Poxel’s Partner Sumitomo Pharma Reports TWYMEEG® Sales for Q4 and FY 2024 in Japan

TWYMEEG® Sales Performance and Forecast Update

Poxel’s Partner Sumitomo Pharma Reports TWYMEEG® Sales for Q4 and FY 2024 in Japan

A clinical-stage biopharmaceutical company dedicated to developing innovative treatments for chronic and serious diseases characterized by metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, has released its latest update on TWYMEEG® sales performance in Japan. The company, in collaboration with its strategic partner Sumitomo Pharma, has reported TWYMEEG®’s gross sales for the fourth quarter of 2024, along with an updated sales forecast as part of Sumitomo Pharma’s Q3 FY2024 financial results.

Importance of TWYMEEG® in Diabetes Management

Koichi Kozuki, Executive Officer and Senior Vice President, Head of Corporate Regulatory Compliance & Quality Assurance Division at Sumitomo Pharma, commented on the progress of TWYMEEG®, emphasizing its importance within the company’s diabetes franchise. “We believe TWYMEEG® is a critical asset in our existing diabetes portfolio, and we remain dedicated to supporting its continued sales growth. Based on the safety and tolerability profile observed in the TWINKLE study, we are currently in discussions with Japanese regulatory authorities regarding potential revisions to the TWYMEEG® package insert for patients with renal impairment,” Kozuki stated.

Q4 2024 Sales Growth and Performance

For the quarter ending December 2024, TWYMEEG® achieved a significant 17% increase in gross sales in Japan, reaching JPY 2.1 billion (EUR 13 million), compared to JPY 1.8 billion (EUR 11.2 million) in the previous quarter. The growth highlights strong market adoption and increasing demand for the drug. As announced on January 20, 2025, TWYMEEG® recorded JPY 5 billion in net sales for the fiscal year 2024. This milestone qualifies Poxel for a royalty payment amounting to 10% of all TWYMEEG® net sales in 2024, in addition to a one-time sales-based payment of JPY 500 million (EUR 3.1 million). Under the royalty monetization agreement with OrbiMed, these proceeds, after fulfilling Poxel’s obligations to Merck Serono, will be allocated toward the reimbursement of the company’s bond issue.

Revised FY2024 Sales Forecast

Looking ahead to the remainder of FY2024, Sumitomo Pharma has revised its TWYMEEG® net sales forecast for Japan, now projecting JPY 7.9 billion (EUR 48.4 million) in revenue. This is a downward adjustment from the previously estimated JPY 11.3 billion (EUR 69.2 million) that was published on May 14, 2024. However, even with this revision, the updated projection still represents an impressive 72% increase over the FY2023 net sales of JPY 4.6 billion. The adjustment in sales expectations is attributed to Sumitomo Pharma’s internal restructuring efforts, alongside evolving market dynamics and competition within Japan’s pharmaceutical landscape.

Measures to Support TWYMEEG® Growth

In response to these market shifts and internal restructuring, Sumitomo Pharma has introduced several strategic initiatives aimed at minimizing potential disruptions to TWYMEEG®’s growth trajectory. The company is taking proactive steps to support the drug’s sales momentum and continues to explore opportunities to enhance the product’s market positioning. One key focus area is the ongoing effort to expand the TWYMEEG® package insert, which could potentially broaden its patient eligibility criteria and boost sales in the coming months.

Clinical Validation and TWINKLE Study Findings

In addition to its commercial success, TWYMEEG® has also demonstrated strong clinical efficacy and safety in post-marketing evaluations. On August 7, 2024, Sumitomo Pharma announced the topline results of the TWINKLE study, a post-marketing long-term clinical assessment conducted in Japanese patients with type 2 diabetes and renal impairment. The study reaffirmed TWYMEEG®’s safety and tolerability profile, aligning with findings from previous clinical trials conducted in the broader type 2 diabetes population.

Regulatory Discussions for Expanded Indication

Given these positive clinical outcomes, Sumitomo Pharma is actively engaged in regulatory discussions to update TWYMEEG®’s package insert to include patients with an estimated glomerular filtration rate (eGFR) of less than 45 mL/min/1.73m². If approved, this revision could enable broader utilization of TWYMEEG® among patients with renal impairment, a segment of the diabetes population that faces limited treatment options. The regulatory decision on this matter is expected in the first half of 2025.

Financial Impact on Poxel

The sustained growth of TWYMEEG® reflects its therapeutic value and increasing acceptance among healthcare providers and patients in Japan. Despite the challenges posed by internal restructuring at Sumitomo Pharma and the competitive landscape, the company remains committed to strengthening TWYMEEG®’s market presence. By leveraging its clinical safety profile and expanding its label indications, Sumitomo Pharma aims to ensure that TWYMEEG® continues to be a preferred treatment option for type 2 diabetes patients, including those with renal impairment.

From a financial standpoint, Poxel stands to benefit from the continued success of TWYMEEG®, given its entitlement to royalty payments. The 10% royalty on net sales and the one-time JPY 500 million payment for 2024 provide a valuable revenue stream that contributes to the company’s financial stability. Under the terms of its royalty monetization agreement with OrbiMed, Poxel will direct these proceeds, after meeting its financial commitments to Merck Serono, toward debt repayment, reinforcing its financial strategy and long-term sustainability.

Future Outlook for TWYMEEG®

Sumitomo Pharma’s strategic initiatives also play a crucial role in mitigating potential risks associated with its internal restructuring. The company has outlined specific measures aimed at minimizing any Poxel adverse effects on TWYMEEG®’s sales performance. These efforts include targeted marketing strategies, enhanced physician engagement, and Poxel ongoing efforts to secure a broader indication for the drug. By addressing these challenges head-on, Sumitomo Pharma Poxel aims to maintain TWYMEEG®’s upward sales trajectory Poxel and capitalize on its market potential Poxel.

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