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Thursday
16 January, 2025
top stories
1. Samsung Bio eyes construction of sixth manufacturing plant to kickstart 2025
2. Charles River disappoints investors with damp outlook for 2025
3. Eli Lilly misses 2024 revenue expectations, stock dips 7%
4. FDA rejects Atara's cell therapy for rare transplant complication, stock craters
5. Aragen gets $100M from private equity firm to expand manufacturing footprint 
6. Vaccine patch startup collects an additional $16M to Series A
7. AstraZeneca, CRISPR tools supplier ink gene editing enzyme licensing deal
8. Australia's BioCina and NovaCina join forces to make one CDMO
9. Denmark’s new manufacturing learning center; Telix buys facility, assets and tech from ImaginAb
Anna Brown
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Eli Lilly CEO Dave Ricks told delegates at the JPM confab that it is considering another manufacturing expansion in the next few months to boost production for its incretins, including Zepbound and Mounjaro. This comes as the company faced destocking challenges from its wholesale customers in the second half of 2024. Read more below.

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Anna Brown
Biopharma Breaking News Reporter, Endpoints News
Rendering of Samsung Biologics' Plant 5 at its Bio Campus II plot in Songdo, South Korea (Credit: Samsung Biologics)
1
by Anna Brown

Fol­low­ing a block­buster 2024, Sam­sung Bi­o­log­ics is con­sid­er­ing build­ing a sixth man­u­fac­tur­ing fa­cil­i­ty to meet the ris­ing de­mand for bi­o­log­ics as it gears up to open its fifth site in April.

Dur­ing the an­nu­al JP Mor­gan Health­care Con­fer­ence in San Fran­cis­co this week, Sam­sung Bio hint­ed that it might con­struct its sixth fac­to­ry to bring its to­tal ca­pac­i­ty to 964,000 liters, ac­cord­ing to a Tues­day press re­lease. The CD­MO is await­ing board ap­proval for the new site.

Last year, the com­pa­ny seemed to buck the trend of CD­MOs strug­gling: Mer­ck KGaA, Catal­ent, Avid Bioser­vices and Ther­mo Fish­er Sci­en­tif­ic all saw man­u­fac­tur­ing rev­enue dip dur­ing at least one quar­ter in 2024. Sam­sung Bio, by con­trast, se­cured mul­ti­ple bil­lion-dol­lar con­tracts with cus­tomers and re­port­ed quar­ter­ly rev­enue jumps. Sam­sung in­tends to build on this growth by open­ing its fifth man­u­fac­tur­ing fa­cil­i­ty, dubbed Plant 5, in April this year.

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2
by Anna Brown

Charles Riv­er Lab­o­ra­to­ries is pre­dict­ing 2025 to be as tough as last year for CD­MOs as phar­ma cus­tomers con­tin­ue to cut costs with man­u­fac­tur­ers.

The com­pa­ny ex­pects its rev­enue for 2025 to de­cline in a sim­i­lar fash­ion as last year, ac­cord­ing to an SEC fil­ing pub­lished on Tues­day. Charles Riv­er’s over­all rev­enue de­clined dur­ing each quar­ter of 2024, most re­cent­ly by 1.6% in Q3, 3.2% in Q2 and 1.7% in Q1.

Charles Riv­er’s stock $CRL was down 6.2% Tues­day morn­ing. William Blair an­a­lysts were “dis­ap­point­ed” in the com­pa­ny’s out­look for this year, which missed their rev­enue growth es­ti­mate of 1%, ac­cord­ing to an an­a­lyst re­port.

The ser­vice provider an­tic­i­pates phar­ma cus­tomers will con­tin­ue to cut their spend­ing with third-par­ty man­u­fac­tur­ers as they re­struc­ture pro­grams and repri­or­i­tize their pipelines. The com­pa­ny’s CEO James Fos­ter had al­ready warned in­vestors these head­winds would per­sist in­to 2025 dur­ing its sec­ond-quar­ter earn­ings in Au­gust.

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David Ricks, Eli Lilly CEO (Jeenah Moon/Bloomberg via Getty Images)
3
by Nicole DeFeudis

Eli Lil­ly ex­pects to miss its re­cent rev­enue es­ti­mate for 2024 by about $400 mil­lion, ac­cord­ing to a pre­lim­i­nary re­port.

The com­pa­ny’s es­ti­mates have var­ied wide­ly this year. Lil­ly raised its 2024 rev­enue pro­jec­tions mul­ti­ple times be­fore tem­per­ing those ex­pec­ta­tions in the third quar­ter. Now ex­ec­u­tives are say­ing the ac­tu­al fig­ure will be around $45 bil­lion, which is $400 mil­lion be­low the low end of its third-quar­ter pro­jec­tion, but still above the mid­point of its first-time es­ti­mate.

In­vestors sent Lil­ly’s stock LLY down 7% on Tues­day af­ter­noon, fol­low­ing the an­nounce­ment.

David Risinger, an an­a­lyst with the in­vest­ment bank Leerink Part­ners, said in a note to in­vestors that this is the “sec­ond quar­ter in a row of dis­ap­point­ing re­sults" for Lil­ly. How­ev­er, he added that the com­pa­ny’s fi­nan­cial and R&D prospects in 2025 and be­yond are “en­cour­ag­ing,” specif­i­cal­ly Lil­ly’s Phase 3 oral GLP-1 can­di­date for weight loss and di­a­betes, or­for­glipron.

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4
by Lei Lei Wu, Max Gelman

US reg­u­la­tors have re­ject­ed a T cell ther­a­py for a rare and se­ri­ous trans­plant com­pli­ca­tion re­lat­ed to Ep­stein-Barr virus from Atara Bio­ther­a­peu­tics and Pierre Fab­re.

The ther­a­py, known as tab­ele­cleu­cel or tab-cel, was turned away af­ter the FDA in­spect­ed a third-par­ty man­u­fac­tur­ing site, Atara said in a Thurs­day press re­lease. FDA's re­jec­tion let­ter "did not iden­ti­fy any de­fi­cien­cies" re­lat­ed to the man­u­fac­tur­ing of the ther­a­py it­self, nor any con­cerns over ef­fi­ca­cy or safe­ty da­ta, Atara said. Ad­di­tion­al­ly, it will not be re­quired to run an­oth­er clin­i­cal tri­al.

Atara's stock price ATRA fell more than 45% on Thurs­day morn­ing.

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5
by Anna Brown

In­di­an CD­MO Ara­gen Life Sci­ences has se­cured a $100 mil­lion in­vest­ment from Sin­ga­pore-head­quar­tered pri­vate eq­ui­ty firm Quadria Cap­i­tal.

Ara­gen will use the in­vest­ment to ex­pand its fa­cil­i­ties to meet grow­ing de­mand from US and Eu­ro­pean cus­tomers for its dis­cov­ery and man­u­fac­tur­ing ca­pa­bil­i­ties, CEO Man­ni Kan­tipu­di said in a Mon­day press re­lease. No fur­ther de­tails were giv­en. Ara­gen has six lo­ca­tions in In­dia as well as sales of­fices in Tokyo, Japan and South Ko­rea.

Quadria will get a mi­nor­i­ty stake in the man­u­fac­tur­er, val­ued at around $1.4 bil­lion, ac­cord­ing to the re­lease. The pri­vate eq­ui­ty firm will be the sec­ond in­vestor in Ara­gen, fol­low­ing Gold­man Sachs who in­vest­ed in May 2021. Quadria has in­vest­ed in oth­er CD­MOs pre­vi­ous­ly, in­clud­ing In­di­an-based Akums Drugs and En­cube Eth­i­cals, as well as Malaysia-based Straits Or­thopaedics.

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