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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Katrine Bosley (AP Photo/Mark Lennihan)

For­mer Ed­i­tas CEO Ka­trine Bosley goes the VC route, join­ing ear­ly-stage in­vestor

More than three years after abruptly exiting Editas Medicine, Katrine Bosley is leaping to the venture capital side of things.

London-based early-stage investor Advent Life Sciences announced Thursday that Bosley is joining the firm as venture partner. It’s also adding two general partners to the team: Dominic Schmidt, formerly of Syncona, will be in the UK; and Satish Jindal, most recently the CEO of investment fund BioMotiv, will be based in Boston, just like Bosley.

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Serhat Gumrukçu, Enochian BioSciences co-founder (Seraph Research Institute)

LA biotech founder ar­rest­ed, charged in mur­der-for-hire scheme be­hind 2018 death

A biotech founder has been arrested and charged for his role in a murder-for-hire scheme that resulted in the death of a man in Vermont back in 2018.

Serhat Gumrukçu, the co-founder of Enochian BioSciences, was arrested in Los Angeles, where the company is based, according to the Department of Justice. He was charged alongside Berk Eratay of Las Vegas, and a third person, Jerry Banks of Colorado, was previously arrested for kidnapping and allegedly murdering the victim, Gregory Davis.

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Adam Russell, ARPA-H's incoming acting deputy director

NI­H's new, in­de­pen­dent break­through drug ac­cel­er­a­tor ARPA-H gets its first em­ploy­ee

Despite the controversy of housing it in NIH, HHS Secretary Xavier Becerra on Wednesday afternoon formally announced the establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the NIH, as HHS had previously stipulated that “NIH may not subject ARPA-H to NIH policies.”

Becerra also announced the appointment of ARPA-H’s inaugural employee, Adam Russell, who will serve as acting deputy director.

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

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.