Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>A US court found <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> guilty of patent infringement related to competitor <a href="https://www.smartkarma.com/entities/sarepta-therapeutics-inc" target="_blank" data-smartkarma-citation="entities:17729:1" rel="noopener">Sarepta Therapeutics (SRPT US)</a>'s DMD drug Vyondys 53 and asked to pay $115M as compensation.  </li>
<li>The jury verdict will have no bearing on Viltepso sales. Nippon Shinyaku disagreed with the verdict, and is considering all options including post jury motions and appeals.</li>
<li>An additional expense to the tune of $115M would surely be a huge drag on the profitability of the company which is already under pressure because of rising costs.</li>
</ul>


A US court found Nippon Shinyaku (4516 JP) guilty of patent infringement related to competitor Sarepta Therapeutics (SRPT US)'s DMD drug Vyondys 53 and asked to pay $115M as compensation.  
The jury verdict will have no bearing on Viltepso sales. Nippon Shinyaku disagreed with the verdict, and is considering all options including post jury motions and appeals.
An additional expense to the tune of $115M would surely be a huge drag on the profitability of the company which is already under pressure because of rising costs.


Nippon Shinyaku (4516 JP): Unfavorable Patent Verdict; Company Vows to Fight Back

Event-Driven

<ul>
<li>
<a href="https://www.smartkarma.com/entities/bristol-myers-squibb-co" target="_blank" data-smartkarma-citation="entities:1133:1" rel="noopener">Bristol Myers Squibb Co (BMY US)</a> is acquiring <a href="https://www.smartkarma.com/entities/karuna-therapeutics-inc" target="_blank" data-smartkarma-citation="entities:28720:1" rel="noopener">Karuna Therapeutics Inc (KRTX US)</a> for $330/share in cash for equity value of ~$14B. The transaction is expected to close in 1H24. </li>
<li>Karuna’s lead asset, KarXT has FDA action date of September 26, 2024 for the treatment of schizophrenia in adults. KarXT has peak annual sales potential of $6–7B.</li>
<li>Considering strong clinical efficacy and favorable risk profile of KarXT, the deal seems to be fairly valued. Current market price of Karuna shares of $318.41 represents absolute spread of ~3.6%.</li>
</ul>



Bristol Myers Squibb Co (BMY US) is acquiring Karuna Therapeutics Inc (KRTX US) for $330/share in cash for equity value of ~$14B. The transaction is expected to close in 1H24. 
Karuna’s lead asset, KarXT has FDA action date of September 26, 2024 for the treatment of schizophrenia in adults. KarXT has peak annual sales potential of $6–7B.
Considering strong clinical efficacy and favorable risk profile of KarXT, the deal seems to be fairly valued. Current market price of Karuna shares of $318.41 represents absolute spread of ~3.6%.


Karuna Therapeutics (KRTX US): BMS Acquisition Offers Decent Short-Term Trading Opportunity

<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>'s FY24 revenue guidance is 3% below mid-term target, while operating and net profits guidance are 20% and 17% below the target, respectively.  </li>
<li>Revenue growth of Viltepso is expected to decelerate to 28% in FY24 from 85% in FY23, dragged by the U.S. sales, which contributes 74% of Viltepso revenue.</li>
<li>Rival <a href="https://www.smartkarma.com/entities/sarepta-therapeutics-inc" target="_blank" data-smartkarma-citation="entities:17729:1" rel="noopener">Sarepta Therapeutics (SRPT US)</a> is expected to receive FDA approval for its next DMD gene therapy drug this month, leading to a new competition for Viltepso.</li>
</ul>



Nippon Shinyaku (4516 JP)'s FY24 revenue guidance is 3% below mid-term target, while operating and net profits guidance are 20% and 17% below the target, respectively.  
Revenue growth of Viltepso is expected to decelerate to 28% in FY24 from 85% in FY23, dragged by the U.S. sales, which contributes 74% of Viltepso revenue.
Rival Sarepta Therapeutics (SRPT US) is expected to receive FDA approval for its next DMD gene therapy drug this month, leading to a new competition for Viltepso.


Nippon Shinyaku (4516 JP): FY24 Guidance Falls Short of Mid-Term Target; DMD Drug Growth Slows Down

<ul>
<li>Driven by continued strong performance of Viltepso and other partnered drugs, <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>  is expected to report accelerated revenue growth momentum.</li>
<li>Viltepso is expected to be the top selling drug of Nippon Shinyaku in FY23. For FY23, the drug is expected to report revenue of ¥14.7 billion (+90% y/y).</li>
<li>In November, Nippon Shinyaku launched Fintepla (fenfluramine) for the treatment of seizures in patients with Dravet syndrome (DS) as an add-on therapy to other anti-epileptic medicines in Japan.</li>
</ul>


Driven by continued strong performance of Viltepso and other partnered drugs, Nippon Shinyaku (4516 JP)  is expected to report accelerated revenue growth momentum.
Viltepso is expected to be the top selling drug of Nippon Shinyaku in FY23. For FY23, the drug is expected to report revenue of ¥14.7 billion (+90% y/y).
In November, Nippon Shinyaku launched Fintepla (fenfluramine) for the treatment of seizures in patients with Dravet syndrome (DS) as an add-on therapy to other anti-epileptic medicines in Japan.


Nippon Shinyaku (4516 JP): Viltepso Has Strong Muscle Power; New Seizure Drug Launch in Japan

<ul>
<li>Chugai’s in-house drug, Actemra is recommended by the WHO for the treatment of hospitalized COVID-19 patients. In-licensed drug Ronapreve is approved for the treatment of mild to moderate COVID-19 patients.</li>
<li>Actemra and Ronapreve together are expected to contribute 29% of total revenue in 2021. Approval of oral COVID-19 anti-viral pill will pressurize both the drugs in 2022 and beyond.</li>
<li>Chugai’s recently in-licensed gene therapy drug candidate for Duchenne muscular dystrophy will have to compete with existing drug and other pipeline candidates in Japan.  </li>
</ul>


Chugai’s in-house drug, Actemra is recommended by the WHO for the treatment of hospitalized COVID-19 patients. In-licensed drug Ronapreve is approved for the treatment of mild to moderate COVID-19 patients.
Actemra and Ronapreve together are expected to contribute 29% of total revenue in 2021. Approval of oral COVID-19 anti-viral pill will pressurize both the drugs in 2022 and beyond.
Chugai’s recently in-licensed gene therapy drug candidate for Duchenne muscular dystrophy will have to compete with existing drug and other pipeline candidates in Japan.  


Chugai Pharmaceutical (4519 JP): Actemra Loses Its Sheen on Arrival of Oral COVID-19 Pill

United States

Sarepta Therapeutics, Inc. is a biopharmaceutical company focused on the discovery and development of unique RNA-based therapeutics for the treatment of both rare and infectious diseases. The Company offers its products to the medical industry in countries around the world.

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Sarepta Therapeutics (SRPT US)

Nippon Shinyaku (4516 JP): Unfavorable Patent Verdict; Company Vows to Fight Back

US court orders Nippon Shinyaku to pay $115M for patent infringement on Sarepta Therapeutics' DMD drug Vyondys 53. This will significantly impact...

Tina Banerjee

Karuna Therapeutics (KRTX US): BMS Acquisition Offers Decent Short-Term Trading Opportunity

BMS is acquiring Karuna Therapeutics for $330/share in cash, with the deal expected to close in 1H24. Current market price of Karuna shares...

Tina Banerjee

Nippon Shinyaku (4516 JP): FY24 Guidance Falls Short of Mid-Term Target; DMD Drug Growth Slows Down

Nippon Shinyaku’s FY24 revenue, operating and net profits guidance are 3%, 20%, and 17% below mid-term target, respectively. Viltepso revenue...

Tina Banerjee

Nippon Shinyaku (4516 JP): Viltepso Has Strong Muscle Power; New Seizure Drug Launch in Japan

Strong performance of DMD drug Viltepso in US market and reviving functional food business have enabled the company to raise FY23 guidance. Late...

Tina Banerjee

Chugai Pharmaceutical (4519 JP): Actemra Loses Its Sheen on Arrival of Oral COVID-19 Pill

Chugai's COVID-19 drugs do not seem to be stack up well against the newly approved oral COVID-19 drugs in 2022 and beyond. The company has already...

Tina Banerjee

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Nippon Shinyaku (4516 JP): Unfavorable Patent Verdict; Company Vows to Fight Back

​US court orders Nippon Shinyaku to pay $115M for patent infringement on Sarepta Therapeutics' DMD drug Vyondys 53. This will significantly impact...

Tina Banerjee

Karuna Therapeutics (KRTX US): BMS Acquisition Offers Decent Short-Term Trading Opportunity

​BMS is acquiring Karuna Therapeutics for $330/share in cash, with the deal expected to close in 1H24. Current market price of Karuna shares...

Tina Banerjee

Nippon Shinyaku (4516 JP): FY24 Guidance Falls Short of Mid-Term Target; DMD Drug Growth Slows Down

Nippon Shinyaku’s FY24 revenue, operating and net profits guidance are 3%, 20%, and 17% below mid-term target, respectively. Viltepso revenue...

Tina Banerjee

Nippon Shinyaku (4516 JP): Viltepso Has Strong Muscle Power; New Seizure Drug Launch in Japan

Strong performance of DMD drug Viltepso in US market and reviving functional food business have enabled the company to raise FY23 guidance. Late...

Tina Banerjee

Chugai Pharmaceutical (4519 JP): Actemra Loses Its Sheen on Arrival of Oral COVID-19 Pill

Chugai's COVID-19 drugs do not seem to be stack up well against the newly approved oral COVID-19 drugs in 2022 and beyond. The company has already...

Tina Banerjee

US court orders Nippon Shinyaku to pay $115M for patent infringement on Sarepta Therapeutics' DMD drug Vyondys 53. This will significantly impact...

BMS is acquiring Karuna Therapeutics for $330/share in cash, with the deal expected to close in 1H24. Current market price of Karuna shares...