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Insmed (INSM)
NASDAQ:INSM

Insmed (INSM) AI Stock Analysis

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INInsmed
(NASDAQ:INSM)
53Neutral
Insmed's stock score is primarily driven by its strong technical performance, indicating potential short-term gains. However, substantial challenges in financial performance, particularly profitability and cash flow, weigh heavily on the overall score. Valuation concerns due to ongoing losses also impact the attractiveness of the stock. Positive momentum and strategic developments provide some counterbalance but do not fully mitigate the financial risks.
Positive Factors
Product Launch
Insmed is well-positioned to drive meaningful value creation through the potential approval and launch in bronchiectasis.
Sales Performance
Arikayce continues to grow, with 4Q24 as the highest single quarter sales to date.
Negative Factors
Earnings
4Q 2024 earnings came in below what was expected with a loss per share of ($1.32), as compared to the estimate of ($1.16) and Consensus at ($1.17).

Insmed (INSM) vs. S&P 500 (SPY)

Insmed Business Overview & Revenue Model

Company DescriptionInsmed Incorporated (INSM) is a global biopharmaceutical company dedicated to improving the lives of patients with serious and rare diseases. The company focuses on developing and commercializing innovative therapies for patients with unmet medical needs, particularly in the area of serious lung diseases. Insmed's core product, ARIKAYCE (amikacin liposome inhalation suspension), is specifically designed for the treatment of patients with refractory Mycobacterium avium complex (MAC) lung disease, which is a chronic and debilitating condition.
How the Company Makes MoneyInsmed generates revenue primarily through the sales of its flagship product, ARIKAYCE, which is approved for use in the United States and other international markets. The company targets patients with refractory MAC lung disease, a subset of nontuberculous mycobacterial (NTM) lung infections. Revenue is generated when healthcare providers prescribe ARIKAYCE to patients, and it is reimbursed through insurance programs or direct payments. Additionally, Insmed invests in research and development to expand its product pipeline, potentially leading to new revenue streams in the future. The company may also engage in strategic partnerships and collaborations to enhance its market presence and leverage distribution networks, although specific partnerships are subject to change.

Insmed Financial Statement Overview

Summary
Despite strong revenue growth, Insmed faces severe profitability and cash flow challenges. The company reports substantial net losses, a negative profit margin, and high operating expenses. The balance sheet shows high leverage and high liabilities, and cash flow statements indicate a reliance on external financing, highlighting sustainability concerns.
Income Statement
45
Neutral
Insmed's revenue has shown a consistent growth trend over the past few years, with an increase from $136.47 million in 2019 to $363.71 million in 2024. However, the company continues to report substantial net losses, with the net profit margin significantly negative, reflecting ongoing profitability challenges. Gross profit margins are relatively healthy, but high operating expenses contribute to negative EBIT and EBITDA margins.
Balance Sheet
30
Negative
The balance sheet reveals a strained financial position with a negative stockholders' equity in 2023, though it improved to a positive equity position in 2024. The debt-to-equity ratio has been volatile, reflecting high leverage. Despite a strong cash position, liabilities remain high, impacting the overall financial stability.
Cash Flow
35
Negative
Insmed's cash flow statements highlight challenges with cash management, as indicated by consistently negative operating and free cash flows. The company has been reliant on external financing to support operations and investment activities, which poses sustainability concerns.
Breakdown
Dec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
363.71M305.21M245.36M188.46M164.41M
Gross Profit
277.96M239.63M190.23M144.31M124.54M
EBIT
-878.25M-709.63M-478.12M-367.76M-265.23M
EBITDA
-818.79M-660.18M-429.44M-375.09M-250.37M
Net Income Common Stockholders
-913.77M-749.57M-481.53M-434.65M-294.09M
Balance SheetCash, Cash Equivalents and Short-Term Investments
1.43B780.45M1.15B716.78M532.76M
Total Assets
2.03B1.33B1.66B1.24B796.15M
Total Debt
45.49M1.20B1.18B612.27M404.84M
Net Debt
-509.54M721.62M103.83M-104.51M-127.91M
Total Liabilities
1.74B1.66B1.57B833.04M520.27M
Stockholders Equity
285.38M-331.92M87.95M410.47M275.88M
Cash FlowFree Cash Flow
-705.80M-549.53M-410.32M-370.59M-226.17M
Operating Cash Flow
-683.88M-536.25M-400.44M-363.30M-219.35M
Investing Cash Flow
-583.17M-223.60M-34.58M-64.28M-6.82M
Financing Cash Flow
1.34B168.44M793.27M612.55M271.00M

Insmed Technical Analysis

Technical Analysis Sentiment
Negative
Last Price73.07
Price Trends
50DMA
75.60
Negative
100DMA
73.93
Negative
200DMA
71.35
Positive
Market Momentum
MACD
-0.51
Positive
RSI
38.79
Neutral
STOCH
13.32
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For INSM, the sentiment is Negative. The current price of 73.07 is below the 20-day moving average (MA) of 78.79, below the 50-day MA of 75.60, and above the 200-day MA of 71.35, indicating a neutral trend. The MACD of -0.51 indicates Positive momentum. The RSI at 38.79 is Neutral, neither overbought nor oversold. The STOCH value of 13.32 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for INSM.

Insmed Risk Analysis

Insmed disclosed 52 risk factors in its most recent earnings report. Insmed 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

Insmed Peers Comparison

Overall Rating
UnderperformOutperform
Sector (49)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
77
Outperform
$13.74B32.758.05%17.35%151.40%
69
Neutral
$9.67B41.8319.71%52.97%
64
Neutral
$128.40B-3.15%11.64%-114.72%
61
Neutral
$2.72B-31.68%32.29%64.39%
54
Neutral
$3.47B-214.50%29.01%23.93%
53
Neutral
$13.56B-320.20%19.17%-4.45%
49
Neutral
$7.05B0.34-55.09%2.46%25.27%-3.43%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
INSM
Insmed
73.07
45.76
167.56%
FOLD
Amicus
8.63
-3.16
-26.80%
BMRN
BioMarin Pharmaceutical
72.03
-13.15
-15.44%
VRTX
Vertex Pharmaceuticals
500.01
87.56
21.23%
SRPT
Sarepta Therapeutics
99.69
-22.31
-18.29%
RARE
Ultragenyx Pharmaceutical
37.50
-10.16
-21.32%

Insmed Earnings Call Summary

Earnings Call Date: Feb 20, 2025 | % Change Since: -12.84% | Next Earnings Date: May 1, 2025
Earnings Call Sentiment Positive
The earnings call reflected a positive outlook for Insmed, highlighting record revenue growth for ARIKAYCE, successful clinical trials, and a strong cash position, despite acknowledging some challenges related to cash burn and market access strategies.
Highlights
Record Revenue Growth for ARIKAYCE
ARIKAYCE achieved the highest quarterly sales in its history in Q4 2024, contributing to a 19% year-over-year growth in global net revenue for 2024, reaching $363.7 million.
Brensocatib's FDA Priority Review
The NDA filing for brensocatib in bronchiectasis was accepted by the FDA under priority review with a PDUFA date of August 12, 2025.
Strong Cash Position
Insmed ended the year with over $1.4 billion in cash, cash equivalents, and marketable securities, providing a strong financial position for future investments.
Phase 3 ASPEN Study Success
The ASPEN study for brensocatib in bronchiectasis showed impressive Phase 3 data, potentially marking the beginning of a significant value creation curve for DPP1 inhibition.
TPIP's Potential as Best-in-Class Treatment
First data from TPIP in PH-ILD revealed its potential as a best-in-class treatment for pulmonary hypertension, with plans to kick off a Phase 3 trial in PH-ILD in the second half of the year.
Lowlights
Increased Cash Burn Rate
The underlying cash burn in Q4 was approximately $191 million, higher than recent quarters due to launch preparations for brensocatib.
Potential Market Access Challenges
Market access for brensocatib may require contracting to ensure a frictionless launch, with concerns about how payers might require multiple documented PEs for access.
Company Guidance
During Insmed's fourth quarter and full year 2024 financial results call, the company provided guidance on several key metrics and future expectations. The anticipated U.S. launch of brensocatib for bronchiectasis is set for the third quarter of 2025, with U.S. list pricing expected in the upper half of the $40,000 to $96,000 annual range. Insmed expects ARIKAYCE to achieve net revenues between $405 million and $425 million in 2025, representing another year of strong double-digit growth. Additionally, the company highlighted the potential of its pipeline, with Phase 2 data for TPIP in PAH expected mid-year and Phase 2 data for brensocatib in CRS without nasal polyps anticipated by year-end. Insmed also mentioned its robust financial position, with over $1.4 billion in cash and marketable securities, supporting its strategic investments and ongoing clinical programs as it positions itself for sustained profitability.

Insmed Corporate Events

Product-Related Announcements
Insmed’s Brensocatib Receives FDA Priority Review
Positive
Feb 24, 2025

On February 24, 2025, Insmed announced that the FDA does not plan to hold an advisory committee meeting for their New Drug Application (NDA) of brensocatib, a treatment for non-cystic fibrosis bronchiectasis. The FDA has granted priority review to the NDA, with a target action date set for August 12, 2025. Brensocatib, based on data from the ASPEN study, could become the first approved treatment for bronchiectasis and represents a new class of medicines targeting neutrophil-mediated diseases.

Executive/Board ChangesBusiness Operations and StrategyFinancial Disclosures
Insmed Board Member Alfred Altomari to Step Down
Positive
Feb 20, 2025

On February 18, 2025, Alfred Altomari announced he would not seek re-election to Insmed’s board at the company’s 2025 Annual Meeting, though this decision was not due to any disagreements with the company. Insmed reported significant financial performance in 2024, with ARIKAYCE generating $363.7 million in revenue, marking a 19% annual growth. The company is also progressing with its drug Brensocatib, which received FDA Priority Review, and anticipates a U.S. launch in 2025 if approved. Insmed’s ongoing research and development efforts, including its robust pipeline and pre-clinical programs, position it for continued growth and expansion in the biopharmaceutical industry.

Product-Related AnnouncementsRegulatory Filings and Compliance
Insmed’s Brensocatib NDA Accepted by FDA
Positive
Feb 6, 2025

On February 6, 2025, Insmed announced that the FDA accepted its New Drug Application for brensocatib, a potential first-in-class treatment for non-cystic fibrosis bronchiectasis, with a target action date set for August 12, 2025. If approved, brensocatib would be the first treatment for bronchiectasis and the first dipeptidyl peptidase 1 inhibitor, reflecting a significant advancement in treating neutrophil-mediated diseases, potentially impacting the market and offering new hope to patients without existing treatment options.

Product-Related AnnouncementsBusiness Operations and StrategyFinancial Disclosures
Insmed Projects Revenue Growth and Advances Drug Pipeline
Positive
Jan 10, 2025

Insmed announced significant commercial and clinical progress, forecasting 2025 global revenues for ARIKAYCE between $405 million and $425 million, which represents continued growth. The company submitted a new drug application for brensocatib to the FDA and plans to launch it in the U.S. in the third quarter of 2025, pending approval. Insmed completed enrollment for various clinical trials, including the Phase 2 study for TPIP in PAH and the Phase 3 ENCORE trial for ARIKAYCE, with results expected in the coming years. Additionally, they plan to initiate a clinical trial for their gene therapy, INS1201, in patients with DMD in the first half of 2025.

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.