| | | |   | Good morning, everyone. Damian here. Today we've got Albert Bourla on the virtues of spending on luxury, a bevy of open C-suite positions, and the rare biotech IPO with an immediate binary. | | | Pfizer is looking for deals, but ‘cheap’ doesn’t always mean ‘valuable’ Pfizer stands to make something on the order of $60 billion next year from Covid-19 alone, putting the pharma giant in an unrivaled position to invest in science that might generate post-pandemic blockbusters.
“The next few years are the years when we can redeploy significant amounts of capital to beef up our research pipeline,” CEO Albert Bourla told STAT. “We are speaking about an unprecedented amount of capital to invest. And the way we want to do that is in biotech.”
And while biotech stocks are down across the board, “things still will be very competitive,” Bourla said, “and we should be ready to pay a competitive price for the things we really want.” Overpay for the right asset, he said, and it will make the money back many times over. Underpay for the wrong one, and every dollar spent is lost.
Read more. | Biotech’s great resignation A combination of bearish market trends and disastrous clinical data has left some biotech companies staring down insolvency. And that means there are vacant jobs in management.
The latest shakeup comes from Cortexyme, whose investigational treatment for Alzheimer’s disease missed its goals in a trial last year, erasing about 80% of the company’s value. CEO Casey Lynch, who called that “a great day for Alzheimer’s research and for patients,” is now out of the job in what Cortexyme called a “departure.” She is joined by the firm’s head scientist.
On Monday, Sio Gene Therapies, formerly known as Axovant Sciences, said CEO Pavan Cheruvu had resigned “to pursue new opportunities,” just as the company “deprioritized” its most advanced pipeline treatment to conserve cash. Also on Monday, Chinook Therapeutics, down 25% this year, said in a filing with the SEC that its chief medical officer had resigned. The company decided not to issue a press release on the matter. | How a machine, with humans-in-the-loop, is transforming clinical intelligence What happens if you apply the scale of artificial intelligence and the editorial analysis of human beings to clinical trials research? A novel approach to monitoring, discovering, and analyzing clinical data. With their new algorithm, accessed through platform STAT Trials Pulse, machine-learning company Applied XL is transforming the clinical intelligence space, speeding up decision-making on partnerships, investments, commercialization, and more. See how they’re doing it. | Gilead beat Wall Street expectations, but investors only care about one thing The good news for Gilead Sciences is that its fourth-quarter revenue beat analysts’ estimates by nearly 10%, the company disclosed yesterday. The bad news is that Wall Street doesn’t exactly trust the company to spend its money wisely, and the next big test of Gilead’s investment strategy is still on the horizon.
Gilead booked $7.2 billion on the quarter, and its full-year sales came in at $27.3 billion, up 11% thanks to the Covid-19 treatment remdesivir. But investors are looking to March for results of a breast cancer study involving a medicine called Trodelvy, data that will double as a referendum on how Gilead spends money.
The company acquired Trodelvy by paying $21 billion for a company called Immunomedics in 2020. Magrolimab, a cancer drug for which Gilead paid about $5 billion, recently ran into safety issues. And Kite Pharma, a cancer-focused firm acquired by Gilead for $12 billion in 2017, is widely considered a poor investment. | The biotech IPO that could blast off or blow up by June Amid all the complaints that biotech companies are going public with little more than mouse data to support their valuations, Amylyx Pharmaceuticals stands out. By June 22, the company will find out whether the FDA is willing to approve its treatment for ALS, providing one of the year’s biggest binaries just six months after its IPO.
The company, which went public at a roughly $1 billion valuation last month, has exactly one drug. It’s called AMX0035, and its FDA filing is based on a single study, completed in 2020, that showed a significant slowing of disease progression in patients with ALS. The agency initially balked at the evidence, asking the company to complete another trial, but later relented and invited Amylyx to submit for approval while preparing a confirmatory study, according to the company.
That makes valuing Amylyx a tricky proposition. Analysts at Evercore ISI believe AMX0035 could be a $1 billion drug at its peak, which would make Amylyx a nearly $3 billion company. A delay to AMX0035’s approval would cut that number in half, but, according to the analysts, it’s hard to see regulators in the FDA’s neurology division rejecting this drug considering their favorable stance on Aduhelm, Biogen’s treatment for Alzheimer’s disease. | More reads - Omicron’s sister variant spreads faster. So why did the one we call Omicron hit first? STAT
- Private equity firms consider bids of $25 billion for Novartis generics unit. Financial Times
- Native American tribes reach deal with J&J and three wholesalers over the opioid crisis. STAT+
- Pfizer and BioNTech seek authorization of first coronavirus vaccine for children under 5. Washington Post
| Thanks for reading! Until tomorrow,  | | | |
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