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>During H1FY26, <a href="https://www.smartkarma.com/entities/shionogi-co-ltd" target="_blank" data-smartkarma-citation="entities:19535:1" rel="noopener">Shionogi &amp; Co (4507 JP)</a> maintained revenue, operating profit, and net profit at the same level as previous year. None of the key parameters achieved their respective targets.</li>
<li>Better-Than-Expected contribution from Torii, additional revenue generation from Quviviq, double-digit revenue growth of cefiderocol in the U.S. and EU, and stable growth in HIV royalty drove overall performance.</li>
<li>Shionogi has reduced FY26 revenue guidance (due to weak prescription drug sales) and raised operating and net profit guidance, driven by strong growth in royalty income and cost optimization initiatives.</li>
</ul>


During H1FY26, Shionogi &amp; Co (4507 JP) maintained revenue, operating profit, and net profit at the same level as previous year. None of the key parameters achieved their respective targets.
Better-Than-Expected contribution from Torii, additional revenue generation from Quviviq, double-digit revenue growth of cefiderocol in the U.S. and EU, and stable growth in HIV royalty drove overall performance.
Shionogi has reduced FY26 revenue guidance (due to weak prescription drug sales) and raised operating and net profit guidance, driven by strong growth in royalty income and cost optimization initiatives.


Shionogi & Co (4507 JP): Muted 1H Result; Solid HIV Business Leads FY Profit Guidance Raise

<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>During Q1FY26, <a href="https://www.smartkarma.com/entities/eisai-co-ltd" target="_blank" data-smartkarma-citation="entities:21001:1" rel="noopener">Eisai Co Ltd (4523 JP)</a> reported 55% YoY increase in operating profit to ¥21B, on just 7% YoY growth in revenue to ¥203B. The company reiterated FY guidance.</li>
<li>During Q1FY26, Leqembi revenue increased 269% YoY and 57% QoQ to ¥23B, driven by growth across all the regions. Eisai has guided for FY26 Leqembi revenue of ¥77B (+73% YoY).</li>
<li>The U.S. approval of Leqembi SC-AI maintenance dosing and the drug’s European launch are the key near-term triggers.</li>
</ul>


During Q1FY26, Eisai Co Ltd (4523 JP) reported 55% YoY increase in operating profit to ¥21B, on just 7% YoY growth in revenue to ¥203B. The company reiterated FY guidance.
During Q1FY26, Leqembi revenue increased 269% YoY and 57% QoQ to ¥23B, driven by growth across all the regions. Eisai has guided for FY26 Leqembi revenue of ¥77B (+73% YoY).
The U.S. approval of Leqembi SC-AI maintenance dosing and the drug’s European launch are the key near-term triggers.


Eisai Co Ltd (4523 JP): Impressive 1Q Result; Subcutaneous Leqembi Is Key for Future Growth

<ul>
<li>
<a href="https://www.smartkarma.com/entities/kyowa-kirin-co-ltd" target="_blank" data-smartkarma-citation="entities:18055:1" rel="noopener">Kyowa Kirin Co Ltd (4151 JP)</a> revenue declined 1% YoY to ¥230.7B, impacted by APAC business restructuring, reduced drug prices in Japan, despite the growth in North America and EMEA.</li>
<li>The company remains heavily dependent on Crysvita generating almost 43% of the total revenue of the company. Crysvita sales rose 10% YoY to ¥99.8B in 1H25.</li>
<li>The next big trigger to the stock price would be the FDA decision on approval of ziftomenib, due in November.</li>
</ul>



Kyowa Kirin Co Ltd (4151 JP) revenue declined 1% YoY to ¥230.7B, impacted by APAC business restructuring, reduced drug prices in Japan, despite the growth in North America and EMEA.
The company remains heavily dependent on Crysvita generating almost 43% of the total revenue of the company. Crysvita sales rose 10% YoY to ¥99.8B in 1H25.
The next big trigger to the stock price would be the FDA decision on approval of ziftomenib, due in November.


Kyowa Kirin (4151 JP): 1H25 Stay Muted, Guidance Reaffirmed, Ziftomenib Approval Decision Awaited

Japan

Kyowa Hakko Kirin Co.,Ltd. develops, manufactures, and markets pharmaceuticals. The Company's products include a protein produced by genetic recombination technology, an anti-anemia agent that attaches new sugar chains through partial modification of the amino acid sequence of human erythropoietin (EPO), and a glycoprotein, human erythropoietin.

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Kyowa Kirin Co Ltd (4151 JP)

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

Nippon Shinyaku and Capricor announce positive Phase 3 results for Deramiocel, with potential FDA approval and commercialization on the horizon....

Tina Banerjee

Shionogi & Co (4507 JP): Muted 1H Result; Solid HIV Business Leads FY Profit Guidance Raise

Shionogi reported flat revenue and profits in H1FY26, missing targets. The company has lowered FY26 revenue guidance, but raised operating and net...

Tina Banerjee

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

Nippon Shinyaku reports mixed 1QFY26 result, with revenue growing 1% YoY and operating profit decreasing 9% YoY due to forex losses. The company...

Tina Banerjee

Eisai Co Ltd (4523 JP): Impressive 1Q Result; Subcutaneous Leqembi Is Key for Future Growth

Eisai gets FDA nod for once weekly Leqembi subcutaneous autoinjector for maintenance dosing. The introduction of easy-to-use SC-AI will allow for...

Tina Banerjee

Kyowa Kirin (4151 JP): 1H25 Stay Muted, Guidance Reaffirmed, Ziftomenib Approval Decision Awaited

Kyowa Kirin 1H revenue declines 1% YoY to ¥230.7B, impacted by APAC restructuring and reduced drug prices in Japan. FDA decision on ziftomenib in...

Tina Banerjee

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52-week Range

Market Cap (USDm)

P/E

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

​Nippon Shinyaku and Capricor announce positive Phase 3 results for Deramiocel, with potential FDA approval and commercialization on the horizon....

Tina Banerjee

Shionogi & Co (4507 JP): Muted 1H Result; Solid HIV Business Leads FY Profit Guidance Raise

​Shionogi reported flat revenue and profits in H1FY26, missing targets. The company has lowered FY26 revenue guidance, but raised operating and net...

Tina Banerjee

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

​Nippon Shinyaku reports mixed 1QFY26 result, with revenue growing 1% YoY and operating profit decreasing 9% YoY due to forex losses. The company...

Tina Banerjee

Eisai Co Ltd (4523 JP): Impressive 1Q Result; Subcutaneous Leqembi Is Key for Future Growth

Eisai gets FDA nod for once weekly Leqembi subcutaneous autoinjector for maintenance dosing. The introduction of easy-to-use SC-AI will allow for...

Tina Banerjee

Kyowa Kirin (4151 JP): 1H25 Stay Muted, Guidance Reaffirmed, Ziftomenib Approval Decision Awaited

​Kyowa Kirin 1H revenue declines 1% YoY to ¥230.7B, impacted by APAC restructuring and reduced drug prices in Japan. FDA decision on ziftomenib in...

Tina Banerjee

Nippon Shinyaku and Capricor announce positive Phase 3 results for Deramiocel, with potential FDA approval and commercialization on the horizon....

Shionogi reported flat revenue and profits in H1FY26, missing targets. The company has lowered FY26 revenue guidance, but raised operating and net...

Nippon Shinyaku reports mixed 1QFY26 result, with revenue growing 1% YoY and operating profit decreasing 9% YoY due to forex losses. The company...

Kyowa Kirin 1H revenue declines 1% YoY to ¥230.7B, impacted by APAC restructuring and reduced drug prices in Japan. FDA decision on ziftomenib in...