How's Amgen's key KRAS launch looking? It's too early for meaningful sales, but expectations are riding high

Amgen
Amgen won approval for Lumakras in late May, three months ahead of the FDA's deadline. (Business Wire)

It’s only been about two months since Amgen’s hot new KRAS inhibitor Lumakras won FDA approval, but it’s clear the drug is already shouldering big expectations. 

While Amgen’s second-quarter financial results don’t indicate a heavy reliance on the new cancer treatment right now, executives and analysts drilled down on the med’s early performance and future prospects during Tuesday’s earnings conference call. 

Since the med is so early in its launch, Lumakras hasn't yet generated meaningful sales. But analysts expect blockbuster revenues in the coming years, and some of Amgen's other growth drivers slipped during the second quarter, showing that Amgen has a lot riding on its launch.

After an earlier than expected FDA approval in late May to treat certain non-small cell lung cancer patients, Amgen was off to the races with its new cancer med. The mutation was once thought to be “undruggable,” so the rollout has commanded considerable attention among oncologists. 

RELATED: Surprise! Amgen's hot KRAS drug seals early FDA approval, winning a shot against 'undruggable' cancer

So far, more than 2,000 patients have received the drug at more than 1,000 treatment sites, R&D chief David Reese, M.D., told analysts during the earnings call. About 900 trial investigators and treating doctors have prescribed the drug, Reese added. 

“We're very pleased with the positive reaction from the oncology community, and we'll be working closely with them to ensure access for patients who can benefit from this breakthrough medicine,” Gordon said.

More importantly for the long-term uptake trajectory, KRAS mutation testing is gaining steam. FDA's May approval of Lumakras marked the first go-ahead for a therapy specifically for patients with the KRAS G12C mutation. 

KRAS testing has reached 70% of newly diagnosed patients with metastatic non-small cell lung cancer, commercial chief Murdo Gordon said. Lumakras is sanctioned for use in adults who have already received at least one prior treatment. 

The company didn’t break out Lumakras’ sales in the second quarter, reporting only that it was among a group of “other” drugs that generated $77 million during the period. Piper Sandler analysts have estimated the drug could reach $1.4 billion in sales in lung cancer by 2023.

Meanwhile, sales for key growth drivers Aimovig, Otezla and Enbrel declined during the period, indicating that the company may look to its new cancer entrant to help drive growth.

Amgen isn’t only focused on Lumakras’ first indication. The company is testing the med in combo with its own Vectibix in colorectal cancer, and Tuesday unveiled a collaboration with Novartis to study the therapy with the Swiss drugmaker's SHP2 inhibitor TN0155. Amgen is also eyeing potential combos with checkpoint inhibitors. 

RELATED: How a protein 'Polaroid' led Amgen to finally crack the 'Achilles heel tumor' with Lumakras in 8 years 

In all, Amgen’s “game plan” seems to be to “rely on Lumakras near term to fill gaps in sales,” Bernstein analyst Ronny Gal wrote in a note to clients, noting that the company faces billions of dollars in patent losses in the coming years. If one of the Lumakras combos succeeds, there could be "upside,” Gal wrote. 

Still, Bernstein’s team thinks that “durability could be an issue due to escape mutations, and the real risk here is later entrants … with potentially improved profiles.” Eli Lilly, Revolution Medicines and Mirati Therapeutics are all advancing their own KRAS inhibitor candidates.  

Overall, Amgen reported $6.53 billion in second-quarter sales, a 5% increase compared with the same period last year. While some key growth drivers slipped, the company's bone drugs and cholesterol med Repatha delivered double-digit sales increases.