PeptiDream (4587): FY2025 Results Summary — Operating Loss on Delayed Out-Licensing as Clinical Pipeline Grows to 13 Programs

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PeptiDream Inc. (TSE: 4587) announced its consolidated financial results (IFRS) for FY2025 on February 16, 2026. Note that PeptiDream’s fiscal year ends in December, so “FY2025” refers to the fiscal year ended December 31, 2025. Revenue came to 18,521 million yen, down sharply from 46,676 million yen in FY2024, and the company posted an operating loss of 5,013 million yen and a net loss of 3,749 million yen. The company explains that the shortfall versus its initial forecast was largely due to an out-licensing agreement for its oral myostatin inhibitor program not being concluded in FY2025, while in the Radiopharmaceuticals business strong PET product sales enabled the business to maintain profitability for the fourth consecutive fiscal year. On the pipeline side, six programs entered clinical development in 2025, and PeptiDream closed the year with a total of 13 programs in clinical development.

Consolidated Results (Full-Year Actual)

For FY2025, revenue was 18,521 million yen against an initial forecast of 49,000 million yen and a revised forecast of 18,000 million yen. EBITDA was ▲2,822 million yen, core operating profit was ▲4,866 million yen, operating profit was ▲5,013 million yen, and net income was ▲3,749 million yen. Earnings per share were ▲28.99 yen, compared with 115.85 yen in FY2024.

Item (JPY M, IFRS)	FY2024 Results	FY2025 Initial Forecasts	FY2025 Revised Forecasts	FY2025 Results
Revenue	46,676	49,000	18,000	18,521
EBITDA	23,425	–	–	▲2,822
Core Operating Profit	21,225	21,700	▲5,300	▲4,866
Operating Profit	21,113	21,600	▲5,400	▲5,013
Net Income	15,014	15,100	▲4,000	▲3,749
Comprehensive Income	16,216	–	–	▲4,336
Earnings Per Share (JPY)	115.85	–	–	▲28.99

On the difference from the initial forecast, the company presents a bridge from the initial revenue forecast of 49.0 billion yen to the actual of approximately 18.5 billion yen, consisting of 21.0 billion yen related to the upfront fee for the myostatin program and approximately 9.5 billion yen of milestones and other upfront fees. Regarding the out-licensing of the proprietary oral myostatin inhibitor program, the company states it did not conclude an agreement as it is prioritizing finding the best partner to maximize the value of the program, and that certain development milestone achievements for existing programs and certain new partnerships originally anticipated in FY2025 will instead happen in FY2026.

Segment Results

PeptiDream reports two business segments. Revenue in the Drug Discovery and Development business was 2,793 million yen, down from 31,313 million yen in FY2024, as the initial forecast was not achieved largely due to the myostatin out-licensing agreement not being concluded. Revenue in the Radiopharmaceutical business was 15,727 million yen, up from 15,363 million yen, with strong PET product sales driving performance.

Segment	Metric	FY2025	FY2024
Drug Discovery and Development Business	Revenue (JPY M)	2,793	31,313
Radiopharmaceutical Business	Revenue (JPY M)	15,727	15,363

On the balance sheet, total assets at the end of FY2025 were 77,033 million yen, with equity of 51,528 million yen (a change of -5,234 million yen from the end of FY2024) and liabilities of 25,504 million yen (-10,502 million yen). The ratio of equity attributable to owners of parent to total assets improved by 6 percentage points from 2024 to 67%, and the company maintained a net cash positive position. Cash and cash equivalents ended the year at 28,682 million yen, down from 48,117 million yen at the end of FY2024, reflecting operating cash flow of ▲13,276 million yen (including payment of income taxes of approximately 8.1 billion yen), investment cash flow of ▲2,053 million yen, and financial cash flow of ▲4,057 million yen (including repayment on outstanding loans of approximately 2.6 billion yen).

FY2026 Forecast

For FY2026, PeptiDream forecasts revenue of 32.0 billion yen plus the upfront fees of out-licensing deal(s), and core operating profit of 4.6 billion yen plus the upfront fees of out-licensing deal(s). By business, the revenue forecast consists of approximately 17.0 billion yen plus α in Drug Discovery and approximately 15.0 billion yen in Radiopharmaceuticals, with the additional upfront payments relating to programs such as Myostatin, IL17, CAIX, and CLDN18.2. The company describes revenue as driven by multiple deals/milestones and the additional potential of partnering of the Myostatin program.

Item	FY2026 Forecast	FY2025 (Actual)
Revenue — Drug Discovery	~17.0 JPY B + α	2,793 JPY M
Revenue — Radiopharmaceuticals	~15.0 JPY B	15,727 JPY M
Revenue — Total	JPY32.0B + UF of out-licensing deal(s)	18,521 JPY M
Core Operating Profit	JPY4.6B + UF of out-licensing deal(s)	▲4,866 JPY M

Pipeline Progress

The company positions its pipeline as the most critical asset supporting future growth, with 13 programs stage-advanced in the clinical development pipeline during 2025. The total number of clinical programs grew from 5 at the end of 2023 and 7 at the end of 2024 to 13 at the end of 2025, and the company expects 6 or more (with the possibility of up to 12) programs to enter clinical development in 2026, for 19–25 clinical programs at the end of 2026. In Japan’s late-stage development pipeline, the registrational trial of 177Lu-PSMA I&T (prostate cancer, therapeutic) was initiated with an NDA in Japan planned for 2029, while 64Cu-PSMA I&T (prostate cancer, diagnostic) and 64Cu-ATSM (malignant brain tumors) target NDAs in Japan planned for 2027; the company states it is on target to bring these three late-stage programs to market in 2027–2029. Globally, 225Ac/68Ga-GPC3 (hepatocellular carcinoma, Ph1/1b ongoing) and 177Lu/68Ga-FAP (Ph1 ongoing) are progressing as partnered programs, and in the in-house RI pipeline, US INDs were cleared for 225Ac-CA9 and 64Cu-CA9 (renal cell carcinoma).

Growth Investments and Medium-Term Direction

PeptiDream is undertaking investments for further growth: a new manufacturing plant for in-house radiotherapeutics launches at Kazusa Akademia Park (construction start in H2 2026, operations start in 2028, construction cost estimated at JPY 10–12 bn), which will expand the radiopharmaceutical formulation line to include next-gen radionuclides such as 177Lu, 225Ac and 64Cu, and a new research building for expanding R&D capabilities (construction start in 2027, operations start in 2029, construction cost estimated at JPY 12–15 bn). As a mid/long-term (~5-year) goal, the company presents revenue of 100bn, driven by asset value creation across its five core areas (RI-PDC, oral peptide, oligo-PDC, cytotoxic-PDC, and MPC) on the PDPS platform. The company also adopted a new organizational structure with an Executive Leadership Team and an EVP/SVP/VP system to enable company expansion and strengthen corporate governance.

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