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.

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.

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.