Poxel to receive sales-based payment and higher earnings levels from Sumitomo Pharma in Q1 2025 for TWYMEEG ® To Achieve JPY 5 billion Net Sales in Japan

• Poxel is entitled to royalties equal to 10% of all TWYMEEG ® sales for 20241 and a one-time sales-based payment of JPY 500 million (EUR 3.1 million2)
• Distribution of all proceeds received from the bond repayment with OrbiMed, following the reduction of Poxel’s obligations to Merck (NS:) Mercy
• Distribution of the remaining amount of USD 5.0 ​​million (EUR 4.8 million2) from the savings account established as part of the agreement with OrbiMed regarding the repayment of part of the debt to the IPF partners.
• Outside of Sumitomo Pharma’s 2024 fiscal year that ends in March 2025, Poxel expects to earn double-digit earnings growth and other payments based on contract sales contracts.

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

POXEL IN ( Euronex (EPA:) : POXEL – FR0012432516), a clinical biopharmaceutical company developing new treatments for serious chronic diseases with metabolic pathophysiology, including the dysfunction associated with steatohepatitis ( MASH) and rare metabolic disorders, today announced that full sales of TWYMEEG ® in Japan. reached JPY 5 billion (EUR 30.6 million2) in Sumitomo Pharma’s fiscal Year 2024, making Poxel eligible for good product sales revenues and a sales-based payment of JPY 500 million. TWYMEEG ® is Poxel’s first commercialized product for the treatment of type 2 diabetes in Japan.

We are very proud that our product has reached this contract sales threshold in Japan, which opens the way for Poxel to receive favorable royalty payments from Merck Serono and a 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 pay off the bonds issued to OrbiMed. Due to strong commercial activity and Sumitomo Pharma’s ongoing discussions with the Japanese authorities to develop the TWYMEEG ® package for Type 2 diabetic patients with renal impairment, we hope to receive increasing earnings beyond 2024.said Thomas Kuhn, Chief Executive Officer of Poxel.

Poxel has been informed by its partner Sumitomo Pharma that total sales of TWYMEEG ® in Japan have exceeded the contractual threshold of JPY 5 billion (EUR 30.6 million2) as of December 31, 2024, making Poxel eligible for rewards equal to 10% of TWYMEEG ® revenue. sales achieved in Japan during Sumitomo Pharma’s 2024 fiscal year, and a sales-based payment of JPY 500 million (EUR 3.1 million2).

According to the royalty agreement signed with OrbiMed in September 2024, all of these revenues for the financial year 2024, after the reduction of Poxel’s commitment to Merck Serono, i.e. a fixed 8% payment based on online sales, will be used to pay. bond issue. In addition, the balance of USD 5.0 ​​million (EUR 4.8 million2) from the savings account opened at the time of the agreement with OrbiMed, from which USD 1.25 million was withdrawn per quarter to pay the bonds issued until OrbiMed receives sales-based payments. and revenues based on sales of TWYMEEG ® in Japan, will be used to repay the debt incurred by IPF Partners.

As a result, Poxel expects that as of March 31, 2025, IPF Partners’ debt position will be approximately EUR 9.3 million, including a balance of EUR 4.8 million from the savings deposit account and capitalized interest. The Company’s runway remains in place until the end of Q1 2025, following the non-approval of financial decisions at the last General Meeting of the Company, which was held on November 28, 2024.

After 2024, Poxel expects to earn double-digit earnings growth, as well as additional sales-based payments upon reaching contract-based sales targets.

About Poxel S.A (WHAT:)

Poxel is a A clinical biopharmaceutical company development New treatment for serious chronic diseases with metabolic pathophysiologyincluding Metabolic syndrome associated with steatohepatitis (MASH) and rare diseases. For MASH treatment, PXL065 (deuterium-stabilized). R-pioglitazone) met its primary endpoint in an updated Phase 2 trial (DESTINY-1). Rare diseases, development of PXL770a first-of-its-kind direct adenosine monophosphate-activated protein kinase (AMPK) activator, focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG® (Imeglimin), Poxel’s first-in-class product targeting mitochondrial dysfunction, has now been commercialized 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 Japan’s Imeglimin. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has operations in Boston, MA, and Tokyo, Japan.

For more information, please visit: www.poxelpharma.com

All statements other than historical statements included in this news release regarding 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 precede, follow or include words such as aim, believe, expect, aim, aim, plan, may expect, estimate, plan, plan, o I have, maybe, , and other words and words that have the same or negative meaning. Forward-looking statements may involve risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to differ materially from the anticipated results or performance expressed or implied by the statements. such anticipated. The Company does not endorse or is otherwise responsible for the content of external hyperlinks mentioned in this press release.

Vocabulary

You will find below a list of terms and/or expressions used in this press release or in Poxel’s communication, for purposes of clarification and transparency:

• Sumitomo Pharma’s financial year it runs from April to March. For example, Fiscal Year 2024 is April 1, 2024, through March 31, 2025.
• TWYMEEG Funds: According to Sumitomo Pharma’s agreement, Poxel has the right to receive royalties from sales of TWYMEEG (Imeglimin) in Japan.
  • Sumitomo Pharma consults gross TWYMEEG sales, while TWYMEEG earnings are calculated by true sales.
  • Gross sales represent the gross sales amount minus possible discounts, allowances and charges such as prepaid freight, postage, shipping, taxes and insurance charges.
  • Poxel is entitled to 8-18% incremental royalties from TWYMEEG true sales from Sumitomo Pharma.
• Good net income: as part of Merck Serono’s license agreement, Poxel pays Merck Serono a fixed 8% fee based on TWYMEEG online sales, regardless of sales level. All revenues that Poxel receives from TWYMEEG sales above 8% are considered as royalties. Therefore, all earnings will be good for Poxel when TWYMEEG’s total sales exceed JPY 5 billion per fiscal year and earnings reach 10% or higher.

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

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Investor Relations / Media

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

Source: POXEL SA