121 0 Kommentare Poxel Provides Corporate Update and Reports Cash and Revenue for the Third Quarter and Nine Months 2023 - Seite 3

Total revenues

1,619

664

955

286

203

Unaudited data

Commercial Update

TWYMEEG (Imeglimin)

For the quarter ended September 2023, TWYMEEG gross sales in Japan increased by 28% to JPY 1.48 billion (EUR 9.4 million) ² over the prior quarter sales of JPY 1.16 billion (EUR 7.4 million)⁵ as reported by Sumitomo Pharma.
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 Pharma’s commercial efforts to leverage TWYMEEG’s potential. Thanks 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 are growing strongly in Japan, and contribute to the increase in sales. These factors have resulted in a much higher increase in demand for TWYMEEG than expected by Sumitomo Pharma, and thus inventories are temporarily tight. Sumitomo Pharma has worked diligently to increase the production and secure inventory capacity to meet this increasing demand.
For its FY 2023, Sumitomo Pharma announced a forecast for TWYMEEG of JPY 4.2 billion¹ (EUR 28.9 million)⁶ which would represent a 90% increase over FY 2022 TWYMEEG gross sales.
For the Sumitomo Pharma FY 2023, as a conservative assumption in line with Sumitomo Pharma’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 Pharma FY 2024 (ending March 31, 2025), Poxel expects TWYMEEG net sales in Japan to reach at least JPY 5 billion (EUR 34.4 million)⁶ entitling Poxel to receive 10% royalties on all TWYMEEG net sales (on which the first 8% will still be paid to Merck Serono) and a sales-based payment of JPY 500 million (EUR 3.4 million)⁶. Beyond Sumitomo Pharma FY 2024, Poxel expects to receive escalating double-digit royalties as well as additional sales-based payments upon achievement of contractually based sales thresholds.
As per the debt restructuring agreements established with its lenders in March, positive net royalties and sales-based payments will be directed to Poxel debt reimbursement until the loans are fully repaid (which Poxel expects in Q2 2029, at the latest). After this time, subsequent net royalties and sales-based payments will revert back to Poxel.
A Phase 4, 52-week, Open-label, Long-Term Study of Imeglimin in Japanese Type 2 Diabetic Patients with Renal Impairment is currently ongoing in Japan to strengthen TWYMEEG profile in this key subpopulation, and top line results are expected in 2024.
For territories not covered by its agreement with Sumitomo Pharma, Poxel is having active discussions with various potential partners for Imeglimin, in several countries. Those discussions also involve India, where local companies have received approval and have launched Imeglimin, in monotherapy only. At the date of this press release, no agreement has been established, and Poxel continues to be committed to asserting its rights in connection with its assets.