Pricing pressure weighs on Amgen as blockbuster hopeful Lumakras posts early decline

When a company continually spotlights a drug’s volume growth, sales might not be moving in the same direction. That was true for a critical launch during Amgen’s third quarter.

Just over a year on the market, Amgen’s blockbuster hopeful Lumakras posted a sequential sales decline. Compared with the second quarter, the lung cancer med’s third-quarter haul dropped 3% to $75 million, coming in 16% below Wall Street’s expectations.

Amgen chalked up the sales drop to a recent price adjustment as part of a reimbursement deal in Germany. In terms of global volumes, Lumakras grew 15% quarter over quarter.

The disappointing financial performance comes as the first-in-class KRAS inhibitor nears a market clash with Mirati Therapeutics’ adagrasib, whose application in KRAS-mutant non-small cell lung caner bears an FDA target action date of Dec. 14.

Amgen recently reported positive results from the CodeBreaK 200 confirmatory trial, teeing up a potential full FDA approval that could block adagrasib’s accelerated approval pathway. Still, that scenario has become unlikely as Amgen has yet to file the confirmatory data with the FDA.

The California drugmaker also recently received topline data from another postmarketing study required by the FDA. That trial compared the drug’s currently approved 960mg daily dosage to a lower dose of 240mg in patients with KRAS G12C-mutated NSCLC.

Amgen plans to submit data from that study and CodeBreaK 200 to the FDA following discussions with the agency, R&D chief David Reese told investors on a conference call Thursday. Reese declined to comment on the results, saying Amgen will share them first with regulators.

As for Amgen’s financials, pricing pressure was a common theme throughout the company’s portfolio in the third quarter. Despite 8% volume growth, companywide revenues were down 1% year over year to $6.7 billion. A 5% decline in selling prices and a 2% hit from foreign exchange rates hurt the company's top line during the period.

PCSK9 cholesterol drug Repatha delivered U.S. volume growth of 32%, but sales only increased by 2% year over year as Amgen offered higher rebates to support Medicare and commercial access, commercial chief Murdo Gordon said on Thursday’s call

Outside of the U.S., Repatha’s inclusion on China’s national reimbursement drug list this year drove a 73% increase in ex-U.S. volume growth, while sales grew just 26% by comparison. Overall, Repatha’s $309 million haul in the quarter came 6% below analysts’ consensus estimates.

Elsewhere, sales of Amgen’s oncology biosimilars dropped a whopping 25% year over year. In this case, pricing deterioration and volume declines were both at play as a result of increased competition. U.S. prices for Amgen’s biosimilars to Roche’s Avastin and Herceptin declined 37% and 38%, respectively, over the same period last year, Gordon said.

Given these drugs’ buy-and-bill reimbursement model, Amgen expects their prices will continue to decline.

“Over time, we expect long-term growth in our biosimilars business to be driven by the addition of new molecules and additional launches,” Gordon said.

On the pipeline front, one closely watched biosimilar at Amgen is Amjevita, which is on track to be the first copycat to AbbVie’s megablockbuster Humira. Amgen expects to launch the biosimilar in the U.S. in early February 2023, Gordon said.

Amgen could also read out clinical data early next year to support an interchangeable label for Amjevita. By Gordon’s estimate, Amgen could have interchangeability around when other Humira biosimilars enter the market.

But Humira biosimilars could also threaten Amgen’s rival TNF inhibitor, Enbrel, which is currently the company’s top-selling drug with $1.1 billion sales in the third quarter. The FDA has approved Enbrel copycats, but they haven’t been able to launch thanks to Amgen’s patent wins.

Enbrel sales decreased 14% year over year in the third quarter. Pricing was once again a driving factor as volumes only shrank 3%.

“Our goal is to maintain that and maybe even improve upon it” going into 2023, Gordon said of Enbrel’s volume decline rate.