Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>After two rejections, Mesoblast has finally received FDA approval for its first drug. Celltrion has received FDA approval for its Stelara biosimilar, which will be launched in February 2025.</li>
<li>Peptidream has become eligible for a milestone payment. Sumitomo Pharma is strengthening R&amp;D for regenerative medicine and cell therapy business. Astellas Pharma in-licenses technology for developing neurology drugs.</li>
<li>Hansoh Pharmaceutical granted an exclusive global license to Merck for its pre-clinical drug candidate. Lupin received FDA approval to market generic version of blockbuster Descovy tablets.</li>
</ul>


After two rejections, Mesoblast has finally received FDA approval for its first drug. Celltrion has received FDA approval for its Stelara biosimilar, which will be launched in February 2025.
Peptidream has become eligible for a milestone payment. Sumitomo Pharma is strengthening R&amp;D for regenerative medicine and cell therapy business. Astellas Pharma in-licenses technology for developing neurology drugs.
Hansoh Pharmaceutical granted an exclusive global license to Merck for its pre-clinical drug candidate. Lupin received FDA approval to market generic version of blockbuster Descovy tablets.


APAC Healthcare Weekly (Dec 22)- Mesoblast, Celltrion, Peptidream, Astellas, Hansoh, Lupin

<ul>
<li>Samsung Biologics signs manufacturing deals worth over $668M with European pharmaceutical company. Celltrion is acquiring iQone Healthcare, a specialty pharmaceutical distribution company in Switzerland. Kyowa Kirin collaborates for leukemia drug.</li>
<li>Takeda launched Hutchmed’s colorectal cancer drug Fruzaqla in Japan. FDA has turned down Astellas Pharma’s application for label update of geographic atrophy drug Izervay. Lunit is partnering with AstraZeneca.</li>
<li>Yuhan is one step ahead for European approval of Leclaza. HK inno.N signs domestic supply contract for Roche’s influenza treatment, Tamiflu. Beigene settles litigation against generic filer of Brukinsa.</li>
</ul>


Samsung Biologics signs manufacturing deals worth over $668M with European pharmaceutical company. Celltrion is acquiring iQone Healthcare, a specialty pharmaceutical distribution company in Switzerland. Kyowa Kirin collaborates for leukemia drug.
Takeda launched Hutchmed’s colorectal cancer drug Fruzaqla in Japan. FDA has turned down Astellas Pharma’s application for label update of geographic atrophy drug Izervay. Lunit is partnering with AstraZeneca.
Yuhan is one step ahead for European approval of Leclaza. HK inno.N signs domestic supply contract for Roche’s influenza treatment, Tamiflu. Beigene settles litigation against generic filer of Brukinsa.


APAC Healthcare Weekly (Nov 24)- Samsung Biologics, Celltrion, Takeda, Kyowa Kirin, Astellas Pharma

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

<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/sumitomo-pharma-co" target="_blank" data-smartkarma-citation="entities:1935:1" rel="noopener">Sumitomo Pharma (4506 JP)</a> reported 18% revenue growth in H1FY25, driven by North America. Operating loss narrowed due to business restructuring. Despite a forex loss, net loss also narrowed.</li>
<li>The company is expected to report core operating profit of ¥1B in H2FY25, while net profit is likely to be ¥16B versus a net loss of ¥247B in H2FY24.</li>
<li>With the ongoing restructuring and streamlining, it will take some time for the results to slowly fall in place. Sumitomo aims for turning positive at net profit level in FY26.</li>
</ul>



Sumitomo Pharma (4506 JP) reported 18% revenue growth in H1FY25, driven by North America. Operating loss narrowed due to business restructuring. Despite a forex loss, net loss also narrowed.
The company is expected to report core operating profit of ¥1B in H2FY25, while net profit is likely to be ¥16B versus a net loss of ¥247B in H2FY24.
With the ongoing restructuring and streamlining, it will take some time for the results to slowly fall in place. Sumitomo aims for turning positive at net profit level in FY26.


Sumitomo Pharma (4506 JP): Challenges Remain, But Slowly Getting There; North America Remains Key

Japan

Astellas Pharma Inc. is a pharmaceutical company committed to the therapeutic fields of urology, immunology including transplantation and infectious diseases, oncology, euroscience and DM complications and metabolic diseases. The Company researches, develops, manufactures, and promotes its prescription drugs through subsidiaries in the US, Europe, and Asia.

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Astellas Pharma (4503 JT)

APAC Healthcare Weekly (Dec 22)- Mesoblast, Celltrion, Peptidream, Astellas, Hansoh, Lupin

Mesoblast got FDA approval for its first drug, while Betta Pharma, Celltrion, and Lupin also received some major FDA approvals. Pharma companies...

Tina Banerjee

APAC Healthcare Weekly (Nov 24)- Samsung Biologics, Celltrion, Takeda, Kyowa Kirin, Astellas Pharma

Samsung Biologics secures new manufacturing deals, Celltrion is acquiring iQone Healthcare, Takeda launches colorectal cancer drug in Japan, and...

Tina Banerjee

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

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

During 9M24, Otsuka reported 19% growth in revenue from pharmaceuticals segment to ¥1201B, mainly driven by a 28% growth in Rexulti to ¥196B. FDA...

Tina Banerjee

Sumitomo Pharma (4506 JP): Challenges Remain, But Slowly Getting There; North America Remains Key

Sumitomo Pharma sees revenue growth in H1FY25, while losses are narrowing due to restructuring. The company is expected to report profit in H2FY25...

Tina Banerjee

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APAC Healthcare Weekly (Dec 22)- Mesoblast, Celltrion, Peptidream, Astellas, Hansoh, Lupin

Mesoblast got FDA approval for its first drug, while Betta Pharma, Celltrion, and Lupin also received some major FDA approvals. Pharma companies...

Tina Banerjee

APAC Healthcare Weekly (Nov 24)- Samsung Biologics, Celltrion, Takeda, Kyowa Kirin, Astellas Pharma

​Samsung Biologics secures new manufacturing deals, Celltrion is acquiring iQone Healthcare, Takeda launches colorectal cancer drug in Japan, and...

Tina Banerjee

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

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

​During 9M24, Otsuka reported 19% growth in revenue from pharmaceuticals segment to ¥1201B, mainly driven by a 28% growth in Rexulti to ¥196B. FDA...

Tina Banerjee

Sumitomo Pharma (4506 JP): Challenges Remain, But Slowly Getting There; North America Remains Key

​Sumitomo Pharma sees revenue growth in H1FY25, while losses are narrowing due to restructuring. The company is expected to report profit in H2FY25...

Tina Banerjee

Samsung Biologics secures new manufacturing deals, Celltrion is acquiring iQone Healthcare, Takeda launches colorectal cancer drug in Japan, and...

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

During 9M24, Otsuka reported 19% growth in revenue from pharmaceuticals segment to ¥1201B, mainly driven by a 28% growth in Rexulti to ¥196B. FDA...

Sumitomo Pharma sees revenue growth in H1FY25, while losses are narrowing due to restructuring. The company is expected to report profit in H2FY25...