Archives May 2026

Business Wire India

Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, will present data across women’s health, biosimilars, dermatology, and neurology at ISPOR 2026, the leading global scientific conference hosted by the International Society for Pharmacoeconomics and Outcomes Research. The conference, focused on health economics and outcomes research, will take place May 17-20, 2026, in Philadelphia, Pennsylvania.

 

Across 8 accepted abstracts, the data reflect Organon’s commitment to generating real-world evidence—rooted in lived experiences—that can help inform healthcare decision-making and improve health outcomes across a range of therapeutic areas.

 

 

“Health economics and outcomes research is critical to ensuring the right treatments reach patients and that health systems can sustain this approach over time,” said Juan Camilo Arjona Ferreira, MD, Head of R&D and Chief Medical Officer at Organon. “At ISPOR 2026, Organon is proud to share research findings about the budget impact, referral patterns, and real-world evidence of treatments for contraception, dermatology, and neurology conditions—each grounded in evidence that puts patient and provider perspectives at the center.”

 

 

Key data from Organon’s portfolio to be presented include:

 

 

• An examination of the cost-effectiveness and budget impact of NEXPLANON^® (etonogestrel implant) 68 mg Radiopaque in Brazil, including analyses that incorporate real-world utilization data and private payer perspectives.
• A budget impact analysis of VTAMA^® (tapinarof) cream, 1%, for the treatment of atopic dermatitis in adult and pediatric patients (2 years of age and older) from a U.S. Medicaid plan perspective.
• Analyses related to POHERDY^® (pertuzumab-dpzb) 420 mg/14 mL injection for intravenous use in certain HER2-positive breast cancer, as well as a real-world budget impact analysis of biosimilar adoption in a mid-sized Brazilian health maintenance organization.
• An exploration of real-world referral patterns and healthcare utilization among patients with headache disorders in the United Kingdom, contributing to a better understanding of patient pathways and healthcare resource use in neurology.

 

Details on the abstracts noted above and additional presentations (including dates and times) can be found below. See below for full product information, including indication and selected safety information.

 

Date and Time (all times listed in EDT)	Abstract Name
Monday, May 18, 2026 | Poster Session 1 | 10:30 AM-1:30 PM	12:30 PM-1:30 PM: EE71 – Management Based on the Institutionalization of Health Technology Assessment (HTA): The Case of the Etonogestrel Subdermal Implant in a Brazilian Private Health Insurance Plan 12:30 PM-1:30 PM: EE57 – Budget Impact and Cost Calculator Model for POHERDY® (pertuzumab-dpzb) in the Treatment of HER2-Positive Breast Cancer
Monday, May 18, 2026 | Poster Session 2 | 4:00 PM-7:00 PM	6:00 PM-7:00 PM: EE174 – Cost-Effectiveness and Budget Impact of the Etonogestrel Subdermal Contraceptive Implant in Brazil 6:00 PM-7:00 PM: EE100 – Real-World Budget Impact Analysis of Biosimilar Adoption in a Mid-Sized Brazilian Health Maintenance Organization 6:00 PM-7:00 PM: EE172 – Cost-Effectiveness and Budget Impact of the Etonogestrel Subdermal Implant Incorporating Real-World Utilization Data from a Large Brazilian Private Health Insurer 6:00 PM-7:00 PM: HSD27 – Patient Characteristics and Utilization of Adalimumab-bwwd in the U.S. Department of Veterans Affairs Population
Tuesday, May 19, 2026 | Poster Session 4 | 4:00 PM-7:00 PM	6:00 PM-7:00 PM: EE412 – Budget Impact of Introducing Tapinarof, a New Aryl Hydrocarbon Receptor Agonist, for the Treatment of Atopic Dermatitis in Adult and Pediatric Patients from a U.S. Medicaid Plan Perspective 6:00 PM-7:00 PM: SA40 – Real-World Referral Patterns and Healthcare Utilization Among Patients with Headache Disorders in the United Kingdom

 

About NEXPLANON^® (etonogestrel implant) 68 mg Radiopaque

 

Indication
NEXPLANON^® is indicated for prevention of pregnancy in women of reproductive potential for up to 5 years.

 

 

Selected Safety Information

 

 

WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION and REMOVAL

 

 

Improper insertion of NEXPLANON increases the risk of complications.

 

 

Proper training prior to first use of NEXPLANON can minimize the risk of improper NEXPLANON insertion.

 

 

Because of the risk of complications due to improper insertion and removal NEXPLANON is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the NEXPLANON REMS.

 

 

CONTRAINDICATIONS

 

 

• NEXPLANON should not be used in women who have known or suspected pregnancy; current or past history of thrombosis or thromboembolic disorders; liver tumors, benign or malignant, or active liver disease; undiagnosed abnormal uterine bleeding; known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer, now or in the past; and/or allergic reaction to any of the components of NEXPLANON.

 

WARNINGS and PRECAUTIONS
Risk of Complications Due to Improper Insertion and Removal

 

Complications of Insertion and Removal

 

 

• NEXPLANON should be inserted subdermally so that it will be palpable after insertion, and this should be confirmed by palpation immediately after insertion. Failure to insert NEXPLANON properly may go unnoticed unless it is palpated immediately after insertion. Undetected failure to insert the implant may lead to an unintended pregnancy. Failure to remove the implant may result in continued effects of etonogestrel, such as compromised fertility, ectopic pregnancy, or persistence or occurrence of a drug-related adverse event.
   
• Complications related to insertion and removal procedures may occur, e.g., pain, paresthesia, bleeding, hematoma, scarring, or infection. If NEXPLANON is inserted deeply (intramuscular or intrafascial), neural or vascular injury may occur.
   
• Postmarketing reports of implants located within the vessels of the arm and the pulmonary artery may have been related to deep insertions or intravascular insertions. Endovascular or surgical procedures may be needed for removal.
   
• Implant removal may be difficult or impossible if the implant is not inserted correctly, is inserted too deeply, not palpable, encased in fibrous tissue, or has migrated. If at any time the implant cannot be palpated, it should be localized, and removal is recommended. When an implant is removed, it is important to remove it in its entirety. Failure to remove the implant may result in continued effects of etonogestrel, such as compromised fertility, ectopic pregnancy, or persistence or occurrence of a drug-related adverse event.

 

Broken or Bent Implants

 

• Cases of breakage or bending of implants while inserted within a patient’s arm have been reported. Cases of migration of a broken implant fragment within the arm have also occurred. These cases may be related to external forces, e.g., manipulation of the implant or contact sports. The release rate of etonogestrel may be slightly increased in a broken or bent implant, based on in vitro data.

 

NEXPLANON is available only through a restricted program under a REMS.

 

NEXPLANON REMS

 

 

• NEXPLANON is only available through a restricted program under a REMS called NEXPLANON REMS because of the risk of complications due to improper insertion and removal.

 

Notable requirements of the NEXPLANON REMS include the following:

 

• Healthcare providers must be certified with the program by enrolling and completing training on the proper insertion and removal of NEXPLANON prior to first use.
• Pharmacies must be certified with the program and must only dispense NEXPLANON to certified healthcare providers who dispense NEXPLANON for insertion.
• Wholesalers and distributors must be registered with the program and must only distribute to certified pharmacies and certified healthcare providers.

 

Further information is available at www.NEXPLANONREMS.com and 1-833-697-7367.

 

Changes in Menstrual Bleeding Patterns

 

 

• After starting NEXPLANON, women are likely to have changes in their menstrual bleeding pattern. These may include changes in frequency, intensity, or duration. Abnormal bleeding should be evaluated as needed to exclude pathologic conditions or pregnancy. In clinical studies of the non-radiopaque etonogestrel implant, reports of changes in bleeding pattern were the most common reason for stopping treatment (11.1%). Women should be counseled regarding bleeding pattern changes that they may experience.

 

Ectopic Pregnancies

 

• Be alert to the possibility of an ectopic pregnancy in women using NEXPLANON who become pregnant or complain of lower abdominal pain.

 

Thrombotic and Other Vascular Events

 

• The use of combination hormonal contraceptives increases the risk of vascular events, including arterial events (strokes and myocardial infarctions) or deep venous thrombotic events (venous thromboembolism, deep venous thrombosis, retinal vein thrombosis, and pulmonary embolism). It is recommended that women with risk factors known to increase the risk of venous and arterial thromboembolism be carefully assessed. There have been postmarketing reports of serious arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, in women using etonogestrel implants. NEXPLANON should be removed in the event of a thrombosis. Due to the risk of thromboembolism associated with pregnancy and immediately following delivery, NEXPLANON should not be used prior to 21 days postpartum. Women with a history of thromboembolic disorders should be made aware of the possibility of a recurrence. Consider removal of the NEXPLANON implant in case of long-term immobilization due to surgery or illness.

 

Ovarian Cysts

 

• If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally, these enlarged follicles disappear spontaneously. Rarely, surgery may be required.

 

Carcinoma of the Breast and Reproductive Organs

 

• Some studies suggest that the use of combination hormonal contraceptives might increase the incidence of breast cancer and increase the risk of cervical cancer or intraepithelial neoplasia. Women with a family history of breast cancer or who develop breast nodules should be carefully monitored.

 

Liver Disease

 

• NEXPLANON should be removed if jaundice occurs.

 

Elevated Blood Pressure

 

• The NEXPLANON implant should be removed if blood pressure rises significantly and becomes uncontrolled.

 

Gallbladder Disease

 

• Studies suggest a small increased relative risk of developing gallbladder disease among combination hormonal contraceptive users. It is not known whether a similar risk exists with progestin-only methods like NEXPLANON.

 

Carbohydrate and Lipid Metabolic Effects

 

• Prediabetic and diabetic women using NEXPLANON should be carefully monitored.

 

Depressed Mood

 

• Women with a history of depressed mood should be carefully observed. Consideration should be given to removing NEXPLANON in patients who become significantly depressed.

 

Return to Ovulation

 

• In clinical trials with the non-radiopaque etonogestrel implant (IMPLANON), the etonogestrel levels in blood decreased below sensitivity of the assay by one week after removal of the implant. In addition, pregnancies were observed to occur as early as 7 to 14 days after removal. Therefore, a woman should re-start contraception immediately after removal of the implant if continued contraceptive protection is desired.

 

Fluid Retention

 

• Hormonal contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention. It is unknown if NEXPLANON causes fluid retention.

 

Contact Lenses

 

• Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

 

ADVERSE REACTIONS
Clinical Trial Experience

 

• The most common adverse reaction causing discontinuation of use of the implant in 3-year clinical trials was change in menstrual bleeding patterns (11.1%). The most common adverse reactions (≥5%) reported in these clinical trials were headache (24.9%), vaginitis (14.5%), weight increase (13.7%), acne (13.5%), breast pain (12.8%), abdominal pain (10.9%), and pharyngitis (10.5%). In a separate clinical trial to assess contraceptive efficacy and safety of NEXPLANON beyond 3 years, up to 5 years, a similar adverse reaction profile was observed as in Years 1 through 3. The most frequently reported adverse reaction >5% was intermenstrual bleeding (5.4%). Changes in menstrual bleeding patterns were the most frequently reported adverse reaction leading to discontinuation occurring in 4.0% of participants.

 

DRUG INTERACTIONS

 

Effects of Other Drugs on Hormonal Contraceptives

 

 

Substances decreasing the plasma concentrations of hormonal contraceptives and potentially diminishing the efficacy of hormonal contraceptives:

 

 

• Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of hormonal contraceptives and potentially diminish the effectiveness of hormonal contraceptives or increase breakthrough bleeding. Women should use an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are used with hormonal contraceptives, and continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.

 

Substances increasing the plasma concentrations of hormonal contraceptives:

 

• Co-administration of certain hormonal contraceptives and strong or moderate CYP3A4 inhibitors may increase the serum concentrations of progestins, including etonogestrel.

 

Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors:

 

• Significant changes (increase or decrease) in the plasma concentrations of progestin have been noted in cases of co-administration with HIV protease inhibitors, HCV protease inhibitors, or non-nucleoside reverse transcriptase inhibitors. These changes may be clinically relevant.

 

Effects of Hormonal Contraceptives on Other Drugs

 

• Hormonal contraceptives may affect the metabolism of other drugs. Consequently, plasma concentrations may either increase (for example, cyclosporine) or decrease (for example, lamotrigine).

 

USE IN SPECIFIC POPULATIONS
Pregnancy

 

• Rule out pregnancy before inserting NEXPLANON.

 

Lactation

 

• Small amounts of contraceptive steroids and/or metabolites, including etonogestrel are present in human milk. No significant adverse effects have been observed in the production or quality of breast milk, or on the physical and psychomotor development of breastfed infants.
• Hormonal contraceptives, including etonogestrel, can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women.

 

Pediatric Use

 

• The safety and effectiveness of NEXPLANON have been established in women of reproductive potential. Safety and effectiveness of NEXPLANON are expected to be the same in postpubertal adolescents as in adult women. NEXPLANON is not indicated before menarche.

 

PATIENT COUNSELING INFORMATION

 

• Advise women to contact their healthcare professional immediately if, at any time, they are unable to palpate the implant.
   
• NEXPLANON does not protect against HIV or other STDs.

 

Before prescribing NEXPLANON, please read the Prescribing Information, including the Boxed Warning. The Patient Information also is available.

 

About VTAMA^® (tapinarof) cream, 1%

 

 

INDICATIONS: VTAMA^® (tapinarof) cream, 1% is an aryl hydrocarbon receptor (AhR) agonist indicated for:

 

 

• the topical treatment of plaque psoriasis in adults
• the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older

 

SELECTED SAFETY INFORMATION

 

Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.

 

 

Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain.

 

 

Before prescribing VTAMA cream, please read the Prescribing Information.

 

 

About POHERDY^® (pertuzumab-dpzb)

 

 

INDICATIONS AND USAGE

 

 

Metastatic Breast Cancer (MBC)
POHERDY is indicated for use in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

 

 

Early Breast Cancer (EBC)
POHERDY is indicated for use in combination with trastuzumab and chemotherapy for:

 

 

• The neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer
• The adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence

 

SELECTED SAFETY INFORMATION

 

LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY

 

 

• Pertuzumab products can cause subclinical and clinical cardiac failure manifesting as decreased left ventricular ejection fraction (LVEF) and congestive heart failure (CHF). Evaluate cardiac function prior to and during treatment. Discontinue POHERDY treatment for a confirmed clinically significant decrease in left ventricular function.
• Exposure to pertuzumab products can cause embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception.

 

CONTRAINDICATIONS
POHERDY is contraindicated in patients with known hypersensitivity to pertuzumab products or to any of its excipients.

 

WARNINGS AND PRECAUTIONS

 

 

Left Ventricular Dysfunction
Pertuzumab products can cause left ventricular dysfunction, including symptomatic heart failure. Decreases in LVEF have been reported with drugs that block HER2 activity, including pertuzumab products.

 

 

Assess LVEF prior to initiation of POHERDY and at regular intervals during treatment to ensure that LVEF is within normal limits. If the LVEF declines and has not improved, or has declined further at the subsequent assessment, consider permanent discontinuation of POHERDY and trastuzumab.

 

 

In the pertuzumab-treated patients with MBC in CLEOPATRA, left ventricular dysfunction occurred in 4% of patients, and symptomatic left ventricular systolic dysfunction (LVSD) (congestive heart failure) occurred in 1% of patients. Patients who received prior anthracyclines or prior radiotherapy to the chest area may be at higher risk of decreased LVEF or left ventricular dysfunction.

 

 

In patients receiving pertuzumab as a neoadjuvant treatment in combination with trastuzumab and docetaxel in NeoSphere, LVEF decline >10% and a drop to <50% occurred in 8% of patients, and left ventricular dysfunction occurred in 3% of patients. LVEF recovered to ≥50% in all of these patients.

 

 

In patients receiving neoadjuvant pertuzumab in TRYPHAENA, LVEF decline >10% and a drop to <50% occurred in 7% of patients treated with pertuzumab plus trastuzumab and fluorouracil, epirubicin, and cyclophosphamide (FEC) followed by pertuzumab plus trastuzumab and docetaxel, 16% of patients treated with pertuzumab plus trastuzumab and docetaxel following FEC, and 11% of patients treated with pertuzumab in combination with docetaxel, carboplatin, and trastuzumab (TCH). Left ventricular dysfunction occurred in 6% of patients treated with pertuzumab plus trastuzumab and FEC followed by pertuzumab plus trastuzumab and docetaxel, 4% of patients treated with pertuzumab plus trastuzumab and docetaxel following FEC, and 3% of patients treated with pertuzumab in combination with TCH. Symptomatic LVSD occurred in 4% of patients treated with pertuzumab plus trastuzumab and docetaxel following FEC, 1% of patients treated with pertuzumab in combination with TCH, and none of the patients treated with pertuzumab plus trastuzumab and FEC followed by pertuzumab plus trastuzumab and docetaxel. LVEF recovered to ≥50% in all but 1 patient.

 

 

In patients receiving neoadjuvant pertuzumab in BERENICE, in the neoadjuvant period, LVEF decline ≥10% and a drop to <50% as measured by ECHO/MUGA assessment occurred in 7% of patients treated with pertuzumab plus trastuzumab and paclitaxel following dose-dense doxorubicin and cyclophosphamide (ddAC) and 2% of patients treated with pertuzumab plus trastuzumab and docetaxel following FEC. Ejection fraction decreased (asymptomatic LVD) occurred in 7% of patients treated with pertuzumab plus trastuzumab and paclitaxel following ddAC and 4% of the patients treated with pertuzumab plus trastuzumab and docetaxel following FEC in the neoadjuvant period. Symptomatic LVSD (New York Heart Association [NYHA] Class III/IV Congestive Heart Failure) occurred in 2% of patients treated with pertuzumab plus trastuzumab and paclitaxel following ddAC and none of the patients treated with pertuzumab plus trastuzumab and docetaxel following FEC in the neoadjuvant period.

 

 

In patients receiving adjuvant pertuzumab in APHINITY, the incidence of symptomatic heart failure (NYHA Class III/IV) with a LVEF decline ≥10% and a drop to <50% was 0.6%. Of the patients who experienced symptomatic heart failure, 47% of pertuzumab-treated patients had recovered (defined as 2 consecutive LVEF measurements above 50%) at the data cutoff. The majority of the events (86%) were reported in anthracycline-treated patients. Asymptomatic or mildly symptomatic (NYHA Class II) declines in LVEF ≥10% and a drop to <50% were reported in 3% of pertuzumab-treated patients, of whom 80% recovered at the data cutoff.

 

 

Pertuzumab products have not been studied in patients with a pretreatment LVEF value of <50%; a prior history of CHF; decreases in LVEF to <50% during prior trastuzumab therapy; or conditions that could impair left ventricular function such as uncontrolled hypertension, recent myocardial infarction, serious cardiac arrhythmia requiring treatment, or a cumulative prior anthracycline exposure to >360 mg/m² of doxorubicin or its equivalent.

 

 

Embryo-Fetal Toxicity
Based on its mechanism of action and findings in animal studies, pertuzumab products can cause fetal harm when administered to a pregnant woman. Pertuzumab products are HER2/neu receptor antagonists. Cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death have been reported with use of another HER2/neu receptor antagonist (trastuzumab) during pregnancy.

 

 

Verify the pregnancy status of females of reproductive potential prior to the initiation of POHERDY. Advise pregnant women and females of reproductive potential that exposure to POHERDY in combination with trastuzumab during pregnancy or within 7 months prior to conception can result in fetal harm, including embryo-fetal death or birth defects. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of POHERDY in combination with trastuzumab.

 

 

Infusion-Related Reactions
Pertuzumab products can cause serious infusion reactions, including fatal events.

 

 

In CLEOPATRA, on the first day, when only pertuzumab was administered, infusion-related reactions occurred in 13% of patients, and <1% were Grade 3 or 4. The most common infusion reactions (≥1%) were pyrexia, chills, fatigue, headache, asthenia, hypersensitivity, and vomiting. During the second cycle when all drugs were administered on the same day, the most common infusion reactions in the pertuzumab-treated group (≥1%) were fatigue, dysgeusia, hypersensitivity, myalgia, and vomiting.

 

 

In APHINITY, when pertuzumab was administered in combination with trastuzumab and chemotherapy on the same day, infusion-related reactions occurred in 21% of patients, with <1% of patients experiencing Grade 3-4 events.

 

 

Observe patients closely for 60 minutes after the first infusion and for 30 minutes after subsequent infusions of POHERDY. If a significant infusion-related reaction occurs, slow or interrupt the infusion, and administer appropriate medical therapies. Monitor patients carefully until complete resolution of signs and symptoms. Consider permanent discontinuation in patients with severe infusion reactions.

 

 

Hypersensitivity Reactions/Anaphylaxis
Pertuzumab products can cause hypersensitivity reactions, including anaphylaxis.
In CLEOPATRA, the overall frequency of hypersensitivity/anaphylaxis reactions was 11% in pertuzumab-treated patients, with Grade 3-4 hypersensitivity reactions and anaphylaxis occurring in 2% of patients.

 

 

In NeoSphere, TRYPHAENA, BERENICE, and APHINITY, hypersensitivity/anaphylaxis events were consistent with those observed in CLEOPATRA. In APHINITY, the overall frequency of hypersensitivity/anaphylaxis was 5% in the pertuzumab-treated group. The incidence was highest in the pertuzumab plus TCH–treated group (8%), with 1% Grade 3-4 events.

 

 

Observe patients closely for hypersensitivity reactions. Severe hypersensitivity, including anaphylaxis and fatal events, has been observed in patients treated with pertuzumab products. Angioedema has been described in postmarketing reports. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use prior to administration of POHERDY.

 

 

ADVERSE REACTIONS

 

 

Metastatic Breast Cancer
The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy.

 

 

Neoadjuvant Treatment of Breast Cancer
The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and docetaxel were alopecia, diarrhea, nausea, and neutropenia.

 

 

The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and docetaxel when given for 3 cycles following 3 cycles of FEC were fatigue, alopecia, diarrhea, nausea, vomiting, and neutropenia.

 

 

The most common adverse reactions (>30%) with pertuzumab in combination with TCH were fatigue, alopecia, diarrhea, nausea, vomiting, neutropenia, thrombocytopenia, and anemia.

 

 

The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and paclitaxel when given for 4 cycles following 4 cycles of ddAC were nausea, diarrhea, alopecia, fatigue, constipation, peripheral neuropathy, and headache.

 

 

The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and docetaxel when given for 4 cycles following 4 cycles of FEC were diarrhea, nausea, alopecia, asthenia, constipation, fatigue, mucosal inflammation, vomiting, myalgia, and anemia.

 

 

Adjuvant Treatment of Breast Cancer
The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and chemotherapy were diarrhea, nausea, alopecia, fatigue, peripheral neuropathy, and vomiting.

 

 

Before prescribing POHERDY, please read the Prescribing Information, including the Boxed Warning about left ventricular dysfunction and embryo-fetal toxicity.

 

 

About HADLIMA^® (adalimumab-bwwd) Injection

 

 

INDICATIONS AND USAGE

 

 

Rheumatoid Arthritis
HADLIMA is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs), for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

 

 

Juvenile Idiopathic Arthritis
HADLIMA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

 

 

Psoriatic Arthritis
HADLIMA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.

 

 

Ankylosing Spondylitis
HADLIMA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

 

 

Crohn’s Disease
HADLIMA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

 

 

Ulcerative Colitis
HADLIMA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.

 

 

Limitations of Use:
The effectiveness of HADLIMA has not been established in patients who have lost response to or were intolerant to tumor necrosis factor (TNF) blockers.

 

 

Plaque Psoriasis
HADLIMA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HADLIMA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

 

 

Hidradenitis Suppurativa
HADLIMA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.

 

 

Uveitis
HADLIMA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

 

 

SELECTED SAFETY INFORMATION

 

 

SERIOUS INFECTIONS
Patients treated with adalimumab products, including HADLIMA, are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

 

 

Discontinue HADLIMA if a patient develops a serious infection or sepsis.

 

 

Reported infections include:

 

 

• Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HADLIMA use and during therapy. Initiate treatment for latent TB prior to HADLIMA use.
• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
• Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

 

Carefully consider the risks and benefits of treatment with HADLIMA prior to initiating therapy in patients:

 

• with chronic or recurrent infection
• who have been exposed to TB
• with a history of opportunistic infection
• who resided in or traveled in regions where mycoses are endemic
• with underlying conditions that may predispose them to infection

 

Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HADLIMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

 

• Do not start HADLIMA during an active infection, including localized infections.
• Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
• If an infection develops, monitor carefully and initiate appropriate therapy.
• Drug interactions with biologic products: A higher rate of serious infections has been observed in rheumatoid arthritis (RA) patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HADLIMA with other biologic DMARDs (eg, anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

 

MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

 

• Consider the risks and benefits of HADLIMA treatment prior to initiating or continuing therapy in a patient with known malignancy.
• In clinical trials, more cases of malignancies were observed among adalimumab-treated subjects compared to control subjects.
• Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated subjects. Examine all patients, particularly those with a history of prolonged immunosuppressant or psoralen and ultraviolet A (PUVA) therapy, for the presence of NMSC prior to and during treatment with HADLIMA.
• In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
• Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

 

HYPERSENSITIVITY
Anaphylaxis and angioneurotic edema have been reported following adalimumab administration. If a serious allergic reaction occurs, stop HADLIMA and institute appropriate therapy.

 

HEPATITIS B VIRUS REACTIVATION
Use of TNF blockers, including HADLIMA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.

 

 

Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.

 

 

Exercise caution in patients who are carriers of HBV and monitor them during and after HADLIMA treatment.

 

 

Discontinue HADLIMA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HADLIMA after HBV treatment.

 

 

NEUROLOGIC REACTIONS
TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.

 

 

Exercise caution when considering HADLIMA for patients with these disorders; discontinuation of HADLIMA should be considered if any of these disorders develop.

 

 

HEMATOLOGIC REACTIONS
Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products.

 

 

Consider stopping HADLIMA if significant hematologic abnormalities occur.

 

 

CONGESTIVE HEART FAILURE
Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab products; exercise caution and monitor carefully.

 

 

AUTOIMMUNITY
Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome or autoimmune hepatitis. Discontinue treatment if symptoms of a lupus-like syndrome or autoimmune hepatitis develop.

 

 

IMMUNIZATIONS
Patients on HADLIMA should not receive live vaccines.

 

 

Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HADLIMA therapy.

 

 

Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero-exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

 

 

ADVERSE REACTIONS
The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (eg, upper respiratory, sinusitis), injection site reactions, headache, and rash.

 

 

Before prescribing HADLIMA, please read the Prescribing Information, including the Boxed Warning about serious infections and malignancies. The Medication Guide and Instructions for Use also are available.

 

 

About Organon
Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets.

 

 

Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook.

 

 

Cautionary Note Regarding Forward-Looking Statements
The information above reflects management’s current intentions and expectations for the future with respect to Organon’s expectations regarding milestone expenses, which constitute “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are subject to a number of risks, assumptions, uncertainties and other factors, such as the completion of Organon’s quarter-end closing process, including review by management and the audit committee of the Organon’s board of directors, which could result in material changes to the preliminary estimates described herein. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission (“SEC”), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings (as amended, where applicable), available at the SEC’s Internet site (www.sec.gov).

 

 

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260515139840/en/

 

Business Wire India

• Two five-year partnerships strengthen the academic-industry research bridge in two states that, together, account for a significant share of India’s pharmaceutical manufacturing, exports and biopharmaceutical capacity.
• This collaboration across the NIPER network- Raebareli, Hajipur, Ahmedabad and Hyderabad is strengthening translational research and opnMe® access, supporting the Biopharma SHAKTI mission and the Viksit Bharat 2047 vision.

 

Boehringer Ingelheim India Private Limited today signed two separate Memoranda of Understanding with the National Institutes of Pharmaceutical Education and Research at Ahmedabad and at Hyderabad.

 

Boehringer Ingelheim India Private Limited today signed two separate Memoranda of Understanding with the National Institutes of Pharmaceutical Education and Research at Ahmedabad and at Hyderabad. The two five-year agreements were signed at a joint ceremony in Hyderabad and establish a framework to advance pharmaceutical research, education and innovation through joint research initiatives, academic exchange and capability-building programmes.

 

The MoU signing ceremony witnessed presence of Dr. Shailendra Saraf, Director, NIPER-Ahmedabad and Hyderabad along with Dr. Srinivas Nanduri, Professor & Dean, NIPER Hyderabad, Dr. Jitender Madan, Professor from NIPER Hyderabad, Dr. Akshay Srivastava, Professor, NIPER Ahmedabad & Dean and Dr. Rajesh Kumar, Assistant Professor, NIPER Hyderabad. Under the terms of the Memoranda, Boehringer Ingelheim India will enable researchers and faculty at both institutes to access opnMe® (www.opnme.com), the company’s global open science portal.

 

Through opnMe®, the same molecules that scientists across the world use to ask new questions in early biology will now be in the hands of researchers in Gandhinagar. This is how a manufacturing state grows into a discovery state. And Biopharma SHAKTI has placed biologics at the centre of India’s next pharmaceutical chapter, with this partnership with the NIPER, Hyderabad positioned exactly there.

 

Boehringer Ingelheim has already shared more than 150 molecules with Indian institutions through opnMe®, and the new collaborations extend this access to two of the country’s most established pharmaceutical and life sciences ecosystems on the same day.

 

Gujarat is the leading pharmaceutical state in India, contributing approximately one-third of the country’s pharmaceutical production and over a quarter of its pharmaceutical exports, and is home to a large number of facilities approved by the United States Food and Drug Administration. The collaboration with the National Institute of Pharmaceutical Education and Research, Ahmedabad adds research depth to a state ecosystem that is widely recognised for its manufacturing strength.

 

Hyderabad is widely recognised as the bulk drug capital of India, accounting for a substantial share of the country’s active pharmaceutical ingredient production and bulk drug exports. The city is home to Genome Valley, India’s first organised life sciences cluster, and is the base for several of the country’s leading biopharmaceutical and vaccine manufacturers. The collaboration with NIPER, Hyderabad strengthens the research and talent foundation of an ecosystem that is central to India’s biopharmaceutical ambitions.

 

The collaborations are aligned with the Government of India’s vision for Viksit Bharat 2047 and with Biopharma SHAKTI (Strategy for Healthcare Advancement through Knowledge, Technology and Innovation), the ten thousand crore rupees national mission announced in the Union Budget 2026-27. Biopharma SHAKTI envisages the expansion of the Biopharma-focused National Institutes of Pharmaceutical Education and Research network through the establishment of three new institutes and the upgradation of the seven existing ones as Centres of Excellence (CoE) in translational research and pharmaceutical talent development.

 

These two MoUs build on the partnerships signed earlier in 2026 with the institutes at Raebareli and Hajipur. With these new agreements, Boehringer Ingelheim India’s open science collaboration now extends across northern, eastern, western and southern India.

 

Dr. Shailendra Saraf, Director, NIPER – Ahmedabad and Hyderabad, “India’s transition from a generics-led to an innovation-led pharmaceutical economy will not be made by any single institution or any single company. It will be made by the academia-industry network we are building across the country. Two Memoranda signed on one day, with two of our most important National Institutes of Pharmaceutical Education and Research, is the pace at which Biopharma SHAKTI is meant to operate, and the pace the sector now expects of itself.”

 

Meenal Gauri, Managing Director, Boehringer Ingelheim India, “opnMe began as a way for Boehringer Ingelheim scientists to share what they had built with the global research community. In India, it is becoming something more, a structured network of partnerships with the institutions that will shape the country’s pharmaceutical talent for the next decade. After Raebareli and Hajipur, signing with Ahmedabad and Hyderabad is a significant commitment, and we see this as the deepening of a long-term commitment to India’s pharmaceutical education network.”

 

The collaborations are structured on a non-profit, non-commercial basis, reflecting the shared commitment of Boehringer Ingelheim India and the National Institutes of Pharmaceutical Education and Research to ethical research, pharmaceutical education and the public good.

The mission-critical connectivity specialist selects Ilex to deliver global communications that drives sales and accelerates market needs 

 

London, UK, 15th May 2026 – Contrivian,  a technology company providing intelligent mission-critical connectivity, has appointed Ilex Content Strategies as its public relations agency of record. Ilex will deliver strategic communications designed to support international sales and strengthen Contrivian’s position across markets.

 

Contrivian serves governments, emergency responders, energy operators, mining and enterprises operating in remote environments where connectivity must remain stable, secure and predictable. Contrivian enables organisations to modernise connectivity without adding complexity or disruption, ensuring all organisations are connected without failure, everywhere. 

Together, Contrivian and Ilex will work to elevate the company’s international profile through targeted media engagement, thought leadership and strategic communications that reinforce Contrivian as a trusted provider of resilient connectivity. The partnership will support Contrivian’s growth, increasing visibility, strengthening market awareness and showcasing its commitment to delivering dependable connectivity in the most demanding remote environments. 

 

“While we have worked with communications agencies in the past, we have never experienced the depth of industry knowledge and expertise that we have with Ilex. They get what we do as a business and I trust that they will support our objectives with strategic media relations that have already generated leads for us,” said Grant Kirkwood, CEO at Contrivian. “It’s rare to find a partner that can deliver value from day one without the need to explain and educate them on the business. That has been a clear differentiator. While we can focus on connectivity, we know our customers are kept in the loop of our news through Ilex’s global reputation and efficiency.”

 

Ilex will work closely with the team at Juniper Digital and fractional Chief Marketing Officer, Matthew Ray, to deliver international media relations and strategic consultancy aligned to sales objectives. Using its Borderless PR model, Ilex will ensure consistent messaging and efficient global reach across key markets, without the complexity of managing multiple local agencies.

 

“Contrivian has strong leadership and clear ambitions for growth. Our focus is on turning that into market momentum, ensuring the right audiences understand who they are, what they stand for and why it matters,” said Matthew Whalley, Managing Director & Co-Founder at Ilex Content Strategies. “When that’s done well, it directly supports sales and accelerates growth. We’re looking forward to working closely with the team to make that happen.”

 

Founded in 2012, Ilex Content Strategies works with telecoms, cloud, cybersecurity, data centre and digital infrastructure organisations at key moments of growth, repositioning and market expansion. Its approach combines deep industry expertise with strategic communications to build visibility, shape positioning and deliver measurable commercial impact.

Business Wire India

EZTax.in, an authorized e-Return Intermediary (ERI), announced new AI-enabled capabilities in its self-service Income Tax e-Filing platform for Assessment Year 2026–27, focused on simplifying reconciliation of AIS, broker statements, and prefilled tax data for self-filing taxpayers.

 

The release includes features such as AIS Upload for Capital Gains, AIS Reconciliation, and automated Income Tax Rule Alerts intended to help taxpayers review disclosures, identify mismatches, and reduce manual consolidation of financial information across multiple reporting sources.

 

As Annual Information Statement (AIS) reporting, prefilled returns, and broker disclosures continue to expand, taxpayers are increasingly required to reconcile information reported across brokers, depositories, registrar and transfer agents, and other financial institutions before filing returns. EZTax said the new capabilities are designed to assist taxpayers in reviewing and validating such data during the filing process.

 

The AIS Upload feature allows taxpayers to upload AIS data and automatically read entries related to capital gains, dividends, interest income, salary, taxes paid, TDS, and other reported transactions. According to the company, the feature is intended to reduce the need for manual compilation of statements from brokers, mutual fund platforms, depositories including CDSL and NSDL, and registrar and transfer agents such as CAMS and KFIN Technologies.

 

The AIS Reconciliation capability compares taxpayer-entered information with government-reported data to identify mismatches, duplicate disclosures, and incomplete reporting prior to submission of returns. EZTax also introduced automated rule-based alerts intended to notify taxpayers of common filing inconsistencies relating to deductions, TDS, capital gains reporting, and tax regime selection.

 

Suneel Dasari, Founder and CEO of EZTax, said, “Tax filing in India is increasingly becoming a process of reconciling information reported across multiple systems and financial institutions. Our focus has been on building agents that help taxpayers review this information with greater clarity and reduce avoidable reporting inconsistencies.”

 

Mr. Dasari added that adoption of AI-assisted filing features on the platform has increased during the current filing season, particularly among taxpayers dealing with capital gains, investment disclosures, and multi-source income reporting.

 

EZTax said the updated filing workflows are available for AY 2026–27 filings as well as updated return submissions for earlier years through its web and mobile platforms.

 

The company provides self-service and expert-assisted tax filing services covering salaried individuals, investors, traders, professionals, businesses, HNIs, and NRIs, including support for capital gains taxation, foreign income disclosures, Form 67 filings, GST, TDS compliance, and tax notices.

 

Availability

The updated filing capabilities are available on EZTax.in for AY 2026–27 filings and updated return submissions for earlier years through the company’s web and mobile platforms.

 

Pricing

EZTax said self-service filing plans for AY 2026–27 start at Rs. 249 plus applicable taxes, while expert-assisted filing plans start at Rs. 999 plus taxes.

 

Business Wire India

 

SES:

 

Société Anonyme
RCS Luxembourg B 81267

 

 

Notice is hereby given of the

 

 

Extraordinary General Meeting

 

 

of SES, Société Anonyme, to be held at the Company’s registered office at Château de Betzdorf,
L-6815 Betzdorf (the “Company“), Luxembourg, on

 

 

Wednesday 17 June 2026 at 3:00 p.m. CET

 

 

AGENDA

 

 

1. Attendance list, quorum and adoption of the agenda
2. Nomination of a secretary and of two scrutineers
3. Cancellation of shares purchased in connection with the buy-back programme of 2 November 2023, as amended on 2 May 2024, in accordance therewith and pursuant thereto – Reduction of the share capital in accordance with article 450-5 of the law of 10 August 1915 on commercial companies, as amended, by forty-four million nine hundred ten thousand seven hundred eighty euro (EUR 44,910,780) through the cancellation of thirty-five million nine hundred and twenty-eight thousand six hundred and twenty-four (35,928,624) shares divided into (i) twenty-three million nine hundred and fifty-two thousand four hundred and sixteen (23,952,416) class A shares without indication of a par value and (ii) eleven million nine hundred and seventy-six thousand two hundred and eight (11,976,208) class B shares without indication of a par value, which are held by SES Astra for and on behalf of the Company and which have been purchased in connection with the buy-back programme of 2 November 2023, as amended on 2 May 2024 and subsequent amendment of article 4, paragraph 1 of the articles of association of the Company
4. Decision to introduce indemnification provisions for the members of the board of directors of the Company and the members of the executive committee of the Company and subsequent addition of new paragraphs (F), (G) and (H) to article 9 of the articles of association of the Company
5. Decision to grant the board of directors of the Company discretion to determine the date of the annual general meeting of shareholders, provided it is held within six (6) months following the end of the financial year and subsequent amendment of article 19, first paragraph of the articles of association of the Company
6. Decision to determine the location of the annual general meeting of the shareholders of the Company and of any other general meetings of the shareholders of the Company and subsequent amendment of article 20 of the articles of association of the Company
7. Decision to amend the convening notice requirements for general meetings of shareholders so as to specify the publication obligations applicable thereto and subsequent amendment of article 21, first paragraph of the articles of association of the Company and addition of a new article 21, second paragraph to the articles of association of the Company
8. Decision to allow general meetings of shareholders to be held in hybrid mode and subsequent addition of a new article 22, fourth paragraph to the articles of association of the Company
9. Decision to allow the Company secretary to sign any copy or extract of the minutes of the meetings of the Board and subsequent amendment of article 14, second paragraph of the articles of association of the Company
10. Decision to determine the documents and items to be approved at the annual general meeting of the shareholders of the Company and subsequent amendment of article 27 of the articles of association of the Company
11. Decision to introduce disclosure obligations requiring the Company to make specified documents and information available to shareholders in connection with general meetings of shareholders and subsequent amendment of article 29 of the articles of association of the Company
12. Decision to determine the matters on which the auditor is called to report on at the annual general meeting of the shareholders of the Company and subsequent amendment of article 30 of the articles of association of the Company
13. Miscellaneous

 

 

The board of directors of the Company recommends that you vote FOR agenda items 1-12 of the extraordinary general meeting of shareholders set forth above.

 

Attendance

 

 

The right of a shareholder to attend the Extraordinary General Meeting (“EGM“) and to participate in the vote will be determined at midnight (CET) on the fourteenth day preceding the EGM, i.e. 3 June 2026 (the “Registration Date“). If a Fiduciary Depositary Receipts (“FDR“) holder wishes to attend the meeting he has to be recorded as a shareholder in the share register of the Company prior to the Registration Date. Anyone not being a shareholder on the Registration Date may not attend or vote at the EGM.

 

 

Withdrawal of FDRs and Conversion into A-shares

 

 

An FDR holder who wants to convert FDRs into A-shares has to request this conversion in accordance with conditions 12 and 16 of the Terms and Conditions of the Amended and Restated Fiduciary Deposit Agreement dated 26 September 2001. This document is available at the Banque et Caisse d’Épargne de l’État, Luxembourg. No charge for conversion will be requested for natural persons who are not yet shareholders of category A and who proceed to a conversion of a maximum of 10,000 FDRs into A-shares, allowing them to participate in the EGM of 17 June 2026.

 

 

The latest date for withdrawing FDRs and converting into A-shares for attendance at the EGM is 3 June 2026 at 4:30 p.m. CET. Shareholders who have converted their FDRs into A-shares prior to that date will receive a copy of the EGM documents and details required to attend the EGM. Please feel free to contact Banque et Caisse d’Épargne de l’État, Luxembourg, for further queries in this respect, at the following address: securitisation.irm@spuerkeess.lu.

 

 

Voting instructions

 

 

The FDR holder is entitled, subject to any applicable provisions (e.g. Luxembourg law, articles of association, shareholders’ thresholds and concession agreement) to instruct the Fiduciary via his bank as to the exercise of the voting rights by means of a voting certificate available on request at the bank where the FDRs are held.

 

 

In order for the voting instructions to be valid, the voting certificate form must be completed and duly signed by the FDR holder or, as the case may be, the beneficial owner. Please feel free to contact Banque et Caisse d’Épargne de l’État, Luxembourg, for further queries in this respect at the following address: securitisation.irm@spuerkeess.lu.

 

 

Upon receipt of the voting certificate on or before the date determined by the Fiduciary (being at the latest 15 June 2026 at 3:00 p.m. CET) with such certification and evidence as requested by the Fiduciary or by the Company, the Fiduciary shall transmit to the Company the relevant certifications and supporting evidence and the Company shall verify whether the relevant holders of FDRs or the beneficial owners thereof would qualify as an A-shareholder of the Company if in lieu of FDRs they would hold the corresponding number of A-shares.

 

 

If within eight Luxembourg business days from the receipt of such certification and supporting evidence, the Company has not notified the Fiduciary of its rejection of the request of a holder to exercise its voting rights pertaining to the A-shares underlying its FDRs, the Company shall be deemed to have accepted the relevant voting request.

 

 

After receipt of the written approval of the voting request by the Company, the Fiduciary shall vote or cause to be voted in accordance with the instructions set forth in such requests. The Fiduciary may designate and appoint authorized representatives to attend the meeting and vote on behalf of the FDR holders.

 

 

The voting instructions are deemed to be irrevocable and definitive 48 hours prior to the time for which the meeting has been convened, i.e. at the latest on 15 June 2026 at 3:00 p.m. CET. If the Fiduciary has not received voting instructions from the FDR holder, the Fiduciary shall be deemed to have been instructed to vote in the manner proposed by the Board of Directors in the relevant meeting.

 

 

There will be no vote under item 13. Miscellaneous.

 

 

Amendments to the Agenda

 

 

One or more shareholders owning together at least 5% of the share capital of SES have the right to add items to the agenda of the EGM and may deposit draft resolutions regarding items listed on the agenda or proposed to be added to the agenda. This request will need to be received at the latest the twenty-second day preceding the EGM, i.e. 26 May 2026, and made in writing via post (SES, Attn. Ms Sarah Gavin, Château de Betzdorf, L-6815 Betzdorf, Luxembourg) or email (shareholders@ses.com) and will need to include a justification or draft resolution to be adopted at the EGM. The written request will need to include a contact address (post or email) to which the Company can confirm receipt within 48 hours from the receipt of the request.

 

 

At the latest fifteen days preceding the EGM, i.e. 2 June 2026, the Company will then publish a revised agenda.

 

 

Documents made available by SES

 

 

Documents made available by the Company (including the draft resolutions proposed to be adopted at the EGM) for the purpose of this meeting may be inspected during normal working hours by the FDR holders at the offices of the Fiduciary, Banque et Caisse d’Épargne de l’État, Luxembourg, Issuer Services/IRM, 16 rue Zithe, L-2954 Luxembourg, or alternatively at the offices of the Listing Agents, BGL BNP Paribas S.A., 50 avenue J.F. Kennedy, L-2951 Luxembourg, and Société Générale, GSSI/GIS/CMO/AGL, 32 rue du Champ de Tir, F-44312 Nantes Cedex 3, France, and are available on the following websites: www.ses.com and www.spuerkeess.lu/SES.

 

 

Please feel free to contact SES for further queries in this respect at the following address: shareholders@ses.com.

 

 

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260514124904/en/