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Amylyx Pharmaceuticals Inc (AMLX)
NASDAQ:AMLX
US Market

Amylyx Pharmaceuticals Inc (AMLX) AI Stock Analysis

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Amylyx Pharmaceuticals Inc

(NASDAQ:AMLX)

57Neutral
Amylyx Pharmaceuticals' overall score is driven by significant financial challenges with declining revenues and operational losses. However, the company shows strong technical momentum and has made notable progress in clinical trials, as discussed in the earnings call. While the financial position has been fortified, these improvements are set against a backdrop of ongoing cash flow issues and the need for effective patient education. Valuation remains a concern due to negative earnings, typical of biotech firms in the R&D phase.
Positive Factors
Financial Performance
Analyst's recommendation upgrades the stock rating to Outperform with a price target increase from $4.00 to $10.00.
Market Potential
Avexitide is expected to derive real value to the name and is the reason for the recent upgrade of the stock.
Product Approval
Avexitide is expected to be the first drug approved for post-bariatric hypoglycemia, a chronic condition with no current treatment.
Negative Factors
Clinical Trial Complexity
The company continues to guide to an unblinded interim safety and efficacy analysis of the Phase 2b portion of the Phase 2b/3 ORION study of AMX0035 in progressive supranuclear palsy (PSP) to inform a go/no-go decision.
Regulatory Challenges
The company is currently engaging with the FDA and believes that the current data will inform the design of the Phase 3 trial.

Amylyx Pharmaceuticals Inc (AMLX) vs. S&P 500 (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 sale of its approved drug, AMX0035, marketed under the brand name Relyvrio in the United States and Albrioza in Canada. The company profits from sales to healthcare providers and institutions treating patients with neurodegenerative diseases. Additionally, revenue streams may include partnerships or collaborations with other pharmaceutical companies or research institutions involved in drug development and commercialization. Regulatory approvals and successful market penetration significantly contribute to the company's earnings, as they allow Amylyx to expand its market reach and increase sales volume.

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. The company needs to address its declining revenue and improve operational efficiency to enhance financial health.
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.
Breakdown
Dec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
87.37M380.79M22.23M285.00K650.00K
Gross Profit
45.22M355.35M19.24M233.00K-23.94M
EBIT
-314.73M38.80M-201.34M-82.69M-39.01M
EBITDA
-290.98M39.89M-200.85M-82.64M-39.00M
Net Income Common Stockholders
-301.74M49.27M-198.38M-87.88M-44.84M
Balance SheetCash, Cash Equivalents and Short-Term Investments
176.50M371.36M346.94M96.12M12.88M
Total Assets
193.63M517.45M391.45M105.61M14.10M
Total Debt
1.98M4.24M6.28M0.001.43M
Net Debt
-75.41M-165.96M-56.25M-50.19M-11.45M
Total Liabilities
28.87M84.02M50.85M256.78M80.83M
Stockholders Equity
164.76M433.43M340.61M-151.17M-66.72M
Cash FlowFree 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 Flow
75.65M92.05M-238.99M-46.41M-151.00K
Financing Cash Flow
348.00K3.54M431.79M158.51M46.82M

Amylyx Pharmaceuticals Inc Technical Analysis

Technical Analysis Sentiment
Positive
Last Price4.84
Price Trends
50DMA
4.17
Positive
100DMA
3.86
Positive
200DMA
3.82
Positive
Market Momentum
MACD
0.18
Positive
RSI
64.46
Neutral
STOCH
58.24
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 4.84 is below the 20-day moving average (MA) of 4.90, above the 50-day MA of 4.17, and above the 200-day MA of 3.82, indicating a bullish trend. The MACD of 0.18 indicates Positive momentum. The RSI at 64.46 is Neutral, neither overbought nor oversold. The STOCH value of 58.24 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 (52)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
63
Neutral
$507.66M-22.95%40.88%-579.73%
57
Neutral
$477.80M-83.24%-100.32%-197.69%
54
Neutral
$348.16M-48.57%-100.00%83.98%
52
Neutral
$5.19B3.04-44.64%2.82%16.45%-0.53%
45
Neutral
$361.13M-1869.55%-60.19%56.60%
38
Underperform
$438.00M-115.47%
36
Underperform
$242.79M-59.60%-100.00%31.43%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AMLX
Amylyx Pharmaceuticals Inc
5.36
3.52
191.30%
BNTC
Benitec Biopharma
13.98
3.51
33.52%
CKPT
Checkpoint Therapeutics
4.16
2.13
104.93%
ALLO
Allogene Therapeutics
1.09
-1.50
-57.92%
ETON
Eton Pharmaceuticals
19.57
15.93
437.64%
ZBIO
Zenas BioPharma, Inc.
11.01
-6.96
-38.73%

Amylyx Pharmaceuticals Inc Earnings Call Summary

Earnings Call Date:May 08, 2025
(Q1-2025)
|
% Change Since: -0.62%|
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 Corporate Events

Business Operations and Strategy
Amylyx Partners with Gubra for GLP-1 Antagonist
Positive
Dec 30, 2024

Amylyx Pharmaceuticals Inc. has entered into a collaboration with Gubra A/S to develop a novel long-acting GLP-1 receptor antagonist. This partnership involves Amylyx making upfront and research payments and Gubra potentially receiving over $50 million in milestones and royalties, with the collaboration expected to enhance Amylyx’s cash runway into 2026.

Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.

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.