Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>On August 29, the Centers for Medicare &amp; Medicaid Services unveiled list of 10 drugs, which will come for the first round of price negotiations under the Inflation Reduction Act.</li>
<li>From June 2022 to May 2023, more than 8 million people covered by Medicare used these 10 drugs, which accounted for more than $50B spending in Medicare Part D.</li>
<li>The negotiated price will be effective on January 1, 2026. Most of the companies will not be significantly impacted by the drug price negotiation.</li>
</ul>


On August 29, the Centers for Medicare &amp; Medicaid Services unveiled list of 10 drugs, which will come for the first round of price negotiations under the Inflation Reduction Act.
From June 2022 to May 2023, more than 8 million people covered by Medicare used these 10 drugs, which accounted for more than $50B spending in Medicare Part D.
The negotiated price will be effective on January 1, 2026. Most of the companies will not be significantly impacted by the drug price negotiation.


10 Drugs To Come Under First Round of Medicare Price Negotiations in US to Curb Inflation

Equity Bottom-Up

<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> reported record-high revenue and operating profit of KRW866 billion and KRW253 billion, up 33% and 49%, YoY, respectively in 2Q23, aided by contract signing spree.</li>
<li>With continued orders from the leading global pharmas, the company’s total cumulative CMO contracts reached to $11.3B in July, up 19% from $9.5B at the end of 2022.</li>
<li>Outlook for H2 is more positive with revenue from Plant 4 will be reflected from Q3. Two new biosimilars launch in the U.S. and EU will also add to revenue.</li>
</ul>



Samsung Biologics (207940 KS) reported record-high revenue and operating profit of KRW866 billion and KRW253 billion, up 33% and 49%, YoY, respectively in 2Q23, aided by contract signing spree.
With continued orders from the leading global pharmas, the company’s total cumulative CMO contracts reached to $11.3B in July, up 19% from $9.5B at the end of 2022.
Outlook for H2 is more positive with revenue from Plant 4 will be reflected from Q3. Two new biosimilars launch in the U.S. and EU will also add to revenue.


Samsung Biologics (207940 KS): Strong Momentum in 2Q23- Revenue Up 33%; Net Profit Jumps 22%

<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 received FDA traditional approval for Leqembi injection for the treatment of Alzheimer’s Disease. Following the approval, CMS confirmed broader Medicare coverage for Leqembi.</li>
<li>Leqembi is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s Disease.</li>
<li>Eisai pegged peak sales of Leqembi at $7.3 billion in 2030. The projection is based on the company’s estimate that about 2.5M people will be eligible for treatment by 2030.</li>
</ul>



Eisai Co Ltd (4523 JP) has received FDA traditional approval for Leqembi injection for the treatment of Alzheimer’s Disease. Following the approval, CMS confirmed broader Medicare coverage for Leqembi.
Leqembi is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s Disease.
Eisai pegged peak sales of Leqembi at $7.3 billion in 2030. The projection is based on the company’s estimate that about 2.5M people will be eligible for treatment by 2030.


Eisai Co Ltd (4523 JP): Becomes the Best Alzheimer’s Disease Play After Full FDA Nod

<ul>
<li>
<a href="https://www.smartkarma.com/entities/sosei-group-corp" target="_blank" data-smartkarma-citation="entities:770:1" rel="noopener">Sosei Group (4565 JP)</a> shares sold off heavily after a major setback in partner’s clinical trial. On June 26, <a href="https://www.smartkarma.com/entities/pfizer-inc" target="_blank" data-smartkarma-citation="entities:1131:1" rel="noopener">Pfizer Inc (PFE US)</a> decided to discontinue the development of lotiglipron (PF-07081532).</li>
<li>PF-07081532 is one of three clinical candidates nominated by Pfizer during its multi-target drug discovery collaboration with Sosei to research and develop potential new medicines.</li>
<li>As lotiglipron was the most advanced clinical candidate using Sosei’s drug discovery platform, the heavy sell-off seen in Sosei shares should not be considered as overreaction.</li>
</ul>



Sosei Group (4565 JP) shares sold off heavily after a major setback in partner’s clinical trial. On June 26, Pfizer Inc (PFE US) decided to discontinue the development of lotiglipron (PF-07081532).
PF-07081532 is one of three clinical candidates nominated by Pfizer during its multi-target drug discovery collaboration with Sosei to research and develop potential new medicines.
As lotiglipron was the most advanced clinical candidate using Sosei’s drug discovery platform, the heavy sell-off seen in Sosei shares should not be considered as overreaction.


Sosei Group (4565 JP): Hit Hard by Partner’s Clinical Trial Termination; Need Time to Recover

<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> is expected to receive full approval from the FDA for Alzheimer’s disease drug, Leqembi, as FDA advisory committee voted unanimously in support of the drug.  </li>
<li>Leqembi application has been granted Priority Review, with PDUFA action date of July 6. Once the FDA grants traditional approval, broader Medicare coverage for Leqembi would begin the same day.</li>
<li>Leqembi is expected to receive approval in Japan, EU, and China in FY24. With these approvals, Leqembi is expected to become the top selling Alzheimer’s disease drug globally.</li>
</ul>



Eisai Co Ltd (4523 JP) is expected to receive full approval from the FDA for Alzheimer’s disease drug, Leqembi, as FDA advisory committee voted unanimously in support of the drug.  
Leqembi application has been granted Priority Review, with PDUFA action date of July 6. Once the FDA grants traditional approval, broader Medicare coverage for Leqembi would begin the same day.
Leqembi is expected to receive approval in Japan, EU, and China in FY24. With these approvals, Leqembi is expected to become the top selling Alzheimer’s disease drug globally.


Eisai Co (4523 JP): Alzheimer’s Drug Approaching Full FDA Approval; Other Countries to Follow Soon

United States

Eli Lilly and Company discovers, develops, manufactures, and sells pharmaceutical products for humans and animals. The Company products are sold in countries around the world. Eli Lilly products include neuroscience, endocrine, anti-infectives, cardiovascular agents, oncology, and animal health products.

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Eli Lilly & (LLY UN)

10 Drugs To Come Under First Round of Medicare Price Negotiations in US to Curb Inflation

CMS announces first round of price negotiations for 10 drugs under Inflation Reduction Act, affecting millions of Medicare users and $50B in...

Tina Banerjee

Samsung Biologics (207940 KS): Strong Momentum in 2Q23- Revenue Up 33%; Net Profit Jumps 22%

Samsung Biologics reported record-high revenue and operating profit in 2Q23, aided by contract signing spree. Outlook for H2 is positive with...

Tina Banerjee

Eisai Co Ltd (4523 JP): Becomes the Best Alzheimer’s Disease Play After Full FDA Nod

Eisai has received FDA traditional approval for Leqembi injection for the treatment of Alzheimer’s Disease. Following the approval, CMS confirmed...

Tina Banerjee

Sosei Group (4565 JP): Hit Hard by Partner’s Clinical Trial Termination; Need Time to Recover

Pfizer decided to discontinue the development of lotiglipron, one of the candidates resulting from Pfizer’s drug discovery collaboration with...

Tina Banerjee

Eisai Co (4523 JP): Alzheimer’s Drug Approaching Full FDA Approval; Other Countries to Follow Soon

The PDUFA action date for traditional approval of Leqembi for the treatment of Alzheimer’s disease has been set for July 6. Leqembi is expected to...

Tina Banerjee

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52-week Range

Market Cap (USDm)

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10 Drugs To Come Under First Round of Medicare Price Negotiations in US to Curb Inflation

​CMS announces first round of price negotiations for 10 drugs under Inflation Reduction Act, affecting millions of Medicare users and $50B in...

Tina Banerjee

Samsung Biologics (207940 KS): Strong Momentum in 2Q23- Revenue Up 33%; Net Profit Jumps 22%

Samsung Biologics reported record-high revenue and operating profit in 2Q23, aided by contract signing spree. Outlook for H2 is positive with...

Tina Banerjee

Eisai Co Ltd (4523 JP): Becomes the Best Alzheimer’s Disease Play After Full FDA Nod

Eisai has received FDA traditional approval for Leqembi injection for the treatment of Alzheimer’s Disease. Following the approval, CMS confirmed...

Tina Banerjee

Sosei Group (4565 JP): Hit Hard by Partner’s Clinical Trial Termination; Need Time to Recover

Pfizer decided to discontinue the development of lotiglipron, one of the candidates resulting from Pfizer’s drug discovery collaboration with...

Tina Banerjee

Eisai Co (4523 JP): Alzheimer’s Drug Approaching Full FDA Approval; Other Countries to Follow Soon

The PDUFA action date for traditional approval of Leqembi for the treatment of Alzheimer’s disease has been set for July 6. Leqembi is expected to...

Tina Banerjee

CMS announces first round of price negotiations for 10 drugs under Inflation Reduction Act, affecting millions of Medicare users and $50B in...