Updating Estimates, Trimming Profit Margin for Deramiocel

Research evidence excerpt

Updating Estimates, Trimming Profit Margin for Deramiocel

Japan | Pharmaceuticals

Nippon Shinyaku EquityJuneResearch30, 2026

TARGET | ESTIMATE CHANGEUpdating Estimates, Trimming Profit Margin

RATING HOLDfor Deramiocel

PRICE ¥4,016^

Following FY3/26 earnings and a catch-up with the IR team, we update our

estimates. As a result of Capricor's litigation, we now assume Deramiocel PRICE TARGET | % TO PT ¥4,300 (¥5,200) | +7%

will adopt a co-commercialization model, and we lower our margin 52W HIGH-LOW ¥6,529 - ¥2,967

forecasts for Nippon Shinyaku. As a result, we arrive at a new PT of ¥4,300 FLOAT (%) | ADV MM (USD) 73.0% | 5.59

and reiterate our Hold rating. The next catalysts are the AdCom on July 29, MARKET CAP ¥270.7B | $1.7B

followed by the PDUFA date on August 22. TICKER 4516 JP ^Prior trading day's closing price unless otherwise

noted.

Deramiocel launch at risk. The federal court had set a July 6 deadline for Capricor to file its

response in the litigation against Nippon Shinyaku; however, the case has been remanded to

FY (Mar) CHANGE TO JEFe JEF vs CONS

a New Jersey state court, making the timeline unclear. While we see a low likelihood that an

2026 2027 2026 2027

injunction will be granted, we believe there is a risk that finalizing the agreement could take

time, potentially delaying the launch timing. REV +9% +2% +6% NM

EPS +31% -34% +23% -13%

AdCom could be a positive event. The AdCom for Deramiocel has been scheduled for July

29 (US time), from 10:00 AM to 4:30 PM. Capricor’s share price reacted negatively (-13%) 2026 (¥) Q1 Q2 Q3 Q4 FY3

to the announcement. However, we view the AdCom as a conservative step by CBER under EPS 121.47 145.80 148.61 84.80 500.67

its new leadership in reviewing a novel modality that has previously received a CRL, and PREV 382.84