Dive Brief:
- Amgen Inc.'s first quarter 2018 revenue increased 2% from the year-prior quarter to $5.6 billion. Net income came in 12% higher at $2.3 billion.
- New and recent launches, including Repatha (evolocumab), Kyprolis (carfilzomib), Prolia (denosumab) and Xgeva (denosumab) have shown double-digit growth.
- "We're looking forward to launching Aimovig, our first neuroscience therapeutic." said CEO Bob Bradway on Amgen's first quarter 2018 earnings call Tuesday. "We're ready to launch Aimovig this quarter in the U.S."
Dive Insight:
Aimovig (erenumab) looks set to become the first therapeutic targeting the calcitonin gene-related peptide (CGRP) pathway to secure a U.S. approval, if all goes according to expectations. The drug's user fee action date for migraine prevention is May 17. Amgen will be working with Novartis AG, and has sales teams trained and in place.
"Novartis [has] a rich history of presence in the neuroscience market, both in terms of the salesforce and an outstanding medical organization. We [are] complementing it with … teams calling on specialists as well as some of the primary care physicians who … look after patients with severe headaches or migraines," said Tony Hooper, Amgen's head of global commercial operations.
Elsewhere, Repatha (evolocumab) sales notched a strong 151% increase year over year, reaching $123 million on higher unit demand. Nevertheless, PCSK9 inhibitors have had a rough time on the market, with pressure from payers slowing prescription uptake. Amgen is looking to learn from this experience for its new launches, particularly Aimovig, which could be the first in its class to reach the market.
"From a timing perspective, we clearly are in the lead. We look forward to launching first, unlike the PCSK9 situation, [where] we had to follow. [Migraine prevention] is clearly a market where patients have huge symptoms and actually know when they're not being properly treated," said Hooper.
This market positioning concern has been cast into the spotlight by a recent draft evidence report from the Institute for Clinical and Economic Review (ICER), which assessed the effectiveness and value of CGRP inhibitors in the prevention of migraine. The report argued Aimovig would add $6,000 in costs per patient, indicating this would mean only 16% of eligible patients could be treated before crossing budget thresholds set by ICER.
"The ICER report doesn't seem to take into account things such as absenteeism and presenteeism, which we would argue is really an important thing to look at from both an employee perspective and an employer perspective. But all of these ranges … will be discussed with the payers," said Hooper.
Express Scripts also has CGRP inhibitor in its crosshairs, according to a report from Reuters. The PBM is asking companies developing this class of drugs refrain from pricing drugs high and then offer rebates, arguing instead for the drugmakers to price lower from the beginning.
Express Scripts is also asking for refunds of two-thirds of the cost if the patient stops taking the drug within 90 days as a result of inefficacy or side effects, Reuters reported. The PBMs could have the CGRP developers over a barrel to some degree — if companies don't show some accommodation, they run the risk of access to their drugs being denied.
"Coming to market first is important; it allows us to set the baseline price," said Hooper. "And we will continue to come forward with prices that are responsible that take into account the co-pay requirements as best we can. We have a number of risk based contracts on the table with Repatha and we [will] talk to payers about risk based contracts with Aimovig."
As a result, analysts aren't necessarily that confident about sales. Jefferies Michael Yee projects a price of $5,000-7,000 per year, predicting 2018 sales of $85 million: "Expectations aren't high as sentiment fears pricing/reimbursement pushback for Year 1," he added.
Leerink analyst Geoffrey Porges is of a similar mind. "The imminent launch of Aimovig … will capture investors' attention, but we expect will have limited financial impact for the immediate future," he wrote.