David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly CEO Ricks echoes a grow­ing re­frain on price ne­go­ti­a­tions: 'We’ll fo­cus our re­sources on oth­er ar­eas'

Eli Lil­ly had some drea­ry Q2 num­bers to re­port Thurs­day. And they kept an­a­lysts and in­vestors on hold for an hour be­fore at­tempt­ing an ex­pla­na­tion, blam­ing the de­lay on out­side tech is­sues.

The late Q2 call didn’t help make the top and bot­tom line look any bet­ter. Sales dropped to $6.49 bil­lion for the quar­ter, a bad miss from the $6.85 bil­lion con­sen­sus. Ac­cord­ing to Lil­ly, that was due to both low­er prices for some prod­ucts — in­sulin was the stand­out — as well as a for­eign ex­change hit as a strong dol­lar bites and a drop of 13% on Covid-19 rev­enue.

Al­im­ta gener­ics al­so be­gan to carve in­to rev­enue.

As a re­sult, Lil­ly dropped their guid­ance on ad­just­ed earn­ings for 2022 down­ward by 25 cents a share, some­thing in­vestors al­ways hate to see. And Lil­ly was pun­ished for it, with its stock price tak­ing a 3%-plus hit ear­ly in the day.

Anne White

Ahead of the call, Lil­ly an­nounced that the FDA had ac­cept­ed the do­nanemab fil­ing for Alzheimer’s, ready to pro­vide a fast as­sess­ment un­der pri­or­i­ty re­view as the phar­ma gi­ant sought an ac­cel­er­at­ed ap­proval with bio­mark­er da­ta, ahead of a Phase III ef­fi­ca­cy read­out. And neu­ro­science chief Anne White said dur­ing the call that they were com­mit­ted to see­ing it through, even though the de­ci­sion by Medicare to re­strict cov­er­age on Aduhelm — and any oth­er es­sen­tial­ly ex­per­i­men­tal drugs — would con­fine ac­cess to a “very lim­it­ed” group of pa­tients.

Like every oth­er Big Phar­ma CEO, David Ricks en­dorsed the cap on out-of-pock­et drug costs for Medicare mem­bers. But drug pric­ing rules — which are anath­e­ma in the phar­ma world, when tied to man­dat­ed pric­ing — came in for crit­i­cism.

Echo­ing a re­mark by Ab­b­Vie CEO Rick Gon­za­lez, Ricks es­sen­tial­ly said that the new rules as pro­posed now would shift R&D re­sources out of small mol­e­cules and in­to bi­o­log­ics, which are bet­ter pro­tect­ed.

Here’s Ricks:

The ne­go­ti­a­tion piece is a prob­lem. I think in the short term it doesn’t do much; they don’t re­al­ly start un­til ’26 any­way… Prob­a­bly to me the most dam­ag­ing thing about it is that it sends a sig­nal to in­vestors and cap­i­tal al­lo­ca­tors like us that small mol­e­cules and par­tic­u­lar­ly small mol­e­cules in dis­eases that re­quire step­wise de­vel­op­ment, like can­cer, where we start in lat­er stages and work our way to ad­ju­vant or even in some or­phan con­di­tions, re­al­ly aren’t want­ed and are worth a lot less. So we’ll fo­cus our re­sources on oth­er ar­eas of in­no­va­tion, we have plen­ty of those, and so will the rest of the sec­tor. And I think that’s a miss for the pa­tients that prob­a­bly want bet­ter oral can­cer drugs in the fu­ture.

Lil­ly set the stage for the awk­ward H1 call on Wednes­day evening, an­nounc­ing that as fed­er­al sup­plies of its Covid-19 an­ti­body dwin­dle with no funds avail­able for any new con­tracts ahead, they’ll shift over to com­mer­cial sales. Now states and hos­pi­tals will be able to or­der bebtelovimab through a sole dis­trib­u­tor.

One of the bright spots at Lil­ly was on the dual GIP/GLP-1 re­cep­tor ag­o­nist Moun­jaro (tirzepatide) front, which got a green light for di­a­betes a few months ago. Ex­pec­ta­tions are run­ning high that Lil­ly can make this one in­to a ma­jor new drug fran­chise, par­tic­u­lar­ly if they can get ap­proved to mar­ket it for obe­si­ty.

David Risinger of SVB Se­cu­ri­ties was hap­py.

Sales were $16mm vs. SVBS’s $10mm and cons’ $12mm; we as­sume up­side was due to ini­tial chan­nel fill. Lil­ly in­di­cat­ed that it ex­pects to have suf­fi­cient sup­ply for launch, which is im­por­tant in light of No­vo Nordisk’s (Not Rat­ed) We­govy pro­duc­tion chal­lenges.

The spot­light now shifts to the reg­u­la­to­ry plan on obe­si­ty as they pur­sue oth­er in­di­ca­tions in the clin­ic, much like No­vo Nordisk is do­ing with We­govy (semaglu­tide). Lil­ly is set­ting up a head-to-head study with No­vo’s drug on obe­si­ty, but to­day there’s still no time­line avail­able on that score.

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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.”