JPM, Day 2: AbbVie's post-Humira battle plan, Vir's antibody edge, Pfizer's out-of-the-box manufacturing—and more

The first day of the first-ever virtual J.P. Morgan Healthcare Conference has officially wrapped, and from our perspective, it's busier than ever. Major COVID-19 players like Gilead Sciences and Moderna were abuzz about pandemic efforts paying off, while Big Pharmas Merck & Co., Bristol Myers Squibb and Novartis talked longterm views on blockbuster meds and M&A. 

Others, like Vertex, were eager to tout expansions into new disease areas, while Genentech's CEO outlined some pandemic lessons learned and Merck KGaA talked resilience amid pandemic demand. 

Here's your need-to-know as Day 2 kicks off. From AbbVie’s hopes for Skyrizi and Rinvoq to shore up sales once Humira loses exclusivity, to Vir’s prospects in COVID-19 and hepatitis B, we’re tracking developments as the day advances.

Hungry for more? We'll be following the latest news from day 2 of #JPM2021 as it happens here. Check out yesterday's updates from Bristol, Vertex, Johnson & Johnson, and many more here, and catch Fierce Biotech's coverage here

UPDATED: Tuesday, Jan. 12 at 6:28 p.m. ET

Is vaccine giant GlaxoSmithKline feeling threatened by the rise of mRNA vaccines and major player Moderna, which is developing candidates for HIV and flu? No, R&D chief Hal Barron said—and it’s working to become a major mRNA player itself. It’s got mRNA programs with collaborator CureVac, as well as an mRNA platform with self-amplification that it thinks “could be very successful,” he noted. “We’re very excited about the potential transformation that’s occurring in vaccines and intend very much to be the leader in all that,” he said.

For sales reps, access to oncology clinics has grown more and more limited over the last several years, and that trend has only been accelerated by the COVID-19 pandemic, Clovis CEO Patrick Mahaffy said Tuesday afternoon. So the company decided to do something about it, creating a “hybrid model” for marketing featuring a “meaningful commitment to new digital content”—not just digital versions of its old content. The initiative involved scaling back its in-person promotional unit and focusing more resources on helping physicians get information from peers, “who they’re going to trust more than they will a sales rep, for the most part,” he said. “Our belief is that a lot of clinics are going to find that they did okay without sales reps in the clinic during the COVID experience,” he added.

UPDATED: Tuesday, Jan. 12 at 5:15 p.m. ET

Following AbbVie’s buyout of Allergan, CEO Richard Gonzalez spent his JPM presentation time by detailing how the company plans to grow past its massive Humira loss of exclusivity in 2023. Humira has played a key role in “defining the standard of care” in numerous diseases over the years, Gonzalez said, but multiple biosimilars are set to launch in the U.S. in 2023. Skyrizi and Rinvoq, two new immunology launches, are set to deliver $15 billion in sales by 2025, Gonzalez said, performing much of the “heavy lifting” in replacing Humira sales. Plus, the company’s multibillion-dollar hematology and neurology franchises are set to gain steam in the coming years, he said. Gonzalez anticipates AbbVie will return to revenue growth in 2024 and that the growth will pick up in 2025 and beyond.

When COVID-19 started spreading around the world, Vir Biotechnology was ready to pivot to address the pandemic—and CEO George Scangos led the charge. Now, the company is developing two antibodies with GlaxoSmithKline and working with RNAi pioneer Alnylam on an siRNA for the virus. While Vir is lagging in the antibody race, Scangos said the company took a different approach that it hopes will yield a more effective treatment. Vir is targeting an epitope—the region of the antigen that elicits the immune response—that’s less likely to mutate and more likely to be vital for the functioning of the virus, Vir’s scientists hypothesized. Meanwhile, Scangos is doing all he can to “make the point that we’re not just a COVID company.” In fact, Vir announced Tuesday it was teaming up with Gilead Sciences to test its siRNA hepatitis B treatment—developed alongside Alnylam—in combination with Gilead’s TLR-8 agonist selgantolimod. Story

COVID-19 forced Aditum Bio—the biotech investment fund set up by former Novartis chief Joe Jimenez—to work differently last year, in a way that’s turned out to be good for the company, Jimenez said in a Fierce JPM Week interview. “This is a very different way of doing business, but I also think it’s going to continue because the efficiencies we get by remote communication is leading to acceleration of clinical trials and acceleration of planning for clinical trials.” Aditum has so far launched a $135 million fund, reviewed more than 1,000 prospects and announced three new companies, with a fourth on the way, Jimenez said. The firm aims to spend its money on digital-drug combos that can work better together. One of its companies, for instance, is working on a therapy for substance abuse that it will pair with a digital device to help patients with behavior modification, Jimenez said. Story

UPDATED: Tuesday, Jan. 12 at 3:33 p.m. ET

How were Pfizer and BioNTech able to up their 2021 COVID-19 vaccine output projection to 2 billion doses? By doing things “very differently and very out of the box in manufacturing,” CEO Albert Bourla explained Tuesday. Pfizer made changes to the way it works with partners on raw materials, redesigned its operational flow to improve capacity, designed new equipment and worked with manufacturers to get the new equipment delivered quickly, and more. There are “so many initiatives we have put in place,” Bourla said, adding that “I have admiration for our manufacturing team as much as I have for our research team—it’s almost equally difficult to scale up manufacturing at that level so fast as it was to develop the vaccine.” Story

The COVID-19 pandemic brought significant changes to the way pharma companies conduct business, and some of them are here to stay. Virtual clinical trials, expanded remote work policies and reduced travel are some of the ways the industry will proceed even after the pandemic subsides, CEOs for Eli Lilly, Moderna, Vir and other companies said in interviews and presentations. Story

UPDATED: Tuesday, Jan. 12 at 2:33 p.m. ET

During last year’s J.P. Morgan Healthcare Conference, Moderna was a clinical-stage biotech company with promising technology and big ambitions. This year, the biotech has one of the only authorized COVID-19 vaccines in the world. The global vaccine rollout could propel the company into the ranks of the top vaccine producers by revenue worldwide, CEO Stéphane Bancel said in an interview for Fierce JPM Week. The company has secured purchase orders for more than $11 billion and is negotiating more deals, Bancel said at a Monday presentation. Meanwhile, Moderna’s success in COVID provided “validation” for its platform as the biotech eyes vaccines against a range of other diseases. Story

To Regeneron, there’s no question about it: “We as a society have to do a much better job” of getting antibody therapies—such as the company’s own—to patients, company R&D chief George Yancopoulos said Monday. While there are some hurdles to treatment—the therapies are infused, meaning patients have to first get a prescription and then make their way to an infusion center for administration—Yancopoulus said Regeneron can “work much more closely with the government” to figure out more effective ways to get the cocktail to patients. “Right now, the vaccine is not helping any of these people,” he added. “The only thing that can really help these people … are these antibody therapies.” Story

UPDATED: Tuesday, Jan. 12 at 11:15 a.m. ET

As the world awaits Johnson & Johnson’s COVID-19 vaccine efficacy data, CEO Alex Gorsky had a simple message to share at his JPM fireside chat on Monday. The company is in the “final stages” of a data analysis and hopes “to have that information very soon,” he said. As the Pfizer and Moderna vaccine rollouts lag expectations in the U.S., J&J’s one-dose regimen could be a “game-changer,” Operation Warp Speed official Moncef Slaoui recently said. J&J plans to produce hundreds of millions of vaccine doses in the first half of 2021 and nearly a billion doses by the end of the year. Story

Even as Pfizer, Moderna and AstraZeneca ship COVID-19 vaccines by the millions, a “second-wave” of vaccines will still be needed to immunize the world, experts said on a Fierce JPM Week panel. Total vaccine demand will reach 16 billion doses, according to one expert, and it’s not clear how long protection will last from the first round of shots. The ongoing vaccine launches will hopefully “help us to end the acute phase of the pandemic,” Swati Gupta, an executive with IAVI said, but because COVID-19 is likely to become endemic, “we also need to plan for longer-term management of the disease.” Valneva CEO Thomas Lingelbach said he’s “absolutely sure” there will be demand for follow-up vaccines. Story

UPDATED: Tuesday, Jan. 12 at 10:10 a.m. ET

About a month after Eli Lilly presented positive topline results on its weekly dual GIP and GLP-1 type 2 diabetes drug tirzepatide, Novo Nordisk CEO Lars Fruergaard Jørgensen said both companies can succeed in the competitive GLP-1 class. Just as Novo promised when Lilly launched Trulicity, Jørgensen now says the two companies can each work to grow the class. And he doesn't see either one “completely wiping the market and having a product that’s just massively differentiated.” So far, Novo is seeing positive uptake on its GLP-1 pill Rybelsus—the first oral med in the class—though initial COVID-19 lockdowns hurt uptake. Now, patients are more comfortable visiting their doctors and Novo is seeing a “stable flow” of new prescriptions.

UPDATED: Tuesday, Jan. 12 at 9:30 a.m. ET

Alexion’s 2020 sales will exceed the high end of its previous expectation of $5.9 billion to $5.95 billion, CFO Aradhana Sarin said. To reach its 2025 sales target of about $9 billion to $10 billion, the company plans to quadruple the U.S. neurology patients its C5 drugs Soliris and Ultomiris treat compared with 2019. As the company’s on track to being acquired by AstraZeneca in a $39 billion deal, Sarin labeled the company’s capabilities as “unique, not easily replicable and necessary to serving patients with rare diseases.” Story

CEO Ken Frazier on Monday seemed especially resistant to the idea that there's trouble brewing for Merck & Co. on the other side of Keytruda's patent expiration date. The company is eyeing co-formulations, combinations and other Keytruda administration routes that could draw out the megablockbuster's lifespan, for one. Plus, “I think our revenue growth prospects are underappreciated between here and 2024,” Frazier said, referring to the company's pipeline candidates. Meanwhile, the company has continued to eke out deals, carrying out 120 transactions in 2020 alone. Frazier knows those smaller pacts may not be what investors are looking for, though. “I think what people are saying is, ‘We’d like to see you do something bigger and later-stage,' ” he acknowledged. Story

Despite some contentious WHO data last fall, U.S. uptake of Gilead Sciences' COVID-19 antiviral Veklury, formerly known as remdesivir, has skyrocketed from just 30% of hospitalized patients in October to around 50% to 60% today, CEO Dan O'Day said Monday. As a result, the company now expects Veklury to bag between $2.8 billion and $2.83 billion in 2020, while it clocked in total 2020 sales at a range of $24.3 billion to $24.35 billion, well above the $23 billion to $23.5 billion estimate it previously sketched out. As for the company's plans beyond Veklury? "Biktarvy, Biktarvy, Biktarvy—that’s very important,” O’Day said of the products that would fuel Gilead’s short-term sales expansion. Story