Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

Neuren Pharmaceuticals / Equity Bottom-Up

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<a href="https://www.smartkarma.com/entities/neuren-pharmaceuticals-ltd" target="_blank" data-smartkarma-citation="entities:4494:1" rel="noopener">Neuren Pharmaceuticals (NEU AU)</a> received A$56M U.S. royalty income from Daybue in 2024 up 110% from A$27M in 2023. Cumulative income from Daybue reached to A$445M over 2023 and 2024. </li>
<li>Assuming Daybue U.S. sales guidance is met and an exchange rate of 0.65, Neuren anticipates earning U.S. royalties of A$62–67M, up 15% YoY at mid-point in 2025.</li>
<li>Daybue will be launched in Canada in 3Q25. European approval is expected in 1Q26. For Japan, Acadia plans to initiate small clinical study by 3Q25 to support a marketing application.</li>
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Neuren Pharmaceuticals (NEU AU) received A$56M U.S. royalty income from Daybue in 2024 up 110% from A$27M in 2023. Cumulative income from Daybue reached to A$445M over 2023 and 2024. 
Assuming Daybue U.S. sales guidance is met and an exchange rate of 0.65, Neuren anticipates earning U.S. royalties of A$62–67M, up 15% YoY at mid-point in 2025.
Daybue will be launched in Canada in 3Q25. European approval is expected in 1Q26. For Japan, Acadia plans to initiate small clinical study by 3Q25 to support a marketing application.


Neuren Pharmaceuticals (NEU AU): Daybue US Sales and Geography Expansion to Drive Growth

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<a href="https://www.smartkarma.com/entities/neuren-pharmaceuticals-ltd" target="_blank" data-smartkarma-citation="entities:4494:1" rel="noopener">Neuren Pharmaceuticals (NEU AU)</a> announced a share buy-back program worth up to A$50M (~3M shares, representing 2.4% of total shares on issue). The 12-month buyback will commence on December 2.</li>
<li>As of September 30, 2024, Neuren has a cash balance of A$210M and the company’s R&amp;D expenses for 1H24 were A$18M. Interest income more than covers Neuren’s corporate expenses.</li>
<li>The buyback announcement follows Neuren’s recent entitlement of one-off income from the sale of partner’s Priority Review Voucher and Daybue’s record high sales in 3Q24.  </li>
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Neuren Pharmaceuticals (NEU AU) announced a share buy-back program worth up to A$50M (~3M shares, representing 2.4% of total shares on issue). The 12-month buyback will commence on December 2.
As of September 30, 2024, Neuren has a cash balance of A$210M and the company’s R&amp;D expenses for 1H24 were A$18M. Interest income more than covers Neuren’s corporate expenses.
The buyback announcement follows Neuren’s recent entitlement of one-off income from the sale of partner’s Priority Review Voucher and Daybue’s record high sales in 3Q24.  


Neuren Pharmaceuticals (NEU AU): Substantial Buyback Plan Announced; Daybue Sales Accelerate in US

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<a href="https://www.smartkarma.com/entities/neuren-pharmaceuticals-ltd" target="_blank" data-smartkarma-citation="entities:4494:1" rel="noopener">Neuren Pharmaceuticals (NEU AU)</a> shares corrected ~14% over the last one month, as Daybue reported disappointing performance in U.S. and partner reduced 2024 revenue guidance for Daybue.</li>
<li>Muted U.S. performance of Daybue in 1H24 seems to be short-lived and the drug is expected to accelerate in 2H24 and beyond.</li>
<li>In 2Q24, the rate of new patient starts was 12% higher than the previous quarter and the rate of discontinuations was 46% lower than in the previous quarter. </li>
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Neuren Pharmaceuticals (NEU AU) shares corrected ~14% over the last one month, as Daybue reported disappointing performance in U.S. and partner reduced 2024 revenue guidance for Daybue.
Muted U.S. performance of Daybue in 1H24 seems to be short-lived and the drug is expected to accelerate in 2H24 and beyond.
In 2Q24, the rate of new patient starts was 12% higher than the previous quarter and the rate of discontinuations was 46% lower than in the previous quarter. 


Neuren Pharmaceuticals (NEU AU): Ready to Fly Again After a Breather

Clinuvel Pharmaceuticals / Equity Bottom-Up

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<a href="https://www.smartkarma.com/entities/clinuvel-pharmaceuticals-limited" target="_blank" data-smartkarma-citation="entities:17714:1" rel="noopener">Clinuvel Pharmaceuticals (CUV AU)</a> released positive update from its CUV151 study, which was evaluating the DNA-repair capacity of afamelanotide on skin of healthy volunteers exposed to UV radiation.</li>
<li>Riding on high trajectory of lead therapy, Scenesse, thanks to the prescriber network growth, treatment demand, and number of prescriptions, Clinuvel has been consistently reporting profitable revenue growth.</li>
<li>Greater patient outreach to be facilitated by more specialty centers able to administer Scenesse in the U.S., expanding geographic footprint, and future label expansions are future growth engines.</li>
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Clinuvel Pharmaceuticals (CUV AU) released positive update from its CUV151 study, which was evaluating the DNA-repair capacity of afamelanotide on skin of healthy volunteers exposed to UV radiation.
Riding on high trajectory of lead therapy, Scenesse, thanks to the prescriber network growth, treatment demand, and number of prescriptions, Clinuvel has been consistently reporting profitable revenue growth.
Greater patient outreach to be facilitated by more specialty centers able to administer Scenesse in the U.S., expanding geographic footprint, and future label expansions are future growth engines.


Clinuvel Pharmaceuticals (CUV AU): Positive Clinical Trial Result; Base Business Going Strong

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<a href="https://www.smartkarma.com/entities/neuren-pharmaceuticals-ltd" target="_blank" data-smartkarma-citation="entities:4494:1" rel="noopener">Neuren Pharmaceuticals (NEU AU)</a> has announced positive top-line result from its phase 2 clinical trial of its second drug candidate NNZ-2591 in children with Phelan-McDermid syndrome (PMS), a genetic disorder.</li>
<li>PMS has an overwhelming unmet medical need. This is an attractive commercial opportunity with an estimated addressable patient population of 24,000 in the U.S. alone.</li>
<li>NNZ-2591 has the potential to become the first FDA-approved drug for PMS. Neuren is also conducting phase 2 clinical trials of NNZ-2591 in children with three other neurodevelopmental disorders.</li>
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Neuren Pharmaceuticals (NEU AU) has announced positive top-line result from its phase 2 clinical trial of its second drug candidate NNZ-2591 in children with Phelan-McDermid syndrome (PMS), a genetic disorder.
PMS has an overwhelming unmet medical need. This is an attractive commercial opportunity with an estimated addressable patient population of 24,000 in the U.S. alone.
NNZ-2591 has the potential to become the first FDA-approved drug for PMS. Neuren is also conducting phase 2 clinical trials of NNZ-2591 in children with three other neurodevelopmental disorders.


Neuren Pharmaceuticals (NEU AU): Positive Trial Result- A Step Ahead for Potential Second Drug

Australia

Neuren Pharmaceuticals Ltd. is a biopharmaceutical company.  The Company researches neurological and metabolic disorders.

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Neuren Pharmaceuticals (NEU AU)