Amgen confident about CGRP market position
- After the close of the market on Tuesday, Amgen reported a 2% revenue increase year-on-year to $5.8 billion for the quarter, driven by Prolia (denusomab), Repatha (evolocumab) and Kyprolis (carfilzomib).
- Repatha sales increased to $83 million for the quarter, an almost three-fold rise year-on-year. Amgen also saw sales falls, including a 1% drop for its top seller Enbrel (etanercept), which now faces biosimilar competition.
- Amgen has increased its earnings per share guidance to $10.79 to $11.37 on a GAAP basis, from a range of $10.64 to $11.32, and tightened its total revenue range slightly, to $22.5 to $23 billion from $22.3 to $23.1 billion.
On the second quarter conference call Tuesday evening, Amgen touted its head start in the race to the migraine market for CGRP inhibitors, and the potential benefit that being the first mover could provide.
Last week, the Food and Drug Administration accepted Amgen's Biologics License Application for its CGRP inhibitor Aimovig (erenumab) for the prevention of migraine in patients experiencing four or more migraine days per month. The FDA has set a user fee goal date of May 17, 2018.
"We've talked to patients, patient bloggers, patient groups about their needs, it's clear the unmet need continues to be large," said Anthony Hooper, EVP of global commercial operations on the call. "We do believe that we will be first to market. We have submitted first. We intend coming to market first. We have a partnership with Novartis, who has an existing strong relationship with the neurologists, a lot of them whom treat migraine. And we expect to be using their skills, competencies and relationships to set us up and to move fast and quickly into the marketplace."
Amgen also believes that Aimovig has a potential differentiator with its mode of administration.
"We can get erenumab to a monthly single small-volume well-tolerated auto injection. I don't know that that's possible with these other agents. The data as it appears to me at this point doesn't suggest that," said Sean Harper, EVP of R&D.
Despite the good position they have with the migraine treatment, Amgen still had to defend itself when it comes to pricing. The company took a lot of backlash when it brought its PCSK9 inhibitor Repatha to market. Amgen is in discussions with regulators and payers following this pushback over the high costs, and hopes recent data from its cardiovascular outcomes trial FOURIER will help further support the drug's price tag.
"We've never given pricing guidance prior to a launch. We estimate about 3.4 million patients presently on prophylactic treatment for migraine, both episodic and chronic… And our discussions have been with payers from a clinical perspective at this particular stage as we move things forward," said Hooper on the call, who indicated the company is looking at "pharmaco-economic value-based pricing models for this particular disease."
"It's going to be a competitive market. That we understand. But our pricing will be made as we get closer to the launch time," he added.
- Amgen Earnings Statement
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