133 0 Kommentare Poxel Announces TWYMEEG (Imeglimin) Fiscal Year 2022 Sales

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 TWYMEEG (Imeglimin) Fiscal Year (FY) and fourth quarter 2022 results, as recently published by Sumitomo Pharma (Sumitomo), its partner commercializing TWYMEEG in Japan.

Thomas Kuhn, Chief Executive Officer of Poxel, stated: “This first full year of TWYMEEG’s commercialization has demonstrated a strong increase in sales, even exceeding the recent forecast that had been increased by Sumitomo Pharma, our commercial partner in Japan. This trend confirms the strong value of our product and gives us confidence in the timing of future expected positive royalties and sales-based payments that will be directed to repay the Company’s debt and fuel the future development of the Company in rare diseases.“

For the quarter ended March 2023, TWYMEEG gross sales in Japan increased 23% to JPY 0.9 billion (EUR 6.2 million)³ over the prior quarter sales of JPY 0.8 billion (EUR 5.5 million)³ as reported by Sumitomo.
As a result, for Sumitomo’s FY 2022, TWYMEEG gross sales reached JPY 2.2 billion (EUR 15.0 million)³, exceeding Sumitomo’s most recent FY 2022 forecast⁴ by 22%.
The sales in recent quarters have accelerated due to the end of initial launch year restrictions for TWYMEEG in September 2022, which limited new products to two weeks prescriptions, and Sumitomo’s commercial efforts to leverage TWYMEEG’s potential. Due to its unique mechanism of action and safety profile, TWYMEEG can be used both as a monotherapy and in combination with other treatments, such as DPP4 inhibitors, the most prescribed treatment for Japanese Type-2-Diabetes patients, and SGLT2 inhibitors, which is growing strongly in Japan. These factors have resulted in a much higher increase in demand for TWYMEEG than expected by Sumitomo, and thus inventories are temporarily tight. Sumitomo is working diligently to increase capacity over the summer.
For its FY 2023, Sumitomo announced a forecast for TWYMEEG of JPY 4.2 billion² (EUR 28.9 million)³ which would represent a 90% increase over FY 2022 TWYMEEG gross sales.
For the Sumitomo FY 2023, as a conservative assumption in line with Sumitomo’s forecast, Poxel expects to receive 8% royalties on TWYMEEG net sales. 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.
During Sumitomo FY 2024 (ending March 31, 2025), Poxel expects TWYMEEG net sales in Japan to reach at least JPY 5 billion (EUR 34.4 million)³ entitling Poxel to receive 10% royalties on all TWYMEEG net sales and a sales-based payment of JPY 500 million (EUR 3.4 million)³. Beyond 2024, Poxel expects to receive escalating double-digit royalties as well as additional sales-based payments upon achievement of contractually based sales thresholds.
As part of the Sumitomo’s ongoing efforts to communicate TWYMEEG’s unique mechanism of action and safety profile, 9 abstracts based on Imeglimin Phase 2b and Phase 3 clinical trials were accepted for oral presentations at the 66th Annual Meeting of the Japanese Diabetes Society (JDS), held in Kagoshima, Japan, May 11-13, 2023.