Dan O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Gilead re­ports 'very strong quar­ter' de­spite slip­ping Vek­lury sales

Gilead CEO Dan O’Day un­corked some sol­id Q2 re­sults on Tues­day, tout­ing a surge in Yescar­ta and Trodelvy sales and an uptick in de­mand for HIV med Bik­tarvy. Will sink­ing Covid sales spoil the par­ty?

Jo­han­na Merci­er

Vek­lury sales were down 48% last quar­ter, top­ping out at $445 mil­lion. That de­cline was ex­pect­ed, chief com­mer­cial of­fi­cer Jo­han­na Merci­er not­ed, as hos­pi­tal­iza­tion rates fall due to milder cas­es and the up­take of oth­er treat­ments like Pfiz­er’s Paxlovid. Even so, rough­ly 60% of hos­pi­tal­ized Covid pa­tients are treat­ed with Vek­lury, she added.

And as we head in­to the fall, Gilead is up­ping its full-year sales pre­dic­tions to $2.5 bil­lion, as op­posed to a pre­vi­ous­ly an­nounced $2 bil­lion.

“We’re proud of our track record of meet­ing glob­al de­mand for Vek­lury since the fall of 2020 and will main­tain our readi­ness to sup­ply Vek­lury where it’s need­ed and have in­creased our full year guid­ance to re­flect an­tic­i­pat­ed pa­tient needs in the sec­ond half,” Merci­er said on the Q2 call.

Mean­while, Gilead record­ed a 66% sales in­crease for Yescar­ta fol­low­ing its re­cent ap­proval in sec­ond-line large B-cell lym­phoma, and a 79% surge in Trodelvy sales.

“This was a very strong quar­ter for our busi­ness de­liv­er­ing rev­enue of 6.1 bil­lion US dol­lars,” O’Day said on the call.

An­drew Dick­in­son

That’s like­ly wel­come news, af­ter Gilead took a $2.7 bil­lion write­down last quar­ter for Trodelvy on the heels of a vague piv­otal read­out. The phar­ma com­pa­ny drew harsh re­views from an­a­lysts back in March when it re­vealed that Trodelvy met its pri­ma­ry end­point of pro­gres­sion-free sur­vival in late-line metasta­t­ic HR+/HER2- breast can­cer, but didn’t share the hard da­ta.

The com­pa­ny took a $2.7 bil­lion im­pair­ment charge in Q1 “to re­flect the like­li­hood of a de­layed launch of Trodelvy” and the com­pet­i­tive land­scape, CFO An­drew Dick­in­son said last quar­ter.

Since then, Gilead has put out the hard da­ta, show­ing Trodelvy had de­layed can­cer pro­gres­sion for 5.5 months com­pared to 4 months for pa­tients re­ceiv­ing chemother­a­py alone. In the mean­time, re­searchers con­tin­ue to fol­low those pa­tients for over­all sur­vival analy­ses, and ex­ecs are in talks with reg­u­la­tors on a path to mar­ket, CMO Mer­dad Parsey re­vealed on the Q2 call.

Mer­dad Parsey

“We took a con­ser­v­a­tive ap­proach to the write­down that we took ear­li­er this year as we looked at the po­ten­tial paths for­ward,” Dick­in­son added. “We’ll con­tin­ue to mon­i­tor it over time at each ma­jor event. Whether it’s reg­u­la­to­ry dis­cus­sions or fil­ings or po­ten­tial ap­provals, we’ll look at that val­ue again.”

The drug is al­so in Phase III tri­als for pa­tients with metasta­t­ic triple-neg­a­tive breast can­cer and a Phase II in first-line non-small cell lung can­cer. It’s on track to en­ter a piv­otal study in first-line NSCLC ac­cord­ing to Gilead’s pre­sen­ta­tion, and raked in $159 mil­lion last quar­ter.

HIV med Bik­tarvy saw a 28% in­crease in sales last quar­ter due to “high­er de­mand and chan­nel mix,” the com­pa­ny said, bal­anc­ing out a steep de­cline in Tru­va­da sales as mul­ti­ple gener­ics are now avail­able. While Bik­tarvy earned more than $2.5 bil­lion last quar­ter (Gilead’s high­est sell­er), Tru­va­da sales fell from $108 mil­lion in Q2 last year to just $34 mil­lion in Q2 2022. Mean­while, the com­pa­ny re­cent­ly cel­e­brat­ed a lift­ed clin­i­cal hold on its long-act­ing drug lenaca­pavir. The com­pa­ny re­sub­mit­ted in June af­ter it was hand­ed a CRL in De­cem­ber, cit­ing is­sues with the com­pat­i­bil­i­ty of the drug and borosil­i­cate vials.

While HIV screen­ing and di­ag­no­sis rates are still be­low pre-pan­dem­ic lev­els, Merci­er said that’s nor­mal.

“What we’ve seen in the past, even pri­or to COVID-19 was see­ing a de­cline of the di­ag­no­sis rates, about 10% year over year,” she said. Plus, Bik­tarvy gained 4% of the mar­ket share year over year, snag­ging a rough­ly 44% share.

“Bik­tarvy dom­i­nates the US HIV mar­ket and the drug’s lead­er­ship is ex­pect­ed to con­tin­ue. Over­all, Gilead’s HIV prod­uct sales growth re­mains rather ane­mic giv­en gener­ic com­pe­ti­tion with the Tru­va­da fran­chise, as well as gen­er­al­ly greater pric­ing pres­sure across the port­fo­lio,” Third Bridge’s Lee Brown said in a note on Tues­day af­ter­noon.

When asked how Bik­tarvy might be af­fect­ed by a pend­ing Sen­ate rec­on­cil­i­a­tion bill that would en­able Medicare ne­go­ti­a­tions, Merci­er said about 50% of busi­ness is in the gov­ern­ment set­ting.

“Medicare rep­re­sents ‘low 20%s’ of GILD’s HIV busi­ness in the Unit­ed States,” Mizuho’s Sal­im Syed added in a note.

“I would al­so sug­gest that we look at the in­cred­i­ble di­ver­si­ty of our port­fo­lio that we’re grow­ing year on year, and al­so the ge­o­graph­i­cal di­ver­si­ty as well which I think will re­al­ly help mit­i­gate some of these pres­sures as we go for­ward,” Merci­er 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.

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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.

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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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