With an FDA approval last February, Lundbeck’s Vyepti, a CGRP inhibitor infusion, launched right into the pandemic and a migraine market that’s now filled with injectables and oral options by Big Pharma players. To fuel Vyepti’s future growth, the Danish company is cutting back elsewhere.
Lundbeck plans to remove 300 positions as part of a “fine-tuning” based on lessons from the pandemic, Chief Financial Officer Anders Götzsche told investors on a third-quarter earnings call Wednesday. Some of the cuts have already been made, and the company expects to record a restructuring cost of between 100 million Danish krone ($15.4 million) to 200 million Danish krone in the fourth quarter, he said.
Part of the savings will go toward investing in Vyepti, Götzsche said. The move comes as Lundbeck expects Vyepti rollout in 15 additional territories between this and next year, including an anticipated European Medicines Agency go-ahead in the first quarter of 2022. Vyepti marks the first drug for which Lundbeck is handling global commercialization by itself.
“We have evaluated how should our cost structure be going forward, how is the most optimal model to drive sales and profitability because we’re extremely focused on profitable sales,” Götzsche said.
The overhaul involves terminating about 100 people in the U.S. and 50 in Canada, and the company has closed its affiliate in India, which Götzsche said wasn’t making any profit. At the same time, Lundbeck plans to hire around 100 to 200 additional Vyepti sales reps for the European market in the next few years, he added.
To hear Lundbeck CEO Deborah Dunsire tell it, Vyepti is having a moment. Demand for Vyepti in the U.S. jumped 43% in the third quarter over the second, as sales climbed to 151 million Danish krone ($23.2 million) from 101 million Danish krone ($15.6 million), she said on the call.
Vyepti is expanding its reach in doctors’ offices and some “alternative sites of care,” Dunsire said. The chief executive also attributed the growth to continued penetration of high-volume prescribing doctors in migraine.
In addition to boosting its sales presence, Lundbeck is also investing in Vyepti R&D projects. Two ongoing Asia-focused trials, SUNLIGHT and SUNRISE, will support applications in China and Japan. The phase 3 ALLEVIARE trial aims to test whether Vyepti can treat episodic cluster headache.
Last week, Lundbeck said the phase 3b DELIVER trial hit its goals, showing Vyepti beat placebo in reducing the number of monthly migraine headache days in migraine patients who had two to four previous preventive treatment failures. The drug also helped significantly more patients achieve at least 50% reduction in migraine days over 12 weeks of treatment.
As Dunsire noted, data from the DELIVER trial are important for Lundbeck to gain coverage for Vyepti in Europe.
Still, as SVB Leerink analyst Marc Goodman pointed out in a Wednesday note, Lundbeck’s pipeline is “heavily tilted to early-stage high-risk, high-reward projects.”
When asked about the company’s business development strategy, Dunsire explained that building the Vyepti brand is already taking a significant investment. “So we felt that we would not do an acquisition that required another big bolus of R&D spend on top of what we're already doing right now with Vyepti,” she said. The chief executive indicated the company might prefer later-stage acquisitions in the near term.
The migraine market is getting more crowded with CGRP inhibitors, especially in the prevention field, in which Vyepti is approved . Besides injectables such as Amgen’s Aimovig, Eli Lilly’s Emgality and Teva’s Ajovy, more convenient oral CGRP drugs like Biohaven’s Nurtec ODT and AbbVie’s newly approved Qulipta are also quickly gaining traction.
Editor's Note: The story has been updated to reflect that Lundbeck is cutting 50 jobs in Canada, not Japan.