Poxel will receive sales-based payments and a higher level of royalties from Sumitomo Pharma in the first quarter of 2025 for TWYMEEG ® which will generate net sales of JPY 5 billion in Japan - ORSOLTECH

Poxel is eligible for a royalty equivalent to 10% of TWYMEEG ® total sales for the year 20241 and a one-time sales-based payment of JPY 500 million (EUR 3.1 million2)
Allocate all proceeds received to repay the bond issue with OrbiMed, after deducting Poxel's obligation to Merck (NS:) Serono
Allocating 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 debts to IPF partners
After Sumitomo Pharma's 2024 fiscal year ends in March 2025, Poxel expects to receive double-digit incremental revenues and additional payments based on contractual sales limits.

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

boxel in ( Euronext (EPA:) POXEL – FR0012432516), a clinical-stage biopharmaceutical company developing innovative therapies for serious chronic diseases with metabolic pathophysiology, including metabolic syndrome-associated steatohepatitis (MASH) and rare metabolic disorders, today announced Net sales of TWYMEEG ® in Japan reached 5 billion JPY (30.6 million EUR2) in Sumitomo Pharma's fiscal year. 2024, making Poxel eligible for a positive net royalty on net product sales and a sales-based payment of JPY500 million. TWYMEEG ® is the first Poxel 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 net positive proceeds from royalty payments to Merck Serono and sales-based payment from our partner Sumitomo Pharma. Based on the agreement signed between Poxel and OrbiMed in September 2024, these funds will be used to repay bonds issued to OrbiMed. Given the strong commercial momentum and Sumitomo Pharma's ongoing discussions with Japanese authorities to review the TWYMEEG ® package for patients with type 2 diabetes with renal insufficiency, we are confident of receiving positive, upside net proceeds beyond 2024.male Thomas Kuhn, CEO of Poxel.

Poxel has been informed by its partner Sumitomo Pharma that net sales of TWYMEEG ® in Japan exceeded the contractual limit of JPY 5 billion (€30.6 million2) as of December 31, 2024, making Poxel eligible for a royalty equivalent to 10% of total net sales of TWYMEEG ®. Sales generated in Japan during Sumitomo Pharma's fiscal year 2024, payment based on sales of JPY 500 million (EUR 3.1 million2).

Pursuant to the royalty monetization agreement signed with OrbiMed in September 2024, all such revenues for fiscal year 2024, net of Poxel's obligation to Merck Serono, i.e. payment of a fixed royalty of 8% based on net sales, will be used to repay the bond issue. In addition, the remaining US$5.0 million (€4.8 million2) of the reserve deposit account opened at the time of the agreement with Orbimed, from which US$1.25 million has been withdrawn every three months to repay the bonds issued until Orbimed receives sales-based payments will be used Equity based on sales of TWYMEEG ® in Japan to repay debt contracted with IPF partners.

As a result, Poxel expects that as of March 31, 2025, the debt level of IPF partners will be approximately EUR 9.3 million, including the remaining EUR 4.8 million of the reserve deposit account and capitalized interest. The company's cash runway continues until the end of the first quarter of 2025, after financial decisions were not approved at the company's last general meeting held on November 28, 2024.

After 2024, Poxel expects to receive double-digit incremental royalties, as well as additional sales-based payments when contractual sales thresholds are achieved.

on Boxel sa (EPA:)

Boxel is Clinical stage biopharmaceutical company Developing Innovative treatments for chronic serious diseases with metabolic pathophysiologyincluded Metabolism-associated steatohepatitis (MASH) and rare disorders. To treat MASH, PXL065 (Deuterium stabilized RPioglitazone met the primary endpoint in the streamlined phase 2 trial (DESTINY-1). In rare diseases, development PXL770a first-in-class adenosine monophosphate direct activator of protein kinase (AMPK), focuses on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWIMIG® (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. Poxel is listed on Euronext Paris and is headquartered in Lyon, France, with subsidiaries in Boston, Massachusetts, 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, but are not limited to, any statements preceded or followed by or include words such as aim, believe, expect, aim, intend, may, expect, estimate, plan, project, will, could, likely, should. , would , could and other words and terms with similar or negative meanings. 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 anticipated expressed or implied by such forward-looking statements. The Company does not endorse or is not responsible for the content of external hyperlinks referenced in this press release.

Glossary

Below you will find a list of words and/or expressions used in this press release or in Poxel communications, intended to provide clarity and transparency:

Sumitomo Pharma fiscal year It runs from April to March. For example, fiscal year 2024 is April 1, 2024 through March 31, 2025.
TWYMEEG Royalties: Pursuant to the Sumitomo Pharma Company Agreement, Poxel is entitled to receive royalties from sales of TWYMEEG (Imeglimin) in Japan.
- Sumitomo Pharma continues total TWYMEEG sales, while TWYMEEG fees are charged on network sales.
- Net sales represent the amount of gross sales that deduct rebates, allowances, and potential costs such as prepaid shipping, postage, freight, customs duties, and insurance fees.
- Poxel is entitled to escalated royalties of 8-18% on TWYMEEG network Sales from Sumitomo Pharma.
Net positive royalties: As part of the Merck Serono License Agreement, Poxel pays Merck Serono a fixed royalty of 8% based on net TWYMEEG sales, regardless of the level of sales. All royalties received by Poxel from TWYMEEG's net sales in excess of the 8% level are considered positive net royalties. Therefore, net royalties will be positive for Poxel when TWYMEEG's net sales exceed JPY5 billion in a fiscal year and royalties reach 10% and above.