Lundbeck Raises Peak Sales Estimate for Migraine Drug Vyepti, Remains Optimistic on Rexulti's Potential

Danish pharmaceutical company Lundbeck has increased its peak sales projection for its CGRP migraine drug Vyepti in the U.S. market, following impressive year-over-year growth. The company also maintains a positive outlook for its antipsychotic drug Rexulti, despite recent setbacks in expanding its indications.

Vyepti's Strong Performance Drives Increased Sales Forecast

Lundbeck has raised its U.S. peak sales estimate for Vyepti to over $1.1 billion, a $100 million increase from previous guidance. This adjustment comes after the drug reported a 54% year-over-year sales increase in the U.S., reaching 1.83 billion Danish kroner ($287 million) in the second quarter, accounting for 87% of the drug's global total.

Vyepti, the only infused CGRP medication in a market dominated by oral pills and subcutaneous injectables, has shown remarkable growth since its FDA approval in 2020 for migraine prevention. As of June, it was the fastest-growing anti-CGRP agent in the U.S., with a 50% year-over-year demand growth compared to the overall market's 20%.

Tom Gibbs, head of Lundbeck's U.S. operations, attributed this success to investments in healthcare provider engagement, patient activation, and support services. "We continue to see accelerating demand by driving depth and breadth of prescribing of Vyepti and continued positive momentum in new patient starts supported by a high written-to-infusion conversion ratio and best-in-class patient persistency," Gibbs stated during an investor call.

Rexulti's Mixed Fortunes: Strong Sales Amid Regulatory Challenges

Rexulti, Lundbeck's Otsuka-partnered antipsychotic, delivered strong sales growth of 28% worldwide, reaching revenue of 3 billion kroner in the second quarter. This growth has been primarily driven by its use in treating Alzheimer's disease agitation.

However, Rexulti recently faced a setback in its bid to expand indications. An FDA advisory committee voted overwhelmingly against approving the drug's use alongside sertraline for post-traumatic stress disorder (PTSD). The negative vote stemmed from one of two phase 3 trials failing to meet statistical significance.

Despite this setback, Lundbeck remains optimistic about Rexulti's potential in PTSD treatment. Johan Luthman, Lundbeck's R&D chief, noted the positive sentiment among some advisory committee members and highlighted the high medical need in PTSD, where the last FDA approval was 23 years ago.

Financial Outlook and Strategic Initiatives

Buoyed by the strong performance of Vyepti and Rexulti, Lundbeck has again raised its full-year growth expectations to 11% to 13% at constant currencies, up from the previous projection of 8% to 11%. For the first half of the year, Lundbeck's total revenue increased by 14% to 12.3 billion kroner ($1.9 billion).

The company's growth strategy includes a capital reallocation initiative launched in 2023, aimed at channeling resources to strategic brands like Vyepti and Rexulti, as well as key R&D projects. As part of this initiative, Lundbeck transferred U.S. rights and promotion responsibility for the depression drug Trintellix to its partner Takeda last year.

CFO Joerg Hornstein reported that the company now expects to redeploy about 1.3 billion to 1.5 billion Danish kroner by 2027, an increase from the previous range of 1 billion to 1.3 billion kroner. This adjustment is partly due to changes in Lundbeck's commercial model following the Trintellix divestiture.