Topiramate

26 scientific abstracts, including two oral presentations, demonstrate UCB's ongoing commitment to advancing research for people living with epilepsies Data include an open-label extension study describing the long-term safety of FINTEPLA®▼ (fenfluramine)[1] and global functioning in children and adults with Dravet syndrome or Lennox-Gastaut syndrome[2] Data provide insights on developmental and epileptic encephalopathies (DEEs), including a qualitative study addressing diagnostic challenges and benefits in adult care settings, and a caregiver survey exploring the daily impacts of unpredictable seizures and disruptive behaviors[3],[4] Additional focus on defining prolonged seizures and their real-world impact on patients and caregivers[5],[6],[7] BRUSSELS, Aug. 29, 2025 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced it will present 26 abstracts from its epilepsy portfolio at the International Epilepsy Congress (IEC) Congress, Lisbon, Portugal, August 30 – September 3, 2025. Data will focus on developmental and epileptic encephalopathies (DEEs), such as Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), as well as prolonged seizures, seizure emergencies and early pipeline research. Dimitrios Bourikas, Global Medical Head of DEE and Epilepsy , UCB, commented: "At UCB, we are committed to driving improvements in all aspects of care for people living with epilepsies and severe epileptic conditions. The breadth of data we are presenting at the International Epilepsy Congress reflects our dedication to advancing innovative solutions that address real-world patient needs. By deepening insights into disease mechanisms, treatment outcomes, and the experiences of both patients and caregivers, we strive to shape a better future for those affected by epileptic conditions." Highlights of data to be presented at IEC : Fenfluramine: A combined open-label extension (OLE) study enrolled 412 patients with DS or LGS who had participated in three previous fenfluramine studies, reporting no new or unexpected safety signals and long-term sustained benefit.[2] Barriers and benefits of identifying patients with DEEs in adult care settings: Although the diagnosis of DEEs in children has become routine, significant diagnostic gaps remain for adults. This qualitative study, based on interviews with caregivers and healthcare professionals in the UK, Germany, France, and Spain, found that a confirmed diagnosis fosters holistic care, which may improve quality of life (QoL), enhance communication and reduce risk of hospitalization for patients.[4] Unpredictable seizures and disruptive behavior in DEEs: Interim results of a caregiver survey: An internet-based anonymous 63-question survey was distributed to caregivers of patients with DEEs by multiple DEE-specific patient groups. Nearly half of caregivers reported that high rates of disruptive seizures/behavior led to temporary loss in abilities, previously associated with reduced quality of life.[3] Prolonged seizures: Research characterizing patient and caregiver experiences of prolonged seizures describes unmet needs and the significant short-term and long-term negative impact on quality of life.[7] Real-world data from Adelphi's Prolonged Seizure Disease Specific Programme™ characterizes the definition, prevalence, and patient population of prolonged seizures finding that people living with epilepsy experiencing prolonged seizures encounter significant seizure worry due to their seizure. In addition, these seizures regularly progress to status epilepticus and/or seizure clusters, leading to emergency care and hospital admissions, despite best practice.[5] A post hoc analysis of video-EEG recordings from 725 patients explores seizure duration and time-point cutoffs for statistically defining possible and probable prolonged seizures by seizure type, supporting the 2-minute cutoff for tonic-clonic seizures (focal/generalized onset) and suggesting a 1 to 3 minutes cutoff for other seizures, confirming that most seizure are abnormally prolonged at 2 minutes or less[6] Seizure pathways: A qualitative study aimed to understand the end-to-end care process for acute seizure emergencies finding that a stronger focus on outpatient guidelines could empower patients and caregivers to manage prolonged seizures in the outpatient setting, potentially avoiding unnecessary seizure escalation, injury, hospitalization and death.[8] Acute medication landscape: A global analysis assessed the availability and reimbursement coverage of seizure acute medications for use in the outpatient setting.[9] Lennox-Gastaut syndrome: Diagnosing LGS is challenging due to the heterogeneity of its clinical presentation and symptom evolution over time. A group of ten epilepsy experts from seven countries convened to develop a simple-to-use checklist for non-specialists to support LGS diagnosis, using the International League Against Epilepsy criteria as a framework.[10] UCB-sponsored symposium: Time matters in developmental and epileptic encephalopathies Date: Monday, September 1st, 13:55 – 15:05 Overview: The upcoming symposium aims to enhance knowledge and awareness of the broader impact of DEEs in adulthood - beyond seizure control. The session will focus on improving diagnosis, understanding treatment journeys and addressing barriers to care in order to drive better individual outcomes. UCB presentations during the International Epilepsy Congress (IEC) Congress Annual Meeting About UCB UCB, Brussels, Belgium () is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news. Forward looking statements This press release may contain forward-looking statements including, without limitation, statements containing the words "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. 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Important Safety Information about FINTEPLA▼ (fenfluramine) in the EU[1] Indications: Treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older. Dosage and Administration: Please refer to SmPC for full information. Should be initiated and supervised by physicians with experience in the treatment of epilepsy. Fintepla is prescribed and dispensed according to the Fintepla controlled access programme. Dravet syndrome: Patients who are not taking stiripentol: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 days, if tolerated, can increase dose to 0.2 mg/kg twice daily (0.4 mg/kg/day). After an additional 7 days, if tolerated and further seizure reduction required, can increase dose to a maximum of 0.35 mg/kg twice daily (0.7 mg/kg/day), which is the recommended maintenance dose. Patients requiring more rapid titration may increase the dose every 4 days. Do not exceed maximum daily dose of 26 mg (13 mg twice daily). Patients who are taking stiripentol: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 days, if tolerated, can increase dose to 0.2 mg/kg twice daily (0.4 mg/kg/day), which is the recommended maintenance dose. Patients requiring more rapid titration may increase the dose every 4 days. Do not exceed a total dose of 17 mg (8.6 mg twice daily). Lennox-Gastaut syndrome: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 days, the dose should be increased to 0.2 mg/kg twice daily (0.4 mg/kg/day), if tolerated. After an additional 7 days, if tolerated, dose should be increased to 0.35 mg/kg twice daily (0.7 mg/kg/day), which is the recommended maintenance dose. Do not exceed maximum daily dose of 26 mg (13 mg twice daily). Discontinuation: When discontinuing treatment, decrease the dose gradually. As with all anti-epileptic medicines, avoid abrupt discontinuation when possible to minimize the risk of increased seizure frequency and status epilepticus. A final echocardiogram should be conducted 3-6 months after the last dose of treatment with fenfluramine. Renal impairment: Generally, no dose adjustment is recommended when administered to patients with mild to severe renal impairment, however, a slower titration may be considered. If adverse reactions are reported, a dose reduction may be needed. Has not been studied in patients with end-stage renal disease. Not known if fenfluramine or its active metabolite, norfenfluramine, is dialyzable. Hepatic impairment: Hepatic impairment: Generally, no dose adjustment is recommended when Fintepla is administered without concomitant stiripentol to patients with mild and moderate hepatic impairment (Child-Pugh Class A and B). In patients with severe hepatic impairment (Child-Pugh C) not receiving concomitant stiripentol, the maximum dosage is 0.2mg/kg twice daily, and the maximal total daily dose is 17 mg. There are limited clinical data on the use of Fintepla with stiripentol in patients with mild impaired hepatic function. A slower titration may be considered in patients with hepatic impairment and a dose reduction may be needed if adverse reactions are reported. No clinical data is available on the use of Fintepla with stiripentol in moderate and severe hepatic impairment, therefore not recommended for use. Elderly: No data available. Paediatric population: Safety and efficacy in children below 2 years of age not yet established. No data available. Contraindications: Hypersensitivity to active substance or any excipients. Aortic or mitral valvular heart disease and pulmonary arterial hypertension. Within 14 days of the administration of monoamine oxidase inhibitors due to an increased risk of serotonin syndrome. Warnings and Precautions: Aortic or mitral valvular heart disease and pulmonary arterial hypertension: Prior to starting treatment, patients must undergo an echocardiogram to establish a baseline and exclude any pre-existing valvular heart disease or pulmonary hypertension. Conduct echocardiogram monitoring every 6 months for the first 2 years and annually thereafter. If an echocardiogram indicates pathological valvular changes, consider follow-up earlier to evaluate whether the abnormality is persistent. If pathological abnormalities seen on echocardiogram, evaluate the benefit versus risk of continuing fenfluramine treatment with the prescriber, caregiver and cardiologist. Once treatment is discontinued for any reasons, a final echocardiogram should be conducted 3-6 months after the last dose of treatment with fenfluramine. If echocardiogram findings suggestive of pulmonary arterial hypertension, perform a repeat echocardiogram as soon as possible and within 3 months to confirm these findings. If echocardiogram finding is confirmed suggestive of an increased probability of pulmonary arterial hypertension defined as intermediate probability, conduct a benefit-risk evaluation of continuation of Fintepla by the prescriber, carer and cardiologist. If echocardiogram suggests a high probability, it is recommended fenfluramine treatment should be stopped. Decreased appetite and weight loss: Fenfluramine can cause decreased appetite and weight loss - an additive effect can occur in combination with other anti-epileptic medicines such as stiripentol. Monitor the patient's weight. Undertake risk-benefit evaluation before starting treatment if history of anorexia nervosa or bulimia nervosa. Fintepla controlled access programme: A controlled access programme has been created to 1) prevent off-label use in weight management in obese patients and 2) confirm that prescribing physicians have been informed of the need for periodic cardiac monitoring in patients taking Fintepla. Somnolence: Fenfluramine can cause somnolence which could be potentiated by other central nervous system depressants. Suicidal behaviour and ideation: Suicidal behaviour and ideation have been reported in patients treated with anti-epileptic medicines in several indications. Advise patients and caregivers to seek medical advice should any signs of suicidal behaviour and ideation emerge. Serotonin syndrome: Serotonin syndrome, a potentially life-threatening condition, may occur with fenfluramine treatment, particularly with concomitant use of other serotonergic agents; with agents that impair metabolism of serotonin such as MAOIs; or with antipsychotics that may affect the serotonergic neurotransmitter systems. Carefully observe the patient, particularly during treatment initiation and dose increases. Increased seizure frequency: A clinically relevant increase in seizure frequency may occur during treatment, which may require adjustment in the dose of fenfluramine and/or concomitant anti-epileptic medicines, or discontinuation of fenfluramine, should the benefit-risk be negative. Cyproheptadine: Cyproheptadine is a potent serotonin receptor antagonist and may therefore decrease the efficacy of fenfluramine. If cyproheptadine is added to treatment with fenfluramine, monitor patient for worsening of seizures. If fenfluramine treatment is initiated in a patient taking cyproheptadine, fenfluramine's efficacy may be reduced. Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma. Discontinue therapy in patients with acute decreases in visual acuity. Consider discontinuation if ocular pain of unknown origin. Effect of CYP1A2 or CYP2B6 inducers: Co-administration with strong CYP1A2 inducers or CYP2B6 inducers will decrease fenfluramine plasma concentrations, which may lower the efficacy of fenfluramine. If co-administration is considered necessary, the patient should be monitored for reduced efficacy and a dose increase of fenfluramine could be considered provided that it does not exceed twice the maximum daily dose (52 mg/day). If a strong CYP1A2 or CYP2B6 inducer is discontinued during maintenance treatment with fenfluramine, consider gradual reduction of the fenfluramine dosage to the dose administered prior to initiating the inducer. Effect of CYP1A2 or CYP2D6 inhibitors: Initiation of concomitant treatment with a strong CYP1A2 or CYP2D6 inhibitor may result in higher exposure and, therefore, adverse events should be monitored, and a dose reduction may be needed in some patients. Excipients: Contains sodium ethyl para-hydroxybenzoate (E 215) and sodium methyl para-hydroxybenzoate (E 219) - may cause allergic reactions (possibly delayed). It also contains sulfur dioxide (E 220) which may rarely cause severe hypersensitivity reactions and bronchospasm. Patients with rare glucose-galactose malabsorption should not take this medicine. The product contains less than 1 mmol sodium (23 mg) per the maximum daily dose of 12 mL; essentially 'sodium-free'. Contains glucose - may be harmful to teeth. Interactions: Pharmacodynamic interactions with other CNS depressants increase the risk of aggravated central nervous system depression. An increase in dose may be necessary when coadministered with rifampicin or a strong CYP1A2 or CYP2B6 inducer. In in vitro studies coadministration with a strong CYP1A2 or CYP2D6 inhibitor may result in higher exposure (see section 4.4 of the SmPC). Coadministration with CYP2D6 substrates or MATE1 substrates may increase their plasma concentrations. Co-administration with CYP2B6 or CYP3A4 substrates may decrease their plasma concentrations. Pregnancy and lactation: Limited data in pregnant women. As a precaution, avoid use of Fintepla in pregnancy. It is unknown whether fenfluramine/metabolites are excreted in human milk. Animal data have shown excretion of fenfluramine/metabolites in milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fintepla taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Drive and use machines.: Fintepla has moderate influence on the ability to drive/ use machines as it may cause somnolence and fatigue. Advise patients not to drive or operate machinery until they have sufficient experience to gauge whether it adversely affects their abilities. Adverse effects: Dravet syndrome: Very common (≥1/10): Upper respiratory tract infection, decreased appetite, somnolence, diarrhoea, pyrexia, fatigue, blood glucose decreased, echocardiogram abnormal (Consisted of trace and mild mitral regurgitation, and trace aortic regurgitation, which are considered physiologic). Common (≥1/100 to <1/10): Bronchitis, abnormal behaviour, aggression, agitation, insomnia, mood swings, ataxia, hypotonia, lethargy, seizure, status epilepticus, tremor, constipation, salivary hypersecretion, weight decreased and blood prolactin increased. Lennox-Gastaut syndrome: Very common (≥1/10): Upper respiratory tract infection, decreased appetite, somnolence, diarrhoea, vomiting, fatigue. Common (≥1/100 to <1/10): Bronchitis, influenza, pneumonia, seizure, status epilepticus, lethargy, tremor, constipation, salivary hypersecretion, blood prolactin increased, weight decreased, fall. Refer to SmPC for other adverse reactions. ▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to the European Summary of Product Characteristics for other adverse reactions and full Prescribing Information: . FINTEPLA® is a registered trademark of the UCB Group of Companies. Important Safety Information about BRIVIACT® (brivaracetam) in the EU[28] Therapeutic indications: BRIVIACT is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. Posology and method of administration: The physician should prescribe the most appropriate formulation and strength according to weight and dose. It is recommended to parent and care giver to administer BRIVIACT oral solution with the measuring device (10 ml or 5 ml oral dosing syringe) provided in the carton box. BRIVIACT solution for injection/infusion is an alternative route of administration for patients when oral administration is temporarily not feasible. There is no experience with twice daily intravenous administration of brivaracetam for a period longer than 4 days. Adults: The recommended starting dose is 50 or 100 mg/day based on physician's assessment of required for seizure reduction versus potential side effects. Brivaracetam can be taken with or without food. Based on individual patient response and tolerability, the dose may be adjusted in the effective dose range of 50 mg/day to 200 mg/day. Children and adolescents weighing 50 kg or more: The recommended starting dose is 50 mg/day. Brivaracetam may also be initiated at 100 mg/day based on physician's assessment of need for seizure control. The recommended maintenance dose is 100 mg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 50 mg/day to 200 mg/day. Children and adolescents weighing from 20 kg to less than 50 kg: The recommended starting dose is 1 mg/kg/day. Brivaracetam may also be initiated at doses up to 2 mg/kg/day based on physician's assessment of need for seizure control. The recommended maintenance dose is 2 mg/kg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day to 4 mg/kg/day. Children weighing from 10 kg to less than 20 kg: The recommended starting dose is 1 mg/kg/day. Brivaracetam may also be initiated at doses up to 2.5 mg/kg/day based on physician's assessment of need for seizure control. The recommended maintenance dose is 2.5 mg/kg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day to 5 mg/kg/day. For adults, adolescents and children from 2 years of age, the dose should be administered in two equally divided doses, approximately 12 hours apart. If patients miss one dose or more, it is recommended that they take a single dose as soon as they remember and take the following dose at the usual morning or evening time. Brivaracetam oral solution can be diluted in water or juice shortly before swallowing; a nasogastric tube or a gastrostomy tube may also be used. Brivaracetam may be initiated with either intravenous or oral administration. When converting from oral to intravenous administration or vice versa, the total daily dose and frequency of administration should be maintained. Brivaracetam may be administered as an intravenous bolus without dilution or diluted in a compatible diluent and administered as a 15-minute intravenous infusion. This medicinal product must not be mixed with other medicinal products. Brivaracetam bolus injection or intravenous infusion has not been studied in acute conditions, e.g. status epilepticus, and is therefore not recommended for such conditions. For patients from 16 years of age, if brivaracetam has to be discontinued, it is recommended that the dose is reduced gradually by 50 mg/day on a weekly basis. For patients below the age of 16 years, if brivaracetam has to be discontinued, it is recommended that the dose is reduced by a maximum of half the dose every week until a dose of 1 mg/kg/day (for patients with a body weight less than 50 kg) or 50 mg/day (for patients with body weight of 50 kg or more) is reached. After 1 week of treatment at 50 mg/day, a final week of treatment at 20 mg/day is recommended. No dose adjustment is needed for elderly patients (≥65 years of age) or for those with renal impairment. Based on data in adults, no dose adjustment is necessary in paediatric patients with impaired renal function. No clinical data are available on paediatric patients with renal impairment. Brivaracetam is not recommended for patients with end-stage renal disease undergoing dialysis due to lack of data. Exposure to brivaracetam was increased in patients with chronic liver disease. In patients with hepatic impairment, the following adjusted doses, administered in 2 divided doses, approximately 12 hours apart, are recommended for all stages of hepatic impairment: In adults, adolescents and children weighing ≥50 kg, a 50 mg/day starting dose is recommended, with a maximum daily dose of 150 mg/day. For adolescents and children weighing from 20 kg to <50 kg, a 1 mg/kg/day is recommended, with a maximum daily dose of 3 mg/kg/day. For children weighing from 10 kg to <20 kg, a 1 mg/kg/day is recommended, with a maximum daily dose of 4 mg/kg/day. No clinical data are available in paediatric patients with hepatic impairment. The efficacy of brivaracetam in paediatric patients aged less than 2 years has not yet been established. Contraindications: Hypersensitivity to the active substance, other pyrrolidone derivatives or any of the excipients. Special warnings and precautions for use: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic drugs (AEDs) in several indications, including brivaracetam. Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers) should be advised to seek medical advice should any signs of suicidal ideation or behaviour emerge. Clinical data on the use of brivaracetam in patients with pre-existing hepatic impairment are limited. Dose adjustments are recommended for patients with hepatic impairment. Brivaracetam film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take brivaracetam. Brivaracetam film-coated tablets, solution for injection/infusion and oral solution contain less than 1 mmol sodium (23mg) per tablet/vial/ml respectively, that is to say essentially 'sodium free'. Brivaracetam oral solution contains 168 mg sorbitol (E420) in each ml. Patients with hereditary fructose intolerance (HFI) should not take this medicinal product. The oral solution contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed). Brivaracetam oral solution contains propylene glycol (E1520). Interaction with other medicinal products and other forms of interaction: In clinical studies, although patient numbers were limited, brivaracetam had no observed benefit over placebo among patients taking concomitant levetiracetam. No additional safety or tolerability concern was observed. In an interaction study between brivaracetam 200 mg single dose and ethanol 0.6 g/L continuous infusion in healthy volunteers, there was no pharmacokinetic interaction, but the effect of alcohol on psychomotor function, attention and memory was approximately doubled with the intake of brivaracetam. Intake of brivaracetam with alcohol is not recommended. In vitro data suggest that brivaracetam has a low interaction potential. The main disposition pathway of brivaracetam® is by CYPindependent hydrolysis; a second pathway involves hydroxylation mediated by CYP2C19. Brivaracetam plasma concentrations may increase when co-administered with CYP2C19 strong inhibitors (e.g. fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19 mediated interaction is considered to be low. Limited clinical data are available implying that coadministration of cannabidiol may increase the plasma exposure of brivaracetam, possibly through CYP2C19 inhibition, but the clinical relevance is uncertain. In healthy subjects, co-administration with the strong enzyme inducer rifampicin (600 mg/day for 5 days), decreased brivaracetam area under the plasma concentration curve (AUC) by 45%. Prescribers should consider adjusting the dose of brivaracetam in patients starting or ending treatment with rifampicin. Brivaracetam plasma concentrations are decreased when co-administered with strong enzyme-inducing AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required. Other strong enzyme inducers such as St John's wort (Hypericum perforatum) may decrease the systemic exposure of brivaracetam. Starting or ending treatment with St John's wort should be done with caution. Brivaracetam at 50 or 150 mg/day did not affect the AUC of midazolam (metabolised by CYP3A4). The risk of clinically relevant CYP3A4 interactions is considered low. In vitro studies have shown that brivaracetam exhibits little or no inhibition of CYP450 isoforms except for CYP2C19 and may therefore increase plasma concentrations of medicinal products metabolised by CYP2C19 (e.g. lansoprazole, omeprazole, diazepam). Brivaracetam did not induce CYP1A1/2 but induced CYP3A4 and CYP2B6 in vitro. No CYP3A4 induction was found in vivo. CYP2B6 induction has not been investigated in vivo and brivaracetam may decrease plasma concentrations of medicinal products metabolised by CYP2B6 (e.g. efavirenz). In vitro interaction studies to determine the potential inhibitory effects on transporters concluded that there were no clinically relevant effects, except for OAT3. In vitro, brivaracetam inhibits OAT3 with a half maximal inhibitory concentration 42-fold higher than the Cmax at the highest clinical dose. Brivaracetam 200 mg/day may increase plasma concentrations of medicinal products transported by OAT3. Brivaracetam is a moderate reversible inhibitor of epoxide hydrolase, resulting in an increased concentration of carbamazepine epoxide, an active metabolite of carbamazepine. In controlled clinical studies, carbamazepine epoxide plasma concentration increased by a mean of 37%, 62% and 98% with little variability at Brivaracetam doses of 50 mg/day, 100 mg/day and 200 mg/day, respectively. No safety risks were observed. There was no additive effect of brivaracetam and valproate on the AUC of carbamazepine epoxide. No dose adjustment is needed when brivaracetam is co-administered with carbamazepine, phenobarbital or phenytoin. Brivaracetam had no clinically relevant effect on the plasma concentrations of clobazam, clonazepam, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, pregabalin, topiramate, valproic acid or zonisamide. There are no data available on the effects of clobazam, clonazepam, lacosamide, pregabalin or zonisamide on brivaracetam plasma concentrations. Co-administration of brivaracetam (100 mg/day) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg) did not influence the pharmacokinetics of either substance. However, when brivaracetam was coadministered at a dose of 400 mg/day (twice the recommended maximum daily dose), a reduction in estrogen and progestin AUCs of 27% and 23%, respectively, was observed without impact on suppression of ovulation. Pregnancy: Data on the use of brivaracetam in pregnant women are limited. There are no data on placental transfer in humans, but brivaracetam was shown to readily cross the placenta in rats. The potential risk for humans is unknown. Animal studies did not detect any teratogenic potential of brivaracetam. In clinical studies, adjunctive brivaracetam used concomitantly with carbamazepine induced a dose-related increase in the concentration of the active metabolite, carbamazepine-epoxide. There are insufficient data to determine the clinical significance of this effect in pregnancy. Brivaracetam should not be used during pregnancy unless clinically necessary. Breast-feeding: Brivaracetam is excreted in human breast milk. The decision to discontinue either breastfeeding or brivaracetam should be made based on the benefit of the medicinal product to the mother. In case of co-administration of brivaracetam and carbamazepine, the amount of carbamazepine-epoxide excreted in breast milk could increase. The clinical significance remains unknown. Fertility: No human data on the effect of brivaracetam on fertility are available. There was no effect on fertility in rats. Effects on ability to drive and use machines: Brivaracetam has minor or moderate influence on the ability to drive and use machines. Patients should be advised not to drive a car or to operate other potentially hazardous machines until they are familiar with the effects of brivaracetam on their ability to perform such activities. Undesirable effects: The most frequently reported adverse reactions with brivaracetam were somnolence (14.3%) and dizziness (11.0%); they were usually mild-to-moderate in intensity. Somnolence and fatigue were reported at a higher incidence with increasing dose. Very common adverse reactions (≥1%-<10%) were influenza, decreased appetite, depression, anxiety, insomnia, irritability, convulsion, vertigo, upper respiratory tract infections, cough, nausea, vomiting, constipation and fatigue. Neutropenia was reported in 6/1099 (0.5%) of brivaracetam and none (0/459) of the placebo-treated patients. Four of these subjects had decreased neutrophil counts at baseline. None of the neutropenia cases were severe, required any specific treatment or led to discontinuation of brivaracetam and none had associated infections. Suicidal ideation was reported in 0.3% (3/1099) of brivaracetam and 0.7% (3/459) of placebo-treated patients. In short-term clinical studies of brivaracetam in patients with epilepsy, there were no cases of completed suicide and suicide attempt; however, both were reported in open-label extension studies. The safety profile of brivaracetam observed in children from 1 month of age was consistent with the safety profile observed in adults. In the open label, uncontrolled, long-term studies suicidal ideation was reported in 4.7 % of paediatric patients (assessed from 6 years onwards, more common in adolescents) compared with 2.4 % of adults and behavioural disorders were reported in 24.8 % of paediatric patients compared with 15.1 % of adults. The majority of events were mild or moderate in intensity, were non-serious, and did not lead to discontinuation of study drug. An additional adverse reaction reported in children was psychomotor hyperactivity (4.7 %). No specific pattern of adverse event (AE) was identified in children from 1 month to < 4 years of age when compared to older paediatric age groups. No significant safety information was identified indicating the increasing incidence of a particular AE in this age group. As data available in children younger than 2 years of age are limited, brivaracetam is not indicated in this age range. Limited clinical data are available in neonates. Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of brivaracetam patients (9/3022) during clinical development. Overdose: There is limited clinical experience with brivaracetam overdose in humans. Somnolence and dizziness have been reported in a healthy subject taking a single dose of 1,400 mg of brivaracetam. The following adverse reactions were reported with brivaracetam overdose: nausea, vertigo, balance disorder, anxiety, fatigue, irritability, aggression, insomnia, depression, and suicidal ideation in the postmarketing experience. In general, the adverse reactions associated with brivaracetam overdose were consistent with the known adverse reactions. There is no specific antidote for overdose with brivaracetam. Treatment of an overdose should include general supportive measures. Since <10% of brivaracetam is excreted in urine, haemodialysis is not expected to significantly enhance brivaracetam clearance. Refer to the European Summary of Product Characteristics for other adverse reactions and full Prescribing Information: BRIVIACT® is a registered trademark of the UCB Group of Companies. References: 1. Fintepla® EU SmPC. Available at:. Accessed: July 2025. 2. Schoonjans A, et al. Tolerability and Safety of Fenfluramine and Global Functioning of Patients in a Combined Open-label Extension Study of Children and Adults With Dravet and Lennox-Gastaut Syndromes. IEC. 2025. Abstract number: 921. 3. Wilkinson AL, et al. Unpredictable Seizures and Disruptive Behavior in Developmental and Epileptic Encephalopathies: Interim Results of a Caregiver Survey. IEC. 2025. Abstract number: 1389. 4. Rodriguez Solis B, et al. Barriers and benefits of identifying patients with DEE in adult care settings. IEC. 2025. Abstract number: 2009. 5. Trinka E, et al. Describing the Population of Patients with Prolonged Seizures: Results from a Global Real-World Point In-Time Study. IEC. 2025. Abstract number: 711. 6. Sile B, et al. Seizure Duration and Time-point Cutoffs for Statistically Defining a Prolonged Seizure: A Post-Hoc Analysis of the SCORE Video-EEG Database. IEC. 2025. Abstract number: 712. 7. Kaye D, et al. Characterising Patient and Caregiver Experiences Resulting from Prolonged Seizures. IEC. 2025. Abstract number: 625. 8. Sain N, et al. Understanding and Optimising the Seizure Emergency Pathway. IEC. 2025. Abstract number: 630. 9. Shafer P, et al. Global Seizure Rescue Medication Landscape: Availability & Reimbursement. IEC. 2025. Abstract number: 628. 10. Specchio N, et al. A checklist to support the diagnosis of Lennox-Gastaut syndrome. IEC. 2025. Abstract number: 1926. 11. Soto Insuga V, et al. Improving Lives in Dravet Syndrome: Overcoming Challenges in the Family Journey. IEC. 2025. Abstract number: 1063. 12. Lothe A, et al. A Retrospective Claims Study Evaluating Mortality in Patients With Lennox-Gastaut or Dravet Syndromes in the United States. IEC. 2025. Abstract number: 912. 13. Montero V, et al. Lennox-Gastaut Syndrome. Situation analysis and Family Journey. IEC. 2025. Abstract number: 1071. 14. Nabbout R, et al. Impact of Fenfluramine on Convulsive Seizure Frequency in Dose-Capped Patients With Dravet Syndrome. IEC. 2025. Abstract number: 926. 15. Lagae L, et al. A Stratified Analysis of Efficacy and Safety of Fenfluramine in Patients With Dravet Syndrome. IEC. 2025. Abstract number: 917. 16. Wirrell E, et al. Real-World Use of Fenfluramine for Dravet Syndrome: a Retrospective Cohort Study Using a National Pharmacy Database. IEC. 2025. Abstract number: 1112. 17. Gjerulfsen CE, et al. Non-seizure benefits of long-term fenfluramine treatment in pediatric patients with Dravet syndrome. IEC. 2025. Abstract number: 955. 18. Rosendahl A, et al. Prospective evaluation of non-seizure benefits related to treatment with fenfluramine in pediatric and adult patients with Dravet syndrome. IEC. 2025. Abstract number: 957. 19. Lothe A, et al. A European Study of the Effectiveness of Risk Minimisation Measures for Fenfluramine Oral Solution in Dravet Syndrome and Lennox-Gastaut Syndrome. IEC. 2025. Abstract number: 1389. 20. Dransfeld CR, et al. Use of Fenfluramine and Cannabidiol in Daily Practice: A Retrospective Analysis of German Prescription Claims. IEC. 2025. Abstract number: 312. 21. Mittur A, et al. Exposure-Response Relationships of Fenfluramine in Patients With Dravet Syndrome and Lennox-Gastaut Syndrome. IEC. 2025. Abstract number: 1983. 22. Zuberi S, et al. Post-hoc Analysis of Fenfluramine for Lennox-Gastaut Syndrome by Baseline Frequency Quartiles of Seizures Associated With a Fall. IEC. 2025. Abstract number: 911. 23. Rodriguez N, et al. AAV gene therapy at neonatal age in a mouse model of STXBP1 haploinsufficiency. IEC. 2025. Poster number: 226. 24. Gomes AR, et al. Rescue of neuronal activity in iPSC-derived STXBP1 in vitro disease models using viral vectors. IEC. 2025. Poster number: 936. 25. Niespodziany I, et al. In vitro electrophysiological study of hippocampal network activity in a mouse model of STXBP1 haploinsufficiency. IEC. 2025. Poster number: 841. 26. Herrewegen YVD, et al. Expression and quantification of STXBP1 splice variants in rodent and primate brain tissues. IEC. 2025. Poster number: 996. 27. Briviact® EU SmPC. Available at:. Accessed: July 2025. 28. Zafeiriou D, et al. Brivaracetam Adjunctive Therapy in Paediatric and Adult Patients With Focal-Onset Seizures in Mid-European Countries: 12-Month, Real-World Outcomes from the BRIVA-REG Study. IEC. 2025. Poster number: 708. Logo: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Corporate News Reports Second-Quarter Diluted EPS of $0.52 on a GAAP Basis, a Decrease of 32.5 Percent; Adjusted Diluted EPS of $2.97, an Increase of 12.1 Percent; These Results Include an Unfavorable Impact of $0.42 Per Share Related to Acquired IPR&D and Milestones Expense Delivers Second-Quarter Net Revenues of $15.423 Billion, an Increase of 6.6 Percent on a Reported Basis or 6.5 Percent on an Operational Basis Second-Quarter Global Net Revenues from the Immunology Portfolio Were $7.631 Billion, an Increase of 9.5 Percent on a Reported Basis, or 9.2 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $4.423 Billion; Global Rinvoq Net Revenues Were $2.028 Billion; Global Humira Net Revenues Were $1.180 Billion Second-Quarter Global Net Revenues from the Neuroscience Portfolio Were $2.683 Billion, an Increase of 24.2 Percent on a Reported Basis, or 24.0 Percent on an Operational Basis; Global Vraylar Net Revenues Were $900 Million; Global Botox Therapeutic Net Revenues Were $928 Million; Combined Global Ubrelvy and Qulipta Net Revenues Were $605 Million Second-Quarter Global Net Revenues from the Oncology Portfolio Were $1.676 Billion, an Increase of 2.6 Percent on a Reported Basis, or 2.4 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $754 Million; Global Venclexta Net Revenues Were $691 Million; Global Elahere Net Revenues Were $159 Million Second-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.279 Billion, a Decrease of 8.1 Percent on a Reported Basis, or 8.0 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $692 Million; Global Juvederm Net Revenues Were $260 Million Raises 2025 Adjusted Diluted EPS Guidance Range from $11.67 - $11.87 to $11.88 - $12.08, which Includes an Unfavorable Impact of $0.55 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the Second Quarter 2025 NORTH CHICAGO, Ill., July 31, 2025 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the second quarter ended June 30, 2025. "AbbVie delivered another outstanding quarter with strong performance from our diversified growth platform. We also made meaningful pipeline progress with several regulatory approvals, encouraging clinical data and strategic investments in promising external innovation," said Robert A. Michael, chairman and chief executive officer, AbbVie. "We're entering the second half of the year with substantial momentum and are once again raising our full-year outlook." Second-Quarter Results Worldwide net revenues were $15.423 billion, an increase of 6.6 percent on a reported basis, or 6.5 percent on an operational basis. Global net revenues from the immunology portfolio were $7.631 billion, an increase of 9.5 percent on a reported basis, or 9.2 percent on an operational basis. Global Skyrizi net revenues were $4.423 billion, an increase of 62.2 percent on a reported basis, or 61.8 percent on an operational basis. Global Rinvoq net revenues were $2.028 billion, an increase of 41.8 percent on a reported basis, or 41.2 percent on an operational basis. Global Humira net revenues were $1.180 billion, a decrease of 58.1 percent on a reported basis, or 58.2 percent on an operational basis. Global net revenues from the neuroscience portfolio were $2.683 billion, an increase of 24.2 percent on a reported basis, or 24.0 percent on an operational basis. Global Vraylar net revenues were $900 million, an increase of 16.3 percent. Global Botox Therapeutic net revenues were $928 million, an increase of 14.1 percent on a reported basis, or 14.2 percent on an operational basis. Global Ubrelvy net revenues were $338 million, an increase of 47.1 percent on a reported basis, or 47.2 percent on an operational basis. Global Qulipta net revenues were $267 million, an increase of 77.5 percent on a reported basis, or 76.9 percent on an operational basis. Global net revenues from the oncology portfolio were $1.676 billion, an increase of 2.6 percent on a reported basis, or 2.4 percent on an operational basis. Global Imbruvica net revenues were $754 million, a decrease of 9.5 percent. Global Venclexta net revenues were $691 million, an increase of 8.5 percent on a reported basis, or 8.3 percent on an operational basis. Global Elahere net revenues were $159 million, an increase of 24.2 percent on a reported basis, or 23.7 percent on an operational basis. Global net revenues from the aesthetics portfolio were $1.279 billion, a decrease of 8.1 percent on a reported basis, or 8.0 percent on an operational basis. Global Botox Cosmetic net revenues were $692 million, a decrease of 5.0 percent on a reported basis, or 4.9 percent on an operational basis. Global Juvederm net revenues were $260 million, a decrease of 24.0 percent. On a GAAP basis, gross margin in the second quarter was 71.8 percent. The adjusted gross margin was 84.4 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 21.1 percent of net revenues. The adjusted SG&A expense was 21.0 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 13.8 percent of net revenues. The adjusted R&D expense was 13.7 percent of net revenues. Acquired IPR&D and milestones expense was 5.3 percent of net revenues. On a GAAP basis, operating margin in the second quarter was 31.7 percent. The adjusted operating margin was 44.3 percent. Net interest expense was $678 million. On a GAAP basis, the tax rate in the quarter was 39.4 percent. The adjusted tax rate was 16.2 percent. Diluted EPS in the second quarter was $0.52 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.97. These results include an unfavorable impact of $0.42 per share related to acquired IPR&D and milestones expense. Global Skyrizi net revenues were $4.423 billion, an increase of 62.2 percent on a reported basis, or 61.8 percent on an operational basis. Global Rinvoq net revenues were $2.028 billion, an increase of 41.8 percent on a reported basis, or 41.2 percent on an operational basis. Global Humira net revenues were $1.180 billion, a decrease of 58.1 percent on a reported basis, or 58.2 percent on an operational basis. Global Vraylar net revenues were $900 million, an increase of 16.3 percent. Global Botox Therapeutic net revenues were $928 million, an increase of 14.1 percent on a reported basis, or 14.2 percent on an operational basis. Global Ubrelvy net revenues were $338 million, an increase of 47.1 percent on a reported basis, or 47.2 percent on an operational basis. Global Qulipta net revenues were $267 million, an increase of 77.5 percent on a reported basis, or 76.9 percent on an operational basis. Global Imbruvica net revenues were $754 million, a decrease of 9.5 percent. Global Venclexta net revenues were $691 million, an increase of 8.5 percent on a reported basis, or 8.3 percent on an operational basis. Global Elahere net revenues were $159 million, an increase of 24.2 percent on a reported basis, or 23.7 percent on an operational basis. Global Botox Cosmetic net revenues were $692 million, a decrease of 5.0 percent on a reported basis, or 4.9 percent on an operational basis. Global Juvederm net revenues were $260 million, a decrease of 24.0 percent. Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. Recent Events AbbVie announced the U.S. Food and Drug Administration (FDA) approved Rinvoq (upadacitinib) as the first oral Janus Kinase (JAK) inhibitor approved for the treatment of adults with giant cell arteritis (GCA). The approval was supported by data from the pivotal Phase 3 SELECT-GCA trial, which met the primary endpoint of sustained remission and key secondary endpoints. This marks the ninth approved indication for Rinvoq in the U.S., across rheumatology, gastroenterology and dermatology. AbbVie announced positive topline results from the first of two pivotal studies in the Phase 3 UP-AA clinical program evaluating the safety and efficacy of Rinvoq in adult and adolescent patients with severe alopecia areata (AA). In the study, Rinvoq achieved the primary endpoint, demonstrating that 44.6% and 54.3% of patients with severe AA treated with Rinvoq 15mg and 30mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by the severity of alopecia tool (SALT) score ≤20. Key secondary endpoints, including improvements in eyebrows and eyelashes, as well as the percentage of subjects with 90% or more scalp coverage (SALT ≤10) and complete scalp hair coverage (SALT=0) at Week 24, were also met. Rinvoq's safety profile in AA was generally consistent with that in approved indications, and no new safety signals were identified in this study. AbbVie and Capstan Therapeutics, a clinical-stage biotechnology company dedicated to advancing in vivo engineering of cells through RNA delivery using targeted lipid nanoparticles (tLNPs), announced a definitive agreement under which AbbVie will acquire Capstan. The transaction includes CPTX2309, a potential first-in-class in vivo tLNP anti-CD19 CAR-T therapy candidate, currently in Phase 1 development for the treatment of B cell-mediated autoimmune diseases. Additionally, AbbVie will acquire Capstan's proprietary tLNP platform technology designed to deliver RNA payloads, such as mRNA, capable of engineering specific cell types in vivo. AbbVie announced new data from its Phase 3 TEMPLE head-to-head study evaluating the tolerability, safety and efficacy of Qulipta (atogepant) compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month. In the study, Qulipta met the primary endpoint of fewer treatment discontinuations attributed to adverse events versus topiramate, and all six secondary endpoints achieved statistical significance for superiority versus topiramate, demonstrating clinical efficacy. Full results from the TEMPLE study will be presented at an upcoming medical meeting. AbbVie announced that Emrelis (telisotuzumab vedotin-tllv) was granted accelerated approval by the FDA for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression who have received a prior systemic therapy. Emrelis is the first treatment approved for previously treated advanced NSCLC patients with high c-Met protein overexpression, a population that often faces poor prognosis and has limited treatment options. AbbVie announced the submission of a supplemental New Drug Application (sNDA) to the FDA for Venclexta (venetoclax) and acalabrutinib combination therapy for the treatment of chronic lymphocytic leukemia (CLL). This combination therapy has potential to be the first all oral, fixed-duration regimen for previously untreated patients with CLL. The submission is supported by data from the Phase 3 AMPLIFY trial which demonstrated that the combination regimen of Venclexta and acalabrutinib improved progression-free survival (PFS) compared to standard chemoimmunotherapy in previously untreated patients with CLL. At the American Society of Clinical Oncology (ASCO) Annual Meeting, AbbVie presented key data that showcased significant progress across AbbVie's robust oncology pipeline, in a range of difficult-to-treat solid tumors and blood cancers. Highlights included new data from AbbVie's novel investigational antibody-drug conjugates (ADCs) telisotuzumab adizutecan (ABBV-400, Temab-A) in advanced NSCLC, ABBV-706 in high-grade neuroendocrine neoplasms (NENs) and pivekimab sunirine (PVEK) in blastic plasmacytoid dendritic cell neoplasm (BPDCN). AbbVie announced the global Phase 3 VERONA trial evaluating Venclexta (venetoclax) in combination with azacitidine in the treatment of newly diagnosed higher-risk myelodysplastic syndrome (MDS) did not meet the primary endpoint of overall survival. No new safety signals were observed and results from the trial will be available in a future medical congress and/or publication. AbbVie and Ichnos Glenmark Innovation (IGI) announced an exclusive licensing agreement for IGI's lead investigational asset, ISB 2001, which is being investigated for the treatment of oncology and autoimmune diseases. ISB 2001 is a first-in-class trispecific T-cell engager currently in Phase 1 development for relapsed/refractory (r/r) multiple myeloma (MM). AbbVie announced the FDA approved a label expansion for Mavyret (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. Mavyret is the first oral eight-week pangenotypic treatment option approved for people with acute or chronic hepatitis C virus (HCV). With this approval, providers can now treat HCV patients immediately at the time of diagnosis. AbbVie and ADARx Pharmaceuticals, a late clinical-stage biotechnology company developing next-generation RNA therapeutics, announced a collaboration and license option agreement to develop small interfering RNA (siRNA) therapeutics across multiple disease areas. The collaboration will leverage AbbVie's expertise in biotherapeutic drug development and commercialization with ADARx's proprietary RNA technology to advance next-generation siRNA therapies across neuroscience, immunology and oncology. Full-Year 2025 Outlook AbbVie is raising its adjusted diluted EPS guidance for the full year 2025 from $11.67 - $11.87 to $11.88 - $12.08, which includes an unfavorable impact of $0.55 per share related to acquired IPR&D and milestones expense incurred year-to-date through the second quarter 2025. The company's 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the second quarter of 2025, as both cannot be reliably forecasted. About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, neuroscience, oncology, and eye care - and products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X (formerly Twitter), Facebook, Instagram, YouTube or LinkedIn. Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our second-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central Time. Non-GAAP Financial Results Financial results for 2025 and 2024 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. Media: Investors: Gabby Tarbert Liz Shea (224) 244-0111 (847) 935-2211 Todd Bosse (847) 936-1182 Jeffrey Byrne (847) 938-2923 AbbVie Inc. Key Product Revenues Quarter Ended June 30, 2025 (Unaudited) % Change vs. 2Q24 Net Revenues (in millions) Reported Operationala U.S. Int'l. Total U.S. Int'l. Total Int'l. Total NET REVENUES $11,762 $3,661 $15,423 5.9 % 9.1 % 6.6 % 8.4 % 6.5 % Immunology 6,097 1,534 7,631 6.7 22.3 9.5 20.7 9.2 Skyrizi 3,843 580 4,423 64.3 49.7 62.2 47.2 61.8 Rinvoq 1,452 576 2,028 42.7 39.6 41.8 37.5 41.2 Humira 802 378 1,180 (66.0) (16.8) (58.1) (17.2) (58.2) Neuroscience 2,333 350 2,683 23.2 30.6 24.2 28.7 24.0 Vraylar 898 2 900 16.2 72.8 16.3 76.8 16.3 Botox Therapeutic 775 153 928 15.9 5.7 14.1 6.0 14.2 Ubrelvy 330 8 338 46.5 73.9 47.1 76.7 47.2 Qulipta 237 30 267 62.8 >100.0 77.5 >100.0 76.9 Vyalev 22 76 98 n/m >100.0 >100.0 >100.0 >100.0 Duodopa 20 77 97 (13.6) (13.7) (13.7) (16.3) (15.7) Other Neuroscience 51 4 55 (11.4) (23.3) (12.3) (21.3) (12.2) Oncology 1,026 650 1,676 (1.0) 8.7 2.6 8.3 2.4 Imbruvicab 543 211 754 (8.9) (11.2) (9.5) (11.2) (9.5) Venclexta 321 370 691 7.4 9.5 8.5 9.1 8.3 Elahere 138 21 159 8.0 n/m 24.2 n/m 23.7 Epkinlyc 22 48 70 57.4 >100.0 93.9 >100.0 92.3 Other Oncology 2 — 2 n/m n/m n/m n/m n/m Aesthetics 797 482 1,279 (7.8) (8.5) (8.1) (8.3) (8.0) Botox Cosmetic 410 282 692 (8.7) 0.9 (5.0) 1.2 (4.9) Juvederm Collection 105 155 260 (23.6) (24.4) (24.0) (24.4) (24.0) Other Aesthetics 282 45 327 1.6 5.8 2.2 6.4 2.3 Eye Care 226 288 514 (5.7) (2.4) (3.9) (1.5) (3.4) Ozurdex 30 95 125 (12.6) 5.8 0.6 4.4 (0.4) Lumigan/Ganfort 52 51 103 19.9 (15.4) (0.8) (15.2) (0.7) Alphagan/Combigan — 36 36 (91.6) (3.1) (25.6) (0.2) (23.5) Other Eye Care 144 106 250 (4.3) (1.7) (3.2) 0.9 (2.1) Other Key Products 835 202 1,037 11.2 (4.4) 7.8 (5.8) 7.5 Mavyret 184 191 375 9.7 (5.1) 1.6 (6.5) 0.8 Creon 404 — 404 8.4 n/m 8.4 n/m 8.4 Linzess/Constella 247 11 258 17.4 10.8 17.1 10.3 17.1 a "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. b Reflects profit sharing for Imbruvica international revenues. c Epkinly U.S. revenues reflect profit sharing. International revenues reflect product revenues as well as profit sharing from certain international territories. n/m = not meaningful AbbVie Inc. Key Product Revenues Six Months Ended June 30, 2025 (Unaudited) % Change vs. 6M24 Net Revenues (in millions) Reported Operationala U.S. Int'l. Total U.S. Int'l. Total Int'l. Total NET REVENUES $21,741 $7,025 $28,766 7.9 % 6.0 % 7.4 % 8.3 % 8.0 % Immunology 10,980 2,915 13,895 11.3 17.9 12.6 20.4 13.1 Skyrizi 6,762 1,086 7,848 69.2 46.9 65.8 49.6 66.2 Rinvoq 2,672 1,074 3,746 53.3 37.6 48.5 40.1 49.3 Humira 1,546 755 2,301 (62.6) (20.8) (54.7) (18.4) (54.3) Neuroscience 4,305 660 4,965 19.3 27.4 20.3 29.8 20.6 Vraylar 1,661 4 1,665 13.4 41.8 13.5 47.4 13.5 Botox Therapeutic 1,498 296 1,794 17.0 5.2 14.9 8.6 15.5 Ubrelvy 563 15 578 33.0 46.7 33.3 51.2 33.4 Qulipta 409 51 460 49.5 >100.0 63.6 >100.0 63.6 Vyalev 28 133 161 n/m >100.0 >100.0 >100.0 >100.0 Duodopa 40 153 193 (16.6) (14.9) (15.2) (14.0) (14.5) Other Neuroscience 106 8 114 (10.4) (12.7) (10.5) (8.1) (10.2) Oncology 2,053 1,256 3,309 2.4 7.1 4.2 9.1 5.0 Imbruvicab 1,072 420 1,492 (11.1) (9.7) (10.7) (9.7) (10.7) Venclexta 633 723 1,356 9.1 7.8 8.4 11.3 10.3 Elahere 303 35 338 57.5 n/m 75.5 n/m 75.5 Epkinlyc 43 78 121 61.8 >100.0 92.1 >100.0 93.3 Other Oncology 2 — 2 n/m n/m n/m n/m n/m Aesthetics 1,437 944 2,381 (12.3) (5.6) (9.8) (3.6) (9.0) Botox Cosmetic 705 543 1,248 (15.9) 3.7 (8.4) 5.8 (7.6) Juvederm Collection 180 311 491 (25.9) (21.5) (23.2) (19.8) (22.2) Other Aesthetics 552 90 642 (1.0) 11.7 0.6 14.5 0.9 Eye Care 447 573 1,020 (4.2) (5.3) (4.8) (1.8) (2.8) Ozurdex 60 188 248 (12.4) 0.8 (2.8) 2.7 (1.4) Lumigan/Ganfort 100 109 209 39.4 (11.0) 7.5 (7.7) 9.6 Alphagan/Combigan 26 70 96 (3.6) (13.1) (10.6) (8.5) (7.2) Other Eye Care 261 206 467 (12.8) (4.4) (9.3) 0.3 (7.3) Other Key Products 1,471 375 1,846 2.5 (12.0) (0.8) (10.4) (0.4) Mavyret 326 355 681 4.9 (12.8) (5.1) (11.2) (4.2) Creon 759 — 759 15.4 n/m 15.4 n/m 15.4 Linzess/Constella 386 20 406 (17.4) 7.0 (16.5) 9.7 (16.4) a "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. b Reflects profit sharing for Imbruvica international revenues. c Epkinly U.S. revenues reflect profit sharing. International revenues reflect product revenues as well as profit sharing from certain international territories. n/m = not meaningful AbbVie Inc. Consolidated Statements of Earnings (Unaudited) (in millions, except per share data) Second Quarter Ended June 30 Six Months Ended June 30 2025 2024 2025 2024 Net revenues $ 15,423 $ 14,462 $ 28,766 $ 26,772 Cost of products sold 4,346 4,202 8,348 8,296 Selling, general and administrative 3,253 3,377 6,546 6,692 Research and development 2,131 1,948 4,198 3,887 Acquired IPR&D and milestones 823 937 1,071 1,101 Other operating income (24) — (24) — Total operating costs and expenses 10,529 10,464 20,139 19,976 Operating earnings 4,894 3,998 8,627 6,796 Interest expense, net 678 506 1,305 959 Net foreign exchange loss 23 1 27 5 Other expense, net 2,639 1,345 4,080 1,931 Earnings before income tax expense 1,554 2,146 3,215 3,901 Income tax expense 613 773 985 1,156 Net earnings 941 1,373 2,230 2,745 Net earnings attributable to noncontrolling interest 3 3 6 6 Net earnings attributable to AbbVie Inc. $ 938 $ 1,370 $ 2,224 $ 2,739 Diluted earnings per share attributable to AbbVie Inc. $ 0.52 $ 0.77 $ 1.24 $ 1.53 Adjusted diluted earnings per sharea $ 2.97 $ 2.65 $ 5.43 $ 4.96 Weighted-average diluted shares outstanding 1,771 1,771 1,772 1,772 a Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1. Specified items impacted results as follows: Quarter Ended June 30, 2025 (in millions, except per share data) Earnings Diluted Pre-tax After-taxa EPS As reported (GAAP) $ 1,554 $ 938 $ 0.52 Adjusted for specified items: Intangible asset amortization 1,864 1,571 0.89 Change in fair value of contingent consideration 2,795 2,709 1.53 Other 91 60 0.03 As adjusted (non-GAAP) $ 6,304 $ 5,278 $ 2.97 a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended June 30, 2025 included acquired IPR&Dand milestone expense of $823 million on a pre-tax and $737 million on an after-tax basis, representing an unfavorable impact of $0.42 to both diluted EPS and adjusted diluted EPS. 2. The impact of the specified items by line item was as follows: Quarter Ended June 30, 2025 (in millions) Cost ofproducts sold SG&A R&D Other operatingincome Other expense,net As reported (GAAP) $ 4,346 $ 3,253 $ 2,131 $ (24) $ 2,639 Adjusted for specified items: Intangible asset amortization (1,864) — — — — Change in fair value of contingent consideration — — — — (2,795) Other (69) (14) (16) 24 (16) As adjusted (non-GAAP) $ 2,413 $ 3,239 $ 2,115 $ — $ (172) 3. The adjusted tax rate for the second quarter of 2025 was 16.2 percent, as detailed below: Quarter Ended June 30, 2025 (dollars in millions) Pre-tax earnings Income taxes Tax rate As reported (GAAP) $ 1,554 $ 613 39.4 % Specified items 4,750 410 8.6 % As adjusted (non-GAAP) $ 6,304 $ 1,023 16.2 % AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1. Specified items impacted results as follows: Quarter Ended June 30, 2024 (in millions, except per share data) Earnings Diluted Pre-tax After-taxa EPS As reported (GAAP) $ 2,146 $ 1,370 $ 0.77 Adjusted for specified items: Intangible asset amortization 1,947 1,651 0.93 Acquisition and integration costs 145 125 0.07 Change in fair value of contingent consideration 1,476 1,438 0.81 Other 90 126 0.07 As adjusted (non-GAAP) $ 5,804 $ 4,710 $ 2.65 a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. Acquisition and integration costs primarily reflect costs related to the ImmunoGen acquisition. Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended June 30, 2024 included acquired IPR&Dand milestone expense of $937 million on a pre-tax and $924 million on an after-tax basis, representing an unfavorable impactof $0.52 to both diluted EPS and adjusted diluted EPS. 2. The impact of the specified items by line item was as follows: Quarter Ended June 30, 2024 (in millions) Cost of products sold SG&A R&D Other expense,net As reported (GAAP) $ 4,202 $ 3,377 $ 1,948 $ 1,345 Adjusted for specified items: Intangible asset amortization (1,947) — — — Acquisition and integration costs (79) (35) (31) — Change in fair value of contingent consideration — — — (1,476) Other (41) (27) — (22) As adjusted (non-GAAP) $ 2,135 $ 3,315 $ 1,917 $ (153) 3. The adjusted tax rate for the second quarter of 2024 was 18.8 percent, as detailed below: Quarter Ended June 30, 2024 (dollars in millions) Pre-tax earnings Income taxes Tax rate As reported (GAAP) $ 2,146 $ 773 36.0 % Specified items 3,658 318 8.7 % As adjusted(non-GAAP) $ 5,804 $ 1,091 18.8 % AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1. Specified items impacted results as follows: Six Months Ended June 30, 2025 (in millions, except per share data) Earnings Diluted Pre-tax After-taxa EPS As reported (GAAP) $ 3,215 $ 2,224 $ 1.24 Adjusted for specified items: Intangible asset amortization 3,722 3,145 1.78 Change in fair value of contingent consideration 4,313 4,186 2.36 Other 153 93 0.05 As adjusted (non-GAAP) $ 11,403 $ 9,648 $ 5.43 a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. Reported GAAP earnings and adjusted non-GAAP earnings for the six months ended June 30, 2025 included acquired IPR&D and milestones expense of $1.1 billion on a pre-tax and $975 million on an after-tax basis, representing an unfavorable impactof $0.55 to both diluted EPS and adjusted diluted EPS. 2. The impact of the specified items by line item was as follows: Six Months Ended June 30, 2025 (in millions) Cost of products sold SG&A R&D Otheroperating income Other expense,net As reported (GAAP) $ 8,348 $ 6,546 $ 4,198 $ (24) $ 4,080 Adjusted for specified items: Intangible asset amortization (3,722) — — — — Change in fair value of contingent consideration — — — — (4,313) Other (97) (27) (32) 24 (21) As adjusted (non-GAAP) $ 4,529 $ 6,519 $ 4,166 $ — $ (254) 3. The adjusted tax rate for the first six months of 2025 was 15.3 percent, as detailed below: Six Months Ended June 30, 2025 (dollars in millions) Pre-tax earnings Income taxes Tax rate As reported (GAAP) $ 3,215 $ 985 30.6 % Specified items 8,188 764 9.3 % As adjusted (non-GAAP) $ 11,403 $ 1,749 15.3 % AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1. Specified items impacted results as follows: Six Months Ended June 30, 2024 (in millions, except per share data) Earnings Diluted Pre-tax After-taxa EPS As reported (GAAP) $ 3,901 $ 2,739 $ 1.53 Adjusted for specified items: Intangible asset amortization 3,838 3,254 1.84 Acquisition and integration costs 656 611 0.34 Change in fair value of contingent consideration 2,136 2,081 1.17 Other 111 145 0.08 As adjusted (non-GAAP) $ 10,642 $ 8,830 $ 4.96 a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. Acquisition and integration costs primarily reflect costs related to the ImmunoGen acquisition. Reported GAAP earnings and adjusted non-GAAP earnings for the six months ended June 30, 2024 included acquired IPR&Dand milestones expense of $1.1 billion on a pre-tax and after-tax basis, representing an unfavorable impact of $0.60 to bothdiluted EPS and adjusted diluted EPS. 2. The impact of the specified items by line item was as follows: Six Months Ended June 30, 2024 (in millions) Cost of productssold SG&A R&D Interestexpense, net Otherexpense, net As reported (GAAP) $ 8,296 $ 6,692 $ 3,887 $ 959 $ 1,931 Adjusted for specified items: Intangible asset amortization (3,838) — — — — Acquisition and integration costs (158) (315) (159) (24) — Change in fair value of contingent consideration — — — — (2,136) Other (57) (30) — — (24) As adjusted (non-GAAP) $ 4,243 $ 6,347 $ 3,728 $ 935 $ (229) 3. The adjusted tax rate for the first six months of 2024 was 17.0 percent, as detailed below: Six Months Ended June 30, 2024 (dollars in millions) Pre-tax earnings Income taxes Tax rate As reported (GAAP) $ 3,901 $ 1,156 29.6 % Specified items 6,741 650 9.6 % As adjusted (non-GAAP) $ 10,642 $ 1,806 17.0 % SOURCE AbbVie For more information Contact us » Subscribe for email alerts Sign up Subscription management We also welcome the opportunity to hear from you in these social channels, but remember we work in a highly-regulated industry with unique legal considerations. Before engaging, please read and adhere to our established community guidelines for each channel. View our social media channel guidelines » AbbVie.com | Site Map | Terms of Use | Privacy Notice | Consumer Health Data Privacy Notice | Cookies Settings | Your Privacy Choices Copyright © 2025 AbbVie Inc. North Chicago, Illinois, U.S.A. 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