For more information about Libmeldy, please see the Summary of Product Characteristics
(SmPC) available on the EMA website.
Libmeldy is approved in the European Union, UK, Iceland, Liechtenstein and Norway. OTL-200 is an investigational therapy in the U.S.
Libmeldy was developed in partnership with the San Raffaele-Telethon
Institute for Gene Therapy (SR-Tiget) in Milan, Italy.
Additional Information and Where to Find It
In connection with the proposed transaction between Kyowa Kirin Co., Ltd. (Kyowa Kirin) and Orchard Therapeutics plc (Orchard), Orchard
intends to file with the Securities and Exchange Commission (the SEC) a Proxy Statement, the definitive version of which (if and when available) will be mailed to Orchard security holders. Orchard may also file other documents with the
SEC regarding the proposed transaction. This document is not a substitute for the Proxy Statement or any other document which Orchard may file with the SEC. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT (WHICH WILL INCLUDE AN
EXPLANATORY STATEMENT IN RESPECT OF THE SCHEME OF ARRANGEMENT OF ORCHARD, IN ACCORDANCE WITH THE REQUIREMENTS OF THE U.K. COMPANIES ACT 2006) AND ANY OTHER RELEVANT DOCUMENTS THAT ARE FILED OR WILL BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR
SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND RELATED MATTERS. Investors and security holders may
obtain a free copy of the Proxy Statement and other relevant documents containing important information about Kyowa Kirin, Orchard and the proposed transaction (if and when they become available) once such documents are filed with the SEC at the
SECs website at www.sec.gov. Copies of the documents filed with the SEC by Orchard will be available free of charge on Orchards website at ir.orchard-tx.com or by contacting
Orchards Investor Relations Department at investors@orchard-tx.com.
Participants in the
Solicitation
Orchard and certain of its directors and executive officers may be deemed to be participants in the solicitation of proxies in respect of
the proposed transaction. Information regarding Orchards directors and executive officers, including a description of their direct interests, by security holdings or otherwise, is contained in Orchards proxy statement for its 2023 annual
general meeting of shareholders, which was filed with the SEC on April 27, 2023, and subsequent statements of beneficial ownership on file with the SEC. Orchard shareholders may obtain additional information regarding the direct and indirect
interests of the participants in the solicitation of proxies in connection with the proposed transaction, including the interests of Orchard directors and executive officers in the transaction, which may be different than those of Orchard
shareholders generally, by reading the Proxy Statement if and when it is filed with the SEC and any other relevant documents that are filed or will be filed with the SEC relating to the transaction. You may obtain free copies of these documents
using the sources indicated above.
Cautionary Statement Regarding Forward-Looking Statements
This communication contains forward-looking statements within the meaning of the federal securities laws, including Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Exchange Act. These forward-looking statements are based on Orchards current expectations, estimates and projections about the expected date of closing of the proposed transaction
and the potential benefits thereof, its business and industry, managements beliefs and certain assumptions made by Orchard and Kyowa Kirin, all of which are subject to change. In this context, forward-looking statements often address expected
future business and financial performance and financial condition, and often contain words such as expect, anticipate, intend, plan, believe, could, seek,
see, will, may, would, might, potentially, estimate, continue, expect, target, explore, evaluate,
predict, project, similar expressions or the negatives of these words or other comparable terminology that convey uncertainty of future events or outcomes. All forward-looking statements by their nature address matters that
involve risks and uncertainties, many of which are beyond Orchards or Kyowa Kirins control, and are not guarantees of future results, such as statements about the consummation of the proposed transaction and the anticipated benefits
thereof. These and other forward-looking statements, are not guarantees of future results and are inherently subject to risks, uncertainties and assumptions that could cause actual results to differ materially from those expressed in any
forward-looking statements. Accordingly, there are or will be important factors that could cause actual results to differ materially from those indicated in such statements and, therefore, you should not place undue reliance on any such statements
and caution must be exercised in relying on forward-looking statements. Important risk factors and uncertainties that may cause such a difference include, but are not limited to, risks and uncertainties surrounding: (i) the completion of the
proposed transaction on anticipated terms and timing, including in connection with obtaining shareholder and regulatory approvals, the sanction of the High Court of Justice of England and Wales, satisfaction of other closing conditions to consummate
the acquisition, anticipated tax treatment, unforeseen liabilities, future capital expenditures, revenues, expenses, earnings, synergies, economic performance, indebtedness, financial condition, losses, future prospects, business and management
strategies for the management, expansion and growth of Orchards business and other conditions to the completion of the transaction; (ii) the occurrence of any event, change or other circumstance that could give rise to the termination of
the definitive transaction agreement relating to the proposed transaction; (iii) Orchards ability to implement its business model and strategic plans for its product, product candidates and pipeline, and challenges inherent in developing,
commercializing, manufacturing, launching, marketing and selling existing and new products; (iv) significant transaction costs associated with the proposed transaction; (v) potential litigation relating to the proposed transaction;
(vi) the risk that disruptions from the proposed transaction will harm Orchards business, including current plans, operations and collaborations, and including as a result of diverting the attention of Orchards and Kyowa
Kirins management from ongoing business operations; (vii) the ability of Orchard to retain and hire key personnel; (viii) potential adverse reactions or changes to business relationships resulting from the announcement or completion
of the proposed transaction; (ix) legislative, regulatory and economic developments affecting Orchards business; (x) general economic and market developments and conditions; (xi) the evolving legal, regulatory and tax regimes
under which Orchard operates; (xii) potential business uncertainty, including changes to existing business relationships, during the pendency of the transaction that could affect Orchards financial performance; (xiii) restrictions
during the pendency of the proposed transaction that may impact Orchards ability to pursue certain business opportunities or strategic transactions; (xiv) the risk that Orchard may be unable to obtain governmental and regulatory approvals
required for the proposed transaction, or that required governmental and regulatory approvals may delay the consummation of the proposed transaction or result in the imposition of conditions that could reduce the anticipated benefits from the
proposed transaction or cause the parties to abandon the proposed transaction; (xv) unpredictability and severity of catastrophic events, including, but not limited to, global pandemic, acts of terrorism or outbreak of war or hostilities, as
well as Orchards response to any of the aforementioned factors; (xvi) potential delays or failures related to research, clinical trials and/or development of Orchards programs or product candidates, which are based on novel gene
therapy and (xvii) the risks related to non-achievement of the CVR milestone and that holders of the CVRs will not receive payments in respect of the CVRs. Additional factors that may affect the future
results of Orchard are set forth in Orchards filings with the SEC, including Orchards most recently filed Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, which are available on the SECs website at www.sec.gov. See in particular Item 1A of
Orchards Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2023,
under the headings Risk Factors. The risks and uncertainties described above and in the SEC filings cited above are not exclusive and further information concerning Orchard and its business,