Investor web conference presentation, 14 July 2023
Released
Released
Announcement PDF
Neuren and Acadia Expand
Global Partnership for
trofinetide (DAYBUETM)
14 July 2023
IMPROVING THE LIVES OF PEOPLE WITH
NEURODEVELOPMENTAL DISABILITIES
Page□
1
Forward looking statements
This presentation contains forward looking statements that involve
risks and uncertainties. Although we believe that the expectations
reflected in the forward looking statements are reasonable at this
time, Neuren can give no assurance that these expectations will
prove to be correct. Actual results could differ materially from those
anticipated. Reasons may include risks associated with drug
development and manufacture, risks inherent in the regulatory
processes, delays in clinical trials, risks associated with patent
protection, future capital needs or other general risks or factors.
2
Transaction to maximize value of trofinetide and NNZ-2591
1
Expands Acadia’s exclusive trofinetide licence to worldwide, for up to additional US$527m to Neuren
(including US$100m up-front) plus mid-teens to low-20s % royalties on net sales outside North America
2
Leverages Acadia’s unique knowledge and expertise from successful DAYBUE development and
commercialization in the US and the established supply chain; Acadia responsible for all costs
3
Unlocks NNZ-2591’s potential application in Rett and Fragile X globally, with separate sales milestones
and royalties to Neuren identical to trofinetide inside and outside North America
4
Significantly strengthens Neuren’s position to explore all strategic options, with cash at 30 June 2023 plus
the up-front payment1 A$226 million
1 Assuming AUD/USD exchange rate of 0.68 and US withholding tax of 5% for the up-front payment
3
Transaction economics to Neuren for trofinetide outside North America
US$100m upfront payment
US$35m following 1st commercial sale in Europe
US$15m following 1st commercial sale in Japan
Up to US$14m in relation to 1st commercial sale of a 2nd indication in Europe and Japan
Total payments
unrelated to sales
performance
Sales milestones
Tiered royalties
US$164m
Up to US$363m On achievement of escalating annual net sales thresholds
Mid-teens to low-20s % of net sales
If Acadia sub-licenses any region within the first 2 years, Neuren is entitled to a share of any upfront and development
milestones received by Acadia. Creditable against future payments to Neuren in the sub-licensed region.
4
Trofinetide North America Economics for Neuren unchanged
Rett Syndrome
Fragile X Syndrome
US$10m
in 2022 following acceptance of NDA for review
US$40m
following 1st commercial sale in the US
US$33m
Up to
US$55m
in relation to development milestones
and 1st commercial sale in the US
one third share of Priority Review Voucher awarded to
Acadia (assuming market value US$100m)
Aggregate of all indications
Tiered Royalty Rates (% of net
sales)1
Annual Net Sales
Rates
Example calculations of royalty/sales
milestones
Sales Milestones
Net Sales in one
calendar year
US$m
Annual Net
Sales in NA
Annual
Royalty
Total Sales
Milestones
Earned
≤US$250m
10%
≥US$250m
50
>US$250m, ≤US$500m
12%
≥US$500m
50
US$500m
US$55m
US$100m
>US$500m, ≤US$750m
14%
≥US$750m
100
US$750m
US$90m
US$200m
>US$750m
15%
≥US$1bn
150
US$1bn
US$128m
US$350m
Total
350
1 Royalty rates payable on the portion of annual net sales that fall within the applicable range
5
Value of NNZ-2591 enhanced
Post Transaction
Before Transaction
Rett
Global
restrictions
Rett
Fragile X
Fragile X
PhelanMcDermid
PhelanMcDermid
Pitt Hopkins
Pitt Hopkins
Angelman
Prader-Willi
Other
Restrictions in
North America
only if Acadia
develops
trofinetide for
an indication
Angelman
Partnership
with Acadia
Neuren
•
Exclusive worldwide licence to Acadia for Rett
and Fragile X syndromes only
•
Potential future payments to Neuren for NNZ2591 in Rett and Fragile X syndromes
identical to the payments for trofinetide inside
and outside North America
•
Neuren retains worldwide rights to NNZ-2591
in all other indications
•
Ongoing Phase 2 clinical trials in PhelanMcDermid, Pitt Hopkins, Angelman and
Prader-Willi syndromes
•
First top-line results expected in Dec 2023
Prader-Willi
Other
6
Transforming catalysts in 2023
Commercial
Trofinetide
NA
Trofinetide
RoW
NNZ-2591
✓ DAYBUE for Rett syndrome approved by FDA
✓ Priority Review Voucher awarded to Acadia
✓ First US commercial sale - US$40m milestone payment
•
Quarterly royalties on net sales
•
Priority Review Voucher value one third share – estimated as US$33m
✓ Global trofinetide partnership with Acadia
•
Receive US$100m upfront payment from Acadia
✓ Initiate Prader-Willi syndrome Phase 2 trial
✓ Complete enrolment in Phelan-McDermid syndrome Phase 2 trials
•
Complete enrolment in Pitt Hopkins and Angelman syndrome Phase 2 trials
•
Top-line results for Phelan-McDermid syndrome in Dec 2023
Development
7
CONTACT
Jon Pilcher, CEO
jpilcher@neurenpharma.com
+61 438 422 271
8
Share your feedback
Discover