Vyepti and Rexulti power Lundbeck (CPH: LUN) to raise 2025 guidance after 22% adjusted EBITDA surge

Danish pharma company H. Lundbeck A/S (CPH: LUN) has upgraded its full-year 2025 revenue and earnings guidance following a strong third quarter marked by double-digit growth in both top-line and profitability metrics. For the nine months ended September 30, 2025, Lundbeck reported revenue of DKK 18,537 million, reflecting a 14 percent increase at constant exchange rates. Adjusted EBITDA surged by 22 percent at constant exchange rates to DKK 6,272 million, supported primarily by continued outperformance of its strategic brands Vyepti and Rexulti.

The upgraded guidance now calls for full-year 2025 revenue growth between 13 percent and 14 percent at constant exchange rates, up from the previous 11 percent to 13 percent range. Adjusted EBITDA is now expected to grow by 22 percent to 25 percent, an increase from the earlier projection of 16 percent to 21 percent. The revision reflects higher-than-anticipated demand for key products, particularly in the United States, where strategic brands like Vyepti and Rexulti have gained considerable market share across targeted indications.

The United States remains Lundbeck’s largest and fastest-growing geography, delivering DKK 9,955 million in revenue for the nine-month period, up 22 percent at constant exchange rates. Europe also posted strong performance with 13 percent growth at constant exchange rates, while international operations were stable overall.

How are Vyepti and Rexulti transforming Lundbeck’s branded portfolio performance in 2025?

Strategic brands accounted for 77 percent of total company revenue in the first nine months of the year, with collective growth of 20 percent at constant exchange rates to DKK 14,260 million. This segment includes Rexulti, Vyepti, Brintellix (also marketed as Trintellix), and the Abilify long-acting injectable franchise.

Vyepti (eptinezumab), Lundbeck’s flagship intravenous migraine prevention therapy, grew by 57 percent at constant exchange rates to DKK 3,254 million. The product now commands 11.2 percent market share within the anti-CGRP category in the United States and continues to show strong global momentum. The performance was bolstered by a 47 percent increase in total prescriptions, higher persistency rates, and increased usage of the 300mg dosage. Key international markets also recorded sharp growth, with Italy up 116 percent, France up 96 percent, and Spain up 73 percent.

Rexulti (brexpiprazole) contributed DKK 4,695 million in revenue, an increase of 26 percent at constant exchange rates. In the United States, the product gained traction in both major depressive disorder and agitation associated with dementia due to Alzheimer’s disease. Total prescriptions grew by 23.5 percent year-on-year. A growing portion of U.S. sales is now driven by Alzheimer’s-related prescriptions, which accounted for 23.4 percent of Rexulti’s U.S. prescriptions in July, compared to 17.8 percent in the same month of the previous year.

Brintellix/Trintellix saw a marginal decline of 1 percent at constant exchange rates, coming in at DKK 3,453 million. While performance in Europe remained strong with gains in market share across Italy, France, and Spain, the overall decline was driven by the U.S. transition of marketing responsibilities to Takeda and by earlier-than-expected generic competition in Canada and China. International operations experienced notable volume erosion due to inventory reductions by wholesalers in anticipation of further generic entry.

The Abilify long-acting injectable franchise grew by 11 percent at constant exchange rates to DKK 2,858 million. The franchise continues to expand its reach in Europe, particularly following the rollout of Abilify Maintena 960mg. In Spain, France, and Italy, the brand has achieved over 30 percent share within the LAI antipsychotics category. In the United States, growth was fueled by Abilify Asimtufii, which gained traction through new patient starts sourced from oral formulations and competing injectables.

How is Lundbeck’s commercial strategy evolving and what are the implications for profitability?

Lundbeck is in the process of implementing a new commercial operating model across 27 international markets, transitioning from direct sales to a partner-led model. The goal is to reallocate capital toward high-growth opportunities and pipeline development, while maintaining access for patients. Key distribution partners in this effort include Swixx Group, Zuellig Pharma, and NewBridge Pharmaceuticals. The transition is expected to be completed by December 2025.

This model shift is already contributing to operating margin improvements. Sales and distribution expenses declined to 30.8 percent of revenue, down from 34.9 percent in the prior-year period. Administrative costs remained flat year-on-year at DKK 1,077 million, while research and development costs rose modestly to DKK 3,440 million. Adjusted for the prior-year impairment related to a discontinued MAGLi program, R&D expenses rose 22 percent at constant exchange rates, reflecting investments in late-stage programs.

The adjusted EBITDA margin improved by 2.2 percentage points to reach 33.8 percent. Operating cash flow stood at DKK 4.56 billion, while free cash flow remained steady at DKK 4.15 billion. However, net cash flow was negative due to Longboard acquisition-related debt repayments and higher dividend payouts. Net debt at the end of the period stood at DKK 9.09 billion, compared to a net cash position of DKK 3.98 billion a year earlier.

What pipeline advancements are positioning Lundbeck for long-term growth in neuroscience?

Lundbeck continues to progress multiple late-stage and near-commercial neuroscience assets. In China, the investigational compound bexicaserin received Breakthrough Therapy Designation for the treatment of seizures associated with Developmental and Epileptic Encephalopathies. Lundbeck presented new data on the asset at the 36th International Epilepsy Congress in Lisbon.

Amlenetug, a novel anti-α-synuclein antibody for Multiple System Atrophy, remains in Phase III development with strong enrollment reported. Vyepti received manufacturing approval for its CHO cell line process from the U.S. Food and Drug Administration, which will improve scalability and cost efficiency for global supply.

In migraine and cluster headache, Lundbeck is advancing Lu AG09222 (anti-PACAP) through Phase IIb trials and has entered preclinical development for a dual VIP-PACAP molecule.

These programs underscore the company’s ambition to expand from its historical psychiatry base into specialty neurology and neuro-rare indications. As of 2025, five to six mid-to-late-stage assets are expected to progress toward regulatory inflection, providing potential upside to Lundbeck’s 2027 strategic targets.

What should investors monitor in the coming quarters as Lundbeck enters a key inflection phase?

Investor sentiment around H. Lundbeck A/S remains constructive, especially following the company’s consistent track record of exceeding quarterly guidance. Adjusted earnings per share for the nine-month period rose by 10 percent to DKK 4.32. Equity analysts and institutional investors are expected to track a few key developments going into 2026.

These include continued performance of Vyepti in Europe and Asia, progression of the bexicaserin and amlenetug programs, and impact of cost synergies from the commercial partnership transition. In the U.S., any regulatory or payer updates around Medicare Part D reforms and their impact on net pricing for Abilify or Trintellix will also be under scrutiny.

The company’s capital reallocation strategy and debt profile, especially following the Longboard acquisition, will remain key discussion points as management moves toward 2027 mid-term objectives. Execution on pipeline, regional access, and brand-level innovation will determine whether Lundbeck can sustain its current growth trajectory beyond its core franchises.

What are the key takeaways from Lundbeck’s upgraded FY25 guidance and Q3 2025 results?

• Lundbeck reported 14% year-on-year revenue growth at constant exchange rates for the first nine months of 2025, reaching DKK 18,537 million.
• Adjusted EBITDA rose 22% at constant exchange rates to DKK 6,272 million, supported by strong performance in strategic brands and cost discipline.
• Vyepti revenue grew 57%, driven by 47% TRx growth in the United States and significant international expansion in Italy, France, Spain, and Canada.
• Rexulti posted 26% revenue growth, with Alzheimer’s-related prescriptions rising to 23.4% of total U.S. volume by July 2025.
• The Abilify LAI franchise expanded by 11%, bolstered by the rollout of Abilify Maintena 960mg and growing adoption of Abilify Asimtufii in the U.S.
• Brintellix revenue declined 1% due to earlier-than-expected generic pressure in Canada and China, despite strong European growth.
• Lundbeck raised full-year 2025 guidance: revenue growth now expected at 13%–14% (vs 11%–13% prior), and adjusted EBITDA at 22%–25% (vs 16%–21% prior).
• Sales and distribution costs fell to 30.8% of revenue, reflecting margin leverage from the shift to a partner-led commercial model in 27 markets.
• Adjusted R&D spending rose 22%, funding late-stage programs including bexicaserin (BTD in China) and amlenetug (Phase III for Multiple System Atrophy).
• Net profit grew 26% to DKK 3,219 million; adjusted EPS rose 10% to DKK 4.32.
• Net debt increased to DKK 9.1 billion due to the Longboard acquisition and bond refinancing, while free cash flow remained stable at DKK 4.15 billion.
• Investors are watching for continued momentum in Vyepti and Rexulti, execution of the new commercial model, and late-stage pipeline progression into 2026.