Albert Bourla, Pfizer CEO (Matthew Busch/Bloomberg via Getty Images)

Pfiz­er's Al­bert Bourla spells out 'tran­si­tion year' for Covid prod­ucts, with sales ex­pect­ed to reach a low point

On the heels of a record sales year, Pfiz­er is brac­ing for im­pact as it ex­pects Covid-19 rev­enue to bot­tom out in 2023.

That’s due to low­er com­pli­ance with vac­cine rec­om­men­da­tions, few­er pri­ma­ry vac­cines be­ing ad­min­is­tered, and a “sig­nif­i­cant” gov­ern­ment sup­ply that’s ex­pect­ed to last through­out ear­ly this year, ex­ecs said Tues­day on the com­pa­ny’s Q4 earn­ings call.

CEO Al­bert Bourla an­tic­i­pates $13.5 bil­lion in Comir­naty sales this year, down 64% from 2022, and just $8 bil­lion in Paxlovid rev­enue, down 58% from 2022.

“We ex­pect 2023 to be a tran­si­tion year in the US,” he said on the call, adding that the com­pa­ny sold more vac­cine and treat­ment dos­es this year than were ac­tu­al­ly used. “This re­sult­ed in a gov­ern­ment in­ven­to­ry build that we ex­pect to be ab­sorbed some­time in 2023 — prob­a­bly the sec­ond half of the year. Around that time, we ex­pect to start sell­ing Comir­naty through com­mer­cial chan­nels at com­mer­cial prices.”

Just 15.5% of el­i­gi­ble Amer­i­cans have re­ceived bi­va­lent boost­er dos­es, com­pared to 69.2% who com­plet­ed their pri­ma­ry se­ries, ac­cord­ing to the CDC’s lat­est da­ta. Last week, the FDA’s vac­cines ad­vi­so­ry com­mit­tee vot­ed unan­i­mous­ly in fa­vor of “har­mo­niz­ing” Covid vac­cine com­po­si­tions, mean­ing all new vac­cine re­cip­i­ents would re­ceive a bi­va­lent shot, re­gard­less of whether they’ve re­ceived the pri­ma­ry se­ries.

Even so, on­ly 31% of peo­ple in the US re­ceived a Covid vac­cine this year, and Pfiz­er ex­pects that num­ber to dip to about 24% in 2023.

David Den­ton

Bourla’s ex­pect­ing a sim­i­lar slump in Paxlovid sales, due to ex­ist­ing un­used gov­ern­ment sup­ply. Ac­cord­ing to da­ta from AS­PR up­dat­ed last week, states have about 4 mil­lion un­used Paxlovid cours­es.

The an­tivi­ral sig­nif­i­cant­ly un­der­per­formed this year, miss­ing Bourla’s pri­or full-year pro­jec­tions by just over $3 bil­lion. Comir­naty seemed to pick up the slack, how­ev­er, rak­ing in rough­ly $37.8 bil­lion in glob­al sales, or about $3.8 bil­lion more than Bourla pre­dict­ed at the end of the third quar­ter.

“While pa­tient de­mand for our Covid prod­ucts is ex­pect­ed to re­main strong through­out 2023, much of that de­mand is ex­pect­ed to be ful­filled by prod­ucts that were de­liv­ered to gov­ern­ments in 2022 and record­ed as rev­enues last year,” CFO David Den­ton said on the call.

An­gela Hwang

Com­mer­cial pric­ing for both Comir­naty and Paxlovid will like­ly kick in around the sec­ond half of this year, ac­cord­ing to Bourla. While the phar­ma gi­ant pre­vi­ous­ly said it ex­pects to charge be­tween $110 and $130 for the BioN­Tech-part­nered shot (al­most qua­dru­pling the price), chief com­mer­cial of­fi­cer An­gela Hwang said the team is still “prepar­ing what those pric­ing sce­nar­ios could look like” for Paxlovid and will “share more at the right time.”

The Pfiz­er team is ex­pect­ing Covid sales to pick back up in the next cou­ple years — and if all goes ac­cord­ing to plan, a suc­cess­ful com­bi­na­tion shot for flu and Covid-19 would “bring the per­cent­age of Amer­i­cans re­ceiv­ing the Covid-19 vac­cine clos­er to the por­tion of peo­ple get­ting flu shots, which is cur­rent­ly about 50%,” Bourla said. The com­pa­ny launched a Phase I study for an mR­NA-based com­bo vac­cine back in No­vem­ber.

Low­er pro­ject­ed Covid sales led Bourla to set his full-year sales ex­pec­ta­tions in 2023 at $67 bil­lion to $71 bil­lion, down rough­ly 30% from 2022, which let down some an­a­lysts.

“PFE guid­ance for 2023 pro­vid­ed with 4Q22 re­sults was dis­ap­point­ing de­spite the com­pa­ny talk­ing down fi­nan­cial prospects in re­cent weeks,” SVB Se­cu­ri­ties an­a­lysts wrote in a note to in­vestors on Tues­day.

How­ev­er, when it comes to R&D in­vest­ment, Bourla’s keep­ing his foot on the gas. As the CEO said back in No­vem­ber, “It’s all about what’s next.”

That’s why he’s ear­mark­ing around $12.4 bil­lion to $13.4 bil­lion for R&D this year, up near­ly 9% from last year. It’s all part of his ef­fort to make up for an ex­pect­ed $17 bil­lion loss due to patent ex­piries be­tween 2025 and 2030.

Last quar­ter, he spelled out am­bi­tious plans to bring 19 new prod­ucts or in­di­ca­tions to mar­ket over the next year and a half. The chief ex­ec­u­tive high­light­ed a few of those pro­grams on Tues­day, in­clud­ing po­ten­tial com­bo shots for flu, Covid-19 and RSV, an oral GLP-1 can­di­date for di­a­betes and obe­si­ty, and po­ten­tial vac­cines for Ly­me dis­ease and shin­gles.

Oth­er pro­grams, how­ev­er, didn’t make the cut. Pfiz­er al­so dis­closed on Tues­day that it cut eight pro­grams, in­clud­ing re­cifer­cept, an achon­dropla­sia drug that was the cen­ter­piece of Pfiz­er’s Ther­a­chon buy­out in 2019, and two Paxlovid in­di­ca­tions that failed their re­spec­tive Phase III tri­als.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Gun­ning for 2023 ap­proval, GSK de­tails PhI­II da­ta for Jem­per­li in front­line en­dome­tri­al can­cer

GSK has a new slate of data to offer on its PD-1 inhibitor, Jemperli — data that the pharma giant hopes will cement one of the four drug approvals it’s expecting this year.

While Jemperli (dostarlimab) is already approved for a subset of patients with second-line endometrial cancer, GSK set out in the Phase III RUBY trial to test it as an earlier line of treatment while also enrolling a broader group of patients. In an interim analysis, Jemperli was shown to extend progression-free survival for both the subset and the overall trial population when added to chemotherapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,800+ biopharma pros reading Endpoints daily — and it's free.

Es­pe­ri­on sues Dai­ichi Sankyo, de­mand­ing pay­ment of $300M mile­stone for car­dio drug

Esperion is suing its business partner Daiichi Sankyo, saying the Japanese drugmaker is improperly refusing to pay a $300 million milestone that the biotech company will be owed after reporting positive data from a large trial of its cardiovascular drug Nexletol.

The 2019 deal between the companies had Daiichi Sankyo pay $150 million upfront plus another $150 million after the first sales of the drug. But another major payout was tied to an outcomes study reported this month, known as CLEAR. Esperion, in its suit against Daiichi, argues that the drug’s more than 20% reduction of heart attack risk is enough to trigger a $300 million payout from Daiichi once it’s added to the drug’s label.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,800+ biopharma pros reading Endpoints daily — and it's free.

Eli Lil­ly to in­crease in­vest­ment to $1B in­to new Irish man­u­fac­tur­ing fa­cil­i­ty — re­port

The US pharma giant Eli Lilly will be increasing its financial commitment to a manufacturing site in Ireland.

According to a release from Ireland’s Industrial Development Agency (IDA) on Monday, Lilly will be investing another $500 million in its manufacturing facility in Limerick, Ireland — bringing the total investment into the facility to approximately $1 billion.

In January of last year, Lilly announced it was placing a $446 million investment into the site to expand active pharmaceutical ingredient and monoclonal antibody production.

Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech read­ies for plunge in Covid sales, will boost mR­NA and on­col­o­gy pipelines

BioNTech is estimating €5 billion (nearly $5.4 billion) in Covid-19 vaccine sales this year, a marked drop from €17.1 billion ($18.5 billion) in 2022 — and way off analysts’ expectations of around €8 billion ($8.6 billion).

In BioNTech’s year-end earnings call on Monday, it reported a total of €17.3 billion ($18.7 billion) in 2022 revenue, almost all from vaccine sales, which include those via its Pfizer deal and direct sales.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,800+ biopharma pros reading Endpoints daily — and it's free.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.