Biogen stock tumbled Thursday after the biotech company guided to "minimal" 2022 sales of its Alzheimer's drug, Aduhelm.
The guidance comes after the Centers for Medicare and Medicaid Services decided to limit access to patients enrolled in clinical studies. As a result, Aduhelm sales in the fourth quarter were just $1 million, below expectations for $1.5 million to $2 million, according to analyst reports.
CMS could overturn its decision in April. But if it doesn't, Biogen says its "anticipated results and guidance may be impacted." Biogen has already slashed Aduhelm's price in half amid concerns of the heightened price tag and questions about the drug's effectiveness.
Aduhelm's light fourth-quarter sales and Biogen's guidance are "unsurprising given the limited public payer reimbursement and continued physician polarization on whether the drug should be used," RBC Capital Markets analyst Brian Abrahams said in a report to clients.
On the stock market today, Biogen stock tumbled 2.1% to 220.17. Biogen stock has fallen precipitously since last June when it gained U.S. approval for Aduhelm.
Biogen Stock: Aduhelm A Sticking Point
During the fourth quarter, Biogen earnings plunged 26% to $3.39 per share, minus some items. Total sales also declined 4% to $2.73 billion. But both measures beat forecasts.
Multiple sclerosis and spinal muscular atrophy drugs — Tecfidera and Spinraza — helped drive the sales beat, RBC's Abrahams said. Tecfidera brought in $486.5 million in sales, down 20% amid generic competition. But that beat forecasts for $439 million. Spinraza sales sank 11.5% to $440.7 million. Analysts projected $437 million.
But guidance for 2022 came in light. The company expects $9.7 billion to $10 billion in revenue, well below Biogen stock analysts' call for $10.33 billion. The guidance assumes "minimal" sales of Aduhelm and continued generic and biosimilar competition for Tecfidera and cancer drug Rituxan.
Biogen noted it's in discussions with CMS ahead of the April coverage decision. The lion's share of Alzheimer's patients receive Medicare, so the decision will be pivotal for Aduhelm's ultimate market. But analysts aren't expecting Medicare to loosen its current restriction.
"Biogen continues to expect minimal revenue from Aduhelm, but so do we," SVB Leerink analyst Marc Goodman said in his note to clients. However, he kept his outperform rating on Biogen stock.
The company also guided to adjusted profit of $14.25-$16 per share, lagging projections for $18.79.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
