UPDATED: JPM22, Day 1: Merck's COVID antiviral, Novartis' spending plans, Pfizer's production boost and more

After last month's pivot from an in-person event amid omicron concerns, the annual J.P. Morgan Healthcare Conference has finally kicked off virtually. So boot up those computers and get your meeting links ready, because it's set to be a week full of biopharma action.

Here's your Day 1 need-to-know. For Day 2 news, click here. For Day 3, check here

UPDATED: Monday, Jan. 10 at 8:05 p.m. ET

The luster came off Merck’s COVID-19 antiviral pill molnupiravir in November when a trial showed it to have 30% efficacy in reducing the risk of hospitalization and death as opposed to the 50% figure reported at the trial’s interim stage. When Pfizer reported 89% efficacy for its COVID-19 pill, Paxlovid, a little more shine came off of Merck's pill.

But on Monday, Merck said it was confident molnupiravir is highly effective against the omicron variant.

“This is a mechanism that has a 90% reduction in mortality,” Dean Li, Merck’s president of Research Laboratories, said. “This mechanism and molecule works for omicron and I would imagine most any variant that comes up.”

Merck produced 10 million courses of the treatment last year and intends to produce 20 million this year, CEO Rob Davis said. The company has not altered its 2022 revenue projection of between $5 billion and $7 billion for molnupiravir.

“We continue to believe that guidance is the right guidance based on what we’re seeing with the contracts we’re signing,” Davis said. “More importantly we’re delivering product. We actually delivered about 950,000 courses to the U.S. government in December. We will deliver 3.1 million courses to the U.S. by the end of January.”  

UPDATED: Monday, Jan. 10 at 7:10 p.m. ET

Two doses of Pfizer’s COVID-19 vaccine are "not enough" for sufficient protection against the omicron variant, the company’s CEO Albert Bourla said on Monday afternoon. While a third dose is "providing quite good protection against death and decent protection against hospitalization," questions remain about the duration of that protection, he added.

The company will have an omicron specific vaccine ready by March. Pfizer also will have a hybrid vaccine ready to go at the same time which would protect against omicron and other COVID-19 variants. At that time, the company will determine which shot could provide the best protection going forward.

Also at his presentation, Bourla said Pfizer aims to produce 120 million courses of its antiviral Paxlovid next year. That's a major increase from the 50 million courses the company originally thought it could make in 2022. Story

UPDATED: Monday, Jan. 10 at 5:59 p.m. ET

When it comes to losses of exclusivity, Takeda isn’t breaking a sweat. A phalanx of 14 brands including Takhzyro, Natpara and Entyvio are expected to hold the line once Vyvanse, Velcade and Azilva plunge off the patent cliff, with some auxiliary support from recent launches Exkivity and Livtencity, Takeda CEO Christophe Weber said Monday. 

Takeda’s 14 banner pharma products snared roughly $11 billion in fiscal year 2020, putting the Japanese drugmaker on track to hit its 2021 revenue growth forecast of 14% to 16%, Weber said. Through 2025, the group of meds is expected to pull in roughly $9 billion in additional sales, more than double the $4.5 billion generics blow it’s expecting for ADHD med Vyvanse, multiple myeloma drug Velcade and blood pressure compound Azilva.

Meanwhile, the biosimilar threat to Crohn’s disease and ulcerative colitis blockbuster Entyvio is looking less immediate. “First, at this point in 2022, we are not aware of Entyvio biosimilars in clinical development,” Weber said. The company estimates it would take at least four to five years for a biosimilar to pass all the clinical hurdles needed to apply for an approval. In addition, Takeda has patents on the drug reaching out to 2032, so any biosimilar rival that tries to launch before then would need to contend with those patents, Weber said.

UPDATED: Monday, Jan. 10 at 4:03 p.m. ET

At last year’s J.P. Morgan Healthcare Conference, Jazz Pharmaceuticals CEO Bruce Cozadd predicted that about half of the company’s revenue would come from new drugs by 2022. One year later, the company appears poised to make that prediction a reality. In the most recent quarter, products launched or acquired since 2019 comprised more than 50% of Jazz’s sales, Cozadd said Monday. For 2022, the company expects newer products to make up more than 65% of sales. 

Those products are the sleep meds Sunosi and Xywav, the GW Pharmaceuticals-acquired epilepsy blockbuster-to-be Epidiolex, plus small cell lung cancer drug Zepzelca and blood cancer therapy Rylaze

The drugs all form parts of a mounting crescendo Jazz has planned for the middle of the decade, when the company aims to snare $5 billion in annual sales. Of that total, $2 billion is expected to come from the company’s oxybate franchise, which includes Xyrem and its follow-up medication Xywav. Another $2.5 billion will come from epilepsy med Epidiolex, with assists from cancer meds Zepzelca and Rylaze, Cozadd said. 

Overall, the company is on track to hit more than $3 billion in revenue for 2021, the CEO noted. 

UPDATED: Monday, Jan. 10 at 3:02 p.m. ET

After a few years of stagnation, BioMarin is counting on a boost from its new dwarfism drug Voxzogo, which was approved in Europe in August and the U.S. in November. Analysts have come to little consensus on the potential of the drug, perhaps because it is the first to address condition.

Monday, BioMarin CEO Jean-Jacques Bienaime said his company projects sales of the daily injected treatment to fall between $80 million and $110 million this year, adding that the “launch (in Europe) is going better than anticipated.”

“We have a lot of anecdotal evidence,” Bienaime said. “Lots of pediatricians and patients’ families are reaching out to us. We are pretty confident in the guidance that I’ve just given, although we might change it a little bit in the next months when we have more information on the U.S. launch."

BioMarin is also working toward approval of Voxzogo in Japan, which the company believes is its second largest market for the drug. With 21,000 potential patients around the world, a $3 billion market awaits, BioMarin said.

UPDATED: Monday, Jan. 10 at 1:42 p.m. ET

Gilead Sciences’ HIV business isn’t slowing down anytime soon. Chalk it up to once-daily pill Biktarvy and long-acting hopeful lenacapavir, which are poised to help deliver sustainable revenue “through 2030 and beyond,” Gilead CEO Daniel O’Day said Monday at the 2022 virtual J.P. Morgan Healthcare Conference. The company expects Biktarvy to fuel growth until later in the decade, when Gilead foresees the treatment market shifting more toward long-acting offerings, O’Day said.

Gilead’s got that angle covered, too, thanks to lenacapavir, which makes up the “foundation” of the company’s long-acting program in both treatment and prevention, the CEO said. Gilead last year kicked off two phase 3 prevention trials evaluating lenacapavir as a monotherapy every six months, and it expects a regulatory decision on that indication around 2025, O’Day said. If approved, Gilead thinks lenacapavir’s six-month dosing schedule would give the drug enough of a convenience edge to help expand the overall prevention market.

Meanwhile, a new oncology age is dawning at Gilead. Back in 2019, the disease made up just 5% of the company’s business. By 2030, however, it is expected to make up more than a third, O’Day said. Gilead’s oncology business is on track to reap more than $1 billion in 2021 sales, which “starts to hint at the revenue potential that we have ahead of us,” the CEO added. Much of that positive momentum can be credited to Trodelvy and Yescarta, which generated $262 million and $632 million in third-quarter sales, respectively.

UPDATED: Monday, Jan. 10 at 1:26 p.m. ET

Ahead of Regeneron's conference presentation, the company revealed that its COVID-19 antibody cocktail generated unaudited sales of $2.29 billion in the fourth quarter, bringing its total haul for the year to $5.82 billion. 

The Regen-Cov treatment has been shown to lack effectiveness against the omicron variant, but the company is busy working on cocktails to treat it and other potential variants. Regeneron believes there will be a long-term market for antibodies, especially for the immunocompromised.

Regeneron also said that U.S. sales of its macular degeneration drug Eylea came in at $1.54 billion for the fourth quarter and $5.79 billion for the year, a healthy increase on the $4.95 billion it generated in 2020. The company hopes a high-dose version of the drug, now in testing, will emerge and give patients an option for fewer injections.

“We have a reasonable chance of now showing that the high-dose Eylea will deliver a similar safety profile while allowing patients to have longer interval of treatment,” Chief Scientific Officer George Yancopoulos, M.D., Ph.D., said Monday.

UPDATED: Monday, Jan. 10 at 12:29 p.m. ET

After asking the FDA to limit Aduhelm’s label right out of the gate, Biogen is now advocating for further restrictions for potential Medicare coverage. Among five possible outcomes from an upcoming Centers for Medicare & Medicaid Services decision, Biogen is advocating for coverage that aligns with Aduhelm’s clinical trial population from the phase 3 EMERGE and ENGAGE trials, Alisha Alaimo, Biogen’s U.S. chief, said during the JPM event. That would mean a narrower population than Aduhlem’s current FDA label, which only requires the drug to be used in patients with mild cognitive impairment or mild dementia.

While coverage with restrictions is what Biogen is wishing for, the company isn’t choosy, said CEO Michel Vounatsos. Story

UPDATED: Monday, Jan. 10 at 10:42 a.m. ET

There’s plenty of buzz around Vertex Pharmaceuticals’ pipeline, but cystic fibrosis (CF) newcomer Trikafta has earned its spot in the limelight, too. In 2021, Vertex clinched reimbursement for the med in 16 countries and launched Trikafta in kids ages 6 to 11 in the U.S., teeing up “thousands” of new patient starts for the nascent blockbuster. Meanwhile, Vertex sees potential for “significant” CF growth “well into the middle of the decade,” CEO Reshma Kewalramani said during the company’s presentation at the 2022 virtual J.P. Morgan Healthcare Conference.

Sizing up the CF market, the CEO estimated some 83,000 CF patients live in the U.S., Europe, Australia and Canada. Vertex “reached thousands of new patients in the past year,” but there are “still more than 25,000” who could benefit from Trikafta who aren’t yet on therapy, Kewalramani said. She broke those patients down into three groups: those who’ve yet to start on Trikafta in countries where it’s been reimbursed, patients in places where the drug hasn’t been reimbursed yet and younger patients, whom Vertex will target through future label expansions.

Part of Vertex’s strategy to expand Trikafta’s reach? Real-world data from more than 16,000 U.S. patients, unveiled at JPM, which show the drug cut the risk of lung transplant by 87%, led to 77% fewer pulmonary exacerbations and slashed the risk of death by 74%. The data “set a very high bar for any future therapy to meet,” Kewalramani said. Story

UPDATED: Monday, Jan. 10 at 10:35 a.m. ET

During a one-on-one conversation with J.P. Morgan senior analyst Chris Schott, Johnson & Johnson’s new CEO Juaquin Duato said he’ll continue to manage the healthcare giant as a “three-sector company” as J&J preps for its consumer healthcare spinoff late next year.  

Within the pharma business, J&J is eying big growth through through the rest of the decade. The company aims to generate $60 billion in pharma sales by 2025, driven mostly by new indications and new formulations for its existing big sellers such as Darzalex and Tremfya. The $60 billion figure excludes any potential revenue from "inorganic" sources such as M&A, Duato said.

As for new launches, Duato highlighted five that could generate $5 billion or more in peak sales. Those include the Legend Biotech-partnered CAR-T medicine Carvykti, the potential “pipeline in a product” drug nipocalimab, Rybrevant in lung cancer, a potential first-in-class oral factor XIa inhibitor milvexian and a potential bladder cancer platform called Taris. J&J expects to see more growth from those drugs in the second half of the decade, Duato said. Story

UPDATED: Monday, Jan. 10 at 9:40 a.m. ET

Moderna has bumped its sales projection for its COVID-19 vaccine from $17 billion in 2022 to $18.5 billion, the company said on Monday at the J.P. Morgan Healthcare Conference. The increase comes from recent contracts signed with the U.K., Switzerland and South Korea to deliver COVID vaccines this fall.

During the presentation, Moderna CEO Stéphane Bancel also explained the company's four-pronged 2022 product strategy. The mRNA specialist hopes to bring to the market a pan-respiratory annual booster vaccine, which would defend against COVID, the flu and respiratory syncytial virus. The vaccine would be customized geographically depending on circulating strains.

Toward this effort, Moderna points to new manufacturing facilities in Canada and Australia that will be able to produce rapid-response shots modified for those areas. The company is working to secure similar manufacturing arrangements with other countries around the world

“It’s a bit like you’ll get an annual upgrade of a product by adding more vaccine in the same vial,” Moderna CEO Stéphane Bancel said Monday on CNBC. “You’ll get an adaptation for the current strains of that year in your geography. In the U.S., or in Europe, or in Japan, as we see a lot of winters, the flu vaccine is perceived not to work because there are actually different strains circulating around the world.”

UPDATED: Monday, Jan. 10 at 9:23 a.m. ET

Novartis will remain disciplined in doing “balanced” capital allocation, CEO Vas Narasimhan told a virtual audience Monday. The Swiss pharma recently sold its longtime stake in crosstown rival Roche for $20.7 billion, and it’s in the process of a strategic review of generics unit Sandoz that could also yield a big windfall. So investors have repeatedly pressed Novartis management for updates on capital allocation strategy.

Just how “balanced” will Novartis be? After closing the Roche share sale, Novartis unveiled a plan to buy back up to $15 billion in shares from investors before the end of 2023. The company has put down $800 million upfront to buy British biotech Gyroscope Therapeutics for a gene therapy currently in phase 2 development for geographic atrophy, an eye disease. It shelled out $300 million upfront and committed $700 million in option exercise fee to license BeiGene’s anti-TIGIT med ociperlimab. Monday, the Swiss pharma unveiled a deal worth 150 million Swiss francs ($163 million) for Molecular Partners’ COVID-19 antiviral ensovibep after seeing positive clinical data.

Pointing to those transactions, Narasimhan said Novartis will continue to look for “value-creating bolt-on” deals that are typically valued at lower than $10 billion. “There’s clearly the opportunity to build a very strong pipeline, without reverting to doing larger deals,” he said.

UPDATED: Monday, Jan. 10 at 8:15 a.m. ET

Kicking off the Big Pharma presentations Monday morning was Bristol Myers Squibb, which stole the show ahead of 2019's J.P. Morgan healthcare conference with its massive Celgene buyout. At BMS' session, execs said the drugmaker aims to grow despite generic and biosimilar competition by expanding its key brands and advancing its pipeline. The company also sees opportunity in "disciplined business development." BMS' new product portfolio can deliver $25 billion or more by 2029, execs figure, and the company is planning seven launches from its mid- to late-stage pipeline. BMS has 50 drugs in its early pipeline and can lean on $45 billion to $50 billion in free cash flow where needed. 

As BMS weathers Revlimid's upcoming loss of exclusivity, it expects megabrands Opdivo and Eliquis to keep on churning in the coming years, delivering many billions in additional sales by 2025 before their own patent cliffs later in the decade. Reblozyl, a first-in-class anemia drug approved in 2020, could generate $4 billion by 2029—although competition may be coming from others in the field. The company also spotlighted several other blockbusters-in-the-making among its late-stage drug candidates. On the dealmaking side, BMS said it plans to continue scouting for small and mid-sized "bolt-on" transactions that can refresh its pipeline. Meanwhile, the company is working on paying down debt and recently authorized a whopping $15 billion share buyback program. Story