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

Regulatory News:

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 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/1.73m².

• 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.

• 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 China⁷, the world’s second largest type 2 diabetes market, further supporting ongoing discussions initiated by the Company to develop Imeglimin beyond Japan.

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