QURE uniQure NV

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

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FORM 8-K

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CURRENT REPORT

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Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

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Date of Report (Date of earliest event reported): July 22, 2024

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uniQure N.V.

(Exact Name of Registrant as Specified in Charter)

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Registrant’s telephone number, including area code: +31-20-566-7394

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(Former Name or Former Address, if Changed Since Last Report)

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

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☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

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☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

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☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

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☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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Securities registered pursuant to Section 12(b) of the Act:

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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Emerging growth company ☐

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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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Amendment to Loan and Security Agreement with Hercules Capital

In connection with the closing of the Lexington Transaction on July 22, 2024 (as defined and described in Item 2.01 below) and the consent of Hercules Capital, Inc. (“Hercules”) to the disposition of certain collateral assets as a component of the Lexington Transaction, uniQure N.V. (the “Company”), certain of its affiliates and Hercules agreed to amend the Company’s third amended and restated loan and security agreement effective as of closing of the Lexington Transaction (as so amended, the “2024 Amended Facility”). As a condition to Hercules’ consent to the Lexington Transaction and the effectiveness of such amendment, the Company prepaid $50.0 million of the $100.0 million of principal outstanding under the 2024 Amended Facility as well as approximately $3.0 million in end-of-term charges. The remaining $50.0 million of principal outstanding is due along with remaining end-of-term charges at the maturity of the 2024 Amended Facility in January 2027. Except as provided for in the amendment, the terms of borrowing under the 2024 Amended Facility otherwise remain unchanged.

The foregoing description of the 2024 Amended Facility does not purport to be complete and is qualified in its entirety by reference to the full text of the 2024 Amended Facility, which will be filed as an exhibit the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2024. The 2024 Amended Facility contains representations, warranties, covenants and other provisions that were made only for purposes of such agreement and as of specific dates, are solely for the benefit of the parties thereto, and may be subject to limitations agreed upon by such parties. The foregoing description of the 2024 Amended Facility is not intended to provide any other factual information about the Company.

Assignment of Lexington Lease and Amendment

In connection with the closing of the Lexington Transaction and the consent of Hartwell Innovation Campus, LLC as landlord (the “Landlord”) with respect to the leased premises located at 113 Hartwell Avenue, Lexington, Massachusetts and the site of the Company’s manufacturing facility (the “Lexington Facility”), uniQure Inc. (“uniQure”) assigned all of its rights, title and interest in and to the lease agreement for the Lexington Facility (the “Lexington Lease”) to Genezen MA, Inc. (“Genezen”), subject to certain retained liabilities and obligations as provided in the applicable assignment and assumption agreement (the “Assignment”). In addition, in connection with the closing of the Lexington Transaction and the Assignment, uniQure, the Landlord and Genezen agreed to modify and amend the Lexington Lease to, among other things, (i) amend the existing uniQure guaranty, (ii) provide for the execution and delivery of a new guaranty by Genezen Holdings, Inc. (“Genezen Holdings”) to the benefit of the Landlord, (iii) extend the term of the Lexington Lease to May 31, 2034, with two additional five-year extension terms available at Genezen’s option, and (iv) provide for certain Landlord contribution amounts available to Genezen for future alterations to the premises.

The foregoing description of the Landlord consent and the Assignment does not purport to be complete and is qualified in its entirety by reference to the full text of such agreements, which will be filed as exhibits to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2024. The Landlord consent and the Assignment contain representations, warranties, covenants and other provisions that were made only for purposes of such agreements and as of specific dates, are solely for the benefit of the parties thereto, and may be subject to limitations agreed upon by such parties. The Landlord consent and Assignment are not intended to provide any other factual information about the parties.

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Item 2.01Completion of Acquisition or Disposition of Assets.

On July 22, 2024, the Company completed its previously announced sale of the Lexington Facility and certain assets and liabilities related to its manufacturing operations pursuant to the Asset Purchase Agreement dated June 29, 2024 (the “Asset Purchase Agreement”), by and among uniQure, uniQure biopharma B.V., Genezen and Genezen Holdings (the “Lexington Transaction”). At the closing of the Lexington Transaction, uniQure received (i) shares of newly issued Series C preferred stock of Genezen Holdings valued at $12.5 million, which are convertible into Genezen Holdings common stock and accrue an 8% per annum cumulative dividend, and (ii) a $12.5 million convertible promissory note from Genezen Holdings, bearing interest at 8% per annum and maturing 63 months following the date of issuance.

In connection with the closing of the Lexington Transaction, the parties entered into certain additional agreements, including (i) a commercial supply agreement (the “CSA”) pursuant to which Genezen will manufacture and supply for uniQure its requirements of HEMGENIX® pursuant to uniQure’s manufacturing and supply obligations to CSL Behring, (ii) a development and other manufacturing services agreement pursuant to which Genezen will manufacture, supply and provide certain development services to support the requirements of uniQure’s investigational gene therapy programs and for other services related to the manufacture of HEMGEMIX® under the CSA, (iii) a transition services agreement pursuant to which each party will provide transitional services to the other related to the operation of the Lexington Facility for a period following the closing of the Lexington Transaction, and (iv) the Assignment.

The Asset Purchase Agreement will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2024. The Asset Purchase Agreement contains representations, warranties, covenants and other provisions that were made only for purposes of such agreement and as of specific dates, are solely for the benefit of the parties thereto, and may be subject to limitations agreed upon by such parties. The Asset Purchase Agreement is not intended to provide any other factual information about the Company.

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In connection with the closing of the Lexington Transaction, on July 22, 2024, the Company notified Pierre Caloz, the Company’s Chief Operating Officer, that his employment was being terminated consistent with the terms of the employment agreement by and between uniQure biopharma B.V. and Mr. Caloz, dated May 17, 2021. The Company wishes to thank Mr. Caloz for his years of leadership, dedication and significant contributions to the Company.

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Item 7.01Regulation FD Disclosure

On July 23, 2024, the Company issued a press release announcing the closing of the Lexington Transaction. A copy of the press release is furnished as Exhibit 99.1 and is incorporated herein by reference.

The information provided in this Item 7.01, including the accompanying Exhibit 99.1, shall be deemed “furnished” and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of such section, nor shall it be incorporated by reference in any filing made by the Company pursuant to the Securities Act of 1933, as amended, or the Exchange Act, regardless of the general incorporation language of such filing, except to the extent that such filing incorporates by reference any or all of such information by express reference.

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Item 9.01Financial Statements and Exhibits.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

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Exhibit 99.1

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uniQure Announces Closing of Sale of Manufacturing Facility to Genezen

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~ uniQure maintains preferential access to industry-leading manufacturing capabilities to support its pipeline of gene therapy candidates ~

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~ Immediate reduction in cash burn, projected to save $40 million annually ~

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Lexington, MA and Amsterdam, the Netherlands, July 23, 2024 — uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced the closing of 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.

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“With the completion of the divestiture, we take an important step toward achieving our goal of significantly reducing expenses and streamlining operations,” stated Matt Kapusta, chief executive officer of uniQure. “Additionally, this transaction provides uniQure continued and preferred access to world-class gene therapy manufacturing capabilities to advance our gene therapy product candidates and enables us to focus our future investments on projects that have the potential to meaningfully increase shareholder value. We remain committed to identifying further cost reduction opportunities and anticipate announcing additional progress later this quarter.”

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uniQure and Genezen expect a seamless transition, with nearly all employees who were offered employment successfully joining Genezen.  As a result of the transaction, uniQure becomes a meaningful shareholder of Genezen and Mr. Kapusta has joined Genezen’s Board of Directors. uniQure expects immediate reductions in future recurring cash burn of approximately $40 million per year, which includes interest expense savings from the retirement of $50 million in outstanding debt.

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With the transaction now complete, Amin Abujoub, Ph.D. who currently serves as Chief Quality Officer has been appointed to the new role of Chief Technical Operations Officer and will be responsible for global oversight of contract manufacturers, including Genezen, as well as internal operations, facilities, process and analytical development, and quality. As a result of the divestiture, the Chief Operating Officer role was eliminated, and Pierre Caloz will depart the company, continuing to lend his expertise in an advisory capacity.

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“I want to express my heartfelt gratitude to Pierre for his years of leadership, dedication and significant contributions to the company, all of which were instrumental in establishing uniQure’s industry-leading commercial manufacturing capabilities and achieving multiple regulatory approvals for HEMGENIX^®,” added Matt Kapusta.  “I also look forward to working with Amin in his new role and am highly confident that he will continue to have significant impact on our mission of delivering transformational gene therapies to patients in need.”

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About Genezen

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Genezen is a contract development and manufacturing organization(“CDMO”) with preclinical to commercial capabilities across retroviral vectors, lentiviral vectors, and AAV. Genezen operates a preclinical and early phase GMP site in Indianapolis, IN and a state of the art, commercially approved gene therapy manufacturing site in Lexington, MA. Led by an extremely experienced team, a science-first approach influences continual

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investment in scalable, high-yield manufacturing processes and best-in-class technologies. For more information about Genezen, please visit genezen.com.

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About uniQure

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uniQure is delivering on the promise of gene therapy – single treatments with potentially curative results. The approvals of uniQure’s gene therapy for hemophilia B – an 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. uniQure is now advancing a pipeline of proprietary gene therapies for the treatment of patients with Huntington's disease, refractory temporal lobe epilepsy, ALS, Fabry disease, and other severe diseases. www.uniQure.com

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uniQure Forward-Looking Statements

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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 availability of manufacturing resources and capacity for the Company’s gene therapy pipeline; the potential for future projects and their ability to increase shareholder value; expectations regarding the transition of the Company’s former employees to Genezen; the Company’s expectations that the transaction will reduce operating expenses and cash burn by approximately $40 million per year; 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 institution or outcome of any legal proceedings that may be instituted against the Company or Genezen following the transaction; (ii) the risk that the proposed transaction disrupts current plans and operations as a result of the announcement and consummation of the proposed transaction; (iii) the ability to recognize the anticipated benefits of the proposed transaction, included preferred access to manufacturing resources for the Company’s gene therapy pipeline; (iv) changes in applicable laws or regulations; (v) costs related to the transaction; (vi) the possibility that the Company may be adversely affected by other economic, business and/or competitive factors; (vii) risks associated with the clinical results and the development and timing of the Company’s programs; (viii) the Company’s interactions with regulatory authorities, which may affect the initiation, timing and progress of clinical trials and pathways to approval; (ix) the Company’s ability to continue to build and maintain the company infrastructure and personnel needed to achieve its goals; (x) the continued development and acceptance of gene therapies; (xi) the Company’s ability to fund its operations and to raise additional capital as needed; and (xii) 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.

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uniQure Contacts:

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