Marc Casper, Thermo Fisher Scientific CEO (Photo by Suzanne Kreiter/The Boston Globe via Getty Images)

Af­ter a busy year of build­outs, Ther­mo Fish­er sets plans for growth in 2023

Last year, Ther­mo Fish­er ex­pand­ed wide­ly across the US and abroad. This year, how­ev­er, it’s ex­pect­ing a big dip in vac­cine and ther­a­peu­tics rev­enue.

The com­pa­ny brought in $44.92 bil­lion in rev­enue last year, a growth of 15%, with rev­enues in the fourth quar­ter to­tal­ing $11.45 bil­lion, a 7% growth from 2021. On the in­vest­ment call, Ther­mo Fish­er CEO Marc Casper said that its phar­ma and biotech sec­tor had “im­pres­sive per­for­mance” with growth in the low teens for the quar­ter and mid-teens for the year.

Casper said that growth this year was dri­ven by prod­uct launch­es and im­prove­ments to its ca­pa­bil­i­ties, as well as lever­ag­ing the man­u­fac­tur­er’s “scale in emerg­ing mar­kets.”

“We con­tin­ue to strength­en our ca­pa­bil­i­ties serv­ing these mar­kets dur­ing the year and high­light a re­cent ex­am­ple. In the quar­ter we opened the new cGMP bi­o­log­ics and ster­ile man­u­fac­tur­ing fa­cil­i­ty in Hangzhou, Chi­na, which pro­vides in­te­grat­ed clin­i­cal and com­mer­cial drug sub­stance and drug prod­uct ca­pa­bil­i­ties to help cus­tomers in Chi­na and the Asia Pa­cif­ic re­gion,” Casper said on the call.

In 2023, Ther­mo Fish­er is ex­pect­ing to reach $45.3 bil­lion in rev­enue, mark­ing a growth of around 7%. CFO Stephen Williamson said on the in­vestor call that the com­pa­ny is ex­pect­ing $400 mil­lion in test­ing rev­enue, and an­tic­i­pates a re­turn to more “nor­mal mar­ket growth con­di­tions in 2023.”

Williamson al­so stat­ed that Ther­mo Fish­er is ex­pect­ing $500 mil­lion of rev­enue for vac­cines and ther­a­pies in 2023, which is $1.2 bil­lion less than in 2023.

In speak­ing to in­vestors on the call, Casper said the fig­ure is re­lat­ed to Ther­mo Fish­er’s phar­ma ser­vices ac­tiv­i­ty, in­clud­ing ac­tive phar­ma­ceu­ti­cal in­gre­di­ents for ther­a­pies and ster­ile fill fin­ish ser­vices for vac­cines and some drugs.

Ther­mo suc­cess­ful­ly ex­pand­ed its foot­print in the US through­out 2022. In its home state of Mass­a­chu­setts, the man­u­fac­tur­er opened a $160 mil­lion, 85,000-square-foot fa­cil­i­ty in Chelms­ford, MA, and a $180 mil­lion, 300,000-square-foot site in Plain­view, MA.

It has al­so opened man­u­fac­tur­ing sites in Ten­nessee, Og­den, UT, and New York State.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Ribbon cutting ceremony for Thermo Fisher's new cell therapy manufacturing site in San Francisco

Ther­mo Fish­er moves on cam­pus with new cell man­u­fac­tur­ing site in San Fran­cis­co

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Mass­a­chu­setts judge dis­miss­es law­suit against Bio­gen over failed launch of Alzheimer's drug Aduhelm

A Massachusetts federal judge on Wednesday dismissed a class action lawsuit filed by investors against Biogen and several of its current and former executives over the company’s failed Alzheimer’s drug, Aduhelm (aducanumab).

The investors argued that Biogen’s contact with the FDA was unlawful and that the company made 25 false and misleading statements, including statements about the rollout and price of the drug.

Af­ter safe­ty re­view, EMA mir­rors FDA with up­dat­ed rec­om­men­da­tions for JAK in­hibitors

The EMA released updated recommendations today for the use of JAK inhibitors (JAKi) after reviewing data from several clinical trials that showed increased incidents of issues in certain patients who have rheumatoid arthritis and other risk factors.

The EMA noted malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality in some patients.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Man­u­fac­tur­ing roundup: Catal­ent to pro­duce low-cost ver­sion of nalox­one; CSL opens R&D site

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

As­pen looks to re­bound in pro­duc­tion and rev­enue af­ter Covid-19

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.