Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>During FY25, <a href="https://www.smartkarma.com/entities/sanbio-co-ltd" target="_blank" data-smartkarma-citation="entities:24540:1" rel="noopener">SanBio Co Ltd (4592 JP)</a> did not generate any revenue and incurred an operating expense of ¥3.5B, down 23% YoY.</li>
<li>The company successfully completed two commercial production runs to accumulate inventories in preparation for launch of Akuugo. The earliest possible timing for shipment is assumed to be Q2FY26.</li>
<li>SanBio has a cash runway through FY26. Further, in March, the company has raised funds of ¥2.1B through third party placement.</li>
</ul>


During FY25, SanBio Co Ltd (4592 JP) did not generate any revenue and incurred an operating expense of ¥3.5B, down 23% YoY.
The company successfully completed two commercial production runs to accumulate inventories in preparation for launch of Akuugo. The earliest possible timing for shipment is assumed to be Q2FY26.
SanBio has a cash runway through FY26. Further, in March, the company has raised funds of ¥2.1B through third party placement.


SanBio Co Ltd (4592 JP): Losses Narrow; AKUUGO Upbeat on Successful Commercial Runs; FY26 Key

<ul>
<li>
<a href="https://www.smartkarma.com/entities/sanbio-co-ltd" target="_blank" data-smartkarma-citation="entities:24540:1" rel="noopener">SanBio Co Ltd (4592 JP)</a> received conditional and time-limited marketing approval for Akuugo suspension for intracranial implantation in Japan, for improving chronic motor paralysis resulting from traumatic brain injury.</li>
<li>The company will run two or so rounds of commercial production to accumulate inventories in preparation for launch. The earliest possible timing for shipment is assumed to be Q1FY26.</li>
<li>SanBio has a cash runway through H1FY26. However, operating expenses will decrease and Akuugo will start generating revenue by H1FY26, thereby providing some more cushion to cash runway.</li>
</ul>



SanBio Co Ltd (4592 JP) received conditional and time-limited marketing approval for Akuugo suspension for intracranial implantation in Japan, for improving chronic motor paralysis resulting from traumatic brain injury.
The company will run two or so rounds of commercial production to accumulate inventories in preparation for launch. The earliest possible timing for shipment is assumed to be Q1FY26.
SanBio has a cash runway through H1FY26. However, operating expenses will decrease and Akuugo will start generating revenue by H1FY26, thereby providing some more cushion to cash runway.


SanBio Co Ltd (4592 JP): Conditional Approval for First Drug; Still a Long Way to Go

<ul>
<li>
<a href="https://www.smartkarma.com/entities/sanbio-co-ltd" target="_blank" data-smartkarma-citation="entities:24540:1" rel="noopener">SanBio Co Ltd (4592 JP)</a> recorded operating loss of ¥7.9B for FY23, better than guidance of ¥8.1B. For FY24, the company guided for operating loss of ¥4.6B, in-line with consensus.</li>
<li>SanBio’s cash position improved with cash and cash equivalents of ¥6.7B at the end of FY23, up from ¥4.6B at the end of the previous fiscal year.</li>
<li>The company aims to obtain approval of its lead candidate SB623 as a treatment for chronic motor deficit from traumatic brain injury during the current fiscal year.</li>
</ul>



SanBio Co Ltd (4592 JP) recorded operating loss of ¥7.9B for FY23, better than guidance of ¥8.1B. For FY24, the company guided for operating loss of ¥4.6B, in-line with consensus.
SanBio’s cash position improved with cash and cash equivalents of ¥6.7B at the end of FY23, up from ¥4.6B at the end of the previous fiscal year.
The company aims to obtain approval of its lead candidate SB623 as a treatment for chronic motor deficit from traumatic brain injury during the current fiscal year.


SanBio (4592 JP): Better-Than-Expected Operating Loss in FY23; Product Approval Expected in FY24

<ul>
<li>In March, <a href="https://www.smartkarma.com/entities/sanbio-co-ltd" target="_blank" data-smartkarma-citation="entities:24540:1" rel="noopener">SanBio Co Ltd (4592 JP)</a> completed the application filing for approval for its investigational product SB623, as a treatment for chronic motor deficit from traumatic brain injury.</li>
<li>With a priority review designation, SB623 approval was expected in September. SanBio is expecting a delay in the approval. SB623 is now expected to be approved next year. </li>
<li>For FY23, the company is now expecting operating expenses of ¥8.1 billion, which exceeds the earlier expectations by ¥2.2 billion due to an anticipated increase in manufacturing-related expenses.</li>
</ul>


In March, SanBio Co Ltd (4592 JP) completed the application filing for approval for its investigational product SB623, as a treatment for chronic motor deficit from traumatic brain injury.
With a priority review designation, SB623 approval was expected in September. SanBio is expecting a delay in the approval. SB623 is now expected to be approved next year. 
For FY23, the company is now expecting operating expenses of ¥8.1 billion, which exceeds the earlier expectations by ¥2.2 billion due to an anticipated increase in manufacturing-related expenses.


SanBio (4592 JP): Remains Unlucky for Second-Time; Delay in First Product Approval Weighs Heavily

<ul>
<li>
<a href="https://www.smartkarma.com/entities/sanbio-co-ltd" target="_blank" data-smartkarma-citation="entities:24540:1" rel="noopener">SanBio Co Ltd (4592 JP)</a> is expected to receive approval for its first regenerative cell medicine SB623 for treating chronic motor deficit from traumatic brain injury in Japan this year.</li>
<li>SB623, with current and future indication approvals, is targeting a large patient population of more than 50 million in major pharmaceutical markets globally. The indications have large unmet need.</li>
<li>SanBio has a pipeline of five other pre-clinical drug candidates, entailing visibility beyond SB623.</li>
</ul>



SanBio Co Ltd (4592 JP) is expected to receive approval for its first regenerative cell medicine SB623 for treating chronic motor deficit from traumatic brain injury in Japan this year.
SB623, with current and future indication approvals, is targeting a large patient population of more than 50 million in major pharmaceutical markets globally. The indications have large unmet need.
SanBio has a pipeline of five other pre-clinical drug candidates, entailing visibility beyond SB623.


SanBio (4592 JP): Marketing Approval of First Product Expected This Year in Japan

Japan

Sanbio Co Ltd researches, develops, manufactures, and sells regenerative cell re lated pharmaceutical products.

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SanBio Co Ltd (4592 JP)