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Iterum Therapeutics Plc (ITRM)
NASDAQ:ITRM
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Iterum Therapeutics
(NASDAQ:ITRM)
34Underperform
Positive Factors
Market Opportunity
The addressable market for ORLYNVAH is approximately 40 million prescriptions per year, which represents a significant commercial opportunity.
Regulatory Approval
The FDA approved oral sulopenem, brand name ORLYNVAH, for the treatment of uncomplicated urinary tract infections in adult women with limited or no alternative oral antibiotic treatment.
Negative Factors
Antimicrobial Resistance
There could be a high risk of sulopenem's off-label use, with significant community risk in the form of increasing antimicrobial resistance against carbapenems.
Iterum Therapeutics (ITRM) vs. S&P 500 (SPY)
Market Cap
$45.30M
Dividend YieldN/A
Average Volume (3M)517.55K
Price to Earnings (P/E)―
Beta (1Y)2.69
Revenue GrowthN/A
EPS Growth55.67%
CountryUS
Employees9
SectorHealthcare
Sector Strength78
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.31
Shares Outstanding34,581,406
10 Day Avg. Volume303,136
30 Day Avg. Volume517,553
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)N/A
Price to Cash Flow (P/CF)-2.80
P/FCF Ratio0.00
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$10.00Price Target Upside646.27% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering0
Iterum Therapeutics Business Overview & Revenue Model
Company DescriptionIterum Therapeutics (ITRM) is a clinical-stage pharmaceutical company focused on developing innovative anti-infectives aimed at combating antibiotic-resistant pathogens. The company's primary product candidate, sulopenem, is a novel, oral and intravenous penem antibiotic intended for the treatment of multi-drug resistant infections, including those caused by Gram-negative and Gram-positive bacteria. Iterum operates within the biotechnology and pharmaceutical industry sectors, emphasizing the development and commercialization of treatments for serious bacterial infections.
How the Company Makes MoneyIterum Therapeutics makes money through the development and potential commercialization of its primary product candidate, sulopenem. The company's revenue model is expected to include income from the sale of sulopenem upon receiving regulatory approval, which would allow the company to market the drug to healthcare providers and institutions. Additionally, Iterum may pursue licensing agreements, strategic partnerships, and collaborations with other pharmaceutical companies to enhance distribution and commercialization efforts. These partnerships could provide upfront payments, milestone payments, and royalties based on sales, contributing significantly to the company's earnings. As a clinical-stage company, Iterum may also rely on funding from investors, grants, and other financial instruments to support its research and development activities until its products reach the market.
Iterum Therapeutics Financial Statement Overview
Summary
Iterum Therapeutics faces significant financial challenges, with consistent net losses, negative cash flows, and a weak balance sheet. The absence of revenue, coupled with financial instability, highlights the need for strategic realignment and operational improvements.Income Statement
Iterum Therapeutics demonstrates significant financial challenges, evidenced by consistent net losses and negative EBIT over the past years. The absence of revenue and gross profit undermines the potential for profitability. The company faces difficulty in generating income, with no visible growth trajectory in revenue, indicating a need for strategic changes to reverse the negative trend.20
Very Negative
Balance Sheet
The balance sheet reveals a precarious financial position with negative stockholders' equity and a high level of liabilities relative to assets. Although the company has managed to reduce net debt, the negative equity indicates financial instability and potential risk for stakeholders. This situation demands a comprehensive approach to improve financial health and sustain operations.15
Very Negative
Cash Flow
Iterum Therapeutics exhibits negative operating and free cash flows, highlighting the challenge of maintaining liquidity without external financing. The reliance on financing activities for cash inflows suggests an unsustainable cash flow model. Improving cash generation from operations is crucial to stabilize cash flow and reduce dependency on external capital.25
Negative
| Breakdown | ||||
| Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|
| Income Statement | Total Revenue | |||
| 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | Gross Profit |
| -254.00K | -1.75M | -1.80M | -2.10M | -161.00K | EBIT |
| -18.70M | -47.47M | -30.38M | -24.54M | -32.13M | EBITDA |
| -18.70M | -34.58M | -39.97M | -83.20M | -36.01M | Net Income Common Stockholders |
| -24.77M | -38.37M | -44.43M | -91.56M | -52.01M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | |||
| 24.13M | 23.93M | 60.84M | 81.34M | 14.51M | Total Assets |
| 44.59M | 26.26M | 66.83M | 91.51M | 32.79M | Total Debt |
| 45.53M | 18.96M | 28.47M | 24.90M | 35.85M | Net Debt |
| 21.41M | 12.88M | 7.37M | -2.55M | 21.34M | Total Liabilities |
| 48.68M | 32.66M | 38.83M | 41.27M | 83.35M | Stockholders Equity |
| -4.08M | -6.40M | 28.00M | 50.23M | -50.56M |
| Cash Flow | Free Cash Flow | |||
| -26.77M | -39.34M | -18.54M | -15.90M | -54.54M | Operating Cash Flow |
| -26.77M | -39.33M | -18.47M | -15.84M | -54.53M | Investing Cash Flow |
| 18.21M | 23.34M | 13.96M | -54.59M | -11.00K | Financing Cash Flow |
| 26.69M | 1.03M | -1.82M | 83.13M | 64.47M |
Iterum Therapeutics Technical Analysis
Negative
1.34
Price Trends
1.55
Negative
1.60
Negative
1.40
Negative
Market Momentum
-0.06
Negative
40.13
Neutral
39.27
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ITRM, the sentiment is Negative. The current price of 1.34 is below the 20-day moving average (MA) of 1.41, below the 50-day MA of 1.55, and below the 200-day MA of 1.40, indicating a bearish trend. The MACD of -0.06 indicates Negative momentum. The RSI at 40.13 is Neutral, neither overbought nor oversold. The STOCH value of 39.27 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for ITRM.
Iterum Therapeutics Risk Analysis
Iterum Therapeutics disclosed 88 risk factors in its most recent earnings report. Iterum Therapeutics reported the most risks in the “Finance & Corporate” category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Iterum Therapeutics Peers Comparison
Overall Rating
UnderperformOutperform
Sector (49)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
51 Neutral | $316.89M | ― | -136.87% | ― | ― | 21.19% | |
51 Neutral | $241.64M | ― | 21.91% | ― | 281.24% | 94.17% | |
49 Neutral | $6.90B | -0.08 | -53.01% | 2.43% | 24.84% | -3.06% | |
44 Neutral | $10.92M | ― | 291.66% | ― | ― | ― | |
34 Underperform | $45.30M | ― | 607.06% | ― | ― | 55.67% |
* Healthcare Sector Average
Performance Comparison
ITRM
Iterum Therapeutics
1.34
-0.18
-11.84%
VSTM
Verastem
7.15
-3.59
-33.43%
AKTX
Akari Therapeutics
0.90
-1.25
-58.14%
TSE:FRX
Fennec Pharmaceuticals
9.26
-3.92
-29.74%
Iterum Therapeutics Earnings Call Summary
Earnings Call Date: Feb 7, 2025 | % Change Since: -10.07% | Next Earnings Date: May 9, 2025
Earnings Call Sentiment Neutral
The earnings call presents significant achievements, particularly the FDA approval of ORLYNVAH and its market potential, coupled with improved financial performance. However, the uncertainty in strategic partnerships and financial obligations create notable challenges.Highlights
FDA Approval of ORLYNVAH
In October 2024, Iterum received FDA approval for ORLYNVAH, the first and only approved oral penem in the United States for the treatment of uncomplicated urinary tract infections.
Market Potential and Exclusivity
ORLYNVAH has a strong market potential in the US, with an estimated 40 million prescriptions annually for uncomplicated urinary tract infections. It also has 10 years of market exclusivity under the GAIN Act and patent protection into 2039.
Financial Performance Improvement
The non-GAAP net loss decreased by $7.6 million for Q4 2024 and $26.2 million for the full year compared to 2023, primarily due to lower R&D expenses.
Lowlights
Uncertain Strategic Alternatives
The process to sell, license, or dispose of rights to ORLYNVAH is ongoing with no definitive offers yet, creating uncertainty regarding future strategic partnerships or financial outcomes.
Regulatory Milestone Payment Obligation
Iterum has a deferred $20 million regulatory milestone payment to Pfizer, with interest accruing at 8% annually, due to the approval of oral sulopenem.
Cash Flow Concerns
Based on current operating plans, cash is expected to fund operations only into the second half of 2025, necessitating potential additional capital raising.
Company Guidance
During the Iterum Therapeutics fourth quarter and full year 2024 financial results call, the company outlined its strategic plans and financial metrics. Iterum reported total operating expenses of $3.7 million for Q4 and $18.7 million for the full year 2024, a decrease from $11.4 million and $47.5 million in 2023, primarily due to the completion of the REASSURE trial. The net loss on a GAAP basis was $6.6 million for Q4 and $24.8 million for the year, while on a non-GAAP basis, it was $3.1 million and $17.6 million, respectively. The company's cash and cash equivalents stood at $24.1 million at year-end, expected to fund operations into the second half of 2025. Iterum aims to maximize the value of ORLYNVAH, its recently FDA-approved product, through potential strategic transactions or direct commercialization, highlighting its unique position in the US market for treating uncomplicated urinary tract infections.Iterum Therapeutics Corporate Events
Executive/Board Changes
Iterum Therapeutics Appoints New Board Members
Neutral
Mar 10, 2025
On March 7, 2025, Iterum Therapeutics plc announced the appointment of Joseph J. Whalen to its Board of Directors, effective March 10, 2025. Mr. Whalen, with over 30 years of experience in the bio-pharmaceutical industry, will serve as a Class III director and join both the audit and compensation committees. His appointment ensures the company’s compliance with Nasdaq’s audit committee requirements. Additionally, David Kelly was appointed as Chairman of the Board, following the resignation of Ronald M. Hunt.
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.