LYON, France–(BUSINESS WIRE)–Regulatory News:
POXEL SA (Euronext: POXEL – FR0012432516) (Paris:POXEL), 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, 2022.
Thomas Kuhn, Chief Executive Officer of Poxel, stated: We are very pleased with the most recent figures of TWYMEEG sales in Japan. These strong sales results support the trend we have observed since the end of the first year of commercialization restrictions, and above all, we believe that TWYMEEG’s benefit to type 2 diabetes patients is recognized more and more among prescribing doctors. We expect this royalty stream from TWYMEEG sales to continue to grow and generate significant revenue for Poxel and we have reached a preliminary agreement with IPF to align the debt repayments with future net positive TWYMEEG royalty flows. We are actively working to finalize our debt restructuring in the coming weeks. We are concurrently working to secure additional financing to launch our POC studies for PXL770 and PXL065 in ALD to start the next chapter of Poxels strategic focus in rare metabolic diseases.
Commercial Update
TWYMEEG® (Imeglimin)
Clinical Updates
NASH
Rare metabolic diseases
Corporate Update & Significant Events after the Period
Full-Year Cash and Revenue ended December 31, 2022
Cash
As of December 31, 2022, total cash and cash equivalents were EUR 13,1 million (USD 14 million)3, as compared to EUR 32,3 million at December 31, 2021 and EUR 17.1 million at September 30, 2022.
EUR (in thousands) | Q4 2022 | Q4 2021 |
Cash | 13,058 | 28,753 |
Cash equivalents | – | 3,534 |
|
|
|
Total cash and cash equivalents* | 13,058 | 32,287 |
Unaudited data.
*Net financial debt (excluding IFRS 16 impacts and derivative debts) was 29.5 million euros at the end of Q4 2022 (including debt obligations with IPF and the banks parts of the French PGE loan, as well as the equity-linked financing with IRIS) and EUR 2.6 million at the end of Q4 2021.
The Company has obtained a standstill of its current debt obligations from IPF Partners until the earlier of the finalization of its debt restructuring or March 31, 2023. The Company anticipates finalizing its debt restructuring in the coming weeks. However, in the absence of debt restructuring and based on the Companys cash position at December 31, 2022, certain financial covenants related to the Companys debt with IPF Partners could be breached after March 31, 2023.
The Company is actively pursuing additional financing options which together with its debt restructuring would significantly extend its cash runway.
Full-Year 2022 Revenue
Poxel reported revenues of EUR 0.674 million for the year ended December 31, 2022, as compared to EUR 13.4 million during the corresponding period in 2021, which mainly reflected the EUR 13.2 million milestone payment for the approval of TWYMEEG in Japan on June 23, 2021.
Revenue for 2022 mainly consists of JPY 93 million (EUR 0.673 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 2022 (April 2022 to March 2023). 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) | 2022 Q1 3 months | 2022 Q2 3 months | 2022 Q3 3 months | 2022 Q4 3 months |
FY 12 months |
FY 12 months |
Sumitomo Pharma Agreement | 32 | 51 | 203 | 388 | 673 | 13,377 |
Other | – | – | – | 1 | 1 | 20 |
Total revenues | 32 | 51 | 203 | 389 | 674 | 13,397 |
Unaudited data
Planned Presentations and Participation at the Following Upcoming Events
Next Financial Press Release: 2022 Annual Results, on March 22, 2023
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), Poxels 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 Companys 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 Companys control that could cause the Companys 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.
1 Sumitomo Pharma fiscal year 2022 ends March 31, 2023.
2 As per Sumitomo Pharma forecast published on January 31, 2023.
3 Currency exchange rate at December 31, 2022.
4 Sumitomo Pharma reports gross sales
Contacts
Contacts – Investor relations / Media
Aurélie Bozza
Investor Relations & Communication Senior Director
aurelie.bozza@poxelpharma.com
+33 6 99 81 08 36
Elizabeth Woo
Senior Vice President, Investor Relations & Communication
elizabeth.woo@poxelpharma.com
NewCap
Emmanuel Huynh or Arthur Rouillé
poxel@newcap.eu
+33 1 44 71 94 94
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