LYON, France–(BUSINESS WIRE)–Regulatory News:
POXEL SA (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 announced its cash position and revenue and provided a corporate update for the twelve months ended December 31, 2023.
Thomas Kuhn, Chief Executive Officer of Poxel, stated: “We remain focused and continue to concentrate all our efforts at securing financing options, prioritizing non-dilutive solution, and partnerships. In particular, our relentless work as well as TWYMEEG®’s robust performance in Japan had led to the ongoing exclusive advanced discussions with a leading investor for monetizing royalties on TWYMEEG® sales in Japan. We’ve also progressed our advanced discussions – in some cases on an exclusive basis – with several potential partners for each of our three proprietary products. Our goal is still to finalize one or more of these financing options and/or partnerships by the end of the first quarter of 2024 to start as soon as possible the next chapter of Poxel in rare metabolic diseases.”
Commercial Update
TWYMEEG® (Imeglimin)
Clinical, Manufacturing and Patent Update
TWYMEEG® (Imeglimin)
Rare metabolic diseases
Full-Year Cash and Revenue, ended December 31, 2023
Cash
As of December 31, 2023, total cash and cash equivalents were EUR 2.3 million (USD 2.6 million)1, as compared to EUR 13.1 million (USD 14.0 million) as of December 31, 2022.
EUR (in thousands) | Q4 2023 | Q4 2022 |
Cash | 2,341 | 13,058 |
Cash equivalents | – | – |
|
|
|
Total cash and cash equivalents* | 2,341 | 13,058 |
Unaudited data.
*Net financial debt (excluding IFRS 16 impacts and derivative debts) was 45.1 million euros at the end of Q4 2023 as compared to EUR 29.5 million at the end of Q4 2022.
With the priority objective of relaunching its R&D activities and executing its strategic plan in rare diseases, the Company has focused in recent months on securing additional financing, in particular non-dilutive solutions. In this context, the Company entered into exclusive negotiations with a leading investor to monetize royalties from TWYMEEG® (Imeglimin) sales in Japan. In addition, the Company is in advanced discussions – in some cases on an exclusive basis – with several potential partners for each of its three products: Imeglimin, for several countries not covered by its agreement with Sumitomo Pharma, PXL065 and PXL770.
Poxel’s goal is to finalize one or more of these financing options and/or partnerships by the end of the first quarter of 2024.
Pending finalization of one or more of these agreements, and in a cautious approach given its limited financial visibility, the Company has completed a cost-saving plan in December, which includes a significant reduction in headcount, in order to adapt the Company’s cost structure to its current operating needs. Key functions that enable the Company to finalize current transaction opportunities and continue its day-to-day operations have been retained, managing clinical, financial and business development activities.
Based on:
Poxel expects that its resources, including funds available to it, will be sufficient to finance its operations and capital expenditure requirements until March 2024, by which time the Company expects to have completed one or more of its ongoing operations.
Full-Year 2023 Revenue
Poxel reported revenues of EUR 2.0 million for the year ended December 31, 2023, as compared to EUR 0.674 thousand during the corresponding period in 2022.
Revenues for 2023 mostly reflects the JPY 313 million (EUR 2.0 million) of royalty revenue from Sumitomo Pharma, which represents 8% of TWYMEEG® net sales in Japan. Based on its current forecast, Poxel expects to receive 8% royalties on TWYMEEG® net sales in Japan through the Sumitomo Pharma fiscal year 2023 (April 2023 to March 2024). 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) | 2023 Q1 3 months | 2023 Q2 3 months | 2023 Q3 3 months | 2023 Q4 3 months |
FY 12 months |
FY 12 months |
Sumitomo Pharma Agreement | 449 | 506 | 664 | 362 | 1,981 | 673 |
Other | – | – | – | – | – | 1 |
Total revenues | 449 | 506 | 664 | 362 | 1,981 | 674 |
Unaudited data
Next Financial Press Release: 2023 Annual Results, on April 09, 2024
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.
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 to bring clarification and transparency:
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 Converted at the exchange rate as of December 31, 2023.
2 Sumitomo Pharma fiscal year 2023 ends March 31, 2024.
3 As per Sumitomo Pharma FY2023 forecast of JPY 4.2 billion published on May 15, 2023.
4 Since March 31, 2023, 6 additional tranches have been drawn for a total amount of EUR 3.3 million.
Contacts
Contacts – Investor relations / Media
NewCap
Nicolas Fossiez, Aurélie Manavarere / Arthur Rouillé
investor@poxelpharma.com
+33 1 44 71 94 94
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