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Medrx Co.,Ltd.

4586Growth MarketPharmaceuticals

株式会社メドレックス logo
Medrx Co.,Ltd.4586

Pharmaceutical Formulation Development Business (Single Segment)

Drug discovery pipeline venture centered on proprietary transdermal formulation technology ILTS®

PeriodCurrentPreviousChange
Revenue (Q1 cumulative)¥5 million¥2 million (same period prior year)
Operating loss (Q1 cumulative)-¥246 million-¥419 million (same period prior year)
Ordinary loss (Q1 cumulative)-¥244 million-¥422 million (same period prior year)
Quarterly net loss attributable to owners of parent (Q1 cumulative)-¥238 million-¥429 million (same period prior year)
SG&A expenses (Q1 cumulative)¥251 million¥420 million (same period prior year)
Cash and deposits (period-end)¥1,463 million¥1,754 million (end of FY2025, ending December 2025)
Total assets¥2,000 million¥2,157 million (end of FY2025, ending December 2025)
Net assets¥1,832 million¥2,048 million (end of FY2025, ending December 2025)
Equity ratio89.0%92.2% (end of FY2025, ending December 2025)
Quarterly net loss per share-¥4.02-¥9.04 (same period prior year)
Full-year forecast - Revenue¥507 million (+296.4% YoY)¥128 million (FY2025 actual, ending December 2025)
Full-year forecast - Operating loss-¥1,472 million-¥941 million (FY2025 actual, ending December 2025)

Business Details

A single-segment company that develops new drugs by transdermal formulation of poorly absorbable drugs, based on its proprietary transdermal formulation technology ILTS® (Ionic Liquid Transdermal System). The business model generates revenue through upfront license fees, milestone fees, and royalty income from licensing out to pharmaceutical companies and others. In September 2025, Bondlido (MRX-5LBT) received marketing approval from the US FDA, and in May 2026 the company entered into a legally binding term sheet for a sales partnership with Terrain Pharmaceuticals, with preparations underway for launch in the second half of 2026.

Recent Overview

Term sheet signed for Bondlido sales partnership; Alto-101 Phase 2 trial did not meet primary endpoint

Revenue for Q1 2026 (January-March) was ¥5 million (up 158.9% year-on-year), and operating loss was ¥246 million (significantly improved from ¥419 million in the same period prior year). SG&A expenses, including R&D costs, were reduced to ¥251 million (from ¥420 million in the same period prior year). In May 2026, the company entered into a legally binding term sheet for a sales partnership with Terrain Pharmaceuticals for Bondlido, with preparations underway for launch in the second half of 2026. Meanwhile, the Phase 2 POC clinical trial for Alto-101 did not achieve statistical significance on the primary endpoint, and Alto announced it would not independently develop the product, instead seeking strategic partnership opportunities. The full-year earnings forecast was revised to revenue of ¥507 million and operating loss of ¥1,472 million (revised from the previous forecast).

Key Products

product
Bondlido (MRX-5LBT)

A novel lidocaine tape formulation using ILTS®. Indicated for postherpetic neuralgia, it offers less skin irritation and superior adhesion compared to the predecessor product Lidoderm. In May 2026, the company entered into a legally binding term sheet for a sales partnership with Terrain Pharmaceuticals (Reno, Nevada), with preparations underway for launch in the second half of 2026. The peak net sales of the leading competing product ZTlido were approximately ¥8.0 billion (52 million USD, 2024).

product
MRX-4TZT

A tape formulation of tizanidine, a central muscle relaxant, using ILTS®. A Phase 2 POC clinical trial was initiated in December 2025, with preliminary results expected in Q4 2026. Compared to the oral formulation, it is expected to offer improved sustainability of effective blood concentration and reduced side effects. The US muscle relaxant market is estimated at approximately ¥260.0 billion (1,743 million USD) in 2025.

product
MRX-9FLT

A fentanyl tape formulation incorporating proprietary technology designed to prevent accidental misuse by infants and children exposed to opioid patches. Received FDA Fast Track designation in July 2021. A preliminary clinical PK study confirmed blood concentration profiles similar to the reference product. The US fentanyl patch market is estimated at approximately ¥19.0 billion (125 million USD) in 2025.

product
MRX-6LDT

A tape formulation using ILTS® that achieves high transdermal penetration of both diclofenac and lidocaine. Designed to provide additive or synergistic pain-relief effects from both drugs. The US pain management drug market is approximately ¥660.0 billion (4,398 million USD) in 2025. Nonclinical studies followed by Phase 1 clinical trials are planned initially.

product
Alto-101

Developed in partnership with Alto Neuroscience, Inc. Preliminary results of the Phase 2 POC clinical trial were obtained in April 2026, showing a near-significant improvement (p=0.052) in the primary endpoint (EEG theta band index), but statistical significance was not achieved. Alto announced it will prioritize resources toward Alto-207 going forward and will not independently develop Alto-101, instead seeking strategic partnership opportunities. The company plans to discuss with Alto the possibility of detailed analysis and formulation improvements. Received FDA Fast Track designation (October 2025).

platform
Microneedle Array (MN)

An assembly of hundreds of micrometer-scale microneedles made from biodegradable resin and other materials. Enables painless transdermal self-administration of vaccines, nucleic acid drugs, protein drugs, and other therapeutics, with expectations of higher immune effects compared to conventional injections. The company operates an MN clinical trial drug manufacturing facility for pharmaceutical and vaccine applications, and is exploring business partnerships while conducting feasibility studies using model animals.

Growth Drivers

  • Launch of Bondlido (MRX-5LBT) in the US in the second half of 2026: term sheet for sales partnership already signed with Terrain Pharmaceuticals, with launch preparations proceeding in parallel while finalizing details of the sales license agreement
  • Progress in licensing-out negotiations and enhancement of corporate value through the success of the MRX-4TZT Phase 2 POC clinical trial (preliminary results expected in Q4 2026)
  • Transformation of revenue structure through generation of royalty and milestone income following the launch of Bondlido
  • Value-added potential and market expansion opportunities for MRX-9FLT (fentanyl tape formulation) due to its misuse/accident prevention functionality
  • Creation of new revenue sources through the establishment of business partnerships for the Microneedle Array
  • Exploration of continued development or licensing-out opportunities through discussions with Alto, including potential formulation improvements for Alto-101

Risks

  • Risk that sales license negotiations for Bondlido fail to conclude successfully, or that post-launch revenue falls short of expectations
  • Risk of failure in the MRX-4TZT Phase 2 POC clinical trial (preliminary results expected Q4 2026, with results potentially having a major impact on corporate value)
  • Risk of pipeline value impairment and loss of milestone income due to Alto-101's failure to achieve statistical significance on the primary endpoint in its Phase 2 POC clinical trial and Alto's decision to abandon independent development
  • Risk of cash depletion due to continued operating losses (full-year FY2026, ending December 2026, operating loss forecast of ¥1,472 million); cash and deposits stood at ¥1,463 million (end of March 2026), a quarterly decrease of ¥291 million
  • High uncertainty in revenue outlook, as the full-year earnings forecast has been revised from the previous forecast
  • Risk of pipeline value impairment due to clinical trial failures (as demonstrated by the Alto-101 case, the risk of failure at the development stage is ever-present)
  • Risk of dependence on a small number of key customers and partners (Terrain Pharmaceuticals, Alto Neuroscience, etc.)

Last updated: March 19, 2026