Amgen’s Otezla, Repatha and biosimilars put on notice, with challenging years ahead

Amgen’s Otezla, Repatha and biosimilars put on notice, with challenging years ahead

Some of Amgen’s key businesses are drawing concerns as competition looms.

Amgen’s 2022 sales could be about $26.3 billion, or $700 million lower than industry watchers’ current expectations, Mizuho analyst Salim Syed warned in a Monday note to investors.

The company’s biosimilars franchise, PCSK9 cholesterol drug Repatha and inflammatory disease therapy Otezla could become its weak points, Syed said.

Syed’s projection for Repatha’s 2022 sales is currently at $1.1 billion, or about $300 million below consensus. The Mizuho analyst’s 2025 estimate for the drug is even more gloomy, at $1 billion, half of the consensus’s $2 billion.

The reason? Novartis’ anticipated launch of rival PCSK9 drug, inclisiran, which has decision day on Jan. 1, 2022.

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Inclisiran, approved in Europe under the brand Leqvio, is given every six months during the maintenance dose, while Repatha requires more frequent dosing of at least once a month. Inclisiran’s generally low-cost structure could give Novartis more leverage during reimbursement talks with insurers and room for discounts, Syed figured.

Repatha brought in $272 million sales in the third quarter, up 33% over the same period last year. In the U.S., Amgen saw a 64% year-over-year volume growth, though it was pulled back by an increasing number of Medicare Part D patients entering the donut hole, Murdo Gordon, Amgen’s commercial chief, told investors during an earnings call earlier this month.

As for Otezla, Sayed pegged the PDE4 inhibitor could reel in $2 billion in 2025 sales, also way below Wall Street’s consensus of about $3 billion.

The main pressure for Otezla could come from Bristol Myers Squibb’s TYK2 inhibitor deucravacitinib. Celgene sold Otezla to Amgen in 2019 for $13.4 billion so that BMS could keep deucravacitinib to win antitrust clearance for its $74 billion Celgene buyout. The U.S. anticompetition regulators forced the Otezla sale after noting the two would compete as oral drugs for inflammatory diseases.

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BMS previously showed that deucravacitinib topped Otezla at clearing skin in patients with moderate to severe plaque psoriasis. The New York pharma expects to launch its offering in the second half in 2022. Otezla’s sales grew by 13% in the third quarter to $609 million.

Besides Otezla and Repatha, Syed also picked on Amgen’s biosimilars franchise, which consists of the Herceptin biosimilar Kanjinti and Avastin copycat Mvasi.

Kanjinti is already struggling amid increased competition; its sales in the third quarter dropped 31% year-over-year to $116 million, thanks to a lower net price despite an 18% volume growth. Mvasi is facing a similar situation, as Amgen expects net price erosions to be wider than volume growth. The Avastin biosim’s third quarter sales, at $274 million, marked a decline from the second quarter.

Meanwhile, a relatively new drug, CGRP inhibitor Aimovig for migraine, has started heading southward. The med suffered a 25% year-over-year decline in the third quarter, with sales at $105 million. In the face of oral CGRP offerings like Biohaven’s Nurtec ODT and AbbVie’s newly approved Qulipta, scripts for under-the-skin products including Aimovig have stalled.

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Even the freshly launched first-in-class KRAS inhibitor Lumakras could soon face direct competition from Mirati Therapeutics’ adagrasib, which posted some competitive cancer data.

Amgen is also looking to roll out another potential first-in-class treatment, tezepelumab. But even that will be launching into a relatively crowded market of injectables for severe asthma, SVB Leerink analyst Geoffrey Porges pointed out in a note earlier.

In the face of all these competitions, Amgen’s cardiovascular portfolio would need an acquisition, Syed wrote in his analysis. Porges also pointed out that investors will likely call for another “in-line product acquisition […] that deliver large and accretive marketed products.” Such deals could fall along the lines of the 2013 $10.4 billion purchase of Onyx Pharmaceuticals, which gave Amgen multiple myeloma drug Kyprolis, or the 2002 $16 billion takeover of Immunex, which came with TNF blocker Enbrel, he said.

This story is brought to you by Fierce Pharma.

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