Yahoo Finance

- 8% of TWYMEEG^® net sales in Japan for 2024 Q1 to Q3,
- 10% of TWYMEEG^® net sales in Japan for 2024 Q4 and a 2% catch up of the net sales related to 2024 Q2 and Q3 following the achievement of the JPY 5 billion net sales threshold for the 2024 Sumitomo Pharma fiscal year started on April 1^st, 2024.

Consolidated revenue for 2024 Q4 also includes the sales based payment of JPY 500 million (EUR 3.1 million)¹. 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.

Consolidated cash and cash equivalents

As of December 31, 2024, total consolidated cash and cash equivalents were EUR 3.7 million (USD 3.8 million)¹, as compared to EUR 13.1 million as of September 30, 2024.

Cash runway following the non-adoption of key financial delegations and financial risk

The non-adoption of the financial delegations at the Combined General Meeting held on February 11, 2025, and, in particular, on the issuance of new shares in redemption for ORANE, triggers an event of default under the IRIS and IPF Partners bonds agreements allowing each of them to request mandatory redemption of the bonds they hold (EUR 4.3 million and EUR 17.1 million respectively).

In this context, despite the recent restructuring of the Company's debt made possible in particular by the royalty monetization transaction with OrbiMed and based on the cash position as of December 31, 2024, amounting to EUR 3.7 million, the Company’s financial outlook is severely impacted, and the situation generates significant uncertainty regarding the Company’s ability to continue as a going concern. The Board of Directors and the Management are actively engaged in working on potential solutions with Poxel’s creditors.

Business update and outlook

TWYMEEG^® (Imeglimin)

• For the quarter ending December 2024, TWYMEEG^® gross sales in Japan increased by 17% to JPY 2.1 billion (EUR 13 million¹) over the prior quarter sales of JPY 1.8 billion (EUR 11.2 million¹) as reported by Sumitomo Pharma.

• As announced on January 20, 2025, TWYMEEG^® achieved JPY 5 billion (EUR 30.6 million) ¹ net sales in Japan in Sumitomo Pharma’s fiscal year 2024, making Poxel eligible for royalties equalling 10% of all TWYMEEG^® net sales for 2024 and a sales-based payment of JPY 500 million (EUR 3.1 million)¹. Based on the recent royalty monetization agreement with OrbiMed, these proceeds for FY 2024, net of Poxel's obligation to Merck Serono, will be directed to the reimbursement of the bonds issuance. From 2025, Poxel expects to receive escalating double-digit royalties as well as additional sales-based payments upon achievement of contractually based sales thresholds.

• As announced on August 7, 2024, topline results obtained 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 in the general type 2 diabetes population. Based on these results, Sumitomo Pharma has initiated discussions with the regulatory authorities in Japan for revising TWYMEEG^® package insert for patients with renal impairment with eGFR (estimated glomerular filtration rate) less than 45 mL/min/1.73m² and expects outcome in the first half of 2025.

Next Financial Press Release:

• 2024 Full-Year Results, on April 22, 2025

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 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.

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

  • Sumitomo Pharma communicates gross sales of TWYMEEG, while TWYMEEG royalties are calculated on net sales.

  • 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.

  • 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 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^th, 2024.

_________________
¹Converted at the exchange rate as of December 31, 2024

View source version on businesswire.com: https://www.businesswire.com/news/home/20250219865130/en/

Contacts

Contacts - Investor relations / Media

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