Press Release

Poxel Reports Consolidated Revenue for the First
Quarter 2025 and Provides Corporate Update

• TWYMEEG® consolidated gross sales in Japan for Sumitomo Pharma Fiscal
Year 20241 achieved JPY 7.6 billion (EUR 47,2 million)2, in line with Sumitomo
Pharma’s latest guidance3
• Sumitomo Pharma forecast for TWYMEEG®’s FY 20254 of JPY 11.2 billion (EUR
69,4 million2), representing a 47% increase over FY 2024 sales
• In FY2024, Poxel started receiving 10% royalties on TWYMEEG® net sales, and
from FY20255 anticipates receiving escalating double-digit royalties and
additional sales-based payments upon achievement of contractual sales
thresholds
• Regulatory approval on April 8, 2025, by the Pharmaceuticals and Medical
Devices Agency (PMDA) in Japan enabling Sumitomo Pharma to immediately
start promoting the use of TWYMEEG® (Imeglimin) in type 2 diabetic patients
with moderate to severe renal impairment
• Ongoing discussions with 1/ creditors to ensure continuity of the Company’s
operations and 2/ potential partners for the development of pipeline
products


LYON, France, May 13, 2025 – POXEL SA (Euronext: POXEL - FR0012432516), a
clinical stage biopharmaceutical company developing innovative treatments for
chronic serious diseases with metabolic pathophysiology, including metabolic
dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders,
today reported its revenue for the quarter ended March 31, 2025 and provided
corporate update.

Thomas Kuhn, Chief Executive Officer of Poxel, stated: “TWYMEEG® has further
demonstrated its strong potential in FY 20241 with the commercial performance in
Japan representing a 65% increase over FY 2023. This robust growth is expected to
continue in FY 2025 and beyond, and should be further strengthened driven by a
number of key recent milestones, including the recent regulatory approval in Japan
allowing TWYMEEG® to be prescribed to type 2 diabetic patients with moderate to
severe renal impairment, a key patient population, particularly elderly individuals with
renal impairment, who are faced with limited treatment options. In parallel of these
achievements, our top priority remains to secure a path forward for the Company. We
continue to be actively engaged in discussions with our creditors with the aim of

1
Sumitomo Pharma fiscal year 2024 ends March 31, 2025
2
Converted at the exchange rate on March 31, 2025
3
As per Sumitomo Pharma FY2024 forecast of JPY 7.9 billion published on January 31, 2025
4
As per Sumitomo Pharma FY2024 forecast published on May 13, 2025




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reaching a structuring solution that would ensure the continuity of the Company’s
operations, and with potential partners to develop strategic opportunities to unlock
the value of our pipeline of products.”

Commercial and Clinical Update
TWYMEEG® (Imeglimin)
• For the quarter ended March 2025, TWYMEEG® gross sales in Japan totalled
JPY 1.9 billion (EUR 12 million)2. As a result, for Sumitomo Pharma’s FY 20241,
TWYMEEG® gross sales reached JPY 7.6 billion (EUR 47.1 million)2, in line with
Sumitomo Pharma’s most recent FY 2024 guidance (JPY 7.9 billion) and
representing an increase by 65% over FY 2023.

• For its FY 20255, Sumitomo Pharma forecasts gross sales for TWYMEEG® of JPY
11.2 billion4 (EUR 69.4 million)2 which would represent a 47% increase over FY
2024 TWYMEEG® gross sales. This forecast includes an incremental uptake
among type 2 diabetic patients with renal impairment following the recent
approval by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan
to revise TWYMEEG® package insert for patients with renal impairment with
eGFR (estimated glomerular filtration rate) less than 45 mL/min/1.73m 2.

• Based on this FY 2025 forecast, TWYMEEG® could reach JPY 10 billion net sales
(EUR 62 million)2 entitling Poxel to receive 12% royalties on all TWYMEEG ® net
sales and a second sales-based payment of JPY 1 billion (EUR 6.3 million)2.
Following the recent royalty monetization agreement with OrbiMed, these
proceeds will go exclusively towards the reimbursement of the bonds issuance.
Beyond 2025, Poxel expects to receive escalating double-digit royalties as well
as additional sales-based payments upon achievement of contractually based
sales thresholds.

• In August 2024, topline results from the post-marketing clinical study, TWINKLE
(TWYMEEG® in diabetic patients with renal impairment: A post-marketing long-
term study) conducted by Sumitomo Pharma in Japanese type 2 diabetic
patients with renal impairment confirmed TWYMEEG®’s safety and tolerability
profile, which is consistent with prior clinical studies. Based on these results,
Sumitomo Pharma led discussions with the Pharmaceuticals and Medical
Devices Agency (PMDA) in Japan leading to the revision of TWYMEEG®
package insert for patients with renal impairment with eGFR (estimated
glomerular filtration rate) less than 45 mL/min/1.73m2 on April 8, 2025. This
approval has enabled Sumitomo Pharma to immediately start promoting the
use of TWYMEEG® in this population.




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Sumitomo Pharma fiscal year 2025 ends March 31, 2026




2
• This regulatory milestone builds on the recently granted patent (n°7635474) by
the Japanese Patent Office to Poxel6 covering the use of Imeglimin in type 2
diabetic patients with moderate to severe renal impairment until 2039,
strengthening TWYMEEG®’s patent portfolio in Japan and protecting its use in
this population. Poxel previously received the grant of this patent in China 7, the
world’s second largest type 2 diabetes market, further supporting ongoing
discussions initiated by the Company to develop Imeglimin beyond Japan.

PXL065

• On March 20, 2025, positive top-line results for PXL065 were obtained from a
preclinical study conducted in a mouse model of hypertrophic cardiomyopathy
(HCM), the most common genetic cardiac disorder. The preclinical study was
financed through a grant by DZHK 8 and conducted at the TUM University
Hospital German Heart Center under a research collaboration. After 10 weeks
of treatment, a significant reduction in myocardial hypertrophy associated with
a significant reduction in cardiac fibrosis was demonstrated, highlighting the
potential of PXL065 in this pathology. These results further support the clinical
development of PXL065 as a potential disease-modifying treatment for
symptomatic and asymptomatic HCM and will be presented at a future
scientific meeting.

First Quarter 2025 Consolidated Revenue

Poxel reported EUR 1,066 thousand2 consolidated revenue for the quarter ended
March 31, 2025, representing a 137% increase compared to the 2024 Q1 revenue.

Consolidated revenue for the first quarter of 2025 reflects JPY 172 million (EUR
1,066 thousand2) of royalty revenue from Sumitomo Pharma, which represents 10%
of TWYMEEG® net sales in Japan. Based on the current forecast, Poxel expects to
receive at least 12% royalties on TWYMEEG® net sales in Japan through the
Sumitomo Pharma fiscal year 20255. As part of the Merck Serono licensing
agreement, Poxel will pay Merck Serono a fixed 8% royalty based on the net sales
of Imeglimin, independent of the level of sales. According to the Royalty
Monetization agreement with OrbiMed, the positive net Royalties will be fully
dedicated to the repayment of the bonds.




6“
Poxel Announces Grant of New Patent in Japan for the Use of Imeglimin in Type-2 Diabetic Patients with Renal Impairment”,
on March 31, 2025
7 “
Poxel Announces the Grant of Patent in China Protecting the Use of Imeglimin for Type-2 Diabetic Patients with Renal
Impairment”, on January 20, 2025
8
DZHK: German Center for Cardiovascular Research (Deutsches Zentrum für Herz-Kreislauf-Forschung)




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Q1 2025* Q1 2024
EUR (in thousands)
3 months 3 months
Sumitomo Pharma Agreement 1,066 449
Other - -
Total consolidated revenues 1,066 449
*Unaudited data


Update on existing event of default under the IRIS and IPF Partners existing
bond financing agreements and search of structuring financial solution to
ensure the continuity of the Company

Since the announcement by the Company of the events of default under the IRIS
and IPF Partners outstanding bond financing agreements triggered by the non-
adoption of the financial delegations at the Combined General Meeting held on
February 11, 2025, the Board of Directors and the Management of Poxel continue
to actively negotiate with the Company’s creditors, with the aim of reaching a
structuring solution that would ensure the continuity of the Company’s operations.
As announced on April 16, 2025, Poxel’s financial outlook remains highly
constrained with a cash runway currently estimated through June 2025, depending
on the outcome of current discussions with the Company’s creditors.
In parallel, the Company is also progressing discussions with several potential
partners for the development of its pipeline products.
As already announced on April 16, 2025, given the potential impact on the
Company’s financial statements of the negotiations with the Company’s creditors
and potential partners, Poxel has postponed the approval and publication of its
2024 Full-Year Results. A new date will be communicated once these negotiations
are finalized.


About Poxel SA

Poxel is a clinical stage biopharmaceutical company developing innovative
treatments for chronic serious diseases with metabolic pathophysiology,
including metabolic dysfunction-associated steatohepatitis (MASH) and rare
disorders. For the treatment of MASH, PXL065 (deuterium-stabilized R-
pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In
rare diseases, development of PXL770, a first-in-class direct adenosine
monophosphate-activated protein kinase (AMPK) activator, is focused on the
treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic
kidney disease (ADPKD). TWYMEEG® (Imeglimin), Poxel’s first-in-class product that
targets mitochondrial dysfunction, is now marketed for the treatment of type 2
diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and



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sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma
for Imeglimin in Japan. Listed on Euronext Paris, Poxel is headquartered in Lyon,
France, and has subsidiaries in Boston, MA, and Tokyo, Japan.
For more information, please visit: www.poxelpharma.com

All statements other than statements of historical fact included in this press release
about future events are subject to (i) change without notice and (ii) factors beyond
the Company’s control. These statements may include, without limitation, any
statements preceded by, followed by or including words such as “target,” “believe,”
“expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can
have,” “likely,” “should,” “would,” “could” and other words and terms of similar
meaning or the negative thereof. Forward-looking statements are subject to
inherent risks and uncertainties beyond the Company’s control that could cause
the Company’s actual results or performance to be materially different from the
expected results or performance expressed or implied by such forward-looking
statements. The Company does not endorse or is not otherwise responsible for the
content of external hyperlinks referred to in this press release.



Contacts - Investor relations / Media

NewCap
Aurélie Manavarere, Théo Martin / Arthur Rouillé
investors@poxelpharma.com
+33 1 44 71 94 94


Glossary

You will find below a list of words and/or expressions that are used in this press
release or in Poxel’s communication, with the aim of bringing clarification and
transparency:

• Sumitomo Pharma fiscal year runs April to March. As an example, Fiscal Year
2024 is April 1, 2024, through March 31, 2025.
• TWYMEEG® royalties: As per the Sumitomo Pharma’s agreement, Poxel is
entitled to receive royalties from the sales of TWYMEEG® (Imeglimin) in Japan
o Sumitomo Pharma communicates gross sales of TWYMEEG®, while
TWYMEEG® royalties are calculated on net sales.
o Net sales represent the amount of gross sales to which are deducted
potential rebates, allowances, and costs such as prepaid freight, postage,
shipping, customs duties and insurance charges.
o Poxel is entitled to receive escalating royalties of 8-18% on TWYMEEG®
net sales from Sumitomo Pharma.
• Positive net royalties: as part of the Merck Serono licensing agreement, Poxel



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will pay Merck Serono a fixed 8% royalty based on the net sales of TWYMEEG®,
independent of the level of sales. All royalties that Poxel receives from
TWYMEEG® net sales above that 8% level are considered as positive net
royalties. Net royalties will therefore be positive for Poxel when TWYMEEG® net
sales exceed JPY 5 billion in a fiscal year and royalties reach 10% and above.
• Poxel refers to the Group Poxel, including its affiliates (Poxel Inc. and Poxel KK)
as well as the 3 security trusts set up as part of the Royalty monetization and
debt restructuring operations announced on September 30, 2024.




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