uniQure Announces Sale of Commercial Manufacturing Facility to Genezen
July 01 2024 - 7:05AM
UK Regulatory
uniQure Announces Sale of Commercial Manufacturing Facility to
Genezen
~ Proposed divestiture streamlines uniQure’s
focus and represents an important milestone in its ongoing effort
to significantly reduce operating expenses ~
~ Genezen to manufacture global commercial
supply of HEMGENIX® and support
uniQure’s pipeline programs as a preferred customer ~
~ uniQure to reduce cash burn by $40 million
per year and receive total consideration of $25 million ~
~ uniQure’s comprehensive review of
operations and options to reduce expenses is ongoing and expected
to be complete in the third quarter of 2024 ~
LEXINGTON, Mass. and AMSTERDAM, July 01, 2024
(GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene
therapy company advancing transformative therapies for patients
with severe medical needs, today announced that it has entered into
an agreement for the sale of its global manufacturing facility in
Lexington, Massachusetts to Genezen, a leading contract development
and manufacturing organization specializing in the supply of
retroviral vectors, lentiviral vectors, and adeno-associated virus
(AAV) technologies.
Genezen agreed to acquire uniQure’s
commercial-scale gene-therapy manufacturing facility for total
consideration of $25 million, comprised of $12.5 million of newly
issued Series C Preferred Stock and a $12.5 million convertible
note. In addition, Matt Kapusta, chief executive officer of
uniQure, will join the Board of Genezen upon the closing of the
transaction, which is expected early in the third quarter of 2024
subject to satisfaction of customary closing conditions.
Under the proposed transaction, Genezen will be
responsible for manufacturing global commercial supply of
HEMGENIX® for CSL and providing development and
manufacturing services to support uniQure’s investigational gene
therapies. uniQure and CSL will be entitled to preferred customer
status. The majority of uniQure’s employees at the Lexington
facility will be offered employment at Genezen to facilitate a
seamless transition.
“Today marks a significant step forward in
achieving a key strategic goal for uniQure,” stated Matt Kapusta,
chief executive officer of uniQure. “We have been focused on
meaningfully reducing costs while maintaining our ability to
develop and potentially commercialize our gene therapy product
candidates. This transaction achieves these objectives by unlocking
significant cost savings while maintaining preferential access to
world-class gene therapy manufacturing.”
“Additionally, we are continuing to closely
review the business to identify additional cost reduction
opportunities and expect to announce further progress in the third
quarter of 2024,” he added. “We believe a more streamlined uniQure
enhances our strategic flexibility for value-creating opportunities
and furthers our mission to deliver transformative medicines for
patients in need.”
As a result of this transaction, uniQure expects
to reduce cash burn by approximately $40 million annually. Upon the
closing of the transaction, uniQure anticipates repaying $50
million of outstanding debt, which is expected to yield additional
savings in interest expense.
Leerink Partners is serving as financial
advisor, and Covington & Burling LLP is serving as legal
counsel to uniQure.
About Genezen
Genezen is a contract development and manufacturing organization
with a decade's experience at the heart of the rapid growth in the
gene and cell therapy market. Genezen is a leader in the supply of
retroviral vectors, lentiviral vectors, and AAV. Led by an
extremely experienced team, a science-first approach influences
continual investment in scalable, high-yield manufacturing
processes and best-in-class technologies. For more information
about Genezen, please visit genezen.com.
About uniQure
uniQure’s mission is to reimagine the future of medicine by
delivering innovative cures that transform lives. The recent
approvals of our gene therapy for hemophilia B – a historic
achievement based on more than a decade of research and clinical
development – represent a major milestone in the field of genomic
medicine and ushers in a new treatment approach for patients living
with hemophilia. We are now leveraging our modular and validated
technology to advance a pipeline of proprietary gene
therapies for the treatment of patients
with Huntington's disease, refractory mesial temporal
lobe epilepsy, amyotrophic lateral sclerosis (ALS), Fabry disease,
and other severe diseases. www.uniQure.com
uniQure Forward-Looking
Statements
This press release contains forward-looking
statements. All statements other than statements of historical fact
are forward-looking statements, which are often indicated by terms
such as "anticipate," "believe," "could," “establish,” "estimate,"
"expect," "goal," "intend," "look forward to", "may," "plan,"
"potential," "predict," "project," “seek,” "should," "will,"
"would" and similar expressions. Forward-looking statements are
based on management's beliefs and assumptions and on information
available to management only as of the date of this press release.
Examples of these forward-looking statements include, but are not
limited to, statements concerning the completion of the transaction
(including the timing thereof), the acquisition of the Company’s
manufacturing facility and assets and the consideration to be
received by the Company therefor; the terms of the transaction and
the post-transaction ownership of Genezen by uniQure; the Company’s
expectations that the transaction will reduce operating expenses
and cash burn by approximately $40 million per year; the Company’s
plans to repay $50 million of outstanding debt in conjunction with
the closing of the transaction and related cost savings; and the
Company’s ongoing review of operations and options to reduce
expenses and expectations regarding the timeline for completion and
announcement thereof and whether such review will be successful in
reducing operation expenses and increasing shareholder value. The
Company’s actual results could differ materially from those
anticipated in these forward-looking statements for many reasons.
These risks and uncertainties include, among others: (i) the
occurrence of any event, change or other circumstances that could
give rise to the termination of the asset purchase agreement for
the transaction or failure to close the transaction; (ii) the
institution or outcome of any legal proceedings that may be
instituted against the Company or Genezen following the
announcement of the proposed transaction; (iii) the inability of
the parties to complete the proposed transaction, including due to
the failure to satisfy the conditions to closing the transaction;
(iv) the risk that the proposed transaction disrupts current plans
and operations as a result of the announcement and consummation of
the proposed transaction; (v) the ability to recognize the
anticipated benefits of the proposed transaction; (vi) changes in
applicable laws or regulations; (vii) costs related to the proposed
transaction; (viii) the possibility that the Company may be
adversely affected by other economic, business and/or competitive
factors; (ix) risks associated with the clinical results and the
development and timing of the Company’s programs; (x) the Company’s
interactions with regulatory authorities, which may affect the
initiation, timing and progress of clinical trials and pathways to
approval; (xi) the Company’s ability to continue to build and
maintain the company infrastructure and personnel needed to achieve
its goals; (xii) the continued development and acceptance of gene
therapies; (xiii) the Company’s ability to fund its operations and
to raise additional capital as needed; and (xiv) the impact of
global economic uncertainty, rising inflation, rising interest
rates or market disruptions on its business. These risks and
uncertainties are more fully described under the heading "Risk
Factors" in the Company’s periodic filings with the U.S. Securities
& Exchange Commission (“SEC”), including its Annual Report on
Form 10-K filed February 28, 2024 and in other filings that the
Company makes with the SEC from time to time. Given these risks,
uncertainties and other factors, you should not place undue
reliance on these forward-looking statements, and the Company
assumes no obligation to update these forward-looking statements,
even if new information becomes available in the future.
uniQure Contacts: |
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FOR INVESTORS: |
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FOR MEDIA: |
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Maria E. Cantor
Direct: 339-970-7536
Mobile: 617-680-9452
m.cantor@uniQure.com
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Chiara Russo
Direct: 617-306-9137
Mobile: 617-306-9137
c.russo@uniQure.com
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Tom Malone
Direct: 339-970-7558
Mobile:339-223-8541
t.malone@uniQure.com
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