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Neuren Pharmaceuticals Limited (AU:NEU)
ASX:NEU

Neuren Pharmaceuticals Limited (NEU) AI Stock Analysis

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AU:NEU

Neuren Pharmaceuticals Limited

(Sydney:NEU)

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Outperform 71 (OpenAI - 5.2)
Rating:71Outperform
Price Target:
AU$18.50
▲(10.84% Upside)
The score is driven primarily by strong financial performance (high profitability and a debt-free balance sheet), partially offset by the significant 2024 earnings-to-cash flow disconnect and year-to-year volatility. Technicals are mildly weak with the stock below key moving averages, while valuation appears reasonable on P/E but lacks dividend support.
Positive Factors
Regulatory Approval
Health Canada approval for NNZ-2591 expands trial reach, enhancing Neuren's position in the rare pediatric neurodevelopmental market.
Partnership Success
FDA approval of DAYBUE STIX strengthens Neuren's market position, providing new revenue streams through royalties and expanding treatment options.
Revenue Growth
Record sales growth for DAYBUE™ indicates strong market demand and enhances Neuren's revenue stability and future growth potential.
Negative Factors
Cash Flow Volatility
Negative cash flow in 2024 despite strong earnings raises concerns about cash conversion sustainability, impacting financial flexibility.
Earnings Volatility
Revenue decline in 2024 highlights potential instability in earnings, posing risks to consistent financial performance and investor confidence.
Regulatory Delays
Regulatory delays for NNZ-2591 could slow development timelines, impacting Neuren's ability to bring new treatments to market promptly.

Neuren Pharmaceuticals Limited (NEU) vs. iShares MSCI Australia ETF (EWA)

Neuren Pharmaceuticals Limited Business Overview & Revenue Model

Company DescriptionNeuren Pharmaceuticals Limited, a biopharmaceutical company, develops drugs for the treatment of neurological disorders. Its lead product is trofinetide, which is in Phase III clinical trial for the treatment of Rett syndrome, as well as has completed Phase II clinical trial to treat Fragile X syndrome. The company also develops NNZ-2591, which has completed Phase I clinical trial for the treatment of Phelan-McDermid, Angelman, Pitt Hopkins, and Prader-Will syndromes. In addition, it provides development services; and holds loan funded shares. The company was incorporated in 2001 and is based in Camberwell, Australia.
How the Company Makes MoneyNeuren Pharmaceuticals Limited primarily generates revenue through the development and commercialization of its pharmaceutical products. The company partners with larger pharmaceutical firms to advance its drug candidates through late-stage clinical trials and eventual market approval. These partnerships often involve licensing agreements, where Neuren receives upfront payments, milestone payments upon reaching specific clinical or regulatory milestones, and royalties on net sales of the drugs once commercialized. Additionally, Neuren may engage in research and development collaborations that contribute to its revenue streams.

Neuren Pharmaceuticals Limited Earnings Call Summary

Earnings Call Date:Feb 29, 2024
(Q4-2023)
|
% Change Since: |
Next Earnings Date:Feb 26, 2026
Earnings Call Sentiment Positive
The earnings call highlighted Neuren's strong financial performance, significant cash growth, and successful collaboration with Acadia. Positive trial results for NNZ-2591 and an expanded global reach were significant achievements. However, challenges such as tax liabilities, exchange rate impacts, and share price volatility were noted. Overall, the positive aspects and strategic advancements overshadow the lowlights.
Q4-2023 Updates
Positive Updates
Record Profit and Cash Growth
Neuren reported a profit of AUD 157 million, with cash growing from $40 million to $229 million without any capital raising.
Strong Financial Performance from Acadia Partnership
Neuren received $27 million of royalty income, $59 million from DAYBUE's first commercial sale milestone, and $146 million from an expanded deal with Acadia.
Successful DAYBUE Sales
DAYBUE net sales in Q4 reached USD 87 million, hitting the top of Acadia's guidance. Total sales for the partial year were USD 177 million, with 2024 guidance between USD 370 million and USD 420 million.
Expanded Global Reach
The deal with Acadia expanded to include markets outside North America, bringing in USD 100 million upfront, with tiered royalties from mid-teens to low 20s expected once they reach the market.
Positive Phase II Trial Results for NNZ-2591
Outstanding results announced for the Phelan-McDermid syndrome trial, exceeding expectations and showing consistent improvements across multiple efficacy measures.
Negative Updates
Exchange Rate Impact
There was an $8.2 million expense due to exchange losses, partially offset by foreign exchange gains.
Tax Liabilities
The company faced a $48 million tax charge, with $18 million withheld in the U.S., leaving a $30 million tax liability.
Seasonality Concerns
DAYBUE sales are expected to be lower in Q1 2024 due to seasonality effects, which could impact perceived growth.
Share Price Volatility
Neuren's share price experienced significant volatility, influenced by external reports and market reactions to announcements.
Company Guidance
During Neuren's 2023 earnings call, CEO Jonathan Pilcher highlighted several key financial metrics. The company reported a profit of AUD 157 million, fueled by AUD 27 million in royalty income, a USD 59 million milestone payment from DAYBUE's first commercial sale in the U.S., and USD 146 million from an expanded deal with Acadia. Cash reserves increased from AUD 40 million to AUD 229 million without any capital raising. Neuren anticipates royalty income between AUD 61 million and AUD 70 million next year, based on a royalty rate that ranges from 10% to 12%. Additionally, Neuren is expecting USD 50 million in milestone payments as DAYBUE's sales exceed USD 250 million. Neuren's R&D expenses totaled AUD 27 million, with significant efforts directed towards four Phase II trials and preparations for Phase III. Acadia's DAYBUE guidance for 2024 forecasts USD 370 million to USD 420 million in sales, indicating substantial growth from 2023's USD 177 million.

Neuren Pharmaceuticals Limited Financial Statement Overview

Summary
Strong profitability and scale-up with very high recent margins and a debt-free balance sheet, but cash flow quality is a key weakness (2024 operating/free cash flow turned negative despite strong earnings) and revenue declined in 2024 vs 2023, adding volatility risk.
Income Statement
86
Very Positive
Revenue scaled sharply from a small base (from ~A$0.5m in 2019 to A$213.2m in 2024), reflecting a major step-change in the business model. Profitability is very strong in the last two annual periods: 2024 net margin ~66.6% with EBIT margin ~82.3%, following 2023 net margin ~67.7% and EBIT margin ~85.9%. The key weakness is volatility: revenue declined in 2024 versus 2023 despite remaining highly profitable, and earlier years show losses and negative operating margins—suggesting earnings power may be less stable than the headline margins imply.
Balance Sheet
88
Very Positive
The balance sheet is conservatively positioned with no debt reported across all periods, which materially lowers financial risk. Equity has built to A$363.9m in 2024 (from A$205.2m in 2023), supporting a larger asset base (A$409.7m). Returns on equity are strong in the latest year (~39.0%), though down from an unusually high 2023 level (~76.5%), indicating profitability is still substantial but can swing meaningfully year to year.
Cash Flow
55
Neutral
Cash flow quality is mixed. 2023 showed excellent cash generation with operating cash flow and free cash flow both around A$184.9m, closely tracking net income. However, 2024 flipped to cash burn (operating cash flow -A$11.3m; free cash flow -A$11.3m) despite strong reported earnings, creating a notable earnings-to-cash disconnect. Earlier years were volatile with periods of negative cash flow as well, which raises questions around working-capital timing and sustainability of cash conversion.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue220.78M213.24M231.93M14.55M3.20M717.00K
Gross Profit190.80M213.22M205.17M14.54M3.19M711.00K
EBITDA186.02M175.57M199.26M-670.00K-10.98M-9.90M
Net Income149.06M142.04M157.08M184.00K-7.79M-9.19M
Balance Sheet
Total Assets331.25M409.71M247.97M43.27M40.06M24.95M
Cash, Cash Equivalents and Short-Term Investments299.54M222.24M228.54M40.18M36.78M24.19M
Total Debt0.000.000.000.000.000.00
Total Liabilities7.98M45.80M42.76M1.68M803.00K753.00K
Stockholders Equity323.27M363.90M205.21M41.59M39.25M24.20M
Cash Flow
Free Cash Flow137.56M-11.28M184.88M3.58M-9.98M-8.08M
Operating Cash Flow137.57M-11.27M184.93M3.60M-9.97M-8.08M
Investing Cash Flow-82.28M4.13M-211.49M-19.00K-10.00K-6.00K
Financing Cash Flow-48.63M-8.78M3.62M-2.00K22.18M19.14M

Neuren Pharmaceuticals Limited Technical Analysis

Technical Analysis Sentiment
Negative
Last Price16.69
Price Trends
50DMA
18.92
Negative
100DMA
19.61
Negative
200DMA
17.13
Negative
Market Momentum
MACD
-0.61
Positive
RSI
30.37
Neutral
STOCH
13.63
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AU:NEU, the sentiment is Negative. The current price of 16.69 is below the 20-day moving average (MA) of 18.47, below the 50-day MA of 18.92, and below the 200-day MA of 17.13, indicating a bearish trend. The MACD of -0.61 indicates Positive momentum. The RSI at 30.37 is Neutral, neither overbought nor oversold. The STOCH value of 13.63 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for AU:NEU.

Neuren Pharmaceuticals Limited Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
73
Outperform
AU$552.21M15.2315.90%0.38%7.76%1.55%
71
Outperform
AU$2.11B14.2954.79%12.35%26.73%
55
Neutral
AU$3.26B-19.37-18.95%198.58%3.97%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
49
Neutral
AU$582.12M-9.36-35.86%-19.21%
41
Neutral
AU$249.60M-25.63-89.70%42.05%-0.84%
41
Neutral
AU$76.13M-5.26-42.68%63.46%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AU:NEU
Neuren Pharmaceuticals Limited
16.69
3.02
22.09%
AU:CUV
Clinuvel Pharmaceuticals
11.00
-0.35
-3.04%
AU:MSB
Mesoblast Limited
2.53
-0.61
-19.43%
AU:OCC
Orthocell Ltd
0.92
-0.55
-37.41%
AU:ATH
Alterity Therapeutics
0.01
>-0.01
-28.57%
AU:IMM
Immutep Ltd
0.40
0.08
23.44%

Neuren Pharmaceuticals Limited Corporate Events

Neuren Defends Timely Disclosure of Material DAYBUE Sales Projections to ASX
Jan 18, 2026

Neuren Pharmaceuticals has confirmed to the ASX that recent information disclosed by its partner Acadia Pharmaceuticals on projected DAYBUE net sales, including a substantial increase in expected 2028 revenue versus 2025 guidance, is materially important for Neuren’s share price because royalties and milestones from DAYBUE are its only current source of product income. The company detailed the timeline of when it became aware of Acadia’s updated projections, outlined how it complied with continuous disclosure obligations by rapidly reviewing Acadia’s announcements, analyst forecasts and internal models before releasing its own market update, and asserted it has reasonable grounds to reference a projection of approximately US$700 million in global DAYBUE sales in 2028, relying on Acadia’s regulated disclosures in the US.

The most recent analyst rating on (AU:NEU) stock is a Buy with a A$23.50 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.

Neuren’s Partner Acadia Sees DAYBUE Sales Climbing to US$700m by 2028
Jan 14, 2026

Neuren Pharmaceuticals reported that its partner Acadia Pharmaceuticals is projecting global net sales of Rett syndrome therapy DAYBUE to reach about US$700 million in 2028, underpinned by the US rollout of the new DAYBUE STIX powder formulation, enhanced US commercial infrastructure, and anticipated international expansion including potential European approval. Since the 2023 US launch, more than 2,000 Rett patients have been treated with DAYBUE, 12‑month treatment persistence has improved to 55%, the diagnosed US Rett population has grown to roughly 6,000 patients, and regulatory and clinical milestones are advancing with DAYBUE oral solution now approved in Israel and a Phase 3 trofinetide trial in Japan expected to deliver top-line data between late 2026 and early 2027, collectively strengthening Neuren’s commercial and clinical position in rare neurological disorders.

The most recent analyst rating on (AU:NEU) stock is a Buy with a A$21.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.

Neuren Advances NNZ-2591 Program as Phase 2 PMS Data Published and Phase 3 Koala Trial Recruits in US
Jan 7, 2026

Neuren Pharmaceuticals has announced that results from its Phase 2 clinical trial of NNZ-2591 in children and adolescents with Phelan-McDermid syndrome have been published in the peer-reviewed journal Neurology Genetics, with the study reporting that the treatment was well tolerated and associated with meaningful improvements in key symptoms as observed by clinicians and caregivers. These Phase 2 data underpin the design of Neuren’s ongoing Koala Phase 3 trial in the United States, a randomized, placebo-controlled study targeting about 160 pediatric patients with Phelan-McDermid syndrome, a rare disorder with no approved therapies and a significant unmet medical need, and the program benefits from US FDA Fast Track, Rare Pediatric Disease and Orphan Drug designations, reinforcing Neuren’s position in the rare neurodevelopmental disease space.

The most recent analyst rating on (AU:NEU) stock is a Buy with a A$21.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.

Neuren Wins Health Canada Nod to Expand Phase 3 Trial of NNZ-2591 in Phelan-McDermid Syndrome
Dec 22, 2025

Neuren Pharmaceuticals has secured Health Canada approval for its Clinical Trial Application for the Koala Phase 3 trial of NNZ-2591 in children aged 3 to 12 with Phelan-McDermid syndrome, allowing Canadian sites to be added to what is the first-ever Phase 3 study in this rare disorder. The trial, which already has US FDA IND clearance, is now enrolling at two activated sites in the United States on both coasts, and the expanded North American footprint marks a significant operational step in advancing NNZ-2591 through late-stage development, potentially strengthening Neuren’s position in the rare paediatric neurodevelopmental disease market and offering new hope to patients and families facing limited treatment options.

The most recent analyst rating on (AU:NEU) stock is a Buy with a A$23.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.

Neuren Pharmaceuticals’ Partner Acadia Gains FDA Approval for New Rett Syndrome Treatment
Dec 14, 2025

Neuren Pharmaceuticals announced that its partner, Acadia Pharmaceuticals, has received FDA approval for DAYBUE STIX, a new powder formulation of trofinetide for Rett syndrome, offering patients and caregivers more flexibility and choice. This approval, based on bioequivalence studies, ensures comparable efficacy and safety to the existing oral solution. DAYBUE STIX is expected to be available in early 2026, with Neuren receiving royalties on sales, potentially impacting its market position and providing new options for stakeholders.

The most recent analyst rating on (AU:NEU) stock is a Buy with a A$23.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.

Neuren Pharmaceuticals Faces Delay in FDA Meeting for NNZ-2591
Dec 9, 2025

Neuren Pharmaceuticals announced a one-month administrative delay in the FDA’s pre-IND meeting for their drug candidate NNZ-2591, now rescheduled for late January 2026. This delay may impact the timeline for developing treatments for hypoxic ischemic encephalopathy (HIE), highlighting the challenges in advancing therapies for rare neurological disorders.

The most recent analyst rating on (AU:NEU) stock is a Buy with a A$23.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.

Neuren Pharmaceuticals to Quote 150,000 New Securities on ASX
Nov 24, 2025

Neuren Pharmaceuticals Limited has announced the quotation of 150,000 fully paid ordinary securities on the Australian Securities Exchange (ASX), effective November 25, 2025. This move is part of the company’s strategy to enhance its capital structure and potentially improve market liquidity, which could positively impact its operations and industry positioning.

The most recent analyst rating on (AU:NEU) stock is a Buy with a A$21.20 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.

Neuren Pharmaceuticals: Advancing Neurodevelopmental Therapies Amidst Industry Challenges
Nov 9, 2025

Neuren Pharmaceuticals Limited has released an investor presentation highlighting their commitment to enhancing the lives of people with neurodevelopmental disabilities. The presentation includes forward-looking statements, emphasizing the potential risks and uncertainties in drug development, regulatory processes, and clinical trials, which could impact the company’s operations and stakeholder interests.

The most recent analyst rating on (AU:NEU) stock is a Buy with a A$25.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.

Neuren Pharmaceuticals Achieves Record DAYBUE™ Sales in Q3 2025
Nov 6, 2025

Neuren Pharmaceuticals reported record net sales of US$101.1 million for DAYBUE™ in Q3 2025, marking an 11% increase from Q3 2024. The company experienced significant growth in patient referrals and community-based prescriptions, with over 1,000 patients receiving shipments for the first time. Neuren’s royalty income also saw a substantial rise, and the company anticipates further growth potential in the US market. Additionally, Acadia, Neuren’s partner, has narrowed its full-year sales guidance and is expanding its market reach with ongoing trials and supply programs in multiple regions.

The most recent analyst rating on (AU:NEU) stock is a Buy with a A$25.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Dec 30, 2025