Poxel Achieves Milestone with TWYMEEG® Sales in Japan, Secures Royalties and Sales-Based Payments
Poxel, a clinical-stage biopharmaceutical company focused on innovative treatments for chronic serious diseases with metabolic pathophysiology—including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders—has announced a significant achievement. The company’s first-in-class product, TWYMEEG®, marketed for type 2 diabetes treatment in Japan, reached net sales of JPY 5 billion (EUR 30.6 million) during Sumitomo Pharma’s fiscal year 2024. This milestone makes Poxel eligible for positive net royalties on TWYMEEG® sales and a sales-based payment of JPY 500 million.
A Major Achievement for Poxel
“We are particularly proud that our product has reached this contractual sales threshold in Japan, paving the way for Poxel to receive positive royalties net of payments to Merck Serono and a sales-based payment from our partner Sumitomo Pharma,” stated Thomas Kuhn, Chief Executive Officer of Poxel. “Based on the agreement signed between Poxel and OrbiMed in September 2024, these funds will be used to repay the bonds issued to OrbiMed. Given the strong commercial momentum and Sumitomo Pharma’s ongoing discussions with Japanese authorities to revise TWYMEEG®’s package insert for type 2 diabetic patients with renal impairment, we are confident of receiving escalating positive net royalties beyond 2024.”
Financial Implications of the Milestone
Poxel’s partner, Sumitomo Pharma, confirmed that TWYMEEG® sales in Japan exceeded the JPY 5 billion threshold (EUR 30.6 million) as of December 31, 2024. This achievement entitles Poxel to a 10% royalty on all net sales of TWYMEEG® during Sumitomo Pharma’s 2024 fiscal year, as well as a one-time sales-based payment of JPY 500 million (EUR 3.1 million).
Under the terms of the royalty monetization agreement signed with OrbiMed in September 2024, these revenues for fiscal year 2024, after deducting an 8% fixed royalty payment obligation to Merck Serono, will be allocated toward repaying the bond issued to OrbiMed. Furthermore, the reserve deposit account established at the time of the OrbiMed agreement, which initially held USD 5.0 million (EUR 4.8 million), will be used to reduce the debt owed to IPF Partners. Previously, USD 1.25 million was withdrawn quarterly from this reserve account to repay the bonds until TWYMEEG® sales-based payments and royalties commenced.
Debt Reduction and Cash Position
By March 31, 2025, Poxel expects the debt level with IPF Partners to be approximately EUR 9.3 million. This figure includes the remaining EUR 4.8 million from the reserve deposit account and capitalized interest. Despite these repayments, the company’s cash runway remains limited, extending only to the end of Q1 2025, as a result of the non-adoption of financial resolutions at the company’s Combined General Meeting on November 28, 2024.
Future Expectations for TWYMEEG®
Looking beyond 2024, Poxel anticipates receiving escalating double-digit royalties from TWYMEEG® sales, in addition to further sales-based payments upon achieving higher contractual sales thresholds. This optimistic outlook is bolstered by TWYMEEG®’s growing commercial success and Sumitomo Pharma’s efforts to expand its indications, including revisions to the product’s package insert to better address the needs of type 2 diabetes patients with renal impairment.
Poxel’s Commitment to Innovation
TWYMEEG® represents a critical step forward in the treatment of type 2 diabetes, particularly in the Japanese market where diabetes prevalence is high. The product’s success not only validates Poxel’s innovative approach to drug development but also reinforces its position as a leader in addressing metabolic disorders.
Thomas Kuhn expressed confidence in the company’s trajectory, stating, “With TWYMEEG® reaching this important milestone and the prospect of higher royalties and sales-based payments, Poxel is well-positioned to advance its mission of delivering transformative treatments for patients with chronic and rare metabolic diseases.”
Strengthening Partnerships
The collaboration between Poxel and Sumitomo Pharma has been instrumental in achieving these results. Sumitomo Pharma’s dedication to TWYMEEG®’s success, including its engagement with regulatory authorities to enhance the product’s labeling, underscores the strength of this partnership. Meanwhile, Poxel’s agreements with OrbiMed and IPF Partners highlight the company’s strategic financial planning to manage debt and secure a sustainable future.
Read more: Poxel to Gain Increased Royalties from Sumitomo Pharma for TWYMEEG Sales in Japan
