ROSHN Group Expands Foreign Real Estate Ownership Opportunities Across Saudi Arabia

 ROSHN Group, Saudi Arabia’s leading master developer and a PIF company, is supporting a new chapter for international participation in the Saudi real estate market, as the Kingdom’s regulations governing non-Saudi property ownership create new opportunities for eligible international buyers and investors.

Thousands of non-Saudi buyers have registered interest with ROSHN Group since the regulatory updates, reflecting the growth and diversification of the Kingdom’s real estate sector by attracting new sources of demand and investment, while complementing the continued delivery of homes and communities for Saudi citizens. For ROSHN Group, this creates an opportunity to broaden access to its growing portfolio while expanding housing supply and choice for local buyers – supporting a larger, more dynamic real estate market over the long term.

Eligible non-Saudi buyers and investors outside the Kingdom may purchase residential units within ROSHN Group’s existing communities in three geographical zones. Purchases can be made seamlessly via the ROSHN App, which offers interactive views of a diverse range of human-centric, integrated residential developments in key cities, including Riyadh, Jeddah, and Makkah, featuring:

SEDRA, the most in-demand community in north Riyadh, offering a new model for integrated living near the Expo 2030 site and the city’s key landmarks. The community provides top tier public and international schools, adjacent to the shopping, entertainment destination, ROSHN Front. With more than 3,000 units already delivered, the community features retail centers, pedestrian pathways, green spaces, landscaped parks, and a variety of housing typologies including apartments, townhouses, and villas.

ALAROUS, located in northern Jeddah on the Red Sea coast, offering a contemporary lifestyle in proximity to MARAFY, ROSHN Group’s iconic waterfront mixed-use destination with apartments expected to be on offer soon, home to the Kingdom’s first-of-its-kind navigable canal.

ALMANAR, the Group’s first integrated community at the western gateway to Makkah Al-Mukarramah, just 20 minutes from Al-Masjid Al-Haram, featuring a diverse mix of residential units that blend vitality and tranquillity within an integrated environment in the Holy Capital.

Through Saudi Properties, the Kingdom’s official digital gateway, qualified buyers can access real estate opportunities across the Kingdom. The ROSHN app offers a fully integrated digital purchasing experience through which international clients can seamlessly complete their entire homebuying journey remotely with ease and security.

For information on residential units and specifications, visit www.roshn.sa/homeownership.

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Contacts

Tyler Jacobson

tjacobson@roshn.sa

Takeda Highlights Late-Stage Oncology Pipeline Progress and Solid Tumor Portfolio Research, Led by Late-Breaking Phase 3 Arcotatug Tavatecan (TAK-921) Data, at ESMO 2026

 

OSAKA, Japan & CAMBRIDGE, Mass. - 

Late-Breaking Abstract to Feature New Data from First Phase 3 Registrational Study of Arcotatug Tavatecan in Previously Treated Advanced Gastric Cancer

TAK-928 Presentations Reinforce Potential in Patients with Immunotherapy-Resistant Non-Small Cell Lung Cancer (NSCLC) and Previously Untreated NSCLC

Takeda Continues to Progress Clinical Development of Arcotatug Tavatecan and TAK-928; New Non-Squamous NSCLC Sub-Trial Added to Global Phase 3 MarsLight-11 Study Evaluating TAK-928 vs. Docetaxel Monotherapy

 

(BUSINESS WIRE) -- Takeda (TSE:4502/NYSE:TAK) announced that new data from its oncology pipeline and portfolio will be presented at the European Society for Medical Oncology (ESMO) Congress, taking place October 23-27, 2026, in Madrid, Spain. Key data will include a late-breaking abstract on arcotatug tavatecan (TAK-921; Innovent R&D code: IBI343*) and two presentations on TAK-928 (Innovent R&D code: IBI363*). Clinical and real-world analyses of ALUNBRIG® (brigatinib) and FRUZAQLA® (fruquintinib) will also be shared at the congress.

“Takeda’s data at ESMO reflect our commitment to delivering rapid progress for patients living with some of the most prevalent and challenging cancers, including advanced gastric cancer and immunotherapy-resistant and previously untreated non-small cell lung cancer,” said Phuong Khanh (P.K.) Morrow, M.D., Head of the Oncology Therapeutic Area Unit at Takeda. “Our mission is to advance new therapeutic approaches for patients who need more options or who remain underserved by current standards of care. Together, our late-stage oncology pipeline and portfolio of thoracic and gastrointestinal cancer medicines are helping address patients’ needs today while building possibilities for the future.”

Late-breaking data from the Phase 3 G-HOPE-001 study (NCT06238843) of arcotatug tavatecan being conducted in Japan and China in patients with previously treated advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA) will be presented during the ESMO proffered paper session on October 23, 13:30-15:00 CEST (Abstract LBA77). Arcotatug tavatecan is an investigational Claudin 18.2-targeted antibody-drug conjugate (ADC) with an exatecan payload and an Fc-silenced backbone designed to reduce Fc-mediated toxicities. Pending evaluation of final study results, data from G-HOPE-001 could support a potential regulatory filing for this indication in Japan.

Additionally, new findings for TAK-928 plus bevacizumab in immunotherapy-resistant non-small cell lung cancer (NSCLC) and TAK-928 plus chemotherapy in first-line NSCLC will be featured in two presentations. TAK-928 is a potential first-in-class PD-1/alpha-biased IL-2 bispecific fusion protein. Based on data showing promising efficacy and manageable safety in NSCLC to date, Takeda is conducting the global Phase 3 MarsLight-11 study (NCT07217301) evaluating TAK-928 vs. docetaxel in patients with squamous NSCLC whose disease has progressed on or after chemotherapy and immunotherapy. Enrollment is ongoing at trial sites globally, including in the U.S. In addition, Takeda will expand the MarsLight-11 study to include a new sub-trial for patients with non-squamous NSCLC.

Takeda is committed to developing oncology medicines in three strategic areas of focus: hematologic, thoracic and gastrointestinal cancers. Further presentations at ESMO 2026 will highlight clinical and real-world analyses spanning Takeda’s approved medicines across thoracic and gastrointestinal cancers, including:

Real-world interim results on treatment patterns and outcomes with ALUNBRIG as a first-line treatment for adults with anaplastic lymphoma kinase positive (ALK+) NSCLC to be presented as an e-poster

Updated results from a global FRUZAQLA Expanded Access Program for patients with previously treated metastatic colorectal cancer (mCRC) to be presented as a poster

Arcotatug tavatecan and TAK-928 are investigational compounds that have not been approved for use by the U.S. FDA or any other regulatory authorities.

*Innovent refers to arcotatug tavatecan (TAK-921) and TAK-928 as IBI343 and IBI363, respectively. Takeda entered into a license and collaboration agreement with Innovent. Under the agreement, Takeda holds the rights to develop, manufacture and commercialize arcotatug tavatecan worldwide outside of greater China. For TAK-928, Takeda will lead global co-development and U.S. co-commercialization and has exclusive commercialization rights outside the U.S. and Greater China.

ALUNBRIG® (brigatinib) IMPORTANT SAFETY INFORMATION

INDICATION

ALUNBRIG is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

WARNINGS AND PRECAUTIONS

Interstitial Lung Disease (ILD)/Pneumonitis

Severe, life-threatening, and fatal pulmonary adverse reactions consistent with interstitial lung disease (ILD)/pneumonitis have occurred with ALUNBRIG. In ALTA 1L, ILD/pneumonitis occurred in 5.1% of patients receiving ALUNBRIG. ILD/pneumonitis occurred within 8 days of initiation of ALUNBRIG in 2.9% of patients, with Grade 3 to 4 reactions occurring in 2.2% of patients. In the ALTA study, at the approved dose (90→180 mg), ILD/pneumonitis occurred in 9.1% of patients. Monitor for new or worsening respiratory symptoms (dyspnea, cough, etc.), particularly during the first week of initiating ALUNBRIG. Withhold ALUNBRIG in any patient with new or worsening respiratory symptoms, and promptly evaluate for ILD/pneumonitis or other causes of respiratory symptoms (e.g., pulmonary embolism, tumor progression, and infectious pneumonia). For Grade 1 or 2 ILD/pneumonitis, either dose reduce or permanently discontinue ALUNBRIG. Permanently discontinue ALUNBRIG for Grade 3 or 4 ILD/pneumonitis or recurrence of Grade 1 or 2 ILD/pneumonitis.

Hypertension

In ALTA 1L, hypertension was reported in 32% of patients receiving ALUNBRIG; 13% of patients experienced Grade 3 hypertension. Control blood pressure prior to treatment with ALUNBRIG. Monitor blood pressure and withhold ALUNBRIG for Grade 3 hypertension despite optimal antihypertensive therapy. Consider permanent discontinuation of treatment with ALUNBRIG for Grade 4 hypertension or recurrence of Grade 3 hypertension. Use caution when administering ALUNBRIG in combination with antihypertensive agents that cause bradycardia.

Bradycardia

In ALTA 1L, heart rates less than 50 beats per minute (bpm) occurred in 8.1% of patients receiving ALUNBRIG; one patient (0.7%) experienced Grade 3 bradycardia. Monitor heart rate and blood pressure during treatment with ALUNBRIG. For symptomatic bradycardia, withhold ALUNBRIG and review concomitant medications for those known to cause bradycardia; dose reduce concomitant medication or ALUNBRIG as appropriate. Discontinue ALUNBRIG for life-threatening bradycardia if no contributing concomitant medication is identified.

Visual Disturbance

In ALTA 1L, Grade 1 or 2 adverse reactions leading to visual disturbance, including blurred vision, photophobia, photopsia, and reduced visual acuity, were reported in 7.4% of patients receiving ALUNBRIG. In the ALTA study, at the approved dose (90→180 mg), Grade 3 macular edema and cataract occurred in one patient each. Advise patients to report any visual symptoms. Withhold ALUNBRIG and obtain an ophthalmologic evaluation in patients with new or worsening visual symptoms of Grade 2 or greater severity; upon recovery, dose reduce as appropriate. Permanently discontinue treatment with ALUNBRIG for Grade 4 visual disturbances.

Creatine Phosphokinase (CPK) Elevation

In ALTA 1L, creatine phosphokinase (CPK) elevation occurred in 81% of patients who received ALUNBRIG. The incidence of Grade 3 or 4 CPK elevation was 24%. Dose reduction for CPK elevation occurred in 15% of patients. Advise patients to report any unexplained muscle pain, tenderness, or weakness. Monitor CPK levels during ALUNBRIG treatment. Withhold ALUNBRIG for Grade 3 or 4 CPK elevation with Grade 2 or higher muscle pain or weakness. Upon resolution or recovery to Grade 1 CPK elevation or baseline, resume ALUNBRIG at the same dose or at a reduced dose.

Pancreatic Enzyme Elevation

In ALTA 1L, amylase elevation occurred in 52% of patients and Grade 3 or 4 amylase elevation occurred in 6.8% of patients who received ALUNBRIG. Lipase elevations occurred in 59% of patients and Grade 3 or 4 lipase elevation occurred in 17% of patients. Monitor lipase and amylase during treatment with ALUNBRIG. Withhold ALUNBRIG for Grade 3 or 4 pancreatic enzyme elevation. Upon resolution or recovery to Grade 1 or baseline, resume ALUNBRIG at the same dose or at a reduced dose.

Hepatotoxicity

In ALTA 1L, aspartate aminotransferase (AST) elevations occurred in 72% of patients and Grade 3 or 4 AST elevations occurred in 4.5% of patients who received ALUNBRIG. Alanine aminotransferase (ALT) elevations occurred in 52% of patients and Grade 3 or 4 ALT elevations occurred in 5.2% of patients. One patient (0.7%) had a serious adverse reaction of hepatocellular injury. Monitor AST, ALT and total bilirubin during treatment with ALUNBRIG, especially during the first 3 months. Withhold ALUNBRIG for Grade 3 or 4 hepatic enzyme elevation with bilirubin less than or equal to 2 × ULN. Upon resolution or recovery to Grade 1 or less (less than or equal to 3 × ULN) or to baseline, resume ALUNBRIG at a next lower dose. Permanently discontinue ALUNBRIG for Grade 2 to 4 hepatic enzyme elevation with concurrent total bilirubin elevation greater than 2 times the ULN in the absence of cholestasis or hemolysis.

Hyperglycemia

In ALTA 1L, 56% of patients who received ALUNBRIG experienced new or worsening hyperglycemia. Grade 3 hyperglycemia, based on laboratory assessment of serum fasting glucose levels, occurred in 7.5% of patients. In the ALTA study, 2 of 20 (10%) patients with diabetes or glucose intolerance at baseline required initiation of insulin while receiving ALUNBRIG. Assess fasting serum glucose prior to initiation of ALUNBRIG and monitor periodically thereafter. Initiate or optimize anti-hyperglycemic medications as needed. If adequate hyperglycemic control cannot be achieved with optimal medical management, withhold ALUNBRIG until adequate hyperglycemic control is achieved and consider reducing the dose of ALUNBRIG.

Photosensitivity

In ALTA 1L, 3.7% of patients who received ALUNBRIG experienced photosensitivity, with 0.7% of patients experiencing Grade 3 to 4 reactions. Advise patients to limit sun exposure while taking ALUNBRIG, and for at least 5 days after discontinuation of treatment. Advise patients, when outdoors, to wear protective clothing and use a broad-spectrum sunscreen (SPF ≥30) to help protect against sunburn. Based on the severity, withhold ALUNBRIG, then resume at the same dose, or reduce the dose, or permanently discontinue.

Embryo-Fetal Toxicity

Based on its mechanism of action and findings in animals, ALUNBRIG can cause fetal harm when administered to pregnant women. There are no clinical data on the use of ALUNBRIG in pregnant women. Advise women of the potential risk to a fetus.

ADVERSE REACTIONS

The most common adverse reactions (≥25%) with ALUNBRIG were diarrhea, fatigue, nausea, rash, cough, myalgia, headache, hypertension, vomiting, and dyspnea.

DRUG INTERACTIONS

CYP3A Inhibitors: Avoid coadministration of ALUNBRIG with strong or moderate CYP3A inhibitors. If coadministration of a strong or moderate CYP3A inhibitor is unavoidable, reduce the dose of ALUNBRIG.

CYP3A Inducers: Avoid coadministration of ALUNBRIG with strong or moderate CYP3A inducers. If coadministration of a moderate CYP3A inducer is unavoidable, increase the dose of ALUNBRIG.

USE IN SPECIFIC POPULATIONS

Females and Males of Reproductive Potential

Verify pregnancy status in females of reproductive potential prior to initiating ALUNBRIG. Advise females of reproductive potential to use effective contraception during treatment with ALUNBRIG and for at least 4 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with ALUNBRIG and for at least 3 months after the final dose. ALUNBRIG may cause reduced fertility in males.

Lactation: Advise patients not to breastfeed.

Hepatic Impairment: Reduce the dose of ALUNBRIG for patients with severe hepatic impairment.

Renal Impairment: Reduce the dose of ALUNBRIG for patients with severe renal impairment.

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc. at 1-844-217-6468 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

FRUZAQLA® (fruquintinib) IMPORTANT SAFETY INFORMATION

INDICATION

FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

WARNINGS AND PRECAUTIONS

Hypertension occurred in 49% of 911 patients with mCRC treated with FRUZAQLA, including Grade 3-4 events in 19%, and hypertensive crisis in three patients (0.3%). Do not initiate FRUZAQLA unless blood pressure is adequately controlled. Monitor blood pressure weekly for the first month and at least monthly thereafter as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue FRUZAQLA based on severity of hypertension.

Hemorrhagic Events including serious, fatal events can occur with FRUZAQLA. In 911 patients with mCRC treated with FRUZAQLA, 6% of patients experienced gastrointestinal hemorrhage, including 1% with a Grade ≥3 event and 2 patients with fatal hemorrhages. Permanently discontinue FRUZAQLA in patients with severe or life-threatening hemorrhage. Monitor the International Normalized Ratio (INR) levels in patients receiving anticoagulants.

Infections. FRUZAQLA can increase the risk of infections, including fatal infections. In 911 patients with mCRC treated with FRUZAQLA, the most common infections were urinary tract infections (6.8%), upper respiratory tract infections (3.2%) and pneumonia (2.5%); fatal infections included pneumonia (0.4%), sepsis (0.2%), bacterial infection (0.1%), lower respiratory tract infection (0.1%), and septic shock (0.1%). Withhold FRUZAQLA for Grade 3 or 4 infections, or worsening infection of any grade. Resume FRUZAQLA at the same dose when the infection has resolved.

Gastrointestinal Perforation occurred in patients treated with FRUZAQLA. In 911 patients with mCRC treated with FRUZAQLA, 1.3% experienced a Grade ≥3 gastrointestinal perforation, including one fatal event. Permanently discontinue FRUZAQLA in patients who develop gastrointestinal perforation or fistula.

Hepatotoxicity. FRUZAQLA can cause liver injury. In 911 patients with mCRC treated with FRUZAQLA, 48% experienced increased ALT or AST, including Grade ≥3 events in 5%, and fatal events in 0.2% of patients. Monitor liver function tests (ALT, AST, and bilirubin) before initiation and periodically throughout treatment with FRUZAQLA. Temporarily hold and then reduce or permanently discontinue FRUZAQLA depending on the severity and persistence of hepatotoxicity as manifested by elevated liver function tests.

Proteinuria. FRUZAQLA can cause proteinuria. In 911 patients with mCRC treated with FRUZAQLA, 36% experienced proteinuria and 2.5% of patients experienced Grade ≥3 events. Monitor for proteinuria before initiation and periodically throughout treatment with FRUZAQLA. For proteinuria ≥2g/24 hours, withhold FRUZAQLA until improvement to ≤Grade 1 proteinuria and resume FRUZAQLA at a reduced dose. Discontinue FRUZAQLA in patients who develop nephrotic syndrome.

Palmar-Plantar Erythrodysesthesia (PPE) occurred in 35% of 911 patients treated with FRUZAQLA, including 8% with Grade 3 events. Based on severity of PPE, withhold FRUZAQLA and then resume at the same or reduced dose.

Posterior Reversible Encephalopathy Syndrome (PRES), a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in one of 911 patients treated with FRUZAQLA. Perform an evaluation for PRES in any patient presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue FRUZAQLA in patients who develop PRES.

Impaired Wound Healing. In 911 patients with mCRC treated with FRUZAQLA, 1 patient experienced a Grade 2 event of wound dehiscence. Do not administer FRUZAQLA for at least 2 weeks prior to major surgery. Do not administer FRUZAQLA for at least 2 weeks after major surgery and until adequate wound healing. The safety of resumption of FRUZAQLA after resolution of wound healing complications has not been established.

Arterial Thromboembolic Events. In 911 patients with mCRC treated with FRUZAQLA, 0.8% of patients experienced an arterial thromboembolic event. Initiation of FRUZAQLA in patients with a recent history of thromboembolic events should be carefully considered. In patients who develop arterial thromboembolism, discontinue FRUZAQLA.

Allergic Reactions to FD&C Yellow No. 5 (Tartrazine) and No. 6 (Sunset Yellow FCF). FRUZAQLA 1 mg capsules contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. FRUZAQLA 1 mg contains FD&C Yellow No. 6 (sunset yellow FCF), which may cause allergic reactions.

Embryo-Fetal Toxicity. Based on findings in animal studies and its mechanism of action, FRUZAQLA can cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to a fetus.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥20%) following treatment with FRUZAQLA included hypertension, palmar-plantar erythrodysesthesia (hand-foot skin reactions), proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.

DRUG INTERACTIONS

Avoid concomitant administration of FRUZAQLA with strong or moderate CYP3A inducers.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during treatment with FRUZAQLA and for 2 weeks after the last dose.

Females and Males of Reproductive Potential

Pregnancy Testing: Verify pregnancy status of females of reproductive potential prior to initiating FRUZAQLA.

Contraception: Females of childbearing potential and males with female partners of childbearing potential should use effective contraception during treatment and for 2 weeks after the last dose of FRUZAQLA.

Infertility: Advise females of reproductive potential that FRUZAQLA may cause post-implantation loss.

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-844-662-8532 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see FRUZAQLA (fruquintinib) full Prescribing Information.

Takeda’s Commitment to Oncology

At Takeda Oncology, we are united by our aspiration to cure cancer, with inspiration from patients and innovation from everywhere. Drawing on decades of leadership in oncology, we work to develop innovative treatments that enhance and extend the lives of people living with cancer. We are committed to ensuring that patients globally can benefit from and access our portfolio of medicines, while also progressing a pipeline of potential treatments for the future. Our research and development efforts are focused on advancing medicines for hematologic, gastrointestinal and thoracic cancers by leveraging modalities best suited to make a difference in the treatment of these diseases. We complement our internal expertise and global footprint with a robust network of collaborators. Together, we strive to bring life-changing medicines to more patients around the world. For more information, visit www.takedaoncology.com.

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including drug pricing, tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260921356638/en/

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Contacts

Media Relations:

Investor Relations

Christopher O’Reilly

takeda.ir.contact@takeda.com

Japanese Media

Tsuyoshi Tada

toiawase_kouhou@takeda.co.jp

U.S. and International Media

Hollie Wyatt

hollie.wyatt@takeda.com

From CSR to Public Health Impact: How Colgate Bright Smiles, Bright Futures® is Driving Behavior Change for the Next Billion Children and Their Families

 NEW YORK - Tuesday, 22. September 2026

Colgate-Palmolive builds on its legacy of oral health, publishing an impact evaluation, evolving its health education tools rooted in behavior change, and scaling its global health partnerships.

 

(BUSINESS WIRE)--Colgate-Palmolive, the worldwide leader in oral care, announced a strategic evolution in its flagship oral health education program, Colgate Bright Smiles, Bright Futures® (BSBF), reflecting the Company’s commitment to global public health.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260922129016/en/

Launched in 1991, the program has reached over two billion children and their families across more than 100 countries, demonstrating how private-sector commitment designed to support communities, can become a powerful force for public health, driving healthier behaviors and positive outcomes at scale. From health education curriculum and school programming to mobile dental vans and free oral health screenings, BSBF helps children and their families access care, adopt healthier habits, and improve long-term oral health outcomes.

“At Colgate-Palmolive, we believe oral health and healthier, brighter futures are inextricably linked,” said Noel Wallace, Chairman, President and Chief Executive Officer, Colgate-Palmolive. “For 35 years, BSBF has created positive impact by combining hands-on education with local partnerships that turn daily habits into healthy lifestyles. Our program is focused on helping more people build healthy habits for life.”

As BSBF is positioning itself to empower the next billion children and their families, the program’s evolution is guided by three core areas: a newly published impact report, human-centered design (HCD) & behavior change assets, and strategic global health partnerships.

Newly Published Impact Report

Authored by Dr. Francisco Ramos-Gomez and Dr. Yan Wang of University of California, Los Angeles (UCLA), Transforming Children's Oral Health Worldwide: Three Decades of the Colgate Bright Smiles, Bright Futures Prevention Program, synthesizes implementation data throughout the program’s global history. It demonstrates that combining curriculum-based lessons with supervised toothbrushing, fluoride varnish and sealants can deliver measurable results, including:

A 75% reduction in new cavities and demineralized lesions on first permanent molars among children in Grenada.

A 23% increase in healthy gingival units among children in Mexico City.

The evidence also highlights the power of role models, including teachers, nurses, community health workers, and sports coaches – in addition to dental professionals – and positions children as "change agents" who drive health habits across households.

“The body of evidence shows that BSBF's impact extends well beyond individual behavior change,” said Dr. Francisco Ramos-Gomez, Professor and Chair, Section of Pediatric Dentistry, UCLA School of Dentistry, and co-author of the report. “It strengthens non-dental workforce capacity, fosters public-private collaboration, and advances oral health equity at scale. BSBF offers a practical framework other global oral health initiatives can benefit from.”

Human-Centered Design (HCD) & Behavior Change Assets

To empower the next generation with lifelong healthy habits, BSBF has launched a new suite of health education resources that are core to its program, developed with Dalberg Design. Rooted in Human-Centered Design (HCD) and evidence-based behavior change principles, these tools were co-created and field-tested with children, caregivers, and educators across India, Kenya, Mexico, and the United States. By equipping teachers and families with culturally adapted learning tools and interactive brushing activities for children, BSBF continues to strengthen community-led health education and establish foundational oral hygiene habits in classrooms and homes worldwide.

Global Health Partnerships

Announced earlier this year at Davos during the World Economic Forum, a multi-year funding commitment to the WHO Foundation supports the World Health Organization’s global oral health program. The collaboration focuses on expanding oral health education, supporting integration of oral health into national health systems, and raising awareness of oral health as a public health priority. “Oral health plays an essential role in overall health,” said Anil Soni, Chief Executive Officer of the WHO Foundation. “Progress depends on long-term investment in prevention, trusted guidance, and strong health systems. Support like this helps enable WHO’s work to advance oral health and improve health outcomes for communities around the world.”

Building on 35 years of measurable behavioral and clinical success, the program is entering its next phase of growth – driving impact by reaching the next billion children and families while inspiring new approaches to tackling global health challenges. On September 22, alongside the 81st United Nations General Assembly, Colgate-Palmolive will convene business, global health experts, and civil society leaders for an expert discussion to examine how evidence, behavior change and cross-sector collaboration can drive sustained health outcomes. Hosted by Noel Wallace, Chairman, President and Chief Executive Officer, and Esha Gupta, Global Head of Public Health and Social Impact, Colgate-Palmolive, the conversation, moderated by Moira Forbes, Executive Vice President, Forbes, will feature an expert discussion with Robert Fabricant, Co-Founder and Partner, Dalberg Design; Dr. Saia Ma’u Piukala, WHO Regional Director for the Western Pacific; Janti Soeripto, CEO and President, Save the Children US; and Anil Soni, CEO, WHO Foundation.

About Colgate-Palmolive

Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries and territories under brands such as Colgate, Palmolive, Ajax, Axion, Darlie, elmex, EltaMD, Fabuloso, Filorga, hello, Hill’s Prescription Diet, Hill’s Science Diet, Irish Spring, Lady Speed Stick, meridol, PCA SKIN, Prime100, Protex, Sanex, Softsoap, Sorriso, Soupline, Speed Stick, Suavitel and Tom’s of Maine. We are recognized for our leadership and innovation in promoting sustainability and community wellbeing, including our achievements in decreasing plastic waste and promoting recyclability, saving water and improving children’s oral health through our Colgate Bright Smiles, Bright Futures program, which has reached over two billion children and their families since 1991. For more information about Colgate-Palmolive and how we make more smiles, visit www.colgatepalmolive.com.

 

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Media Contact

Campbell O’Connor

Real Chemistry

203-993-5551

coconnor@realchemistry.com

NIQ Announces Friendly Bid to Acquire The U Group & Co Limited, Expanding Trusted Intelligence for the AI Era

 (BUSINESS WIRE)--NielsenIQ (NYSE: NIQ), a leading consumer intelligence company, today announced that its wholly-owned Australian subsidiary, Nielsen Connect Australia Pty Ltd (NIQ Australia) has launched a conditional off-market offer for all outstanding shares of The U Group & Co Limited (The U Group) as a friendly takeover bid (Offer). The U Group is an Australian-based company specializing in first-party, consumer-consented purchase data collection through its ReceiptJar app, receipt intelligence, and AI-powered data processing capabilities.

In connection with the Offer, NIQ Australia has lodged its Bidder's Statement with the Australian Securities and Investments Commission and dispatched the Offer materials to shareholders of The U Group in accordance with applicable Australian regulatory requirements. The Board of The U Group has unanimously recommended that shareholders accept the Offer for the reasons set out in the Target's Statement.

The Offer reflects NIQ's commitment to strengthening trusted intelligence and enhancing The Full View™ for clients. If successful, the transaction would add differentiated, consumer-contributed purchase signals and real-world shopping data to NIQ's global intelligence assets, further enhancing its measurement and understanding of consumer purchasing behavior. By combining NIQ's trusted measurement and analytics capabilities with The U Group's ReceiptJar mobile app and related technologies, the transaction would create opportunities for a more complete view of the consumer, enabling new forms of insight, connectivity, and innovation.

As AI increasingly transforms how organizations make decisions, trusted intelligence and real-world behavioral signals are becoming critical inputs for innovation, advanced analytics, and AI-enabled decision-making.

"We believe AI is only as effective as the intelligence behind it," said Jim Peck, Executive Chairman and Chief Executive Officer of NIQ. "We've worked with The U Group for five years and know the value of what they've built. Bringing these capabilities together would strengthen The Full View, enhance our trusted intelligence foundation and help clients make better decisions."

Through its ReceiptJar mobile app and related technologies, The U Group captures consumer-consented purchase information and provides AI-powered receipt intelligence capabilities that complement NIQ's existing data and measurement ecosystem. Consumers voluntarily contribute their purchase data through the app, creating a trusted source of first-party shopping insights. These additional purchase signals would help broaden NIQ's measurement of consumer behavior and create opportunities for future innovation and stronger client outcomes.

"The future of consumer intelligence will increasingly be powered by the combination of trusted data, consumer participation, and AI-driven innovation," said Tyler Spooner, CEO of The U Group & Co Limited. "Our longstanding relationship with NIQ has demonstrated the potential of bringing these capabilities together, and we are excited about the opportunity to create even greater value for clients in a rapidly evolving marketplace."

The Offer remains subject to the condition of 90% shareholder acceptance by The U Group shareholders and other customary conditions. Until the Offer is declared unconditional and the process to acquire 100% is completed, NIQ and The U Group will continue operating independently, and there are no immediate changes to products, services, employee roles, or client support models.

About NIQ

NielsenIQ (NYSE: NIQ) is a leading consumer intelligence company, delivering the most complete and trusted understanding of consumer buying behavior and revealing new pathways to growth. By combining an unmatched global data footprint and granular consumer and retail measurement with decades of AI modeling expertise, NIQ builds decision systems that help companies turn complex data into confident action.

With operations in more than 90 countries, NIQ covers approximately 82% of the world’s population and more than $7.4 trillion in global consumer spend. Through cloud-based platforms, advanced analytics and AI-driven insights, NIQ delivers The Full View™—helping brands and retailers understand what consumers buy, why they buy it, and what to do next. For more information, please visit NIQ.com

© 2026 Nielsen Consumer LLC. All Rights Reserved.

Media Holding Statement

NielsenIQ can confirm that its wholly-owned Australian subsidiary, Nielsen Connect Australia Pty Ltd (NIQ Australia) has launched a conditional friendly off-market bid for The U Group & Co Limited. The proposed transaction aligns with NIQ's strategy to strengthen The Full View and its trusted intelligence foundation by adding differentiated real-world consumer purchase signals that support measurement, analytics and AI-powered innovation. The off-market bid remains subject to a minimum 90% shareholder acceptance condition and other customary conditions, and we are not commenting further at this time. Securityholders of the U Group & Co Limited should refer to the Bidder's Statement and Target's Statement as sent to them for full details of the takeover offer. The Board of The U Group has recommended that shareholders accept the Offer for the reasons outlined in the Target's Statement.

NIQ-IR

 

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Media Contact: media.relations@nielseniq.com

 

Regnology Research Maps Route From AI Pilots to Production in Regulatory Reporting

 Global study of 276 practitioners across 22 countries defines the “Agentic Gap” and outlines how financial institutions can transition from experimentation to governed, high-impact deployment.

Supporting analysis by Oliver Wyman finds reporting absorbs 1% to 3% of total bank expenditure, with a concentrated share of it addressable by agentic workflows.

(BUSINESS WIRE) -- Regnology, a leader in regulatory, risk, tax and finance reporting technology, today published “The Agentic Gap: From Control to Intelligence in Regulatory Reporting”, accompanied by a video foreword from Chief Executive Officer Rob Mackay. The global study sets out where agentic AI can take on meaningful operational load today, and gives institutions a practical roadmap from isolated pilots into scaled production.

The research finds an industry already mobilizing. 87% of respondents are exploring, piloting or embedding AI in operations, and only 13% report no current plan. The constraint is a shared one. Embedded, production-level use sits between 8% and 15% at every institution tier, and 16% of respondents overall have reached it, with 89% of financial institutions yet to get there. Resources buy experimentation, but production use is earned on the same terms everywhere. The report calls that solvable distance, between testing a concept and relying on it inside the reporting cycle, the agentic gap. Where agentic AI cannot yet take responsibility, the report finds the binding constraint is usually the data or the governance around it, not the maturity of the technology.

The economic incentive to close it is substantial. Research by Oliver Wyman, commissioned by Regnology, finds regulatory reporting typically absorbs 1% to 3% of total expenditure at the banks profiled. Between 30% and 50% of reporting spend goes on running the process internally, the largest single cost pool and a reflection of how much of the work is still performed by hand. In illustrative Tier 1 case studies, Oliver Wyman estimates roughly 15% to 25% of reporting spend could be addressable by agentic workflows. The estimate is directional.

Rob Mackay, Chief Executive Officer of Regnology, said: “Banks are conservative by nature, and in regulatory reporting they are right to be. The tolerance for error is close to zero, and a manual process may be inefficient, but it is familiar and readily defensible. The harder part is rarely the technology. It is finding people who understand the regulatory logic in depth and can turn it into something a system can apply safely. That combination is scarce, and it is what Regnology brings alongside institutions rather than asking them to assemble it alone.”

Rather than offering abstract benchmarks, the report provides a practical blueprint for execution. It introduces a diagnostic framework mapping the cost of inaction against AI readiness to help institutions prioritize high-impact workflows, baseline existing processes before piloting, and design governance into systems before deployment. Moving from priority to production means matching the authority given to AI to the risk and repeatability of the individual process, ensuring outputs can be traced and reconstructed, and aligning with requirements such as the EU AI Act.

Linda Middledith, Chief Product & Engineering Officer of Regnology, comments: “Agentic is not one thing. It runs from explaining what the numbers mean, to recommending what should happen next, to carrying out defined work under human oversight. How much authority each process can carry is a decision institutions make process by process, not once for the whole organization.”

Regnology’s own response to these findings is RGI, the Regnology Intelligence layer, which combines explainability, AI-assisted decision support and agentic workflows under human oversight. The wider industry conversation continues at the RegTech Convention, organized by Regnology since 1993 and now one of the largest conferences on financial regulation and regulatory technology. Its 33rd edition runs from 23 to 26 November under the theme From Control to Intelligence, bringing together supervisory authorities, supranational bodies, financial institutions and industry experts with hubs in Frankfurt, London, New York, Singapore and Zürich. Building on last year’s focus on Straight Through Reporting, the agenda turns to unlocking intelligence across reporting, risk and finance, and to the opportunities and risks that come with it.

Regnology’s Agentic Gap report is based primarily on research conducted by Regnology between February and July 2026, capturing perspectives from 276 practitioners across 22 countries and territories in Europe, North America and Asia-Pacific, spanning financial institutions, professional services, technology and supervision. Where relevant, it draws on supporting research into the economics of regulatory reporting conducted by Oliver Wyman and commissioned by Regnology. Neither Regnology nor Oliver Wyman accepts liability to any third party in respect of the whitepaper.

About Regnology

Regnology is a recognized leader in regulatory, risk, tax, and finance reporting technology, connecting regulators and the regulated across more than 100 countries. Our unique position enables us to span the full spectrum of industry needs, delivering solutions that address both oversight and compliance requirements to a broad range of clients, including global Tier 1 banks, local and regional institutions, corporates, insurers, and authorities.

For more information about Regnology, connect with us on LinkedIn and X.

Visit our website: www.regnology.net.

 

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Mireille Adebiyi – Chief Marketing Officer

Email: mireille.adebiyi@regnology.net

 

Quaise Energy Selected for Up to $25 Million in U.S. Department of Energy Support to Advance World's First Commercial Superhot Geothermal Power Plant

 HOUSTON - Tuesday, 22. September 2026 AETOSWire Print 

Quaise's Project Obsidian, a commercial-scale superhot Enhanced Geothermal System (EGS), selected to receive federal funding as part of $99 million DOE effort to advance geothermal energy development across the United States

Supports completion of the first well triplet at Project Obsidian, targeting more than 25 megawatts of gross electric power

Project team includes Pacific Northwest National Laboratory, Lawrence Berkeley National Laboratory and Oregon State University

 

(BUSINESS WIRE)--Quaise Energy, a leading developer of utility-scale superhot geothermal energy, today announced that it has been selected by the U.S. Department of Energy (DOE) for up to $25 million in funding under the Next-Generation Geothermal Field Tests and Geothermal Resource Characterization and Confirmation funding opportunity. The support brings the U.S. closer to commercializing superhot Enhanced Geothermal Systems — technology that could unlock firm, clean power from hot rock beneath virtually any geography in the country.

The funding will advance Project Obsidian, the world's first commercial superhot geothermal power plant, in Central Oregon. It will support analysis of the drilling, stimulation, and flow results of the first two wells to optimize a third well at the Obsidian site. The three-well configuration is targeting average reservoir temperatures of over 300°C and is designed to demonstrate more than 25 megawatts of gross electric power capacity. The DOE funding will also enable Quaise and its research partners to collect, analyze and share field data from drilling, stimulation and flow testing — establishing a replicable template to help unlock further EGS development.

“This DOE support is a recognition of what we are building at Quaise and the progress we are making in the field, including the confirmation well currently being drilled at Project Obsidian,” said Carlos Araque, CEO and President of Quaise Energy. “Our ambition has always been to make superhot geothermal a commercial reality, and Project Obsidian is where we first deliver on that promise.”

Project Obsidian, currently under construction south of Bend, Oregon, sits on one of the most extensively studied geothermal resources in the United States. The project is expected to deliver first power to the Pacific Northwest grid in 2030 with potential for expansion up to one gigawatt of electricity.

Learnings from these three wells will directly inform subsequent drilling at the site. Using EGS and advanced drilling techniques, Quaise expects to drill the hottest well in the Western Hemisphere at Project Obsidian reaching temperatures over 400°C — above the range of current commercial geothermal projects. Phase one of the project is expected to produce more than 50 megawatts of electric power by 2030.

The full value of the proposed DOE funding is subject to completion of award negotiations. The project team includes experts from Pacific Northwest National Laboratory, Lawrence Berkeley National Laboratory, and Oregon State University.

The selection follows Quaise's close of $180 million in Series B financing in August 2026, led by Nabors Industries and Prelude Ventures, with participation from JERA Co., Inc. and Idemitsu Kosan, to fund Project Obsidian.

About Quaise Energy

Quaise Energy is unlocking the Earth’s deep heat to deliver clean, reliable, baseload energy at scale—almost anywhere in the world. As both a technology innovator and project developer, Quaise builds and operates solutions that harness superhot geothermal energy far below the surface, enabling power generation that can rival the output of today’s most efficient fossil fuel and nuclear plants. With its millimeter wave drilling technology, developed after more than a decade of research at the Massachusetts Institute of Technology (MIT), Quaise’s mission is to make superhot geothermal a backbone of the modern energy system, offering affordable, zero-carbon power and true energy independence for communities and nations everywhere. https://www.quaise.com/

Forward Looking Statement:

This press release contains forward-looking statements, including statements regarding the Company's future financial performance, business plans, and expectations. These forward-looking statements are based on assumptions deemed reasonable by the Company at the time they were made. There is no assurance that such statements will prove accurate, and actual results may differ materially from those expressed or implied herein due to various risks, uncertainties, and other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release and are based on the aforementioned assumptions. The Company assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by applicable law.

Quaise.com | LinkedIn | X | Instagram | Facebook | YouTube

 

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Media Contact:

Diane Hughes

Vice President, Marketing & Communications, Quaise Energy

press@quaise.com

Philip Morris International Publishes Inaugural Taskforce on Nature-related Financial Disclosures Report

 Nature-related assessment highlights links between ecosystem resilience and business performance

(BUSINESS WIRE) -- Philip Morris International Inc. (PMI) (NYSE: PM) today published its inaugural Taskforce on Nature-related Financial Disclosures (TNFD) Report, providing shareholders and other stakeholders with its most comprehensive assessment to date of nature-related dependencies, impacts, risks, and opportunities (DIROs) across the company’s global value chain.

As an early adopter of the TNFD recommendations, PMI’s TNFD Report supports the company’s efforts to sharpen its understanding of how natural capital considerations influence business resilience and decision-making over time, while contributing to emerging practices in nature-related disclosure.

Nature is one of the six strategic priorities that define PMI’s Value Plan 2030+, the company’s framework for long-term sustainable value creation, alongside Consumers, Circularity, Climate, Our Workforce, Workers in Our Value Chain.

The TNFD Report follows the release of PMI’s 2025 Climate Transition Plan, prepared in line with the TCFD framework, and represents a natural next step in broadening the company’s environmental assessment and disclosure. PMI’s environmental stewardship and transparency have been widely recognized over the years, most recently with the company’s inclusion in Forbes’ 2026 Net Zero Leaders list for the fourth consecutive year, ranking fourth.

“Natural capital functions, from fertile soils and clean water to pollination services and climate-stabilizing services, support every part of our business,” said Scott Coutts, Global Chief Operations Officer, PMI. “The assessments underpinning our TNFD Report give us a clear view of where dependencies on ecosystem services could affect agricultural production, manufacturing, and access to key raw materials. These insights help us strengthen operational resilience and focus our efforts where they can have the greatest impact.”

“This report reflects a deliberate choice: to treat our relationship with nature as a strategic enabler of long-term value creation, not a compliance exercise,” said Jennifer Motles, Chief Sustainability Officer, PMI. “By making nature visible in how we set targets, allocate resources, and shape our strategy, we are building an understanding that will only grow in importance as the reporting landscape matures – and we are proud as an early adopter to help shape that path for others navigating it alongside us.”

The TNFD Report also includes ‘Stories of Impact’, which bring the company’s strategy to life through examples of local initiatives and projects around the world, including work on water stewardship, biodiversity, soil restoration, and product circularity.

PMI’s TNFD Report should be read alongside PMI’s annual Value Report, where performance and updates on progress are disclosed. The company’s non-financial disclosures provide stakeholders with greater transparency on sustainability topics most relevant to PMI’s business success.

Philip Morris International: A Global Smoke-Free Champion

Philip Morris International is a leading international consumer goods company, actively delivering a smoke-free future and evolving its portfolio for the long term to include products outside of the tobacco and nicotine sector. The company’s current product portfolio primarily consists of cigarettes and smoke-free products, including heat-not-burn, nicotine pouch and e-vapor products. Our smoke-free products are available for sale in over 105 markets, and as of December 31, 2025, PMI estimates they were used by over 43 million legal-age consumers around the world, many of whom have moved away from cigarettes or significantly reduced their consumption. The smoke-free business accounted for approximately 42% of PMI’s second-quarter 2026 total net revenues. Since 2008, PMI has invested over $16 billion to develop, scientifically substantiate and commercialize innovative smoke-free products for legal age adults who would otherwise smoke or use other nicotine-containing consumer products, with the goal of completely ending the sale of cigarettes. This includes the building of world-class scientific assessment capabilities, notably in the areas of pre-clinical systems toxicology, clinical and behavioral research, as well as post-market studies. Following a robust science-based review, the U.S. Food and Drug Administration has authorized the marketing of Swedish Match’s General snus, ZYN nicotine pouches and versions of PMI’s IQOS devices and consumables - the first-ever such authorizations in their respective categories. Versions of IQOS devices and consumables, General snus and 20 ZYN nicotine pouch variants also obtained the first-ever Modified Risk Tobacco Product authorizations from the FDA in their respective categories. With a strong foundation and significant expertise in life sciences, PMI has a long-term ambition to expand into wellness areas. References to “PMI”, “we”, “our” and “us” mean Philip Morris International Inc., and its subsidiaries. For more information, please visit www.pmi.com and www.pmiscience.com.

Forward-Looking and Cautionary Statements

This press release contains projections of future results and goals and other forward-looking statements, including statements regarding business plans and strategies. Achievement of future results is subject to risks, uncertainties, and inaccurate assumptions. In the event that risks or uncertainties materialize, or underlying assumptions prove inaccurate, actual results could vary materially from those contained in such forward-looking statements. Pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, PMI is identifying important factors that, individually or in the aggregate, could cause actual results and outcomes to differ materially from those contained in any forward-looking statements made by PMI.

PMI’s business risks include: marketing and regulatory restrictions that could reduce our competitiveness, disrupt our SFP commercialization efforts, eliminate our ability to communicate with adult consumers, or ban certain of our products in certain markets or countries; excise tax increases and discriminatory tax structures; health concerns relating to the use of tobacco and other nicotine-containing products; litigation related to tobacco and/or nicotine products and intellectual property rights; intense competition; inability to anticipate changes in adult consumer preferences; use and reliance on third-parties; the adverse effects of global and individual country economic, regulatory and political developments, natural disasters and conflicts; geopolitical instability; the impact and consequences of Russia's invasion of Ukraine; changes in legal-age adult smoker behavior; continued decline of tax-paid cigarettes; lost revenues as a result of counterfeiting, contraband and cross-border purchases; governmental investigations; unfavorable currency exchange rates and currency devaluations, sustained periods of elevated inflation, and limitations on the ability to repatriate funds; adverse changes in applicable corporate tax laws; disruptions in the credit markets or changes to its credit ratings; recent and potential future tariffs imposed by the U.S. and other countries; adverse changes in the cost, availability, and quality of tobacco and other agricultural products and raw materials, as well as product components for its electronic devices; and the integrity of its information systems and effectiveness of its data privacy policies. PMI's future profitability may also be adversely affected should it be unsuccessful, in key markets or systemically, in its efforts to introduce, commercialize, and grow smoke-free products or if regulation or taxation do not differentiate between such products and cigarettes; if it is unable to successfully introduce new products, and promote brand equity; if there are prolonged disruptions of facilities used to produce its products; if it is unable to enter new markets or improve its margins through increased prices and productivity gains; if other market participants are more successful in their SFP commercialization efforts; if it is unable to attract and retain the best global talent; or if it is unable to successfully integrate and realize the expected benefits from recent transactions and acquisitions. Future results are also subject to the lower predictability of our smoke-free products performance.

PMI is further subject to other risks detailed from time to time in its publicly filed documents, including PMI’s Annual Report on Form 10-K for the fourth quarter and year ended December 31, 2025 and the Quarterly Report on Form 10-Q for the second quarter ended June 30, 2026. PMI cautions that the foregoing list of important factors is not a complete discussion of all potential risks and uncertainties. PMI does not undertake to update any forward-looking statement that it may make from time to time, except in the normal course of its public disclosure obligations.

 

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Philip Morris International

Corey Henry

T. +1 (202) 679 7296

E. corey.henry@pmi.com