Nxera Pharma Receives a Manufacturing Approval Partial Amendment Regarding the Addition of a Manufacturing Site in Asia for QUVIVIQ(TM) 25 and 50 mg

Executive Summary

• Nxera Pharma obtained a partial amendment approval to add a second API manufacturing site in Asia for QUVIVIQ® (daridorexant), complementing its existing European facility.
• The new Asian facility is expected to generate manufacturing cost reductions that will begin contributing to profitability from 2027 through the end of 2028, supporting the company’s 2030 Vision of >JPY 50 bn sales and >30% profit margin.
• Commercial forecasts: Shionogi’s full‑year sales forecast for QUVIVIQ® in Japan (FY ending March 2026) is JPY 2.5 bn; Nxera’s own FY 2025 sales forecast for the product is JPY 4.0–5.0 bn.

Key Details

• Regulatory Approval: Partial amendment to the Japanese manufacturing approval for QUVIVIQ® 25 mg and 50 mg, permitting a second API site in Asia.
• Facility Timeline: Asian API plant will be brought online in phases; cost‑reduction benefits expected to start materializing in 2027 and continue through 2028.
• Cost‑Reduction Projects: Three major initiatives planned; one (the new facility) is now approved, with the remaining two slated for completion by end‑2028.
• 2030 Vision Alignment: Cost savings are projected to help achieve sales >JPY 50 bn and profit margin >30% by 2030.
• Commercial Partnership – Shionogi:
• Shionogi holds exclusive distribution/sales rights for QUVIVIQ® in Japan.
• Shionogi’s FY2026 sales forecast: JPY 2.5 bn.
• Nxera’s FY2025 sales forecast: JPY 4.0–5.0 bn.
• Taiwan License Agreement: In February 2025, Nxera entered a license, supply and commercialization agreement with Holling Bio‑Pharma Corp. for daridorexant in Taiwan.
• Quote – COO Toshihiro Maeda: Emphasized that the new Asian API facility enhances supply resilience, meets rising APAC demand, and will drive gradual cost reductions starting 2027, supporting high‑margin growth objectives.

Notable Quotes

“This approval enables Nxera to establish a second API manufacturing facility in Asia for QUVIVIQ®, … we anticipate cost reduction effects to start materializing from 2027, thereby achieving both improved profitability and stable supply to patients with insomnia in Japan and across the APAC region.” – Toshihiro Maeda, Chief Operating Officer, Nxera Pharma