Yesterday, argenx's stock slipped by more than 2%—with its shares still down slightly as of Friday morning—after the Dutch pharma reported its third quarter earnings. Strong sales for the company’s autoimmune darling, Vyvgart, appeared to be overshadowed by slightly by lower-than-expected operating profit and a new trial requirement in a phase 3 program.
Increasing Vyvgart adoption propelled third quarter net sales to $1.7 billion, up from $1.13 billion at the same time last year, all told a 54% jump.
The neonatal Fc receptor (FcRn) blocker is approved in the U.S. to treat two autoimmune neuromuscular disorders: generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). On the company's third quarter earnings call Thursday, argenx CEO Karen Massey said that five years post-launch, the company is “still early in realizing Vyvgart’s potential across MG and CIDP.”
Argenx executives touted five possible launches in 2027, including Vyvgart’s potential break into rheumatology with a hoped-for immune-mediated necrotizing myopathy (IMNM) nod, expansions into pediatric and ocular MG and a potential autoinjector formulation of the drug, which currently boasts a subQ dosing format via pre-filled syringe, known as Vyvgart Hytrulo.
The leadership also said it expects 10 molecules in clinical development by the end of 2026, including FB102, the autoimmune treatment it acquired as part of its $2.2 billion Forte buyout in August, which is being tested in vitiligo and celiac disease.
The sales win and promising pipeline plans, however, were apparently not enough to appease all of investors' concerns. Citi analysts believe the main driver of this week's minor stock slip revolved around argenx’s plan to conduct an additional registrational trial for Vyvgart in dermatomyositis (DM). The drugmaker’s Alkivia phase 3 showed positive results in both IMNM and DM, however the trial did not reach statistical significance in DM specifically, and the FDA has asked argenx for confirmatory data.
“Vyvgart showed a clear signal of activity but missed on statistical significance due to the small size of the DM subgroup in Alkivia,” William Blair analysts wrote, saying they believe this was the cause of the company's Thursday share weakness. The William Blair team acknowledge that there had been "the possibility of seeking approval in DM based on the ALKIVIA data alone" but admitted that they "are not surprised that argenx is conducting a second study.”
On top of the phase 3 double back, Jeffries analysts said argenx’s higher-than-expected operating expenses were likely a point of tension with investors. The company reported $486 million in operating profit with a 28% operating margin when analysts had estimated closer to $565 million. The decline was due, in part, to costs associated with the $2.2 billion Forte deal.
In a major moment still to come, argenx also disclosed that its Empassion trial will read out before the year is over. The phase 3 study is comparing investigational monoclonal antibody empasiprubart against standard-of-care intravenous immunoglobulin in multifocal motor neuropathy (MMN). The goal is to determine if argenx’s treatment delivers non-inferior results with a lower treatment burden.
The company did not disclose the inferiority margin, but if results are positive, CEO Massey said argenx will pursue priority review with the FDA.