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Research from Water Tower Research

Water Tower Research is a leading equity research firm that provides research on micro, small and mid cap companies.

Water Tower Research was founded by Wall Street veterans after witnessing a fundamental shift in the investment research industry with the result being a declining knowledge base among investors, a lack of awareness and a shrinking pool of fundamental research being conducted on companies across the small-cap and micro-cap spectrum. The same issues are now increasingly occurring in the mid-cap space. This sea change within the investment community is impacting not only the companies themselves but also current shareholders and potential investors. With significantly less active sell-side sponsorship by Wall Street, a substantial information gap has developed between companies and various constituents in the financial community. The net result is fewer channels for insight and information to flow between companies and investors.

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<ul><li>The HHS rescheduled the CDC’s postponed February ACIP (vaccine experts panel) meeting for mid-April, with a revised agenda to include the ongoing measles outbreak.</li><li>Flu vaccine guidelines for fall strains are not on the schedule, as the <span style="font-size: var(--content-font-size);">FDA issued recommendations without the usual ACIP guidance. </span></li><li><span style="font-size: var(--content-font-size);">The </span>CDC’s Division of HIV Prevention is under review, which could disrupt a major funding source of HIV prophylaxis (PrEP) drugs (GILD, GSK). </li></ul>

The HHS rescheduled the CDC’s postponed February ACIP (vaccine experts panel) meeting for mid-April, with a revised agenda to include the ongoing measles outbreak.Flu vaccine guidelines for fall strains are not on the schedule, as the FDA issued recommendations without the usual ACIP guidance. The CDC’s Division of HIV Prevention is under review, which could disrupt a major funding source of HIV prophylaxis (PrEP) drugs (GILD, GSK). 

Biopharma Week in Review - March 24, 2025

Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>During 9MFY25, <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> reported revenue growth of 8% YoY to ¥121B, while operating profit stood at ¥33B, up 8% YoY.</li>
<li>Viltepso witnessed growth both in Japan and the U.S. and licensing income also increased on higher overseas sales of Uptravi.</li>
<li>Guidance for FY25 have been raised with sales now expected to be ¥160B, up 8% YoY.</li>
</ul>


During 9MFY25, Nippon Shinyaku (4516 JP) reported revenue growth of 8% YoY to ¥121B, while operating profit stood at ¥33B, up 8% YoY.
Viltepso witnessed growth both in Japan and the U.S. and licensing income also increased on higher overseas sales of Uptravi.
Guidance for FY25 have been raised with sales now expected to be ¥160B, up 8% YoY.


Nippon Shinyaku (4516 JP): Strong 9MFY25 Numbers; FY25 Guidance Raised; Regular Launches Remain Key

<ul><li>Vaccine makers (PFE, MRNA, BNTX, NVAX) had an up-and- down week, as the HHS postponed the CDC’s first scheduled ACIP (vaccine experts panel) meeting of the year.</li><li>Deeper concerns came with reports of RFK Jr.’s plans to overhaul the committee (Politico), possibly replacing members with vaccine skeptics.</li><li>Ending the group’s week was a new bat coronavirus identified in China with transmission potential to humans. </li></ul>

Vaccine makers (PFE, MRNA, BNTX, NVAX) had an up-and- down week, as the HHS postponed the CDC’s first scheduled ACIP (vaccine experts panel) meeting of the year.Deeper concerns came with reports of RFK Jr.’s plans to overhaul the committee (Politico), possibly replacing members with vaccine skeptics.Ending the group’s week was a new bat coronavirus identified in China with transmission potential to humans. 

Biopharma Week in Review - February 24, 2025

<ul>
<li>Daiichi Sankyo received seventh FDA approval for Enhertu in certain types of breast cancers. Eisai received FDA approval for Leqembi’s intravenous monthly maintenance dosing.</li>
<li>Nippon Shinyaku entered into an option agreement with AB2 BIO for the rights of commercialization of Tadekinig alfa in the U.S. for certain rare autoinflammatory diseases.</li>
<li>Shionogi announced positive results from Phase 2 trial of its novel investigational RSV oral antiviral candidate S-337395. Celltrion has received FDA approval for Actemra biosimilar.</li>
</ul>


Daiichi Sankyo received seventh FDA approval for Enhertu in certain types of breast cancers. Eisai received FDA approval for Leqembi’s intravenous monthly maintenance dosing.
Nippon Shinyaku entered into an option agreement with AB2 BIO for the rights of commercialization of Tadekinig alfa in the U.S. for certain rare autoinflammatory diseases.
Shionogi announced positive results from Phase 2 trial of its novel investigational RSV oral antiviral candidate S-337395. Celltrion has received FDA approval for Actemra biosimilar.


APAC Healthcare Weekly (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

<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

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)

Biopharma Week in Review - March 24, 2025

The HHS rescheduled the CDC’s postponed February ACIP (vaccine experts panel) meeting for mid-April, with a revised agenda to include the ongoing...

Water Tower Research

Nippon Shinyaku (4516 JP): Strong 9MFY25 Numbers; FY25 Guidance Raised; Regular Launches Remain Key

Nippon Shinyaku sees high single-digit revenue and profit growth in 9MFY25, with Viltepso and Uptravi driving sales increase. FY25 sales guidance...

Tina Banerjee

Biopharma Week in Review - February 24, 2025

Vaccine makers (PFE, MRNA, BNTX, NVAX) had an up-and- down week, as the HHS postponed the CDC’s first scheduled ACIP (vaccine experts panel)...

Water Tower Research

APAC Healthcare Weekly (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

APAC healthcare companies continued to get approvals for new products and initiates clinical trials. The companies continued with acquisitions and...

Tina Banerjee

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

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Biopharma Week in Review - March 24, 2025

The HHS rescheduled the CDC’s postponed February ACIP (vaccine experts panel) meeting for mid-April, with a revised agenda to include the ongoing...

Water Tower Research

Nippon Shinyaku (4516 JP): Strong 9MFY25 Numbers; FY25 Guidance Raised; Regular Launches Remain Key

​Nippon Shinyaku sees high single-digit revenue and profit growth in 9MFY25, with Viltepso and Uptravi driving sales increase. FY25 sales guidance...

Tina Banerjee

Biopharma Week in Review - February 24, 2025

Vaccine makers (PFE, MRNA, BNTX, NVAX) had an up-and- down week, as the HHS postponed the CDC’s first scheduled ACIP (vaccine experts panel)...

Water Tower Research

APAC Healthcare Weekly (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

APAC healthcare companies continued to get approvals for new products and initiates clinical trials. The companies continued with acquisitions and...

Tina Banerjee

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

Nippon Shinyaku sees high single-digit revenue and profit growth in 9MFY25, with Viltepso and Uptravi driving sales increase. FY25 sales guidance...

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