Commercialization of the nasal migraine drug “Atzumi™” by U.S. consolidated subsidiary Satsuma Pharmaceuticals, Inc. and the Company’s response
Satsuma Pharmaceuticals, Inc. (Satsuma Pharmaceuticals, Inc., SHIN NIPPON BIOMEDICAL LABORATORIES,LTD.’s U.S. consolidated subsidiary) and SHIN NIPPON BIOMEDICAL LABORATORIES,LTD.
The U.S. market and regions outside the United States; the nasal migraine drug “Atzumi™”
Because Atzumi™ is a second-line treatment for the acute treatment of migraine and a combination product comprising a device and a drug formulation, the Company has been unable to reach agreement with a partner on the terms it had assumed.
The operating loss of Satsuma Pharmaceuticals, Inc. of ¥3,528 million has been incorporated into the full-year consolidated earnings forecast for the fiscal year ending March 2027. No revenue from Atzumi™ or licensing income is expected to be recorded.
Fiscal year ending March 2027 (1 April 2026 to 31 March 2027)
The full-year consolidated earnings forecast for the fiscal year ending March 2027 does not include any revenue from Atzumi™ or licensing income, and incorporates an operating loss of ¥3,528 million for Satsuma Pharmaceuticals, Inc. based on business activity expenses related to the product launch.
Company response
Trinity Life Sciences was engaged to conduct a third-party assessment of the migraine drug market in the United States and the commercial potential of Atzumi™.
Satsuma Pharmaceuticals, Inc. will establish the organization required to launch Atzumi™, and will proceed with negotiations with sales partners and health insurers, collaboration with prescribing physicians, and negotiations for regional licensing-out arrangements outside the United States. SHIN NIPPON BIOMEDICAL LABORATORIES,LTD. will support these activities as the parent company.
The Company will promptly disclose any event that it determines could have a material impact on earnings, taking into account changes in market conditions, progress in business activities, and partnering developments.
| Item | Details |
|---|---|
| Event name | Commercialization of the nasal migraine drug “Atzumi™” by U.S. consolidated subsidiary Satsuma Pharmaceuticals, Inc. and the Company’s response |
| Date of occurrence | 11 May 2026 (the Board of Directors decided on the commercialization plan and response) |
| Subject Entity | Satsuma Pharmaceuticals, Inc. (Satsuma Pharmaceuticals, Inc., SHIN NIPPON BIOMEDICAL LABORATORIES,LTD.’s U.S. consolidated subsidiary) and SHIN NIPPON BIOMEDICAL LABORATORIES,LTD. |
| Target Locations / Products | The U.S. market and regions outside the United States; the nasal migraine drug “Atzumi™” |
| Cause | Because Atzumi™ is a second-line treatment for the acute treatment of migraine and a combination product comprising a device and a drug formulation, the Company has been unable to reach agreement with a partner on the terms it had assumed. |
| Amount of Impact on Business Performance | The operating loss of Satsuma Pharmaceuticals, Inc. of ¥3,528 million has been incorporated into the full-year consolidated earnings forecast for the fiscal year ending March 2027. No revenue from Atzumi™ or licensing income is expected to be recorded. |
| Accounting period in which recognized | Fiscal year ending March 2027 (1 April 2026 to 31 March 2027) |
| Impact on Earnings Forecast | The full-year consolidated earnings forecast for the fiscal year ending March 2027 does not include any revenue from Atzumi™ or licensing income, and incorporates an operating loss of ¥3,528 million for Satsuma Pharmaceuticals, Inc. based on business activity expenses related to the product launch. |
| Investigation structure | Trinity Life Sciences was engaged to conduct a third-party assessment of the migraine drug market in the United States and the commercial potential of Atzumi™. |
| Outlook | Satsuma Pharmaceuticals, Inc. will establish the organization required to launch Atzumi™, and will proceed with negotiations with sales partners and health insurers, collaboration with prescribing physicians, and negotiations for regional licensing-out arrangements outside the United States. SHIN NIPPON BIOMEDICAL LABORATORIES,LTD. will support these activities as the parent company. |
| Planned follow-up disclosure | The Company will promptly disclose any event that it determines could have a material impact on earnings, taking into account changes in market conditions, progress in business activities, and partnering developments. |
Items this document does not state (14)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Because Atzumi™ is a second-line treatment for the acute treatment of migraine and is a combination product comprising a device and a drug formulation, agreement has not been reached with a partner on the terms assumed by the Company. Meanwhile, a third-party assessment confirmed that the second-line treatment market is sufficiently large and that Atzumi™ has significant business potential. The Company has therefore decided to establish a manufacturing and marketing structure and proceed with the product launch.