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Insmed (INSM)
NASDAQ:INSM

Insmed (INSM) AI Stock Analysis

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Insmed

(NASDAQ:INSM)

49Neutral
Insmed's overall score reflects strong revenue growth and positive developments in clinical trials and regulatory reviews, offset by substantial profitability and cash flow challenges. The technical indicators suggest bearish trends, and valuation metrics are unattractive due to ongoing losses.
Positive Factors
Commercial strategy
Insmed's commercial initiatives have shown a positive impact, especially given strong patient interest.
Financial performance
End of 1Q25 cash of $1.1B provides a strong financial runway well beyond the potential commercial launch for brenso.
Regulatory approval
The PDUFA date for brensocatib in NCFBE is expected to see approval due to no AdComm planned.
Negative Factors
Leadership changes
The resignation of the Chief Commercial Officer has no impact on the outlook for the business or the upcoming brensocatib launch.
Prescription challenges
Some initial access limitations are acknowledged, as most prescriptions will require medical exceptions and payers are cautious.
Revenue decline
1Q25 global Arikayce revenue was $92.8M, showing a decrease of 11% quarter over quarter.

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

Insmed Business Overview & Revenue Model

Company DescriptionInsmed Incorporated, a biopharmaceutical company, develops and commercializes therapies for patients with serious and rare diseases. The company offers ARIKAYCE for the treatment of Mycobacterium avium complex lung disease as part of a combination antibacterial drug regimen for adult patients. It is also developing Brensocatib, an oral reversible inhibitor of dipeptidyl peptidase 1 for the treatment of patients with bronchiectasis and other neutrophil-mediated diseases; and Treprostinil Palmitil Inhalation Powder, an inhaled formulation of a treprostinil prodrug treprostinil palmitil for the treatment of pulmonary arterial hypertension and other rare pulmonary disorders. Insmed Incorporated was founded in 1988 and is headquartered in Bridgewater, New Jersey.
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
Insmed shows strong revenue growth but faces significant profitability and cash flow challenges. Negative equity in the past and high debt levels raise concerns about financial sustainability.
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 Price65.08
Price Trends
50DMA
72.97
Negative
100DMA
73.92
Negative
200DMA
73.56
Negative
Market Momentum
MACD
-1.44
Positive
RSI
35.80
Neutral
STOCH
16.52
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 65.08 is below the 20-day moving average (MA) of 70.07, below the 50-day MA of 72.97, and below the 200-day MA of 73.56, indicating a bearish trend. The MACD of -1.44 indicates Positive momentum. The RSI at 35.80 is Neutral, neither overbought nor oversold. The STOCH value of 16.52 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 (52)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
79
Outperform
$13.60B12.0319.94%19.85%21.16%
77
Outperform
$11.29B21.849.64%17.99%152.10%
76
Outperform
$7.45B60.9621.52%30.93%11.78%
75
Outperform
$11.54B184.440.47%17.13%-88.78%
63
Neutral
$14.05B-8.58%46.62%50.50%
52
Neutral
$5.15B3.56-42.52%2.83%14.56%-0.50%
49
Neutral
$11.85B-320.20%20.77%-13.60%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
INSM
Insmed
65.08
39.25
151.96%
BMRN
BioMarin Pharmaceutical
58.86
-21.64
-26.88%
CORT
Corcept Therapeutics
70.23
42.70
155.10%
INCY
Incyte
58.98
1.38
2.40%
UTHR
United Therapeutics
301.42
37.08
14.03%
ITCI
Intra-Cellular Therapies
131.87
65.55
98.84%

Insmed Earnings Call Summary

Earnings Call Date:May 08, 2025
(Q1-2025)
|
% Change Since: -4.69%|
Next Earnings Date:Jul 31, 2025
Earnings Call Sentiment Positive
The earnings call highlighted strong financial performance, significant progress in clinical programs, and promising regulatory advancements. However, challenges remain in navigating regulatory processes and potential tariff impacts. Overall, the positive aspects, particularly the revenue growth and clinical milestones, outweigh the lowlights.
Q1-2025 Updates
Positive Updates
Strong Start to 2025
Insmed started 2025 with strong execution in research, development, and regulatory teams, achieving significant progress in all its clinical programs.
ARIKAYCE Revenue Growth
ARIKAYCE delivered another quarter of double-digit year-over-year revenue growth, marking the sixth consecutive quarter of such achievement. Japan and Europe saw growth rates around 50%, with the U.S. recording a 14% increase.
Progress with Brensocatib
The Phase 3 ASPEN trial results for brensocatib in bronchiectasis were published in the New England Journal of Medicine, and regulatory processes in the U.S., Europe, and the U.K. are on track.
TPIP Program Advancements
The Phase 2 trial of TPIP in pulmonary arterial hypertension is nearing a topline readout, with expectations for significant reductions in pulmonary vascular resistance.
Financial Stability
Insmed reported a strong cash position with approximately $1.2 billion in cash, cash equivalents, and marketable securities, supporting its upcoming clinical and commercial activities.
Negative Updates
Potential Tariff Impacts
Concerns were raised about the potential impacts of tariffs on Insmed's operations, though the company estimates a relatively small financial impact in the single-digit millions annually.
Regulatory Uncertainty
There are uncertainties regarding the finalization of FDA inspections and the potential for unexpected regulatory requirements that could impact approval timelines.
Market Access Challenges
Discussions with market access participants highlight potential challenges in pricing and reimbursement strategies for new therapies like brensocatib.
Company Guidance
During the Insmed First Quarter 2025 Financial Results Call, CEO Will Lewis provided optimistic guidance, highlighting significant achievements and expectations for the year. ARIKAYCE reported double-digit year-over-year revenue growth in Q1 2025, and the company anticipates the FDA's decision on brensocatib for bronchiectasis by the PDUFA date of August 12. Insmed is advancing three mid to late-stage programs: brensocatib, TPIP, and ARIKAYCE, with recent publication of brensocatib's Phase 3 ASPEN trial results in the New England Journal of Medicine. The company reports over a million unique visits to their disease awareness website and over 53,000 engaged patients. Insmed's TPIP program for PAH targets a placebo-adjusted reduction in pulmonary vascular resistance of 20% as a successful outcome. With a strong cash position of approximately $1.2 billion, Insmed remains well-capitalized, aiming for a "frictionless launch" of brensocatib and prepared to address potential geopolitical uncertainties.

Insmed Corporate Events

Executive/Board Changes
Insmed’s Chief Commercial Officer Resigns for Personal Reasons
Neutral
Apr 17, 2025

On April 16, 2025, J. Drayton Wise resigned as Chief Commercial Officer of Insmed Incorporated for personal and medical reasons, effective immediately. His resignation was not due to any issues with the company’s financial or operational results. Mr. Wise will continue to provide consulting services to Insmed until December 31, 2025, with possible extensions. He will receive a monthly consulting fee and his equity awards will continue to vest during this period.

Spark’s Take on INSM Stock

According to Spark, TipRanks’ AI Analyst, INSM is a Neutral.

Insmed’s stock score reflects strong growth prospects driven by product pipeline advancements and revenue increases. However, financial performance concerns, including profitability challenges and high leverage, weigh heavily. Technical indicators suggest bearish sentiment, while a positive earnings call outlook provides some counterbalance.

To see Spark’s full report on INSM stock, click here.

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.

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.