- GENFIT completes a royalty
financing of up to €185 million with HCRx after unanimous OCEANE
bondholder approval, triggering a €130 million upfront payment with
potential for an additional €55 million upon achieving near-term
milestones
- Non-dilutive financing
extends cash runway beyond 2027 and supports GENFIT’s R&D
efforts
- Financing strengthens
GENFIT's ACLF pipeline development and commitment to transformative
therapies
- GENFIT to use €61.66
million to repurchase 1,882,891 2025 OCEANEs after exercise by
certain bondholders of their put option, reducing the nominal
amount of GENFIT’s convertible debt to €586 thousand
Lille (France), Cambridge
(Massachusetts, United States), Zurich (Switzerland), March 20,
2025 - GENFIT (Nasdaq and Euronext:
GNFT), a biopharmaceutical company dedicated to improving
the lives of patients with rare and life-threatening liver diseases
(the “Company”), is pleased to announce the
successful completion of its royalty financing transaction with
HealthCare Royalty (“HCRx”) and the results of the repurchase offer
to 2025 OCEANEs holders.
Pascal Prigent, CEO of GENFIT,
commented: “We are very pleased that we have now successfully
closed this transaction. It gives us financial visibility beyond
2027 and will enable us to pursue development of all the programs
in our very rich pipeline. We also believe it is positive for our
shareholders as we have lifted our convertible debt burden without
any dilution.”
This achievement follows the approval of the
amendment to the terms and conditions of the 2025 OCEANEs by the
bondholders during the general meeting, which took place on March,
10, 2025 where bondholders unanimously approved all resolutions
proposed by the Company, with a quorum of 95.79%. Subsequent to the
closing of the transaction, GENFIT will implement the repurchase of
the 2025 OCEANEs at a price of € 32.75 per bond, (the
“Repurchase”) and pay the €0.90 consent fee (the
“Consent Fee”), expected to occur on March 26,
2025, and April 14, 2025, respectively.
The completion of this royalty financing
transaction with HCRx marks a significant milestone for GENFIT with
an upfront payment of €130 million. This substantial infusion of
capital, coupled with the potential to receive up to an additional
€55 million contingent upon achieving near-term milestones,
provides GENFIT with a robust financial foundation. HCRx will be
compensated and repaid out of a portion of the royalties which
GENFIT is eligible to receive from its partner Ipsen. Cumulative
payment to HCRx is capped at a maximum value and subject to
time-limits. Once the cap or time-limit is met, all future
royalties will revert back to GENFIT. GENFIT retains the right to
receive any regulatory, commercial and sales-based milestone
payments under the Ipsen agreement, including the €26.55 million
milestone expected in 2025 pending a third pricing and
reimbursement approval of Iqirvo® (elafibranor) in a major European
market.
This non-dilutive financing arrangement is
pivotal in enabling GENFIT to fund its operating expenses and
capital expenditure requirements beyond the end of 2027. This is
based on current assumptions and programs and does not include
exceptional events. This estimation assumes i) our expectation to
receive significant future milestone revenue in 2025, including the
€26.55 million milestone pending a third pricing and reimbursement
approval of Iqirvo® (elafibranor) in a major European market and
Ipsen meeting its sales-based thresholds, ii) drawing down all
instalments under the Royalty Financing, and iii) the Repurchase of
the OCEANEs as described below and the reimbursement at maturity in
October 2025 of any OCEANES not repurchased and cancelled.
With this financial backing, GENFIT is
well-positioned to continue the development of its Acute-on-Chronic
Liver Failure (ACLF) pipeline, which includes several promising
assets at various stages of development, as well as to support
general corporate purposes.
Implementation of the
Repurchase
By the March 19, 2025 deadline for bondholders
participating in the Repurchase to exercise their put option,
holders of 2025 OCEANEs exercised their put option for a total of
1,882,891 2025 OCEANEs, i.e. 99% of the total number of 2025
OCEANEs outstanding. At a price of €32.75 per bond, this represents
a total Repurchase amount of € 61,664,680.25.
The settlement of the Repurchase is expected to
occur on March 26, 2025. The repurchased 2025 OCEANEs will be
canceled by the Company.
Payment of the Consent Fee
On April 14, 2025, GENFIT will pay the Consent
Fee approved at the March 10, 2025 bondholders’ meeting. The record
date for the payment of the Consent Fee is April 11, 2025, 5:00
p.m. (Paris time). The 2025 OCEANEs that will have been repurchased
and cancelled as described above and those that will have been
converted prior to that record date will not receive the Consent
Fee. Assuming no conversions and on the basis of the 2025 OCEANEs
still outstanding after the Repurchase (and cancellation), this
will amount to €17,826.30.
GENFIT will publish a press release if any of
the dates indicated above were to be modified.
Advisors
Van Lanschot Kempen acted as sole financial
advisor to GENFIT. Goodwin Procter LLP acted as lead legal advisor
to GENFIT, with Clifford Chance LLP acting as special legal advisor
on financing aspects of the transaction. Morgan, Lewis &
Bockius LLP and Racine Avocats acted as legal advisors to
HCRx.Natixis acted as sole solicitation advisor to assist GENFIT to
obtain the consent of the holders of the 2025 OCEANEs and in the
repurchase of the 2025 OCEANEs. CMS Francis Lefebvre acted as legal
advisor to GENFIT in the context of the consent solicitation of the
2025 OCEANEs holders and the Repurchase.
ABOUT GENFIT
GENFIT is a biopharmaceutical company committed
to improving the lives of patients with rare, life-threatening
liver diseases whose medical needs remain largely unmet. GENFIT is
a pioneer in liver disease research and development with a rich
history and a solid scientific heritage spanning more than two
decades. Today, GENFIT has built up a diversified and rapidly
expanding R&D portfolio of programs at various stages of
development. The Company focuses on Acute-on-Chronic Liver Failure
(ACLF). Its ACLF franchise includes five assets under development:
VS-01, NTZ, SRT-015, CLM-022 and VS-02-HE, based on complementary
mechanisms of action using different routes of administration.
Other assets target other serious diseases, such as
cholangiocarcinoma (CCA), urea cycle disorder (UCD) and organic
acidemia (OA). GENFIT's expertise in the development of
high-potential molecules from early to advanced stages, and in
pre-commercialization, was demonstrated in the accelerated approval
of Iqirvo® (elafibranor1) by the U.S. Food and Drug Administration,
the European Medicines Agency and the Medicines and Healthcare
Regulatory Agency in the UK for Primary Biliary Cholangitis (PBC).
Beyond therapies, GENFIT also has a diagnostic franchise including
NIS2+® in Metabolic dysfunction-associated steatohepatitis (MASH,
formerly known as NASH for non-alcoholic steatohepatitis) and TS-01
focusing on blood ammonia levels. GENFIT is headquartered in Lille,
France and has offices in Paris (France), Zurich (Switzerland) and
Cambridge, MA (USA). The Company is listed on the Nasdaq Global
Select Market and on the Euronext regulated market in Paris,
Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became
one of GENFIT's largest shareholders, acquiring an 8% stake in the
Company's capital. www.genfit.com
FORWARD LOOKING STATEMENTS
This press release contains certain
forward-looking statements, including those within the meaning of
the Private Securities Litigation Reform Act of 1995 with respect
to GENFIT, including, but not limited to statements about the
Company’s cash runway, the potential and management’s expectations
to receive royalties and near-term milestones under the Ipsen
Agreement, the meeting of the milestones necessary to draw down on
the second and third instalments under the royalty financing, and
the implementation calendar of the OCEANEs 2025 Repurchase. The use
of certain words, such as "believe", "potential", "expect",
“target”, “may”, “will”, "should", "could", "if" and similar
expressions, is intended to identify forward-looking statements.
Although the Company believes its expectations are based on the
current expectations and reasonable assumptions of the Company’s
management, these forward-looking statements are subject to
numerous known and unknown risks and uncertainties, which could
cause actual results to differ materially from those expressed in,
or implied or projected by, the forward-looking statements. These
risks and uncertainties include, among others, the uncertainties
inherent in research and development, including in relation to
safety of drug candidates, cost of, progression of, and results
from, our ongoing and planned clinical trials, review and approvals
by regulatory authorities in the United States, Europe and
worldwide, of our drug and diagnostic candidates, pricing, approval
and commercial success of elafibranor in the relevant
jurisdictions, exchange rate fluctuations, and our continued
ability to raise capital to fund our development, as well as those
risks and uncertainties discussed or identified in the Company’s
public filings with the AMF, including those listed in Chapter 2
"Risk Factors and Internal Control" of the Company's 2023 Universal
Registration Document filed on April 5, 2024 (no. D.24-0246) with
the Autorité des marchés financiers ("AMF"), which is available on
GENFIT's website (www.genfit.fr) and the AMF's website
(www.amf.org), and those discussed in the public documents and
reports filed with the U.S. Securities and Exchange Commission
("SEC"), including the Company’s 2023 Annual Report on Form 20-F
filed with the SEC on April 5, 2024, the Half-Year Business and
Financial Report dated September 19, 2024 and subsequent filings
and reports filed with the AMF or SEC or otherwise made public, by
the Company. In addition, even if the results, performance,
financial position and liquidity of the Company and the development
of the industry in which it operates are consistent with such
forward-looking statements, they may not be predictive of results
or developments in future periods. These forward-looking statements
speak only as of the date of publication of this press release.
Other than as required by applicable law, the Company does not
undertake any obligation to update or revise any forward-looking
information or statements, whether as a result of new information,
future events or otherwise.
CONTACTS
GENFIT | InvestorsTel: +33 3
2016 4000 | investors@genfit.com
GENFIT | MediaStephanie Boyer –
Press relations | Tel: +333 2016 4000 |
stephanie.boyer@genfit.com
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos -
FRANCE | +333 2016 4000 | www.genfit.com
1 Elafibranor is marketed and commercialized in the U.S by Ipsen
under the trademark Iqirvo®.
- GENFIT Announces Completion of Non-dilutive Royalty Financing
Agreement with HCRx and Results of Repurchase Offer to 2025 OCEANEs
holders
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