Lars Fruergaard Jørgensen, Novo Nordisk CEO (Christopher Goodney/Bloomberg via Getty Images)

No­vo Nordisk notch­es big GLP-1 sales amid re­bound­ing sup­plies, but cau­tions on fu­ture 'pe­ri­od­ic con­straints'

With No­vo Nordisk’s obe­si­ty treat­ment We­govy ful­ly back in stock in De­cem­ber, sales are be­gin­ning to soar, the Dan­ish phar­ma re­port­ed dur­ing its an­nu­al earn­ings call on Wednes­day. To­tal scripts of the glucagon-like pep­tide 1 (GLP-1) We­govy topped 37,000 week­ly in mid-Jan­u­ary, a hock­ey stick uptick from end-of-year lev­els be­low 15,000 per week.

The new pre­scrip­tions come on top of the over­all mo­men­tum of No­vo obe­si­ty drug sales in 2022, al­though the then sup­ply-con­strained We­govy was on­ly part of that. Sib­ling obe­si­ty med Sax­en­da ac­count­ed for DKK 10.7 bil­lion ($1.58 bil­lion) of the to­tal DKK 16.9 bil­lion ($2.49 bil­lion), or about 63%, in No­vo Nordisk’s re­port­ed obe­si­ty seg­ment sales.

And the fu­ture in obe­si­ty looks even brighter.

“We know for a fact that there is pent-up de­mand,” CEO Lars Fruer­gaard Jør­gensen said. “It’s re­al­ly for us to size it, to be hon­est. We are ob­vi­ous­ly im­pressed by the trend­line we see, but we al­so do be­lieve that there will be a nor­mal­iza­tion of that.”

No­vo has fore­cast­ed sales growth be­tween 13% to 19% with a “large chunk” of that at­trib­uted to We­govy, CFO Karsten Munk Knud­sen said.

Ex­ec­u­tives were care­ful to point out that while GLP-1 sup­plies are back, they still ex­pect “pe­ri­od­ic sup­ply con­straints” in the com­ing year.

For the full year 2022, No­vo Nordisk re­port­ed to­tal sales of DKK 177 bil­lion (about $26 bil­lion), mark­ing a 16% in­crease over 2021.

Di­a­betes drugs made up the bulk of No­vo Nordisk’s rev­enue, with GLP-1s lead­ing the sales growth charge.

Sales of GLP-1 drugs for type 2 di­a­betes — the trio of Ozem­pic, Vic­toza and Ry­bel­sus — jumped by 57% to DKK 26.2 bil­lion ($3.87 bil­lion) in 2022. The big GLP-1 gains helped off­set a cas­cade of loss­es in oth­er in­sulin sales cat­e­gories, in­clud­ing long-act­ing (down 1%), pre­mixed (down 9%) and hu­man in­sulin (down 18%) to give No­vo Nordisk’s di­a­betes care rev­enues a 10% bump and to­tal glob­al sales of DKK 139.5 bil­lion ($20.58 bil­lion).

No­vo Nordisk said it now holds a 50.3% US mar­ket share of to­tal GLP-1 pre­scrip­tions in both obe­si­ty and di­a­betes in the lat­est Jan­u­ary da­ta.

Camil­la Sylvest

One po­ten­tial bright spot in No­vo’s in­sulin port­fo­lio is its in­sulin icodec, a once-a-week can­di­date in di­a­betes. It plans to file for US, Cana­da and EU ap­proval in the first half of this year, and as head of the com­mer­cial strat­e­gy Camil­la Sylvest said, No­vo sees the drug as a po­ten­tial stan­dard of care for new­ly di­ag­nosed type 2 di­a­betes pa­tients as a new and con­ve­nient — and en­vi­ron­men­tal­ly friend­ly — way to man­age in­sulin.

Mean­while, No­vo’s fore­cast for We­govy stands at DKK 25 bil­lion ($3.69 bil­lion) by 2025, but at least one an­a­lyst ques­tioned if that could be con­ser­v­a­tive.

Cit­i­group an­a­lyst Pe­ter Ver­dult did some rough math, not­ing that with We­govy ap­proach­ing 40,000 week­ly scripts, that would mean sales of about $2 bil­lion for the year. As for what might be pos­si­ble for 2023, he asked if that “pent-up de­mand” and ac­tive pro­mo­tion of We­govy could dri­ve sales to the $3 bil­lion to $4 bil­lion range.

Karsten Munk Knud­sen

Knud­sen point­ed back to No­vo’s 13% to 19% es­ti­mat­ed growth and the fact that a lot of that comes from We­govy.

“That 19% is not a mag­ic ceil­ing in terms of our guid­ance — it’s ba­si­cal­ly a func­tion of prod­ucts and ge­o­gra­phies and tim­ing,” he said, adding that No­vo is scal­ing man­u­fac­tur­ing with one line to be added in the first half and an­oth­er in the sec­ond half.

He al­so cau­tioned, “We do not have un­lim­it­ed ca­pac­i­ty and so trad­ing on ver­ti­cal TRx up­take is im­pos­si­ble. That’s why we’ve been say­ing be care­ful with the first da­ta points be­cause they are im­pact­ed by the pent-up de­mand that Doug (Lan­ga, pres­i­dent and head of North Amer­i­ca op­er­a­tions) was talk­ing about.”

The ele­phant in the room, though, was the on­go­ing ques­tion about the use of GLP-1s off-la­bel for weight loss as a source of growth. While asked by sev­er­al me­dia mem­bers and fi­nan­cial an­a­lysts about the mar­ket dy­nam­ics and re­ports of runs on GLP-1s ap­proved for type 2 be­ing pre­scribed off-la­bel, No­vo Nordisk ex­ec­u­tives de­flect­ed on an of­fi­cial link be­tween the two. They did ac­knowl­edge the short­ages and the sky­rock­et­ing use, but main­ly re­ferred to it more sim­ply as “de­mand.”

Jør­gensen an­swered one query about me­dia re­ports of off-la­bel use of type 2 GLP-1s by point­ing out that No­vo Nordisk has a very clear fo­cus on ex­act­ly what Ozem­pic and We­govy are ap­proved and used for.

“We have a keen fo­cus on es­tab­lish­ing two dif­fer­ent seg­ments with dif­fer­ent prod­ucts and dif­fer­ent com­mer­cial tac­tics,” he said.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

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Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Ribbon cutting ceremony for Thermo Fisher's new cell therapy manufacturing site in San Francisco

Ther­mo Fish­er moves on cam­pus with new cell man­u­fac­tur­ing site in San Fran­cis­co

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

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The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Man­u­fac­tur­ing roundup: Catal­ent to pro­duce low-cost ver­sion of nalox­one; CSL opens R&D site

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

As­pen looks to re­bound in pro­duc­tion and rev­enue af­ter Covid-19

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.

Feng Zhang (Susan Walsh/AP Images)

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Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.