This year's For­tune 500 list is out. And phar­ma com­pa­nies saw ma­jor prof­it growth

2021 was a year of good for­tune for phar­ma­ceu­ti­cal com­pa­nies — at least the ones on this year’s For­tune 500 list. Many saw a mas­sive surge in prof­its last year, led by Gilead and its mam­moth 4,961% growth.

How­ev­er, it ap­pears Gilead isn’t alone in that re­spect. De­spite its gains, the com­pa­ny ac­tu­al­ly fell 13 spots in For­tune’s rank to No. 129, as sev­er­al oth­er com­pa­nies more than dou­bled their prof­its.

Pfiz­er saw a 128.6% growth, mov­ing up 34 spots on For­tune’s rank to No. 43. The phar­ma gi­ant raked in $81.3 bil­lion last year, and this year ex­pects to earn $32 bil­lion in Covid-19 vac­cine sales alone.

CEO Al­bert Bourla has big plans for those fresh bil­lions, ad­mit­ting on the Q1 call that “ac­qui­si­tions are ob­vi­ous­ly very much in the cards.” On­col­o­gy, vac­cines, rare dis­eases and in­ter­nal med­i­cine are among the core fo­cus­es in R&D, ac­cord­ing to chief busi­ness in­no­va­tion of­fi­cer Aamir Ma­lik.

Ab­b­Vie saw a 150% in­crease in prof­its, mov­ing up five spots to No. 63 as CEO Rick Gon­za­lez fo­cus­es on lin­ing up suc­ces­sors to the com­pa­ny’s block­buster Hu­mi­ra. Last year, Hu­mi­ra crossed the $20 bil­lion mark in sales. Look­ing ahead, Gon­za­lez said Skyrizi and Rin­voq can sur­pass Hu­mi­ra’s peak sales.

The chief ex­ec­u­tive re­vealed ear­li­er this year that Ab­b­Vie will look to add sev­er­al new in­di­ca­tions to the Skyrizi and Rin­voq la­bels in the com­ing months. But he isn’t re­ly­ing on those prod­ucts en­tire­ly. Gon­za­lez con­tin­ues to beef up the ear­ly-stage pipeline, and just last week shelled out $48.5 mil­lion to jump in­to the Treg space with Cu­gene.

Re­gen­eron leapfrogged the most spots on For­tune’s list, jump­ing 123 places to No. 231, with a 129.9% prof­it growth. The biotech’s mon­o­clon­al an­ti­body treat­ment for Covid-19 brought in $6.19 bil­lion last year, out of a to­tal $16.07 bil­lion in sales. That’s chang­ing, though, as the FDA halt­ed its use ear­li­er this year due to “marked­ly re­duced ac­tiv­i­ty” against the Omi­cron vari­ant.

Mod­er­na al­so made its For­tune 500 de­but this year, clock­ing in at No. 195, af­ter rak­ing in more than $18 bil­lion last year from its mR­NA Covid-19 vac­cine. Ear­li­er this year, CEO Stéphane Ban­cel pegged a $19 bil­lion sales es­ti­mate for 2022.

Mean­while, John­son & John­son re­mains the high­est bio­phar­ma com­pa­ny on For­tune’s list, stand­ing at No. 37 with a 41.9% growth in prof­its. It may not stay there for long, as J&J re­cent­ly low­ered its full-year sales fore­cast to be­tween $94.8 bil­lion and $95.8 bil­lion, down about $1 bil­lion from what the com­pa­ny pre­dict­ed back in Jan­u­ary. The com­pa­ny al­so sus­pend­ed fi­nan­cial guid­ance for its Covid-19 vac­cine, as a glob­al sup­ply sur­plus and vac­cine hes­i­tan­cy af­fect de­mand.

How­ev­er, CEO Joaquin Du­a­to main­tained on the Q1 call that the phar­ma gi­ant will be able to do “small, medi­um and large scale ac­qui­si­tions should the right op­por­tu­ni­ty present it­self.”

While For­tune cel­e­brat­ed 44 com­pa­nies on the list that are led by women (an all-time high) on­ly two are from the phar­ma­ceu­ti­cal in­dus­try: Zoetis, led by Kristin Peck; and Ver­tex Phar­ma­ceu­ti­cals, led by Resh­ma Ke­wal­ra­mani.

Wal­mart, Ama­zon, Ap­ple and CVS Health topped this year’s For­tune 500 list. Ed­i­tor-in-chief Alyson Shon­tell is al­ready look­ing to see which com­pa­nies will make a come­back this year, say­ing in a news re­lease:

“Sev­er­al pan­dem­ic win­ners make their de­buts this year. Vac­cine mak­er Mod­er­na clocked in at No. 195. Zil­low, which ben­e­fit­ed from the red-hot hous­ing mar­ket, comes in at No. 424. And Coin­base (No. 437) be­came the first cryp­to com­pa­ny to join the 500. […] The re­al win­ners will be the com­pa­nies that not on­ly thrived un­der the freak­ish cir­cum­stances of Covid, but can flour­ish once the world opens back up.”

Cor­rec­tion: RE­GEN-COV brought in $2.3 bil­lion in Q4, and $6.19 bil­lion for the full year. 

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Mark Cuban (Jed Jacobsohn/AP Images)

Mov­ing to the em­ploy­er side of health­care, Mark Cuban's Cost Plus Drugs part­ners with a PBM

From “Shark Tank” to direct-to-consumer generic drugs, Mark Cuban has made another inroad in the ongoing battle over prescription drug prices. His cost-plus-15% generic drug company, frequently undercutting many competitors, now has its sights set on the employer healthcare market.

Cost Plus Drugs, which originally pledged to cut out PBMs, has now partnered with the PBM EmsanaRx, majority owned by the Purchaser Business Group on Health, to launch a supplemental drug discount program designed specifically for self-funded employers, the company announced Thursday.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

The generics manufacturer Lupin has been given another Form 483 from the FDA this year.

US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.

The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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