Cash of $279M; Files Lawsuit Against NS, Deramiocel August 22nd PDUFA Date

研报英文原文证据摘录

Cash of $279M; Files Lawsuit Against NS, Deramiocel August 22nd PDUFA Date

cardiomyopathy, we 52-Week High / Low US$40.37 / US$4.30

could see broad approval in DMD. Capricor could also receive a valuable PRV upon Shares Out (mil) 57.7

approval. Press release as of March 31, 2026.

Market Cap. (mil) US$1,818.7

Total Assets ($mil) 326

• Operational Readiness for Commercial Launch. Following a successful FDA pre- Avg Daily Vol (000) 1,300

license inspection with all Form 482 observations addressed, Capricor’s San Diego site Book Value/Share US$4.83

has initial commercial supply for 200-250 DMD boys. Capricor is currently expanding Price/Book 653%

this facility to increase annual supply for 2,000-2,5000 boys by next year. Capricor Net Cash Per Share US$4.83

currently has ~100 boys in open-label extension studies, who could rapidly convert into Div Yield 0.00%

commercial patients. Fiscal Year End Dec

Price Performance - 1 Year

• Lawsuit Against Nippon Shinyaku. Capricor filed a lawsuit against distribution partner

Nippon Shinyaku and U.S. subsidiary NS Pharma in the Superior Court of New Jersey, USD 40

seeking to regain full U.S. distribution rights to deramiocel. 35

• Capricor and NS have been unable to negotiate a wholesale price. Additionally, Capricor 25

asserts that NS has not made meaningful efforts to prepare for U.S. launch and that 20

NS has sub-contracted other distributors without written consent. The complaint seeks 15

a preliminary injunction so that Capricor can market deramiocel in the U.S. upon FDA 10

approval. We see upside if the lawsuit is successful as Capricor is currently eligible for 5

40% of deramiocel revenues less COGS. 0

May-25 Jul-25 Sep-25 Nov-25 Jan-26 Mar-26 May-26

RISKS TO ACHIEVEMENT OF PT & RECOMMENDATION Source: Bloomberg