JPM, Day 1: Moderna's 'inflection year,' Gilead's Veklury boost, Genentech's 'silver linings'

Boot up your computers and get those meeting room links ready: This year's virtual J.P. Morgan healthcare conference has officially kicked off. Several players in the COVID-19 fight have already sketched out and updated their battle plans for the pandemic's second year, as other Big Pharmas eye M&A in the months to come. 

Here's your need to know, from Moderna's plans in COVID-19 and beyond to Gilead's Veklury sales boost to Amgen's drug pricing ambitions under a new president—and more. 

Fierce Pharma will be covering the day's biggest news at it happens. Check back here for updates, and catch Fierce Biotech's coverage here

UPDATED: Monday, Jan. 11 at 8:30 p.m. ET

The pandemic has proved an unexpected boon for many manufacturers—and that’s certainly true of Merck KGaA’s own manufacturing business, CEO Stefan Oschmann said Monday. Merck’s process solutions orders soared more than 50% during the first nine months of 2020, thanks to a spate of customers working on COVID-19 drugs and vaccines. Elsewhere, the company’s looking to expand its contract testing and CDMO firepower in spaces like cell and gene therapy, antibody-drug conjugates and mRNA. In fact, Merck just last week snapped up German mRNA manufacturer AmpTec, Oschmann pointed out. On the pharma side, Merck expects U.S. approval “in the coming weeks” for its MET inhibitor tepotinib in non-small cell lung cancer, while its bifunctional fusion protein immunotherapy bintrafusp alfa is due for its first data readouts early this year.

UPDATED: Monday, Jan. 11 at 5:51 p.m. ET

Monday wasn’t the first time Takeda laid out its goal of generating 5 trillion yen—or about $47 billion—in sales by 2030, but investors pressed CEO Christophe Weber to explain how the company planned to get there. The helmsman cited growth from global brands, including IBD therapy Entyvio and hereditary angioedema treatment Takhzyro, as well as the 40 clinical-stage new molecular entities in its pipeline. “Not all will succeed, but if we did a good job—and we believe we did—the majority of them will,” he said. The company is also “very realistic” when it comes to goal-setting, he added, emphasizing that “we deliver on our objectives.”

Merck CEO Ken Frazier gets why investors are worried about what will happen when megablockbuster Keytruda eventually loses patent protection. He just thinks the concerns are overstated. “We see it as not as big an issue as I think some investors may see it,” he said during a Monday afternoon fireside chat. Of course, that doesn’t mean Merck won’t be looking for buys to supplement what it’s doing in its own labs. “We do need to continue to focus on getting the best external science we can, both in oncology and outside oncology, to diversify our portfolio, and we’re going to continue to focus on that,” he said—though, as he stressed repeatedly, Merck won’t be chasing big buys that don’t create value. Story

UPDATED: Monday, Jan. 11 at 5:06 p.m. ET

Moderna’s profile has been dramatically elevated due to its COVID-19 vaccine success, and in 2021, the company is poised for an “inflection year,” CEO Stéphane Bancel said at his JPM presentation. The company has secured $11.7 billion in advance purchase orders for its coronavirus shot, and it’s actively negotiating for more deliveries this year and next year. Beyond COVID-19, Bancel said the pandemic will raise the public’s awareness of the need for more infectious diseases vaccines. The company has numerous other candidates in flu, Zika, RSV and other diseases, including a cytomegalovirus hopeful set to enter phase 3 this year. That program could bring in $2 billion to $5 billion at peak, Bancel said.

Gilead surprised investors Monday morning by preannouncing higher-than-expected fourth-quarter sales and updated 2020 guidance that revealed a big boost from COVID-19 therapy Veklury, better known as remdesivir. What changed since Gilead last put out guidance in October? For one, hospitalizations are up fourfold—and Veklury utilization is way up, too. “One in two patients hospitalized now is treated with Veklury in the United States,” CEO Dan O’Day said, noting that Veklury use in the setting is up from 30% in October to around 50% to 60% today. “It speaks volumes to the role Veklury is playing in this pandemic,” he added. Story

As President-elect Joe Biden is set to be sworn in next week, Amgen CEO Robert Bradway said the company “looks forward to working with the new administration” and lawmakers on “both sides of the aisle” on healthcare and drug pricing issues. The company wants to work on updates to rules and regulations Bradway said are “outdated,” as well as to boost patient access. Still, the company wants to keep in place the “ecosystem” that enabled drugmakers to deliver COVID-19 drugs and vaccines in less than a year. Drug pricing is often a topic of conversation at JPM, but this year, the pandemic has drawn more attention.

UPDATED: Monday, Jan. 11 at 3:45 p.m. ET

Seagen is pretty pleased with how metastatic bladder cancer med Padcev is performing on the market so far, but it’s also eager to move the drug earlier into treatment in tandem with Merck’s Keytruda. During his Monday afternoon presentation, CEO Clay Siegall told investors for the first time that Seagen would complete enrollment of the phase 1b/2 EV-103 trial—whose Cohort K is testing Padcev among previously untreated metastatic patients, plus or minus Keytruda—by the end of 2021. “My scientific part of me believes that the two drugs together will probably work better, but we don’t know that for sure,” he said. Based on previous data, “one could presume that the combination may in fact win out against the monotherapy, but obviously we need to be driven by the data when we have it,” Chief Medical Officer Roger Dansey, M.D., agreed.

Since the COVID-19 pandemic hit, things haven’t been all bad—at least, not from the perspective of a major R&D player like Genentech. “There’s an enormous number of silver linings” that have come out of the pandemic, CEO Alexander Hardy said during an interview that aired Monday as part of Fierce JPM Week. One major example? Faster, more plentiful partnerships—both public-private, but also private-private. Genentech has struck “a range of partnerships that have happened very, very quickly with parties that we traditionally have not partnered with,” Hardy said.

UPDATED: Monday, Jan. 11 at 3:15 p.m. ET

As COVID-19 vaccines from Pfizer, Moderna, and AstraZeneca are administered around the world, Johnson & Johnson is nearly ready to present phase 3 data from its own program. The company is in the “final stages” of a phase 3 analysis, CEO Alex Gorsky said during a JPM fireside chat Monday. Meanwhile, J&J is “on track” to deliver hundreds of millions of doses in the first half of 2021 and nearly a billion doses by the end of the year, Gorsky said. J&J doesn’t see the other coronavirus vaccine players as rivals, he said, but is instead “cheering for all of those companies.” And amid the news of viral mutations, Gorsky said it’s “really incumbent for all society around the world to get vaccines not only distributed, but administered" to try and stem the tide of the pandemic.

UPDATED: Monday, Jan. 11 at 1:15 p.m. ET

Despite a raft of new dermatology competitors, Novartis’ Cosentyx has been able to hang onto share in a way that’s “been quite remarkable,” company CEO Vas Narasimhan said—and he attributed the success to the drug’s ability to clear psoriasis not only from the skin, but also the nails, scalp and other areas. Still, dermatology is only one piece of the puzzle for Cosentyx, which is moving toward a 50-50 sales split between dermatology and rheumatology. “I think the real story for Cosentyx … is that you’re going to see the majority of the sales come from these rheumatology and newer indications,” he said, adding that those “will become the growth driver” for the projected $5 billion seller. In the meantime, “we’ll continue to be disciplined and thoughtful in how we rebate in the U.S. so we don’t give up price in dermatology at the cost of all these other indications,” he noted.

UPDATED: Monday, Jan. 11 at 12:07 p.m. ET

Last year, Roche lost roughly $5 billion in sales to biosimilar competition, but the company still put up top-line growth, CFO Alan Hippe said. He pointed to Phesgo, a fixed-dose combination of Herceptin and Perjeta, as one countermeasure, but also stressed innovation as “the best line of defense.” Last year, the Swiss pharma signed 132 new collaborations across pharma, digital and personalized healthcare and diagnostics to drive innovation. Story

Biogen and its investors have a lot riding on the company’s FDA application for Alzheimer’s candidate aducanumab, and now the fateful decision is less than 2 months away. At Monday’s JPM presentation, CEO Michel Vounatsos said 2021 could be a “transformative year” for the company as it awaits an FDA decision on the candidate—expected by March 7—and as it delivers new data on a series of pipeline programs.

Independent experts convened by the FDA in November voted against recommending approval for aducanumab, but Biogen R&D chief Al Sandrock said Monday the vote was “nonbinding” and that there’s precedent for the FDA to go against panel recommendations. As the aducanumab situation plays out, Vounatsos said Biogen presents a “balanced” risk reward profile for investors due to its marketed meds, its growing biosimilar business and its pipeline. The company could see “multiple blockbuster launches” in the coming years, he added.

UPDATED: Monday, Jan. 11 at 10:00 a.m. ET

Even after shelling out $74 billion for Celgene and $13.1 billion for MyoKardia, Bristol Myers Squibb still has “significant financial flexibility” to pull off deals, Bristol Myers CEO Giovanni Caforio said. Specifically, the company’s constantly exploring “midsize bolt-on deals” like that of MyoKardia, he added. The company expects to have $45 billion to $50 billion in free cash flow around 2021 to 2023. Story

One month back, the FDA told Regeneron to pump the brakes on its experimental blood cancer drug trial, citing safety concerns. After looking to "fulfill their need" to lift the hold, the company has done its part, and the ball is now in the FDA's court, CSO George Yancopoulos, M.D., Ph.D., said. Regeneron has since paused enrollment on the study—while treatment continues for consenting patients—and sent off a new protocol amendment to the FDA, with the “goal of resuming patient enrollment in the first quarter of 2021.” Story

BioNTech says it's gunning to produce 2 billion doses of its Pfizer-partnered vaccine—now dubbed Comirnaty—in 2021, up from its previous goal of 1.3 billion doses. And that's not all BioNTech has in store for year two of the pandemic; the company is looking to boost capacity by rolling out a six-dose vial; plus, it's continuing to expand with new sites, suppliers and CMOs. A Comirnaty manufacturing site with annual capacity for 750 million doses is pegged to come online by the end of February, for instance. Beyond distribution, the company is also eyeing label expansions in children, pregnant women and other sub-populations. Story

After years of focusing on cystic fibrosis, Vertex Pharmaceuticals is advancing pipeline candidates and eyeing deals in other disease areas. Amid its worldwide rollout for triple combo CF therapy Trikafta, the company has new “firepower” to scout for mid- and late-stage drug programs, CEO Reshma Kewalramani, M.D., said Monday.

Reshma Kewalramani, M.D.
(Vertex Pharmaceuticals)

The drugmaker is scouting for candidates that complement its pipeline, or new “tools and technology” to grow Vertex’s toolkit, she added. Within its own pipeline, the company is enthusiastic about gene-editing therapy CTX001 in sickle cell disease and beta-thalassemia, Kewalramani said. Meanwhile, the company is focused on growing Trikafta in new patient groups and launching in countries where it’s not yet available.

While Novavax wasn’t a first-to-market COVID-19 vaccine player, the Maryland biotech has big goals for 2021. The company plans to report interim phase 3 data for its vaccine, NVX-CoV-2373, sometime during the first quarter, and it’s already stockpiling vaccine doses in case the program wins regulatory green lights. Since the start of last year, Novavax has established a worldwide manufacturing network able to produce 2 billion vaccine doses per year, CEO Stan Erck said during Monday’s presentation. Novavax expects to deliver 110 million doses to the U.S. in the second quarter of 2021. While the duration of protection from the vaccine remains uncertain—as does overall efficacy—R&D head Gregory Glenn said the biotech is exploring the potential for a booster dose.