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Subjects: EARNINGS, Conference Call, Webcast, Business Update

Poxel Reports Financial Results for Full Year 2022 and Provides Corporate Update

Regulatory News:

POXEL SA (Euronext: POXEL - FR0012432516) (Paris:POXEL), a clinical stage biopharmaceutical company developing innovative treatments for serious chronic diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announced its results for the year ended December 31, 2022 and provided a corporate update.

"This past September marked the anniversary of the first year of commercialization of TWYMEEG, our first approved drug, for type-2-diabetes patients in Japan. We have observed a strong growth trajectory in sales in the past few months, that led our partner to increase its full year 2022 forecast by 20%, and also gives us better visibility on our future royalties and royalty rate, which we expect will increase to 10% during Sumitomo Pharma's fiscal year 2024. The year has also been important for Poxel''s development, as we completed our Phase II study in NASH for PXL065, with positive results that opens the way to further development with potential partners. There have been several positive developments in NASH over the past few months, and it is very encouraging for the field, as there still is no approved medicine for patients," stated Thomas Kuhn, Chief Executive Officer of Poxel. "Given the momentum of TWYMEEG sales and the potential of our development pipeline, we are pleased that the successful restructuring of our debt, concurrently with a new equity-linked financing, will significantly extend our cash runway through Q2 2025. We are actively working to finalize other additional financing, including ongoing partnership discussions, to be able to advance our rare diseases strategy, starting with our ALD studies."

Commercial Update

TWYMEEG® (Imeglimin)

Clinical Development Updates

Rare metabolic diseases

Adrenoleukodystrophy (ALD)

Autosomal-dominant polycystic kidney disease (ADPKD)


Corporate Update

Significant Events after the Period


Financial Statements for Full Year 2022 (IFRS Standards)

Income statement

EUR (in thousands)





12 months


12 months*




Cost of sales



Gross margin



Net research and development expenses**



General and administrative expenses



Operating income (loss)



Financial income (expenses)



Income tax



Net income (loss)



* Change in accounting policies related to the application of IFRIC decision dated April 20, 2021
**Net of R&D tax credit.
The audit procedures are ongoing.

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 95 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.

Cost of sales amounted to EUR 0.672 million, corresponding to the 8% royalties on net sales of Imeglimin in Japan due to Merck Serono, as part of the Merck Serono license agreement.

R&D expenses totaled EUR 12.4 million in 2022, as compared to EUR 25.2 million in 2021. R&D expenses in 2022 primarily reflect the clinical study costs incurred for the Phase 2 DESTINY-1 study evaluating PXL065 in NASH.

R&D costs are net of the R&D Tax Credit (CIR) and other subsidies that resulted in income of EUR 1.5 million in 2022, as compared to EUR 2.3 million in 2021.

General and administrative expenses totaled EUR 9.4 million in 2022, as compared to EUR 10.6 million in 2021.

The financial loss amounted to EUR 9.5 million in 2022, as compared to a loss of EUR 1.3 million in 2021. It primarily reflects the interests and fees attached to the Company indebtedness.

The net result for the financial period ending December 31, 2022 was a net loss of EUR 31.4 million, as compared to a net loss of EUR 23.8 million in 2021.


As of December 31, 2022, total cash and cash equivalents were EUR 13,1 million (USD 14 million)5 as compared to EUR 32.3 million at December 31, 2021. Net financial debt (excluding IFRS16 impacts and derivative instruments) amounted to EUR 29.5 million at December 31, 2022, compared to EUR 2.6 million at December 31, 2021.

EUR (in thousands)






Cash equivalents






Total cash and cash equivalents*



The audit procedures are ongoing.
*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.

Based on the debt restructuring announced today and:

  1. its cash position of EUR 13.1 million at December 31, 2022,
  2. the full drawdown available under the new equity-linked financing with IRIS7,
  3. its current research and development plan, excluding the initiation of Phase 2a POC biomarker studies for PXL770 and PXL065 in ALD, and
  4. a strict control of its operating expenses,

the Company expects that its resources will be sufficient to fund its operations and capital expenditure requirements through Q2 2025.

The Company is actively pursuing additional financing options, including ongoing active partnership discussions related to its programs, that will fund the launch of Phase 2a clinical POC biomarker studies for PXL065 and PXL770 in ALD.

Planned Presentations and Participation at the Following Upcoming Events:

Next Financial Press Release: First Quarter 2023 and Financial Update, on May 17, 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), 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.

1 First 8% of royalties on net sales of Imeglimin are paid to Merck Serono. Net royalties above 8% retained by Poxel.
2 Sumitomo Pharma fiscal year 2024 ends March 31, 2025.
3 Sumitomo Pharma fiscal year 2022 ends March 31, 2023.
4 As per Sumitomo Pharma forecast published on January 31, 2023.
5 Currency exchange rate at December 31, 2022.
6 Sumitomo Pharma reports gross sales.
7 The full drawdown of the new IRIS equity linked financing can be made at the Company's sole discretion, subject only to the condition described in today's separate press release under the paragraph "operation arrangements". Based on the initial drawdown of EUR 3.5 million only, the Company expects that its resources will be sufficient to fund its operations and capital expenditure requirements until November 2023.

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