Adalimumab-BWWD (Samsung Bioepis)

JERSEY CITY, N.J.--(BUSINESS WIRE)--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 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 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 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: Carefully consider the risks and benefits of treatment with HADLIMA prior to initiating therapy in patients: 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).

First quarter 2026 revenue of $1.460 billion, down 4% as-reported and down 9% excluding the impact of foreign currency. First quarter 2026 diluted earnings per share of $0.55 and non-GAAP Adjusted diluted earnings per share of $0.71. First quarter 2026 net income of $146 million and Adjusted EBITDA (non-GAAP) of $415 million, representing an Adjusted EBITDA margin of 28.4%. On April 26, 2026, the company announced its pending merger into Sun Pharmaceutical Industries Limited (together with its subsidiaries and/or associated companies, “Sun Pharma”) in an all-cash transaction (the “merger”). The merger is expected to close in early 2027, subject to customary closing conditions, including receipt of required regulatory approvals and approval by Organon stockholders. In light of the pending merger, Organon will not be providing financial guidance or hosting quarterly earnings calls. JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN) today announced its results for the first quarter ended March 31, 2026. First Quarter 2026 Revenue in $ millions Q1 2026 Q1 2025 VPY VPY ex-FX Women’s Health $ 389 $ 463 (16)% (19)% General Medicines Biosimilars 173 141 23% 21% Established Brands 880 887 (1)% (7)% Other (1) 18 22 (15)% (21)% Revenue $ 1,460 $ 1,513 (4)% (9)% Totals may not foot due to rounding and percentages are computed using unrounded amounts. (1) Other includes manufacturing sales to third parties. For the first quarter of 2026, total revenue was $1.460 billion, down 4% on an as-reported basis and down 9% excluding the impact of foreign currency (ex-FX), compared with the first quarter of 2025. Women’s Health revenue declined 16% as-reported and declined 19% ex-FX in the first quarter of 2026, compared with the first quarter of 2025. Sales of Nexplanon® (etonogestrel implant) decreased 21% ex-FX in the first quarter compared with the first quarter of 2025. In the U.S., sales of Nexplanon declined 28% primarily due to both decreased physician demand following the five-year label approval which as expected, has delayed reinsertions; and continued uncertainty around federal funding. Outside of the U.S., Nexplanon sales declined 4% ex-FX, due to the timing of shipments in selective emerging markets, partially offset by increased demand and access in Brazil. Sales of oral contraceptives Marvelon TM (desogestrel and ethinyl estradiol pill) and Mercilon TM (desogestrel and ethinyl estradiol pill) declined 36% ex-FX in the first quarter of 2026 primarily due to decreased demand and market contraction in China and the timing of shipments in Asia Pacific. Global Fertility revenue was down 9% ex-FX as a result of competition-driven price reductions in the U.S. partially offset by modest market growth in China. In January of 2026 the company completed the sale of the Jada® system to Laborie. Biosimilars revenue increased 23% as-reported and 21% ex-FX in the first quarter of 2026, compared with the first quarter of 2025, primarily due to the strong performance of Hadlima® (adalimumab-bwwd) associated with stronger demand in the U.S., and increased demand in Puerto Rico. Biosimilars also benefitted from contribution from new assets, Bildyos® (denosumab-nxxp) and Bilprevda® (denosumab-nxxp) which were approved by the U.S. Food and Drug Administration (“FDA”) in the third quarter of 2025, and Tofidence® (tocilizumab-bavi), which the company acquired in the second quarter of 2025. Established Brands revenue declined 1% as-reported and declined 7% ex-FX in the first quarter of 2026. Revenue contribution from Emgality® (1) (galcanezumab-gnlm) partially offset a decline in the respiratory portfolio, which was driven by pricing pressure, as well as volume declines related to the adoption of revised medical guidelines that deprioritize the use of montelukast, including Singulair® (montelukast sodium) , in various international markets, most recently, in China. Global sales of Dulera® (mometasone furoate and formoterol fumarate dihydrate) also declined in the first quarter of 2026 primarily due to pricing pressure and decreased demand in the U.S. VTAMA ® (tapinarof) grew modestly in the first quarter of 2026 compared with the first quarter of 2025. (1) Organon acquired certain European licensing and distribution rights to Emgality from Eli Lilly and Company (“Eli Lilly”) beginning in early 2024. Emgality is a registered trademark of Eli Lilly in the European Union and other countries (used under license). First Quarter 2026 Profitability in $ millions, except per share amounts Q1 2026 Q1 2025 VPY Revenues $ 1,460 $ 1,513 (4)% Cost of sales 677 672 1% Gross profit 783 841 (7)% Non-GAAP Adjusted gross profit (1) 861 934 (8)% Net income 146 87 68% Non-GAAP Adjusted net income (1) 188 265 (29)% Diluted Earnings per Share (EPS) 0.55 0.33 67% Non-GAAP Adjusted diluted EPS (1) 0.71 1.02 (30)% Acquired in-process research & development (IPR&D) and milestones — 6 NM Adjusted EBITDA (Non-GAAP) (1) 415 484 (14)% Q1 2026 Q1 2025 Gross margin 53.6 % 55.6 % Non-GAAP Adjusted gross margin (1) 59.0 % 61.7 % Adjusted EBITDA margin (Non-GAAP) (1, 2) 28.4 % 32.0 % (1) See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures. Reported gross margin in the first quarter of 2026 was 53.6% compared with 55.6% in the prior year period. Non-GAAP Adjusted gross margin was 59.0% in the first quarter of 2026, compared to 61.7% in the first quarter of 2025. Unfavorable pricing and product mix as well as foreign exchange rates were notable drivers in the decline of both reported gross margin and non-GAAP Adjusted gross margin. Net income for the first quarter of 2026 was $146 million, or $0.55 per diluted share, compared with net income of $87 million, or $0.33 per diluted share, in the first quarter of 2025. For the first quarter of 2026, non-GAAP Adjusted net income was $188 million, or $0.71 per diluted share, compared with $265 million, or $1.02 per diluted share, for the first quarter of 2025. Non-GAAP Adjusted EBITDA margin was 28.4% in the first quarter of 2026 compared with 32.0% in the first quarter of 2025. The year-over-year decline was primarily driven by a decrease in Adjusted Gross Margin. Capital Allocation Today, Organon’s Board of Directors declared a quarterly dividend of $0.02 for each issued and outstanding share of the company's common stock. The dividend is payable on June 11, 2026, to stockholders of record at the close of business on May 11, 2026. As of March 31, 2026, cash and cash equivalents were $1.12 billion, and debt was $8.57 billion. Webcast Information As is customary during the pendency of an acquisition, Organon has suspended its quarterly earnings calls and will not host a conference call in conjunction with today’s first quarter earnings release. 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 and follow us on LinkedIn , Instagram , X , YouTube , TikTok and Facebook . Cautionary Note Regarding Non-GAAP Financial Measures This press release contains “non-GAAP financial measures,” which are financial measures that either exclude or include amounts that are correspondingly not excluded or included in the most directly comparable measures calculated and presented in accordance with U.S. generally accepted accounting principles (“GAAP”). Specifically, the company makes use of the non-GAAP financial measures Adjusted EBITDA, Adjusted EBITDA margin, Adjusted gross margin, Adjusted gross profit, Adjusted net income, Adjusted EPS, and Adjusted diluted EPS, which are not recognized terms under GAAP and are presented only as a supplement to the company’s GAAP financial statements. This press release also provides certain measures that exclude the impact of foreign exchange. We calculate foreign exchange by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. The company believes that these non-GAAP financial measures help to enhance an understanding of the company’s financial performance. However, the presentation of these measures has limitations as an analytical tool and should not be considered in isolation, or as a substitute for the company’s results as reported under GAAP. Because not all companies use identical calculations, the presentations of these non-GAAP measures may not be comparable to other similarly titled measures of other companies. Please refer to Table 4 and Table 5 of this press release for additional information, including relevant definitions and reconciliations of non-GAAP financial measures contained herein to the most directly comparable GAAP measures. The company’s management uses the non-GAAP financial measures described above to evaluate the company’s performance and to guide operational and financial decision making. Further, the company’s management believes that these non-GAAP financial measures, which exclude certain items, help to enhance its ability to meaningfully communicate its underlying business performance, financial condition and results of operations. Cautionary Note Regarding Forward-Looking Statements Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to the merger, including the anticipated timing of completion thereof. Forward-looking statements may be identified by words such as “proposed,” “will,” “continue,” “expects,” “believes,” “estimates,” “opportunity,” “pursue,” “anticipate,” “be able to,” “intend,” or words of similar meaning. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to uncertainties as to the timing of the merger; the risk that the merger may not be completed on the anticipated terms in a timely manner or at all; the failure to satisfy any of the conditions to the consummation of the merger, including receiving, on a timely basis or otherwise, the minimum vote required by Organon’s stockholders to approve the merger; the possibility that competing offers or acquisition proposals for Organon will be made; the possibility that any or all of the various conditions to the consummation of the merger may not be satisfied or waived, including the failure to receive any required regulatory approvals from any applicable governmental entities (or any conditions, limitations or restrictions placed on such approvals); the occurrence of any event, change or other circumstance that could give rise to the termination of the definitive agreement, including in circumstances which would require Organon to pay a termination fee; the effect of the announcement or pendency of the merger on Organon’s ability to retain and hire key personnel, its ability to maintain relationships with its customers, suppliers and others with whom it does business, or its operating results and business generally; risks related to diverting management’s attention from Organon’s ongoing business operations; the risk that stockholder litigation in connection with the merger may result in significant costs of defense, indemnification and liability; certain restrictions during the pendency of the merger that may impact Organon’s ability to pursue certain business opportunities or strategic transactions; the risk that any announcements relating to the merger could have adverse effects on the market price of Organon’s common stock, including if the merger is not consummated; risks that the benefits of the merger are not realized when and as expected; and legislative, regulatory and economic developments. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings with the SEC, including the company’s most recent Annual Report on Form 10-K, Current Report on Form 8-K, filed by the company on April 27, 2026, and other SEC filings, available at the SEC’s Internet site ( ). Additional Information and Where to Find It This press release may be deemed to be solicitation material in respect of the proposed merger. In connection with the merger, Organon intends to materials with the SEC, including Organon’s proxy statement in preliminary and definitive form on Schedule 14A (the “Merger Proxy Statement”). Organon will mail the Merger Proxy Statement and a proxy card to its stockholders in connection with the merger. INVESTORS AND STOCKHOLDERS OF ORGANON ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING THE MERGER PROXY STATEMENT (WHEN THEY ARE AVAILABLE), BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT ORGANON, SUN PHARMA AND THE MERGER AND RELATED MATTERS. Investors and stockholders of Organon are or will be able to obtain these documents (when they are available) free of charge from the SEC’s website at , or through the investor relations section of Organon’s website, . Participants in the Solicitation Organon and its directors, executive officers and other members of management and employees, under SEC rules, may be deemed to be “participants” in the solicitation of proxies from stockholders of Organon in favor of the proposed acquisition. Information about Organon’s directors and executive officers is set forth in the 2026 Annual Meeting Proxy Statement, filed with the SEC on April 24, 2026, and which is available at . To the extent holdings of Organon’s securities by its directors or executive officers have changed since the amounts set forth in the 2026 Annual Meeting Proxy Statement, such changes have been or will be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Change in Ownership on Form 4 filed with the SEC, which are available at . Additional information concerning the interests of Organon’s participants in the solicitation, which may, in some cases, be different than those of Organon’s stockholders generally, will be set forth in the Merger Proxy Statement when it becomes available. TABLE 1 Organon & Co. Condensed Consolidated Statement of Income (Unaudited, $ in millions except shares in thousands and per share amounts) Three Months Ended March 31, 2026 2025 Revenues $ 1,460 $ 1,513 Cost of sales 677 672 Gross Profit 783 841 Selling, general and administrative 424 420 Research and development 93 96 Acquired in-process research and development and milestones — 6 Restructuring costs 31 86 Interest expense 111 124 Exchange losses (gains) 7 (4 ) Other (income) expense, net (96 ) 12 Income before income taxes 213 101 Income tax expense 67 14 Net income $ 146 $ 87 Earnings per share: Basic $ 0.56 $ 0.34 Diluted $ 0.55 $ 0.33 Weighted average shares outstanding: Basic 260,370 257,862 Diluted 262,896 261,001 TABLE 2 Organon & Co. Sales by top products (Unaudited, $ in millions) Three Months Ended March 31, 2026 2025 ($ in millions) U.S. Int’l Total U.S. Int’l Total Women’s Health Nexplanon/Implanon NXT $ 127 $ 74 $ 201 $ 176 $ 72 $ 248 Follistim AQ 21 39 61 35 34 69 NuvaRing 6 18 24 6 16 22 Ganirelix Acetate Injection 2 24 26 5 23 27 Marvelon/Mercilon — 26 26 — 39 39 Jada 5 — 5 15 — 15 Other Women’s Health ( 1) 17 30 46 15 27 43 General Medicines Biosimilars Renflexis 42 15 57 44 12 57 Hadlima 51 16 67 33 14 47 Ontruzant 4 1 5 4 14 18 Brenzys — 20 20 — 14 14 Other Biosimilars (1) 11 13 24 — 5 5 Established Brands Cardiovascular Atozet — 85 85 — 77 77 Zetia 1 86 87 1 84 85 Cozaar/Hyzaar 2 55 57 2 53 55 Vytorin 1 20 21 1 22 23 Rosuzet — 6 6 — 4 4 Other Cardiovascular (1) 1 27 28 — 30 30 Respiratory Singulair 2 38 40 2 72 74 Nasonex — 65 65 — 71 72 Dulera 23 12 35 34 10 43 Clarinex 1 30 31 — 34 34 Other Respiratory (1) 11 1 12 10 3 13 Non-Opioid Pain, Bone and Dermatology Arcoxia — 59 59 — 62 62 Fosamax — 29 29 1 32 33 Diprospan — 35 35 — 30 30 Vtama 23 2 25 20 4 24 Other Non-Opioid Pain, Bone and Dermatology (1) 3 65 68 4 65 68 Other Propecia 1 28 30 1 24 26 Emgality — 54 54 — 32 32 Proscar — 26 26 — 24 24 Other (1) 3 85 87 3 76 78 Other (2) — 18 18 — 22 22 Revenues $ 358 $ 1,102 $ 1,460 $ 412 $ 1,101 $ 1,513 Totals may not foot due to rounding. Trademarks appearing above in italics are trademarks of, or are used under license by, the Organon group of companies. (1) Includes sales of products not listed separately. (2) Other includes manufacturing sales to third parties. TABLE 3 Organon & Co. Sales by geographic area (Unaudited, $ in millions) Three Months Ended March 31, 2026 2025 Europe and Canada $ 412 $ 376 United States 358 412 Asia Pacific and Japan 226 251 China 194 204 Latin America, Middle East, Russia, and Africa 247 240 Other (1) 23 30 Revenues $ 1,460 $ 1,513 (1) Other includes manufacturing sales to third parties. TABLE 4 Organon & Co. Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Unaudited, $ in millions) Three Months Ended March 31, 2026 2025 GAAP Gross Profit $ 783 $ 841 Adjusted for: Manufacturing network costs (1) 21 29 Stock-based compensation 3 4 Amortization 47 50 Acquisition-related costs (2) 7 9 Other — 1 Adjusted Non-GAAP Gross Profit $ 861 $ 934 (1) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to Table 5. (2) Acquisition-related costs relate to costs from the acquisition of Dermavant. For additional details refer to Table 5. Three Months Ended March 31, 2026 2025 GAAP Gross Margin 53.6 % 55.6 % Total impact of Non-GAAP adjustments 5.4 % 6.1 % Adjusted Non-GAAP Gross Margin 59.0 % 61.7 % Three Months Ended March 31, 2026 2025 GAAP Selling, general and administrative expenses $ 424 $ 420 Adjusted for: Stock-based compensation (13 ) (16 ) Restructuring related charges — (6 ) Other (13 ) (3 ) Adjusted Non-GAAP Selling, general and administrative expenses $ 398 $ 395 TABLE 4 Organon & Co. Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Continued) (Unaudited, $ in millions except per share amounts) Three Months Ended March 31, 2026 2025 GAAP Research and development expenses $ 93 $ 96 Adjusted for: Manufacturing network costs (1) (3 ) (3 ) Stock-based compensation (3 ) (4 ) Other (1 ) (1 ) Adjusted Non-GAAP Research and development expenses $ 86 $ 88 (1) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to Table 5. Three Months Ended March 31, 2026 2025 GAAP Reported Net Income $ 146 $ 87 Adjusted for: Cost of sales adjustments 78 93 Selling, general and administrative adjustments 26 25 Research and development adjustments 7 8 Jada divestiture (81 ) — Restructuring 31 86 Change in fair value of contingent consideration (5 ) 11 Other (gain) expense, net (3 ) 4 Tax impact on adjustments above (1) (11 ) (49 ) Non-GAAP Adjusted Net Income $ 188 $ 265 (1) For the three months ended March 31, 2026 and 2025, the GAAP income tax rates were 31.4% and 13.4%, respectively, and the non-GAAP income tax rates were 29.3% and 19.2%, respectively. These adjustments represent the estimated tax impacts on the reconciling items by applying the statutory rate and applicable law of the originating territory of the non-GAAP adjustments. Three Months Ended March 31, 2026 2025 GAAP Diluted Earnings per Share $ 0.55 $ 0.33 Total impact of Non-GAAP adjustments 0.16 0.69 Non-GAAP Adjusted Diluted Earnings per Share $ 0.71 $ 1.02 TABLE 5 Organon & Co. Reconciliation of GAAP Net (Loss) Income to Non-GAAP Adjusted EBITDA (Unaudited, $ in millions) Three Months Ended March 31, 2026 2025 GAAP Reported Net Income $ 146 $ 87 Depreciation (1) 38 32 Amortization 47 50 Interest expense 111 124 Income tax expense (benefit) 67 14 EBITDA (Non-GAAP) $ 409 $ 307 Restructuring and related charges 31 92 Manufacturing network related (2) 27 36 Acquisition-related costs (3) 7 9 Change in contingent consideration (5 ) 11 Jada divestiture (81 ) — Other costs 8 5 Stock-based compensation 19 24 Adjusted EBITDA (Non-GAAP) $ 415 $ 484 Adjusted EBITDA margin (Non-GAAP) 28.4 % 32.0 % (1) Excludes accelerated depreciation included in one-time costs. (2) Manufacturing network related costs, including exiting of temporary manufacturing and supply agreements with Merck & Co., Inc., Rahway, NJ, US, reflect accelerated depreciation, exit premiums, technology transfer costs, stability and qualification batch costs, and third-party contractor costs. (3) Acquisition related costs for the three months ended March 31, 2026 and 2025, reflect the amortization pertaining to the fair value inventory purchase accounting adjustment for the Dermavant transaction. As the costs described in (1) through (3) above are directly related to the separation of Organon and acquisition related activities and therefore arise from a one-time event outside of the ordinary course of the company’s operations, the adjustment of these items provides meaningful, supplemental, information that the company believes will enhance an investor's understanding of the company's ongoing operating performance. Contacts Media Contacts: Felicia Bisaro (646) 703-1807 Kate Vossen (732) 675-8448 Investor Contacts: Jennifer Halchak (201) 275-2711 Renee McKnight (551) 204-6129