Severin Schwan, Roche Group CEO (AP Images)

Roche re­gains pre-pan­dem­ic sales foot­ing, high­lights burst­ing pipeline — with one key fail­ure

While many phar­ma for­tunes are tied to Covid-19 pan­dem­ic peaks and val­leys, Roche’s con­nec­tions are more com­pli­cat­ed than most, born out in its 2021 fi­nan­cial re­port­ing.

On one hand, its al­ways top-of-mind di­ag­nos­tics busi­ness, bol­stered by anti­gen and PCR test­ing, saw soar­ing sales, up 29% to CHF $17.76 bil­lion ($19.3B) in 2021. On the oth­er hand, its phar­ma busi­ness — while be­gin­ning to re­bound by year’s end with growth 2% high­er than an­a­lyst ex­pec­ta­tions in Q4 — moved up just 3% in 2021 end­ing with sales of CHF $45.04 bil­lion ($49 bil­lion).

And there are more ups and downs like­ly to come. For 2022, Roche is pre­dict­ing a strong first quar­ter for Covid tests and di­ag­nos­tics but ex­pects a drop-off af­ter that.

Roche Group CEO Sev­erin Schwan laid out two main sce­nar­ios the com­pa­ny is gaug­ing — one in which Covid-19 re­mains in a “steady state” and a sec­ond in which the virus dies out with Omi­cron as the last wave. For now, Roche is bas­ing its guid­ance for the year on a slow­down of in­fec­tions, and the need for test­ing, in the sec­ond quar­ter and be­yond.

To­tal sales re­bound­ed to CHF $62.8 bil­lion ($68.2 bil­lion) in 2021, up from $58.3 bil­lion in 2020 and $61.5 bil­lion in 2019.

Be­yond Covid and its ef­fects, Schwan high­light­ed Roche’s pipeline in his “ab­solute fa­vorite slide” show­ing three drug launch­es — Susvi­mo and Vabysmo in oph­thal­mol­o­gy and Po­livy in first-line — along with the fil­ing and launch of two CD20xCD3 bi-specifics mo­sune­tuzum­ab and glofi­ta­m­ab drugs in can­cer, four Tecen­triq ad­ju­vant stud­ies and four tiragolum­ab + Tecen­triq stud­ies, plus three oth­er re­sult read­outs. It al­so in­clud­ed four di­ag­nos­tic pipeline launch­es set for the year.

Roche re­port­ed it start­ed 16 Phase III tri­als in 2021 with now a to­tal of 14 new com­pounds in Phase III or filed for ap­proval. But the glob­al play­er al­so qui­et­ly sig­naled a com­plete flop in its late-stage pipeline.

Last fall Roche ex­e­cut­ed a quick re­treat from the Phase III pipeline when etrolizum­ab, once known as RG7413, got the ax for ul­cer­a­tive col­i­tis af­ter putting it in 4 late-stage stud­ies on UC. But it kept truck­ing on 2 oth­er Phase II­Is for Crohn’s dis­ease.

Un­til re­cent­ly.

In the lat­est quar­ter­ly up­date, the phar­ma gi­ant fin­ished wip­ing up the pro­gram, not­ing that the drug had failed to make the cut in Q4 for Crohn’s dis­ease as well.

There’s no ex­pla­na­tion, as is usu­al in these small print buri­als. But ear­li­er, Cowen’s Steve Scala had high­light­ed the drug as a po­ten­tial star play­er, which had been an­gling to carve out a po­si­tion for it­self in a high­ly com­pet­i­tive field.

Al­so out in the Q4 culling: mid-stage drugs for au­toim­mune dis­eases (RG7835, a con­ju­gate of  IL-2 and IgG), meta­bol­ic dis­eases and NASH (RG7992, a bis­pe­cif­ic of an­ti-FGFR1/KLB, BFKB8488A), and choroi­deremia (RG6367). Phase I stud­ies for melanoma and hy­poparathy­roidism al­so got cut.

Schwan de­scribed 2022 as “a very, very im­por­tant year, in par­tic­u­lar on the phar­ma side.”

Eval­u­ate an­a­lysts agreed, es­pe­cial­ly the Tec­netriq/tiragolum­ab stud­ies, high­light­ing four piv­otal read­outs.

“The big ques­tion will be whether tiragolum­ab’s huge piv­otal pro­gramme sug­gests sig­nif­i­cant ac­tiv­i­ty in any of the oth­er tu­mour types Roche high­light­ed at to­day’s fourth-quar­ter pre­sen­ta­tion,” an­a­lysts wrote in a post Thurs­day.

Along with Tecen­triq com­bi­na­tions and in­di­ca­tions, one of the “oth­er” pipeline drug read­outs be­ing care­ful­ly watched is gan­tenerum­ab in Alzheimer’s dis­ease with re­sults ex­pect­ed now for the fourth quar­ter.

Bill An­der­son

When asked about the tim­ing and re­sults, CEO of Roche Phar­ma­ceu­ti­cals Bill An­der­son said he’s con­fi­dent the re­sults will be ready in Q4 and dis­cussed the cur­rent Alzheimer’s en­vi­ron­ment with Bio­gen’s Aduhelm drug fac­ing crit­i­cism, skep­ti­cism and low up­take. The re­cent CMS draft guid­ance to hold off pay­ing for Aduhelm ex­cept through clin­i­cal tri­als has every­one go­ing through it with “a fine-toothed comb,” he said.

“What it comes down to is that physi­cians, pa­tients, pay­ers want com­pelling ev­i­dence. In this par­tic­u­lar case for var­i­ous rea­sons, they seem to be — um yeah — vot­ing with their feet that they don’t seem to have that yet.”

He added re­gard­ing Roche’s own tri­als: “We’ve been com­pelled since we start­ed the Grad­u­ate pro­gram with gan­tenerum­ab that we need two de­liv­er large, ro­bust stud­ies run to the end. … We want to ba­si­cal­ly have the longest rea­son­able study we can run with 100% of pa­tients at the max­i­mum dose. And that’s what we’re go­ing to be de­liv­er­ing in Q4 this year. And I think that’s the best any­one can do.”

Roche is ready­ing two new­ly ap­proved treat­ments for launch, Susvi­mo for wet age-re­lat­ed mac­u­lar de­gen­er­a­tion and Vabysmo for di­a­bet­ic mac­u­lar ede­ma and wet age-re­lat­ed mac­u­lar de­gen­er­a­tion. Vabysmo ap­proved just days ago faces a tough bat­tle for share with the well-es­tab­lished Re­gen­eron’s Eylea.

On the com­pe­ti­tion front, Roche loss­es are fi­nal­ly be­gin­ning to slow — the fourth quar­ter marked its first pos­i­tive growth in the US af­ter six neg­a­tive quar­ters thanks main­ly to biosim­i­lars en­croach­ment on its three ma­jor can­cer meds — Avastin, Her­ceptin, Rit­ux­an.

Over­all, Roche cal­cu­lat­ed loss­es to biosim­i­lars at $4.5 bil­lion CHF ($4.9 bil­lion) for 2021 but an­tic­i­pates a low­er $2.5 bil­lion ef­fect in 2022.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

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One of the paintings from Gilead's latest campaign making AI art to help MBC patients be 'seen and heard.'

Gilead com­bines ar­ti­fi­cial in­tel­li­gence and art to draw at­ten­tion and hope to MBC

What if you could “see” the emotions and feelings of people living with metastatic breast cancer? That’s what Gilead Sciences’ agency VMLY&R Health did last year, using artificial intelligence and sound analytics to turn the interviews of three women living with metastatic triple-negative breast cancer into works of art.

Using the sound waves, a robotic painting device translated their stories of struggle and hope into colors, contours and brush strokes. The result? An art exhibition called “Paintings of Hope” that was first displayed at ESMO in September in Paris, but has since traveled to hospitals and medical conferences in Europe and Spain.

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