The Readout Damian Garde & Meghana Keshavan

What kind precedent is Biogen up against?

The FDA’s decision to extend the review of Biogen’s treatment for Alzheimer’s disease has invited all manners of conjecture, ranging from assurance of approval to guarantee of rejection. For a quantitative view, the analysts at EvercoreISI crunched the numbers on similar situations and found that there’s precedent for this being good news for Biogen.

Starting from a pool of 155 advisory committees, the analysts isolated 26 panel votes deemed “super negative” — a term that fairly applies to the stinging rebuke Biogen endured in November. Of those 26 drugs, four had their FDA reviews extended, just as Biogen’s did. And of those four, three went on to win approval.

That doesn’t mean Biogen has 75% odds of success, the analysts note, and with such a small sample size, it may not mean much at all. But it does establish precedent, and it gives Biogen’s management a talking point for Wednesday’s earnings call.

Moderna is going to make a lot of money. Just how much is the subject of debate

Beneath the unquestionably positive headlines tied to Moderna’s Covid-19 vaccine, Wall Street is engaged in a debate: Just how much money will the company make from changing the world?

The consensus among analysts is that Moderna’s vaccine will bring in revenue of about $11 billion this year, drop to $7 billion or so in 2022, and then flatten out to roughly $5 billion a year through 2030. But those numbers don’t add up to everyone on Wall Street. Yesterday, Bank of America downgraded Moderna, forecasting a much steeper drop in revenue and calling the consensus estimates “unrealistic.” SVB Leerink analyst Mani Foroohar made a similar point, arguing that competition in the Covid-19 field is likely to erode Moderna’s sales much faster than the market expects.

Underlining any conversation about Moderna’s future as a business is the fact that its valuation, sitting now at $63 billion, has long since decoupled from the nuts and bolts of analyzing a stock. The aforementioned SVB Leerink note actually raised Foroohar’s stock price target, from $69 to $89, but it still reads as a bearish analysis because Moderna opened the day at $173.

Don't forget Pfizer

Speaking of Covid-19 vaccine revenue, Pfizer is about to tell the world just how much vaccine it expects to sell this year.

At 10 a.m. ET, Pfizer will present its earnings from 2020 and guidance for 2021, which, as CEO Albert Bourla promised earlier this month, will include an estimate of full-year vaccine revenue. Pfizer will separate its Covid-19 projections from its normal business, because, in Bourla’s words, “it’s complicated.”

Complicated or not, the number could be quite large. Pfizer has committed to manufacturing 2 billion doses of its BioNTech-partnered vaccine in 2021. Even if the average price slips below the $20 per dose Pfizer is charging the U.S. government, the company would be on pace for a massive windfall. Beyond the numerals of Pfizer’s vaccine projections, it’ll be worth tuning in for Bourla’s comments on the changing market dynamics for Covid-19 vaccines, including new commercial competitors and the evolving threat of viral variants.

Here comes the Sana IPO

The biggest biotech IPO in more than two years is expected to price this week, with Sana Biotechnology looking to raise $323 million at a $4 billion valuation.

Sana’s business is developing technology that can modify any cell type, and its early targets include Huntington’s disease, multiple sclerosis, heart failure, and diabetes. The company is early in the development process, with no clinical trials planned until 2022 at the earliest.

Sana’s debut is a test of whether the IPO market, which has been more than kind to biotech, has an appetite for one of the sector’s wait-and-see unicorns, companies that arrive with large valuations and long timelines. There’s a mixed record of success. Rubius Therapeutics went public at a $2 billion valuation in 2018 and has since lost 55% of its value. Moderna debuted at $7.5 billion in biotech’s largest ever IPO but saw its stock price languish until Covid-19 made it a household name in 2020.

More reads

  • Amid a crush of Covid-19 research, scientists hone an AI tool to rapidly screen studies. (STAT+)
  • EU’s push for vaccine supplies gets help from Bayer agreement. (Bloomberg)
  • Pharmacy benefit managers take heavy criticism from a new source: local officials. (STAT+)
  • AstraZeneca COVID-19 vaccine applies for full regulatory approval in Brazil. (Reuters)

Thanks for reading! Until tomorrow,

Tuesday, February 2, 2021


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