tiprankstipranks
Trending News
More News >
Amylyx Pharmaceuticals Inc (AMLX)
NASDAQ:AMLX
US Market
Advertisement

Amylyx Pharmaceuticals Inc (AMLX) AI Stock Analysis

Compare
620 Followers

Top Page

AMLX

Amylyx Pharmaceuticals Inc

(NASDAQ:AMLX)

Rating:57Neutral
Price Target:
$9.50
▼(-4.52% Downside)
Amylyx Pharmaceuticals' overall stock score is primarily impacted by its financial performance challenges, including declining revenues and operational losses. While technical analysis shows positive momentum, the company's valuation is weak due to a negative P/E ratio and lack of dividends. The recent halt of the ORION program further adds to the uncertainty, despite some positive developments in other clinical trials.
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.
Market Opportunity
KOL discussions at ENDO, coupled with ASMBS survey data and Lee et al., suggest the medically important PBH population could exceed the commonly cited 167,000 patients, highlighting a significant market opportunity.
Pricing Potential
Avexitide’s orphan and breakthrough therapy designations suggest it can command premium pricing, estimated at $144,000 per patient annually.
Negative Factors
Awareness Issues
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.
Diagnosis Challenges
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., a clinical-stage biopharmaceutical company, engages in developing various therapeutics for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases. The company's product pipeline includes AMX0035, a dual UPR-Bax apoptosis inhibitor composed of sodium phenylbutyrate and taurursodiol for the treatment of amyotrophic lateral sclerosis. It is also developing AMX0035 for other neurodegenerative diseases. The company was founded in 2013 and is headquartered in Cambridge, Massachusetts.
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: |
Next Earnings Date:Nov 06, 2025
Earnings Call Sentiment Positive
The earnings call was overall positive, with significant progress reported in clinical trials and pipeline expansion. Financial management shows a strong cash position, although there are challenges related to market education and cash flow reduction.
Q2-2025 Updates
Positive Updates
Progress in Avexitide Clinical Trials
The Phase III LUCIDITY trial for Avexitide is underway, with recruitment expected to be completed by year-end and data expected in the first half of 2026.
Strong Financial Position
The company ended the second quarter with $180.8 million in cash, down from $204.1 million, but sufficient to fund operations through 2026.
Pipeline Expansion
AMX0114 received Fast Track designation from the FDA and is progressing in the Phase I LUMINA trial for ALS.
Phase IIb/III ORION Trial for AMX0035
The trial is ongoing for progressive supranuclear palsy, with top-line data expected this quarter.
Reduction in Operating Expenses
Operating expenses were significantly reduced by 43% compared to the same period in 2024.
Negative Updates
Decrease in Cash Position
Cash decreased from $204.1 million to $180.8 million during the quarter.
Operating Losses
The company reported total operating expenses of $42.9 million, which, while reduced, still represents a significant expenditure.
Challenges in Market Education
The need for further education of primary care physicians and the lack of an ICD-10 code for PBH were identified as challenges.
Company Guidance
During the Amylyx Pharmaceuticals Second Quarter 2025 earnings call, guidance was provided on several key metrics and timelines. The company plans to complete recruitment for the Phase III LUCIDITY trial of Avexitide by the end of 2025, with top-line data expected in the first half of 2026. The trial focuses on post-bariatric hypoglycemia, a condition affecting an estimated 160,000 individuals in the U.S. Additionally, the company anticipates top-line data from the Phase IIb portion of the ORION trial for progressive supranuclear palsy (PSP) this quarter, a condition affecting approximately 23,000 people in the U.S. Amylyx also expects early cohort data from the Phase I LUMINA trial of AMX0114, targeting amyotrophic lateral sclerosis, by the end of the year. Financially, the company reported a cash position of $180.8 million at the end of Q2, with operating expenses of $42.9 million, and anticipates a cash runway through the end of 2026.

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 Price9.95
Price Trends
50DMA
8.02
Positive
100DMA
6.49
Positive
200DMA
5.21
Positive
Market Momentum
MACD
0.56
Negative
RSI
67.64
Neutral
STOCH
94.06
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 9.95 is above the 20-day moving average (MA) of 8.67, above the 50-day MA of 8.02, and above the 200-day MA of 5.21, indicating a bullish trend. The MACD of 0.56 indicates Negative momentum. The RSI at 67.64 is Neutral, neither overbought nor oversold. The STOCH value of 94.06 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
$460.99M-22.06%85.40%40.95%
58
Neutral
$715.03M-88.40%
57
Neutral
$889.89M-87.42%-100.08%-2.45%
51
Neutral
$7.91B-0.36-41.71%2.23%23.45%-1.86%
47
Neutral
$361.60M-48.57%-100.00%83.98%
45
Neutral
-60.19%56.60%
42
Neutral
$246.29M-55.12%-100.00%30.91%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AMLX
Amylyx Pharmaceuticals Inc
9.95
7.58
319.83%
BNTC
Benitec Biopharma
14.00
4.98
55.21%
CKPT
Checkpoint Therapeutics
4.26
2.16
102.86%
ALLO
Allogene Therapeutics
1.11
-1.30
-53.94%
ETON
Eton Pharmaceuticals
17.87
13.28
289.32%
ZBIO
Zenas BioPharma, Inc.
16.98
-0.99
-5.51%

Amylyx Pharmaceuticals Inc Corporate Events

Product-Related Announcements
Amylyx Pharmaceuticals Halts ORION Program for AMX0035
Negative
Aug 27, 2025

On August 27, 2025, Amylyx Pharmaceuticals announced the discontinuation of its ORION program for AMX0035 in adults with progressive supranuclear palsy, as the drug showed no significant differences compared to placebo in primary or secondary outcomes at Week 24. Consequently, the company will halt the Phase 2b trial and open-label extension, and will not proceed with the Phase 3 portion, although safety data remained consistent with previous studies.

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.

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 28, 2025