Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>During 1H24 <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 18% YoY growth in revenue from pharmaceuticals segment to ¥767B, mainly driven by a 27% YoY growth in Rexulti revenue to ¥122B.</li>
<li>The company has revised upward 2024 revenue and business profit, while reduced 2024 operating and net profit guidance due to the recording of an impairment loss.</li>
<li>Otsuka is acquiring Jnana Therapeutics for $800M. The transaction includes JNT-517, a potential first-in-class oral treatment for Phenylketonuria, a rare inherited metabolic disorder. The acquisition will close in 3Q24.</li>
</ul>


During 1H24 Otsuka Holdings (4578 JP) reported 18% YoY growth in revenue from pharmaceuticals segment to ¥767B, mainly driven by a 27% YoY growth in Rexulti revenue to ¥122B.
The company has revised upward 2024 revenue and business profit, while reduced 2024 operating and net profit guidance due to the recording of an impairment loss.
Otsuka is acquiring Jnana Therapeutics for $800M. The transaction includes JNT-517, a potential first-in-class oral treatment for Phenylketonuria, a rare inherited metabolic disorder. The acquisition will close in 3Q24.


Otsuka Holdings (4578 JP): H1 Revenue Rises 17% on Rexulti; Picks Up Jnana Therapeutics for $800M

<ul>
<li>
<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> announced FDA acceptance of indication expansion filing for Rexulti for the treatment of post-traumatic stress disorder. The FDA action date is February 8, 2025.</li>
<li>Due to impairment loss associated with termination of a pipeline asset, the company has reduced operating and net profit guidance for 1H24. However, 1H24 revenue guidance has been raised.</li>
<li>2028 revenue is expected to reach ¥2.5T, an increase of ¥480B from 2023 results, that too after absorbing the negative impact of ~¥310B for loss of exclusivity of core drugs.</li>
</ul>



Otsuka Holdings (4578 JP) announced FDA acceptance of indication expansion filing for Rexulti for the treatment of post-traumatic stress disorder. The FDA action date is February 8, 2025.
Due to impairment loss associated with termination of a pipeline asset, the company has reduced operating and net profit guidance for 1H24. However, 1H24 revenue guidance has been raised.
2028 revenue is expected to reach ¥2.5T, an increase of ¥480B from 2023 results, that too after absorbing the negative impact of ~¥310B for loss of exclusivity of core drugs.


Otsuka Holdings (4578 JP): Label Expansion of Rexulti; 1H24 Guidance Revision; New Mid-Term Plan

<ul>
<li>On July 2, <a href="https://www.smartkarma.com/entities/eli-lilly-co" target="_blank" data-smartkarma-citation="entities:19419:1" rel="noopener">Eli Lilly &amp; Co (LLY US)</a> has received FDA approval for its Alzheimer’s disease drug Kisunla, which will compete head-on-head with <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>'s Leqembi.  </li>
<li>Efficacy and indications of both the drugs are similar. Price comparison is tricky. However, Kisunla can be stopped when amyloid plaques are removed, which is not the case for Leqembi.</li>
<li>Eisai is not expected to face immediate competition and should comfortably meet Leqembi FY25 revenue target of ¥56.5B, including ¥43.5B from the U.S. Recently, Leqembi has been launched in China.</li>
</ul>


On July 2, Eli Lilly &amp; Co (LLY US) has received FDA approval for its Alzheimer’s disease drug Kisunla, which will compete head-on-head with Eisai Co Ltd (4523 JP)'s Leqembi.  
Efficacy and indications of both the drugs are similar. Price comparison is tricky. However, Kisunla can be stopped when amyloid plaques are removed, which is not the case for Leqembi.
Eisai is not expected to face immediate competition and should comfortably meet Leqembi FY25 revenue target of ¥56.5B, including ¥43.5B from the U.S. Recently, Leqembi has been launched in China.


Eisai Co Ltd (4523 JP): New Competition Is Coming for Alzheimer’s Disease Drug; No Immediate Threat

Global Healthcare Strategist

Vincy Ip

Thematic (Sector/Industry)

<ul>
<li>Brain disorders, including various neurological and mental diseases, are the hidden danger with the largest social burden among all diseases. </li>
<li>With strong government support across the globe and accelerating private financing, we identify four key areas of investment opportunities in brain science, including neurotherapeutics, neurodiagnostics, neurosurgery, and brain-computer interface (BCI).</li>
<li>Even though the concept of BCI looks promising, its scalability, application, and monetisation potential remain uncertain in the near term and hence the invesmtent risks would be high. </li>
</ul>


Brain disorders, including various neurological and mental diseases, are the hidden danger with the largest social burden among all diseases. 
With strong government support across the globe and accelerating private financing, we identify four key areas of investment opportunities in brain science, including neurotherapeutics, neurodiagnostics, neurosurgery, and brain-computer interface (BCI).
Even though the concept of BCI looks promising, its scalability, application, and monetisation potential remain uncertain in the near term and hence the invesmtent risks would be high. 


Brain Science - An Opportunity or a Trap?

<ul>
<li>
<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> has guided for FY25 Leqembi revenue of ¥56.5B (~$366M), with ¥43.5B from U.S., and ¥10.0B from Japan. In FY24, Leqembi reported worldwide revenue of ¥4.2B.</li>
<li>Leqembi is expected to grow significantly due to increase in prescriptions following the progress in the development of AD diagnosis and treatment pathways in the U.S. and Japan.</li>
<li>The current rally can be short lived, as the competitor drug is expected to get FDA approval in 3Q24.</li>
</ul>



Eisai Co Ltd (4523 JP) has guided for FY25 Leqembi revenue of ¥56.5B (~$366M), with ¥43.5B from U.S., and ¥10.0B from Japan. In FY24, Leqembi reported worldwide revenue of ¥4.2B.
Leqembi is expected to grow significantly due to increase in prescriptions following the progress in the development of AD diagnosis and treatment pathways in the U.S. and Japan.
The current rally can be short lived, as the competitor drug is expected to get FDA approval in 3Q24.


Eisai Co Ltd (4523 JP): Leqembi Is Gathering Momentum; Imminent Competition May Spoil the Party

Japan

Eisai Co., Ltd. produces prescription drugs and medical equipment and sells mainly to sales agents and subsidiaries.  Through its subsidiary, Sanko Junyaku, the Company produces and sells diagnostic drugs.  Eisai also markets its products through related companies in the US, Europe, and Asia.  The Company also manufactures and sells foods, livestock feeds, chemical, and agrochemicals.

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Eisai Co Ltd (4523 JP)

Otsuka Holdings (4578 JP): H1 Revenue Rises 17% on Rexulti; Picks Up Jnana Therapeutics for $800M

Otsuka reports 27% revenue growth in Rexulti in 1H24. The company raised 2024 sales and business profit guidance. Acquisition of Jnana...

Tina Banerjee

Otsuka Holdings (4578 JP): Label Expansion of Rexulti; 1H24 Guidance Revision; New Mid-Term Plan

Otsuka’s 2Q24 result is anticipated to exceed revised forecast, due to stronger than expected business performance and lower than expected...

Tina Banerjee