- Despite the early success of Amgen's migraine drug Aimovig, questions on whether the big biotech can find enough new growth to offset declining legacy products remain top of mind for Wall Street.
- Quarterly sales decreases on half a dozen products added up to a $295 million hit to product sales, which grew 1% overall to total $5.5 billion during the third quarter. Company execs, however, focused on Aimovig, which beat consensus sales estimates.
- Murdo Gordon, Amgen's new head of global commercial operations, called Aimovig's debut "one of the strongest launches that I've seen in my experienced in this industry, both within this therapeutic area and even more broadly." That said, the drug only earned $22 million in the three months from July to September, as many prescriptions came through a free drug program.
While its CGRP inhibitor Aimovig (erenumab-aooe) impressed, Amgen remains in the middle of some of industry's largest battlegrounds. The biotech is dealing with pricing pressures, battling biosimilar competition in the market and the courthouse and working to replace fading blockbusters with a next generation of top-sellers.
Amgen CEO Bob Bradway largely toed the standard line with comments on the overall U.S. political environment. The chief executive remarked that the U.S. political focus on drugs "remains very topical" and that he doesn't "expect this to end anytime soon." Bradway, who is also PhRMA's chairman, reiterated a commitment to working with government to find market-based reforms that won't crimp innovation.
The comments come a week after the Trump administration proposed changing up how Medicare Part B pays for some drugs, in part by linking them to a composite of international prices.
Biosimilar competition, meanwhile, began taking a bite out of two valuable Amgen franchises: Neulasta (pegfilgrastim) and Epogen (epoetin alfa), respectively showing 6% and 5% year-over-year declines in third quarter net sales.
And Neulasta could face a second biosimilar in addition to Mylan's Fulphila soon. Coherus BioSciences is expected to receive a decision from the Food and Drug Administration on its own Neulasta copycat on Nov. 3.
Bradway also noted closing arguments in a trial between Amgen and Sandoz over a biosimilar to Enbrel (etanercept) are expected to happen later this year, putting analysts' expectation for a court decision in the first half of 2018. Enbrel accounted for $5.4 billion in sales last year, and has posted nearly $3.7 billion in the first nine months of this year.
Those three biologics, all under biosimilar threat, made up approximately 51% of Amgen's total product sales last year.
Overall, Wall Street equity analysts seemed to hold healthy amounts of skepticism about the biotech.
Cowen & Co.'s Phil Nadeau fretted in an Oct. 31 note that roughly $15 billion of the company's $22.1 billion expected revenue for 2018 — nearly 70% — will come from legacy products encountering new competition or pricing pressure. The question facing investors, Nadeau wrote, is "not whether they will decline, but how quickly."
While acknowledging a "great start" for Aimovig and a "solid result" on the quarter overall, Leerink's Geoffrey Porges called the biotech's pipeline "either too small, or too distant, to move the needle for valuation."
Shares in Amgen were up nearly 2% in value by midday.