PCI Pharma Services to Acquire US-based Aseptic Fill-Finish CDMO Ajinomoto Althea
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Acquisition creates a world-class large-scale manufacturing hub in San Diego region with state-of-the-art aseptic facilities for prefilled syringes, cartridges and high potent formulations such as ADCs, complementing existing global sterile fill-finish and advanced drug delivery operations.
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PHILADELPHIA — PCI Pharma Services ('PCI') – a leading global contract development and manufacturing organization (CDMO) focused on innovative biopharma therapies – is acquiring an entire equity stake in Ajinomoto Althea, Inc. ('Althea'), a US-based sterile fill-finish CDMO and 100% subsidiary of Japan-based Ajinomoto Co., Inc. Scheduled for completion in May 2025, the acquisition provides PCI with its first-ever North American manufacturing location for prefilled syringes and cartridges – including isolator technology for these formats – as well as high potent manufacturing suitable for antibody-drug conjugates (ADCs).
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Althea's robust clinical- and commercial-stage services for injectable drug products augments PCI's deep industry experience, aligning with the company's global sterile fill-finish capabilities and established expertise in advanced drug delivery. In addition, Althea's substantial knowledge base, skillsets and capacity in scalable, custom oligonucleotides and peptides complements PCI's existing manufacturing capabilities in complex formulations and lyophilization across a broad range of injectables – including nanoparticles, mRNA, MABs, proteins, and other biologics for delivery formats such as vials, bottles, prefilled syringes and autoinjectors.
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The acquisition also adds high potent vial filling with lyophilization, making PCI one of very few US-based CDMOs capable of producing the emerging oncology modality of antibody-drug conjugates (ADCs). Building upon PCI's legacy in high potent molecules, the strategy creates an end-to-end offering for clients via specialized capabilities across the globe, and broadens its biologics development and manufacturing leadership.
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For PCI's advanced drug delivery systems and drug-device combination business, Althea's assets supplement PCI's leadership position in final device assembly and packaging facilities in both Europe and North America. Acquiring Althea's San Diego campus also makes PCI one of the largest manufacturing centers in the US West Coast's biopharma stronghold and is a natural extension of PCI's current clinical trial services and early phase robotic sterile fill-finish capabilities, creating a scalable, flexible manufacturing complex with state-of-the-art facilities within minutes of each other.
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'To continue supporting the needs of our customers in their endeavors to bring life-changing therapies to patients, PCI continues to make sizable investments in the sterile fill-finish category that bring additional capabilities, capacity and technologies into our portfolio,' said Salim Haffar, CEO of PCI Pharma Services. 'Welcoming Althea into the PCI family expands our capabilities to support several therapeutic and drug delivery modalities, including the emerging ADC marketplace, and complements our broad end-to-end solutions alongside clinical trial services and advanced drug delivery.'
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PCI is a world-leading CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products' speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the healthcare services business. The company currently has 30 sites across seven countries (Australia, Canada, U.S., Ireland, Wales, Germany and Spain), and over 7,000 employees working to bring life-changing therapies to patients.
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Leading technology and continued investment enable PCI Pharma Services to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and commercialization. Its clients utilize PCI as an extension of their business, and a collaborative partner with the shared goal of improving patients' lives. For more information, visit pci.com.
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In connection with the Offering, an underwriting agreement will be entered into by and among Perpetua Resources, National Bank of Canada Financial Markets and BMO Capital Markets as representatives of the several Underwriters (the "Underwriting Agreement"). In the event that the Option is exercised in full, the aggregate gross proceeds of the Offering will be approximately US$345 million. The Offering is expected to close on or about June 16, 2025. Closing of the Offering will be subject to a number of customary conditions to be included in the Underwriting Agreement. The Offering to the public in the United States is being made pursuant to the Company's effective shelf registration statement on Form S-3 (File No. 333-266071) (the "U.S. Registration Statement"), including a base prospectus, previously filed with the Securities and Exchange Commission (the "SEC"). The Offering in the United States will be made only by means of a prospectus and related prospectus supplement meeting the requirements of Section 10 of the Securities Act of 1933, as amended. You may obtain these documents for free by visiting EDGAR on the SEC's website at Alternatively, copies of the U.S. Registration Statement, preliminary prospectus supplement and base prospectus may be obtained from National Bank of Canada Financial Markets, 130 King Street West, 4 th Floor Podium, Toronto, Ontario M5X 1J9, by email at [email protected] or by telephone at (416) 869-8414. The Offering may also be conducted in Canada and in offshore jurisdictions on a private placement basis in accordance with applicable securities laws. The Company intends to rely on the exemption in section 602.1 of the TSX Company Manual in respect of the Offering and the Private Placement as an eligible interlisted issuer. The Private Placement is expected to close concurrently with the closing of the Offering and is subject to customary conditions, including the completion of the Offering, but the Offering is not contingent upon the consummation of the Private Placement. The sale of the Common Shares under the Private Placement will not be registered under the Securities Act of 1933, as amended. Since neither the fair market value of the Common Shares to be acquired by the Paulson (an insider of the Company), nor the consideration for the Common Shares paid by Paulson, exceeds 25% of the Company's market capitalization as calculated in accordance with MI 61-101 (as defined below), the Private Placement is exempt from the formal valuation and minority approval requirements of Multilateral Instrument 61-101 - Protection of Minority Security Holders in Special Transactions ("MI 61-101") pursuant to subsections 5.5(a) and 5.7(1)(a) of MI 61-101. No securities regulatory authority has either approved or disapproved the contents of this news release. This news release does not constitute an offer to sell or the solicitation of an offer to buy Common Shares, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. About Perpetua Resources and the Stibnite Gold Project Perpetua Resources Corp., through its wholly owned subsidiaries, is focused on the exploration, site restoration and redevelopment of gold-antimony-silver deposits in the Stibnite-Yellow Pine district of central Idaho that are encompassed by the Stibnite Gold Project. The Stibnite Gold Project is one of the highest-grade, open pit gold deposits in the United States and is designed to apply a modern, responsible mining approach to restore an abandoned mine site and produce both gold and the only mined source of antimony in the United States. Perpetua Resources has been awarded a Technology Investment Agreement of US$59.2 million in Defense Production Act Title III funding to advance construction readiness and permitting of the Stibnite Gold Project. Antimony trisulfide from Stibnite is the only known domestic reserves of antimony that can meet U.S. defense needs for many small arms, munitions, and missile types. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS OR INFORMATION Investors should be aware that the EXIM Letter of Interest ("LOI") is non-binding and conditional, and does not represent a financing commitment. A funding commitment, if any, is conditional upon successfully completing the due diligence and underwriting process, which may not be completed on the expected timeline, or at all. If the Company's application is approved, there can be no assurance that the EXIM financing will be for the full amount indicated in the LOI or the increased amount requested in the application, or that the approved EXIM financing will be sufficient for the Company to commence construction of the Project. Further, release of funding under any such commitment would be subject to the satisfaction of certain conditions and covenants by the Company. Investors should be aware that the Company has not entered into any definitive agreement with respect to a royalty, streaming or guarantee and may not be able to enter into such agreement on the anticipated terms and timeline, or at all. In addition, the outcomes from such agreement, when entered into, may not be sufficient to satisfy the aggregate obligations of the Company to provide construction phase financial assurance under applicable federal and state law prior to commencing construction. Securing the financial assurance does not guarantee the Company will receive the USFS notice to proceed under the approved plan of operation and consummating the royalty financing may not satisfy the financial assurance conditions of various federal and state permits required to commence construction. Further, a buy back of a portion of the royalty would be subject to the satisfaction of certain conditions and covenants by the Company under the royalty and financing arrangement. Investors should be aware that state regulators are not bound by permitting schedules and anticipated timelines may be delayed materially or not be satisfied. Statements contained in this news release that are not historical facts are "forward-looking information" or "forward-looking statements" (collectively, "Forward-Looking Information") within the meaning of applicable Canadian securities legislation and the United States Private Securities Litigation Reform Act of 1995. Forward-Looking Information includes, but is not limited to, disclosure regarding the conduct of the Offering and Private Placement; the granting of the Underwriters' over-allotment option; the anticipated use of proceeds from the Offering and Private Placement; the occurrence of the expected benefits from the anticipated use of proceeds from the Offering, Private Placement, EXIM financing and royalty financing disclosure regarding the review process, anticipated timing and potential outcome of the Company's EXIM financing application; the amount of potential debt financing available to the Company; the eligibility of the Project for funding under the MMIA and CTEP initiatives; the timing and potential outcome of any other discussions with governmental agencies; the status and anticipated terms and timing of the royalty, streaming and financial assurance negotiations; the estimate of the initial financial assurance obligations; the anticipated timing of the issuance of certain state permits or a USFS notice to proceed; our ability to fully fund the construction of the Project and related financial assurance obligations; our ability to successfully implement and fund the Project; and the occurrence of the expected benefits from the Project, including providing a domestic source of antimony, national defense benefits, creation of jobs and environmental benefits. In certain cases, Forward-Looking Information can be identified by the use of words and phrases or variations of such words and phrases or statements such as "anticipate", "expect", "plan", "likely", "believe", "intend", "forecast", "project", "estimate", "potential", "could", "may", "will", "would" or "should". In preparing the Forward-Looking Information in this news release, Perpetua Resources has applied several material assumptions, including, but not limited to, assumptions that the EXIM application will be reviewed and approved within the expected timeframe at the amount equal to or higher than the amount indicated in the LOI; that the Company will be able to satisfy the conditions to obtain a funding commitment from EXIM and to receive committed funds when needed; the ongoing royalty financing negotiations will proceed in a timely manner and result in a binding agreement on the terms anticipated; that the Company will be able to satisfy financial assurance requirements applicable under applicable federal and state law; that the Company's proposed financing package will be sufficient to finance permitting, pre-construction and construction of the Project or that the company will be able to secure alternate financing if necessary; that the current exploration, development, environmental and other objectives concerning the Project can be achieved and that its other corporate activities will proceed as expected; that general business and economic conditions will not change in a materially adverse manner and that permitting and operations costs will not materially increase; and that we will be able to discharge our liabilities as they become due and continue as a going concern. Forward-Looking Information are based on certain material assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Perpetua Resources to be materially different from any future results, performance or achievements expressed or implied by the Forward-Looking Information. Such risks and other factors include, among other things, risks related to delays in the EXIM application review process; any approved amount of EXIM financing may not be sufficient to commence construction of the Project; the terms of the guarantee agreement and related surety agreements may not be sufficient to satisfy financial assurance requirements applicable under applicable federal and state law; risks related to unforeseen delays in the review and permitting process, including as a result of legal challenges to the ROD or other permits; risks related to opposition to the Project; risks related to increased or unexpected costs in operations or the permitting process; risks that necessary financing will be unavailable when needed on acceptable terms, or at all, as well as those factors discussed in Perpetua Resources' public filings with the SEC and its Canadian disclosure record. Although Perpetua Resources has attempted to identify important factors that could affect Perpetua Resources and may cause actual actions, events or results to differ materially from those described in Forward-Looking Information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that Forward-Looking Information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on Forward-Looking Information. For further information on these and other risks and uncertainties that may affect the Company's business and liquidity, see the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's filings with the SEC, which are available at and with the Canadian securities regulators, which are available at Except as required by law, Perpetua Resources does not assume any obligation to release publicly any revisions to Forward-Looking Information contained in this news release to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. SOURCE Perpetua Resources Corp.
