ethris, as we advance our lead candidate further into clinical development and continue to validate the potential of Ethris’ innovative platform,” said Dr. Thomas Langenickel, Chief Medical Officer of Ethris. “ETH47 stands out as a highly promising candidate with a novel mechanism of action designed to directly strengthen the body’s antiviral defenses in the airways. By targeting viral infections upstream, ETH47 has the potential to fundamentally change the way asthma is managed and reduce the burden of acute attacks. The trial gives us the opportunity to validate a new paradigm of care and, if successful, set a new standard for asthma treatment and open doors for broader advances in respiratory disease.”

Sebastian Johnston, Professor of Respiratory Medicine at the Imperial College London and Director & Chief Medical Officer of VirTus Respiratory Research Ltd, an internationally recognized expert in the field of asthma and viral respiratory infections and one of Ethris’ scientific advisors, added, “After more than three decades investigating the role of respiratory viruses in asthma, it is clear that we need new approaches to address the underlying triggers of asthma exacerbations. Most therapies today focus on managing symptoms or reducing inflammation. There remains a significant unmet need for interventions that directly target viral triggers and boost antiviral defenses in the airways. This is precisely where innovative new approaches like ETH47 could make a real difference for patients and healthcare systems.”

The Phase 2a clinical trial is a randomized, double-blind, placebo-controlled study being conducted by VirTus Respiratory Research Ltd at St. Mary’s Hospital, London, UK. It will enroll 50 adult patients with asthma who will undergo a rhinovirus challenge and will then be equally randomized to receive either ETH47 or placebo. The primary endpoint will evaluate the impact of ETH47 on respiratory symptoms, as measured by the Lower Respiratory Symptoms Score (LRSS) – a commonly used, standardized survey completed by participants twice daily. The primary objective is to assess whether ETH47 can help restore respiratory health in asthmatic patients, bringing them closer to the level observed in healthy individuals.

After the successful completion of this trial, Ethris plans to progress ETH47 into a broader Phase 2b study, further evaluating its potential to reduce asthma exacerbations and improve patient outcomes.

About ETH47

ETH47 is Ethris’ first-in-class mRNA-based product candidate encoding interferon lambda (IFNλ) that was developed using the company’s Stabilized Non-Immunogenic mRNA (SNIM®RNA) platform, and uniquely designed to be administered locally to the respiratory tract through inhalation or nasal spray using Ethris’ proprietary Stabilized NanoParticle (SNaP®) LNP platform. ETH47 is meant to induce a mucosal innate immune defense response at virus entry sites as well as inhibit viral replication. ETH47’s versatile, virus- and mutation-independent mode of action has the potential to broadly address seasonal and emerging respiratory virus infections, including virus-driven exacerbation of chronic respiratory diseases such as asthma.

About Ethris

Ethris, a clinical-stage biotechnology company, has paved a new path from genes to therapeutic proteins, using its proprietary RNA and lipidoid nanoparticle technology platform to discover, design and develop innovative therapies. With more than a decade as an mRNA pioneer, Ethris is a global leader in delivering stabilized mRNAs directly to the respiratory system via optimised formulation and nebulisation technologies. The company is rapidly advancing its mRNA pipeline of immuno-modulation, protein replacement therapies, and differentiated vaccines, with the ultimate goal of improving patients’ lives.

For more information, visit www.ethris.com

Contacts

Ethris contact:
Dr. Philipp Schreppel

+49 89 244 153 042

schreppel@ethris.com

Alcon Agrees to Acquire STAAR Surgical




Alcon Agrees to Acquire STAAR Surgical

• STAAR Surgical is a leader in refractive surgery using Implantable Collamer Lenses, offering solutions for moderate to high myopes

• Acquisition of STAAR is complementary to Alcon’s laser vision correction business and is expected to be accretive in year two

• Alcon to purchase all outstanding shares of STAAR for $28 per share in cash, valuing STAAR at approximately $1.5 billion in equity value

Ad Hoc Announcement Pursuant to Art. 53 LR

GENEVA & LAKE FOREST, Calif.–(BUSINESS WIRE)–Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, and STAAR Surgical Company (NASDAQ: STAA), the manufacturer of the Implantable Collamer^® Lens (ICL), today announced the companies have entered into a definitive merger agreement through which Alcon intends to acquire STAAR. The acquisition includes the EVO family of lenses (EVO ICL™) for vision correction for patients with moderate to high myopia (nearsightedness), with or without astigmatism.

Under the terms of the agreement, Alcon will purchase all outstanding shares of STAAR common stock for $28 per share in cash, which represents approximately a 59% premium to STAAR’s 90-day Volume Weighted Average Price (VWAP) and a 51% premium to the closing price of STAAR common stock on August 4, 2025. The transaction represents a total equity value of approximately $1.5 billion.

“With the number of high myopes rising globally, the acquisition of STAAR enhances our ability to offer a leading surgical vision correction solution for those who are not ideal candidates for other refractive surgeries such as LASIK,” said David Endicott, CEO of Alcon. “This transaction will allow us to provide treatment options across the full spectrum of myopia—from contact lenses to surgical interventions—reinforcing our commitment to addressing the most significant needs in eye care.”

An estimated 50% of the world will be myopic by 2050 and today nearly 500 million people are considered high myopes.¹

With its innovative design, the EVO family of ICLs are implantable lenses that address a wide range of vision correction needs, including myopia with and without astigmatism, through a minimally invasive procedure that is reversible. The EVO family of ICLs are implanted between the iris (the colored part of the eye) and the natural crystalline lens during a procedure that does not remove corneal tissue.

“We believe the transaction with Alcon represents the best path forward and provides the greatest value for STAAR shareholders,” said Stephen Farrell, CEO of STAAR. “As we’ve shared, fluctuating demand in China over the past two years has continued to create significant headwinds for STAAR as a standalone company. I’m proud of our team’s efforts to address recent challenges, but there is more work to do. As a significantly larger company, Alcon has the capabilities and scale to accelerate EVO ICL adoption and bring our innovative technology to more surgeons and patients worldwide.”

Dr. Elizabeth Yeu, Chair of the STAAR Board of Directors, said, “The STAAR Board is committed to maximizing value for shareholders. We have determined that this carefully negotiated transaction is in the best interest of STAAR shareholders as it delivers immediate and certain value at a significant premium, value that exceeds what we believe could be achieved under STAAR’s standalone strategy.”

The transaction is not subject to a financing condition. Alcon intends to finance the transaction through the issuance of short- and long-term credit facilities.

The transaction is anticipated to close in approximately six to 12 months, subject to customary closing conditions, including regulatory approval and approval by STAAR’s shareholders. The transaction is expected to be accretive to earnings in year two.

The Boards of Directors of Alcon and STAAR have each unanimously approved the transaction.

Morgan Stanley & Co. LLC is serving as financial advisor to Alcon, and Gibson, Dunn & Crutcher LLP is serving as legal advisor to Alcon. Citi is serving as the exclusive financial advisor to STAAR, and Wachtell, Lipton, Rosen & Katz is serving as legal advisor to STAAR.

As previously announced, STAAR will release financial results for its second quarter that ended June 27, 2025, on Wednesday, August 6, 2025, after the market close. Given the pending acquisition by Alcon, STAAR will not host a conference call in conjunction with earnings.

Forward-looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the potential transaction between Alcon and STAAR and the expected timing, impacts and benefits thereof, Alcon’s and STAAR’s business strategies, performance, market adoption and estimates of market size. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “approach,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “should,” “target,” “will,” “would,” or the negative thereof and similar words and expressions.

Forward-looking statements are based on Alcon’s and STAAR’s management’s current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions. The following factors could cause actual results and future events to differ materially from those set forth or contemplated in the forward-looking statements: (i) the proposed merger may not be completed in a timely manner or at all, including the risk that any required regulatory approvals are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect STAAR or the expected benefits of the proposed merger or that the approval of STAAR’s stockholders is not obtained; (ii) the failure to realize the anticipated benefits of the proposed merger; (iii) the possibility that competing offers or acquisition proposals for STAAR will be made; (iv) risks that third parties and/or STAAR stockholders may oppose consummation of the proposed merger on the proposed terms or at all; (v) the possibility that any or all of the various conditions to the consummation of the merger may not be satisfied or waived (vi) the occurrence of any event, change or other circumstance that could give rise to the termination of the merger, including in circumstances which would require either party to pay a termination fee; (vii) the effect of the announcement or pendency of the merger on STAAR’s ability to retain and hire key personnel, STAAR’s ability to retain key customers, suppliers or distributors or its operating results and business generally, (viii) there may be liabilities related to the merger that are not known, probable or estimable at this time or unexpected costs, charges or expenses; (ix) the merger may result in the diversion of management’s time and attention to issues relating to the merger; (x) there may be significant transaction costs in connection with the merger; (xi) legal proceedings may be instituted against STAAR following the announcement of the merger, which may have an unfavorable outcome; and (xii) STAAR’s stock price may decline significantly if the merger is not consummated. In addition, a number of other important factors could cause actual future results and other future circumstances to differ materially from those expressed in any forward-looking statements, including but not limited to those important factors discussed under the heading “Risk Factors” contained in Alcon’s Annual Report on Form 20-F for the fiscal year ended December 31, 2024 and in STAAR’s Annual Report on Form 10-K for the fiscal year ended December 27, 2024, each as filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in such company’s other filings with the SEC, accessible on the SEC’s website at www.sec.gov and the Investor Relations section of STAAR’s website at investors.staar.com and Alcon’s website at investor.alcon.com.

All forward-looking statements are expressly qualified in their entirety by such factors. Except as required by law, neither Alcon nor STAAR undertake any obligation to publicly update or review any forward-looking statement, whether because of new information, future developments or otherwise. These forward-looking statements should not be relied upon as representing Alcon’s or STAAR’s views as of any date subsequent to the date of this press release.

About Alcon

Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at www.alcon.com.

About STAAR Surgical

STAAR Surgical (NASDAQ: STAA) is the global leader in implantable phakic intraocular lenses, a vision correction solution that reduces or eliminates the need for glasses or contact lenses. Since 1982, STAAR has been dedicated solely to ophthalmic surgery, and for 30 years, STAAR has been designing, developing, manufacturing, and marketing advanced Implantable Collamer^® Lenses (ICLs), using its proprietary biocompatible Collamer material. STAAR ICL’s are clinically-proven to deliver safe long-term vision correction without removing corneal tissue or the eye’s natural crystalline lens. Its EVO ICL™ product line provides visual freedom through a quick, minimally invasive procedure. STAAR has sold more than 3 million ICLs in over 75 countries. Headquartered in Lake Forest, California, the company operates research, development, manufacturing, and packaging facilities in California and Switzerland. For more information about ICL, visit www.EVOICL.com. To learn more about STAAR, visit www.staar.com.

Important Safety Information for the EVO Family of ICLs

The EVO Visian ICL Lens is intended for the correction of moderate to high nearsightedness. EVO Visian ICL and EVO Visian TICL surgery is intended to safely and effectively correct nearsightedness between -3.0 D to -15.0 D, the reduction in nearsightedness up to -20.0 D and treatment of astigmatism from 1.0 D to 4.0 D. If patients have nearsightedness within these ranges, EVO Visian ICL surgery may improve distance vision without eyeglasses or contact lenses. Because the EVO Visian ICL corrects for distance vision, it does not eliminate the need for reading glasses, patients may require them at some point, even if they have never worn them before.

Implantation of the EVO Visian ICL is a surgical procedure, and as such, carries potentially serious risks. Patients should discuss the risks with their eye care professional. Complications, although rare, may include need for additional surgical procedures, inflammation, loss of cells from the back surface of the cornea, increase in eye pressure, and cataracts. For additional information with potential benefits, risks and complications please visit DiscoverICL.com.

Additional Information

This press release may be deemed solicitation material in respect of the proposed acquisition of STAAR. A special stockholder meeting will be announced soon to obtain stockholder approval in connection with the proposed merger. STAAR expects to file with the SEC a proxy statement and other relevant documents in connection with the proposed merger. Investors of STAAR are urged to read the definitive proxy statement and other relevant materials carefully and in their entirety when they become available because they will contain important information about the Company and the proposed merger. Investors may obtain a free copy of these materials (when they are available) and other documents filed by STAAR with the SEC at the SEC’s website at www.sec.gov and at STAAR’s website at investors.staar.com.

No Offer or Solicitation

This communication is for informational purposes only and is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law.

Participants in the Solicitation

Alcon, STAAR and certain of their respective directors, executive officers and other members of management and employees may be deemed to be participants in soliciting proxies from its stockholders in connection with the proposed merger. Information regarding Alcon’s directors and executive officers is contained in Alcon’s annual report on Form 20-F for its fiscal year ended December 31, 2024, which was filed with the SEC on February 25, 2025. Information regarding the persons who may, under the rules of the SEC, be considered to be participants in the solicitation of STAAR’s stockholders in connection with the proposed merger will be set forth in STAAR’s definitive proxy statement for its special stockholder meeting. Additional information regarding these individuals and any direct or indirect interests they may have in the proposed merger will be set forth in the definitive proxy statement when and if it is filed with the SEC in connection with the proposed merger.

References

1. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Brien A Holden at al. Ophthalmology. 2016 May;123(5):1036-42.

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Contacts

Alcon Investor Relations
Daniel Cravens, Allen Trang

+ 41 589 112 110 (Geneva)

+ 1 817 615 2789 (Fort Worth)

investor.relations@alcon.com

Alcon Media Relations
Steven Smith

+ 41 589 112 111 (Geneva)

+ 1 817 551 8057 (Fort Worth)

globalmedia.relations@alcon.com

STAAR Investor & Media Relations
Niko Liu, CFA

United States: 626-303-7902 ext 3023

Hong Kong: +852-6092-5076

nliu@staar.com
investorrelations@staar.com