LYON, France--(BUSINESS WIRE)--
Regulatory News:
(Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today reported its revenue for the quarter ended March 31, 2024 and provided a business update.
Thomas Kuhn, Chief Executive Officer of Poxel, stated: “TWYMEEG® continues to demonstrate its effectiveness through its steadily progressively increasing sales in Japan. The Full-Year 2024 sales forecast of JPY 11.3 billion (EUR 69.1 million) expected by our strategic partner Sumitomo Pharma, could lead to two sales-based payments and double-digit royalties for Poxel, further strengthening the Company’s ongoing funding initiatives. Supported by this strong sales trend, we continue to progress on the exclusive discussions based on the monetization of royalties from TWYMEEG® sales. We expect that this financing will contribute to start as soon as possible the next chapter of Poxel in rare metabolic diseases.”
TWYMEEG® (Imeglimin)
Commercial Update
- For the quarter ended March 2024, TWYMEEG® gross sales in Japan increased by more than 26% to JPY 1.1 billion (EUR 6.6 million)2 over the prior quarter sales of JPY 0.85 billion (EUR 5.2 million)2 as reported by Sumitomo Pharma. As a result, for Sumitomo Pharma’s FY 20231, TWYMEEG® gross sales reached JPY 4.6 billion (EUR 27.9 million)2, exceeding Sumitomo Pharma’s most recent FY 2023 forecast3 by more than 8%.
- For its FY 2024, Sumitomo Pharma forecasts4 gross sales for TWYMEEG® of JPY 11.3 billion3 (EUR 69.1 million)2 which would represent a 150% increase over FY 2023 TWYMEEG® gross sales.
- During Sumitomo Pharma FY 2024 (ending March 31, 2025), Poxel expects TWYMEEG® net sales in Japan to reach at least JPY 5 billion (EUR 30.6 million)2 entitling Poxel to receive 10% royalties on all TWYMEEG® net sales and a sales-based payment of JPY 500 million (EUR 3.1 million)2. Based on this FY 2024 forecast, TWYMEEG® net sales could also reach JPY 10 billion (EUR 61.2 million)4 entitling Poxel to receive 12% royalties on all TWYMEEG® net sales and a second sales-based payment of JPY 1 billion (EUR 6.1 million)2. Beyond 2024, Poxel expects to receive escalating double-digit royalties as well as additional sales-based payments upon achievement of contractually based sales thresholds.
First Quarter 2024 Revenue
Poxel reported EUR 449 thousand5 revenue for the quarter ended March 31, 2024, similar to the revenue reported during the corresponding period in 2023.
Revenue for the first quarter of 2024 reflects JPY 75.9 million (EUR 465 thousand2) of royalty revenue from Sumitomo Pharma, which represents 8% of TWYMEEG® net sales in Japan. Based on the current forecast, Poxel expects to receive at least 10% royalties on TWYMEEG® net sales in Japan through the Sumitomo Pharma fiscal year 20244. 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.
EUR (in thousands) |
Q1 2024 |
Q1 2023 |
3 months |
3 months |
|
Sumitomo Pharma Agreement |
449 |
449 |
Other |
- |
- |
Total revenues |
449 |
449 |
Unaudited data
About Poxel SA
Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare disorders. For the treatment of NASH, 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 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, China, and eleven other Asian countries. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan.
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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 to bring clarification and transparency:
- Sumitomo Pharma fiscal year runs April to March. As an example, Fiscal Year 2023 is April 1, 2023, through March 31, 2024.
-
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.
1 Sumitomo Pharma fiscal year 2023 ends March 31, 2024
2 Converted at the exchange rate on March 31, 2024
3 As per Sumitomo Pharma FY2023 forecast of JPY 4.2 billion published on May 15, 2023
4 As per Sumitomo Pharma FY2024 forecast published on May 14, 2024
5 Including 2024 Q1 Royalties and foreign exchange impact on the 2023 Q4 revenue
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