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.

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:

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.

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.

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.

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.”