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.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

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On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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Ursula von der Leyen, president of the European Commission (AP Images)

Covid-19 roundup: EU to sup­port vac­cine man­u­fac­tur­ing ef­forts in Africa — re­port; Sput­nik Light ap­proved for use in Venezuela

The EU is expected to back an effort to expand vaccine manufacturing in Africa, unnamed officials told the Financial Times. 

Only 1% of Covid-19 vaccines administered worldwide have been given in Africa — down from 2% a few weeks ago, the WHO reported on Friday. The country normally gets many of its vaccine doses from the Serum Institute of India, which is now diverting its Covid-19 shots for domestic use.

Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.