JPM Day 1: Merck's assurances, Teva's shutdown tally, Biogen's launch prep and one CEO's word on another

Biogen and Incyte both made pipeline pickups on Day 1 of the J.P. Morgan Healthcare Conference in San Francisco. (Pixabay)

The first day of #JPM20 is officially wrapped. No big deal news—much to attendees' disappointment—but big players jumped out to a fast start on-site Monday, with CEOs and top execs onstage touting their businesses.

Here's your need-to-know, from Merck & Co. talking up its pipeline to Gilead Sciences talking deals, from BioMarin laying out its plans to beat Roche to Biogen offering a peek into its Alzheimer's launch prep. Plus Novartis, Vertex Pharmaceuticals, Johnson & Johnson, Regeneron, Teva and many others.

Want more? Follow FiercePharma and FierceBiotech's ongoing coverage here and here. And check out the Day 2 roundup covering the on-the-ground skinny from Tuesday's action.

UPDATED: Tuesday, 08:08 a.m. P.T.

Despite unrelenting controversy around Alzheimer's candidate aducanumab, Biogen's already started gearing up for a potential approval as it's still prepping for an FDA filing. It's assembling “top talent” for its launch teams, beefing up manufacturing and talking to stakeholders about pricing, CEO Michel Vounatsos said. The company has developed its “go-to-market model” for the U.S., Vounatsos said, without giving out any details. Story

BioMarin has significantly anted up its gene therapy manufacturing capacity in anticipation of EU and FDA approvals for its hemophilia A drug valoctocogene roxaparvovec. Now being able to support up to 10,000 patients per year, the company can theoretically—not that it will—treat all existing U.S. severe hem A patients in two years, ahead of the expected launch of Roche's rival drug SPK-8011, CEO Jean-Jacques Bienaime said. That's important “because first-mover advantage in gene therapy is fundamental in a sense that every time you treat a patient that patient is off the market,” he said. Story

UPDATED: Monday, 10:20 p.m. P.T.

It’s a question investors have asked Merck & Co. again and again: Does the company have enough in its pipeline to supplement Keytruda when the drug’s mammoth sales one day slow down? But the way R&D chief Roger Perlmutter sees it, it’s a fair one. “Everyone recognizes that Keytruda is no ordinary drug,” he said, pointing to the way it’s changing practice and growing “enormously.”

That said, he and CEO Ken Frazier agree that the pharma giant’s pipeline has never been “more deserving of investment,” with other oncology assets and vaccines coming in hot.

With Reshma Kewalramani preparing to take the reins as Vertex CEO, the company is eyeing a number of disease areas beyond its current core, cystic fibrosis. And moving from one disease area to many is “something we’ve been thinking about and working on diligently” over a number of years, she said Monday, adding, “I cannot underestimate” that challenge.

But the disease areas Vertex is targeting with its pipeline candidates all have some things in common. For starters, they’re all programs with efficient development pathways and they’re all served by specialty markets, Kewalramani said.

UPDATED: Monday, 3:44 p.m. P.T.

Johnson & Johnson has posted market-beating pharma growth for years, and it doesn't expect that to change anytime soon. How will it keep the sales churning? Drugs it's already fielding. About 75% of J&J's growth through 2023 will come from existing drugs, whether through market share gains, new indications or approvals in earlier lines of treatment, said Jennifer Taubert, the drugmaker’s worldwide pharma chairman. Asked during the Q&A session about the tough pricing environment across the industry, she said she doesn’t see things getting any easier. But J&J's already counting on volume-based growth, she said, and its diverse set of businesses offer ballast in any one sector's storm.

UPDATED: Monday, 2:05 p.m. P.T.

With an FDA approval for its second RNAi therapy in hand, Alnylam is calling its shot in 2020, predicting a "catalyst-rich" year ahead with at least four late-stage candidates on the way to launch in the next 12 to 24 months. The promising results for newly minted Givlaari, an RNA therapy for acute hepatic porphyria approved in November, could put Alnylam on the path to becoming a "top five" biopharma, CEO John Maraganore told investors Monday at JPM, though we weren't sure which five he meant. The drugmaker is aiming for launches of homegrown late-stage candidates lumasiran and vutrisiran as well as partner meds including highly touted PCSK9 candidate inclisiran and hemophilia hopeful fitusiran. Story

UPDATED: Monday, 1:29 p.m. P.T.

Want to know what Gilead Sciences is plotting next in terms of business development? Take a good, long look at the company’s $5.1 billion Galapagos partnership from last July. “We want to find complementary arrangements like we had with Galapagos,” CEO Daniel O’Day said during Gilead’s presentation.

Of course, every deal can’t be as wide-reaching as the 10-year Galapagos pact. “You can’t do a lot of these, but we would like to find a way to do at least one more” over the next few years, Chief Financial Officer Andy Dickinson said during a breakout session afterward. Beyond that, investors should expect a “regular cadence of partnerships,” Dickinson said, including small and medium deals. And O’Day assured investors Gilead would still do some straight M&A, too. “I think we need to think about multiple approaches here,” he said. In terms of what stage transactions Gilead is thinking about, the “vast majority of deals” will be earlier-stage, but “rest assured we are looking at supplementing our late-stage portfolio,” too. Story

Novartis is no stranger to scandal, but the company is intent on rehabbing its reputation, CEO Vas Narasimhan said at JPM on Monday. To demonstrate that, Novartis is rolling out official goals on ethics, pricing, global health and corporate citizenship and has a new executive team to keep track of its progress. The kicker? Performance against the goals will be linked to exec pay. Story

Aside from Narasimhan’s trust pledge, the CEO highlighted its digital ambitions; it now employs 1,500 data scientists, he said. And to keep its full range of goals on track, the company has to be a “launch machine,” with 15 ongoing or near-term launches in the works. And like other big pharmas, Novartis has growth plans in China, with 50 expected approvals there in the next five years.

UPDATED: Monday, 12:58 p.m. P.T.

It’s only been about a month since Sanofi and Regeneron split up rights to Praluent and Kevzara and doubled down on Dupixent, but so far the change has “really been great,” Regeneron CEO Len Schleifer said Monday at JPM. The new arrangement is better because there won’t be two companies focusing on “products that are not nearly as important as Dupixent,” Schleifer said. Instead, both companies can focus on that runaway immunology med, which is generating about $2.4 billion per year based on third-quarter 2019 results. Of Sanofi’s new CEO Paul Hudson, Schleifer said he’s “quite capable” and “focused” on turning Dupixent into a megablockbuster.

Two years ago, when Teva CEO Kåre Schultz took the stage at JPM, “we had a pretty dramatic situation,” as he put it Monday. Between major debt, competition to star drug Copaxone and a “dramatic decline” in U.S. generics pricing, things were looking dire. But this year, Schultz was ready to offer a progress report.

Teva has closed or sold off 13 manufacturing sites and is in the process of winding down or selling 10 more. It’s closed 40 labs and offices. And perhaps most importantly to Schultz, who proclaimed “I don’t like debt,” Teva has taken its tab down by more than $8 billion over two years. So what's the next phase for Teva? Optimizing manufacturing in a more “sophisticated” way, leveraging its generics expertise for biosimilar launches, growing in China and expanding Austedo and Ajovy, two meds Schultz said will soon offset revenue losses from still-declining Copaxone.

In a whirling week of dealmaking and limited space, our FierceBiotech team had one question in mind: Where do all the mattresses go? A cherished tradition of hosting investor meetings in emptied-out hotel rooms during JPM's weeklong networking extravaganza creates a logistical challenge, with hotels forced to shuttle unused mattresses into rooms that could otherwise sell for hundreds of dollars per night. But for the smaller players in San Francisco this week, even more creative solutions must be found. Story

Last year, Bristol-Myers stole the show with its $74 billion deal agreement for Celgene. But one year later, with the deal just recently closed, CEO Caforio says BMS has made “great progress” with integration: Its leadership teams are in place, it’s designed the new company’s operating model and things are coming together smoothly on the commercial and R&D sides. But in other ways, it’s just getting started. Story

While 2020 hasn't started in similar style, a report from EY's experts suggests M&A the rest of the year should be just as strong as last—but this time around, biotech and medtech could play a bigger part. And with $1.4 trillion in dealmaking firepower at hand, the healthcare industry can certainly afford it. Story

Case in point: Incyte, fresh off a trial flop early this month, agreed to pay $750 million for licensing rights to MorphoSys' anti-CD19 antibody tafasitamab, which is facing an FDA approval decision in combo with Bristol-Myers Squibb's Revlimid in diffuse large B-cell lymphoma. Incyte will pony up the $750 million to license the drug, buy $150 million in MorphoSys shares and shell out up to $1.1 billion if future milestones go the right way. Story

Biogen, diving even further into Alzheimer's R&D, will pick up Pfizer's early-stage candidate PF-05251749 for a tidy $75 million. The drug is a CK1 inhibitor that moved into the clinic on the strength of evidence it can cross the blood-brain barrier and regulate circadian rhythms, thereby improving behavioral and neurological symptoms in patients with diseases including Alzheimer’s. On top of its $75 million check, Biogen will shell out up to $635 million in milestone payments if development and commercialization targets are met. Story

Roche inked a 15-year, nonexclusive partnership with Illumina that will see the two companies work together to develop the DNA sequencing giant's pan-cancer assay as a companion diagnostic for different cancer drugs, including with expertise from Roche's Foundation Medicine division. Additionally, Roche will opt to develop and manufacture its genomic test kits for tumor tissue and blood samples for use on Illumina's current and upcoming lines of sequencing hardware. Story 

After netting a 510(k) clearance from the FDA last year, Ivenix brought on a new CEO to help guide the market launch of its digital infusion pump designed to help reduce medication errors. Jorgen Hansen, formerly president and CEO of Cantel Medical, has also held global strategy and operations positions at ConvaTec and Coloplast, and serves on the board of AdvaMed. According to Ivenix, infusion-related medication errors make up about half of the adverse safety events reported to the FDA. Story 

As Regeneron prepared for its JPM presentation Monday afternoon, the drugmaker highlighted booming sales of its eye med Eylea, which hit $4.14 billion in 2019––a 14% increase over the previous year––in a filing with the Securities and Exchange Commission. In the fourth quarter, Eylea nabbed an estimated $1.22 billion in global sales, a 13% jump, the drugmaker said. Eylea nabbed an FDA nod in May to treat all stages of diabetic neuropathy, a condition that affects about 8 million people worldwide, the company said.

Looking for a game-changer in biotech, EQRx and its CEO, Alexis Borisy, has raised $200 million in funding for a new kind of company—one with a mission to create "equally good or better drugs” and sell them at cheaper prices. The new company will focus on equivalars, essentially new medicines designed after existing meds or soon-to-debut therapies. But according to Borisy, EQRx meds will not infringe other companies’ intellectual property and will be protected by their own patents. Story

As all biotech watchers know, the San Francisco Bay Area isn't just the home of JPM. But soon, in addition to HQs for some of the biggest names in the business, SFO will house a state-of-the-art R&D facility for Johnson & Johnson's Janssen unit. The biotech unit penned a deal for space in The Shore at Sierra Point in Brisbane, California––a region the drugmaker deems to be a “critical innovation hotbed.” Janssen said the expansion will help it bridge “key interdisciplinary capabilities” such as biology and data science to “fuel a step-change in how it creates medicines.” It didn’t say whether it would be employing new staffers nor how many. Story