Ipsen delivers solid H1 2023 results and upgrades its full-year guidance
27 Juli 2023 - 7:00AM
Paris,
France: 27 July
2023Ipsen (Euronext: IPN; ADR:
IPSEY), a global specialty-care biopharmaceutical company, presents
today its financial results for the first half of 2023.
- H1 2023 total sales up by 7.4% at CER1 (7.2% as reported), with
growth-platforms’2 sales increasing by 17.7%1 and a strong
contribution from newly acquired medicines,
Bylvay® (odevixibat) and Tazverik® (tazemetostat).
Somatuline® (lanreotide) sales, now comprising around a third of
the total, fell by 12.0%1
- H1 2023 core operating margin of 34.0%, a decline of 5.6%
points, driven by investment in the pipeline, mainly from Bylvay
and Tazverik. IFRS operating margin of 19.2%, down by 15.7% points,
including the integration costs and amortization of intangible
assets from Albireo and Epizyme
- Acquisition of Albireo accompanied by several favorable
developments in the pipeline, including Onivyde® (irinotecan),
Bylvay, palovarotene and elafibranor
- Upgraded 2023 financial guidance: total-sales growth greater
than 6.0% at CER1 (prior guidance: greater than 4.0% at CER1); core
operating margin greater than 30.0% of total sales (prior guidance:
around 30%)
Extract of consolidated results for H1 2023 and
H1 20223:
|
H1 2023 |
H1 2022 |
% change |
€m |
€m |
Actual |
CER1 |
Total Sales |
1,536.6 |
1,433.7 |
7.2% |
7.4% |
Core
Operating Income |
523.2 |
568.0 |
-7.9% |
|
Core operating
margin |
34.0% |
39.6% |
-5.6% pts |
|
Core
Consolidated Net Profit |
393.0 |
420.5 |
-6.5% |
|
Core earnings
per share (fully diluted) |
€4.73 |
€5.06 |
-6.6% |
|
IFRS Operating Income |
295.6 |
501.3 |
-41.0% |
|
IFRS operating
margin |
19.2% |
35.0% |
-15.7% |
|
IFRS
Consolidated Net Profit |
195.1 |
394.3 |
-50.5% |
|
IFRS earnings
per share (fully diluted) |
€2.35 |
€4.74 |
-50.5% |
|
Free Cash Flow |
371.5 |
339.0 |
9.6% |
|
Closing net cash/(debt)4 |
(272.2) |
168.2 |
n/a |
|
David Loew, Chief Executive Officer,
commented:
“The successful delivery on our strategic roadmap is yielding
more top-line growth, advancements in the pipeline and further
positive developments from external innovation. Improving execution
supported another strong performance from our growth platforms in
Oncology and Neuroscience in the first half of the year, while I
was particularly pleased with the Rare Disease progress of the
pipeline, including another regulatory approval for Bylvay in the
U.S., positive clinical-trial results for elafibranor and a
favorable regulatory step for palovarotene in the U.S. These
developments have the potential to significantly benefit patients
across a range of indications.
The performance in the first half of the year is
reflected in today’s upgrade to our full-year guidance. We look
forward to more milestones and further expansion of the pipeline
over time through additional external-innovation transactions. I am
confident, as we continue to deliver more medicines to patients, in
ensuring the sustainable growth of Ipsen.”
Full-year 2023
guidanceIpsen has upgraded its financial guidance
for FY 2023:
- Total-sales growth greater than
6.0%, at constant currency (prior guidance: greater than 4.0% at
constant currency). Based on the average level of exchange rates in
June 2023, an adverse impact on total sales of around 3% from
currencies is expected
- Core operating margin greater than
30.0% of total sales, excluding any potential impact of incremental
investments from future external-innovation transactions (prior
guidance: around 30%)
Pipeline updateSeveral
announcements regarding Ipsen’s pipeline were published in June
2023:
- The U.S. Food and Drug
Administration (FDA) accepted its supplemental New Drug Application
for Onivyde plus 5 fluorouracil/leucovorin and oxaliplatin (the
NALIRIFOX regimen) as a potential first-line treatment for
metastatic pancreatic ductal adenocarcinoma. The Prescription Drug
User Fee Act (PDUFA) goal date is 13 February 2024
- The U.S. FDA approved Bylvay for
the treatment of cholestatic pruritus in patients from 12 months of
age with Alagille syndrome (ALGS). In July 2023, the European
Medicine Agency’s (EMA) Committee for Medicinal Products for Human
Use (CHMP) issued a positive opinion recommending the approval of
Bylvay for the treatment of cholestatic pruritus in patients with
ALGS aged six months or older. The Committee for Orphan Medicinal
Products (COMP), a scientific committee of the EMA, concurrently
issued a negative opinion for the maintenance of Bylvay’s orphan
drug designation in ALGS. This latter opinion prevents the
retention of orphan-drug status in Bylvay’s marketing authorization
in ALGS and might delay a final European Commission decision. Ipsen
plans to submit an appeal in respect of the COMP opinion
- The U.S. FDA Endocrinologic and
Metabolic Drugs Advisory Committee voted in favor of
investigational palovarotene as an effective treatment, with a
positive risk-benefit profile, for people living with the
ultra-rare bone disease, fibrodysplasia ossificans progressiva
(FOP). The PDUFA goal date is 16 August 2023. In May 2023, the CHMP
confirmed the negative opinion on palovarotene as a potential
treatment for FOP, and it was therefore not subsequently approved
by the European Commission
- Positive top-line data from the
pivotal ELATIVE Phase III trial were published. In the trial, the
efficacy and safety of elafibranor was assessed for the treatment
of patients with the rare cholestatic liver disease, primary
biliary cholangitis, who have an inadequate response or intolerance
to the current standard of care therapy, ursodeoxycholic acid. The
trial met its primary endpoint, and full trial data will be
presented at a future scientific congress
Update on Galderma partnership
In July 2023, Ipsen notified Galderma of the
termination of the July 2014 R&D collaboration related to the
parties’ respective neurotoxin programs.
Ipsen will retain all rights and obligations
related to its early-stage R&D neurotoxin pipeline, including
the development of IPN10200 (longer-acting neurotoxin). This
decision does not impact the two ICC arbitrations initiated by
Galderma. Ipsen intends to fully defend and vindicate its rights
against Galderma’s allegations.
Consolidated financial statements
The Board of Directors approved the condensed
consolidated financial statements on 26 July 2023. The Company’s
auditors performed a limited review of the H1 2023 condensed
consolidated financial statements. The interim financial report,
with regards to the regulated information, will be available on
ipsen.com in due course, under the Reports and Accounts tab in the
Investor Relations section.
Conference call
A conference call and webcast for investors and
analysts will begin today at 2pm, Paris time. Participants can
access the call and its details by registering here; webcast
details can be found here.
CalendarIpsen intends to
publish its year-to-date and third-quarter sales update on 26
October 2023. The Company also anticipates hosting a
capital-markets event on 7 December 2023 in London. It will be
webcast live and details will be available in due course.
Notes
All financial figures are in € millions
(€m). The performance shown in this announcement covers the
six-month period to 30 June 2023 (H1 2023) and the three-month
period to 30 June 2023 (Q2 2023), compared to six-month period
to 30 June 2022 (H1 2022) and the three-month period to
30 June 2022 (Q2 2022), respectively, unless stated
otherwise. Commentary is based on the performance in H1 2023,
unless stated otherwise. The performance of the Consumer HealthCare
(CHC) business, divested in July 2022, has been excluded from all
commentary and comparisons to prior performance.
Ipsen
Ipsen is a global, mid-sized biopharmaceutical
company focused on transformative medicines in Oncology, Rare
Disease and Neuroscience. With total sales of €3.0bn in FY 2022,
Ipsen sells medicines in over 100 countries. Alongside its
external-innovation strategy, the Company’s research and
development efforts are focused on its innovative and
differentiated technological platforms located in the heart of
leading biotechnological and life-science hubs: Paris-Saclay,
France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has
around 5,300 colleagues worldwide and is listed in Paris (Euronext:
IPN) and in the U.S. through a Sponsored Level I American
Depositary Receipt program (ADR: IPSEY). For more information,
visit ipsen.com.
Contacts
Investors |
|
Craig MarksVice President, Investor Relations+44
7584 349 193 |
Nicolas
BoglerSenior Investor Relations Manager+33 6 52 19 98
92 |
Media |
|
Amy WolfVice President and Head of Corporate Brand
Strategy and Communications+41 79 576 07 23 |
Ioana PiscociuSenior Manager, Global
Media Relations+33 6 69 09 12 96 |
1At constant exchange rates (CER), which exclude any
foreign-exchange impact by recalculating the performance for the
relevant period by applying the exchange rates used for the prior
period.2Dysport® (abobotulinumtoxinA), Decapeptyl® (triptorelin),
Cabometyx® (cabozantinib) and Onivyde.3Extract of consolidated
results. The Company’s auditors performed a limited review of the
condensed consolidated financial statements.4Net cash/(debt)
excluding contingent liabilities (earnouts and CVR), previously
part of the net cash/(debt) definition.
- H1 2023 - results announcement
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