Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/nippon-shinyaku-co-ltd" target="_blank" data-smartkarma-citation="entities:6634:1" rel="noopener">Nippon Shinyaku (4516 JP)</a> and <a href="https://www.smartkarma.com/entities/capricor-therapeutics-inc" target="_blank" data-smartkarma-citation="entities:37671:1" rel="noopener">Capricor Therapeutics (CAPR US)</a> announced positive topline results from its pivotal Phase 3 HOPE-3 trial evaluating Deramiocel.  </li>
<li>Capricor plans to submit its response to the Complete Response Letter incorporating HOPE-3 data, following prior alignment with FDA.</li>
<li>The next big trigger for the stock would be the approval of Deramiocel and RGX-121 by FDA followed by their commercialization.</li>
</ul>



Nippon Shinyaku (4516 JP) and Capricor Therapeutics (CAPR US) announced positive topline results from its pivotal Phase 3 HOPE-3 trial evaluating Deramiocel.  
Capricor plans to submit its response to the Complete Response Letter incorporating HOPE-3 data, following prior alignment with FDA.
The next big trigger for the stock would be the approval of Deramiocel and RGX-121 by FDA followed by their commercialization.


Nippon Shinyaku (4516 JP): Deramiocel Data Positive, Approval and Commercialization Next Big Trigger

<ul>
<li>In 1QFY26, <a href="https://www.smartkarma.com/entities/nippon-shinyaku-co-ltd" target="_blank" data-smartkarma-citation="entities:6634:1" rel="noopener">Nippon Shinyaku (4516 JP)</a> revenue grew 1% YoY to ¥39.5B and operating profit stood at ¥10.1B (down 9% YoY) as company incurred forex losses.</li>
<li>Viltepso witnessed slowing in US. Licensing income increased on higher overseas sales of Uptravi. Newly launched drugs like Vyxeos and Fintepla showed promise.</li>
<li>FY26 guidance revised downwards taking into account FDA’s rejection of BLA for CAP-1002. The company reduced FY26 revenue guidance to ¥166B from ¥173B.</li>
</ul>


In 1QFY26, Nippon Shinyaku (4516 JP) revenue grew 1% YoY to ¥39.5B and operating profit stood at ¥10.1B (down 9% YoY) as company incurred forex losses.
Viltepso witnessed slowing in US. Licensing income increased on higher overseas sales of Uptravi. Newly launched drugs like Vyxeos and Fintepla showed promise.
FY26 guidance revised downwards taking into account FDA’s rejection of BLA for CAP-1002. The company reduced FY26 revenue guidance to ¥166B from ¥173B.


Nippon Shinyaku (4516 JP): Flurry of Concerns Going Ahead; Revenue Steady for Now; Guidance Revised

<ul>
<li>In FY25, <a href="https://www.smartkarma.com/entities/nippon-shinyaku-co-ltd" target="_blank" data-smartkarma-citation="entities:6634:1" rel="noopener">Nippon Shinyaku (4516 JP)</a> revenue grew 8% YoY to ¥160B and operating profit stood at ¥35.5B, up 6.5%.</li>
<li>Viltepso witnessed growth both in Japan and the U.S., licensing income also increased on higher overseas sales of Uptravi. Newly launched drugs like Vyxeos and Fintepla showed promise.</li>
<li>FY26 guidance indicate forex headwinds as higher costs will dent margins.</li>
</ul>


In FY25, Nippon Shinyaku (4516 JP) revenue grew 8% YoY to ¥160B and operating profit stood at ¥35.5B, up 6.5%.
Viltepso witnessed growth both in Japan and the U.S., licensing income also increased on higher overseas sales of Uptravi. Newly launched drugs like Vyxeos and Fintepla showed promise.
FY26 guidance indicate forex headwinds as higher costs will dent margins.


Nippon Shinyaku (4516 JP): Stable FY25; New Launches Key; Guidance Indicates A Forex Wary FY26

<ul>
<li>During 9MFY25, <a href="https://www.smartkarma.com/entities/nippon-shinyaku-co-ltd" target="_blank" data-smartkarma-citation="entities:6634:1" rel="noopener">Nippon Shinyaku (4516 JP)</a> reported revenue growth of 8% YoY to ¥121B, while operating profit stood at ¥33B, up 8% YoY.</li>
<li>Viltepso witnessed growth both in Japan and the U.S. and licensing income also increased on higher overseas sales of Uptravi.</li>
<li>Guidance for FY25 have been raised with sales now expected to be ¥160B, up 8% YoY.</li>
</ul>


During 9MFY25, Nippon Shinyaku (4516 JP) reported revenue growth of 8% YoY to ¥121B, while operating profit stood at ¥33B, up 8% YoY.
Viltepso witnessed growth both in Japan and the U.S. and licensing income also increased on higher overseas sales of Uptravi.
Guidance for FY25 have been raised with sales now expected to be ¥160B, up 8% YoY.


Nippon Shinyaku (4516 JP): Strong 9MFY25 Numbers; FY25 Guidance Raised; Regular Launches Remain Key

<ul>
<li>A US court found <a href="https://www.smartkarma.com/entities/nippon-shinyaku-co-ltd" target="_blank" data-smartkarma-citation="entities:6634:1" rel="noopener">Nippon Shinyaku (4516 JP)</a> guilty of patent infringement related to competitor <a href="https://www.smartkarma.com/entities/sarepta-therapeutics-inc" target="_blank" data-smartkarma-citation="entities:17729:1" rel="noopener">Sarepta Therapeutics (SRPT US)</a>'s DMD drug Vyondys 53 and asked to pay $115M as compensation.  </li>
<li>The jury verdict will have no bearing on Viltepso sales. Nippon Shinyaku disagreed with the verdict, and is considering all options including post jury motions and appeals.</li>
<li>An additional expense to the tune of $115M would surely be a huge drag on the profitability of the company which is already under pressure because of rising costs.</li>
</ul>


A US court found Nippon Shinyaku (4516 JP) guilty of patent infringement related to competitor Sarepta Therapeutics (SRPT US)'s DMD drug Vyondys 53 and asked to pay $115M as compensation.  
The jury verdict will have no bearing on Viltepso sales. Nippon Shinyaku disagreed with the verdict, and is considering all options including post jury motions and appeals.
An additional expense to the tune of $115M would surely be a huge drag on the profitability of the company which is already under pressure because of rising costs.


Nippon Shinyaku (4516 JP): Unfavorable Patent Verdict; Company Vows to Fight Back

Japan

Nippon Shinyaku Co., Ltd. manufactures pharmaceutical and health foods products. The Company produces drugs for urinary, nerve, respiratory, and circulatory systems as well as analgesic and anti-inflammatory drugs.  Nippon Shinyaku also develops synthetic anti-bacterial agents.

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Nippon Shinyaku (4516 JP)