Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>In Q1FY24, <a href="https://www.smartkarma.com/entities/shionogi-co-ltd" target="_blank" data-smartkarma-citation="entities:19535:1" rel="noopener">Shionogi &amp; Co (4507 JP)</a> recorded 52% YoY revenue growth to ¥109B, reflecting a one-time payment received for the transfer of co-development and co-commercialization license for ADHD drugs.  </li>
<li>Shionogi has reiterated FY24 guidance. The company expects FY24 revenue of ¥450B (up 6% YoY), operating profit of ¥150B (up 1% YoY), and net profit of ¥155B (down 16% YoY).</li>
<li>Despite competition, Xocova captured a 60% market share of the treatment group patients in Japan. Over a six-month period since emergency approval, more than 70K patients have used Xocova.</li>
</ul>


In Q1FY24, Shionogi &amp; Co (4507 JP) recorded 52% YoY revenue growth to ¥109B, reflecting a one-time payment received for the transfer of co-development and co-commercialization license for ADHD drugs.  
Shionogi has reiterated FY24 guidance. The company expects FY24 revenue of ¥450B (up 6% YoY), operating profit of ¥150B (up 1% YoY), and net profit of ¥155B (down 16% YoY).
Despite competition, Xocova captured a 60% market share of the treatment group patients in Japan. Over a six-month period since emergency approval, more than 70K patients have used Xocova.


Shionogi & Co (4507 JP): Non-Recurring Income Lifts Q1 Revenue; FY24 Guidance Reiterated

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<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%

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<li>
<a href="https://www.smartkarma.com/entities/moderna-inc" target="_blank" data-smartkarma-citation="entities:28744:1" rel="noopener">Moderna Inc (MRNA US)</a> has submitted marketing authorization applications for the investigational RSV vaccine, mRNA-1345, in Europe and Australia and initiated submission process in the U.S.</li>
<li>Moderna anticipates to launch RSV vaccine in 2024 in US. Each year in US, approximately 60,000–120,000 older adults are hospitalized, and 6,000–10,000 of them die due to RSV infection.</li>
<li>This year, FDA has already approved two RSV vaccines, Arexvy from GSK and Abrysvo from Pfizer, which are scheduled to be launched in the U.S. by this fall.</li>
</ul>



Moderna Inc (MRNA US) has submitted marketing authorization applications for the investigational RSV vaccine, mRNA-1345, in Europe and Australia and initiated submission process in the U.S.
Moderna anticipates to launch RSV vaccine in 2024 in US. Each year in US, approximately 60,000–120,000 older adults are hospitalized, and 6,000–10,000 of them die due to RSV infection.
This year, FDA has already approved two RSV vaccines, Arexvy from GSK and Abrysvo from Pfizer, which are scheduled to be launched in the U.S. by this fall.


Moderna (MRNA US): Second Product Submission Is Not Big Enough Needle-Mover

<ul>
<li>
<a href="https://www.smartkarma.com/entities/genmab-a-s-26418c4e-f8a3-407b-a60e-422af04febfe" target="_blank" data-smartkarma-citation="entities:28558:1" rel="noopener">Genmab A/S (GMAB US)</a> recorded 30% YoY growth in royalty revenue on net sales of Darzalex to DKK1,952 million, representing 68% of total revenue in 1Q23.</li>
<li>Genmab has guided for 2023 Darzalex royalty revenue of DKK10.4–11.1B, compared to royalty revenue of DKK10.1B in 2022, based on estimated Darzalex 2023 net sales of $9.4 – 10.0B.</li>
<li>In May 2023, Genmab received FDA approval for Epkinly as the first and only T-cell engaging bispecific antibody for the treatment of relapsed or refractory diffuse large B-cell lymphoma.</li>
</ul>



Genmab A/S (GMAB US) recorded 30% YoY growth in royalty revenue on net sales of Darzalex to DKK1,952 million, representing 68% of total revenue in 1Q23.
Genmab has guided for 2023 Darzalex royalty revenue of DKK10.4–11.1B, compared to royalty revenue of DKK10.1B in 2022, based on estimated Darzalex 2023 net sales of $9.4 – 10.0B.
In May 2023, Genmab received FDA approval for Epkinly as the first and only T-cell engaging bispecific antibody for the treatment of relapsed or refractory diffuse large B-cell lymphoma.


Genmab A/S (GMAB US): Darzalex Continued to Be the Cash Cow; Epkinly Approval Adds Another Catalyst

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<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

United States

Pfizer Inc. is a research-based, global pharmaceutical company that discovers, develops, manufactures, and markets medicines for humans and animals.  The Company's products include prescription pharmaceuticals, non-prescription self-medications, and animal health products such as anti-infective medicines and vaccines.

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Pfizer Inc (PFE US)

Shionogi & Co (4507 JP): Non-Recurring Income Lifts Q1 Revenue; FY24 Guidance Reiterated

In Q1, revenue surged 52% YoY to ¥109B, reflecting a one-time payment received for the transfer of the license for ADHD drugs. Shionogi expects...

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

Moderna (MRNA US): Second Product Submission Is Not Big Enough Needle-Mover

Moderna is in process to submit marketing approval in the US for the investigational respiratory syncytial virus vaccine, mRNA-1345. This year, FDA...

Tina Banerjee

Genmab A/S (GMAB US): Darzalex Continued to Be the Cash Cow; Epkinly Approval Adds Another Catalyst

Royalty revenue from top-selling cancer drug Darzalex continues to contribute ~70% of Genmab’s revenue. The company’s 2 proprietary FDA-approved...

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

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