- Belgian drugmaker Galapagos announced Monday the planned retirement of co-founder and CEO Onno van de Stolpe, marking an end to a more than two-decade stretch with him at the helm.
- Under van de Stolpe, Galapagos secured its first drug approval with filgotinib, a rheumatoid arthritis treatment sold in Europe as Jyseleca. The company also scored a landmark $5 billion research deal with Gilead in 2019. Since then, however, it has faced several setbacks, including the Food and Drug Administration rejecting an approval application for filgotinib — an outcome which dimmed Gilead's hopes for the treatment. More recently, investors were disappointed in preliminary data for another one of Galapagos' most closely watched programs.
- The company said in a statement that van de Stolpe will stay on as CEO until a successor is appointed, and that its supervisory board has begun an external search for his replacement.
Galapagos looked to be in a strong position at the start of 2020. It had recently closed a major research deal with Gilead that not only provided substantial amounts of money, but also included terms which all but guaranteed Galapagos could remain an independent company.
And on the drug development front, Galapagos had several important milestones on the horizon. It was expected that, by August, the FDA would approve filgotinib for rheumatoid arthritis, putting the drug one step closer to the multibillion-dollar sales estimates which analysts had forecasted. The company was also hard at work on "Toledo," a secretive program to which it devoted half of its research organization.
Investors seemed enthused with the direction van de Stolpe had taken, and by late February 2020, Galapagos shares were trading at an all-time high of $274 apiece, valuing the company at almost $17.5 billion.
"To me, it could very well be the next Regeneron, the next Genentech," Pasha Sarraf, a former analyst at SVB Leerink, said of Galapagos in late 2019. "We just have to wait and see."
In the roughly year and half since, sentiment around Galapagos has changed.
Last August, the FDA rejected filgotinib because, according to Gilead, the agency had concerns about the higher, more effective dose of the drug — namely, whether its benefits outweigh the potential risks. The decision was a surprise to Gilead and Galapagos as well as their investors, and set off somewhat of a domino effect.
In Gilead's view, the higher dose was essential to filgotinib's chances at competing in a crowded market of rheumatoid arthritis drugs. So, with the FDA's rejection and feedback in mind, Gilead had by December decided not push for U.S. approval in rheumatoid arthritis. Additionally, the company elected to hand back some of the rights to filgotinib it secured through the Galapagos partnership.
Galapagos shares lost about a fifth of their value following that announcement.
They then fell again last month, when Galapagos unveiled highly anticipated results from the Toledo program.
The preliminary results came from three small studies testing a drug known as GLPG3970 against either moderate to severe psoriasis, ulcerative active or rheumatoid arthritis. While the psoriasis study did have positive findings, with more patients experiencing skin clearing when on GLPG3970 as opposed to placebo, the ulcerative colitis and rheumatoid arthritis studies showed no significant differences between treatment with the Galapagos drug and a placebo.
After releasing the results, Galapagos suggested GLPG3970 would not be further developed.
By Monday, Galapagos' share value sat at roughly $55. Yet, some analysts argue the planned changed in leadership provides an opportunity for the company to forge a new direction and reinvigorate investor optimism.
"Galapagos currently has an operating profile that is imbalanced compared to its peer group, and the hope is that a new CEO would provide a differentiated path forward from the current operating plan," wrote Dane Leone, an analyst at Raymond James, in a note to clients.
"Overall, we think that the significant negative [enterprise value] that the company currently trades at does include a management discount that could be alleviated in part by the news today," he added.
Looking ahead, the Raymond James team envisions that Galapagos, as it hunts for a new CEO, will be much less likely to pursue certain business operations, such as spending considerable money to acquire some external asset.
Conversely, the team believes Galapagos' supervisory board, which includes Gilead CEO Daniel O'Day, may be more likely to consider alternative strategic options. A new CEO also "greatly increases the odds of a major strategic shift away from the current drug development model," Leone wrote.
Until a replacement is selected, however, van de Stolpe will remain at the helm of the company he created.
"The time has come, after 22 years at [Galapagos] my farewell has been announced," van de Stolpe wrote on Twitter. "Of course it would have been better if Galapagos was in a better situation. But I will leave a company with [5 billion euros] in cash, guaranteed independence and a highly motivated and skilled staff."
Galapagos shares were up about 8% in Tuesday morning trading.