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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European counties, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

Mark Womack, BioCina CEO

Q&A: BioCi­na’s new CEO Mark Wom­ack on the CD­MO he says is 'worth trav­el­ing over'

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

The Melon family, as seen in Concussion Awareness Now's latest campaign

Ab­bott in­tro­duces the Mel­on fam­i­ly to raise con­cus­sion aware­ness

Abbott is renewing its concussion awareness campaign, weeks after the company received FDA clearance for its lab-based traumatic brain injury (TBI) blood test.

The unbranded campaign features three generations of the Melon family — animated talking melons who slip on toys or take a spill while playing pickleball.

“Don’t mess with your melon. If you hit it, get it checked,” a narrator says.