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Amylyx Pharmaceuticals Inc (AMLX)
NASDAQ:AMLX
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Amylyx Pharmaceuticals Inc (AMLX) AI Stock Analysis

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AMLX

Amylyx Pharmaceuticals Inc

(NASDAQ:AMLX)

Rating:56Neutral
Price Target:
$8.00
▼(-4.88% Downside)
The overall stock score of 56 reflects significant financial challenges, including declining revenues and operational losses, which are partially offset by positive technical indicators and a strong earnings call highlighting clinical advancements and financial stability. Valuation concerns due to negative earnings further weigh on the score.
Positive Factors
Clinical Trials
The company presented positive 48-week long-term data from the Phase 2 HELIOS trial, showing sustained improvement in key health metrics.
Financial Performance
The company ended the quarter with approximately $180M of cash, providing cash runway through the end of 2026.
Market Opportunity
The medically important PBH population could exceed the commonly cited 167,000 patients, indicating a larger market opportunity for avexitide.
Negative Factors
Awareness
There might be work needed in terms of awareness, especially among primary care physicians, with respect to early diagnosis and establishment of an official PBH code.
Competition
Despite the rise of GLP-1 receptor agonists, Roux-en-Y gastric bypass remains indispensable, indicating a sustained need for alternative treatments like avexitide.
Market Awareness
Absence of ICD-10 coding and severe underdiagnosis undermines the true prevalence of the disease.

Amylyx Pharmaceuticals Inc (AMLX) vs. SPDR S&P 500 ETF (SPY)

Amylyx Pharmaceuticals Inc Business Overview & Revenue Model

Company DescriptionAmylyx Pharmaceuticals Inc (AMLX) is a biopharmaceutical company focused on developing therapies for neurodegenerative diseases. The company operates in the biotechnology sector and is dedicated to creating innovative treatment options for conditions such as amyotrophic lateral sclerosis (ALS) and Alzheimer's disease. Its core product, AMX0035, is designed to slow the progression of these debilitating diseases and improve patient quality of life.
How the Company Makes MoneyAmylyx Pharmaceuticals Inc generates revenue primarily through the commercialization of its therapeutic products. The company's revenue model is centered around the sale of AMX0035, which has been developed for the treatment of neurodegenerative diseases like ALS. Revenue streams include product sales in approved markets and potential partnerships or collaborations with other pharmaceutical companies for distribution and further development. Regulatory approvals and successful market penetration are significant factors contributing to its earnings. However, as a company in the biotechnology industry, research and development activities also play a crucial role in advancing its pipeline and supporting future revenue growth.

Amylyx Pharmaceuticals Inc Earnings Call Summary

Earnings Call Date:Aug 07, 2025
(Q2-2025)
|
% Change Since: 2.69%|
Next Earnings Date:Nov 06, 2025
Earnings Call Sentiment Positive
The earnings call emphasizes significant progress in clinical trials for Avexitide and AMX0035, alongside financial stability with reduced expenses. However, challenges remain in cash management and market education. Overall, the highlights in drug development and financial management outweigh the concerns, indicating a positive outlook.
Q2-2025 Updates
Positive Updates
Avexitide Advancements in Phase III LUCIDITY Trial
Successfully dosed first participant in pivotal Phase III LUCIDITY trial for post-bariatric hypoglycemia (PBH). Recruitment expected to complete by year-end, with anticipated commercial launch in 2027 if approved.
Positive Developments in AMX0035 Trials
Long-term Week 48 data for AMX0035 in Wolfram syndrome showed sustained stabilization or improvement. Phase IIb data from PSP trials expected this quarter to inform Phase III decisions.
Financial Stability and Reduced Operating Expenses
Cash position of $180.8 million, with operating expenses down 43% from the same period in 2024. Cash runway expected to last through the end of 2026.
FDA Fast Track Designation for AMX0114
The FDA granted Fast Track designation to AMX0114 for ALS, allowing for more frequent interactions with the FDA and potential for expedited review.
Significant Reduction in Hypoglycemic Events with Avexitide
Avexitide led to a 64% reduction in hypoglycemic events in Phase II trials, with more than half of participants experiencing no Level 2 or Level 3 hypoglycemic events during treatment.
Negative Updates
Decreased Cash Position
Cash position decreased from $204.1 million at the end of the first quarter to $180.8 million, reflecting ongoing expenses despite reduced operating costs.
Challenges in Patient Recruitment and Market Education
Efforts needed to educate PCPs and broader market about PBH diagnosis and Avexitide's potential benefits. Lack of ICD-10 code complicates prevalence estimates and diagnosis.
Company Guidance
During the Amylyx Pharmaceuticals Second Quarter 2025 Earnings Conference Call, the company provided guidance on multiple clinical and financial metrics. The company is advancing its lead asset, Avexitide, through the pivotal Phase III LUCIDITY trial for post-bariatric hypoglycemia (PBH) and expects to complete recruitment by the end of 2025, with top-line data anticipated in the first half of 2026. For Avexitide, a commercial launch is planned for 2027 if approved. Their pipeline also includes AMX0035, with top-line data from the Phase IIb ORION trial in progressive supranuclear palsy (PSP) expected this quarter, and AMX0114, which received Fast Track designation, with early cohort data expected by year-end. Financially, Amylyx ended the second quarter with a cash position of $180.8 million and anticipates a cash runway extending through the end of 2026, supporting its clinical milestones and early commercial preparations. Total operating expenses for the quarter were $42.9 million, with research and development expenses at $27.2 million, primarily driven by increased spending on Avexitide and AMX0035.

Amylyx Pharmaceuticals Inc Financial Statement Overview

Summary
Amylyx Pharmaceuticals faces significant financial challenges, with declining revenues and substantial operational losses reflected in negative profit margins. The balance sheet shows a relatively low level of debt and strong equity ratio, although historical negative equity points to potential financial instability. Cash flow analysis reveals persistent cash generation issues, which could impact future operational sustainability.
Income Statement
40
Negative
The company's revenue showed a significant decrease from 2023 to 2024, indicating a revenue growth rate of -77.05%. Despite having a gross profit margin of 51.76% in 2024, the net profit margin was highly negative at -345.20%, reflecting substantial operational losses. The EBIT and EBITDA margins were also negative, highlighting ongoing profitability challenges.
Balance Sheet
55
Neutral
Amylyx Pharmaceuticals maintains a low debt-to-equity ratio of 0.01, suggesting minimal reliance on debt. However, the company has a strong equity ratio of 85.10%, indicating that a majority of the assets are financed by shareholders' equity. Despite this, the company has consistently reported negative equity in previous years, pointing to financial instability risks.
Cash Flow
35
Negative
The company experienced a decline in free cash flow from 2023 to 2024, with a negative growth rate of -1671.46%. The operating cash flow to net income ratio is negative, reflecting operational inefficiencies. This indicates ongoing cash flow challenges, as the company is not generating sufficient cash from operations to cover its expenses.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue-249.00K87.37M380.79M22.23M285.00K650.00K
Gross Profit-1.36M-37.26M355.35M19.24M233.00K-23.94M
EBITDA-194.88M-290.98M39.89M-200.85M-82.64M-39.00M
Net Income-187.60M-301.74M49.27M-198.38M-87.88M-44.84M
Balance Sheet
Total Assets194.60M193.63M517.45M391.45M105.61M14.10M
Cash, Cash Equivalents and Short-Term Investments180.83M176.50M371.36M346.94M96.12M12.88M
Total Debt5.96M1.98M4.24M6.28M0.001.43M
Total Liabilities26.72M28.87M84.02M50.85M256.78M80.83M
Stockholders Equity167.88M164.76M433.43M340.61M-151.17M-66.72M
Cash Flow
Free Cash Flow-165.68M-167.80M10.68M-182.40M-75.15M-36.85M
Operating Cash Flow-165.65M-167.65M11.92M-179.87M-74.80M-36.70M
Investing Cash Flow83.13M75.65M92.05M-238.99M-46.41M-151.00K
Financing Cash Flow65.82M348.00K3.54M431.79M158.51M46.82M

Amylyx Pharmaceuticals Inc Technical Analysis

Technical Analysis Sentiment
Positive
Last Price8.41
Price Trends
50DMA
7.02
Positive
100DMA
5.74
Positive
200DMA
4.99
Positive
Market Momentum
MACD
0.28
Positive
RSI
62.36
Neutral
STOCH
86.67
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AMLX, the sentiment is Positive. The current price of 8.41 is above the 20-day moving average (MA) of 8.07, above the 50-day MA of 7.02, and above the 200-day MA of 4.99, indicating a bullish trend. The MACD of 0.28 indicates Positive momentum. The RSI at 62.36 is Neutral, neither overbought nor oversold. The STOCH value of 86.67 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for AMLX.

Amylyx Pharmaceuticals Inc Risk Analysis

Amylyx Pharmaceuticals Inc disclosed 89 risk factors in its most recent earnings report. Amylyx Pharmaceuticals Inc reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Amylyx Pharmaceuticals Inc Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
66
Neutral
$464.48M-22.06%85.40%40.95%
58
Neutral
$665.16M-88.40%
56
Neutral
$731.17M-87.42%-100.08%-2.45%
51
Neutral
$7.44B-0.20-46.00%2.27%22.80%-2.27%
47
Neutral
$325.24M-48.57%-100.00%83.98%
43
Neutral
$225.29M-55.12%-100.00%30.91%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AMLX
Amylyx Pharmaceuticals Inc
8.41
6.25
289.35%
BNTC
Benitec Biopharma
12.66
4.06
47.21%
ALLO
Allogene Therapeutics
1.07
-1.23
-53.48%
ETON
Eton Pharmaceuticals
16.70
12.69
316.46%
ZBIO
Zenas BioPharma, Inc.
16.76
-1.21
-6.73%

Amylyx Pharmaceuticals Inc Corporate Events

Executive/Board ChangesShareholder Meetings
Amylyx Pharmaceuticals Inc Holds Annual Stockholder Meeting
Neutral
Jun 5, 2025

On June 5, 2025, Amylyx Pharmaceuticals Inc. held its Annual Meeting of Stockholders where three key proposals were voted on. The stockholders elected Karen Firestone, Justin Klee, and Bernhardt Zeiher, M.D. as Class I directors for a three-year term. They also ratified Deloitte & Touche LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2025, and approved, on an advisory basis, the compensation of the Company’s named executive officers.

The most recent analyst rating on (AMLX) stock is a Buy with a $8.00 price target. To see the full list of analyst forecasts on Amylyx Pharmaceuticals Inc stock, see the AMLX 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: Aug 12, 2025