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Milestone Pharmaceuticals (MIST)
NASDAQ:MIST
US Market

Milestone Pharmaceuticals (MIST) AI Stock Analysis

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Milestone Pharmaceuticals

(NASDAQ:MIST)

Rating:39Underperform
Price Target:
Milestone Pharmaceuticals' overall stock score reflects substantial financial difficulties, including no revenue and negative cash flows. However, the upcoming launch of CARDAMYST provides a potential turnaround opportunity, which is a significant positive factor. Technical indicators suggest a bearish trend, and valuation metrics highlight the lack of earnings and dividends, indicating a speculative investment.
Positive Factors
FDA Feedback
The FDA did not raise any clinical safety or efficacy concerns, indicating confidence in the drug's fundamental attributes.
Financial Stability
Milestone has a cash runway expected to last into mid-2026, providing financial stability until the anticipated launch.
Market Opportunity
The PSVT market remains significantly underserved, presenting a notable opportunity for CARDAMYST as a first-line, in-pocket treatment for acute PSVT episodes.
Negative Factors
Launch Delays
The launch of CARDAMYST has been delayed due to a Complete Response Letter from the FDA, pushing the potential launch timeline by approximately one year.
Regulatory Challenges
The FDA issued a Complete Response Letter for CARDAMYST due to Chemistry, Manufacturing, and Controls issues, delaying approval.
Uncertainty in Resubmission
Timelines to NDA resubmission remain unclear given concerns on FDA CMC requirements and agency functionality.

Milestone Pharmaceuticals (MIST) vs. SPDR S&P 500 ETF (SPY)

Milestone Pharmaceuticals Business Overview & Revenue Model

Company DescriptionMilestone Pharmaceuticals Inc. (MIST) is a biopharmaceutical company primarily operating in the healthcare sector, focusing on the development and commercialization of innovative cardiovascular medicines. The company is committed to providing effective treatment solutions for patients with episodic cardiovascular conditions. Its core product is etripamil, a novel, fast-acting nasal spray designed for the acute treatment of paroxysmal supraventricular tachycardia (PSVT) and other cardiovascular indications.
How the Company Makes MoneyMilestone Pharmaceuticals generates revenue through the development and commercialization of its pharmaceutical products, primarily etripamil. The company aims to secure regulatory approvals and bring its products to market, targeting healthcare providers and institutions as its primary customers. Revenue streams are expected from product sales, potential partnerships, and licensing agreements with larger pharmaceutical companies that may include upfront payments, milestones, and royalties. Additionally, strategic collaborations and partnerships can enhance its market reach and provide funding to support further research and development efforts, contributing to its overall earnings.

Milestone Pharmaceuticals Financial Statement Overview

Summary
Milestone Pharmaceuticals faces significant financial challenges, with no revenue in the latest period, high leverage, and negative cash flows. The company must address its revenue generation and operational efficiency to improve financial health. Despite these challenges, liquidity remains relatively strong, providing a short-term buffer.
Income Statement
10
Very Negative
The income statement reveals that Milestone Pharmaceuticals is struggling with revenue generation, recording zero revenue for the most recent year and significant net losses consistently. Gross and net profit margins are negative, reflecting ongoing operational challenges in achieving profitability.
Balance Sheet
35
Negative
The balance sheet indicates high leverage with a debt-to-equity ratio increasing over time due to declining equity. The equity ratio is low, and the company's liabilities are a significant portion of its assets, raising concerns about financial stability. However, cash reserves are relatively robust compared to liabilities, providing some liquidity cushion.
Cash Flow
20
Very Negative
Cash flow from operations is negative, and free cash flow remains substantially negative, indicating ongoing cash burn. While there is some improvement in financing cash flows, the reliance on external financing highlights the need for sustainable cash generation from operations.
Breakdown
TTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
0.000.001.00M5.00M15.00M0.00
Gross Profit
-26.00K0.001.00M4.52M15.00M-376.00K
EBIT
-52.15M-42.10M-61.10M-59.64M-43.07M-50.71M
EBITDA
-49.60M-42.10M-56.84M-58.36M-42.98M-50.71M
Net Income Common Stockholders
-31.16M-41.52M-59.69M-57.13M-42.63M-49.97M
Balance SheetCash, Cash Equivalents and Short-Term Investments
55.96M69.69M66.00M64.58M114.14M142.31M
Total Assets
61.88M75.50M75.23M74.48M119.85M149.97M
Total Debt
55.59M54.80M51.77M2.49M698.00K941.00K
Net Debt
10.50M29.48M38.02M-5.14M-113.44M-71.37M
Total Liabilities
68.01M62.35M58.45M8.13M7.25M6.86M
Stockholders Equity
-6.12M13.15M16.77M66.35M112.60M143.12M
Cash FlowFree Cash Flow
-33.90M-28.88M-46.54M-52.74M-33.22M-50.73M
Operating Cash Flow
-33.78M-28.85M-46.42M-52.47M-33.22M-50.73M
Investing Cash Flow
68.76M8.28M4.76M-57.12M70.00M-70.00M
Financing Cash Flow
166.60K32.12M47.79M3.09M5.05M73.22M

Milestone Pharmaceuticals Technical Analysis

Technical Analysis Sentiment
Positive
Last Price1.65
Price Trends
50DMA
1.26
Positive
100DMA
1.59
Positive
200DMA
1.65
Positive
Market Momentum
MACD
0.11
Positive
RSI
58.65
Neutral
STOCH
35.93
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For MIST, the sentiment is Positive. The current price of 1.65 is above the 20-day moving average (MA) of 1.57, above the 50-day MA of 1.26, and above the 200-day MA of 1.65, indicating a bullish trend. The MACD of 0.11 indicates Positive momentum. The RSI at 58.65 is Neutral, neither overbought nor oversold. The STOCH value of 35.93 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for MIST.

Milestone Pharmaceuticals Risk Analysis

Milestone Pharmaceuticals disclosed 71 risk factors in its most recent earnings report. Milestone Pharmaceuticals 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

Milestone Pharmaceuticals Peers Comparison

Overall Rating
UnderperformOutperform
Sector (54)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
68
Neutral
$433.25M5.55-58.97%23.81%146.45%
54
Neutral
$5.38B3.27-45.10%3.30%16.81%0.02%
52
Neutral
$49.58M-10.49%8286.79%87.23%
41
Neutral
$46.48M-130.87%-100.00%30.65%
39
Underperform
$88.22M-307.27%-100.00%51.19%
35
Underperform
$57.11M-83.37%28.92%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
MIST
Milestone Pharmaceuticals
1.65
0.26
18.71%
ATNM
Actinium Pharmaceuticals
1.49
-6.44
-81.21%
CTMX
CytomX Therapeutics
2.75
1.38
100.73%
ANEB
Anebulo Pharmaceuticals
1.39
-0.64
-31.53%
IPSC
Century Therapeutics
0.58
-2.57
-81.59%

Milestone Pharmaceuticals Corporate Events

Product-Related AnnouncementsBusiness Operations and Strategy
Milestone Pharmaceuticals Prepares for CARDAMYST Launch
Positive
Feb 25, 2025

On February 25, 2025, Milestone Pharmaceuticals announced its preparation for the potential launch of CARDAMYST, a nasal spray containing etripamil, pending FDA approval. The company anticipates a significant impact on its operations with the expected approval and commercial launch in mid-2025, which could extend its patent estate to 2042 and provide a $75 million payment upon approval. This development is seen as transformative for Milestone, potentially reducing healthcare costs and empowering patients by providing a new therapeutic option.

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.