Poxel Reports Cash and Revenue for the Third Quarter and Nine Months 2024 and Provides Corporate Update

   -- TWYMEEG$(R)$ sales continue to increase in Japan for the last quarter 
      (July-September) by 5% over the prior quarter and by 23% over the 3rd 
      quarter 2023 
 
   -- Poxel expects TWYMEEG(R) net sales in Japan in the near term to reach at 
      least JPY 5 billion (EUR 30.6 million)1 entitling the Company to receive 
      10% royalties on all TWYMEEG(R) net sales and a sales-based payment of 
      JPY 500 million (EUR 3.1 million) 1 
 
   -- Continued discussions with potential partners in parallel of reviewing 
      the clinical development strategy for PXL770 and PXL065 for the treatment 
      of multiple rare diseases 
 
   -- As of September 30, 2024, cash and cash equivalents were EUR 13.1 million 
      (USD 14.7 million)2 
 
   -- Following the non-dilutive financing agreement with OrbiMed, cash runway 
      extension until end of 2025, including the full residual drawdown of the 
      equity-linked financing facility put in place with IRIS 
LYON, France--(BUSINESS WIRE)--November 06, 2024-- 

Regulatory News:

POXEL SA (Euronext : POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, today provided a corporate update and announced its cash position and revenue for the third quarter and the nine months ended September 30, 2024.

"We are pleased to see the good sales trajectory for TWYMEEG(R) in Japan, which should lead to the achievement of JPY 5 billion net sales in the coming months, at which point, Poxel will be entitled to 10% royalties on all TWYMEEG(R) net sales and a sales-based payment of JPY 500 million (EUR 3.1 million)(1) . These amounts, based on our recent royalty monetization agreement, will serve to start repayment of bonds to OrbiMed. Additionally, Poxel will benefit from the residual amount of the reserve deposit made under the terms of the agreement with OrbiMed, in addition to the USD 42.5 million proceeds received upon closing. This deposit amount will be used to further reduce our debt obligations towards IPF Partners," stated Thomas Kuhn, Chief Executive Officer of Poxel.

TWYMEEG(R) (Imeglimin)

   -- For the quarter ended September 2024, TWYMEEG(R) gross sales in Japan 
      increased by 5% to JPY 1.8 billion (EUR 11.4 million) 2 over the prior 
      quarter sales of JPY 1.7 billion (EUR 10.1 million)3 as reported by 
      Sumitomo Pharma. 
   -- During Sumitomo Pharma FY 2024, Poxel expects TWYMEEG(R) net sales in 
      Japan to reach at least JPY 5 billion (EUR 30.6 million)1, entitling 
      Poxel to receive 10% royalties on all TWYMEEG(R) net sales and a 
      sales-based payment of JPY 500 million (EUR 3.1 million)1. Based on the 
      recent royalty monetization agreement with OrbiMed, these proceeds for 
      FY2024, net of Poxel's obligation to Merck Serono, will be directed to 
      the reimbursement of the bonds issuance. Beyond 2024, Poxel expects to 
      receive escalating double-digit royalties as well as additional 
      sales-based payments upon achievement of contractually based sales 
      thresholds. 
   -- Sumitomo Pharma has announced an early retirement program in Japan that 
      could impact their organization, including Sales & Marketing division. 
      However, to support TWYMEEG(R) sales trajectory, Sumitomo Pharma is 
      implementing measures to minimize potential impact from this program. 
   -- As announced on August 7, 2024, topline results obtained from the 
      post-marketing clinical study, TWINKLE (TWYMEEG(R) in diabetic patients 
      with renal impairment: A post-marketing long-term study) conducted by 
      Sumitomo Pharma in Japanese type 2 diabetic patients with renal 
      impairment confirmed TWYMEEG(R)'s safety and tolerability profile, which 
      is consistent with prior clinical studies in the general type 2 diabetes 
      population. Based on these results, Sumitomo Pharma has initiated 
      discussions with the regulatory authorities in Japan for revising 
      TWYMEEG(R) package insert for patients with renal impairment with eGFR 
      (estimated glomerular filtration rate) less than 45 ml/min/1.73m2. 
   -- In parallel of the non-dilutive financing agreement with OrbiMed 
      announced on September 30, 2024, Poxel recovered the Imeglimin rights for 
      Asian countries other than Japan4 from Sumitomo Pharma. The Company has 
      already initiated discussions to develop and market Imeglimin in China, 
      the world's second largest type 2 diabetes market. 

Third Quarter and Nine Months Ended September 30, 2024, Revenue and Cash

Revenue

Poxel reported revenues of EUR 854 thousand for the third quarter 2024, bringing the revenues for the nine months ended September 30, 2024, to EUR 2,016 thousand as compared to EUR 1,619 thousand during the corresponding period in 2023.

Revenue for the first nine months of 2024 mostly reflects the JPY 328 million (EUR 2,016 thousand)(2) of royalty revenue from Sumitomo Pharma which represents 8% of TWYMEEG(R) net sales in Japan. Based on the current forecast, Poxel expects to receive 10% royalties on TWYMEEG(R) net sales in Japan through the Sumitomo Pharma fiscal year 2024 and a sales-based payment of JPY 500 million (EUR 3.1 million)(1) . 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. According to the Royalty Monetization agreement with OrbiMed, the positive net Royalties will be fully dedicated to the repayment of the bonds.

 
                  Sept.    Q3 2024      H1       Sept.       Q3         H1 
EUR               2024 9      3        2024      2023 9     2023       2023 
 (in thousands)   months    months    6 months   months    3 months   6 months 
---------------  --------  --------  ---------  --------  ---------  --------- 
Sumitomo Pharma 
 Agreement        2,016      854       1,162     1,619       664        955 
---------------  --------  --------  ---------  --------  ---------  --------- 
Other               -         -          -         -          -          - 
---------------  --------  --------  ---------  --------  ---------  --------- 
Total revenues    2,016      854       1,162     1,619       664        955 
---------------  --------  --------  ---------  --------  ---------  --------- 
 

Unaudited data

Cash and cash equivalents

As of September 30, 2024, total cash and cash equivalents were EUR 13.1 million (USD 14.7 million)(2) , as compared to EUR 2.8 million as of June 30, 2024.

 
EUR (in thousands)                Q3 2024  Q2 2024  Q1 2024  Q4 2023 
--------------------------------  -------  -------  -------  ------- 
Cash                              13,149    2,812    2,460    2,341 
--------------------------------  -------  -------  -------  ------- 
Cash equivalents                     -        -        -        - 
--------------------------------  -------  -------  -------  ------- 
Total cash and cash equivalents   13,149    2,812    2,460    2,341 
--------------------------------  -------  -------  -------  ------- 
Unaudited data 
 

Following the non-dilutive financing agreement with OrbiMed, and according to Poxel's current forecasts, including in particular:

(i) The Company's cash position as of September 30, 2024, at EUR 13.1 million;

(ii) the partial redemption of the PGE loans for a total amount of EUR 2.8 million;

(iii) the advisory fees linked to the transaction;

(iv) the full residual drawdown of the equity-linked financing facility put in place with IRIS(5) ; and

(v) the anticipated business plan including strict control of its operating expenses;

the Company expects that its resources will be sufficient to finance its operations and capital expenditures until the end of 2025.

Next Financial Press Releases:

   -- First Half Results, on December 9, 2024 
   -- Fourth Quarter 2024 Cash and Revenue update, on February 12, 2025 

About Poxel SA

Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare disorders. For the treatment of MASH, 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 $(ALD.AU)$ and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG(R) (Imeglimin), Poxel's first-in-class product that targets mitochondrial dysfunction, is now 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. 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

(MORE TO FOLLOW) Dow Jones Newswires

November 06, 2024 12:20 ET (17:20 GMT)