ROCKVILLE, Md., Dec. 22, 2020 /PRNewswire/ -- REGENXBIO Inc.
(Nasdaq: RGNX), a leading clinical-stage biotechnology company
seeking to improve lives through the curative potential of gene
therapy based on its proprietary NAV® Technology
Platform, today announced that it has entered into an agreement to
sell a portion of the royalty rights due to REGENXBIO from Novartis
Gene Therapies from the net sales of Zolgensma® to entities managed
by Healthcare Royalty Management, LLC (HCR) for a gross purchase
price of $200 million. This
transaction provides immediate, non-dilutive capital to REGENXBIO
for continued innovation in the development of potential
breakthrough gene therapies for patients and completion of its
internal manufacturing capabilities.
"Our rapidly advancing internal pipeline has enabled us to
broaden the potential impact that gene therapies can have for
patients in both large and orphan indications. This agreement with
HCR provides us with significant additional non-dilutive funding to
continue our momentum in the clinic focused on RGX-314 and our rare
neurodegenerative disease platform, including RGX-121, as well as
the opportunity to develop new innovations for patients in other
disease areas," said Kenneth T.
Mills, President and Chief Executive Officer of REGENXBIO.
"The capital will continue to support our pipeline transition into
late-stage development and the establishment of internal
manufacturing facilities with 2,000 liter scale using our platform
suspension cell culture process for emerging commercial
requirements, so that we can continue to work towards our mission
of improving the lives of patients."
Under the terms of the agreement, REGENXBIO will receive
$200 million from HCR as an upfront
payment in exchange for REGENXBIO's royalty rights from the net
sales of Zolgensma, including a portion of the royalties received
in the fourth quarter of 2020, up to 1.3 times the purchase price
until November 7, 2024 or, if such
cap is not met by November 7, 2024,
up to 1.5 times the purchase price thereafter. If either cap is
met, the royalty rights would revert to REGENXBIO.
Zolgensma is currently approved for the treatment of Spinal
Muscular Atrophy (SMA) in the United
States, Japan, Europe, Brazil and Canada. Novartis is also pursuing registration
in additional countries.
"Zolgensma is a truly innovative treatment for SMA based on
REGENXBIO's NAV technology which we believe demonstrates the
transformational impact that gene therapy can offer patients. We
are pleased to partner with REGENXBIO in this royalty agreement to
recognize the value of this therapy, and to enable the further
development of their internal pipeline of new gene therapies for
patients in need," said Clarke B.
Futch, Managing Partner & Chairman of HCR.
Morgan Stanley & Co. LLC served as sole structuring agent
and Covington & Burling LLP served as counsel to
REGENXBIO. Morgan Lewis &
Bockius LLP acted as counsel to HCR.
About REGENXBIO Inc.
REGENXBIO is a leading clinical-stage biotechnology company
seeking to improve lives through the curative potential of gene
therapy. REGENXBIO's NAV Technology Platform, a proprietary
adeno-associated virus (AAV) gene delivery platform, consists of
exclusive rights to more than 100 novel AAV vectors, including
AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV
Technology Platform Licensees are applying the NAV Technology
Platform in the development of a broad pipeline of candidates in
multiple therapeutic areas.
About HCR
HCR is a private investment firm that purchases royalties and
uses debt-like structures to invest in commercial or
near-commercial stage biopharmaceutical assets. HCR has raised
$5.7 billion in cumulative capital
commitments with offices in Stamford (CT), San Francisco, Boston and London For more information,
visit www.healthcareroyalty.com
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," "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 clinical trials,
future operations 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
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, the impact of the COVID-19 pandemic or similar
public health crises on REGENXBIO's business, 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, 2019, and comparable
"risk factors" sections of REGENXBIO's Quarterly Reports on Form
10-Q and other filings, which have been filed with the U.S.
Securities and Exchange Commission (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. 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.
Zolgensma® is a registered trademark of Novartis Gene Therapies.
All other trademarks referenced herein are registered trademarks of
REGENXBIO.
Contacts:
Tricia Truehart
Investor Relations and Corporate Communications
347-926-7709
ttruehart@regenxbio.com
Investors:
Eleanor Barisser, 212-600-1902
eleanor@argotpartners.com
Media:
David Rosen, 212-600-1902
david.rosen@argotpartners.com
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SOURCE REGENXBIO Inc.