Eli Lil­ly shares take a hit as com­pa­ny low­ers full-year fore­cast

The roll­out of Covid-19 vac­cines and the de­ci­sion to halt dis­tri­b­u­tion of its an­ti­body ther­a­py has left Eli Lil­ly with some dis­ap­point­ing news to share.

On Tues­day, the com­pa­ny re­port­ed that it missed an­a­lysts’ ex­pec­ta­tions for Q1 prof­its and cut the top end of its full-year fore­cast by about $400 mil­lion. As a re­sult, its stock $LLY dipped about 3.38% on Tues­day morn­ing, pric­ing in around $180 per share.

Anat Ashke­nazi

CFO Anat Ashke­nazi said on the earn­ings call that while Lil­ly once ex­pect­ed to pull in be­tween $1 bil­lion and $2 bil­lion from its Covid-19 an­ti­bod­ies in 2021, it’s now nar­row­ing that range to $1 bil­lion to $1.5 bil­lion, based on the roll­out of vac­cines, cur­rent uti­liza­tion rate and sup­ply, and the de­ci­sion to halt the dis­tri­b­u­tion of bam­lanivimab, its mon­o­clon­al an­ti­body that was au­tho­rized for emer­gency use back in No­vem­ber.

Last month, the US slammed the brakes on the use of bam­lanivimab in three states due to the preva­lence of a vari­ant that isn’t sus­cep­ti­ble to the mon­o­clon­al an­ti­body. Ear­li­er this week, the US gov­ern­ment and Eli Lil­ly agreed to drop all use of the an­ti­body as a sin­gle ther­a­py, due to the “sus­tained in­crease” of vari­ants. All treat­ment de­liv­ery sites will still be able to or­der Lil­ly’s com­bo Covid-19 treat­ment of bam­lanivimab and ete­se­vimab, the FDA said.

The US end­ed its pur­chase agree­ment for bam­lanivimab alone and can­celed the re­main­ing 350,856 dos­es that were sched­uled to be de­liv­ered by the end of last month. At a cost of $1,250 per dose of bam­lanivimab, which Lil­ly an­nounced in Oc­to­ber 2020, the end­ing of that pur­chase agree­ment will cost the com­pa­ny about $440 mil­lion.

Those changes led Lil­ly to cut the top end of its to­tal rev­enue fore­cast for 2021 from $28 bil­lion to $27.6 bil­lion. The com­pa­ny end­ed up with quar­ter­ly earn­ings of $1.87 per share, miss­ing Za­cks In­vest­ment Re­search’s con­sen­sus es­ti­mate of $2.12 per share. To­tal Q1 rev­enue for the com­pa­ny’s Covid-19 an­ti­bod­ies to­taled $650.6 mil­lion in the US, and $159.5 mil­lion out­side the US.

Dave Ricks

Look­ing be­yond that, CEO Dave Ricks at­tempt­ed to paint a pic­ture of a “a strong and grow­ing core busi­ness” dur­ing the earn­ings call.

Over­all, Lil­ly saw a rev­enue growth of 16% com­pared to Q1 2020, or about 7% for the core busi­ness, ex­clud­ing rev­enue from its Covid-19 an­ti­bod­ies and $250 mil­lion in Q1 2020 rev­enue from “in­creased cus­tomer buy­ing pat­terns and pa­tient pre­scrip­tion trends.”

Near­ly half of Lil­ly’s to­tal rev­enue for the quar­ter (46%) came from the com­pa­ny’s key growth prod­ucts: Trulic­i­ty, Verzenio, Olu­mi­ant, Tyvyt, Em­gal­i­ty, Jar­diance, Retev­mo, Cyra­mza and Taltz. Trulic­i­ty, Lil­ly’s ther­a­py for adults with type 2 di­a­betes mel­li­tus, brought in a to­tal of $1.45 bil­lion — an 18% in­crease com­pared to Q1 2020.

Sales for Hu­mulin, Jar­diance, Verzenio, Cyra­mza, Olu­mi­ant, Em­gal­i­ty and Tyvyt al­so saw an in­crease this quar­ter. But that suc­cess was matched with dips in rev­enue from Hu­ma­log, Taltz, Basaglar and For­teo.

Ricks said:

We rec­og­nize this quar­ter was noisy, catch­ing the in­creased con­sumer stock­ing from the Q1 2020 in our quar­ter­ly com­pare and in­creased Covid-19 ther­a­py R&D spend in 2021. These items cou­pled with the FX rate move­ment, and a num­ber of changes to US gov­ern­ment pur­chase agree­ments for Covid-19 an­ti­bod­ies through­out the quar­ter make for a longer earn­ings call, and press re­lease, and we re­al­ize for those keep­ing score on sell side mod­el ac­cu­ra­cy, per­haps some dis­ap­point­ment.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.

UP­DAT­ED: Feds charge an­oth­er CRO staffer with fak­ing da­ta in a Glax­o­SmithK­line pe­di­atric asth­ma study

A Florida woman has been indicted as part of a clinical trial fraud scheme over a GlaxoSmithKline pediatric asthma study, the Justice Department announced Tuesday, the latest development in a case where three individuals have already pleaded guilty.

Jessica Palacio was charged with participating in a plot to falsify medical records, giving off the appearance that trial participants were making their scheduled visits to a Miami CRO and taking an experimental asthma medication as required. Palacio was also charged with lying to FDA investigators about her conduct.

Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.