Pascal Soriot, AstraZeneca CEO (Raphael Lafargue/Abaca/Sipa USA; Sipa via AP Images)

As­traZeneca's non-prof­it vac­cine is, for now, cost­ing them mon­ey

For the first earn­ings re­port of the year, As­traZeneca in­vent­ed a new met­ric: the prof­it they’d have if you didn’t count their Covid-19 vac­cine costs.

When As­traZeneca an­nounced last year that they would de­vel­op Ox­ford’s Covid-19 can­di­date, they said they would sell it on a not-for-prof­it ba­sis dur­ing the pan­dem­ic. The terms ful­filled the vac­cine’s aca­d­e­m­ic in­ven­tors’ de­sire to see their shot de­ployed cheap­ly around the world, while al­so al­low­ing the drug­mak­er to do some good and, po­ten­tial­ly, se­cure a mas­sive PR coup.

The PR coup they want­ed would turn in­to a PR night­mare over the last 8 months, as the Swedish-British phar­ma pre­sent­ed what ex­perts de­scribed as mot­tled da­ta and missed man­u­fac­tur­ing tar­gets to the point the EU filed a law­suit. Con­cerns al­so arose over a rare but se­ri­ous side ef­fect as­so­ci­at­ed with the shot.

Now, it looks like the vac­cine is cost­ing As­traZeneca mon­ey too. Al­though the com­pa­ny did not break down pre­cise­ly what they spent on their vac­cine in their Q1 earn­ings, they said the costs were the first of three fac­tors that cut their gross prof­it by 3%. The oth­er two fac­tors were re­duced re­im­burse­ments from Chi­na and changes in their prof­it-shar­ing agree­ment with Mer­ck on the block­buster can­cer drug Lyn­parza.

“If you ex­clude the im­pact of our Covid-19 vac­cine, our rev­enue grew by 7%,” CEO Pas­cal So­ri­ot told in­vestors on a con­fer­ence call. “There will be ups and downs — small ones quar­ter to quar­ter — with this vac­cine.”

As­traZeneca ex­pects their cost and rev­enue for the in­oc­u­la­tion will even­tu­al­ly even out, but at the mo­ment, the com­pa­ny has faced sig­nif­i­cant de­vel­op­ment, man­u­fac­tur­ing and de­ploy­ment costs. Go­ing for­ward, they will al­so ac­crue costs for track­ing the vac­cine’s re­al-world safe­ty and ef­fec­tive­ness. At the same time, with the com­pa­ny fac­ing man­u­fac­tur­ing de­lays in Eu­rope and reg­u­la­to­ry de­lays in the US, they re­main sig­nif­i­cant­ly be­hind sched­ule in glob­al sales of the vac­cine.

The com­pa­ny so far has sold 68 mil­lion dos­es, they dis­closed in fil­ings, for $275 mil­lion in rev­enue. The fig­ure con­firms ear­li­er re­port­ing that the com­pa­ny would sell the vac­cine for about $4 to $6 per dose.

Al­though 68 mil­lion dos­es were dis­trib­uted di­rect­ly by As­traZeneca, the com­pa­ny’s vac­cine has al­ready had a larg­er im­pact, with its part­ners around the globe dis­trib­ut­ing 300 mil­lion dos­es, So­ri­ot said. That in­cludes the 48 mil­lion dos­es that In­dia’s Serum In­sti­tute de­liv­ered to the CO­V­AX ini­tia­tive for low- and mid­dle-in­come coun­tries — vir­tu­al­ly the en­tire sup­ply of Covid-19 vac­cine the ini­tia­tive has re­ceived thus far.

The new dis­clo­sures al­so make clear just how much As­traZeneca has fore­gone in elect­ing to sell their vac­cine on a non-prof­it ba­sis. Mod­er­na and Pfiz­er, by con­trast, be­lieve they will make $18.4 bil­lion and $15 bil­lion this year through their Covid-19 vac­cines, de­spite plans to pro­duce few­er over­all dos­es.

Out­side of vac­cine news, As­traZeneca al­so un­veiled a small hand­ful of busi­ness and pipeline up­dates. Most no­tably, they will pay around $3 bil­lion over the next three years for the last 45% of stock in Ac­er­ta, the can­cer biotech they ac­quired in 2015 for $2.5 bil­lion up­front. The key mile­stones in that deal hinged on the progress of the BTK in­hibitor Calquence. The last op­tion was trig­gered up­on its No­vem­ber ap­proval in the Eu­ro­pean Union.

Ad­di­tion­al­ly the com­pa­ny slashed a cou­ple of ear­ly stage pro­grams, in­clud­ing the asth­ma can­di­date AZD8154 and ME­DI2228, an an­ti­body drug con­ju­gate for mul­ti­ple myelo­ma. The lat­ter change re­flects a grow­ing shift in the mul­ti­ple myelo­ma field, as new and ef­fec­tive bis­pe­cif­ic an­ti­bod­ies and cell ther­a­pies come on the mar­ket.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Common performs onstage, December 2020 (Getty Images)

Com­mon, Jamie Foxx among celebs stand­ing up for clin­i­cal tri­als in star-stud­ded can­cer group's pan­dem­ic push

Healthcare screenings and clinical trial enrollment were battered by the pandemic. But the well-known celebrity-backed Stand Up To Cancer non-profit, along with pharma and advocacy partners, has been working to reverse that and make up lost ground, by stepping up awareness campaigns.

Twelve campaigns launched in 2020 and another five in 2021 amplify the need for cancer screening and care, especially for underserved communities. While pharma companies have long been donors to the cancer research group, Covid brought new support — and increased awareness efforts.

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

UP­DAT­ED: Am­gen halts some drug dis­counts for safe­ty net hos­pi­tals as SCO­TUS takes on 340B case

Amgen will soon be the 10th biopharma company to pull back on offering drug discounts to contract pharmacies of safety-net hospitals under a federal program. Like its peers, Amgen argues that the growth of these contract pharmacies has ballooned in recent years and needs to be reigned in.

Beginning Jan. 3, 2022, Amgen’s policy will only allow 340B covered hospitals to designate a single pharmacy location, with the exception of federal grantees and contract pharmacies wholly owned by a 340B hospital, or that have common ownership with a health system.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.