Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<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

<ul>
<li>
<a href="https://www.smartkarma.com/entities/kaken-pharmaceutical-co-ltd" target="_blank" data-smartkarma-citation="entities:18819:1" rel="noopener">Kaken Pharmaceutical (4521 JP)</a> witnessed 31% YoY revenue growth in FY25 to ¥94 billion on the back of flurry of one-time upfront payments, resulting in surge in profits too.</li>
<li>Kaken’s major drug Clenafin saw revenue drop of 2% YoY to ¥17 billion on patent cliff, while Artz revenue grew 6% YoY to ¥19 billion.</li>
<li>For FY26, Kaken expects revenue to fall 6% to ¥88 billion. No respite from immediate pangs of revenue loss from NHI drug price revision and generic competition for top-selling products.</li>
</ul>



Kaken Pharmaceutical (4521 JP) witnessed 31% YoY revenue growth in FY25 to ¥94 billion on the back of flurry of one-time upfront payments, resulting in surge in profits too.
Kaken’s major drug Clenafin saw revenue drop of 2% YoY to ¥17 billion on patent cliff, while Artz revenue grew 6% YoY to ¥19 billion.
For FY26, Kaken expects revenue to fall 6% to ¥88 billion. No respite from immediate pangs of revenue loss from NHI drug price revision and generic competition for top-selling products.


Kaken Pharmaceutical (4521 JP): Bleak FY26 Ahead, No Immediate Respite In Sight

<ul>
<li>
<a href="https://www.smartkarma.com/entities/kissei-pharmaceutical-co-ltd" target="_blank" data-smartkarma-citation="entities:18303:1" rel="noopener">Kissei Pharmaceutical (4547 JP)</a> reported 16.9% YoY jump in revenue during FY25 driven by Beova and Tavneos despite price revision pressures and generic competition.</li>
<li>The company has issued FY26 guidance of revenue rising 3.6%, with pharmaceuticals segment remaining flat dragged by lower overseas licensing fees.</li>
<li>The only trigger point at this moment happens to be the recent licensing deals signed by the company with various players gives it an opportunity to expand offerings and market.</li>
</ul>



Kissei Pharmaceutical (4547 JP) reported 16.9% YoY jump in revenue during FY25 driven by Beova and Tavneos despite price revision pressures and generic competition.
The company has issued FY26 guidance of revenue rising 3.6%, with pharmaceuticals segment remaining flat dragged by lower overseas licensing fees.
The only trigger point at this moment happens to be the recent licensing deals signed by the company with various players gives it an opportunity to expand offerings and market.


Kissei Pharmaceutical (4547 JP): Steady FY25, Licensing Fees To Drag FY26, Margins To Stay Strong

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)