Werner Baumann, Bayer CEO (Malte Ossowski/SVEN SIMON/picture-alliance/dpa/AP Images)

Bay­er CEO Wern­er Bau­mann says com­pa­ny is 'putting ma­jor lit­i­ga­tion be­hind us' while high­light­ing Q2 growth

Bay­er CEO Wern­er Bau­mann high­light­ed “strong op­er­a­tional per­for­mance” on Thurs­day while rais­ing the full-year guid­ance. But be­fore div­ing in­to the de­tails, he sum­ma­rized Bay­er’s plan to set­tle a slate of on­go­ing lit­i­ga­tion.

“We are mak­ing good progress in putting ma­jor lit­i­ga­tion be­hind us,” Bau­mann said on a Q2 call with in­vestors and an­a­lysts.

He added that the com­pa­ny is “con­fi­dent in the lit­i­ga­tion strat­e­gy” when it comes to glyphosate, the ac­tive in­gre­di­ent in the weed­killer Roundup. Bay­er has faced mul­ti­ple cas­es al­leg­ing that Roundup caused can­cer, and re­cent­ly an­nounced a five-point plan to “a clear path to clo­sure of the U.S. glyphosate lit­i­ga­tion.”

The com­pa­ny has al­ready set­tled 107,000 of 138,000 cas­es, ac­cord­ing to its web­site.

“From to­day’s per­spec­tive, we are suf­fi­cient­ly pro­vi­sioned to deal with the cur­rent and al­so the fu­ture cas­es,” Bau­mann said.

Bay­er has faced scruti­ny since clos­ing $30 bil­lion in val­u­a­tion af­ter its $63 bil­lion buy­out of US agri­cul­tur­al gi­ant Mon­san­to in 2018.

As for law­suits al­leg­ing Mon­san­to and oth­er com­pa­nies should be held re­spon­si­ble for en­vi­ron­men­tal im­pacts from car­cino­genic chem­i­cals called poly­chlo­ri­nat­ed biphenyls (PCBs), Bay­er said a class ac­tion set­tle­ment is like­ly com­ing in Q4.

“The opt out pe­ri­od for the class set­tle­ment re­cent­ly ex­pired and we ex­pect to fi­nal­ize the na­tion­al class ac­tion set­tle­ment in quar­ter four,” Bau­mann said.

He al­so said an ar­bi­tra­tion rul­ing is ex­pect­ed soon in its case with BASF, which claimed Bay­er didn’t ful­ly dis­close per­son­nel costs when it ne­go­ti­at­ed as­sets from the crop sci­ence port­fo­lio.

“We ex­pect the de­ci­sion by the ar­bi­tral tri­bunal to be is­sued short­ly,” the com­pa­ny said.

As for the phar­ma busi­ness, sales were slight­ly up thanks to gains from Eylea, Bay­er’s vas­cu­lar en­dothe­lial growth fac­tor (VEGF) in­hibitor used to treat sev­er­al eye-re­lat­ed con­di­tions, in­clud­ing neo­vas­cu­lar (wet) age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD), mac­u­lar ede­ma fol­low­ing reti­nal vein oc­clu­sion (RVO), di­a­bet­ic mac­u­lar ede­ma (DME) and di­a­bet­ic retinopa­thy (DR).

Eylea earned rough­ly $826 mil­lion last quar­ter (€807 mil­lion), up from $728 mil­lion (€711 mil­lion) in Q2 of 2021.

Bay­er main­tained its con­fi­dence in Eylea de­spite the emer­gence of com­peti­tors, in­clud­ing Roche’s two prod­ucts Susvi­mo and Vabysmo. Back in May, a Spher­ix study re­vealed that while most oph­thal­mol­o­gists have heard of Susvi­mo, a ma­jor­i­ty of the re­spon­dents said they’d turn to Eylea as a safer and more ac­ces­si­ble op­tion.

How­ev­er, Bay­er not­ed that phar­ma growth was held back by “price- and vol­ume-re­lat­ed de­clines for Xarel­to that were large­ly due to ten­der pro­ce­dures in Chi­na and the ex­pi­ra­tion of our patent in Brazil.”

Xarel­to earned rough­ly $1.1 bil­lion (€1.1 bil­lion) in Q2, down slight­ly from the near­ly $1.2 bil­lion it raked in for the sec­ond quar­ter last year.

Con­sumer health sales were up 6.8% this quar­ter, large­ly dri­ven by a 17% growth in al­ler­gy and sales as a high­er num­ber of cold in­ci­dents oc­curred due to less so­cial dis­tanc­ing, the com­pa­ny said.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.

Anna Protopapas, Mersana CEO

In $1.36B biobuck deal with GSK, Mer­sana touts 'biggest pre­clin­i­cal ADC deal ever'

Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.

FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”