-- Consolidated net sales of TWYMEEG$(R)$ in Japan for the first quarter of 2026 reached JPY 2.3 billion (EUR12.8 million 1), up 36% compared to the first quarter of 2025. -- Poxel generated revenue of EUR1.277 million for the first quarter of 2026. -- Consolidated net sales of TWYMEEG(R) in Japan for Sumitomo Pharma2 reached JPY 9.35 billion (EUR51 million), up 40% compared to the previous fiscal year. -- During Sumitomo Pharma's fiscal year 20253, Poxel received royalties of 10% on TWYMEEG(R) net sales -- Sumitomo Pharma expects moderate double-digit growth slightly above 10% in TWYMEEG(R) sales for its fiscal year 20264. -- Sumitomo Pharma notably expects TWYMEEG(R) net sales to exceed the JPY 10 billion threshold. -- Upon reaching this threshold, Poxel will receive a contractual milestone payment of JPY 1 billion (EUR5.5 million1), with the royalty rate increasing from 10% to 12%. LYON, France--(BUSINESS WIRE)--May 20, 2026--
Regulatory News:
Poxel (Euronext: POXEL - FR0012432516), a clinical-stage biopharmaceutical company developing innovative treatments for severe chronic diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic diseases, today announced its revenue for the first quarter ended March 31, 2026, and provided a business update.
Commercial and Clinical Activity Update
TWYMEEG(R) (Imeglimin)
-- For the quarter ended March 2026, TWYMEEG(R) net sales in Japan
increased by 36% to JPY 2.3 billion (EUR12.8 million) compared to sales
of JPY 1.7 billion for the quarter ended March 2025, as reported by
Sumitomo Pharma.
-- For fiscal year 20265, Sumitomo Pharma expects moderate double-digit
sales growth slightly above 10% for TWYMEEG(R). Sumitomo Pharma
anticipates that TWYMEEG(R) net sales could exceed JPY 10 billion,
entitling Poxel to receive royalties of 12% on all TWYMEEG(R) net sales
and a payment of JPY 1 billion (EUR5.5 million1). In accordance with the
royalty monetization agreement entered into with OrbiMed, the proceeds
will be exclusively allocated to the repayment of the bond financing.
-- In August 2024, initial results from the post-marketing clinical study
TWINKLE (TWYMEEG(R) in diabetic patients with renal impairment: A
post-marketing long-term study), conducted by Sumitomo Pharma in Japanese
patients with type 2 diabetes and renal impairment, confirmed the safety
and tolerability profile of TWYMEEG(R), consistent with previous clinical
studies. Based on these results, Sumitomo Pharma initiated discussions
with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan,
which resulted, on April 8, 2025, in the revision of the TWYMEEG(R)
prescribing information for patients with renal impairment with an eGFR
(estimated glomerular filtration rate) below 45 ml/min/1.73 m(2). This
approval enabled Sumitomo Pharma to promote the use of TWYMEEG(R) within
this patient population.
-- This regulatory milestone follows the recent grant of patent No.
7635474 by the Japan Patent Office to Poxel, covering the use of
imeglimin in type 2 diabetic patients with moderate to severe renal
impairment through 2039, thereby strengthening the TWYMEEG(R) patent
portfolio in Japan and protecting its use within this population. Poxel
had previously obtained an equivalent patent in China, the world's second
largest type 2 diabetes market, supporting the Company's ongoing
discussions to expand the commercialization of imeglimin beyond Japan.
Consolidated Revenue for the First Quarter of 2026
-- Poxel generated consolidated revenue of EUR1.277 million for the
quarter ended March 31, 2026.
-- Consolidated revenue for the first quarter of 2026 reflects JPY 234
million (EUR1.277 million1) in royalties from Sumitomo Pharma,
representing 10% of TWYMEEG(R) net sales in Japan.
-- Based on Sumitomo Pharma's guidance, Poxel expects to receive 12%
royalties on TWYMEEG(R) net sales in Japan during Sumitomo Pharma's
fiscal year 20265.
-- Under the license agreement entered into with Merck Serono, Poxel will
pay Merck Serono a fixed royalty of 8% based on net imeglimin sales,
regardless of the level of sales.
-- In accordance with the royalty monetization agreement entered into with
OrbiMed, positive net royalties will be fully allocated to the repayment
of the bonds.
Q1 2026 Q1 2025
EUR (in thousands) 3 months 3 months
--------------------------- --------- ---------
Sumitomo Pharma agreement 1 277 1 066
--------------------------- --------- ---------
Other - -
--------------------------- --------- ---------
Total consolidated revenue 1 277 1 066
--------------------------- --------- ---------
* Unaudited data
About Poxel
Poxel is an international biopharmaceutical company at the commercial and clinical development stage, specialized in the development of innovative treatments for severe chronic diseases with metabolic pathophysiology, including rare metabolic diseases and hypertrophic cardiomyopathy $(HCM)$.
TWYMEEG(R) (Imeglimin), its first-in-class product targeting mitochondrial dysfunction, is marketed in Japan for the treatment of type 2 diabetes by Sumitomo Pharma, Poxel's strategic partner for imeglimin in this territory. Poxel expects to receive royalties as well as sales-based payments from TWYMEEG(R) .
For the treatment of MASH, PXL065 a deuterium-stabilized R-pioglitazone, achieved its primary endpoint in the Phase 2 DESTINY-1 study.
PXL770 is focused on rare diseases, notably autosomal dominant polycystic kidney disease (ADPKD). On March 31, 2026, Poxel announced the divestment of PXL770 to Scynexis for a total potential consideration of up to $196 million. The Company received an upfront payment of $8 million, with additional near-term development milestone payments of up to $8 million and up to $180 million in commercial milestone payments. Scynexis will develop PXL770 in its potential ADPKD indications.
Poxel is listed on Euronext Paris, 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 concerning future events are subject to (i) change without notice and (ii) factors beyond the Company's control. These statements may include, but are not limited to, any statements preceded by, followed by, or including words such as 'objective,' 'believe,' 'expect, ' 'aim,' 'intend,' 'may,' 'anticipate,' 'estimate,' 'plan,' 'project,' 'will,' 'could,' 'likely,' 'should,' and other words and terms of similar meaning, or the negative form of these words and terms. 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 differ materially from the results or performance expected, expressed or implied in such forward-looking statements. Actual events or results may differ from those described in this document due to a number of risks or uncertainties described in the Company's 2024 Universal Registration Document available on the Company's website and that of the AMF . The Company does not endorse and is not responsible for the content of external hyperlinks mentioned in this press release.
Glossary
For the sake of clarity and transparency, below is a list of words and/or expressions used in this press release or in other communications issued by Poxel:
-- Sumitomo Pharma's fiscal year runs from April to March. For example,
fiscal year 2025 runs from April 1, 2025, to March 31, 2026.
-- TWYMEEG royalties: pursuant to the agreement with Sumitomo Pharma,
Poxel is eligible to receive royalties on TWYMEEG (Imeglimin) sales in
Japan
-- Sumitomo Pharma reports TWYMEEG gross sales, while royalties on
TWYMEEG(R) sales are calculated based on net sales;
-- Net sales represent gross sales, less potential rebates,
allowances and costs such as prepaid freight, shipping,
transportation charges, customs duties and insurance expenses;
-- Poxel is eligible to receive tiered royalties ranging from 8% to
18% on Sumitomo Pharma's TWYMEEG net sales.
-- Positive net royalties: pursuant to the license agreement with Merck
Serono, Poxel will pay Merck a fixed percentage of 8% on TWYMEEG net
sales, regardless of the level of sales. Royalties received by Poxel on
TWYMEEG net sales above this 8% threshold are referred to as positive net
royalties. Accordingly, net royalties will become positive for Poxel once
TWYMEEG net sales exceed JPY 5 billion during a fiscal year and the
applicable royalty rate reaches 10% or more.
-- Poxel refers to the Poxel Group as well as the three security trusts
established in connection with the royalty monetization transactions and
debt restructuring announced on September 30, 2024.
(1) Converted to JPY-EUR exchange rate = 183.44
(2) Sumitomo Parma's fiscal year 2025 ends March 31, 2026
(3) According to Sumitomo Pharma's fiscal year 2025 guidance
(4) According to Sumitomo Pharma's fiscal year 2026 guidance
(5) Sumitomo Parma's fiscal year 2026 ends March 31, 2027
View source version on businesswire.com: https://www.businesswire.com/news/home/20260519638053/en/
CONTACT: Investor relations / Media
NewCap
Théo Martin
investors@poxelpharma.com
(MORE TO FOLLOW) Dow Jones Newswires
May 20, 2026 02:00 ET (06:00 GMT)