Stanley Erck, Novavax CEO (Photographer: Kevin Dietsch/UPI/Bloomberg via Getty Images)

No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months af­ter No­vavax cel­e­brat­ed its first prof­itable quar­ter as a com­mer­cial com­pa­ny, the Gaithers­burg, MD-based com­pa­ny is back in the red.

Sales for No­vavax’s Covid-19 vac­cine slipped to $55 mil­lion last quar­ter, down from $586 mil­lion in Q1, CEO Stan­ley Er­ck re­vealed on Mon­day af­ter mar­ket close. The com­pa­ny’s stock $NVAX plum­met­ed more than 32% in af­ter-hours trad­ing.

Up­on kick­ing off the call with an­a­lysts and in­vestors, Er­ck ad­dressed the ele­phant in the room:

“Rev­enue for the quar­ter came in well be­low any­one’s pro­jec­tions and with re­spect to all of 2022, we’re ex­pect­ing to fall short of our ear­li­er pro­jec­tions,” he said.

Over­all, No­vavax raked in $186 mil­lion last quar­ter, down from $298 mil­lion in Q2 2021. That’s on top of a hefty net loss, which rang in at $510 mil­lion last quar­ter, com­pared to $352 mil­lion in Q2 2021. The com­pa­ny not­ed a $255 mil­lion loss alone from “ex­cess, ob­so­lete, or ex­pired in­ven­to­ry and loss­es on firm pur­chase com­mit­ments un­der our third par­ty sup­ply agree­ments.”

As a re­sult, Er­ck had to low­er the full-year guid­ance from ex­pec­ta­tions as high as $5 bil­lion to a $2 bil­lion to $2.3 bil­lion range.

“The short­fall was a re­sult of a cou­ple of is­sues, one of which is short-term, the tim­ing of our ship­ments to Eu­rope. The oth­er is a broad­er is­sue and will take some time to work through,” Er­ck said, ref­er­enc­ing changes in ex­pec­ta­tions from two ma­jor mar­kets, the US and CO­V­AX.

Er­ck added that he isn’t ex­pect­ing any ad­di­tion­al rev­enue this year from the US gov­ern­ment or CO­V­AX, where­as the com­pa­ny was pre­vi­ous­ly an­tic­i­pat­ing rev­enue from the sale of 110 mil­lion and 350 mil­lion dos­es, re­spec­tive­ly.

“Glob­al­ly and par­tic­u­lar­ly with re­spect to CO­V­AX, there was a surge of sup­ply and when cou­pled with chal­lenges CO­V­AX had with the dis­tri­b­u­tion in­to low- and mid­dle-in­come coun­tries, this lim­it­ed the need for them to or­der con­tract­ed prod­uct from us and oth­er vac­cine man­u­fac­tur­ers,” Er­ck said. “In the case of the US I be­lieve we were late to the mar­ket, and US vac­ci­na­tion was dri­ven by what was avail­able and shown to work, mR­NA vac­cines.”

Look­ing ahead, ap­provals for ado­les­cent use and boost­er shots are the com­pa­ny’s top pri­or­i­ty. While Nu­vax­ovid, al­so known as NVX-CoV2373, is au­tho­rized for adults in 43 coun­tries, it’s on­ly cleared for kids aged 12 through 17 in the EU, In­dia, Aus­tralia, Japan and Thai­land. The com­pa­ny has filed for ado­les­cent use in Great Britain, Cana­da, Switzer­land, New Zealand, Tai­wan and to the WHO.

John Trizzi­no

Mean­while, the shot is au­tho­rized for use as a boost­er in Japan, Aus­tralia and New Zealand. How­ev­er, as ex­ec­u­tive VP, chief com­mer­cial of­fi­cer and chief busi­ness of­fi­cer John Trizzi­no not­ed on the call, “re­ceiv­ing boost­er and ado­les­cent la­bel ex­pan­sions glob­al­ly has tak­en longer than ex­pect­ed.”

“We are hope­ful that we can get through this in days and weeks, but the ab­sence of these in­di­ca­tions slows the glob­al roll­out of our vac­cine,” Er­ck said.

No­vavax is work­ing on next-gen can­di­dates, in­clud­ing an Omi­cron-tar­get­ing pro­gram which the com­pa­ny hopes to sub­mit to reg­u­la­tors in Q4. When asked if a BA.5-spe­cif­ic vac­cine will be avail­able this year, Er­ck said po­ten­tial­ly lat­er in the year. “It’s not go­ing to be for Oc­to­ber us­age,” he added.

Nu­vax­ovid won FDA au­tho­riza­tion back in Ju­ly, be­com­ing the first pro­tein-based Covid vac­cine in the US, af­ter suf­fer­ing de­lay af­ter de­lay for its EUA fil­ing.

Fil­ip Dubovsky

The com­pa­ny tout­ed its glob­al de­liv­ery of more than 73 mil­lion dos­es to date, in­clud­ing more than 23 mil­lion since the start of Q3. How­ev­er, that pales in com­par­i­son to the 2 bil­lion an­nu­al dos­es that No­vavax pre­dict­ed it would roll out this year at the time of its Q3 call last Sep­tem­ber.

Don’t count Nu­vax­ovid out, Fil­ip Dubovsky, ex­ec­u­tive VP and CMO, stressed to an an­a­lyst on the call, adding that the com­pa­ny has seen peo­ple ask for the vac­cine in the boost­er in­di­ca­tion even in ter­ri­to­ries where it isn’t yet au­tho­rized.

“What we do know where the da­ta is avail­able, where our vac­cine is avail­able along­side oth­er vac­cines is that peo­ple are mak­ing a choice,” he said.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis un­veils 'US-first' strat­e­gy ahead of San­doz spin­off

Weeks after announcing the spinoff of generics arm Sandoz, Vas Narasimhan paints a picture of the new, slimmer Novartis — with a “US-first mindset,” he said at an investor event on Thursday.

The CEO unveiled ambitious plans to become a top-five player in the US by 2027 at Novartis’ “Meet the Management” event in Basel, Switzerland, which means ramping up clinical trials in the states and “building capability and talent, among other things.” The company’s also shooting for a top-three ranking in China.

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Pfiz­er sacks phar­ma com­pe­ti­tion in ear­ly NFL TV ad­ver­tis­ing sea­son

If pharma advertising had a fantasy football league, Pfizer would be crushing the competition. A dive into the National Football League’s TV commercial buys across early season games by iSpot shows a hefty lead with its Covid-19 Comirnaty vaccine ads.

More than 175 million impressions with $9.5 million in media spending put Pfizer in the top spot with a 65% share of voice across NFL pharma spending, according to the real-time TV ad tracker. In a distant second place is Bristol Myers Squibb’s Opdivo with 44 million impressions, $5.2 million in spending and a 16% share, followed by BMS’ Zeposia with 31 million impressions, $3.3 million in media buys and an 11% share.

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