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Science

Catalent announces launch of private offering of $475 million of senior unsecured notes due 2029

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 “Operating Subsidiary”), intends to offer, subject to market and other conditions, $475 million in aggregate principal amount of senior unsecured notes due 2029 (the “Notes”) in a private offering (the “Private Offering”) that is exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”).

The Operating Subsidiary intends to use the net proceeds from the Private Offering to (i) redeem in full its 4.875% senior notes due 2026 (the “2026 Notes”), plus any accrued and unpaid interest thereon, (ii) pay related fees and expenses, and (iii) provide cash on its balance sheet for general corporate purposes, including capital expenditures.

The Notes will be guaranteed by all of the wholly owned U.S. subsidiaries of the Operating Subsidiary that guarantee its senior secured credit facilities. The Notes will not be guaranteed by PTS Intermediate Holdings, LLC or Catalent, the direct and indirect parent companies of the Operating Subsidiary.

The Notes will be offered and sold to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act and to certain non-U.S. persons outside the United States pursuant to Regulation S under the Securities Act.

The Notes have not been and will not be registered under the Securities Act or applicable state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the Notes or any other securities described above and shall not constitute an offer, solicitation or sale in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful. This press release does not constitute a notice of redemption under the Indenture, or an offer to tender for, or purchase, any of the 2026 Notes or any other security.

There can be no assurance that the Operating Subsidiary will (i) consummate the Private Offering on favorable terms or at all or (ii) redeem the 2026 Notes.

About Catalent

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. 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 global clinical and commercial product supply. Catalent employs over 14,000 people, including over 2,400 scientists and technicians, at more than 40 facilities across four continents, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.

Forward-Looking Statement Notice

This release contains both historical and forward-looking statements, including statements regarding the Private Offering and plans, projections and estimates regarding the use of proceeds from the Private Offering. 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 and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally can be identified because they relate to the topics set forth above or by the use of statements that include phrases such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “plan,” “project,” “foresee,” “likely,” “may,” “will,” “would,” or other words or phrases with similar meanings. Similarly, statements that describe Catalent’s objectives, plans, or goals are, or may be, forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Catalent’s expectations and projections. Some of the factors that could cause actual results to differ include, but are not limited to, the following: the current or future effects of the COVID-19 pandemic on Catalent’s and its clients’ businesses; participation in a highly competitive market and increased competition that may adversely affect Catalent’s business; demand for Catalent’s offerings, which depends in part on Catalent’s customers’ research and development and the clinical and market success of their products; product and other liability risks that could adversely affect Catalent’s results of operations, financial condition, liquidity and cash flows; failure to comply with existing and future regulatory requirements; failure to provide quality offerings to customers could have an adverse effect on Catalent’s business and subject it to regulatory actions and costly litigation; problems providing the highly exacting and complex services or support required; global economic, political and regulatory risks to the operations of Catalent; inability to enhance existing or introduce new technology or service offerings in a timely manner; inadequate patents, copyrights, trademarks and other forms of intellectual property protections; fluctuations in the costs, availability, and suitability of the components of the products Catalent manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials; changes in market access or healthcare reimbursement in the United States or internationally; fluctuations in the exchange rate of the U.S. dollar against other currencies, including as a result of the U.K.’s exit from the European Union; adverse tax, legislative or regulatory initiatives or challenges or adjustments to Catalent’s tax positions; loss of key personnel; risks generally associated with information systems; inability to complete any future acquisitions or other transactions that may complement or expand Catalent’s business or divest of non-strategic businesses or assets and difficulties in successfully integrating acquired businesses and realizing anticipated benefits of such acquisitions; risks associated with timely and successfully completing, and correctly anticipating the future demand predicted for, capital expansion projects at existing or any acquired facilities, offerings and customers’ products that may infringe on the intellectual property rights of third parties; environmental, health and safety laws and regulations, which could increase costs and restrict operations; labor and employment laws and regulations or labor difficulties, which could increase costs or result in operational disruptions; additional cash contributions required to fund Catalent’s existing pension plans; substantial leverage resulting in the limited ability of Catalent to raise additional capital to fund operations and react to changes in the economy or in the industry; and exposure to interest-rate risk to the extent of Catalent’s variable-rate debt preventing Catalent from meeting its obligations under its indebtedness. For a more detailed discussion of these and other factors, see the information under the caption “Risk Factors” in Catalent’s Annual Report on Form 10-K for the fiscal year ended June 30, 2020, filed August 31, 2020. 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.

Contacts

Catalent, Inc.

Investor Contact:

Paul Surdez, 732-537-6325

investors@catalent.com

Categories
Healthcare

Humanigen expands partnership with Catalent biologics to manufacture investigational COVID-19 therapeutic candidate lenzilumab

  • Humanigen’s investigational monoclonal antibody, lenzilumab, was developed using Catalent’s proprietary GPEx® cell line development technology
  • Expanded partnership established product supply for lenzilumab, an investigational Phase 3 product for COVID-19
  • Catalent’s OneBio® integrated biologics suite expected to accelerate development, manufacturing and supply of lenzilumab for clinical trial use in COVID-19 patients and potential commercialization

SOMERSET, N.J. & BURLINGAME, Calif.–(BUSINESS WIRE)–Catalent and Humanigen, Inc. (HGEN) (“Humanigen”) today announced the expansion of their relationship, under which Catalent will provide development, manufacturing and commercialization services for lenzilumab, Humanigen’s proprietary Humaneered® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody.

Catalent is the leading global provider of advanced delivery technologies, development, manufacturing and clinical supply solutions for drugs, biologics, cell and gene therapies and consumer health products. Humanigen is a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s lead therapeutic candidate.

Mayo Clinic recently announced data on the first clinical use of lenzilumab in 12 patients with severe and critical COVID-19 pneumonia, the majority of whom showed rapid recovery and hospital discharge. A Phase 3 study is currently underway evaluating hospitalized COVID-19 patients.

“Based on lenzilumab’s promising clinical data, we are pleased to expand our relationship with Catalent to solidify our ability to manufacture and supply lenzilumab,” commented Cameron Durrant, MD, MBA, Chief Executive Officer of Humanigen. “If we are able to secure FDA approvals or Emergency Use Authorization, Catalent Biologics’ deep expertise and integrated OneBio solution will accelerate our ability to get this therapy to patients that need it most.”

Catalent has partnered closely with Humanigen to develop and supply lenzilumab for clinical trials,” commented Karen Flynn, President of Catalent Biologics and Chief Commercial Officer. “The experience we already have with lenzilumab, and our OneBio integrated offering from development to supply, make Catalent uniquely suited to support Humanigen in the journey to make this promising therapy available to COVID-19 patients as soon as possible following receipt of regulatory approvals.”

To date, Catalent Biologics has provided early-stage development and clinical cGMP drug substance manufacturing for lenzilumab at its facility in Madison, Wisconsin to support Humanigen’s ongoing clinical trials across various disease categories. Under the expanded partnership, Catalent is also providing clinical supply support for Humanigen’s Phase 3 potential registration study in COVID-19 from its Philadelphia facility.

Lenzilumab was originally manufactured in Catalent’s Madison facility using Catalent Biologics’ proprietary GPEx® cell line development technology. As part of the expanded partnership, Catalent intends to provide additional drug substance clinical supply for Humanigen’s clinical trials, Expanded Access Program (EAP), as well as additional late-stage development and clinical and potential commercial drug substance manufacturing and vial filling at its Madison and Bloomington, Indiana, sites.

Catalent Biologics’ Madison facility provides development and drug substance manufacturing, including GPEx cell line development, process development, process validation, formulation development, and clinical and commercial cGMP manufacturing. Its Bloomington facility has deep expertise in sterile formulation, with drug substance development and manufacturing and drug product fill/finish capacity across liquid and lyophilized vials, prefilled syringes, and cartridges as well as primary and secondary packaging.

Catalent’s OneBio Suite is an integrated solution for the development, manufacturing, and supply of biologic drugs. Launched in May 2019, the suite of offerings is designed to integrate activities and accelerate timelines, reduce risk and simplify development with a single contract, program manager, and development timeline from cell line development to supply, with harmonized quality systems.

About Humanigen, Inc.

Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. The company’s immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, the company is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit www.humanigen.com.

About Catalent Biologics

Catalent Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 20 years of proven expertise, Catalent Biologics has worked with 600+ mAbs and 80+ proteins, produced 13 biopharmaceutical drugs using GPEx® cell line development technology, and manufactured 35+ commercially approved products. Catalent Cell & Gene Therapy, a unit of Catalent Biologics, is a full-service partner for adeno-associated virus (AAV) vectors and CAR-T immunotherapies, with deep experience in viral vector scale-up and production. Catalent recently acquired MaSTherCell, adding expertise in autologous and allogeneic cell therapy development and manufacturing. Catalent Cell & Gene Therapy has produced 100+ cGMP batches across 70+ clinical and commercial programs. For more information, visit biologics.catalent.com.

About Catalent

Catalent is the leading global provider of advanced delivery technologies, development, manufacturing, and clinical supply solutions for drugs, biologics, cell and gene therapies, and consumer health products. 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 global clinical and commercial product supply. Catalent employs over 13,500 people, including over 2,400 scientists and technicians, at more than 40 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.

More products. Better treatments. Reliably supplied.™

Humanigen’s Forward-Looking Statements

This release contains forward-looking statements. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as “will,” “expect,” “intend,” “plan,” “potential,” “possible,” “goals,” “accelerate,” “continue,” and similar expressions identify forward-looking statements, including, without limitation, statements regarding our expectations for the Phase III study and the potential future development of lenzilumab to minimize or reduce the severity of lung dysfunction associated with severe and critical COVID-19 infections or to be approved by FDA for such use or to help CAR-T reach its full potential or to deliver benefit in preventing GvHD. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to conduct the Phase III study and grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the “Risk Factors” sections and elsewhere in the Company’s periodic and other filings with the Securities and Exchange Commission.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.

Contacts

Chris Halling

+44 (0)7580 041073

chris.halling@catalent.com

Richard Kerns

+44 (0) 161 728 5880

richard@nepr.agency