Neuren Pharmaceuticals Limited (NEU) AI Stock Analysis

• Market Cap: AU$2.43B
• Dividend Yield: N/A
• Average Volume (3M): 305.98K
• Price to Earnings (P/E): 16.5
• Beta (1Y): 2.05
• Revenue Growth: 12.35%
• EPS Growth: 26.73%
• Country: AU
• Employees: 8
• Sector: Healthcare
• Sector Strength: 45
• Industry: Biotechnology
• EPS (TTM): 0.12
• Shares Outstanding: 126,639,530
• 10 Day Avg. Volume: 278,541
• 30 Day Avg. Volume: 305,983
• PEG Ratio: -1.07
• Price to Book (P/B): 4.39
• Price to Sales (P/S): 7.49
• P/FCF Ratio: -141.59
• Enterprise Value/Market Cap: N/A
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: N/A
• Enterprise Value/Ebitda: N/A
• 1Y Price Target: AU$25.14
• Price Target Upside: 30.81% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 4
• EPS Forecast (FY): N/A
• Revenue Forecast (FY): N/A

• Rating: 71 Outperform
• Price Target: AU$21.00 ▲(9.26% 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 Business Overview & Revenue Model

Company Description

Neuren 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 Money

Neuren 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 Financial Statement Overview

Summary

Neuren Pharmaceuticals Limited displays strong financial health with excellent profitability and a robust balance sheet featuring no debt. However, cash flow management presents challenges, as indicated by negative free cash flow and a negative operating cash flow to net income ratio.

Income Statement

Neuren Pharmaceuticals Limited shows a strong financial performance with a significant improvement in revenue and profitability. The company achieved a high gross profit margin of 84.8% and a net profit margin of 65.5% for 2024, reflecting efficient cost management and profitability. There is a notable decline in revenue growth rate, but the company maintains a strong EBIT margin of 67.4% and EBITDA margin of 82.6%.

Balance Sheet

The company's balance sheet is robust, with a debt-to-equity ratio of 0, indicating no debt burden. The equity ratio stands at 88.8%, showcasing financial stability and strong shareholder equity. The return on equity is impressive at 39.0%, indicating effective use of equity to generate profit.

Cash Flow

The cash flow statement highlights a decrease in operating cash flow, resulting in negative free cash flow for 2024. However, the company previously showed strong free cash flow growth and the free cash flow to net income ratio remains positive. The operating cash flow to net income ratio is negative, suggesting potential cash flow management challenges.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	220.78M	213.24M	231.93M	14.55M	3.20M	717.00K
Gross Profit	190.80M	213.22M	205.17M	14.54M	3.19M	711.00K
EBITDA	186.02M	175.57M	199.26M	-670.00K	-10.98M	-9.90M
Net Income	149.06M	142.04M	157.08M	184.00K	-7.79M	-9.19M
Balance Sheet
Total Assets	331.25M	409.71M	247.97M	43.27M	40.06M	24.95M
Cash, Cash Equivalents and Short-Term Investments	299.54M	222.24M	228.54M	40.18M	36.78M	24.19M
Total Debt	0.00	0.00	0.00	0.00	0.00	0.00
Total Liabilities	7.98M	45.80M	42.76M	1.68M	803.00K	753.00K
Stockholders Equity	323.27M	363.90M	205.21M	41.59M	39.25M	24.20M
Cash Flow
Free Cash Flow	137.56M	-11.28M	184.88M	3.58M	-9.98M	-8.08M
Operating Cash Flow	137.57M	-11.27M	184.93M	3.60M	-9.97M	-8.08M
Investing Cash Flow	-82.28M	4.13M	-211.49M	-19.00K	-10.00K	-6.00K
Financing Cash Flow	-48.63M	-8.78M	3.62M	-2.00K	22.18M	19.14M

Neuren Pharmaceuticals Limited Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 19.22
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Positive
• MACD: Positive
• RSI: Neutral
• STOCH: Neutral

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AU:NEU, the sentiment is Positive. The current price of 19.22 is below the 20-day moving average (MA) of 19.33, below the 50-day MA of 19.37, and above the 200-day MA of 16.58, indicating a neutral trend. The MACD of -0.16 indicates Positive momentum. The RSI at 49.85 is Neutral, neither overbought nor oversold. The STOCH value of 28.29 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for AU:NEU.

Neuren Pharmaceuticals Limited Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
CUV	73 Outperform	AU$634.54M	17.50	15.90%	0.38%	7.76%	1.55%
NEU	71 Outperform	AU$2.43B	16.46	54.79%	―	12.35%	26.73%
MSB	55 Neutral	AU$3.94B	-23.51	-18.95%	―	198.58%	3.97%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
IMM	49 Neutral	AU$641.07M	-10.31	-35.86%	―	―	-19.21%
OCC	41 Neutral	AU$293.01M	-30.08	-89.70%	―	42.05%	-0.84%
ATH	41 Neutral	AU$87.00M	-5.26	-42.68%	―	―	63.46%

Neuren Pharmaceuticals Limited Corporate Events

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

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

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

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

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

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

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.

Neuren Pharmaceuticals Receives FDA Fast Track for NNZ-2591 in Phelan-McDermid Syndrome

Neuren Pharmaceuticals announced that the FDA has granted Fast Track designation for NNZ-2591 for treating Phelan-McDermid syndrome (PMS), a condition with no current FDA-approved treatments. This designation aims to expedite the drug’s development and review process, highlighting the urgent unmet medical need for PMS therapies. The company is conducting a Phase 3 clinical trial, marking the first of its kind for PMS, which could significantly impact the community affected by this syndrome. Fast Track status has also been granted for NNZ-2591 in Angelman syndrome, enhancing Neuren’s positioning in the neurodevelopmental disorder treatment market.

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 Expands Market Presence with New Securities Quotation

Neuren Pharmaceuticals Limited announced the quotation of 200,000 ordinary fully paid securities on the Australian Securities Exchange (ASX) as of October 3, 2025. This move is part of the company’s strategic efforts to enhance its market presence and provide additional value to its stakeholders by leveraging financial instruments.

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.