uniQure Announces Closing of Sale of Manufacturing Facility to Genezen

Rhea-AI Summary

uniQure has closed the sale of its global manufacturing facility in Lexington, Massachusetts to Genezen, a contract development and manufacturing organization. This strategic move is expected to reduce uniQure's annual cash burn by $40 million and streamline operations while maintaining preferential access to gene therapy manufacturing capabilities.

Key points:

• uniQure becomes a significant shareholder in Genezen
• CEO Matt Kapusta joins Genezen's Board of Directors
• $50 million in outstanding debt retired
• Amin Abujoub appointed as new Chief Technical Operations Officer
• Chief Operating Officer role eliminated

The company aims to focus future investments on projects with potential to increase shareholder value and plans to announce additional cost reduction measures later this quarter.

Positive

• Expected annual cash burn reduction of $40 million
• Retirement of $50 million in outstanding debt
• Maintained preferential access to gene therapy manufacturing capabilities
• uniQure becomes a significant shareholder in Genezen
• CEO Matt Kapusta joins Genezen's Board of Directors

Negative

• Divestiture of global manufacturing facility
• Elimination of Chief Operating Officer role

Insights

Financial Analyst

Critical Evaluation: The sale of uniQure's manufacturing facility is a financially impactful event. By shedding an asset that requires significant maintenance and operational costs, uniQure immediately reduces its cash burn by approximately $40 million annually. This move will bolster the company's balance sheet and improve its financial health by reducing interest expenses associated with the retirement of $50 million in debt.

Implications: For investors, this means an increase in operational efficiency and a more focused allocation of resources towards high-potential projects. The reduction in recurring expenses can lead to improved profitability and potential stock price appreciation in the medium to long term. However, investors should monitor how the company's strategic shift impacts overall production capacity and the execution of its pipeline projects.

Market Research Analyst

Industry Context: The biotech and gene therapy sectors are highly capital-intensive. Strategic moves like divesting non-core assets can be important for sustaining operations and funding important R&D activities. By divesting its manufacturing facility to Genezen, uniQure can now leverage Genezen's specialized expertise without the overhead costs of maintaining its own facility.

Future Outlook: The preferential access to Genezen's manufacturing capabilities ensures that uniQure's pipeline should not face significant disruptions. Investors should consider the strategic benefit of becoming a significant shareholder in Genezen, which may offer additional revenue streams or strategic advantages in the future. The seamless transition of employees is also a positive sign, minimizing potential operational hiccups.

Medical Research Analyst

Impact on R&D: Maintaining access to Genezen’s industry-leading gene therapy manufacturing capabilities is important for uniQure’s ongoing R&D efforts. This move allows uniQure to continue advancing its gene therapy candidates without the financial and logistical burden of operating its own facility. The experienced personnel transitioning to Genezen also ensures continuity in expertise and process knowledge.

Strategic Realignment: This operation reaffirms uniQure's commitment to focusing on high-value projects that could potentially yield significant clinical and commercial outcomes. The shift in strategic focus might expedite the development and approval of new therapies, enhancing long-term shareholder value.

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

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

LEXINGTON, Mass. and AMSTERDAM, July 23, 2024 (GLOBE NEWSWIRE) -- 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.

“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.”

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.

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.

“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.”

About Genezen

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

About uniQure

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

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 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.

uniQure Contacts:
FOR INVESTORS:	FOR MEDIA:
Chiara Russo	Tom Malone
Direct: 617-306-9137	Direct: 339-970-7558
Mobile: 617-306-9137	Mobile:339-223-8541
c.russo@uniQure.com	t.malone@uniQure.com

FAQ

What is the expected annual cost savings for uniQure (QURE) from the sale of its manufacturing facility?

uniQure expects to save approximately $40 million annually in recurring cash burn as a result of the sale of its manufacturing facility to Genezen.

How much outstanding debt did uniQure (QURE) retire through this transaction?

uniQure retired $50 million in outstanding debt through the sale of its manufacturing facility to Genezen.

Who is the new Chief Technical Operations Officer at uniQure (QURE) following the facility sale?

Amin Abujoub, Ph.D., previously the Chief Quality Officer, has been appointed as the new Chief Technical Operations Officer at uniQure.

What role did uniQure's (QURE) CEO Matt Kapusta gain at Genezen after the transaction?

Following the transaction, uniQure's CEO Matt Kapusta joined Genezen's Board of Directors.