Poxel will receive a sales-based payment and a higher level of royalty from Sumitomo Pharma in the first quarter of 2025 for TWYMEEG ® Achieving net sales of ¥5 billion in Japan

• Poxel qualified for royalties of 10% of TWYMEEG ® total net sales for 2024 and a one-time sales-based payment of ¥500 million (EUR 3.1 million2)
• Distribution of all received income for repayment of issued bonds with OrbiMed, after deduction of Poxel’s obligation to Merck (NS:) Serono
• Distribution of the remaining amount of USD 5.0 ​​million (EUR 4.8 million2) from the reserve deposit account established as part of the agreement with OrbiMed for the partial repayment of the debt to IPF Partners
• After Sumitomo Pharma’s fiscal year 2024, which ends in March 2025, Poxel expects double-digit royalty increases and additional payments based on agreed sales thresholds

LYON, France–(BUSINESS WIRE)–Regulatory news:

POXEL SA ( Euronext (EPA:) : POXEL – FR0012432516), a clinical biopharmaceutical company developing innovative treatments for serious chronic diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, today announced that net sales of TWYMEEG ® in Japan in reached 5 billion JPY (30.6 million euros2). Sumitomo Pharma fiscal year 2024, making Poxel eligible for positive net royalties on net product sales and a sales-based payment of ¥500 million. TWYMEEG ® is Poxel’s first-in-class product to be marketed for the treatment of type 2 diabetes in Japan.

We are particularly proud that our product has reached this contractual sales threshold in Japan, paving the way for Poxel to receive positive royalties net of royalty payments to Merck Serono and sales-based payments from our partner Sumitomo Pharma. Based on the contract signed between Poxel and OrbiMed in September 2024, these funds will be used to repay the bonds issued to OrbiMed. Given the strong commercial momentum and Sumitomo Pharma’s ongoing discussions with the Japanese authorities to revise the package insert for TWYMEEG ® for patients with type 2 diabetes with renal impairment, we are confident that we will receive increasing positive net royalties beyond 2024.it is stated Thomas Kuhn, CEO of Poxel.

Poxel has been informed by its partner Sumitomo Pharma that net sales of TWYMEEG ® in Japan have exceeded the contractual threshold of ¥5 billion (EUR 30.6 million2) as of December 31, 2024, which qualifies Poxel for a royalty of 10% of total TWYMEEG ® net sales generated in Japan during Sumitomo Pharma’s fiscal year 2024 and a sales-based payment of ¥500 million (EUR 3.1 million2).

Pursuant to the royalty monetization agreement signed with OrbiMed in September 2024, all of these revenues for fiscal year 2024, after deducting Poxel’s liability to Merck Serono, i.e. payments of 8% fixed royalty based on net sales, will be used to pay off bond issues. In addition, the remaining amount of USD 5.0 ​​million (EUR 4.8 million2) from the reserve deposit account opened at the time of the contract with OrbiMed, from which USD 1.25 million was withdrawn quarterly to repay the bonds issued until OrbiMed received payments based on sales and royalties based on TWYMEEG ® sales in Japan will be used to repay the debt contracted with IPF Partners.

As a result, Poxel expects that as of March 31, 2025, IPF Partners’ debt level will be approximately EUR 9.3 million, including the remaining amount of EUR 4.8 million from the reserve deposit account and capitalized interest. The Company’s money remains until the end of the first quarter of 2025, after the failure to adopt financial decisions at the last Combined General Assembly of the Company, held on November 28, 2024.

After 2024, Poxel expects to receive rising double-digit royalties, as well as additional sales-based payments upon achievement of contract-based sales thresholds.

About Poxel SA (EPA:)

Poxel is a clinical stage biopharmaceutical company developing innovative treatments for serious chronic diseases with metabolic pathophysiologyincluding steatohepatitis associated with metabolic dysfunction (MASH) and rare disorders. To treat MASH, PXL065 (stabilized with deuterium R-pioglitazone) met its primary endpoint in a simplified phase 2 trial (DESTINY-1). In rare diseases, development PXL770a first-in-class direct activator of adenosine monophosphate-activated protein kinase (AMPK), aimed at the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG ® (Imeglimin), Poxel’s first-in-class product targeting mitochondrial dysfunction, is now being marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma, and Poxel expects to receive royalties and 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, with subsidiaries in Boston, MA, and Tokyo, Japan.

For more information, 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 that are preceded, followed by or include words such as aim, believe, expect, target, intend, may, anticipate, estimate, plan, project, will, may have, likely, should, would, could and other words and terms with a similar or negative meaning. 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 expected results or performance expressed or implied by such forward-looking statements. The Company does not endorse or is otherwise responsible for the content of external hyperlinks provided in this press release.

Glossary

Below you will find a list of words and/or expressions used in this press release or in Poxel’s communications, for the purpose of clarification and transparency:

• Sumitomo Pharma Fiscal Year lasts from April to March. For example, fiscal year 2024 is April 1, 2024 through March 31, 2025.
• TWYMEEG royalties: Under the Sumitomo Pharma agreement, Poxel is entitled to receive royalties from sales of TWYMEEG (Imeglimin) in Japan
  • Sumitomo Pharma communicates gross sales of TWYMEEG, while TWYMEEG royalties are calculated on net sales.
  • Net sales represent the amount of gross sales less potential rebates, fees and expenses such as prepaid freight, postage, shipping, customs and insurance costs.
  • Poxel is entitled to receive escalating royalties of 8-18% on TWYMEEG net sold by Sumitomo Pharma.
• Positive net royalties: as part of the Merck Serono licensing agreement, Poxel pays Merck Serono fixed fees of 8% based on net sales of TWYMEEG, regardless of sales level. Any royalties that Poxel receives from TWYMEEG net sales above that 8% level are considered positive net royalties. Net royalties will therefore be positive for Poxel when TWYMEEG’s net sales exceed ¥5 billion in a fiscal year and royalties reach 10% and above.

1 Sumitomo Pharma’s fiscal year 2024 ends on March 31, 2025.
2 Converted at the exchange rate on December 31, 2024

See the original version on businesswire.com: https://www.businesswire.com/news/home/20250119375255/en/

Investor Relations / Media

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Nicolas Fossiez, Aurélie Manavarere / Arthur Rouillé
investors@poxelpharma.com
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Source: POXEL SA