Pierre-Alain Ruffieux, CEO of Lonza

Lon­za posts full 2022 re­sults as it looks to buy back $2B+ in shares

Swiss con­tract man­u­fac­tur­er Lon­za record­ed growth in its lat­est re­sults post­ed for 2022, but it ex­pects some slow­down for Covid sales.

Ac­cord­ing to the man­u­fac­tur­er on Wednes­day, it re­port­ed sales of CHF 6.2 bil­lion ($6.7 bil­lion), a growth in sales of 15%. The fi­nan­cial boost was a re­sult of a com­bi­na­tion of its gen­er­al busi­ness per­for­mance and a “Covid-re­lat­ed sales peak” last year, which gave a lift to its sales and mar­gin.

A Lon­za spokesper­son said in an email to End­points News that the sales growth in 2022 is due to op­er­at­ing in an “at­trac­tive in­dus­try.” The man­u­fac­tur­er man­aged to rope in 115 new cus­tomers and around 375 new clin­i­cal and com­mer­cial pro­grams, ul­ti­mate­ly bring­ing its num­ber of cus­tomers to 790.

For this year, Lon­za will be en­gag­ing in a share buy­back pro­gram of up to CHF 2 bil­lion ($2.2 bil­lion). Ac­cord­ing to the Lon­za spokesper­son, the buy­back is in­tend­ed to re­turn “ex­cess cap­i­tal” back to share­hold­ers. The buy­back is ex­pect­ed to start some­time in the first half of this year and be com­plet­ed in 2025.

“[The buy­back] does not im­pact our ca­pa­bil­i­ty to de­liv­er on our cap­i­tal al­lo­ca­tion, which fo­cus­es on in­vest­ment in or­gan­ic growth, sup­port­ed by bolt-on ac­qui­si­tions when rel­e­vant op­por­tu­ni­ties arise,” the spokesper­son’s email said.

Lon­za’s out­look for the rest of the year in­cludes a “high sin­gle-dig­it” sales growth as it ex­pects a re­duc­tion in Covid-re­lat­ed sales growth, fol­low­ing a “peak” last year.

“Look­ing to 2023, we will con­tin­ue to grow the com­pa­ny while build­ing our cus­tomer pipeline and dri­ving op­er­a­tional ex­cel­lence. We will re­main fo­cused on ex­e­cut­ing our growth plans and pur­su­ing new projects. We are al­so pleased to con­firm our Mid-Term Guid­ance 2024, sup­port­ed by new ca­pac­i­ty com­ing on­line and ro­bust in­dus­try fun­da­men­tals,” said Lon­za CEO Pierre-Alain Ruffieux in a state­ment.

While the con­tract man­u­fac­tur­er man­aged to ex­pand its phys­i­cal foot­print last year, the spokesper­son did not give End­points any de­tails for any new projects at this time. Lon­za’s ex­pan­sion in the US in­clud­ed cap­ping off an ex­pan­sion in Bend, OR, called the Ear­ly Phase Clin­i­cal Man­u­fac­tur­ing fa­cil­i­ty. Lon­za added the new fa­cil­i­ty to its small mol­e­cules site that al­so serves as its cen­ter of ex­cel­lence for bioavail­abil­i­ty en­hance­ment and in­haled de­liv­ery for its small mol­e­cules busi­ness unit. The new, mul­ti­mil­lion-dol­lar, 13,000-square-foot fa­cil­i­ty in­cludes sev­en GMP pro­cess­ing suites.

Mean­while, on its home turf in Switzer­land, Lon­za will be con­struct­ing a CHF 500 mil­lion, or $519 mil­lion, large-scale com­mer­cial drug fill-fin­ish fa­cil­i­ty in Stein, which is ex­pect­ed to be com­plet­ed in 2026. The fa­cil­i­ty will al­so be con­struct­ed on the same cam­pus as Lon­za’s cur­rent clin­i­cal drug prod­uct fa­cil­i­ty.

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

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New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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Richard Gonzalez, AbbVie CEO (Chris Kleponis/picture-alliance/dpa/AP Images)

Up­dat­ed: $100B+ in sav­ings? Why the in­com­ing Hu­mi­ra biosim­i­lars will take time to catch on

The 20-year reign of AbbVie’s best-selling biologic of all time — the autoimmune disease biologic Humira (adalimumab) that has brought in upwards of $200 billion during its monopoly — is coming to an end tomorrow with the launch of Amgen’s biosimilar Amjevita.

The launch comes more than four years after Europe saw the exact same competition, leading to steep discounts in price, higher uptake, and big cost savings across the board.

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A new Genentech 'MS Visibility' campaign video features Black women living with or connected to MS talking about their experiences. (Genentech)

Roche’s Genen­tech de­buts next it­er­a­tion of MS cam­paign, high­lights ex­pe­ri­ences in Black com­mu­ni­ty

Roche’s Genentech is tackling diversity in multiple sclerosis again, this time with a focus on the Black community. Its “MS Visibility” effort, debuted in 2021, is now adding to the awareness campaign with new work that includes a set of videos featuring discussions among Black women and healthcare professionals.

“They’re incredibly inspiring Black women living with or connected to MS and they’re having just honest conversation about their experience and the unique barriers that their community faces,” said Jennifer Kim, head of neuroimmunology at Genentech marketing.

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