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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:57Neutral
Price Target:
$8.50
▲(2.41%Upside)
Amylyx Pharmaceuticals' overall stock score is influenced by strong technical momentum and positive earnings call developments, offset by significant financial performance challenges and a weak valuation profile. The company's ability to continue advancing its clinical programs and manage cash flow effectively will be crucial for future prospects.
Positive Factors
Clinical Outcomes
New exploratory data reveals a 64% reduction in severe hypoglycemic events, a clinically meaningful outcome for avexitide.
Drug Development
Avexitide shows promise in the Phase 3 LUCIDITY study with encouraging new PK data supporting the use of a 90 mg QD dose.
Market Opportunity
The unmet medical need and growing number of bariatric surgeries highlight a significant market opportunity for avexitide.
Negative Factors
Awareness and Diagnosis
Lack of awareness among primary care physicians regarding early diagnosis and the absence of an official PBH code are challenges.
Regulatory Challenges
Upcoming Phase 3 data in primary supranuclear palsy presents a high-risk/high-reward event with a potential for program discontinuation.
Underdiagnosis
Severe underdiagnosis due to absence of ICD-10 coding undermines the true prevalence of post-bariatric hypoglycemia.

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:May 08, 2025
(Q1-2025)
|
% Change Since: 70.43%|
Next Earnings Date:Aug 07, 2025
Earnings Call Sentiment Positive
The earnings call highlighted significant clinical and financial advancements, including the successful commencement of key trials and a strengthened financial position. However, challenges remain, particularly in educating the target patient population for avexitide.
Q1-2025 Updates
Positive Updates
Successful Dosing in Key Clinical Trials
First participants were dosed in the pivotal Phase 3 LUCIDITY clinical trial of avexitide for post-bariatric hypoglycemia and in the Phase 1 LUMINA trial of AMX0114 for ALS.
Financial Position Strengthened
Raised approximately $65.5 million, extending cash runway through the end of 2026. Ended the quarter with a cash position of $204.1 million.
Progress in Clinical Programs
Reported positive top-line data from the Phase 2 HELIOS trial for Wolfram syndrome. Enrollment completed for the Phase 2b ORION trial in PSP.
FDA Breakthrough Therapy Designation
Avexitide received FDA breakthrough therapy designation for post-bariatric hypoglycemia, highlighting its potential impact.
Decrease in Operating Expenses
Total operating expenses for the quarter were $37.8 million, down 82% from the same period in 2024.
Negative Updates
Challenges with PBH Patient Education
A large patient education campaign is needed for avexitide due to the lack of awareness about post-bariatric hypoglycemia among patients.
Residual Cash Obligations
Residual cash obligations related to the discontinuation of RELYVRIO and ALBRIOZA are $3.1 million, expected to be paid through 2025.
Company Guidance
During the first quarter 2025 earnings call, Amylyx Pharmaceuticals provided detailed guidance on their ongoing clinical programs and financial position. The company highlighted that they dosed the first participant in the Phase 3 LUCIDITY trial for avexitide, aimed at treating post-bariatric hypoglycemia (PBH), a condition affecting approximately 160,000 individuals in the U.S. They anticipate enrollment completion by 2025 and expect top-line data in the first half of 2026, with a potential commercial launch in 2027. Additionally, Amylyx advanced their Phase 1 LUMINA trial of AMX0114 for ALS and the Phase 2b ORION trial for progressive supranuclear palsy (PSP), with data expected in the third quarter of 2025. Financially, the company raised approximately $65.5 million, boosting their cash position to $204.1 million, which extends their anticipated cash runway through the end of 2026. Operating expenses for the quarter were $37.8 million, down 82% from Q1 2024, with research and development costs at $22.1 million and selling, general, and administrative expenses at $15.7 million.

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.
BreakdownDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue87.37M380.79M22.23M285.00K650.00K
Gross Profit-37.26M355.35M19.24M233.00K-23.94M
EBITDA-301.23M39.89M-200.85M-82.64M-39.00M
Net Income-301.74M49.27M-198.38M-87.88M-44.84M
Balance Sheet
Total Assets193.63M517.45M391.45M105.61M14.10M
Cash, Cash Equivalents and Short-Term Investments176.50M371.36M346.94M96.12M12.88M
Total Debt1.98M4.24M6.28M0.001.43M
Total Liabilities28.87M84.02M50.85M256.78M80.83M
Stockholders Equity164.76M433.43M340.61M-151.17M-66.72M
Cash Flow
Free Cash Flow-167.80M10.68M-182.40M-75.15M-36.85M
Operating Cash Flow-167.65M11.92M-179.87M-74.80M-36.70M
Investing Cash Flow75.65M92.05M-238.99M-46.41M-151.00K
Financing Cash Flow348.00K3.54M431.79M158.51M46.82M

Amylyx Pharmaceuticals Inc Technical Analysis

Technical Analysis Sentiment
Positive
Last Price8.30
Price Trends
50DMA
6.11
Positive
100DMA
5.07
Positive
200DMA
4.68
Positive
Market Momentum
MACD
0.69
Negative
RSI
67.07
Neutral
STOCH
61.17
Neutral
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 8.3 is above the 20-day moving average (MA) of 7.45, above the 50-day MA of 6.11, and above the 200-day MA of 4.68, indicating a bullish trend. The MACD of 0.69 indicates Negative momentum. The RSI at 67.07 is Neutral, neither overbought nor oversold. The STOCH value of 61.17 is Neutral, 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 90 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 (60)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
60
Neutral
HK$17.07B6.10-7.44%2.88%11.55%-28.15%
60
Neutral
$410.04M-22.95%40.88%-579.73%
58
Neutral
$653.45M-115.47%
57
Neutral
$747.89M-83.24%-100.32%-197.69%
50
Neutral
$330.28M-59.60%-100.00%31.43%
47
Neutral
$311.07M-48.57%-100.00%83.98%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AMLX
Amylyx Pharmaceuticals Inc
8.30
6.33
321.32%
BNTC
Benitec Biopharma
11.91
2.51
26.70%
ALLO
Allogene Therapeutics
1.51
-1.49
-49.67%
ETON
Eton Pharmaceuticals
15.37
11.79
329.33%
ZBIO
Zenas BioPharma, Inc.
16.32
-1.65
-9.18%

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: Jul 15, 2025