Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

Neuren Pharmaceuticals / Equity Bottom-Up

<ul>
<li>
<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>
</ul>



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

<ul>
<li>
<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>
</ul>



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

<ul>
<li>
<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>
</ul>



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

<ul>
<li>
<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>
</ul>



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

<ul>
<li>
<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 the expansion of partnership with Acadia Pharmaceuticals for trofinetide. Acadia’s exclusive license for trofinetide in North America has been expanded to a worldwide exclusive license. </li>
<li>Neuren is now entitled for additional payments and will receive $100M up-front, plus additional potential milestone payments of upto $427M and royalties on net sales of trofinetide outside North America.</li>
<li>Neuren has also granted Acadia an exclusive worldwide license to develop and commercialize NNZ-2591 for Rett and Fragile X syndromes and retains worldwide rights to NNZ-2591 in all other indications.</li>
</ul>



Neuren Pharmaceuticals (NEU AU) announced the expansion of partnership with Acadia Pharmaceuticals for trofinetide. Acadia’s exclusive license for trofinetide in North America has been expanded to a worldwide exclusive license. 
Neuren is now entitled for additional payments and will receive $100M up-front, plus additional potential milestone payments of upto $427M and royalties on net sales of trofinetide outside North America.
Neuren has also granted Acadia an exclusive worldwide license to develop and commercialize NNZ-2591 for Rett and Fragile X syndromes and retains worldwide rights to NNZ-2591 in all other indications.


Neuren Pharmaceuticals (NEU AU): Shares Roar on Expanded Global Partnership for Newly Launched Drug

United States

ACADIA Pharmaceuticals Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule drugs for the treatment of central nervous system disorders. The company is currently working on the treatment of induced dysfunction in Parkinson's disease ,schizophrenia, neuropathic pain and glaucoma.

Price Gauge
52-week Range	0.00 - 0.00
Market Cap (USDm)	0.00
P/E	0.00
Dividend (Yield)	0.00

Acadia Pharmaceuticals (ACAD US)

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

Neuren Pharmaceuticals got confirmation from the FDA for the primary endpoints for its planned Phase 3 pivotal clinical trial of NNZ-2591 in Phelan...

Tina Banerjee

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

Neuren announces A$50M share buy-back program following the company's recent entitlement of one-off income from the sale of partner’s Priority...

Tina Banerjee

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

Neuren shares dip due to disappointing U.S. performance of Daybue. Muted US performance of Daybue in 1H24 seems to be short-lived and the drug is...

Tina Banerjee

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

Neuren announced positive phase 2 trial results for NNZ-2591 in Phelan-McDermid syndrome, a genetic disorder. NNZ-2591 has the potential to become...

Tina Banerjee

Neuren Pharmaceuticals (NEU AU): Shares Roar on Expanded Global Partnership for Newly Launched Drug

Neuren expanded Acadia’s trofinetide license to worldwide, for up to additional $527M to Neuren (including $100M up-front) plus mid-teens to low...

Tina Banerjee

Price Gauge

52-week Range

Market Cap (USDm)

P/E

Dividend (Yield)

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

Neuren Pharmaceuticals got confirmation from the FDA for the primary endpoints for its planned Phase 3 pivotal clinical trial of NNZ-2591 in Phelan...

Tina Banerjee

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

​Neuren announces A$50M share buy-back program following the company's recent entitlement of one-off income from the sale of partner’s Priority...

Tina Banerjee

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

​Neuren shares dip due to disappointing U.S. performance of Daybue. Muted US performance of Daybue in 1H24 seems to be short-lived and the drug is...

Tina Banerjee

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

​Neuren announced positive phase 2 trial results for NNZ-2591 in Phelan-McDermid syndrome, a genetic disorder. NNZ-2591 has the potential to become...

Tina Banerjee

Neuren Pharmaceuticals (NEU AU): Shares Roar on Expanded Global Partnership for Newly Launched Drug

Neuren expanded Acadia’s trofinetide license to worldwide, for up to additional $527M to Neuren (including $100M up-front) plus mid-teens to low...

Tina Banerjee

Neuren announces A$50M share buy-back program following the company's recent entitlement of one-off income from the sale of partner’s Priority...

Neuren shares dip due to disappointing U.S. performance of Daybue. Muted US performance of Daybue in 1H24 seems to be short-lived and the drug is...

Neuren announced positive phase 2 trial results for NNZ-2591 in Phelan-McDermid syndrome, a genetic disorder. NNZ-2591 has the potential to become...