ENVALITH
窪田製薬ホールディングス株式会社 logo

Kubota Pharmaceutical Holdings Co., Ltd.

4596Growth MarketPharmaceuticals

窪田製薬ホールディングス株式会社 logo
Kubota Pharmaceutical Holdings Co., Ltd.4596

Business

Kubota Pharmaceutical Holdings Co., Ltd. is an ophthalmic medical solutions company dedicated to helping patients with eye diseases maintain and restore their vision. Its pipeline consists of three pillars: the wearable myopia device "Kubota Glass," which utilizes the company's proprietary active stimulation technology "Kubota Glasses Technology"; the home/telemedicine monitoring device "eyeMO"; and "Emixustat Hydrochloride," a small-molecule compound targeting Stargardt disease and diabetic retinopathy. In 2024, the company relocated its R&D base from the United States to Japan, and is advancing commercialization in global markets including Japan, China, Taiwan, the United States, and Europe. Listed on the Tokyo Stock Exchange Growth Market.

Business Model

At present, the company's main revenue consists solely of product sales from direct sales of Kubota Glass (in Japan, China, etc.), which totaled ¥21 million in FY2025 (ending December 2025). Over the medium to long term, the revenue pillars are designed to be royalty income from the licensing agreement for Emixustat Hydrochloride (an exclusive supply and license agreement concluded with Laboratoires KÔL of France in March 2026), as well as expanded sales through a Kubota Glass distributor network across multiple regions. Fundraising relies mainly on share issuance through the exercise of stock acquisition rights.

Company Strengths

The active stimulation technology, which suppresses myopia progression through artificial light stimulation to the retina, was developed independently in-house. The company has accumulated a track record of regulatory compliance, including obtaining Taiwan medical device manufacturing approval in 2021, completing U.S. FDA medical device registration in 2022, and acquiring ISO 13485:2016 certification, positioning the maintenance of its intellectual property portfolio as a pillar of its management strategy.

Emixustat Hydrochloride has received orphan drug designation for Stargardt disease from both the FDA (2017) and the EMA (2019). A post-hoc subgroup analysis of the Phase 3 clinical trial confirmed that, in the patient group with smaller atrophic lesions, the progression rate of macular atrophy at 24 months was suppressed by 40.8% compared to placebo (p=0.0206).

Research and development expenses decreased by 42.9% from ¥544 million in FY2024 (ended December 2024) to ¥311 million in FY2025 (ended December 2025), while selling, general and administrative expenses decreased by 23.6% from ¥710 million to ¥543 million. Cash outflow from operating activities improved by ¥612 million, from ¥1,195 million to ¥583 million, and cash and cash equivalents at period-end stood at ¥1,919 million.

ENVALITH's Perspective

Operating loss for Q1 FY2026 (ending December 2026) expanded to ¥313 million from ¥259 million in the same quarter of the previous year. The main cause was a sharp increase in research and development expenses, which rose 96.1% year-on-year to ¥139 million due to increased development costs for Emixustat Hydrochloride and Kubota Glass®. Business revenue contracted to ¥5 million (down 35.2% year-on-year), and the timing for a full-scale ramp-up of monetization remains unclear at this point.

The balance of cash and cash equivalents has followed a long-term declining trend: ¥4,049 million at the end of FY2022 (ended December 2022) → ¥2,768 million at the end of FY2023 (ended December 2023) → ¥1,455 million at the end of FY2024 (ended December 2024) → ¥1,919 million at the end of FY2025 (ended December 2025) → ¥1,788 million at the end of Q1 FY2026 (ending December 2026). Negative operating cash flow has continued, and the company's own recognition that circumstances exist which raise material doubt about its ability to continue as a going concern remains a significant risk.

Concrete developments in business progress include the license agreement concluded with Laboratoires KÔL (March 2026), the new initiation of clinical trials in Shanghai, China, and the launch of a subscription-based sales program for Kubota Glass®. On the other hand, the number of shares outstanding increased by approximately 20%, from 115,404,288 shares at the end of FY2025 (ended December 2025) to 138,504,288 shares at the end of Q1 FY2026 (ending December 2026), driven mainly by the exercise of stock acquisition rights, the company's primary means of fundraising. Continued dilution of existing shareholders' equity stakes warrants attention.

Growth Strategy

Advancing global expansion of Kubota Glass and CUP-based monetization of Emixustat Hydrochloride as twin growth drivers

Building a nationwide sales network covering all of China in collaboration with four distributors, transitioning from the market exploration/hypothesis-testing stage to a concrete execution phase. Newly initiated a clinical trial in Shanghai, China aimed at pediatric myopia prevention, establishing a foundation for validating product value and future business expansion.

Entered into a supply and license agreement with Laboratoires KÔL on March 2, 2026. Began GMP-compliant active pharmaceutical ingredient manufacturing from April 2026. Working with KÔL to advance the application for compassionate use approval with French authorities.

In Taiwan, continuing launch discussions with the contracted partner and formulating promotional and PR measures together with the local marketing partner. Held dialogue with over 100 industry stakeholders at the "100% Optical" exhibition in the UK. In South Asia, ongoing discussions with a local partner regarding market potential and business feasibility.

Began offering the "Kubota Glass® My Vision Program," establishing an environment for long-term continued customer use. Aiming to strengthen the business foundation by building a recurring revenue base. Resumed sales activity via the Taobao e-commerce channel in the Chinese market.

Effective April 30, 2026, reduced capital by ¥567,576 thousand out of total capital of ¥577,576 thousand without compensation, transferring the amount to other capital surplus. Further transferred ¥3,460,412 thousand of other capital surplus to retained earnings brought forward to offset accumulated losses. Aims to strengthen financial soundness and secure future flexibility in capital policy.

Last updated: July 17, 2026