Biogen is trying to escape the dark Aduhelm cloud hanging over its Alzheimer's disease drug launch. So far, the launch has triggered layoffs, a CEO switch and much more.
Now, Biogen has quietly unveiled a sizable inventory write-off. In a recent Securities and Exchange Commission (SEC) filing, the company said its Aduhlem inventories as of June 30 were "de minimis," or functionally worthless. That was $233 million lower than at the end of 2021, meaning the company wrote off the remaining value of its Aduhlem inventories in the first half of this year.
Biogen didn't expand further in its quarterly SEC filing, but a spokesperson said the Aduhelm inventory continues to be available for commercial patients and clinical trial participants. She explained that Biogen made the decision to write off the value of the inventory after the Centers for Medicare & Medicaid Services' (CMS') national coverage determination in April severely restricted use of the drug.
"Inventory levels were written off from an accounting standpoint considering the final NCD decision effectively denies all Medicare beneficiaries access to Aduhelm," Biogen's spokesperson said over email. "In the most basic terms, inventory write-offs are a formal recognition of when the financial value of a company’s inventory decreases."
This write-off follows a similar move—worth $120 million—in the fourth quarter of 2021.
It’s been a long and winding road for Aduhelm. After the drug's controversial FDA approval about a year ago, Biogen sought to grow it into a blockbuster.
Instead, thanks to scrutiny around its data and regulatory process—plus the CMS restriction—its sales have been marginal. The challenges have forced Biogen to downsize and triggered a CEO switch.
In its recent filing, Biogen said it will continue a re-dosing study of the drug and start a phase 4 postmarketing study required under the drug's accelerated approval.