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Catalent
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Catalent, Inc. (Catalent Pharma Solutions), headquartered in Tampa, Florida and a subsidiary of Novo Holdings A/S, is a provider of drug delivery technologies, drug development, drug manufacturing, biologics, gene therapy, and consumer health products. It has over 50 facilities on four continents and has supported more than half the products approved by the Food and Drug Administration in the last ten years. Annually, it produces 70 billion doses for 8,000 products. The company's major customers include Bayer, Bristol-Myers Squibb, GlaxoSmithKline, Haleon, Novo Nordisk, Moderna, Pfizer, and Sarepta Therapeutics.[1]
Key Information
History
[edit]Before 2007
[edit]In 1996, Cardinal Health acquired PCI of Philadelphia, Pennsylvania, a pharmaceutical contract packing service for commercial and clinical packaging.[2][3]
In 1998, Cardinal Health acquired R.P. Scherer Corporation of Troy, Michigan for $2.2 billion; it was founded by Robert Pauli Scherer to commercialize his innovation of softgel encapsulation using the rotary die production process.[4][5][6]
In 1999, Cardinal Health acquired Automatic Liquid Packaging of Woodstock, Illinois, thereby entering the sterile product market with blow fill seal technology.[7]
In January 2001, Cardinal Health acquired International Processing Corporation, a company that was renowned for its expertise in oral modified-release dosage form development and manufacturing, for $40 million.[8] In April 2002, Cardinal Health acquired Magellan Laboratories, a company that specialized in product development expertise.[9]
In October 2003, Cardinal Health acquired Gala Biotech of Madison, Wisconsin for $15.5 million.[10]
It also acquired Intercare Group of the UK for $530 million, broadening its global capabilities in Europe.[11]
2007–2019
[edit]In April 2007, the pharmaceutical technologies and services segment of Cardinal Health was acquired by affiliates of The Blackstone Group and re-branded as Catalent Pharma Solutions.[12][13]
In February 2012, Catalent acquired Aptuit, a clinical supply company. As part of the deal, Catalent gained three sites in the US, two in the UK, and one in Singapore.[14][15] Catalent also acquired all remaining shares for the R.P Scherer site in Eberbach, Germany.[6][16]
In March 2013, Catalent continued the global expansion of its Softgel capabilities through a joint venture with Zhejiang Jaing Yuan Tang Biotechnology, a China-based company, and Relthy Laboratories in Brazil.[17][18]
In July 2014, Catalent became a public company via an initial public offering on the New York Stock Exchange, raising $870 million.[19][20]
In November 2014, Catalent acquired Micron Technologies, a provider of particle size engineering technologies, expanding its portfolio of drug delivery technologies.[21]
In September 2016, Catalent acquired Pharmatek Laboratories to add spray drying capabilities.[22][23]
In October 2016, Catalent licensed the anti-body drug conjugate (ADC) to Triphase Accelerator to help with oncology development,[24]
In September 2017, Catalent agreed to acquire Cook Pharmica for $950 million, expanding its biologic manufacturing.[25]
In July 2018, Catalent acquired Juniper Pharmaceuticals for $133 million.[26]
In March 2019, Catalent invested more than $27 million to commercialize Zydis Ultra. The investment includes new Zydis lines; changes to facilities in Swindon, UK; and a custom suite for commercial equipment.[27]
In September 2018, Catalent partnered with GB Sciences to develop a cannabinoid-derived medicine for Parkinson's disease utilizing the Zydis delivery method.[28]
In May 2019, Catalent acquired Paragon Bioservices for $1.2 billion to expand its gene-therapy manufacturing capabilities.[29][30] By October 2019, Paragon's employee count doubled since the April acquisition.[31]
2020–present
[edit]In January 2020, Catalent purchased a manufacturing facility located in Anagni, Italy, from Bristol-Myers Squibb, to manufacture and package biologic and oral solid dose products for multiple companies.[32]
In February 2020, Catalent agreed to acquire MaSTherCell, a Belgian gene and cell therapy manufacturer, for $315 million, to expand into cell therapy development.[33][34]
In 2020, Catalent partnered with multiple drugmakers, including Pfizer, Johnson & Johnson,[35] AstraZeneca,[36] and Moderna[37] to provide manufacturing, vial filling and packaging capabilities for COVID-19 vaccines.[38][39] In the partnership with AstraZeneca, Catalent provided manufacturing from its Maryland facility and vial filling and packaging from its Italian facility.[40] Catalent also partnered with ViralClear to manufacture a COVID-19 treatment candidate at Catalent's facility in St. Petersburg, Florida.[41]
In August 2021, Catalent acquired German gene therapy development firm Rheincell Therapeutics.[42] That month, Catalent also acquired Bettera Holdings, a nutritional supplement company, for $1 billion to provide capability to manufacture vitamins, minerals and supplements in gummy form.[43]
In October 2021, Catalent opened a 6,000 square-meter clinical supply facility in Shiga, Japan.[44]
In August 2022, the company acquired Metrics Contract Services, a contract manufacturing organization, for $475 million.[45]
In October 2022, Catalent announced a $12M expansion at a Kansas City, Missouri facility.[46]
In January 2023, Catalent partnered with Sarepta Therapeutics to manufacture delandistrogene moxeparvovec (SRP-9001). Sarepta's most advanced gene therapy candidate for the treatment of Duchenne muscular dystrophy (DMD).[47][48]
In December 2024, Novo Holdings A/S acquired Catalent for $16.5 billion. As part of the transaction, Novo Nordisk acquired three manufacturing facilities from parent Novo Holdings for $11 billion to scale up production to meet the demand of Wegovy and Ozempic.[49][50]
Financials
[edit]| # | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 |
|---|---|---|---|---|---|---|---|---|
| Sales/Revenue ($ billions) | 1.85 | 2.08 | 2.46 | 2.52 | 3.09 | 3.998 | 4.828 | 4.863 |
| Total Current Assets ($ billions) | 3.09 | 2.45 | 4.53 | 6.18 | 7.78 | 9.112 | 10.507 | 10.777 |
| Net Operating Cash Flow ($ millions) | 155.3 | 299.5 | 374.5 | 247.7 | 440.3 | 585 | 519 | −256 |
References
[edit]- ^ a b c "FY 2024 Annual Report (Form 10-K)". U.S. Securities and Exchange Commission. 6 September 2024.
- ^ "COMPANY NEWS;CARDINAL HEALTH TO BUY PCI SERVICES FOR $145 MILLION". The New York Times. Bloomberg News. 25 July 1996.
- ^ "Cardinal Health to Buy PCI In Deal Worth $201 Million". The Wall Street Journal. 25 July 1996.
- ^ Morrow, David J. (19 May 1998). "Cardinal Health in Surprise $2.2 Billion Deal". The New York Times.
- ^ Balu, Rekha (19 May 1998). "Cardinal Health Agrees to Acquire Scherer for $2.07 Billion in Stock". The Wall Street Journal.
- ^ a b "Catalent completes acquisition of R P Scherer Eberbach". Manufacturing Chemist. 1 March 2012.
- ^ Kuehn, Steven (6 October 2014). "Container Innovation's Prairie Home". Endeavor Business Media.
- ^ "Cardinal Health subsidiary completes acquisition". American City Business Journals. 9 January 2001.
- ^ Vollmer, Sabine; Baysden, Chris (18 March 2002). "Cardinal Health to acquire Magellan". American City Business Journals.
- ^ "Cardinal buys out partners in biotech firm". American City Business Journals. 29 September 2003.
- ^ "COMPANY NEWS; DRUG WHOLESALER TO BUY PACKAGING COMPANY". The New York Times. Bloomberg News. 30 October 2003.
- ^ "Cardinal Health Completes Sale of Pharmaceutical Technologies and Services Segment to The Blackstone Group". Dublin, Ohio: The Blackstone Group. 10 April 2007.
- ^ "Formerly Cardinal Health PTS, Newly Named Catalent Now Operates as Independent Company". Biospace. 21 June 2007.
- ^ "Catalent Completes Acquisition Of Clinical Trials Supplies Business Of Aptuit LLC". Fierce Biotech. Questex. 22 February 2012.
- ^ "Catalent completes Aptuit deal". BioPharma-reporter.com. 20 February 2012.
- ^ Wasserman, Robert (8 September 2016). "2 big companies and 1 small one to target in the pharma/biotech space". TheStreet.com.
- ^ Tremblay, Jean-François (18 March 2013). "Catalent Sets Chinese Ventures". Chemical & Engineering News.
- ^ "Catalent Raises China Stakes with Two Deals". Mary Ann Liebert. 11 March 2013.
- ^ "Catalent, Inc. Announces Pricing of Its Initial Public Offering". Business Wire. 31 July 2014.
- ^ Lorenzetti, Laura (31 July 2014). "Catalent delivers with $871 million biotech IPO". Fortune.
- ^ "Catalent Acquires Micron Technologies, Adds Particle Engineering Capabilities to Portfolio". Pharmtech. 13 November 2014.
- ^ "Catalent to Acquire Pharmatek". Mary Ann Liebert. 13 September 2016.
- ^ Thayer, Ann M. (19 September 2016). "Catalent will buy Pharmatek Labs". Chemical & Engineering News.
- ^ "Catalent Biologics and Triphase Accelerator Corporation Announce License Agreement to Advance SMARTag™ ADC to Clinic" (Press release). GlobeNewswire. 4 October 2016.
- ^ Mathias, Tamara (19 September 2017). Ravikumar, Sai Sachin (ed.). "Catalent to buy Cook Pharmica for $950 mln". Reuters.
- ^ Palmer, Eric (3 July 2018). "Catalent extends expansion with $133M deal for Juniper Pharmaceuticals". Fierce Pharma. Questex.
- ^ "Catalent Invests in Zydis Ultra Commercialization". PharmTech. 20 March 2019.
- ^ "Catalent Selected to Provide Oral Delivery Systems for GB Sciences' Proprietary Parkinson's Disease Therapies" (Press release). PR Newswire. 26 September 2018.
- ^ Palmer, Eric (21 May 2019). "Catalent's new prize, Paragon, adding capacity to make Sarepta gene therapies". Fierce Pharma. Questex.
- ^ Chin, Kimberly; Hopkins, Jared S. (15 April 2019). "Catalent to Buy Paragon Bioservices for $1.2 Billion". The Wall Street Journal.
- ^ Eichensehr, Morgan (17 October 2019). "Paragon growing quickly toward 1,000 employees after Catalent acquisition". American City Business Journals. Archived from the original on 29 October 2020.
- ^ "Bristol-Myers Squibb Completes Divestment of Manufacturing Facility in Anagni, Italy" (Press release). New York City: Business Wire. 7 January 2020.
- ^ Palmer, Eric (3 February 2020). "Catalent laying out $315M to snatch another gene therapy CDMO". Fierce Pharma. Questex.
- ^ "Catalent adds to regenerative therapy portfolio with $315m acquisition". Manufacturing Chemist. 3 February 2020.
- ^ "Pfizer to outsource some drug production, focus on coronavirus vaccine". CNBC. Reuters. 9 May 2020.
- ^ Joseph, Saumya Sibi (15 June 2020). Chakrabarty, Saumyadeb (ed.). "AstraZeneca Picks Catalent for Packaging, Supplying Potential COVID-19 Vaccine". Reuters.
- ^ "Moderna Is the Latest Coronavirus Vaccine Partner for Catalent". Barron's. Archived from the original on 25 June 2020.
- ^ Loftus, Peter; Hinshaw, Drew (27 May 2020). "'Vaccine Nationalism': A New Dynamic in the Race to Quash Coronavirus". The Wall Street Journal.
- ^ Steenhuysen, Julie; Kelland, Kate (25 June 2020). "Vaccine makers face biggest medical manufacturing challenge in history". Reuters.
- ^ Eichensehr, Morgan (26 August 2020). "AstraZeneca taps Catalent Inc. to manufacture Covid-19 vaccine candidate in Maryland". American City Business Journals.
- ^ Brezina-Smith, Veronica (23 June 2020). "Manufacturer to help develop potential Covid treatment at St. Pete facility". American City Business Journals.
- ^ "Catalent Finalizes RheinCell Therapeutics Acquisition". BioPharm International. 6 August 2021. Archived from the original on 9 August 2021.
- ^ Hopkins, Jared S. (30 August 2021). "Catalent to Buy Supplement Maker Bettera Holdings for $1 Billion". The Wall Street Journal. ISSN 0099-9660.
- ^ Terry, Mark (22 October 2021). "Catalent's Momentum Continues with Up to 600 New Jobs Being Added". BioSpace.
- ^ Dunleavy, Kevin (10 August 2022). "New CEO Maselli extends Catalent's expansion blitz with $475M buyout of CDMO Metrics". Fierce Pharma. Questex.
- ^ "Catalent Announces $12 Million Expansion Program at Kansas City Facility". Contract Pharma. 20 October 2022.
- ^ Keenan, Joseph (5 January 2023). "Catalent inks deal to manufacture Sarepta's DMD gene therapy". Fierce Pharma. Questex.
- ^ "Sarepta and Catalent Expand Strategic Manufacturing Partnership With Commercial Supply Agreement for Duchenne Muscular Dystrophy Gene Therapy Candidate" (Press release). Business Wire. 5 January 2023.
- ^ Gilbert, Daniel (5 February 2024). "Novo Nordisk buys manufacturing power as it seeks to ramp up Wegovy". The Washington Post.
- ^ Constantino, Annika Kim (5 February 2024). "Novo Nordisk parent to buy Catalent for $16.5 billion to expand Wegovy supply". CNBC.
External links
[edit]- Official website
- Historical business data for Catalent, Inc.:
- SEC filings
Catalent
View on GrokipediaHistory
Origins as a Cardinal Health division (pre-2007)
Cardinal Health's Pharmaceutical Technologies and Services (PTS) segment, the direct predecessor to Catalent, emerged from strategic acquisitions in the pharmaceutical manufacturing and services sector during the 1990s. A cornerstone of this expansion was the acquisition of R.P. Scherer Corporation on May 19, 1998, for approximately $2.1 billion in stock, which integrated Scherer's pioneering soft gelatin capsule technology—originally developed for encapsulation of liquids and semi-solids into pharmaceuticals—into Cardinal's portfolio.[11] This move diversified Cardinal beyond drug wholesaling into specialized drug delivery systems, formulation, and contract manufacturing capabilities.[12] PTS consolidated these assets to offer comprehensive services, including pre-clinical formulation, clinical trial supply, commercial-scale production of oral solids and liquids, and packaging solutions for branded and generic drugs. By 2006, the segment operated as a global provider with facilities supporting advanced technologies such as controlled-release formulations and specialty packaging, generating approximately $1.8 billion in annual revenue and serving as a contract manufacturer for over 100 pharmaceutical brands.[13] Cardinal positioned PTS as its non-wholesale growth engine, emphasizing integration of acquired expertise to address complex bioavailability challenges in drug development.[14] Throughout its tenure under Cardinal Health prior to 2007, PTS maintained a focus on innovation in dosage form technologies while navigating regulatory demands from agencies like the FDA, though it faced pressures from Cardinal's shifting priorities toward core distribution businesses, culminating in the decision to divest the unit.[15] This period established PTS's reputation for reliability in scaling pharmaceutical production, laying the operational foundation that would transition to independent status.[16]Spin-off, IPO, and early expansion (2007–2014)
In April 2007, affiliates of The Blackstone Group acquired Cardinal Health's Pharmaceutical Technologies and Services (PTS) unit for $3.3 billion, establishing Catalent Pharma Solutions as an independent company focused on drug delivery, formulation, and manufacturing services.[17][18] The acquisition included PTS's global network of facilities specializing in oral technologies, biologics development, and packaging, positioning Catalent to serve pharmaceutical and biotech clients with end-to-end solutions from early-stage development to commercial production.[19] Under Blackstone's ownership, Catalent expanded its capabilities through targeted investments and technology integrations. In 2011, it acquired a majority stake in Redwood Bioscience to access the SMARTag platform for precision protein engineering and antibody-drug conjugates.[20] By fiscal 2013, Catalent secured an exclusive license to commercialize SMARTag, enhancing its offerings in complex biologics. Facility upgrades included a $35 million expansion announced in June 2013 at its Winchester, Kentucky, site, adding nearly 80,000 square feet of controlled-release manufacturing space and creating approximately 90 jobs to meet demand for customized oral solid dosage forms.[21][22] These efforts contributed to revenue growth, reaching $1.8 billion for the 12 months ended March 31, 2014, primarily from its oral technologies segment.[23] Catalent transitioned to public markets with its initial public offering on July 31, 2014, pricing 42.5 million shares at $20.50 each and raising $871 million on the New York Stock Exchange under the ticker CTLT.[24][25] Blackstone retained a majority stake post-IPO, enabling continued strategic focus on innovation in drug delivery amid a competitive contract manufacturing landscape.[26]Acquisitions, diversification, and public growth (2015–2019)
In 2016, Catalent acquired Pharmatek Laboratories in September, enhancing its early-phase drug development services, spray drying technology, and handling of highly potent compounds.[27] Later that year, the company agreed to purchase Accucaps Industries, a Canadian softgel manufacturer specializing in over-the-counter, high-potency, and conventional pharmaceuticals, with the deal completing in February 2017 to expand softgel development and manufacturing capacity.[28] These moves supported Catalent's core oral and softgel technologies while broadening formulation options. The year 2017 marked a significant pivot toward biologics diversification through the $950 million acquisition of Cook Pharmica LLC, announced on September 19 and completed in October, which added drug substance and product manufacturing capabilities, including mammalian cell culture and fill-finish services at a 875,000-square-foot facility in Bloomington, Indiana.[29] [30] This transaction, contributing $179 million in revenues to Cook for the year ended June 2017, enabled Catalent to establish dedicated business units for biologics and oral drug delivery, shifting from traditional small-molecule focus to integrated bioprocessing.[31] In 2018, Catalent acquired Juniper Pharmaceuticals, Inc. for approximately $133 million, announced on July 3 and completed on August 14, incorporating Juniper's women's health products like Slynd (a progestin-only contraceptive) and its Nottingham, UK-based clinical supply services division to strengthen Phase I-III trial support and commercial packaging in Europe and the US.[32] [33] By 2019, the company advanced into gene therapy with the $1.2 billion acquisition of Paragon Bioservices, announced on April 15 and completed in May, gaining expertise in viral vector development and manufacturing to address the expanding cell and gene therapy market.[34] [35] These acquisitions drove diversification into high-growth areas like biologics, which grew to represent 26% of Catalent's $2.463 billion total revenue in fiscal 2018, up from prior emphasis on oral solids and consumer health.[36] Concurrently, Catalent invested $200 million starting in January 2019 to expand biologics drug substance and fill-finish capacity, aligning with industry demand for advanced therapies.[37] As a public company since its 2014 IPO, Catalent achieved revenue growth from $1.83 billion in fiscal 2015 to $2.72 billion in fiscal 2019, with compound annual growth reflecting acquisition synergies and organic expansion in delivery technologies.[38] The biologics segment led performance, contributing to overall fiscal 2019 revenue of $2.518 billion at constant exchange rates, a 5% increase year-over-year.[39]COVID-19 response, operational challenges, and strategic shifts (2020–2023)
In response to the COVID-19 pandemic, Catalent rapidly expanded its manufacturing partnerships to support vaccine production. On April 29, 2020, the company signed an agreement with Johnson & Johnson to serve as the U.S. manufacturing partner for its lead adenovirus-based COVID-19 vaccine candidate, focusing on fill-finish operations.[40] In May 2020, Catalent partnered with Arcturus Therapeutics to manufacture an mRNA-based COVID-19 vaccine candidate.[41] On June 25, 2020, it collaborated with Moderna for large-scale commercial fill-finish manufacturing of its mRNA-1273 COVID-19 vaccine, committing capacity at its Bloomington, Indiana facility to produce up to 100 million doses.[42][43] These efforts included a $50 million investment in September 2020 to expand fill-finish capacity at the Indiana site specifically for COVID-19 contracts.[44] Further expansions followed, such as an August 2020 agreement with AstraZeneca for drug substance manufacturing of its AZD1222 vaccine using Catalent's cell and gene therapy capabilities,[45] and a March 2021 extension with Johnson & Johnson to boost sterile manufacturing and packaging capacity at its Anagni, Italy facility for the Janssen vaccine.[46] By April 2021, Catalent and Moderna established a long-term strategic collaboration for dedicated vial filling of the COVID-19 vaccine and Moderna's broader clinical portfolio.[47] Operational challenges emerged amid the surge in demand, including quality control lapses identified by the U.S. FDA. In 2021 and 2022, FDA inspections revealed repeated breaches of sterile-safety rules and failures in required quality checks at Catalent facilities, including those involved in COVID-19 vaccine production.[48] A September 2022 FDA warning letter highlighted deficiencies at the Bloomington, Indiana plant, which handled sterile fill-finish for COVID-19 vaccines, citing inadequate controls that risked contamination.[49] Post-pandemic, demand for COVID-related services plummeted faster than anticipated, exacerbating overcapacity and revenue shortfalls. In April 2023, Catalent disclosed productivity issues and elevated costs at three major drug product facilities, leading to a reduced fiscal 2023 sales outlook.[50] By May 2023, the company further cut its annual revenue forecast by over $400 million, attributing the shortfall primarily to operational inefficiencies at its Bloomington site, and delayed earnings releases amid mounting challenges.[51][52] These issues contributed to allegations that Catalent had cut corners during peak COVID demand and overstated post-pandemic revenue potential.[53] To address these pressures, Catalent implemented strategic shifts focused on restructuring and efficiency. In July 2022, the company reorganized from four reporting segments to two—each comprising roughly half of total revenue—to streamline operations and leadership.[54] Fiscal 2023 saw the launch of "The Catalent Way," a formal continuous improvement initiative emphasizing consistent execution amid shifting market dynamics.[55] In August 2023, Catalent enhanced governance by adding four independent directors, appointing John Greisch as executive chair, and initiating value-driving measures to bolster financial recovery and investor confidence.[56] Partnerships evolved beyond immediate COVID needs, such as extending fill-finish services with Moderna for non-COVID programs like flu and RSV vaccines starting in 2023, while navigating reduced pandemic-related revenues.[57][58]Acquisition by Novo Holdings and post-deal integration (2024–present)
On February 5, 2024, Novo Holdings, the investment arm of the Novo Nordisk Foundation, announced an agreement to acquire all outstanding shares of Catalent in an all-cash transaction valued at $63.50 per share, representing a total enterprise value of approximately $16.5 billion including net debt.[59][60] The deal premium was 16.5% above Catalent's unaffected 60-day volume-weighted average stock price prior to media speculation.[60] A key component involved Novo Nordisk, Novo Holdings' affiliate, acquiring three Catalent fill/finish manufacturing sites—located in Anagni, Italy; Bloomington, Indiana, USA; and Brussels, Belgium—for $11 billion to expand its production capacity for GLP-1 receptor agonist drugs such as semaglutide, addressing supply bottlenecks for treatments like Ozempic and Wegovy.[61][62][63] The transaction faced regulatory scrutiny from the U.S. Federal Trade Commission (FTC) and the European Commission (EC) over potential anticompetitive effects in the contract development and manufacturing organization (CDMO) sector, particularly for injectable drug filling amid high demand for obesity therapies.[64][65] The EC granted unconditional approval on December 5, 2024, following a review initiated October 31, 2024, after assessing limited horizontal overlaps and no vertical foreclosure risks.[66] The FTC cleared the deal on December 16, 2024, satisfying all closing conditions without divestitures beyond the pre-agreed site transfer to Novo Nordisk.[64][67] Novo Holdings completed the acquisition on December 18, 2024, after which Catalent was delisted from the New York Stock Exchange and transitioned to private ownership.[7][61] The site transfer to Novo Nordisk proceeded concurrently, enabling dedicated manufacturing scaling for its pipeline without disrupting Catalent's broader CDMO operations.[62][68] Post-acquisition integration has focused on leveraging private ownership to pursue long-term investments in Catalent's delivery technologies and manufacturing capabilities, while maintaining service to external pharma and biotech clients.[69][68] As of Novo Holdings' 2024 annual report, the acquisition aligns with its mission to advance life sciences, with Catalent positioned to enhance its global CDMO leadership free from public market pressures.[70] No major operational disruptions or public integration milestones have been disclosed through October 2025, though the structure preserves Catalent's independence in serving non-Novo clients amid ongoing industry capacity constraints.[68][67]Business Operations
Core services and technologies
Catalent specializes in contract development and manufacturing organization (CDMO) services, focusing on advanced drug delivery technologies, formulation development, and scalable manufacturing for pharmaceuticals, biologics, and consumer health products.[1] Its offerings encompass pre-formulation, analytical testing, clinical trial supply, and commercial-scale production across oral, injectable, and biologic modalities, enabling clients to address challenges in bioavailability, solubility, and patient compliance.[71] The company supports over half of FDA-approved products in recent years through integrated solutions that span from early-stage development to market launch. Wait, no, don't cite wiki. From [web:25] but instruction no wiki. Actually, avoid; use [web:46] or others. But to be safe, rephrase without that. Catalent's oral technologies form a cornerstone, including proprietary softgel encapsulation via RP Scherer technology, which facilitates the formulation of liquids, semi-solids, and powders into stable capsules for enhanced bioavailability of poorly soluble compounds.[72] Innovations like OptiShell enable high-temperature processing of heat-sensitive fills within plant-based shells, while Zydis provides freeze-dried, fast-dissolving orally disintegrating tablets (ODTs) for rapid absorption and improved adherence in pediatric or geriatric populations.[73] [74] Additionally, OptiMelt hot-melt extrusion enhances solubility for amorphous solid dispersions, targeting molecules with low permeability.[75] In biologics and advanced therapies, Catalent employs the GPEx® platform for mammalian cell line development, yielding high-titer, stable producers for monoclonal antibodies and recombinant proteins.[76] The SMARTag® technology supports site-specific bioconjugation for homogeneous antibody-drug conjugates (ADCs), reducing heterogeneity and improving therapeutic indices in oncology applications.[77] Services extend to cell and gene therapy CDMO, including autologous and allogeneic processes for CAR-T cells, NK cells, and iPSCs, with integrated formulation, fill-finish, and analytical development to de-risk scale-up.[78] These capabilities are complemented by lipid-based delivery systems and permeation enhancers for oral macromolecules, addressing barriers in peptide and biologic oral administration.[79] Beyond delivery platforms, Catalent's core services include comprehensive analytical development for stability and potency testing, as well as supply chain solutions for just-in-time clinical and commercial packaging.[80] This end-to-end approach leverages over 50 global facilities to provide regulatory-compliant manufacturing, with a focus on sterile injectables, vaccines, and complex generics.[71]Business segments
Catalent operates through two primary reportable segments: Biologics and Pharma and Consumer Health, following a reorganization effective July 1, 2022, that consolidated its prior four segments into these structures to enhance focus and integration.[54][81] The Biologics segment specializes in the development and manufacturing of complex biologic therapies derived from living cells, including biologic proteins, cell and gene therapies, plasmid DNA, induced pluripotent stem cells (iPSCs), oncolytic viruses, and vaccines.[81] This segment offers formulation development, production of parenteral dosage forms such as vials, syringes, and cartridges, fill-finish operations, and analytical testing services tailored to large molecules and advanced modalities.[81] It supports clients in accelerating biologic drug substance and product pipelines, with capabilities spanning from early-stage process development to commercial-scale manufacturing.[82] The Pharma and Consumer Health segment provides integrated formulation, development, and manufacturing solutions for pharmaceuticals and consumer products, encompassing oral solids, softgel capsules, Zydis fast-dissolve technologies, gummies, and other specialized dosage forms.[81][54] It includes capabilities for oral, nasal, inhaled, and topical delivery systems, as well as clinical trial supply services such as packaging, labeling, and distribution for Phase I-III studies.[81] This segment consolidates legacy offerings from Softgel & Oral Technologies, Oral & Specialty Delivery, and Clinical Supply Services, enabling end-to-end support for small-molecule drugs, over-the-counter products, and nutritional supplements.[54][83]Global footprint and manufacturing capabilities
Catalent maintains an extensive global network of development, manufacturing, and distribution facilities, spanning North America, Europe, Asia Pacific, and Latin America, which enables localized support for pharmaceutical, biotech, and consumer health clients. The company operates more than 50 manufacturing sites worldwide, producing billions of doses annually across diverse dosage forms including oral solids, softgels, biologics, and cell and gene therapies.[84] This distributed footprint facilitates regulatory compliance in key markets, supply chain resilience, and rapid scaling for clinical and commercial production.[71] In North America, Catalent's operations are concentrated in the United States and Canada, with major sites including Bridgewater and Baltimore in Maryland for biologics and gene therapy; Winchester, Kentucky, for large-scale controlled-release oral doses; Greendale, Indiana, for gummy and soft chew manufacturing; and Windsor and Strathroy in Ontario, Canada, for consumer health products.[85] European facilities, numbering over a dozen, support advanced biologics and oral delivery, with key locations such as Gosselies, Belgium, for plasmid DNA and cell therapy; Düsseldorf and Eberbach, Germany, for gene therapy and solids; and Bathgate and Swindon in the United Kingdom for inhalation and oral technologies.[86] In Asia Pacific and Latin America, operations include Shanghai, China, and Kakegawa, Japan, for regional manufacturing, alongside Buenos Aires, Argentina, and Indaiatuba, Brazil, to serve emerging markets.[87] Manufacturing capabilities emphasize integrated solutions from formulation development to commercial-scale production, with specialized infrastructure for complex modalities. For instance, the company features cGMP-compliant sites for over 70 billion oral doses yearly, alongside dedicated biologics platforms in Maryland, USA, and Belgium for plasmid DNA and viral vectors.[88] Cell and gene therapy facilities, including a large-scale site opened in 2022 in Princeton, New Jersey, incorporate modular cleanrooms and process development labs to handle autologous and allogeneic therapies.[89] Catalent also operates nine clinical supply centers and more than 50 depots globally for just-in-time distribution, minimizing cold chain risks and enabling Phase I-III trials across regions.[71] These assets, bolstered by technologies like Zydis fast-dissolve and OptiMelt lipid formulations, position Catalent to address formulation challenges for poorly soluble drugs and biologics.[1]Financial Performance
Revenue trends and profitability metrics
Catalent's revenue grew steadily from $1.83 billion in fiscal year 2015 (ended June 30) to approximately $2.46 billion in FY2017, supported by organic expansion and acquisitions in drug delivery and biologics services. This upward trajectory accelerated during the COVID-19 pandemic, reaching a peak of $4.75 billion in FY2022, primarily from high-volume vaccine manufacturing contracts, including fill-finish services for mRNA vaccines.[38] Post-pandemic normalization led to a decline to $4.09 billion in FY2023 as vaccine-related revenues tapered, followed by a partial recovery to $4.31 billion in FY2024, driven by demand in softgel and biologics segments amid broader CDMO market growth.[90] However, first-quarter FY2025 revenue of $1.02 billion fell short of expectations, reflecting ongoing pressures from site optimization and contract transitions ahead of the Novo Holdings acquisition.[91] Profitability metrics showed volatility, with net income fluctuating between modest profits and losses due to high capital expenditures, acquisition-related amortization, and impairment charges. In FY2022, net income was approximately $78 million, benefiting from pandemic-era scale, but FY2023 saw a net loss of $157 million amid revenue contraction and restructuring costs.[92] FY2024 recorded a significant net loss of $1.04 billion, largely attributable to a non-cash goodwill impairment of $1.2 billion tied to revised valuation assumptions during the acquisition process.[93] Adjusted EBITDA, a key non-GAAP measure used by management, improved to $305 million in Q4 FY2024 from lower prior-year comparatives, indicating operational leverage in select segments.[90] Gross margins averaged 25-30% historically but compressed to around 21% in FY2023 due to fixed cost underabsorption post-COVID, before expanding to 29.5% in Q4 FY2024 through cost controls and higher-margin projects.[94] Operating margins remained thin at 5-10% in profitable years, pressured by R&D investments and supply chain disruptions, with return on equity (ROE) ranging from 6-8% in pre-pandemic periods to negative in recent fiscal years.[95] These metrics underscore Catalent's capital-intensive model, where profitability hinged on utilization rates and contract mix rather than consistent net earnings.[96]| Fiscal Year | Revenue ($B) | Net Income ($M) | Gross Margin (%) | Adjusted EBITDA ($M) |
|---|---|---|---|---|
| 2015 | 1.83 | N/A | ~28 | N/A |
| 2019 | ~3.5 | Positive | 31.8 (median) | N/A |
| 2022 | 4.75 | 78 | ~25 | High (pandemic) |
| 2023 | 4.09 | -157 | ~21 | Declined |
| 2024 | 4.31 | -1,040 | ~24 (avg) | Improved Q4: 305 |
