Ascendis Pharma A/S (Nasdaq: ASND) and Royalty Pharma plc (Nasdaq:
RPRX) today announced that Ascendis has entered into a $150 million
capped synthetic royalty funding agreement with Royalty Pharma
based on U.S. net SKYTROFA revenue.
“This transaction reflects the significant value of SKYTROFA. We
are pleased to partner with Royalty Pharma, a leading funder of
innovation across the biopharma industry, and look forward to
partnering with them in the coming years,” said Jan Mikkelsen,
Ascendis Pharma’s President and Chief Executive Officer. “With this
funding, we continue to reduce our cost of capital and provide
added flexibility to support our global commercial capabilities to
bring our TransCon products to patients as fast as possible.”
“We are excited to partner with Ascendis, a global, integrated
biopharmaceutical company focused on endocrine rare disease and
oncology,” said Pablo Legorreta, founder and Chief Executive
Officer of Royalty Pharma. “SKYTROFA, as the first U.S. approved
weekly growth hormone therapy for pediatrics, addresses significant
unmet patient need, which is underscored by its strong launch. We
look forward to Ascendis’ continued success in reaching as many
patients as possible with this important therapy as well as the
potential for label expansion in additional indications.”
Under the terms of the agreement, Ascendis Pharma receives an
upfront payment of $150 million in exchange for a 9.15% royalty on
U.S. net SKYTROFA revenue, beginning on January 1, 2025. The
royalty payments to Royalty Pharma will cease upon reaching a
multiple of 1.925x, or 1.65x if Royalty Pharma receives royalties
in that amount by December 31, 2031.
Evercore acted as financial advisor and Latham & Watkins and
Mazanti-Andersen acted as legal advisors to Ascendis on the
transaction. Goodwin Procter, Kromann Reumert and Fenwick &
West acted as legal advisors to Royalty Pharma.
About SKYTROFA®
(lonapegsomatropin-tcgd) SKYTROFA® (lonapegsomatropin-tcgd) is a
prodrug of somatropin, administered once weekly, and designed to
provide sustained release of active, unmodified somatropin. The
unmodified, unbound parent drug released from lonapegsomatropin is
recombinant human growth hormone (hGH; somatropin) that binds to
growth hormone receptors throughout the body, with the identical
191 amino-acid sequence and size (22 kDa) as endogenous growth
hormone and the growth hormone in daily products. SKYTROFA was
developed as TransCon hGH and approved in 2021 by the U.S. Food
& Drug Administration for the treatment of pediatric patients 1
year and older who weigh at least 11.5 kg and have growth failure
due to inadequate secretion of endogenous growth hormone (GH).
SKYTROFA has been studied in over 300 children with GHD across the
Phase 3 program which consists of the heiGHt Trial (for
treatment-naïve patients), the fliGHt Trial (for
treatment-experienced patients), and the enliGHten Trial (an
ongoing long-term extension trial), with some patients on SKYTROFA
for over four years.
About Ascendis Pharma A/SAscendis Pharma is
applying its innovative TransCon technology platform to build a
leading, fully integrated biopharma company focused on making a
meaningful difference in patients’ lives. Guided by its core values
of patients, science and passion, the company uses its TransCon
technologies to create new and potentially best-in-class therapies.
Ascendis is headquartered in Copenhagen, Denmark and has additional
facilities in Germany (Heidelberg, Berlin and Munich) and the
United States (Palo Alto and Redwood City, California, and
Princeton, New Jersey). Please visit ascendispharma.com to learn
more.
About Royalty Pharma plcFounded in 1996,
Royalty Pharma is the largest buyer of biopharmaceutical royalties
and a leading funder of innovation across the biopharmaceutical
industry, collaborating with innovators from academic institutions,
research hospitals and non-profits through small and mid-cap
biotechnology companies to leading global pharmaceutical companies.
Royalty Pharma has assembled a portfolio of royalties which
entitles it to payments based directly on the top-line sales of
many of the industry’s leading therapies. Royalty Pharma funds
innovation in the biopharmaceutical industry both directly and
indirectly - directly when it partners with companies to co-fund
late-stage clinical trials and new product launches in exchange for
future royalties, and indirectly when it acquires existing
royalties from the original innovators. Royalty Pharma’s current
portfolio includes royalties on more than 35 commercial products,
including Vertex’s Trikafta, Kalydeco, Orkambi and Symdeko,
Biogen’s Tysabri, AbbVie and Johnson & Johnson’s Imbruvica,
Astellas and Pfizer’s Xtandi, GSK’s Trelegy, Novartis’ Promacta,
Pfizer’s Nurtec ODT, Johnson & Johnson’s Tremfya, Roche’s
Evrysdi, Gilead’s Trodelvy, and 11 development-stage product
candidates.
Ascendis Forward-Looking Statements This press
release contains forward-looking statements that involve
substantial risks and uncertainties. All statements, other than
statements of historical facts, included in this press release
regarding Ascendis’ future operations, plans and objectives of
management are forward-looking statements. Examples of such
statements include, but are not limited to, statements relating to
(i) Ascendis’ expectations regarding its use of proceeds; (ii)
Ascendis’ intent to bring its TransCon products to patients as fast
as possible, (iii) SKYTROFA’s ability to address significant unmet
patient need, (iv) the potential for label expansion in additional
indications; (v) SKYTROFA’s ability to provide sustained release of
active, unmodified somatropin; (vi) Ascendis’ ability to apply its
TransCon technology platform to build a leading, fully integrated,
global biopharma company, and (vii) Ascendis’ use of its TransCon
technologies to create new and potentially best-in-class therapies.
Ascendis may not actually achieve the plans, carry out the
intentions or meet the expectations or projections disclosed in the
forward-looking statements and you should not place undue reliance
on these forward-looking statements. Actual results or events could
differ materially from the plans, intentions, expectations and
projections disclosed in the forward-looking statements. Various
important factors could cause actual results or events to differ
materially from the forward-looking statements that Ascendis makes,
including the following: dependence on third party manufacturers,
distributors and service providers for Ascendis’ products and
product candidates; unforeseen safety or efficacy results in its
development programs or on-market products; unforeseen expenses
related to commercialization of any approved Ascendis products;
unforeseen expenses related to Ascendis’ development programs;
unforeseen selling, general and administrative expenses, other
research and development expenses and Ascendis’ business generally;
delays in the development of its programs related to manufacturing,
regulatory requirements, speed of patient recruitment or other
unforeseen delays; Ascendis’ ability to obtain additional funding,
if needed, to support its business activities; the impact of
international economic, political, legal, compliance, social and
business factors, including inflation, the effects on its business
from the worldwide COVID-19 pandemic and ongoing conflicts such as
that in the region surrounding Ukraine and Russia. For a further
description of the risks and uncertainties that could cause actual
results to differ from those expressed in these forward-looking
statements, as well as risks relating to Ascendis’ business in
general, see Ascendis’ Annual Report on Form 20-F filed with the
U.S. Securities and Exchange Commission (SEC) on February 16, 2023
and Ascendis’ other future reports filed with, or submitted to, the
SEC. Forward-looking statements do not reflect the potential impact
of any future licensing, collaborations, acquisitions, mergers,
dispositions, joint ventures, or investments that Ascendis may
enter into or make. Ascendis does not assume any obligation to
update any forward-looking statements, except as required by
law.
Royalty Pharma Forward-Looking Statements The
information set forth herein does not purport to be complete or to
contain all of the information you may desire. Statements contained
herein are made as of the date of this document unless stated
otherwise, and neither the delivery of this document at any time,
nor any sale of securities, shall under any circumstances create an
implication that the information contained herein is correct as of
any time after such date or that information will be updated or
revised to reflect information that subsequently becomes available
or changes occurring after the date hereof.
This document contains statements that constitute
“forward-looking statements” as that term is defined in the United
States Private Securities Litigation Reform Act of 1995, including
statements that express the company’s opinions, expectations,
beliefs, plans, objectives, assumptions or projections regarding
future events or future results, in contrast with statements that
reflect historical facts. Examples include discussion of Royalty
Pharma’s strategies, financing plans, growth opportunities and
market growth. In some cases, you can identify such forward-looking
statements by terminology such as “anticipate,” “intend,”
“believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,”
“will,” “would,” “could” or “should,” the negative of these terms
or similar expressions. Forward-looking statements are based on
management’s current beliefs and assumptions and on information
currently available to the company. However, these forward-looking
statements are not a guarantee of Royalty Pharma’s performance, and
you should not place undue reliance on such statements.
Forward-looking statements are subject to many risks, uncertainties
and other variable circumstances, and other factors. Such risks and
uncertainties may cause the statements to be inaccurate and readers
are cautioned not to place undue reliance on such statements. Many
of these risks are outside of the company’s control and could cause
its actual results to differ materially from those it thought would
occur. The forward-looking statements included in this document are
made only as of the date hereof. The company does not undertake,
and specifically declines, any obligation to update any such
statements or to publicly announce the results of any revisions to
any such statements to reflect future events or developments,
except as required by law.
Certain information contained in this document relates to or is
based on studies, publications, surveys and other data obtained
from third-party sources and the company's own internal estimates
and research. While the company believes these third-party sources
to be reliable as of the date of this document, it has not
independently verified, and makes no representation as to the
adequacy, fairness, accuracy or completeness of, any information
obtained from third-party sources. In addition, all of the market
data included in this document involves a number of assumptions and
limitations, and there can be no guarantee as to the accuracy or
reliability of such assumptions. Finally, while the company
believes its own internal research is reliable, such research has
not been verified by any independent source.
For further information, please reference Royalty Pharma’s
reports and documents filed with the U.S. Securities and Exchange
Commission (SEC). You may get these documents by visiting EDGAR on
the SEC website at www.sec.gov.
Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company
logo, TransCon, and SKYTROFA® are trademarks owned by the Ascendis
Pharma group. © September 2023 Ascendis Pharma A/S.
Investor Contacts:
Tim Lee
Ascendis Pharma
+1 (650)
374-6343
tle@ascendispharma.com ir@ascendispharma.com
Media Contact:Melinda BakerAscendis Pharma+1
(650) 709-8875media@ascendispharma.com
Patti BankICR Westwicke+1 (415)
513-1284patti.bank@westwicke.com
Royalty Pharma Investor Contacts:+1 (212)
883-6772ir@royaltypharma.com
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