REGENXBIO Announces Strategic Royalty Monetization Agreement for Up to $250 Million
Rhea-AI Summary
REGENXBIO (NASDAQ: RGNX) has secured a strategic royalty monetization agreement with Healthcare Royalty (HCRx) worth up to $250 million. The company received $150 million upfront, extending its cash runway into early 2027. The non-dilutive agreement includes rights to royalties from ZOLGENSMA sales and milestone payments from various partnerships.
Additional funding includes $50 million tied to ZOLGENSMA sales milestones (by April 2027) and another $50 million upon mutual agreement. HCRx will receive quarterly interest payments from royalty revenue and warrants to purchase 268,096 shares at $14.92. REGENXBIO retains rights to other funding sources, including a potential Priority Review Voucher for RGX-121 and milestones from AbbVie and Nippon Shinyaku.
Positive
- Secured $150 million upfront non-dilutive funding, extending cash runway into early 2027
- Additional $100 million potential funding through milestone achievements and mutual agreement
- Retains valuable assets including Priority Review Voucher and milestone payments from partnerships
- Warrants issued at 100% premium to current stock price, minimizing immediate dilution
Negative
- Company taking on debt secured against future royalty streams
- Giving up portions of future royalty revenue from ZOLGENSMA and other programs
- Quarterly interest payments will reduce cash flow from royalty revenues
News Market Reaction
On the day this news was published, RGNX gained 2.15%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
$150 million - REGENXBIO retains additional potential non-dilutive funding opportunities, including monetization of Priority Review Voucher (PRV) and milestones from AbbVie
"This strategic financing brings future potential funds forward and extends our runway beyond multiple meaningful milestones, including the potential FDA approval of RGX-121 for MPS II, top-line data readout and BLA submission for RGX-202 for Duchenne, and top-line data readouts for two pivotal studies of subretinal ABBV-RGX-314 for wet AMD," said Mitchell Chan Chief Financial Officer of REGENXBIO. "Along with fueling our late-stage activities, this transaction enables us to retain future potential non-dilutive opportunities and the potential long-term financial upside from our NAV® licensees and MPS programs. As we approach potential first- or best-in-class product launches, we remain focused on leveraging low-cost, non-dilutive capital to advance our differentiated portfolio and unlock significant value for shareholders. This capital infusion positions us well to accelerate commercial preparations and continue extending our longstanding leadership in rare and retinal gene therapies."
"This financing capitalizes on REGENXBIO's unique position as a late-stage gene therapy company with multiple royalty-generating assets," said Clarke Futch, Chairman and Chief Executive Officer of HCRx. "We recognize the value embedded in REGENXBIO's differentiated portfolio. This deal demonstrates HCRx's commitment to providing innovative capital structures to benefit our clients and their shareholders."
Terms of the Agreement
Under the terms of the agreement, HCRx will provide REGENXBIO an up to
HCRx will receive quarterly interest payments derived solely from the royalty and milestone revenue received, less any payments to REGENXBIO's upstream licensors, and warrants to purchase up to 268,096 shares of the Company's common stock at an exercise price of
In addition to the
REGENXBIO's other future potential non-dilutive funding sources, including the potential sale of the expected Priority Review Voucher for RGX-121, development and sales milestones from AbbVie, and a majority of the development milestones from Nippon Shinyaku, are not included in this agreement and are retained by REGENXBIO.
Zolgensma using intravenous delivery has been approved for the treatment of SMA in more than 50 countries. In January 2025, Novartis announced the Phase III study of Zolgensma using intrathecal delivery had met its primary endpoint.
Covington & Burling LLP served as legal advisor to REGENXBIO and Morgan, Lewis & Bockius LLP advised HCRx.
ABOUT REGENXBIO Inc.
REGENXBIO is a biotechnology company on a mission to improve lives through the curative potential of gene therapy. Since its founding in 2009, REGENXBIO has pioneered the field of AAV gene therapy. REGENXBIO is advancing a late-stage pipeline of one-time treatments for rare and retinal diseases, including RGX-202 for the treatment of Duchenne; clemidsogene lanparvovec (RGX-121) for the treatment of MPS II and RGX-111 for the treatment of MPS I, both in partnership with Nippon Shinyaku; and surabgene lomparvovec (ABBV-RGX-314) for the treatment of wet AMD and diabetic retinopathy, in collaboration with AbbVie. Thousands of patients have been treated with REGENXBIO's AAV platform, including those receiving Novartis' ZOLGENSMA®. REGENXBIO's investigational gene therapies have the potential to change the way healthcare is delivered for millions of people. For more information, please visit WWW.REGENXBIO.COM.
ABOUT HEALTHCARE ROYALTY
HealthCare Royalty is a leading royalty acquisition company focused on commercial or near-commercial biopharmaceutical products. With offices in
FORWARD-LOOKING STATEMENTS
This press release includes "forward-looking statements," within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements express a belief, expectation or intention and are generally accompanied by words that convey projected future events or outcomes such as "believe," "may," "will," "estimate," "continue," "anticipate," "assume," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would" or by variations of such words or by similar expressions. The forward-looking statements include statements relating to, among other things, REGENXBIO's future operations, clinical trials, costs and cash flow. REGENXBIO has based these forward-looking statements on its current expectations and assumptions and analyses made by REGENXBIO in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors REGENXBIO believes are appropriate under the circumstances. However, whether actual results and developments will conform with REGENXBIO's expectations and predictions is subject to a number of risks and uncertainties, including the timing of enrollment, commencement and completion and the success of clinical trials conducted by REGENXBIO, its licensees and its partners, the timing of commencement and completion and the success of preclinical studies conducted by REGENXBIO and its development partners, the timing or likelihood of payments from AbbVie or Nippon Shinyaku, the monetization of any priority review voucher, the timely development and launch of new products, the ability to obtain and maintain regulatory approval of product candidates, the ability to obtain and maintain intellectual property protection for product candidates and technology, trends and challenges in the business and markets in which REGENXBIO operates, the size and growth of potential markets for product candidates and the ability to serve those markets, the rate and degree of acceptance of product candidates, and other factors, many of which are beyond the control of REGENXBIO. Refer to the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of REGENXBIO's Annual Report on Form 10-K for the year ended December 31, 2024, and comparable "risk factors" sections of REGENXBIO's Quarterly Reports on Form 10-Q and other filings, which have been filed with the SEC and are available on the SEC's website at WWW.SEC.GOV. All of the forward-looking statements made in this press release are expressly qualified by the cautionary statements contained or referred to herein. The actual results or developments anticipated may not be realized or, even if substantially realized, they may not have the expected consequences to or effects on REGENXBIO or its businesses or operations. Such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Readers are cautioned not to rely too heavily on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this press release. Except as required by law, REGENXBIO does not undertake any obligation, and specifically declines any obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts:
Dana Cormack
Corporate Communications
dcormack@regenxbio.com
Investors:
George E. MacDougall
Investor Relations
IR@regenxbio.com
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SOURCE REGENXBIO Inc.
FAQ
What is the value of RGNX's royalty monetization agreement with Healthcare Royalty?
How long will RGNX's cash runway extend after the royalty deal?
What royalty rights did RGNX give up in the Healthcare Royalty agreement?
What assets did REGENXBIO retain after the royalty monetization deal?
What warrants were issued to Healthcare Royalty in the RGNX deal?
