Poxel SA and Sumitomo Pharma: A Closer Look at TWYMEEG®’s Sales Performance and Strategic Growth Initiatives
In the rapidly evolving landscape of metabolic disease treatments, Poxel SA (Euronext: POXEL – FR0012432516) stands out as a pioneering clinical-stage biopharmaceutical company. With a focus on chronic and serious diseases such as metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, Poxel has consistently pushed the boundaries of innovation. Recently, the company announced the Q4 2024 gross sales figures for its flagship product, TWYMEEG®, in Japan. These results, disclosed by its partner Sumitomo Pharma as part of their Q3 FY2024 financial report, provide valuable insights into the drug’s performance and future prospects.
TWYMEEG®: A Pillar in Diabetes Treatment
TWYMEEG® has emerged as a cornerstone in Sumitomo Pharma’s diabetes portfolio, thanks to its safety, tolerability, and efficacy. Koichi Kozuki, Executive Officer of the Corporate Regulatory Compliance & Quality Assurance Division and Senior Vice President at Sumitomo Pharma, highlighted the drug’s importance. “TWYMEEG® is a crucial asset, and we remain committed to supporting its sales trajectory,” he stated. This commitment extends beyond commercial success; it includes efforts to expand the drug’s accessibility to broader patient populations.
One significant step in this direction is the ongoing dialogue with Japanese regulatory authorities to revise TWYMEEG®’s package insert. The goal is to include patients with renal impairment, based on findings from the TWINKLE study. This post-marketing clinical trial reaffirmed the drug’s safety and tolerability profile in type 2 diabetic patients with reduced kidney function. Regulatory approval for this update is anticipated in the first half of 2025, marking a pivotal moment for TWYMEEG®’s market expansion.
Q4 2024 Sales Figures and Financial Impact
For the quarter ending December 2024, TWYMEEG® achieved gross sales of JPY 2.1 billion (EUR 13 million) in Japan, reflecting a 17% increase compared to JPY 1.8 billion (EUR 11.2 million) in the previous quarter. As of January 20, 2025, net sales for Sumitomo Pharma’s fiscal year 2024 reached JPY 5 billion. This milestone makes Poxel eligible for a 10% royalty on all TWYMEEG® net sales for 2024, alongside a one-time sales-based payment of JPY 500 million (EUR 3.1 million).
These proceeds are particularly significant as they align with Poxel’s royalty monetization agreement with OrbiMed. Under this arrangement, the funds will be used to repay the company’s bond issue, after accounting for obligations to Merck Serono. This financial strategy underscores Poxel’s disciplined approach to managing resources while ensuring sustained growth.
Revised Sales Forecast: Challenges and Opportunities
Despite the positive momentum, Sumitomo Pharma has revised its FY2024 forecast for TWYMEEG® net sales in Japan. The updated projection stands at JPY 7.9 billion (EUR 48.4 million), down from the earlier estimate of JPY 11.3 billion (EUR 69.2 million) announced on May 14, 2024. While this downward adjustment may raise concerns, it is essential to note that the revised forecast still represents a robust 72% increase over FY2023 sales, which totaled JPY 4.6 billion.
The revision reflects both internal restructuring initiatives and shifts in Japan’s competitive pharmaceutical landscape. Sumitomo Pharma is undergoing strategic realignments to enhance operational efficiency and adapt to market dynamics. These changes, while necessary, have influenced the projected sales trajectory for TWYMEEG®. However, the company remains steadfast in its commitment to mitigating potential challenges.
Strategic Measures to Sustain Growth
To counteract any adverse effects stemming from internal restructuring, Sumitomo Pharma has implemented several proactive measures. One key initiative involves minimizing disruptions caused by organizational changes. By maintaining a laser focus on customer engagement and market penetration, the company aims to sustain TWYMEEG®’s sales growth and solidify its position in Japan’s competitive pharmaceutical sector.
Additionally, efforts to expand the drug’s package insert for patients with an estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73m² demonstrate Sumitomo Pharma’s dedication to broadening TWYMEEG®’s therapeutic reach. Regulatory approval for this update is expected to unlock new opportunities, enabling the drug to serve a larger patient population and drive further revenue growth.
Next Financial Announcement
Poxel will release its Fourth Quarter 2024 Cash and Revenue Update on February 19, 2025.
About Poxel SA
Poxel SA is a clinical-stage biopharmaceutical company focused on developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including MASH and rare metabolic disorders. Poxel’s lead candidate for MASH, PXL065 (a deuterium-stabilized R-pioglitazone), successfully met its primary endpoint in a Phase 2 trial (DESTINY-1). In rare diseases, PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is being developed for adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD).
TWYMEEG® (Imeglimin), Poxel’s first-in-class product targeting mitochondrial dysfunction, is now marketed in Japan for type 2 diabetes by Sumitomo Pharma. Poxel expects to receive ongoing royalties and sales-based payments through its strategic partnership with Sumitomo Pharma. The company is headquartered in Lyon, France, with subsidiaries in Boston, MA, and Tokyo, Japan.
