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.
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.
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.
By the time 2023 is over, Novartis expects to be moving much lighter: It will have spun out its generics subsidiary Sandoz, completed layoffs of thousands of staffers worldwide and put in new internal structures for running the company.
And it will be ready to hunt for blockbusters.
CEO Vas Narasimhan underscored Novartis’ upcoming transformation into a “pure-play” company, reiterating across a series of calls — one with reporters, two with investors and analysts — that the new structure would boost its R&D productivity and sharpen its focus on big, new medicines.
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Four of Amgen’s top drugs all saw record sales last quarter and strong annual growth, but the California-based biopharma company still has more than a couple remaining question marks to resolve moving into 2023 and beyond.
In its Q4 earnings report yesterday, execs highlighted the success of its osteoporosis drug Prolia (12% sales growth in 2022 vs. 2021), its other bone drug Evenity (48% annual sales growth), its cholesterol injection Repatha (16% sales growth over the year), and its migraine drug Aimovig (31% annual sales growth).
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Cancer Treatment Centers of America is now City of Hope. That’s the brand change announced today after City of Hope’s buyout of the cancer hospital network almost one year ago — and it’s also the first line of its TV commercial debuting next week.
The ad’s voiceover points out that the now-combined group creates “one of the leading cancer care and research networks” in the country. City of Hope is a long-time top nonprofit cancer research center and has now converted the Cancer Treatment Centers of America (CTCA) to nonprofit status as well.
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National Football League games, and big viewing audiences, are typically popular with drugmakers looking to advertise product brands. However, this year, Pfizer’s broader Covid vaccine encouragement and treatment awareness advertising led the pharma charge by a wide margin during both NFL regular season and postseason national broadcasts, according to real-time TV ad tracker iSpot.tv.
Pfizer spent almost $90 million during the regular season and another $18 million during the playoffs ahead of all pharma companies and brands, iSpot reported in a tabulation for Endpoints News.
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Novo Nordisk consumer marketing chief Mark Materacky wants to change the conversation around obesity. And with Wegovy, the first new anti-obesity med approval in a decade — with good efficacy and safety data — Novo seems well positioned to do that.
However, in the year and a half since its approval, Wegovy, or semaglutide for weight loss, a cascade of events has marred the way.
Type 2 diabetes meds, including semaglutide, marketed for diabetes treatment under the brand Ozempic, and tirzepatide, sold as Mounjaro by Eli Lilly, started getting picked up by new online telehealth companies, along with personal physicians who realized the meds could be prescribed off-label for obesity and weight loss.
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Last year, Thermo Fisher expanded widely across the US and abroad. This year, however, it’s expecting a big dip in vaccine and therapeutics revenue.
The company brought in $44.92 billion in revenue last year, a growth of 15%, with revenues in the fourth quarter totaling $11.45 billion, a 7% growth from 2021. On the investment call, Thermo Fisher CEO Marc Casper said that its pharma and biotech sector had “impressive performance” with growth in the low teens for the quarter and mid-teens for the year.
The step change that Emma Walmsley promised at GSK is here, and the CEO has financial results that surpassed forecasts to show for it.
GSK reported Q4 sales of nearly £7.4 billion, bringing full year 2022 sales to £29.3 billion — which the British drugmaker said marks a 13% growth at constant exchange rates. Record sales for Shingrix, GSK’s shingles vaccines, contributed a significant part of the growth.
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FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.
CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”
Pfizer has expanded Ibrance’s use to include a new subset of breast cancer patients, the company slipped into its quarterly earnings report on Tuesday.
The drug was approved in combination with an aromatase inhibitor (AI) in mid-December to treat women with HR-positive, HER2-negative metastatic breast cancer regardless of menopausal status, Pfizer announced.
Ibrance was first approved in postmenopausal women with advanced breast cancer back in 2015. The CDK4/6 inhibitor has since racked up a slate of label expansions, but until the latest add-on, the AI combo treatment was only indicated for postmenopausal women or men.
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