As Vyvgart launch gains steam, Argenx CEO says his company can achieve 'standalone' success

Armed with “pipeline in a product” efgartigimod, approved in generalized myasthenia gravis (gMG) as Vyvgart, Argenx is confident it can triumph on its own.

In fact, Argenx chief Tim Van Hauwermeiren thinks his company could serve as a “role model” for future biotech innovators amid an era of midsized biopharma buyouts. But in gMG, the budding company will need to prove its merit against a much larger rival in AstraZeneca's Alexion.

Vyvgart, which has racked up green lights in the U.S., Japan and—most recently—Europe, is “launching well,” Van Hauwermeiren said in a recent interview. That should prove to investors that “we know how to sell a product,” the Argenx CEO added. With that in mind, Van Hauwermeiren stood firm that his company can create shareholder value in a “standalone scenario.”

It’s ultimately up to those shareholders to decide whether Argenx continues to fly solo or gets sold off, the CEO explained. Even still, Argenx has made its broader immunology ambitions clear, helping its investors glean a “clear understanding” of the company’s planned trajectory.

Argenx has reason to feel confident. After building demand for Vyvgart in 2022’s first quarter, the company recorded second-quarter revenues of $75 million. For a rare disease med like Vyvgart, that’s a fair bit more than the $60 million Evercore ISI analysts ballparked in a note to clients earlier this year. And even then, the Evercore team’s prediction was nearly twice consensus forecasts around Vyvgart sales for the period.

Now, the company hopes Vyvgart’s launch gains enough steam so that Argenx can “earn the right to continue to run the show,” the CEO explained.

In the U.S., Argenx previously said it would need to focus its efforts on building demand. Part of that strategy hinged on an unbranded DTC campaign, where Argenx was effectively “mobilizing the patients,” Van Hauwermeiren said.

Argenx’s ad doesn’t call out Vyvgart by name. It instead points out that a new treatment option is available for patients.

“What we’ve heard from the patient population over the past few years is that [there] hasn’t been much forward innovation in treatments for them, and very little done in awareness,” Rebecca McLeod, Argenx’s U.S. general manager and marketing lead, told Fierce Pharma earlier this year.

“We knew that a new drug like Vyvgart would not be prescribed by a physician unless there would have been a face-to-face interaction,” added CEO Van Hauwermeiren.

Apart from marketing to patients, Argenx has “invested heavily” in doctor education, the helmsman said. Those physician outreach efforts will be paramount if Vyvgart hopes to tangle with AstraZeneca and Alexion’s Soliris successor Ultomiris, which bagged a gMG approval in April, just two months after Vyvgart’s launch, Evercore analysts said in July.

“Vyvgart may exceed consensus heading into earnings, but it is highly vulnerable to Ultomiris,” the analysts warned at the time, flagging the potential benefit of “an aggressive physician awareness campaign.”

The next frontier for Argenx’s med will be Europe, where Vyvgart snagged a recent marketing authorization as an add-on to standard therapy for certain adults with gMG. To start, Argenx plans to debut Vyvgart in Germany before the year is out. The approval process will take slightly longer in other countries, Van Hauwermeiren pointed out.

While Argenx won’t be afforded the same direct-to-consumer marketing opportunities across the pond thanks to European marketing regulations, the company will continue to stress doctor education, the CEO said.

One potential hurdle in Europe? Patients in the bloc are slightly more reluctant to use infused medications, instead preferring options like oral immunosuppressants, he said.

The Evercore team also stressed the importance of convenience and flexibility in Argenx’s Vyvgart marketing push against Ultomiris. On that front, the company could soon have a below-the-skin injection ready to roll, adding additional optionality for patients.

After a phase 3 win in March, Argenx is on track to submit its FDA application for subcutaneous Vyvgart by the end of the year. The company will eventually angle for similar approvals in Europe and Japan, Van Hauwermeiren said.

Aside from Argenx itself, Van Hauwermeiren noted there's a "whole class" of biotechs seeking to usher their products to commercialization. It’s important to see and understand that those solo efforts are possible, the CEO added.

“Look at the BioNTechs of this world—the Evotecs, the Genmabs, the Argenxs—they all do it in their own way,” he explained, noting that those companies’ efforts could be “inspiring” for up-and-comers in the field.