Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>During H1FY25, <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 3% YoY growth in revenue, driven by mainstay drugs. However, operating profit declined 11% YoY and net profit decreased 6% YoY.</li>
<li>Although Eisai kept its FY25 total revenue guidance unchanged, it has reduced Leqembi FY25 revenue guidance by ¥14B to ¥42.5B due to lower revenue expectation from Americas.</li>
<li>Leqembi is expected to be approved in Europe for a narrower set of patients. Next year, the drug will face competition in the U.S.</li>
</ul>


During H1FY25, Eisai Co Ltd (4523 JP) reported 3% YoY growth in revenue, driven by mainstay drugs. However, operating profit declined 11% YoY and net profit decreased 6% YoY.
Although Eisai kept its FY25 total revenue guidance unchanged, it has reduced Leqembi FY25 revenue guidance by ¥14B to ¥42.5B due to lower revenue expectation from Americas.
Leqembi is expected to be approved in Europe for a narrower set of patients. Next year, the drug will face competition in the U.S.


Eisai Co Ltd (4523 JP): Mixed H1FY25 Performance; Guidance Reaffirmed; Leqembi Struggle Continues

Thematic (Sector/Industry)

<ul>
<li>GenScript Biotech established operations site and logistics center in Australia. Eisai has received positive opinion from CHMP recommending approval of lecanemab. Otsuka forms JV to boost IV supply in US.</li>
<li>Lunit formed strategic alliance in France to expand AI solution deployment. Daiichi Sankyo and AstraZeneca submitted a new BLA for accelerated approval in the U.S. for datopotamab deruxtecan for NSCLC.</li>
<li>Cellid has completed recruiting and dosing all participants in its Phase 3 clinical trial of COVID-19 vaccine targeting Omicron variant. Alembic Pharmaceutical received FDA approval for hypertension drug.</li>
</ul>


GenScript Biotech established operations site and logistics center in Australia. Eisai has received positive opinion from CHMP recommending approval of lecanemab. Otsuka forms JV to boost IV supply in US.
Lunit formed strategic alliance in France to expand AI solution deployment. Daiichi Sankyo and AstraZeneca submitted a new BLA for accelerated approval in the U.S. for datopotamab deruxtecan for NSCLC.
Cellid has completed recruiting and dosing all participants in its Phase 3 clinical trial of COVID-19 vaccine targeting Omicron variant. Alembic Pharmaceutical received FDA approval for hypertension drug.


APAC Healthcare Weekly (Nov 17)- GenScript Biotech, Eisai, Otsuka, Daiichi Sankyo, Cellid, and Lunit

<ul>
<li>During 9M24, <a href="https://www.smartkarma.com/entities/otsuka-holdings-co-ltd" target="_blank" data-smartkarma-citation="entities:12292:1" rel="noopener">Otsuka Holdings (4578 JP)</a> reported 19% YoY growth in revenue from pharmaceuticals segment to ¥1201B, mainly driven by a 28% YoY growth in Rexulti revenue to ¥196B.</li>
<li>The company has reduced 2024 revenue guidance marginally, raised the operating profit projections, while net profit guidance was kept unchanged.</li>
<li>In 3Q24, Rexulti received approval in Japan for agitation associated with dementia due to Alzheimer's disease. FDA action date for post-traumatic stress disorder indication is on February 8, 2025.</li>
</ul>


During 9M24, Otsuka Holdings (4578 JP) reported 19% YoY growth in revenue from pharmaceuticals segment to ¥1201B, mainly driven by a 28% YoY growth in Rexulti revenue to ¥196B.
The company has reduced 2024 revenue guidance marginally, raised the operating profit projections, while net profit guidance was kept unchanged.
In 3Q24, Rexulti received approval in Japan for agitation associated with dementia due to Alzheimer's disease. FDA action date for post-traumatic stress disorder indication is on February 8, 2025.


Otsuka Holdings (4578 JP): Revenue and Profit Continue to Rise, Rexulti Remains Key

<ul>
<li>
<a href="https://www.smartkarma.com/entities/astellas-pharma-inc" target="_blank" data-smartkarma-citation="entities:6091:1" rel="noopener">Astellas Pharma (4503 JP)</a> reported revenue of ¥936B, up 22% YoY in H1FY25. The U.S. sales of Xtandi jumped 35% YoY to ¥245B.</li>
<li>Xtandi and Padcev will continue to be the key drivers of future growth and are expected to contribute 57% of total revenues in FY25.</li>
<li>Astellas raised guidance of FY25 revenue by 9% to ¥1800B (up 12% YoY). Core operating profit and net profit are also expected to rise, while margins to be under pressure.</li>
</ul>



Astellas Pharma (4503 JP) reported revenue of ¥936B, up 22% YoY in H1FY25. The U.S. sales of Xtandi jumped 35% YoY to ¥245B.
Xtandi and Padcev will continue to be the key drivers of future growth and are expected to contribute 57% of total revenues in FY25.
Astellas raised guidance of FY25 revenue by 9% to ¥1800B (up 12% YoY). Core operating profit and net profit are also expected to rise, while margins to be under pressure.


Astellas Pharma (4503 JP): US Momentum Drives 1HFY25 Result; Guidance Revised Upward

<ul>
<li>
<a href="https://www.smartkarma.com/entities/samsung-biologics-co-ltd" target="_blank" data-smartkarma-citation="entities:22932:1" rel="noopener">Samsung Biologics (207940 KS)</a> signed a contract manufacturing agreement worth KRW1.7T ($1.2B) with an Asian pharmaceutical company. <a href="https://www.smartkarma.com/entities/celltrion-inc" target="_blank" data-smartkarma-citation="entities:991:1" rel="noopener">Celltrion Inc (068270 KS)</a> has announced KRW100B ($72M) share buyback, starting October 28.</li>
<li>
<a href="https://www.smartkarma.com/entities/astellas-pharma-inc" target="_blank" data-smartkarma-citation="entities:6091:1" rel="noopener">Astellas Pharma (4503 JP)</a> received FDA approval for Vyloy for gastric cancer. <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> received FDA Fast Track designation for its RSV drug candidate, S-337395.</li>
<li>
<a href="https://www.smartkarma.com/entities/zai-lab-ltd-94df40cf-c15e-462f-b3de-8d2d434ae935" target="_blank" data-smartkarma-citation="entities:36261:1" rel="noopener">Zai Lab (9688 HK)</a> announced positive topline data from global Phase 1a/1b study of ZL-1310 in small cell lung cancer. <a href="https://www.smartkarma.com/entities/legend-biotech-corp" target="_blank" data-smartkarma-citation="entities:28963:1" rel="noopener">Legend Biotech Corp (LEGN US)</a> sheds Genscript Biotech as its majority shareholder.</li>
</ul>



Samsung Biologics (207940 KS) signed a contract manufacturing agreement worth KRW1.7T ($1.2B) with an Asian pharmaceutical company. Celltrion Inc (068270 KS) has announced KRW100B ($72M) share buyback, starting October 28.

Astellas Pharma (4503 JP) received FDA approval for Vyloy for gastric cancer. Shionogi &amp; Co (4507 JP) received FDA Fast Track designation for its RSV drug candidate, S-337395.

Zai Lab (9688 HK) announced positive topline data from global Phase 1a/1b study of ZL-1310 in small cell lung cancer. Legend Biotech Corp (LEGN US) sheds Genscript Biotech as its majority shareholder.


APAC Healthcare Weekly (Oct 27)- Samsung Biologics, Celltrion, Astellas, Otsuka, Legend, and Zai Lab

Japan

Otsuka Holdings Co Ltd is a pharmaceutical company. The Company manufactures, sells, imports and exports pharmaceuticals, clinical testing, and medical equipment for intractable diseases.

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Otsuka Holdings (4578 JP)

Eisai Co Ltd (4523 JP): Mixed H1FY25 Performance; Guidance Reaffirmed; Leqembi Struggle Continues

Eisai sees revenue growth but profit decline in H1FY25. The company reduced Leqembi guidance for FY25. Leqembi is expected to be approved in...

Tina Banerjee

APAC Healthcare Weekly (Nov 17)- GenScript Biotech, Eisai, Otsuka, Daiichi Sankyo, Cellid, and Lunit

Biotech companies expand operations globally with new sites and drug approvals, advancing healthcare solutions and treatments. A phase 3 trial for...

Tina Banerjee