RECORDATI ANNOUNCES AGREEMENT TO ACQUIRE THE GLOBAL RIGHTS TO ENJAYMO®, STRENGTHENING ITS RARE DISEASES FRANCHISE
October 04 2024 - 1:45AM
UK Regulatory
RECORDATI ANNOUNCES AGREEMENT TO ACQUIRE THE GLOBAL RIGHTS TO
ENJAYMO®, STRENGTHENING ITS RARE DISEASES FRANCHISE
Milan, 4th October
2024 – Recordati today announces an agreement with Sanofi to
acquire the global rights to Enjaymo® (sutimlimab), a biologic
which is the only approved targeted product for the treatment of
cold agglutinin disease (CAD), a rare B-cell lymphoproliferative
disorder.
Enjaymo® (sutimlimab) is a humanized monoclonal
antibody indicated for the treatment of hemolysis in adults with
CAD. In 2022, it was granted approval by the U.S. Food and Drug
Administration (FDA), the European Commission (EC) and the Japanese
Ministry of Health, Labor and Welfare. Administered as chronic IV
treatment, Enjaymo® addresses a serious unmet medical need in
patients with CAD.
Financial highlights
Enjaymo® generated approximately € 100 million in revenue over the
last 12 months as of August 2024 and is expected to generate
revenue in excess of € 150 million in FY 2025, with peak sales
potential of € 250-300 million, more than double current levels.
Subject to the closing date, Recordati expects minimal revenue
contribution in 2024. The transaction is expected to be immediately
accretive at the EBITDA level, with margin above the current Rare
Diseases average as of 2025.
Transaction details
Under the terms of the agreement, Recordati will
make an upfront payment of US$ 825 million and additional
commercial milestone payments of up to US$ 250 million, if net
sales reach certain thresholds at or above the top end of peak year
sales expectations. The transaction is expected to close by the end
of 2024, subject to regulatory clearances.
The deal will be funded by existing cash and new
committed bank debt facilities. Net debt is expected to be
approximately 2.4 - 2.5x EBITDA (pro-forma) at the end of 2024,
de-leveraging to less than 2.0x EBITDA at the end of 2025, assuming
no additional business development transactions. The Group’s
dividend and capital allocation policy remains unchanged.
Rob Koremans, Chief Executive Officer of
Recordati, commented: “This transaction is in-line with
our broader strategy, reaffirms our commitment to the Rare Diseases
space and is complementary to our Oncology portfolio, specifically
Sylvant®. Enjaymo® further expands our Rare Diseases footprint in
the U.S., Japan and Europe, and will contribute positively to both
our top and bottom lines. Most importantly, with a strong clinical
profile and as the only product approved for the treatment of CAD,
Enjaymo® addresses a serious unmet medical need for patients living
with this debilitating disease.”
About Cold agglutinin disease
(CAD)
Cold agglutinin disease (CAD) is a rare B-cell lymphoproliferative
disorder, a subgroup of autoimmune hemolytic anemia (AIHA), caused
by autoantibodies secreted by B-cells that bind to erythrocytes
(temp ≤ 37°C) leading to erythrocyte destruction. CAD symptoms
include severe, debilitating fatigue and other anemic
manifestations (e.g. arthralgia, muscle weakness), that can
significantly impact patients’ quality of life. Disease prevalence
in the U.S., Japan and Europe is approximately 11K patients, and
while median age of onset is approximately 60 years, CAD has been
diagnosed in patients as young as 30.
About Enjaymo®(sutimlimab)
Enjaymo® is a humanized monoclonal antibody that is designed to
selectively target and inhibit C1s in the classical complement
pathway, which is part of the innate immune system. By blocking
C1s, Enjaymo® inhibits the activation of the complement cascade in
the immune system and inhibits C1-activated hemolysis in CAD to
prevent the abnormal destruction of healthy red blood cells.
Enjaymo® does not inhibit the lectin and alternative pathways.
Enjaymo® was approved by the US Food and Drug Administration (FDA)
in February 2022 as the first and only treatment indicated to
decrease the need for red blood cell transfusion due to hemolysis
in adults with CAD. The Japanese Ministry of Health, Labor and
Welfare approved Enjaymo® in June 2022. The European Medicines
Agency (EMA) also made the decision to maintain orphan
designation.
Conference Call
Recordati will host a conference call today,
4th
October, at 13:00 CEST
(12:00 p.m. GMT) to discuss the agreement to
acquire Enjaymo®. The dial-in numbers for the conference call
service are:
Italy + 39 02 802 09 11, toll free 800 231 525
UK + 44 1 212818004, toll free (44) 0 800 0156371
USA +1 718 7058796, toll free (1) 1 855 2656958
France +33 1 70918704
Germany +49 6917415712
Participants are invited to dial in 10 minutes
before conference time. If conference operator assistance is
required to connect, please dial *0.
The slides that will be referenced during the call will be
available at www.recordati.com under Investors/Company
Presentations.
The audio conference live webcast will also be available at the
following link
Recordati (REC.MI)
is an international pharmaceutical group listed on the Italian
Stock Exchange (ISIN IT 0003828271) uniquely structured to bring
treatment across specialty and primary care and rare diseases. We
believe that health, and the opportunity to live life to the
fullest, is a right, not a privilege. We want to support people in
unlocking the full potential of their lives. We have fully
integrated operations across research & development, chemical
and finished product manufacturing through to commercialization and
licensing. Established in 1926, Recordati operates in approximately
150 countries across EMEA, Americas and APAC regions. At the end of
2023, Recordati employed over 4,450 people and consolidated revenue
of € 2,082.3 million. For more information, please visit
www.recordati.com
RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA
S.p.A.
Registered office VIA M.
CIVITALI, 1 20148 MILAN, ITALY TEL. +39 0248787.1 FAX +39
0240073747 |
SHARE CAPITAL € 26,140,644.50 fully paid up
BUSINESS REGISTER OF MILAN, MONZA, BRIANZA and LODI 00748210150
TAX CODE/VAT NO. 00748210150
MILAN ECONOMIC AND ADMINISTRATIVE INDEX (REA) 401832 |
Company subject to management and coordination by Rossini
Luxembourg S.àr.l of life.
Investor Relations
Eugenia Litz
+44 7824 394 750
investorelations@recordati.it
Gianluca Saletta
+39 348 979 4876
investorelations@recordati.it
Media Relations
ICR Healthcare US:
Alexis Feinberg
+1 203 939 2225
recordatiuspr@westwicke.com
UK, Europe & Rest of World:
Jessica Hodgson
+44 7561 424 788
recordati@consilium-comms.com
This document contains forward-looking
statements relating to future events and future operating, economic
and financial results of the Recordati group. By their nature,
forward-looking statements involve risk and uncertainty because
they depend on the occurrence of future events and circumstances.
Actual results may therefore differ materially from those forecast
as a result of a variety of reasons, most of which are beyond the
Recordati group’s control. The information on the pharmaceutical
specialties and other products of the Recordati group contained in
this document is intended solely as information on the activities
of the Recordati Group, and, as such, it is not intended as a
medical scientific indication or recommendation, or as
advertising.
- CS_Accordo per acquisire i diritti globali di Enjaymo FINAL IN
ITALIAN 10.4.2024
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