At the time the tender offer is commenced, Catalent and its acquisition subsidiary will file tender offer materials on Schedule TO with the SEC, and Juniper will file with the SEC a Solicitation . [40], January 2023, Catalent partnered with Sarepta to manufacture delandistrogene moxeparvovec (SRP-9001). By using this website you understand and accept that Catalent tracks your website activities to be able to offer you a more tailored response or information to meet your requirements, and that your personal data will be held in accordance with our, Copyright 2023, Catalent, Inc - All Rights Reserved, Copyright 2020, Catalent, Inc - All Rights Reserved, Catalent Adds New Cryogenic Capabilities at Shiga, Japan, Facility, Catalent to Present on Integrated UpTempo Gene Therapy Development Platform at Upcoming ASGCT Annual Meeting, Catalent Chief Scientific Officer to Present at Upcoming Symposium of the International Consortium for Advanced Medicines Manufacturing, Catalent Experts to Co-Host Workshops on Supply Chain Management at Upcoming Global Clinical Supplies Group Conference, Mitigating the Risk of Pitfalls in Nasal Drug Product Development, Testing and Manufacturing, Road to IND: Accelerating Development & Manufacturing of Biologics, Preclinical Toxicology vs Clinical: Key Considerations in Using Lipid-based Formulations, Highly Potent Active Pharmaceutical Ingredients. Segment EBITDA margin was 17.9% in the third quarter of fiscal 2021, compared to 31.0% in the third quarter of the prior year. (3) The tax effect of adjustments to Adjusted Net Income are computed by applying the statutory tax rate in the jurisdictions to the income or expense items that are adjusted in the period presented; if a valuation allowance exists, the rate applied is zero. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Ongoing elevated demand across our drug product, drug substance and cell and gene therapy offerings, as well as new demand related to potential COVID-19 vaccines and treatments, were partially offset by headwinds in our Softgel and Oral Technologies and Oral and Specialty Delivery segments, said John Chiminski, Chair and Chief Executive Officer of Catalent, Inc. Included in this release is a reconciliation of operating earnings/(loss) to EBITDA from operations and a reconciliation of net earnings/(loss) to Adjusted EBITDA and Adjusted Net Income. Leading Global CDMO for Pharma & Biotech | Catalent These statements are based on current expectations of future events. A Rich History that Informs Our Future Focus. Condensed Consolidated Balance Sheets (Dollars in millions) September 30, 2020 . of our reports dated August 30, 2021, with respect to the consolidated financial statements of Catalent, Inc. and subsidiaries and the effectiveness of internal control over financial reporting of Catalent, Inc. and subsidiaries included in this Annual Report (Form 10-K) of Catalent, Inc. and subsidiaries for the year ended June 30, 2021. March 31, Nine Months Ended . Condensed Consolidated Statements of Cash Flows Adjusted Net Income (Loss) is not defined under U.S. GAAP, is not a measure of operating income, operating performance, or liquidity presented in accordance with U.S. GAAP and is subject to important limitations. 2021 . It employs more than 14,000 people,[3] including approximately 2,400 scientists and technicians. [7], In 1998, Cardinal Health acquired R.P. The current debt structure does not include any significant maturity until 2026. WHOLLY OWNED SUBSIDIARIES OF CATALENT PHARMA SOLUTIONS, INC. 1. Reconciliation of Net Earnings to Adjusted Net Income*, (Unaudited; in millions, except per share data), Discrete income tax (benefit)/expense items (4). Scherer End 60 Year Joint Venture", "Catalent's Brazilian acquisition supports global softgel strategy", "Catalent Issues Initial Public Offering", "Catalent Acquires Micron Technologies, Adds Particle Engineering Capabilities to Portfolio", "Catalent Buys Pharmatek and Lands Spray Drying Technology", "Catalent targets biologics with Cook Pharmica acquisition", "Catalent extends expansion with $133M deal for Juniper Pharmaceuticals", "Catalent Names Alessandro Maselli President and Chief Operating Officer", "Catalent Invests in Zydis Ultra Commercialization", "Wellness products take off in the growing recreational cannabis market", "Catalent to Buy Paragon Bioservices for $1.2 Billion", "Catalent's new prize, Paragon, adding capacity to make Sarepta gene therapies", "Paragon growing quickly toward 1,000 employees after Catalent acquisition", "Bristol-Myers offloads manufacturing plant to Catalent", "Catalent laying out $315M to snatch another gene therapy CDMO", "Catalent adds to regenerative therapy portfolio with $315m acquisition", "Pfizer to outsource some drug production, focus on coronavirus vaccine", "AstraZeneca Picks Catalent for Packaging, Supplying Potential COVID-19 Vaccine", "Moderna Is the Latest Coronavirus Vaccine Partner for Catalent", "Vaccine makers face biggest medical manufacturing challenge in history", "AstraZeneca taps Catalent Inc. to manufacture Covid-19 vaccine candidate in Maryland", "Manufacturer to help develop potential Covid treatment at St. Pete facility", "Catalent Finalizes RheinCell Therapeutics Acquisition", "WSJ News Exclusive | Catalent to Buy Supplement Maker Bettera Holdings for $1 Billion", "Catalent's Momentum Continues with Up to 600 New Jobs Being Added", "Catalent Announces $12 Million Expansion Program at Kansas City Facility", "Catalent inks deal to manufacture Sarepta's DMD gene therapy", "Sarepta marches forward with its potential DMD gene therapy and an expanded Catalent manufacturing deal", "Sarepta and Catalent Expand Strategic Manufacturing Partnership With Commercial Supply Agreement for Duchenne Muscular Dystrophy Gene Therapy Candidate", https://en.wikipedia.org/w/index.php?title=Catalent&oldid=1138334559, Drug pre-formulation, formulation, analytical testing, clinical and commercial manufacturing, clinical packaging and supply chain, regulatory consulting, This page was last edited on 9 February 2023, at 03:14. Under the terms of the agreement, Catalent has purchased the shares of SCTS, previously held by Bone Therapeutics, and a purpose-built CGxP facility of approximately 41,000 square-foot (3,800 square-meter), including its related quality control and product development laboratories, warehouse, grade C and B cleanrooms and equipment as well as land for further development. [21] Later in 2019, Catalent partnered with GB Sciences to develop a cannabinoid-derived medicine for Parkinson's disease utilizing the Zydis delivery method. [23] The deal was completed in May 2019 and included an agreement with Sarepta Therapeutics, a gene therapy manufacturer. You can unsubscribe to any of the investor alerts you are subscribed to by visiting the unsubscribe section below. All forward-looking statements speak only as of the date of this release or as of the date they are made, and Catalent does not undertake to update any forward-looking statement as a result of new information or future events or developments except to the extent required by law. Biologics $ 179.9 $ 51.9 $ 421.9 $ 150.7 Softgel and Oral Technologies 59.6 (Unaudited; dollars in millions, except per share data). (Unaudited; dollars and shares in millions, except per share data), Selling, general, and administrative expenses, Impairment charges and (gain) loss on sale of assets, Less: Net earnings attributable to preferred shareholders, Net earnings attributable to common shareholders, Weighted average shares outstanding - basic, Weighted average shares outstanding - diluted, Catalent, Inc. and Subsidiaries As a result, Catalent does not believe that a U.S. GAAP reconciliation would provide meaningful supplemental information about its outlook. Catalent Completes Acquisition of Gene Therapy Leader Paragon Catalent, Inc. and Subsidiaries. The shares began trading on the NYSE on 31 July 2014, under the ticker symbol CTLT. It also allows us to further focus on our core activity: developing innovative cell-based treatments for conditions with high unmet medical needs. Following the acquisition of MaSTherCell, the additional manufacturing capacity and technical expertise that this deal with Bone Therapeutics gives us will immediately expand our functional clinical and commercial capacity for current late-stage customers. Catalent, Inc. - Investor Relations (Unaudited; dollars in millions), March 31, Catalent, Inc. and Subsidiaries List of significant subsidiaries - EX 21.1 SOMERSET, N.J.--(BUSINESS WIRE)-- It is a global provider of delivery technologies, development, drug manufacturing, biologics, gene therapies and consumer health products. Scherer Corporation to commercialize his innovation of softgel encapsulation using the rotary die production process. All statements other than statements of historical fact, are, or may be deemed to be, forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. (4) The tax effect of adjustments to Adjusted Net Income are computed by applying the statutory tax rate in the jurisdictions to the income or expense items that are adjusted in the period presented; if a valuation allowance exists, the rate applied is zero. Paul Surdez [38], In October 2021, Catalent opened a 6,000 square-meter clinical supply facility in Shiga, Japan. [14], In November 2014, Catalent announced it had acquired Micron Technologies, a provider of particle size engineering technologies. Learn More CATALENT EXPANDS UPTEMPO AAV PLATFORM TO ACCELERATE DEVELOPMENT OF GENE THERAPIES Learn More How can we work together ORAL BIOLOGICS CELL & GENE THERAPY A fully diluted share count in the range of 178 million to 180 million shares on a weighted-average basis, counting the Series A convertible preferred shares as-if converted, unchanged from previous guidance. Net revenue for fiscal 2021 in the range of $3.875 billion to $3.975 billion, compared to the previous range of $3.80 billion to $3.95 billion; Adjusted EBITDA for fiscal 2021 in the range of $975 million to $1.015 billion, compared to the previous range of $950 million to $1.000 billion; Adjusted Net Income for fiscal 2021 in the range of $500 million to $540 million, compared to the previous range of $475 million to $525 million; and. Catalent Completes Acquisition of Cell Therapy Manufacturing Facility Catalent believes these measures are a useful financial metric to assess its operating performance across periods by excluding certain items that it believes are not representative of its core business and Catalent uses these measures for business planning purposes. (2) Represents the gain on sale of subsidiary associated with the blow-fill-seal business divestiture. Net revenue in the range of $3.58 billion to $3.78 billion, compared to the previous range of $3.45 billion to $3.60 billion; Adjusted EBITDA in the range of $880 million to $950 million, compared to the previous range of $840 million to $890 million; Adjusted Net Income in the range of $410 million to $470 million, compared to the previous range of $390 million to $435 million; and. Included in this release is a reconciliation of net earnings (loss) to EBITDA from operations, Adjusted EBITDA and Adjusted Net Income. 732-537-6325 By using this website you understand and accept that Catalent tracks your website activities to be able to offer you a more tailored response or information to meet your requirements, and that your personal data will be held in accordance with our, Copyright 2022, Catalent, Inc - All Rights Reserved, Catalent, Inc. Reports First Quarter Fiscal 2021 Results, Highly Potent Active Pharmaceutical Ingredients, https://www.businesswire.com/news/home/20201103005180/en/. [25], In June 2019, Catalent acquired Bristol-Myers' European launch pad to expand its global CDMO. [17] In September 2017, Catalent agreed to acquire Cook Pharmica for $950 million, allowing Catalent to expand their biologic manufacturing. If you experience any issues with this process, please contact us for further assistance. Catalent calculates constant currency by calculating current-year results using prior-year foreign currency exchange rates. For more information, visit www.catalent.com. The current debt structure does not include any significant maturity until 2027. Catalent employs more than 14,000 people, including approximately 2,400 scientists, at more than 40 facilities across four continents and in fiscal 2020 generated over $3 billion in annual revenue. The revised guidance projects: The Companys management will host a webcast to discuss the results at 8:15 a.m. In connection with the acquisition of Paragon, Catalent Pharma Solutions, Inc., as borrower, and certain other wholly owned subsidiaries of Catalent entered into an amendment, dated as of May 17 . Catalent CTS Kansas City LLC Company Profile, Financial and - digitGaps (6) Represents Adjusted Net Income divided by the weighted average sum of (a) the number of shares of Common Stock outstanding, plus (b) the number of shares of Common Stock that would be issued assuming exercise or vesting of all potentially dilutive instruments, plus (c) the number of shares of Common Stock equivalent to the shares of Series A Preferred Stock outstanding under the "if-converted" method. Consolidated Statements of Operations The Softgel and Oral Technologies segment represented 26% of Catalents total net revenue in the first quarter of fiscal 2021. Adjusted EBITDA is the covenant compliance measure used in the credit agreement governing debt incurrence and restricted payments. [26], 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. Similarly, statements that describe Catalents objectives, plans, or goals are, or may be, forward-looking statements. Catalent, Inc. (NYSE: CTLT), an S&P 500 company, is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. SOMERSET, N.J.-- ( BUSINESS WIRE )--Catalent, Inc. ("Catalent") (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that its wholly owned subsidiary, Catalent Pharma Solutions, Inc. (the ". Segment EBITDA in the first quarter of fiscal 2021 was $106.5 million, an increase of 197% as reported and 194% in constant currency compared to the first quarter a year ago.