Escitalopram

- Presentations include pooled post-hoc analysis of the Phase 3 ADMIRAL and COMMODORE data on post-transplant gilteritinib resumption in relapsed or refractory FLT3m+ AML - - Findings from the Phase 3 MORPHO trial in the post-transplant maintenance setting and Phase 1/2 VICEROY trial in newly diagnosed disease highlight how treatment timing, sequencing and combination approaches may influence outcomes - TOKYO, Dec. 5, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that new data evaluating XOSPATA™ (gilteritinib) across FMS-like tyrosine kinase 3 mutation-positive (FLT3m+) acute myeloid leukemia (AML), including in relapsed or refractory (R/R), newly diagnosed and post-transplant maintenance settings, will be presented at the upcoming American Society of Hematology (ASH) Annual Meeting taking place from 6-9 December 2025 in Orlando, Fla. Through ongoing research with gilteritinib, Astellas is advancing the science of FLT3m+ AML and generating new evidence across the disease stages, to help improve long-term outcomes for people diagnosed with FLT3m+ AML. Highlights from Astellas at ASH 2025 will include: A pooled post-hoc analysis of the Phase 3 ADMIRAL and COMMODORE trials evaluating gilteritinib in R/R FLT3m+ AML, exploring treatment sequencing and resumption post-transplant to improve outcomes. In collaboration with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) , data from a post-hoc analysis of the Phase 3 MORPHO study examining how time from diagnosis to transplant, use of FLT3 inhibitors before transplant and use of gilteritinib post-transplant influenced outcomes in FLT3m+ AML. Results from the ongoing Phase 1/2 VICEROY study (NCT05520567) investigating triplet combination therapy approach including gilteritinib in newly diagnosed FLT3m+ AML patients ineligible for intensive chemotherapy, focused on safety, efficacy and dosing optimization. Moitreyee Chatterjee-Kishore, PhD, MBA, Head of Oncology Development, Astellas "Building on gilteritinib's foundation in treating relapsed or refractory FLT3-mutated AML - one of the most challenging forms of leukemia characterized by high rates of treatment failure and relapse - Astellas is dedicated to advancing research that provides valuable insights to inform clinical practice. This new data exemplifies our 'bench to bedside' approach, translating scientific innovation into VALUE for patients who urgently need new treatment options." Gilteritinib is a FLT3 inhibitor with demonstrated activity against FLT3-ITD, a common driver mutation that presents with a high disease burden and poor prognosis, and FLT3-tyrosine kinase domain (TKD) mutations.1 Gilteritinib is available as XOSPATA® across the world, including in the U.S., Japan, China and multiple European countries for the treatment of adult patients who have relapsed or refractory FLT3m+ AML. The ongoing, randomized, multicenter, open-label, Phase 3 PASHA study (NCT04027309) is evaluating gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by one year of maintenance in patients with newly diagnosed FLT3-mutated AML eligible for intensive chemotherapy. About Gilteritinib Gilteritinib is an FMS-like tyrosine kinase 3 (FLT3) inhibitor with demonstrated activity against FLT3-ITD, a common driver mutation that presents with a high disease burden and poor prognosis, and FLT3-TKD mutations.1 It was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global development, commercialization and manufacturing rights to gilteritinib.2 Gilteritinib was evaluated in ADMIRAL (NCT02421939), a Phase 3, open-label, multicenter, randomized clinical trial comparing gilteritinib with prespecified salvage chemotherapy in adult patients with relapsed or refractory FLT3-mutated AML. About Acute Myeloid Leukemia (AML) Acute myeloid leukemia (AML) is an aggressive cancer that affects the bone marrow and blood, and its incidence increases with age.3,4 Of patients newly diagnosed with AML and tested for FLT3 mutations, approximately one-third have an alteration to the FLT3 gene. FLT3-ITD mutations have been associated with worsened disease-free survival and overall survival, and a higher risk of getting the disease more than once. FLT3 mutation status can change over the course of AML treatment, even after relapse.5-8 About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at . Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. XOSPATA (gilteritinib) U.S. Indication & Important Safety Information Indication XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test. Important Safety Information Contraindications XOSPATA is contraindicated in patients with hypersensitivity to gilteritinib or any of the excipients. Anaphylactic reactions have been observed in clinical trials. Warnings and Precautions Differentiation Syndrome (See BOXED WARNING) 3% of 319 patients treated with XOSPATA in the clinical trials experienced differentiation syndrome. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated. Symptoms and other clinical findings of differentiation syndrome in patients treated with XOSPATA included fever, dyspnea, pleural effusion, pericardial effusion, pulmonary edema, hypotension, rapid weight gain, peripheral edema, rash, and renal dysfunction. Some cases had concomitant acute febrile neutrophilic dermatosis. Differentiation syndrome occurred as early as 1 day and up to 82 days after XOSPATA initiation and has been observed with or without concomitant leukocytosis. If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement. Taper corticosteroids after resolution of symptoms and administer corticosteroids for a minimum of 3 days. Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid treatment. If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, interrupt XOSPATA until signs and symptoms are no longer severe. Posterior Reversible Encephalopathy Syndrome (PRES) 1% of 319 patients treated with XOSPATA in the clinical trials experienced posterior reversible encephalopathy syndrome (PRES) with symptoms including seizure and altered mental status. Symptoms have resolved after discontinuation of XOSPATA. A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI). Discontinue XOSPATA in patients who develop PRES. Prolonged QT Interval XOSPATA has been associated with prolonged cardiac ventricular repolarization (QT interval). 1% of the 317 patients with a post-baseline QTc measurement on treatment with XOSPATA in the clinical trial were found to have a QTc interval greater than 500 msec and 7% of patients had an increase from baseline QTc greater than 60 msec. Perform electrocardiogram (ECG) prior to initiation of treatment with XOSPATA, on days 8 and 15 of cycle 1, and prior to the start of the next two subsequent cycles. Interrupt and reduce XOSPATA dosage in patients who have a QTcF >500 msec. Hypokalemia or hypomagnesemia may increase the QT prolongation risk. Correct hypokalemia or hypomagnesemia prior to and during XOSPATA administration. Pancreatitis 4% of 319 patients treated with XOSPATA in the clinical trials experienced pancreatitis. Evaluate patients who develop signs and symptoms of pancreatitis. Interrupt and reduce the dose of XOSPATA in patients who develop pancreatitis. Embryo-Fetal Toxicity XOSPATA can cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with XOSPATA and for 6 months after the last dose of XOSPATA. Advise males with female partners of reproductive potential to use effective contraception during treatment with XOSPATA and for 4 months after the last dose of XOSPATA. Pregnant women, patients becoming pregnant while receiving XOSPATA or male patients with pregnant female partners should be apprised of the potential risk to the fetus. Adverse Reactions Fatal adverse reactions occurred in 2% of patients receiving XOSPATA. These were cardiac arrest (1%) and one case each of differentiation syndrome and pancreatitis. The most frequent (≥5%) nonhematological serious adverse reactions reported in patients were fever (13%), dyspnea (9%), renal impairment (8%), transaminase increased (6%) and noninfectious diarrhea (5%). 7% discontinued XOSPATA treatment permanently due to an adverse reaction. The most common (>1%) adverse reactions leading to discontinuation were aspartate aminotransferase increased (2%) and alanine aminotransferase increased (2%). The most frequent (≥5%) grade ≥3 nonhematological adverse reactions reported in patients were transaminase increased (21%), dyspnea (12%), hypotension (7%), mucositis (7%), myalgia/arthralgia (7%), and fatigue/malaise (6%). Other clinically significant adverse reactions occurring in ≤10% of patients included: electrocardiogram QT prolonged (9%), hypersensitivity (8%), pancreatitis (5%), cardiac failure (4%), pericardial effusion (4%), acute febrile neutrophilic dermatosis (3%), differentiation syndrome (3%), pericarditis/myocarditis (2%), large intestine perforation (1%), and posterior reversible encephalopathy syndrome (1%). Lab Abnormalities Shifts to grades 3-4 nonhematologic laboratory abnormalities in XOSPATA treated patients included phosphate decreased (14%), alanine aminotransferase increased (13%), sodium decreased (12%), aspartate aminotransferase increased (10%), calcium decreased (6%), creatine kinase increased (6%), triglycerides increased (6%), creatinine increased (3%), and alkaline phosphatase increased (2%). Drug Interactions Combined P-gp and Strong CYP3A Inducers Concomitant use of XOSPATA with a combined P-gp and strong CYP3A inducer decreases XOSPATA exposure which may decrease XOSPATA efficacy. Avoid concomitant use of XOSPATA with combined P-gp and strong CYP3A inducers. Strong CYP3A inhibitors Concomitant use of XOSPATA with a strong CYP3A inhibitor increases XOSPATA exposure. Consider alternative therapies that are not strong CYP3A inhibitors. If the concomitant use of these inhibitors is considered essential for the care of the patient, monitor patient more frequently for XOSPATA adverse reactions. Interrupt and reduce XOSPATA dosage in patients with serious or life-threatening toxicity. Drugs that Target 5HT2B Receptor or Sigma Nonspecific Receptor Concomitant use of XOSPATA may reduce the effects of drugs that target the 5HT2B receptor or the sigma nonspecific receptor (e.g., escitalopram, fluoxetine, sertraline). Avoid concomitant use of these drugs with XOSPATA unless their use is considered essential for the care of the patient. P-gp, BCRP, and OCT1 Substrates Based on in vitro data, gilteritinib is a P-gp, breast cancer resistant protein (BCRP), and organic cation transporter 1 (OCT1) inhibitor. Coadministration of gilteritinib may increase the exposure of P-gp, BCRP, and OCT1 substrates, which may increase the incidence and severity of adverse reactions of these substrates. For P-gp, BCRP, or OCT1 substrates where small concentration changes may lead to serious adverse reactions, decrease the dose or modify the dosing frequency of such substrate and monitor for adverse reactions as recommended in the respective prescribing information. Specific Populations Lactation Advise women not to breastfeed during treatment with XOSPATA and for 2 months after the last dose. Please see Full Prescribing Information, including BOXED WARNING for additional safety information. 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VALBY, Denmark., Nov. 11, 2025 /PRNewswire/ -- Key highlights Lundbeck's total revenue grew by +14% CER[1] (+13% DKK) to DKK 18,537 million in the first nine months of 2025. Growth in the U.S. and Europe was the driver of this strong performance. United States: DKK 9,955 million (+22% CER; +19% DKK) Europe: DKK 4,318 million (+13% CER; +13% DKK) International Operations: DKK 3,880 million (+0% CER; -4% DKK) The revenue of Lundbeck's strategic brands increased by +20% CER (+18% DKK), reaching DKK 14,260 million, representing 77% of total revenue Rexulti®: DKK 4,695 million (+26% CER; +23% DKK) Brintellix®/Trintellix®: DKK 3,453 million (-1% CER; -3% DKK) Vyepti®: DKK 3,254 million (+57% CER; +54% DKK) Abilify LAI franchise[2]: DKK 2,858 million (+11% CER; +9% DKK) EBITDA increased to DKK 6,207 million, growing +39% CER (+38% DKK) and adjusted EBITDA[3] reached DKK 6,272 million, growing +22% CER (+21% DKK), driven by continuous strong momentum across strategic brands fueled by the strong performance of Vyepti® and Rexulti®. Lundbeck's disciplined capital reallocation framework allows for both investing for the future and delivering on the near-term targets, supported by a healthy cost mindset and continuous optimization of capital deployment toward the highest-return opportunities. EBITDA growth was mainly impacted by an impairment loss from one of the MAGLi projects recognized in the third quarter of 2024. Financial guidance 2025 raised On 11 November 2025, Lundbeck announced an increase in its full-year revenue and adjusted EBITDA guidance at CER. Revenue is now expected to grow by 13% to 14% at CER, up from the previous forecast of 11% to 13%, compared to the prior year's revenue excluding hedging effects. Adjusted EBITDA growth is now projected at 22% to 25% at CER, previously 16% to 21%, also excluding hedging effects. Further details can be found in section 2.8 Outlook. Lundbeck's President and CEO, Charl van Zyl said: "In the third quarter, Lundbeck continued its strong financial performance, driven by higher-than-expected growth for Vyepti ® and Rexulti ® in the U.S. The performance is a result of targeted investments enabled through our capital reallocation program. This leads us to upgrade our guidance. During the quarter, we also announced a new commercial operating model, under which 27 markets are transitioning to a partnership model. This approach frees up additional capital for reinvestment in growth opportunities, including our transformed pipeline and key commercial focus markets." Recent events On 27 October 2025, Lundbeck announced a strategic collaboration with OpenAI to transform how the company innovates and operates across its entire value chain – from molecule to patient. Through the deployment of ChatGPT Enterprise to its global workforce, Lundbeck empowers employees with AI capabilities designed to accelerate discovery, enhance decision-making, and drive unprecedented efficiency. The collaboration marks a bold step toward redefining innovation in brain health. On 20 October 2025, Lundbeck and Contera Pharma announced a strategic research collaboration aiming to accelerate the discovery and development of innovative oligonucleotide-based medicines for patients living with serious neurological conditions, where significant unmet medical needs remain. Together, the companies will explore novel RNA-targeting treatment approaches designed to deliver transformative benefits for patients worldwide. On 13 October 2025, Lundbeck announced that its investigational drug bexicaserin, for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs), has been granted Breakthrough Therapy Designation (BTD) by China's Center for Drug Evaluation (CDE). The BTD procedure is designed to accelerate the development and review of innovative medicines for serious or life-threatening diseases with no adequate treatment options, or where early evidence shows substantial advantages over existing therapies. On 2 October 2025, Lundbeck announced that pipeline developments regarding amlenetug, a novel investigational molecule for the potential treatment of Multiple System Atrophy (MSA), were presented at the 2025 International Congress of Parkinson's Disease and Movement Disorders® in Honolulu, Hawaii (5-9 October). At the congress, Lundbeck shared Insights into the design of the phase III MASCOT trial and its use of innovative Bayesian progression modeling methods. On 20 September 2025, Lundbeck and Otsuka America Pharmaceutical, Inc., (Otsuka) announced that Otsuka has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the supplemental New Drug Application (sNDA) for use of Rexulti® (brexpiprazole) in combination with sertraline as a treatment of adults with post-traumatic stress disorder (PTSD). The CRL states that the FDA has completed their review but cannot approve the application in the current form, as the application does not provide substantial evidence of effectiveness to support the approval. On 11 September 2025, Lundbeck announced a step forward in its commitment to advancing brain health by enhancing its leadership in migraine with a comprehensive collection of datasets presented at the 2025 International Headache Congress, which took place in São Paulo (10-13 September). Among data presented, Lundbeck announced the full results of the 12-week, open-label extension of the RESOLUTION trial investigating eptinezumab for the prevention of migraine in patients with chronic migraine and associated medication overuse headache (MOH) who also received standardized patient education. On 9 September 2025, Lundbeck announced a change to its commercial operating model, aimed at focusing resources and capital on the highest-growth opportunities while ensuring continued patient access to our medicines. As a next step in the continued execution of its Focused Innovator strategy, Lundbeck will transition its operations to a partnership model in 27 markets in Europe and International Operations through new partnerships with Swixx Group, Zuellig Pharma, and NewBridge Pharmaceuticals. The phased transition to the partnership model is expected to be completed by December 2025 in all countries. On 25 August 2025, Lundbeck announced that new data regarding bexicaserin, a novel treatment under investigation for seizures associated with Developmental and Epileptic Encephalopathies (DEEs), were presented at the 36th International Epilepsy Congress (IEC) in Lisbon, Portugal (30 August – 3 September). Strategy update – Focused Innovator Conference call Tomorrow at 13.00 CET, Lundbeck will be hosting a conference call for the financial community. You can find dial-ins and a link for webcast online at under the Investor section. Strategy update – Focused Innovator Lundbeck progresses well on the Focused Innovator Strategy laid out in the beginning of 2024. Scaling for the Next Phase of Growth Lundbeck is building a stronger foundation for scale and long-term value creation. Vyepti® and Rexulti® provide a durable engine for reinvestment into innovation. With five to six mid to late-stage pipeline assets on track by 2026, including amlenetug and bexicaserin, and efficiency gains from the new commercial operating model, Lundbeck is structurally positioned for sustained profitability and growth driven by Rexulti® and Vyepti®. Building on strong cash generation and late-stage visibility, Lundbeck is well placed to deliver on its 2027 mid-term targets and extend its leadership in neuroscience well into the next decade. Sustained growth from Strategic Brands Lundbeck continues to demonstrate strong and consistent progress on its Focused Innovator strategy, with strategic brands delivering revenue growth of +20% CER in the first nine months of 2025 and now representing 77% of total revenue. Lundbeck's double-digit CER growth reflects the continued transformation of its commercial model toward higher-value, innovation-driven franchises. Growth was led by Vyepti®, which continued to deliver double-digit CER growth and maintained its strong momentum across all regions. Demand remained particularly strong in the U.S., supported by total patient growth (+35%), world-class persistency (58%), and increasing dosage, overall further fueled by expanding access across Europe and International Operations. Rexulti® sustained above 20% growth for three consecutive quarters and contributed to the strong growth in the first nine months of 2025, with targeted affordability initiatives introduced earlier in 2025 now driving stronger patient access and demand in both the Major Depressive Disorder (MDD) and agitation associated with dementia due to Alzheimer's disease (AADAD) segments. This broad-based strength underscores Lundbeck's ability to combine focused commercial execution, portfolio discipline, and operating leverage in support of sustained growth. Pipeline Advancing Toward Late-Stage Inflection Lundbeck advanced its late-stage pipeline during the quarter, reinforcing its commitment to deliver differentiated innovation in brain health. In migraine, Vyepti® achieved a key regulatory milestone with FDA approval of its CHO manufacturing process and submission to the European Medicines Agency, supporting long-term supply scalability and cost efficiency. Lu AG09222 (anti-PACAP) continues to progress in phase IIb, with dose-response analyses guiding pivotal design, while a dual-active VIP-PACAP molecule has entered pre-clinical development with intended indication in cluster headache. In neuro-rare, amlenetug recruitment remains strong and remained positioned as a potential first disease-modifying therapy for Multiple System Atrophy. Bexicaserin is advancing according to plan and was granted Breakthrough Therapy Designation in China, further underscoring its global potential and the growing momentum behind Lundbeck's next wave of innovation. Capital Efficiency Powering Innovation Lundbeck delivered another strong operational and financial performance, demonstrating continued capital discipline and cost efficiency while investing in innovation and growth. The company achieved an adjusted EBITDA margin of 33.8% in the first nine months of 2025, supported by solid revenue growth and active cost allocation management. Strategic reallocation of resources within the Focused Innovator Strategy framework continues to fund late-stage R&D programs (adjusted R&D spending increasing 22% CER in the first nine months of 2025) and launch readiness activities without compromising profitability. Transition of 27 markets to a partnership-led model is progressing as planned and will enhance Lundbeck's flexibility and scalability across geographies. Reinvestment from these efficiencies, together with a stronger balance sheet and operating cash flow of more than DKK 4.5 billion year to date, provides Lundbeck with the capacity to advance its late-stage pipeline and support future launches. The company remains focused on maintaining a robust financial foundation while driving sustainable, innovation-led growth. CONTENT 1 Financial highlights. 5 2 Business performance. 6 2.1 Revenue by product 6 2.2 Revenue by geographical area. 8 2.3 Gross profit 9 2.4 EBIT and adjusted EBITDA. 10 2.5 Net profit and adjusted EPS. 11 2.6 Cash flow and balance sheet 12 2.7 Summary of key developments in the third quarter of 2025. 13 2.8 Outlook. 15 2.9 Lundbeck's development portfolio. 17 2.10 Sustainability update. 18 2.11 General corporate matters. 20 3 Condensed financial statements. 23 4 Notes. 28 Financial calendar 2025. 30 1 Change at CER (Constant Exchange Rates) does not include effects from hedging. 2 Adjusted gross profit is the gross profit excluding depreciation and amortization and other adjustments linked to sales. 3 EBITDA refers to Earnings Before Interest, Taxes, Depreciation and Amortization, including impairment losses. 4 Adjusted EBITDA is defined as EBITDA adjusted by certain items, for details see note 4.3 Adjusted EBITDA. 5 Adjusted net profit is the net profit excluding depreciation and amortization and other adjustments, net of taxes. 2 BUSINESS PERFORMANCE 2.1 REVENUE BY PRODUCT Revenue reached DKK 18,537 million representing growth of +14% CER (+13% DKK). The strong performance in strategic brands was driven by the U.S. and Europe, growing +26% CER (+23% DKK) and +18% CER (+18% DKK) , respectively. Approximately 84% of the strategic brands growth was attributable to the strong performance of Vyepti® and Rexulti® in the U.S. in the first nine months of 2025. Vyepti® and Rexulti® sales in the U.S. grew +56% CER (+53% DKK) and +26% CER (+24% DKK), respectively. The largest markets for the strategic brands was the U.S., Spain, Canada, Italy and France. Strategic brands The Focused Innovator Strategy amplifies Lundbeck's strategic brands representing the company's growth engine, driving revenue expansion, margin improvement, and sustainable long-term value creation. Rexulti ® (brexpiprazole) revenue reached DKK 4,695 million representing growth of +26% CER (+23% DKK). In the U.S., revenue benefitted from continued strong demand growth[4] in both agitation associated with dementia due to Alzheimer's disease (AADAD) and major depressive disorder (MDD). Total prescriptions (TRx) grew +23.5% year-over-year in the first nine months of 2025, reaching all-time high market share of 2.69% in August, and contributing to +21.1% growth in overall demand volume in the third quarter. In AADAD, Rexulti ® reached 4.35% market share within the Alzheimer segment and accounted for 23.4% of total U.S. Rexulti ® prescriptions in July, up from 17.8% same month of last year. In Europe and International Operations, Rexulti ® continued the strong and stable growth into the third quarter, driven by demand growth in countries such as Spain (+117%), expanding market share on the back of the 2024 launch, and Brazil (+13%), maintaining market share in a growing market, while Canada (+14%) continues the strong momentum on the back of nationwide reimbursement. The revenue distribution by region was 93%, 2% and 5% in the U.S., Europe and International Operations, respectively. The largest markets are the U.S., Brazil, Canada, Australia and Mexico. Brintellix®/Trintellix® (vortioxetine) revenue reached DKK 3,453 million representing a decline of -1% CER (-3% DKK), with strong performance in Europe. In Europe, the brand continued to gain market share across key markets, such as Italy (5.2% market share), France (4.1% market share), and Spain (6.4% market share). In International Operations, Japan maintained over 12% market share in the third quarter of 2025, resulting in +11% demand growth in the third quarter of 2025. The impact from generic competition was greater than expected in the third quarter of 2025. In Canada, this was primarily driven by earlier than expected decline in demand for the product following generic market entry, as well as by wholesalers reducing inventory levels to a greater extent than expected across the country. In addition, the brand has experienced the continued price and volume pressure from post–volume-based procurement (VBP) in China, which remained stable compared with the second quarter, along with ongoing generic erosion in Brazil. The year-over-year revenue development reflects the transfer of U.S. sales operations to Takeda, effective 1 January 2025 as well as the Medicare Part D redesign impacts. The revenue distribution by region was 28%, 43% and 29% in the U.S., Europe and International Operations, respectively. The largest markets for this product are the U.S., Spain, Canada, Italy and Japan. Vyepti ® (eptinezumab) delivered strong growth in the first nine months of 2025, with revenue reaching DKK 3,254 million, an increase of +57% CER (+54% DKK). Vyepti ® maintained its strong momentum across all regions. In the U.S., Vyepti ® accelerated sequentially in the third quarter of 2025, being the fastest-growing aCGRP in the U.S., reaching 11.2% market share during September through continued increase of new patient starts as well as growth in existing patient base through improved persistency with demand volume growing by +46.8%. The performance was driven by continued growth in treated patients, higher 300mg utilization, and improved persistency and infusion conversion rates across the Vyepti Infusion Network, reflecting stronger patient adherence. In Europe and International Operations, Vyepti ® maintained absolute growth momentum into the third quarter of 2025, building on consistently strong demand growth across key markets such as France (+96%), Spain (+73%), Germany (+62%), Canada (+68%) and Italy (+116%). aCGRP has expanded across all markets in overall market share with Vyepti ® outgrowing the market growth. The revenue distribution by region was 87%, 9% and 4% in the U.S., Europe and International Operations, respectively. The largest markets are the U.S., France, Canada, Spain and U.A.E. Abilify LAI franchise revenue reached DKK 2,858 million and grew +11% CER (+9% DKK). The franchise delivered solid growth in the first nine months of 2025. The Abilify LAI franchise in the U.S. grew in the third quarter to reach +10% CER growth in the first nine months of 2025 on the back of +9.5% growth in demand volume in the third quarter of 2025 on an expanding market share for the brands. Strong uptake in total prescriptions (TRx) for Abilify Asimtufii ® (63.1% in September), which grew market share to reach 3.9% in August as Lundbeck continue to source patients from oral aripiprazole, other oral antipsychotics, LAIs other than Abilify Maintena ® and naïve patients. The Abilify LAI franchise grew in Europe, driven by continued market share gains following the launch of Abilify Maintena ® 960mg, particularly in Spain (31% LAI market share), France (32% LAI market share) and Italy (42% LAI market share), underpinning the brand's ability to capture business from other antipsychotics. Conversion reached 22% by the end of the third quarter of 2025 in these countries. International Operations reported continued demand growth of Abilify Maintena ® in Canada (+6%). Australia is impacted by reduction in order volumes in anticipation of generic entry for Abilify Maintena ®, which is partially offset by launch of Abilify Asimtufii ®. The revenue distribution by region was 37%, 46% and 17% in the U.S., Europe and International Operations, respectively. The largest markets are the U.S., Spain, Canada, Italy and Australia. Mature brands Lundbeck's mature brands comprise established neuroscience treatments that provide stable cash generation and a solid earnings base, supporting continued investment in innovation and future growth opportunities. Cipralex®/Lexapro® (escitalopram) revenue reached DKK 1,573 million and remained unchanged at CER (-3% DKK). This performance is mainly impacted by the continued generic erosion, particularly in Japan, Canada and Italy, partially offset by price increases in Argentina driven by inflation. Regional revenue distribution was 68% and 32% in International Operations and Europe, respectively, with China, South Korea and Brazil as the largest markets. Revenue from Other pharmaceuticals, which comprises the remainder of Lundbeck's products, reached DKK 2,320 million representing a decline of -5% CER (-6% DKK). The decrease reflects the expected generic erosion of mature products such as Northera ®, Xenazine ® and Deanxit ®. This is offset by the strong performance of Sabril® in the U.S. The largest markets for Other pharmaceuticals are the U.S., China, France, South Korea and the UK. Lundbeck's five largest markets are the U.S., China, Spain, Italy and Canada constituting 70% of the total revenue. United States revenue reached DKK 9,955 million representing growth of +22% CER (+19% DKK) and continued the quarterly streak of more than 20% growth CER per quarter. The strategic brands reached DKK 9,228 million, increasing +26% CER (+23% DKK) and representing 93% of the revenue in this market. Vyepti® was the primary growth contributor, with growth accelerating in the third quarter, driven by a +46% increase in TRx demand underpinned by strong patient conversion supported by patient access and direct to consumer promotional activities. The growth was further fueled by increased 300mg dose usage, now representing nearly half of total U.S. units. The strong performance was reflected in the all-time-high market share of 11.2% in September, underpinning the exceptional performance as being the fastest-growing aCGRP in the U.S. On top of improved conversion and higher dosage, the growth was further supported by sustained high persistency (62%). Rexulti® delivered strong growth of +26% CER, supported by demand in both MDD and AADAD indications, where market share increased across all patient segments. TRx growth reached +23%, with AADAD accounting for over 21% of total prescriptions, up from 17% in the same period last year. The Abilify LAI franchise growth in the third quarter of 2025 was supported by continued TRx growth of +10.6%, primarily from Abilify Asimtufii®, which rose +57%. Growth in Abilify Maintena® was impacted by gross-to-net headwinds linked to the Medicare Part D redesign. Trintellix® reflects the effect of the Takeda transition, effective 1 January 2025 as well as the Medicare Part D redesign impacts. Mature brands declined overall, with continued erosion for Northera®, Onfi® and Xenazine®, offset by the strong performance of Sabril®. Europe revenue reached DKK 4,318 million representing a growth of +13% CER (+13% DKK). The strategic brands reached DKK 3,169 million, increasing +18% CER (+18% DKK) and representing 73% of revenue in this market. Solid growth in Europe in the first nine months of 2025 reflected sustained demand for Brintellix® and Vyepti®, together with the continued rollout of Abilify Maintena® 960mg across key markets. Growth was particularly strong in Spain, Italy, the UK and France, where demand momentum continued into the third quarter. Vyepti® further expanded its market share, underpinned by strong performance in France, Italy and Spain in particular. Brintellix® also continued to expand across markets, especially in Spain and Italy. The largest markets in Europe are Spain, Italy, France, Switzerland and the UK. International Operations comprises all Lundbeck's markets outside the U.S. and Europe. Revenue reached DKK 3,880 million and remained unchanged at CER (-4% DKK). The strategic brands reached DKK 1,863 million, increasing by +1% CER (-4% DKK) and representing 48% of revenue in this market. Despite strong momentum in strategic brands such as Rexulti® and Vyepti®, driven by continued uptake in revenue and market share expansion across key markets, and solid performance of the Abilify LAI franchise across countries, total revenue continued to decline in the third quarter of 2025 in International Operations, driven by generic competition for Brintellix® in Canada, Brazil and China. The biggest markets are China, Canada, Australia, Brazil and South Korea. China and Canada constitute approximately 42% of the regional revenue. Effects from hedging Lundbeck hedges a significant part of the revenue currency risk for a period of 12-18 months. Hedging had a positive impact of DKK 99 million on revenue in the first nine months of 2025 contributing to mitigate risks regarding the foreign exchange risks in our revenue, compared to a negative impact of DKK 43 million in the same period last year. Cost of sales reached DKK 3,021 million, decreasing by -3% CER (-4% DKK), mainly driven by the reversal of the Vyepti® provision for inventory obsolescence of DKK 389 million triggered by Vyepti®'s commercial performance. In addition, the decrease was also driven by lower amortization costs due to fully amortized product rights, partially offset by increased sales as well as costs related to a manufacturing contract for amlenetug. Excluding the reversal of the Vyepti® provision for inventory obsolescence, cost of sales increased +10% CER (+8% DKK). Gross profit reached DKK 15,516 million, increasing by +18% CER (+17% DKK). The gross margin was 83.7% representing an increase of 2.9 percentage points. Gross margin was mainly impacted by a combination of higher revenue, the reversal of the Vyepti® provision for inventory obsolescence and lower amortization costs, partially offset by costs related to a manufacturing contract for amlenetug. Adjusted gross profit is the gross profit excluding depreciation and amortization and other adjustments linked to sales and cost of sales. The adjusted gross margin was 87.8% representing a decrease of 0.7 percentage points primarily reflecting the effect of costs related to a manufacturing contract for amlenetug. Total operating expenses (OPEX) reached DKK 10,616 million, corresponding to an increase of +5% CER (+4% DKK). The OPEX ratio declined by 4.7 percentage points to 57.3%. The development primarily reflects the strong revenue growth and lower S&D ratio, partially offset by other operating expenses related to the commercial restructuring provision announced in September 2025 and higher R&D costs. Adjusted for the effect of impairment loss of DKK 547 million related to one of the MAGLi projects recognized in the third quarter of 2024, OPEX ratio declined by 1.4 percentage points in the first nine months of 2025. Sales and distribution costs reached DKK 5,714 million, corresponding to an increase of +2% CER (-1% DKK). The S&D ratio decreased by 4.1 percentage points to 30.8%, primarily reflecting leverage from the strong revenue growth and improved cost efficiency. Additionally, the decrease in S&D ratio reflects the redeployment of resources following the Trintellix® transition in the U.S., alongside disciplined resource allocation and capital reallocation in line with the Focused Innovator strategy. These savings have enabled continued investments in strategic brands, particularly Rexulti® and Vyepti® in the U.S., supporting sales force expansion and the global roll-out of Vyepti®. Administrative expenses reached DKK 1,077 million and was in line with the same period last year. The administrative expense ratio reached 5.8%, representing a decrease of 0.8 percentage points. Adjusting for non-recurring items in both periods, underlying costs rose by DKK 107 million, mainly due to inflation as well as continued investment in Longboard integration. Research and development costs reached DKK 3,440 million, with an R&D ratio of 18.6%, increasing +2% CER (+2% DKK). The development in the first nine months of 2025 reflects the continued commitment to innovation and was primarily driven by advancing key pipeline programs, including bexicaserin and amlenetug (anti-α-synuclein), as well as ongoing progress in anti-ACTH and anti-PACAP programs. In addition, in the third quarter of 2024, Lundbeck recognized an impairment loss of DKK 547 million on part of the carrying amount of one of the MAGLi projects following a negative data read out from a phase I project. Adjusted for the MAGLI impairment loss, R&D costs increased +22% CER (+21% DKK). Other operating expenses, net reached DKK 385 million due to the already announced commercial restructuring in September 2025. EBIT reached DKK 4,900 million, increasing by +59% CER (+58% DKK) reflecting a combination of improved gross profit driven by strong sales growth, the reversal of the Vyepti® provision for inventory obsolescence and lower amortization costs as well as lower S&D ratio. This performance was partially offset by other operating expenses regarding the commercial restructuring provision announced in September 2025 as well as costs related to a manufacturing contract for amlenetug and higher R&D costs. EBIT growth was also impacted by an impairment loss from one of the MAGLi projects recognized in the third quarter of 2024. Total amortization and depreciation reached DKK 1,307 million, representing a decrease of -6% CER (-7% DKK), mainly driven by fully amortized product rights of one product since February 2024. Amortization of product rights amounted to DKK 977 million, corresponding to a decrease of -10% CER (-11% DKK). Amortization of other intangible assets corresponded to DKK 45 million in the first nine months of 2025. Depreciation amounted to DKK 285 million, corresponding to an increase of +5% CER (+4% DKK). Adjusted EBITDA reached DKK 6,272 million representing an increase of +22% CER (+21% DKK) reflecting the sales growth driven by strong performance of strategic brands, despite continued investments in building the R&D pipeline and the commercial investments to support the growth of strategic brands. The adjusted EBITDA margin was 33.8%, representing an increase of 2.2 percentage points. Net financial (income)/expenses amounted to an expense of DKK 773 million in the first nine months of 2025, primarily driven by the higher interest costs due to new debt obtained in connection with the acquisition of Longboard as well as unfavorable foreign exchange effects of DKK 342 million mainly due to the depreciation of USD leading to the negative impact through currency revaluation. The effective tax rate for the first nine months of 2025 was 22.0% (23.0% for the first nine months of 2024). The tax rate is in line with the full-year expectation. Net profit reached DKK 3,219 million, corresponding to a growth of 26%. Adjusted net profit and EPS Adjusted net profit is the net profit excluding depreciation and amortization and other adjustments, net of taxes. Adjusted net profit reached DKK 4,289 million, increasing +10%. The main difference from reported EBIT to adjusted net profit is the net financials development, primarily impacted by unfavorable foreign exchange and higher interest costs related to financial debts. Adjusted EPS was DKK 4.32, corresponding to an increase of +10%, in line with the adjusted net profit. Cash flows from operating activities amounted to an inflow of DKK 4,560 million compared to an inflow of DKK 4,480 million in the first nine months of 2024. This increase was primarily driven by higher EBIT and lower trade and other payables, partially offset by a higher prepaid tax in the first quarter of 2025. Lundbeck's net cash flows from investing activities were an outflow of DKK 409 million compared to an outflow of DKK 346 million in the first nine months of 2024. The investing activities mainly include capital expenditures in property, plant and equipment. Lundbeck's net cash flows from financing activities were an outflow of DKK 5,297 million compared to an outflow of DKK 808 million in the first nine months of 2024. The increase primarily reflects repayments of the Revolving Credit Facility (RCF) used for the acquisition of Longboard. Additionally, a four-year EUR 500 million bond was issued in the second quarter of 2025 to refinance the RCF mentioned above. Higher dividend payouts in March 2025 also contributed to the outflow. The net cash outflow reached DKK 1,146 million compared to an inflow of DKK 3,326 million in the first nine months of 2024. Net debt increased from a net cash position of DKK 3,982 million at the end of September 2024 to a net debt of DKK 9,085 million at the end of September 2025, primarily due to higher leverage following the acquisition of Longboard. The net debt/EBITDA ratio is 1.3x at the end of September 2025 versus 1,8x at the end of June 2025, compared to -0.8x at the end of September 2024. Interest-bearing debt was DKK 12,564 million at the end of September 2025 compared to DKK 4,340 million at the end of September 2024. On 30 September 2025, Lundbeck's total assets amounted to DKK 53,193 million compared to DKK 56,976 million at the end of 2024 mainly driven by intangible assets due to ongoing amortization and the impact from translation of foreign currencies as well as lower cash and cash equivalents reflecting repayments of the Revolving Credit Facility used for the acquisition of Longboard. On 30 September 2025, Lundbeck's total liabilities amounted to DKK 28,040 million compared to DKK 31,966 million at the end of 2024. The decrease primarily reflects repayments of the Revolving Credit Facility used for the acquisition of Longboard, partially offset by the issuance of a four-year EUR 500 million bond in the second quarter of 2025. On 30 September 2025, Lundbeck's equity amounted to DKK 25,153 million. 1 Change at CER (Constant Exchange Rates) does not include effects from hedging. 2 Adjusted gross profit is the gross profit excluding depreciation and amortization and other adjustments linked to sales. 3 EBITDA refers to Earnings Before Interest, Taxes, Depreciation and Amortization. 4 EBITDA refers to Earnings Before Interest, Taxes, Depreciation and Amortization. Adjusted EBITDA is defined as EBITDA adjusted by certain items, for details see section 4 Notes, note 3 Adjusted EBITDA. REVENUE Revenue reached DKK 6,279 million representing a growth of +14% CER (+10% DKK) in the third quarter of 2025. The increase in revenue is mainly driven by strong performance across the strategic brands reaching DKK 4,824 million, representing a growth of +18% CER (+12% DKK), equivalent to 77% of total revenue (see section 2.1) in the third quarter of 2025. The increase in revenue was partly offset by unfavorable currency effects primarily coming from USD, CAD and BRL in the third quarter of 2025. The performance is mainly driven by higher demand for Rexulti® and Vyepti® primarily in the U.S. (+26% CER and +56% CER, respectively). Moreover, Brintellix® / Trintellix® revenue decreased despite the strong performance in Europe, mainly driven by demand growth in Spain (+17% CER), Italy (+11% CER) and France (+7% CER). In Canada, the impact from generic competition was greater than expected in the third quarter of 2025, this was primarily driven by earlier than expected decline in demand for the product following generic market entry, as well as by wholesalers reducing inventory levels to a greater extent than expected across the country. The decline in the U.S. reflects the transfer of U.S. sales operations to Takeda, effective 1 January 2025 as well as the Medicare Part D redesign impacts. The Abilify LAI franchise grew in all regions, driven by strong demand growth of Abilify Maintena® 960mg in Spain, France and Germany as well as Abilify Asimtufii ® in the U.S. Mature brands decreased -1% CER (-5% DKK) due to the continued generic erosion. GROSS PROFIT Cost of sales decreased to DKK 846 million decreasing by -19% CER (-23% DKK) mainly driven by the reversal of the Vyepti® provision for inventory obsolescence of DKK 389 million. In addition, the decrease was also driven by lower amortization costs due to fully amortized product rights, partially offset by increased sales as well as costs related to a manufacturing contract for amlenetug. Excluding the reversal of Vyepti® provision for inventory obsolescence, cost of sales increased +16% CER (+13% DKK). In the third quarter of 2025, gross profit reached DKK 5,433 million increasing by +22% CER (+17% DKK). The gross margin was 86.5% representing an increase of 5.6 percentage points. Gross margin was mainly impacted by a combination of higher revenue, the reversal of the Vyepti® provision for inventory obsolescence and lower amortization costs, partially offset by costs related to a manufacturing contract for amlenetug. Adjusted gross margin was 86.3% in the third quarter of 2025 representing a decrease of 1.9 percentage point primarily reflecting the effect of costs related to a manufacturing contract for amlenetug. EBIT AND ADJUSTED EBITDA Total operating expenses (OPEX) reached DKK 3,802 million corresponding to an increase of +3% CER (+0% DKK). The OPEX ratio decreased by 6.1 percentage points primarily driven by the strong revenue growth and lower S&D ratio, partially offset by higher R&D costs. Adjusted for the effect of impairment loss of DKK 547 million related to the MAGLi projects recognized in the third quarter of 2024, OPEX ratio increased by 3.5 percentage points in the third quarter of 2025. Sales and distribution costs reached DKK 1,896 million corresponding to an increase of +3% CER (-3% DKK). The S&D ratio decreased by 3.9 percentage points in the third quarter of 2025 primarily driven by strong revenue growth and improved cost efficiency. As Lundbeck has limited variable sales and distribution costs, significant revenue growth translates into meaningful ratio improvement. Administrative expenses reached DKK 364 million increasing by +8% CER (+6% DKK) mainly impacted by inflation and continued investment in Longboard integration. The administrative expense ratio reached 5.8%, decreasing by 0.2 percentage points. Research and development costs reached DKK 1,157 million corresponding to a decrease of -22% CER (-24% DKK) with an R&D ratio of 18.4%. The development in the third quarter of 2025 reflects the continued commitment to innovation and was primarily driven by advancing key pipeline programs, including bexicaserin and amlenetug (anti-α-synuclein), as well as ongoing progress in anti-ACTH and anti-PACAP programs. In addition, in the third quarter of 2024, Lundbeck recognized an impairment loss of DKK 547 million on part of the carrying amount of one of the MAGLi projects following a negative data read out from a phase I project. Adjusted for the impairment loss of DKK 547 million prior year, R&D costs increased +21% CER (+19% DKK). Other operating expenses, net reached DKK 385 million due to the already announced commercial restructuring in September 2025. EBIT reached DKK 1,631 million increasing by +109% CER (+101% DKK) reflecting a combination of improved gross profit driven by strong sales growth, the reversal of the Vyepti® provision for inventory obsolescence and lower amortization costs as well as lower S&D ratio. This performance was partially offset by other operating expenses regarding the commercial restructuring provision announced in September 2025 and higher R&D costs. EBIT growth was also impacted by an impairment loss from one of the MAGLi projects recognized in the third quarter of 2024. Total amortization, depreciation and impairment losses reached DKK 426 million representing a decrease of -6% CER (-9% DKK) mainly driven by lower product rights amortization. Amortization of product rights amounted to DKK 317 million corresponding to a decrease of -9% CER (-12% DKK). Amortization of other intangible assets corresponded to DKK 15 million in the third quarter of 2025. Depreciation amounted to DKK 94 million, corresponding to an increase of +2% CER (+2% DKK). Adjusted EBITDA reached DKK 2,051 million representing an increase of +16% CER (+12% DKK) reflecting the strong revenue growth driven by performance of strategic brands, which offsets the continued investment in the R&D pipeline and the commercial investments to support the growth of strategic brands. The adjusted EBITDA margin was 32.7% representing an increase of 0.7 percentage points. NET PROFIT AND ADJUSTED EPS Net financial (income)/expenses reached DKK 219 million driven by unfavorable foreign exchange due to the depreciation of USD and higher interest costs related to financial debts. The effective tax rate for the third quarter of 2025 was 22.0%. Net profit reached DKK 1,101 million corresponding to an increase of +42%. Adjusted net profit reached DKK 1,429 million, representing an increase of +11%, reflecting the EBIT development including unfavorable foreign exchange and higher interest costs related to financial debts. 2.8 OUTLOOK Financial guidance 2025 On 11 November 2025, Lundbeck announced an increase in its full-year revenue and adjusted EBITDA guidance at constant exchange rates (CER). Based on the strong performance of Vyepti® and Rexulti®, revenue is now expected to grow by 13% to 14% at CER (previously 11% to 13%) compared to the prior year's revenue excluding hedging effects. The upgrade reflects higher-than-expected demand driven by additional investments in these two strategic brands. Our expectations for adjusted EBITDA growth have also been raised, primarily driven by the higher contribution from Vyepti® and Rexulti®, as well as effective execution of Lundbeck's capital reallocation program. Lundbeck now expects adjusted EBITDA growth of 22% to 25% at CER (previously 16% to 21%) in 2025. The updated guidance continues to include the expected initial impact from loss of exclusivity (LoE) on Brintellix® in Canada, while the generic entry for Abilify Maintena® in Europe now is expected in 2026. Brintellix®/Trintellix® will continue to be affected by the modified collaboration with Takeda in the U.S. as well as the generic entry in Canada in June 2025. The underlying erosion of mature brands is expected to continue, thereby expected to show a mid-single-digit revenue decline. Given the current exchange rates against the Danish krone, sales growth reported in DKK is expected to be approximately 1.5 percentage lower to CER. As a central component of our Focused Innovator strategy, Lundbeck remains committed to invest in research and development, advancing both our late-stage and early development pipeline. In 2025, we anticipate an acceleration of investments in R&D, including the integration of Longboard and the initiated phase III clinical trials of bexicaserin and amlenetug. Lundbeck anticipates increasing R&D investments up to DKK 5.0 billion in 2025, compared to DKK 3,954 million in 2024 (excluding the MAGLi impairment loss communicated in October 2024). This significant increase in R&D investments is financed by the dedicated efforts towards capital reallocation initiatives across our full value chain, as well as additional contributions from accelerated revenue growth. Lundbeck's capital reallocation program has accelerated ahead of expectations in the first nine months of 2025. Given the current exchange rates against the Danish krone, growth in adjusted EBITDA reported in DKK is expected to be around 1 percentage points lower than at CER. The 2025 guidance underscores Lundbeck's ability and focus to sustain profitability while expanding and progressing the pipeline. Effects from hedging are expected to reach a gain around DKK 300 million compared to a loss of DKK 52 million for 2024. Depreciation, amortization, and impairment losses are expected to be around 1.8 billion, compared to DKK 1,876 million in 2024. Lundbeck anticipates financial items (net) to result in a loss of approximately 750 million following the acquisition of Longboard in 2024, compared to an income of DKK 449 million in 2024. The effective tax rate for 2025 is expected to range between 21% and 24%, compared to 15.5% in 2024. This guidance assumes no significant changes in the global or regional macroeconomic and political environment that would impact Lundbeck's business, including major healthcare reforms, legislative changes, or legal outcomes. It also assumes stable currency exchange rates from current level, particularly the U.S. dollar against the Danish krone, and reflects current estimates of gross-to-net developments in U.S. sales. The guidance excludes potential effects from new significant business development transactions, significant impairments of intangible assets in 2025, and any shifts in trade policy, such as pharmaceutical tariffs or further healthcare reforms. 1 Total revenue at CER for the period divided by total revenue (IFRS) before hedging for the comparative period. 1 Adjusted EBITDA at CER for the period divided by adjusted EBITDA before hedging for the comparative period. Mid-term targets Based on organic growth, the company expects revenue to show a mid-single digit compound annual growth rate (CAGR) over the mid-term period (2023 to 2027). The company maintains its target for adjusted EBITDA-margin of more than 30% at the end of the mid-term period in 2027, to account for the impact of the Longboard acquisition, progression of the pipeline and excluding any business development activities. Lundbeck plans to ensure appropriate investments in R&D and prelaunch activities for bexicaserin and amlenetug following the successful closure of the acquisition of Longboard. Several R&D projects are expected to mature in the period, including projects such as Lu AF28996 (D1/D2 agonist). Moreover, in accordance with the Focused Innovator strategy, Lundbeck has initiated its most significant capital reallocation program in its history to sustain the company's growth with increased focus on innovation. The mid-term targets exclude potential effects from new significant business development transactions, significant impairments of intangible assets in 2025, and any shifts in trade policy, such as pharmaceutical tariffs or further healthcare reforms. Forward-looking statements Forward-looking statements are subject to risks, uncertainties, and inaccurate assumptions. This may cause actual results to differ materially from expectations. Various factors may affect future results, including interest rates and exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, governance-mandated or market-driven price decreases for products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws, and unexpected growth in expenses. 2.9 LUNDBECK'S DEVELOPMENT PORTFOLIO Lundbeck is developing several new and promising medicines for the treatment of brain diseases. The pipeline developments are summarized below. 1 CGRP: Calcitonin gene-related peptide. 2 Two phase III clinical studies completed, supporting registration in Asia, including China and Japan: SUNRISE, and SUNSET trials. 3 PACAP: Pituitary adenylate cyclase activating peptide. 4 ACTH: Adrenocorticotropic hormone. Two phase Ib trials are currently ongoing in Congenital Adrenal Hyperplasia and Cushing's Disease. For technical reasons, officially categorized as a phase II trial to adhere to local requirements in some countries. 5 Acts as a partial agonist at 5-HT1A and dopamine D2 receptors at similar potency, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors. 6 Complete Response Letter Received 20 September 2025. 7 Post-traumatic stress disorder. 8 The DEEp clinical program consists of two-phase III trials in Dravet Syndrome (DEEpSEA) and DEEs and Lennox-Gastaut Syndrome (DEEpOCEAN). 9 Monoacylglycerol lipase inhibitor ("MAGLipase"). 10 Dopamine receptor D1 and D2. 11 Phase Ib trial ongoing in TED (Thyroid Eye Disease). Key developments in the quarter Circuitry / neuronal biology Brexpiprazole in Post-Traumatic Stress Disorder (PTSD) On 20 September 2025, a Complete Response Letter (CRL) was issued by the FDA regarding the sNDA for use of Rexulti® (brexpiprazole) in combination with sertraline as a treatment of adults with PTSD. The CRL states that the FDA has completed their review but cannot approve the application in the current form, as the application does not provide substantial evidence of effectiveness to support the approval. This follows the review of the sNDA for Rexulti (brexpiprazole) in combination with sertraline as a potential treatment for PTSD by the FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) in July 2025. Following a thorough review of the data, the committee voted 1–10, concluding that the efficacy of brexpiprazole, when initiated concurrently with sertraline, has not been established for the treatment of PTSD based on the evidence presented. Lundbeck filed a supplemental new drug application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with PTSD in June 2024. The sNDA is based on data from three randomized clinical trials evaluating the safety and efficacy of brexpiprazole in combination with sertraline in adult patients with PTSD, namely the phase II trial 061 and the two phase III trials 071 and 072. The primary endpoint for all three trials was the change from week 1 to week 10 in the Clinician-Administered PTSD Scale (CAPS-5) total score for brexpiprazole and sertraline combination therapy versus sertraline plus placebo in patients diagnosed with PTSD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). The trials were randomized, double blind, and active-controlled, and trials 061 and 071 were flexible-dose trials, while trial 072 was a fixed-dose trial. In both trials 061 and 071, brexpiprazole in combination with sertraline was associated with a statistically significant reduction (p<0.05) in PTSD symptoms compared to sertraline plus placebo, as measured by the change in the CAPS-5 total score from week 1 to week 10 (primary end-point). In trial 072, while the primary endpoint was not met, reductions in PTSD symptom severity with brexpiprazole in combination with sertraline were consistent with trials 061 and 071. Across the three randomized trials, the combination of brexpiprazole and sertraline in adult patients with PTSD was generally well-tolerated, and no new safety observations were identified. Bexicaserin in Developmental and Epileptic Encephalopathies (DEEs) – Phase III In October 2025 bexicaserin was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) in China for the treatment of seizures associated with DEEs, highlighting bexicaserin's potential to address significant unmet medical needs of patients and their caregivers living with DEEs in China. Bexicaserin has shown encouraging anti-seizure effects to date in preclinical and clinical studies, with its next-generation super agonist mechanism specifically targeting 5-HT2C receptors, supporting bexicaserin's potential to offer a highly differentiated and best-in-class profile, and emphasized by having U.S. FDA Break-Through Designation, while being afforded Orphan Drug designation in both Dravet Syndrome and Lennox-Gastaut Syndrome in the U.S. In 2024, Lundbeck acquired Longboard with the lead asset bexicaserin which holds blockbuster potential. A global phase III program (DEEp) has been initiated, evaluating bexicaserin for the treatment of seizures associated with Dravet Syndrome in the DEEp SEA trial, as well as seizures associated with Developmental and Epileptic Encephalopathies (DEEs), including Lennox-Gastaut Syndrome (LGS) in the DEEp Ocean trial. 2.10 SUSTAINABILITY UPDATE Lundbeck's sustainability strategy aims to ensure that we mitigate our most significant sustainability risks and adverse impacts, while acting on the opportunities to make a positive impact on the environment, for patients, and the communities where we operate. This sustainability update presents progress on key sustainability matters and metrics. ENVIRONMENTAL PERFORMANCE 1 See Annual Report 2024 for accounting policies and definitions. 2 All comparative figures were updated to reflect the implementation of Corporate Sustainability Reporting Directive in 2024, e.g., inclusion of emissions from affiliates. This is reflected in the updated accounting policy. Climate Action Lundbeck is committed to protecting the environment and believes that a healthy environment is a precondition for good health and wellbeing. Lundbeck has net-zero targets to reduce its total carbon footprint across its own operations, supply chain, and distribution. In the first nine months of 2025, Scope 1 + 2 GHG emissions decreased by 11%, compared to the first nine months of 2024. Scope 1 GHG emissions decreased by 8%, compared with the same period last year, primarily reflecting the increasing share of electric and hybrid vehicles in the company's fleet. Emissions from production sites and affiliates remained broadly stable. Scope 2 GHG emissions decreased by 20%, mainly due to the acquisition of Guarantees of Origin electricity certificates for the Valbonne site and EU sales affiliates, along with the general decarbonization of electricity grids. Lundbeck remains on track to meet its climate targets for Scope 1 + 2 GHG emissions, as the planned actions in the low carbon transition plan will come into effect. Other topics In 2022, traces of PFAS (per- and polyfluoroalkyl substances) were found at Lundbeck's Lumsås production facility. The pollution stems from the use of fire-retardant foam containing the PFAS type PFOS (perfluorooctane sulfonate) until 2011, in compliance with national fire safety and environmental regulations at the time. Lundbeck switched to a supply of PFOS-free fire-retardant foam. Since the pollution was detected, Lundbeck has been engaged in a close and recurring dialogue with the Danish Environmental Protection Agency (EPA) and local authorities regarding the mapping and remediation possibilities of the pollution. Lundbeck continues this close dialogue with the authorities and affected stakeholders and is also conducting additional testing to determine more precisely the extent of the pollution. Lundbeck has received orders from the EPA requiring the installation of a pump and treat solution for subsoil water. The implementation work has been initiated, and it is estimated that the pump and treat solution will be operational in the end of 2025. SOCIAL PERFORMANCE 1 New accounting policy: Upper management includes all members of Executive Leadership Team (ELT) who report to the Board of Directors, as stated in their employment contract, which corresponds to layer 1 as defined in the Gender Balance Act. Additionally, it includes employees who report directly to a member of ELT and hold formal people management responsibilities. These individuals correspond to layer 2 in the Gender Balance Act. 2 9M 2024 data has been restated following an update to the accounting policy, which affected the classification of upper management roles. For previously published Corporate Releases in 2024, data was reported for senior management and is therefore not fully comparable to the figures reported in this release. 3 Variation in percentage points. Inclusion, Diversity and Equity Lundbeck embraces the unique perspectives and experiences of each individual enhancing our ability to address complex challenges and driving our commitment to improving brain health. Our ethos and culture foster an environment which fuels creativity, enhances decision-making, and drives innovation where every colleague is empowered to contribute, collaborate, and bring perspectives that reflect the communities we serve every day. Lundbeck recognizes the target required in accordance with the Danish Gender Balance Act to reach and maintain gender balance in upper management. In the first nine months of 2025, the underrepresented gender balance in upper management decreased to 40.7% female, compared to 42.6% in the first nine months of 2024, a decrease of 1.9 percentage points. The change primarily reflects organizational adjustments and external recruitments during the period, where a higher proportion of leadership appointments were male, leading to a slight decline in the overall share of the underrepresented gender. Lundbeck's commitment to a diverse leadership pipeline is reinforced through initiatives such as the global Enterprise Leadership Program launched in the third quarter of 2025. By combining leadership development with an unbiased recruitment approach, Lundbeck strengthens succession planning and supports progress toward gender balance targets. HEALTH AND SAFETY 1 See Annual Report 2024 for accounting policies and definitions. Health and Safety The health and safety of our workplace is a priority at Lundbeck, and we are committed to fostering a safety culture that minimizes work-related accidents. To support this, we closely monitor the frequency, number, and severity of incidents, enabling us to establish action plans and set ambitious safety objectives. In the first nine months of 2025, the Lost Time Incident Rate (LTIR) decreased to 1.9, compared to 3.1 in the first nine months of 2024. The positive development represents a -39% overall reduction in accidents resulting in absence compared to last year. The improvement reflects the effectiveness of site-specific safety initiatives, particularly in Valbonne, France where ergonomic improvements have had a significant impact. Additionally, the global prevention campaign Take Care, launched in early 2025, continues to strengthen safety awareness and promote safer work practices by focusing on a dedicated safety topic each month. Other topics In connection with the announced commercial restructuring on 9 September 2025, Lundbeck has conducted sustainability due diligence as part of the selection of the new commercial partners. Lundbeck has also carried out impact assessments and put action plans in place to mitigate potential negative impact on patients and people in the countries that are in scope of this change. 2.11 GENERAL CORPORATE MATTERS Pending legal proceedings Lundbeck is involved in several legal proceedings, including patent disputes and environmental matters, the most significant of which are described below. Some of these involve significant amounts and are subject to considerable uncertainty. Management continuously assesses the risks associated with the legal proceedings, and their likely outcome. Management is of the opinion that, apart from items recognized in the financial statements, the outcome of these legal proceedings and disputes are not probable or cannot be reliably estimated in terms of amount or timing. Further, ongoing proceedings may develop over time, and new proceedings may occur, in a way which could have a material impact on the Group's financial position and/or cash flows. In June 2013, Lundbeck received the European Commission's decision that agreements concluded with four generic competitors concerning citalopram violated competition law. The decision included fining Lundbeck EUR 93.8 million (approximately DKK 700 million). Lundbeck paid and expensed the fine in the third quarter of 2013. In March 2021, the European Court of Justice rejected Lundbeck's final appeal of the European Commission's decision. So-called "follow-on claims" for reimbursement of alleged losses, resulting from violation of competition law, often arise when decisions and fines issued by the European Commission are upheld by the European Court of Justice. The below mentioned "follow-on claims" are ongoing or threatened. Lundbeck disagrees with all claims and intends to defend itself against them. At the end of first quarter 2023, the UK health authorities served their claim form on Lundbeck and several generic companies, and Lundbeck filed its defense in the third quarter of 2023. The hearing on whether the claim is time-barred was held in the second quarter of 2024 and the Competition Appeal Tribunal has subsequently issued a decision in favor of the UK health authorities. Lundbeck was granted permission to appeal the decision to the Court of Appeal, and the Court of Appeal issued a decision in favor of the UK health authorities in the second quarter of 2025. Lundbeck has filed an application for permission to appeal the time-barring decision to the Supreme Court with the Courts of Appeal. In late October 2021, Lundbeck received a writ of summons from a German health care company claiming compensation for an alleged loss of profit plus interest payments, allegedly resulting from Lundbeck's conclusion of agreements with two of the four generic competitors, which were comprised by the EU Court of Justice ruling. Lundbeck filed its first defense in May 2022, and the parties have subsequently exchanged additional pleadings. The first instance court hearing was held in the second quarter of 2024, and Lundbeck currently expects a first instance court ruling in 2025 or 2026. The first instance court ruling may be appealed, and it make take several years before a final conclusion is reached by the German courts. In October 2024, Lundbeck received a claim form from the health authority in one of the regions (comunidades autónomas) in Spain and in November 2024 Lundbeck filed its defense. The first instance court hearing was held in the second quarter of 2025, and a first instance ruling was issued in the third quarter of 2025. The court dismissed the health authority's claim based on time-barring. The health authority has appealed the decision. Lundbeck has been informed about potential claims in several European countries, however, it is still uncertain whether the potential claims will be actively pursued. In Canada, Lundbeck is involved in two product liability class-action lawsuits relating to Cipralex®/Celexa® (one case alleging various Celexa-induced birth defects and one case against several SSRI manufacturers (incl. Lundbeck) alleging that SSRI (Celexa®/Lexapro®) induces autism birth defect), three relating to Abilify Maintena® (alleging i.a. failure to warn about compulsive behavior side effects) and one relating to Rexulti® (also alleging i.a. failure to warn about compulsive behavior side effects). Lundbeck strongly disagrees with the claims. The Celexa birth defect litigation has been discontinued in Quebec (already approved by court) and Ontario (court approval of the discontinuance in Ontario is expected in 2025). A settlement agreement has been signed by the parties in the Abilify Maintena® cases and has been approved by the courts in Quebec and Ontario. In the Rexulti® matter, a settlement agreement was signed by the parties on 13 June 2025, and court approval of the settlement is expected in the fourth quarter of 2025. Lundbeck received a Civil Investigative Demand ("CID") from the U.S. Department of Justice ("DOJ") in March 2020. The CID seeks information regarding the sales, marketing, and promotion (including the promotional speaker program) of Trintellix®. Lundbeck is cooperating with the DOJ. Otsuka and Lundbeck have received paragraph IV certifications from Sun Pharma, Apotex and Alvogen with respect to certain of the patents listed for Abilify Maintena® in the U.S. and commenced patent infringement proceedings against all three companies. The FDA will stay approval to Sun, Apotex and Alvogen until 30 months from receipt of the respective paragraph IV certifications or a court decision in Sun's and/or Apotex' favor. In June 2022 in the U.S., several entities, created for the purpose of receiving assignment of claims from payors providing health insurance coverage pursuant to Medicare Parts C and D and Medicaid, filed a complaint against Lundbeck and others. The complaint alleges that Lundbeck and the other defendants conspired to increase the unit price and quantity dispensed of Xenazine®. The case was dismissed with prejudice earlier in 2023 and is currently under appeal. In June 2023 in the U.S., Humana Inc., an insurer, filed a complaint against Lundbeck U.S. legal entities. The complaint alleges that Lundbeck engaged in an illegal kickback scheme to increase the sales and sale price of Lundbeck's Xenazine®. The complaint alleges that Lundbeck's activities targeted Humana Inc. and other private Medicare insurers who were forced to bear the costs of the alleged illegally subsidized drug sales. Lundbeck denies the allegations in the complaint and intends to defend itself. STATEMENT OF THE BOARD OF DIRECTORS AND THE REGISTERED EXECUTIVE LEADERSHIP TEAM The Board of Directors and the Registered Executive Leadership Team have discussed and adopted the financial report of H. Lundbeck A/S for the period 1 January to 30 September 2025. The financial report is presented in accordance with IAS 34 Interim Financial Reporting, as adopted by the EU and additional Danish disclosure requirements for interim financial reports of listed companies. We consider the accounting policies applied to be appropriate. Accordingly, the financial report gives a true and fair view of the Group's assets, liabilities and financial position as of 30 September 2025, and of the results of the Group's operations and cash flows for the period, which ended on 30 September 2025. In our opinion, the Management's Review (pages 6-21) gives a true and fair view of activity developments, the Group's general financial position and the results for the period. It also gives a fair view of the significant risks and uncertainty factors that may affect the Group relative to the disclosures in the Annual Report 2024. The financial report has not been subject to audit or reviewed by the company's independent auditors. Valby, 11 November 2025 Registered Executive Leadership Team Board of Directors 3 CONDENSED FINANCIAL STATEMENTS CONDENSED STATEMENT OF PROFIT OR LOSS STATEMENT OF COMPREHENSIVE INCOME CONDENSED STATEMENT OF FINANCIAL POSITION STATEMENT OF CHANGES IN EQUITY CONDENSED STATEMENT OF CASH FLOWS STATEMENT OF PROFIT OR LOSS – ADJUSTED EBITDA RECONCILIATION (9M AND Q3) 4 NOTES 4.1 BASIS OF PREPARATION The interim condensed consolidated financial statements for the first nine months ended 30 September 2025, have been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the EU and additional Danish disclosure requirements for interim financial reporting of listed companies. The interim condensed consolidated financial statements do not include all the information and disclosures required in the annual financial statements and should be read in conjunction with the Group's annual consolidated financial statements at 31 December 2024, published 5 February 2025. The accounting policies, judgements and significant estimates are consistent with those applied in the Annual Report 2024. Further IAS 34 disclosure requirements for interim financial reporting are included in section 2, Business Performance. For disclosures regarding revenue and segment information see section 2.1 Revenue by product and section 2.2 Revenue by geographical area and for disclosures regarding pending legal proceedings (contingent liabilities) see section 2.11 General corporate matters. As part of the acquisition of Longboard (Longboard Pharmaceuticals, Inc) on 2 December 2024, Lundbeck is finalizing the purchase price allocation assessment, which is expected to be reflected in our consolidated financial statements 2025 in line with the IFRS requirements. A number of new amendments came into effect from 1 January 2025. The Group did not have to change its accounting policies or make retrospective adjustments as a result of adopting these amended standards. 4.2 FAIR VALUE MEASUREMENT Financial assets and financial liabilities measured or disclosed at fair value 1 Measured at fair value 2 Disclosed at fair value The fair value of listed securities is based on publicly quoted prices of the invested assets. The fair value of derivatives is calculated by applying recognized measurement techniques, whereby assumptions are based on the market conditions prevailing at the balance sheet date. The fair value of contingent consideration is calculated as the discounted cash outflows (DCF method) from future milestone payments, taking probability of success into consideration. The fair value of other financial assets is calculated through the financial performance of the market inputs (i.e. interest s) and other market conditions prevailing at the balance sheet date. The carrying amount of bank and bond debt is believed to be equal to or close to fair value as the interest is variable for these instruments. 4.3 ADJUSTED EBITDA Adjusted EBITDA is the main performance indicator measuring ongoing operational profitability and is used internally and externally. To permit a better understanding of the underlying operational performance, the operating result is adjusted to exclude depreciation and amortization, impairment losses and reversals of impairment losses, as well as adjustments restricted to the following categories: (i) Integration expenses, (ii) Restructuring expenses, (iii) Gains/losses on divestment of businesses, (iv) Acquisition expenses, (v) Other adjustments. Adjusted EBITDA, adjusted gross profit, adjusted net profit and adjusted EPS are non-IFRS performance measures. FINANCIAL CALENDAR 2026 Lundbeck contacts About H. Lundbeck A/S Lundbeck is a biopharmaceutical company focused exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole. Lundbeck has approximately 5,700 employees in more than 50 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site  and connect with us via LinkedIn. Safe Harbor/Forward-Looking Statements This corporate release contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance. Forward looking statements include, without limitation, any statement that may predict, forecast, indicate or imply future results, performance or achievements, and may contain words like "believe", "anticipate", "expect", "estimate", "intend", "plan", "project", "will be", "will continue", "will result", "could", "may", "might", or any variations of such words or other words with similar meanings. All statements other than statements of historical facts included in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to our products), are forward looking statements. Such forward looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward looking statements. Factors that may affect future results include, among others, interest rate and currency exchange rate fluctuations, delay or failure of development projects, production or distribution problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses. The forward-looking statements in this document and oral presentations made on behalf of Lundbeck speak only as at the date of this document. Lundbeck does not undertake any obligation to update or revise forward-looking statements in this presentation or oral presentations made on behalf of Lundbeck, nor to confirm such statements to reflect subsequent events or circumstances after the date of the presentation or in relation to actual results, unless otherwise required by applicable law or applicable stock exchange regulations. [1] Change at CER (Constant Exchange Rates) does not include effects from hedging. [2] Abilify long-acting injectable (LAI) franchise comprises following products: Abilify Maintena®, Abilify Maintena® 960 mg and Abilify Asimtufii® [3] EBITDA refers to Earnings Before Interest, Taxes, Depreciation and Amortization, including impairment losses. Adjusted EBITDA is defined as EBITDA adjusted by certain items, for details see note 4.3 Adjusted EBITDA. [4] Demand in the U.S. is based on prescription level data, thereby constituting patient demand. Demand in Europe and International Operations is based on volume sell-in to pharmacies and thereby considered a proxy for patient demand. CONTACT: H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Denmark +45 3630 1311 [email protected] This information was brought to you by Cision The following files are available for download: SOURCE H. Lundbeck A/S 21% more press release views with Request a Demo