It wasn’t long ago when Seattle Genetics shareholders moved past earlier letdowns and cheered strong performance from key cancer drug Adcetris. But now, they might be disappointed again.
During the fourth quarter, Adcetris pulled in sales of $166.2 million in the U.S. and Canada, a 26% increase over 2018. Still, the number came below the Street’s expectations of $174.5 million as well as its own third-quarter sales of $167.6 million.
The fourth-quarter haul brought the antibody-drug conjugate’s 2019 total to $627.7 million, which was at the bottom end of the company’s guidance provided in October, SVB Leerink analyst Andrew Berens said in a Friday note to clients.
Seattle Genetics itself doesn’t predict significant improvement in the near term. For 2020, the company expects Adcetris sales to come in between $675 million and $700 million, under Berens’ previous estimate of around $788 million. The company is only expecting organic sales increases in the single-digit percentages, the analyst noted. Seattle Genetics just raised the drug’s list price by 3.9% in December, he wrote.
The FDA first approved Adcetris in 2011 and the drug has turned in years of double-digit growth. Still, analysts were bothered by the slowdown and pressed management for answers on a conference call Thursday.
The med is already approved for certain patients with Hodgkin lymphoma and systemic anaplastic large cell lymphoma, but it has remaining opportunity in untreated classical Hodgkin lymphoma, CEO Clay Siegall responded.
Seattle Genetics is looking forward to upcoming five-year data from the Echelon-1 trial that tests Adcetris’ use—in tandem with chemo—in that use. Success could help establish the drug as the standard of care, and the company is eying other uses, as well.
“We’re looking at things in [diffuse large B-cell lymphoma], elderly Hodgkin lymphoma, retreatment and there is early-stage I and II Hodgkin lymphoma,” Siegall said.
These days, the company has another focus in freshly launched, Astellas-partnered ADC Padcev. So far, physician feedback is “very positive,” chief commercial officer Robin Taylor told analysts, and the number of prescriptions has “exceeded our expectations in January.” The company also hasn't run into payer pushback.
Padcev won an accelerated FDA nod in December to treat patients with locally advanced or metastatic bladder cancer who have previously received a PD-1/L1 inhibitor and a platinum chemo.
There are about 3,200 treatment centers in the U.S. that treat metastatic bladder cancer. Among them, Seattle Genetics and Astellas are focusing on about 2,800 that represent the vast majority of sales. So far, in just the first five weeks, their sales reps have called upon 1,500 centers, Siegall said.
Looking ahead, Seattle Genetics has already completed enrollment of a confirmatory phase 3 trial dubbed EV-301 with aims to win full FDA nod and for global filings in later-line bladder cancer. Encouraged by early data that showed a Padceva-Keytruda pairing might work in newly diagnosed bladder cancer patients, Seattle Genetics has just launched a phase 3, evaluating the combo with or without chemo in the same setting.
All told, Seattle Genetics reported total fourth-quarter revenues—including from royalties and licensing agreements—of $289.8 million, a 66% year-over-year jump, beating analyst expectations.