Kyowa Kirin to Acquire Orchard Therapeutics-Orchard Therapeutics is a global gene therapy leader with experience
successfully developing and commercializing medicines for rare diseases-Acquisition enriches Kyowa Kirin’s portfolio, enables the development of
numerous promising candidates with a clinically differentiated platform, andhelps resource the ongoing and future launches of Libmeldy® (atidarsagene
autotemcel)-Acquisition price of $16.00 per ADS in cash plus an additional contingent value
right of $1.00 per ADS, representing a total maximum equity value ofapproximately $477.6 million-Kyowa Kirin to host investor conference call on Oct 5 at 18:30 p.m. JSTTokyo, London and Boston, October 5, 2023, — Kyowa Kirin Co., Ltd. (Kyowa Kirin,
TSE: 4151) a Japan-based global specialty pharmaceutical company (J-GSP) creating
innovative medical solutions utilizing the latest biotechnology, and Orchard Therapeutics
plc (Orchard Therapeutics, Nasdaq: ORTX), a global gene therapy leader, today
announced the companies have entered into a definitive agreement under which Kyowa
Kirin will acquire Orchard Therapeutics for $16.00 per American Depositary Share (ADS) in
cash (approximately $387.4 million, or ¥57.3 billion), under which Orchard shareholders
will hold an additional contingent value right (CVR) of $1.00 per ADS. An additional $1.00
CVR will be paid for a total of $17.00 per ADS, or approximately $477.6 million (¥70.7
billion) if the conditions are met.
Kyowa Kirin has established a 2030 Vision to consistently create and deliver medicineswith life-changing value that ultimately makes people smile, as a J-GSP. At the core of thisstrategy is a commitment to life, and a desire to match transformative science to areas ofgreat unmet need. Kyowa Kirin believes the potential of cell and gene therapies to help
patients aligns well with its Vision, patient commitment, and emerging expertise incommercializing rare disease medicines worldwide.

The gene therapy approach pioneered by Orchard Therapeutics harnesses the uniquepower of a patient’s own genetically modified hematopoietic stem cells (HSCs) topotentially correct the underlying cause of a genetic disease using a single administration.
Upon closing, the acquisition would provide Kyowa Kirin with a global leadership position in
the burgeoning field of genetic medicine, including a portfolio spanning commercial,clinical, and pre-clinical HSC gene therapies designed to address serious diseases where
the burden is immense for patients, families and society and current treatment options arelimited or do not exist.
Orchard Therapeutics’ portfolio comprises Libmeldy® (atidarsagene autotemcel), also
known as OTL-200, intended for eligible patients with early-onset metachromatic
leukodystrophy (MLD), a rare and life-threatening inherited disease of the body’s
metabolic system. In the most severe form of MLD, babies develop normally but in late
infancy start to rapidly lose the ability to walk, talk and interact with the world aroundthem. Libmeldy is approved by the European Commission (EC) and UK Medicines and
Healthcare products Regulatory Agency (MHRA) for the treatment of "late infantile" and"early juvenile" MLD patients. It is currently an investigational drug under Priority Review
by the Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA)
goal date of March 18, 2024.
Using the same HSC gene therapy technology platform, Orchard Therapeutics isprogressing two clinical-stage programs known as OTL-203 and OTL-201 for thetreatment of another group of severe pediatric neurometabolic disorders,
mucopolysaccharidosis type I Hurler’s syndrome (MPS-IH) and mucopolysaccharidosis type
IIIA (MPS-IIIA), also known as Sanfilippo syndrome, respectively.
This acquisition will allow Kyowa Kirin to maximize the value of Libmeldy® and efficiently
accelerate the development of Orchard Therapeutics’ next-in-line MPS programs, as wellas its other early research programs, including a severe, genetic form of Crohn’s disease
and frontotemporal dementia (FTD). Furthermore, the combination of Orchard
Therapeutics' innovative HSC gene therapy platform technology and Kyowa Kirin's
capabilities, resources and infrastructure will enable the continued development of
numerous promising biopharmaceutical candidates with the potential to deliver life-changing value in medical care, including in therapeutic areas and indications where
Kyowa Kirin has deep experience, such as oncology and autoimmune diseases.
“We are excited to announce that we have signed the Transaction Agreement to acquire
Orchard Therapeutics, one of the leading providers of HSC gene therapy.” said Takeyoshi
Yamashita, Ph.D., Director of the Board, chief medical officer, senior managing executive
officer of Kyowa Kirin. “With this transaction, we anticipate being able to use a newmodality that can have a profound impact on patients' lives. Orchard Therapeutics is acompany with a steady track record in this field and has already launched its HSC genetherapy in Europe and filed for review in the U.S. Our hope is to combine the strengths of
Kyowa Kirin and Orchard Therapeutics with mutual respect to realize the successful
creation and delivery of life-changing value for patients living with rare and life-threatening
inherited diseases.”“This is an exciting opportunity designed to accelerate the realization of our shared visionof ending the devastation caused by severe genetic diseases and deliver life-changing
value in medical care,“ said Bobby Gaspar, co-founder and chief executive officer ofOrchard Therapeutics. “We remain as true to our mission as ever, and joining Kyowa
Kirin’s global network ensures we are well-resourced to progress anticipatedcommercialization of OTL-200 in the U.S., if approved, continue investing in initiatives
aimed at accelerating Libmeldy growth in Europe, capitalize on opportunities for global
expansion, as well as advance our next-in-line neurometabolic programs in MPS disorders
and earlier-stage research programs. We look forward to collaborating with our newcolleagues at Kyowa Kirin to fully unlock the curative potential of HSC gene therapy for the
benefit of patients and society.”
Kyowa Kirin will hold a conference for investors on October 5 at 18:30 p.m. JST.
Outline of the transaction
Under the terms of the agreement, Kyowa Kirin will initiate a scheme of arrangement toacquire all Orchard Therapeutics’ ADSs at a price of $16.00 per ADS in cash (oraggregated value of approximately $387.4 million, or approximately ¥57.3 billion) at
closing, which represents a premium of 144% to Orchard Therapeutics’ volume-weighted
average price per ADS over the previous 30 days ended October 4.

In connection with the transaction, a non-transferable CVR will be distributed to Orchard
Therapeutics shareholders. Holders of the CVR will be entitled to receive a cash paymentof $1.00 per ADS related to the approval of OTL-200 for the treatment of MLD in the U.S.
as defined in the CVR Agreement.
Warrants outstanding as of the date of the Transaction Agreement will continue to besatisfied in accordance with their terms.
The transaction has been unanimously approved by both company’s Board of Directors
and is expected to close in the first quarter of 2024 subject to Orchard Therapeutics’shareholder approval, receipt of applicable regulatory approvals and other customary
closing conditions.
Following the completion of the acquisition, Orchard Therapeutics will become a whollyowned subsidiary of Kyowa Kirin.
Kyowa Kirin is represented by Goldman Sachs Japan Co., Ltd. as financial advisor andMorrison & Foerster LLP. as legal advisor. Orchard Therapeutics is represented byGuggenheim Securities, LLC as financial advisor, Goodwin Procter LLP as U.S. legal
advisor, and Slaughter & May Ltd. as UK legal advisor.
Overview of Orchard Therapeutics
(1)

Name

(2)

Location(3)

Orchard Therapeutics plc
245 Hammersmith Road, 3rd Floor London W6 8PW United
Kingdom

Job title and name ofChief Executive Officer

representative

Bobby Gaspar
Development and commercialization of hematopoietic stem

(4)

Description of business(5)

Share capital$29,456 thousand (as of June 30, 2023)(6)

Date of establishment

2015

cell gene therapy

RA Capital Management, LP (25.7%)(7)

Major shareholders

Deep Track Capital LP (9.0%)

and ownership ratios

Zentree Investment Management Pte Ltd (8.3%)(as of June 30, 2023)

Relationship between(8)

Kyowa Kirin andOrchardCapital relationship

None

Personnel relationship

None

Business relationship

None

Related Party Status

None

About Kyowa Kirin
Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a
Japan-based Global Specialty Pharmaceutical Company with a heritage of 70+ years, weapply cutting-edge science including an expertise in antibody research and engineering, toaddress the needs of patients and society across multiple therapeutic areas including
Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions –Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, tomake people smile, and are united by our shared values of commitment to life,
teamwork/Wa, innovation, and integrity. You can learn more about the business of Kyowa
Kirin at: https://www.kyowakirin.com.
About Orchard Therapeutics
At Orchard Therapeutics, our vision is to end the devastation caused by genetic and othersevere diseases. We aim to do this by discovering, developing and commercializing newtreatments that tap into the curative potential of hematopoietic stem cell (HSC) genetherapy. In this approach, a patient’s own blood stem cells are genetically modified outsideof the body and then reinserted, with the goal of correcting the underlying cause of
disease in a single treatment.
In 2018, the company acquired GSK’s rare disease gene therapy portfolio, which
originated from a pioneering collaboration between GSK and the San Raffaele Telethon
Institute for Gene Therapy in Milan, Italy. Today, Orchard is advancing a pipeline spanningpre-clinical, clinical and commercial stage HSC gene therapies designed to address serious
diseases where the burden is immense for patients, families and society and current
treatment options are limited or do not exist.
Orchard has its global headquarters in London and U.S. headquarters in Boston. For more
information, please visit www.orchard-tx.com, and follow us on X (Twitter) and LinkedIn.
About Libmeldy / OTL-200
Libmeldy® (atidarsagene autotemcel), also known as OTL-200, has been approved by theEuropean Commission for the treatment of metachromatic leukodystrophy (MLD) inpatients characterized by biallelic mutations in the ARSA gene leading to a reduction of the
ARSA enzymatic activity in children with i) late infantile or early juvenile forms, withoutclinical manifestations of the disease, or ii) the early juvenile form, with early clinicalmanifestations of the disease, who still have the ability to walk independently and before
the onset of cognitive decline. Libmeldy is the first therapy approved for eligible patientswith early-onset MLD.
The most common adverse reaction attributed to treatment with Libmeldy was theoccurrence of anti-ARSA antibodies. In addition to the risks associated with the genetherapy, treatment with Libmeldy is preceded by other medical interventions, namely bonemarrow harvest or peripheral blood mobilization and apheresis, followed by myeloablative
conditioning, which carry their own risks. During the clinical studies of Libmeldy, the safety
profiles of these interventions were consistent with their known safety and tolerability.
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. OTL200 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 versionof 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 filewith the SEC. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXYSTATEMENT (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 CONTAINIMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND RELATEDMATTERS. 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 SEC’s website at www.sec.gov. Copies of the
documents filed with the SEC by Orchard will be available free of charge on Orchard
website at ir.orchard-tx.com or by contacting Orchard’s 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 beparticipants in the solicitation of proxies in respect of the proposed transaction.
Information regarding Orchard’s directors and executive officers, including a description of
their direct interests, by security holdings or otherwise, is contained in Orchard’s proxystatement 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 theSEC. Orchard shareholders may obtain additional information regarding the direct andindirect interests of the participants in the solicitation of proxies in connection with theproposed 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 thefederal 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
Orchard’s current expectations, estimates and projections about the expected date ofclosing of the proposed transaction and the potential benefits thereof, its business andindustry, management’s 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, andoften 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 thenegatives of these words or other comparable terminology that convey uncertainty of
future events or outcomes. All forward-looking statements by their nature address mattersthat involve risks and uncertainties, many of which are beyond Orchard’s or Kyowa Kirin’s
control, and are not guarantees of future results, such as statements about theconsummation of the proposed transaction and the anticipated benefits thereof. These andother 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 areor will be important factors that could cause actual results to differ materially from thoseindicated 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 proposedtransaction on anticipated terms and timing, including in connection with obtaining
shareholder and regulatory approvals, the sanction of the High Court of Justice of Englandand 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 Orchard’s business and other conditions to the completion of thetransaction; (ii) the occurrence of any event, change or other circumstance that could giverise to the termination of the definitive transaction agreement relating to the proposedtransaction; (iii)Orchard’s 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 fromthe proposed transaction will harm Orchard’s business, including current plans, operations
and collaborations, and including as a result of diverting the attention of Orchard’s andKyowa Kirin’s 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 Orchard’s business; (x)general economic and market developments and conditions; (xi) the evolving legal,
regulatory and tax regimes under which Orchard operates; (xii) potential businessuncertainty, including changes to existing business relationships, during the pendency of
the transaction that could affect Orchard’s financial performance; (xiii) restrictions during
the pendency of the proposed transaction that may impact Orchard’s ability to pursue
certain business opportunities or strategic transactions; (xiv) the risk that Orchard may beunable to obtain governmental and regulatory approvals required for the proposedtransaction, 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 toabandon 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 Orchard’s response to any of the aforementioned factors; (xvi)
potential delays or failures related to research, clinical trials and/or development ofOrchard’s 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 affectthe future results of Orchard are set forth in Orchard’s filings with the SEC, including
Orchard’s 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 areavailable on the SEC’s website at www.sec.gov. See in particular Item 1A of Orchard’s
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,
including factors that potentially could materially affect Orchard’s business, financial
conditions or operating results, may emerge from time to time. Moreover, other risks anduncertainties of which Orchard is not currently aware may also affect Orchard’s forwardlooking statements and may cause actual results and the timing of events to differ
materially from those anticipated. Readers are urged to consider these factors carefully inevaluating these forward-looking statements, and not to place undue reliance on any
forward-looking statements, which speak only as of the date hereof and reflect the views
stated therein with respect to future events as at such dates, even if they aresubsequently made available by Orchard on its website or otherwise. Readers should also
carefully review the risk factors described in other documents that Orchard files from time
to time with the SEC. Except as required by law, Orchard assumes no obligation to updateor revise these forward-looking statements for any reason, even if new information
becomes available in the future.
No Offer or Solicitation
This communication is not intended to and shall not constitute an offer to buy or sell or
the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or
approval, nor shall there be any offer, solicitation or sale of securities in any jurisdiction inwhich such offer, solicitation or sale would be unlawful prior to registration or qualification
under the securities laws of any such jurisdiction. No offer of securities shall be made in
the United States absent registration under the U.S. Securities Act of 1933, as amended,or pursuant to an exemption from, or in a transaction not subject to, such registration
requirements.