Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<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>announced that ziftomenib is now commercially available in the U.S. Company will be eligible for 50% profit sharing from drug sales in the U.S.</li>
<li>Rocatinlimab, under Phase 3 trials, represents a potentially novel upstream approach for the management of mild to severe atopic dermatitis. It is also undergoing Phase 3 trials for Prurigo nodularis.</li>
<li>2026 will be an inflection point. Ziftomenib results will slowly fall in place. Positive results of rocatinlimab and new manufacturing facilities has potential to play out in long term.</li>
</ul>



Kyowa Kirin Co Ltd (4151 JP) announced that ziftomenib is now commercially available in the U.S. Company will be eligible for 50% profit sharing from drug sales in the U.S.
Rocatinlimab, under Phase 3 trials, represents a potentially novel upstream approach for the management of mild to severe atopic dermatitis. It is also undergoing Phase 3 trials for Prurigo nodularis.
2026 will be an inflection point. Ziftomenib results will slowly fall in place. Positive results of rocatinlimab and new manufacturing facilities has potential to play out in long term.


Kyowa Kirin (4151 JP): Ziftomenib Approval and Commercialization A Positive, What Lies Ahead?

<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

Thematic (Sector/Industry)

<ul>
<li>We have screened for APAC (ex-China) healthcare companies using their respective Smart Score, a compound score for a company indicating its overall outlook based on key factors.</li>
<li>Smart Score screens the stock based on five major components including value, dividends, growth, resilience, and momentum. It also provides a cumulative score, which puts equal weightage on each parameter.  </li>
<li>Parameters used to screen the stocks: market cap≥ $800M and smart score≥ 3.5. We have seen stocks having high smart score has strong growth prospects and qualify for investment proposition.</li>
</ul>


We have screened for APAC (ex-China) healthcare companies using their respective Smart Score, a compound score for a company indicating its overall outlook based on key factors.
Smart Score screens the stock based on five major components including value, dividends, growth, resilience, and momentum. It also provides a cumulative score, which puts equal weightage on each parameter.  
Parameters used to screen the stocks: market cap≥ $800M and smart score≥ 3.5. We have seen stocks having high smart score has strong growth prospects and qualify for investment proposition.


Top APAC (Ex-China) Investment Worthy Healthcare Companies Using Smartkarma’s Smart Score Screener

<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> announced muted 1Q25 performance, with flat revenue and 50%+ drop in operating and net profits. Drug price revision and competition are dragging Japan revenue.</li>
<li>Kyowa Kirin guided for 2025 revenue and operating profit of ¥478B (-4% YoY) and ¥80B (-16% YoY), respectively. The company expects 5% YoY decline in 2025 net profit to ¥57B.</li>
<li>Since our last insight on Kyowa Kirin, shares lost ~15%. We opined “amid gloomy outlook, Kyowa Kirin shares will need time to recover.” Our take on the company remains same.</li>
</ul>



Kyowa Kirin Co Ltd (4151 JP) announced muted 1Q25 performance, with flat revenue and 50%+ drop in operating and net profits. Drug price revision and competition are dragging Japan revenue.
Kyowa Kirin guided for 2025 revenue and operating profit of ¥478B (-4% YoY) and ¥80B (-16% YoY), respectively. The company expects 5% YoY decline in 2025 net profit to ¥57B.
Since our last insight on Kyowa Kirin, shares lost ~15%. We opined “amid gloomy outlook, Kyowa Kirin shares will need time to recover.” Our take on the company remains same.


Kyowa Kirin (4151 JP): Muted 1Q25 Result; 2025 Guidance Reaffirmed; Near-Term Pain to Continue

<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

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)

Kyowa Kirin (4151 JP): Ziftomenib Approval and Commercialization A Positive, What Lies Ahead?

Kyowa Kirin's ziftomenib is now commercially available in the U.S. Rocatinlimab shows promise for atopic dermatitis and Prurigo nodularis in Phase...

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

Top APAC (Ex-China) Investment Worthy Healthcare Companies Using Smartkarma’s Smart Score Screener

We have screened APAC (ex-China) healthcare companies with market cap≥$800M using Smartkarma’s Smart Score and picked up 2 investable ideas by...

Tina Banerjee

Kyowa Kirin (4151 JP): Muted 1Q25 Result; 2025 Guidance Reaffirmed; Near-Term Pain to Continue

Kyowa Kirin reports flat revenue and 50%+ profit drop in 1Q25, dragged by drug price revision and competition in Japan. The company guides for...

Tina Banerjee

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

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52-week Range

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Kyowa Kirin (4151 JP): Ziftomenib Approval and Commercialization A Positive, What Lies Ahead?

​Kyowa Kirin's ziftomenib is now commercially available in the U.S. Rocatinlimab shows promise for atopic dermatitis and Prurigo nodularis in Phase...

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

Top APAC (Ex-China) Investment Worthy Healthcare Companies Using Smartkarma’s Smart Score Screener

We have screened APAC (ex-China) healthcare companies with market cap≥$800M using Smartkarma’s Smart Score and picked up 2 investable ideas by...

Tina Banerjee

Kyowa Kirin (4151 JP): Muted 1Q25 Result; 2025 Guidance Reaffirmed; Near-Term Pain to Continue

​Kyowa Kirin reports flat revenue and 50%+ profit drop in 1Q25, dragged by drug price revision and competition in Japan. The company guides for...

Tina Banerjee

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

Kyowa Kirin's ziftomenib is now commercially available in the U.S. Rocatinlimab shows promise for atopic dermatitis and Prurigo nodularis in Phase...

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...

Kyowa Kirin reports flat revenue and 50%+ profit drop in 1Q25, dragged by drug price revision and competition in Japan. The company guides for...

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