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Iterum Therapeutics Plc (ITRM)
NASDAQ:ITRM
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Iterum Therapeutics
(NASDAQ:ITRM)
Rating:35Underperform
Price Target:―
Positive Factors
Financial Stability
Iterum expects to have runway into 2026, providing financial stability for ongoing operations.
Intellectual Property
ORLYNVAH is covered by robust IP protection extending into 2039.
Product Uniqueness
Orlynvah is the first oral penem approved in the US for uncomplicated urinary tract infections, adding unique value to the market.
Negative Factors
Competition
A key challenge for Iterum may have been the overhang of the impending approval of Glaxo's gepotidacin, which could impact market dynamics.
Iterum Therapeutics (ITRM) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$37.27M
Dividend YieldN/A
Average Volume (3M)590.80K
Price to Earnings (P/E)―
Beta (1Y)1.90
Revenue GrowthN/A
EPS Growth55.67%
CountryUS
Employees9
SectorHealthcare
Sector Strength42
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.10
Shares Outstanding40,000,000
10 Day Avg. Volume672,615
30 Day Avg. Volume590,800
Financial Highlights & Ratios
PEG Ratio-0.03
Price to Book (P/B)-6.08
Price to Sales (P/S)0.00
P/FCF Ratio-1.63
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$7.00Price Target Upside652.69% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering2
Iterum Therapeutics Business Overview & Revenue Model
Company DescriptionIterum Therapeutics plc, a clinical-stage pharmaceutical company, engages in developing and commercializing anti-infectives in Ireland, Bermuda, and the United States. It is developing sulopenem, a novel anti-infective compound with oral and IV formulations that is in Phase III clinical trials for the treatment of uncomplicated urinary tract infections, complicated urinary tract infections, and complicated intra-abdominal infections. The company was incorporated in 2015 and is headquartered in Dublin, Ireland.
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
0.93
Price Trends
1.15
Negative
1.33
Negative
1.37
Negative
Market Momentum
-0.06
Positive
39.94
Neutral
21.92
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 0.93 is below the 20-day moving average (MA) of 1.01, below the 50-day MA of 1.15, and below the 200-day MA of 1.37, indicating a bearish trend. The MACD of -0.06 indicates Positive momentum. The RSI at 39.94 is Neutral, neither overbought nor oversold. The STOCH value of 21.92 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 3 New Risks
1.
In the event our strategic process does not result in any type of transaction, and subject to our ability to raise sufficient capital to fund operations, we may seek a commercial partner and/or directly commercialize ORLYNVAH™ in the United States with a targeted sales force in the community setting. Should we seek to commercialize ORLYNVAH™, we are heavily dependent on the success of ORLYNVAH™, which the FDA has approved for the treatment of uUTIs caused by certain designated microorganisms in adult women who have limited or no alternative oral antibacterial treatment options. Any failure to successfully commercialize ORLYNVAH™ or inability to obtain marketing approval for any other product candidates, or significant delays in doing so, will materially harm our business. Q4, 2024
2.
In the event that we do not successfully identify a viable strategic option or, consummate such a transaction, or if we are unable to raise sufficient capital to fund our operations and commercialize ORLYNVAH™, our board of directors may determine that a liquidation and dissolution of our business approved by shareholders is the best method to seek to maximize shareholder value. In such an event, the amount of cash available for distribution to our shareholders, if any, will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities. Q4, 2024
3.
If we are unable to establish sales, marketing and distribution capabilities or enter into sales, marketing and distribution arrangements with third parties, we may not be successful in commercializing ORLYNVAH™ or sulopenem in additional indications and/or any future products, if approved. Q4, 2024
Iterum Therapeutics Peers Comparison
Overall Rating
UnderperformOutperform
Sector (53)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
53 Neutral | $56.62M | ― | -71.64% | ― | -98.90% | -177.17% | |
53 Neutral | $5.14B | 3.03 | -43.89% | 2.83% | 16.75% | -0.06% | |
48 Neutral | $51.16M | ― | -181.84% | ― | -32.11% | 88.12% | |
48 Neutral | $38.93M | 10.83 | -107.28% | ― | -71.68% | -397.61% | |
44 Neutral | $17.95M | 1.38 | 121.75% | ― | ― | ― | |
38 Underperform | $53.71M | ― | <0.01% | ― | ― | -29.01% | |
35 Underperform | $37.27M | ― | 607.06% | ― | ― | 55.67% |
* Healthcare Sector Average
Performance Comparison
ITRM
Iterum Therapeutics
0.93
-0.42
-31.11%
FBIO
Fortress Biotech
1.78
-0.09
-4.81%
OTLK
Outlook Therapeutics
1.60
-6.30
-79.75%
SPRO
Spero Therapeutics
0.70
-0.77
-52.38%
XFOR
X4 Pharmaceuticals
3.10
-23.99
-88.56%
RPTX
Repare Therapeutics
1.32
-1.80
-57.69%
Iterum Therapeutics Earnings Call Summary
Earnings Call Date:May 13, 2025
(Q1-2025)
| % Change Since: -7.92%|
Next Earnings Date:Aug 08, 2025
Earnings Call Sentiment Neutral
The earnings call highlighted significant progress in reducing operating and R&D expenses, extending the cash runway, and preparing for the potential market launch of ORLYNVAH. However, challenges include increased G&A expenses, the inability to secure a strategic partner, competition from new market entrants, and ongoing net losses. While there are positive steps toward commercialization, the balance of highlights and lowlights suggests a cautious outlook.Q1-2025 Updates
Positive Updates
Decreased Operating Expenses
Total operating expenses were $3.7 million in Q1 2025, compared to $6.2 million in Q1 2024, showing a significant reduction in costs.
Reduction in R&D Expenses
R&D costs were approximately $600,000 in Q1 2025, compared to $4 million in Q1 2024, primarily due to decreased costs associated with the REASSURE trial.
Extended Cash Runway
The company has extended its cash runway into 2026, including the potential launch of ORLYNVAH by Q4 2025.
Potential Market for ORLYNVAH
The U.S. market for uncomplicated urinary tract infections is large, with 40 million prescriptions annually. ORLYNVAH could capture a market share leading to over $250 million in net sales at peak.
Repayment of Debt
In January 2025, Iterum Therapeutics repaid the outstanding principal and interest on its exchangeable notes, eliminating a significant debt liability.
Negative Updates
Lack of Strategic Partnerships
Efforts to secure a business development partner have not resulted in a transaction that meets the board's standards.
Increased G&A Expenses
General and administrative costs increased to $2.8 million in Q1 2025, from $2.2 million in Q1 2024, primarily due to pre-commercialization activities.
Net Loss
Net loss on a GAAP basis was $4.9 million for Q1 2025, compared to a net loss of $7.1 million in Q1 2024.
New Competition in the Market
A new product was approved in April 2024, and GlaxoSmithKline received approval for a product in Q1 2025, increasing competition in the uncomplicated urinary tract infection space.
Company Guidance
During the Iterum Therapeutics plc first quarter 2025 earnings call, the company provided guidance on several key metrics. The potential commercialization of ORLYNVAH is planned for the fourth quarter of 2025, targeting the U.S. market for uncomplicated urinary tract infections. With approximately 40 million prescriptions generated annually in the U.S., ORLYNVAH's addressable market is estimated at around 26 million prescriptions for at-risk patients. Iterum anticipates capturing a 1% market share could result in over $250 million in annual net sales. Financially, Iterum reported a reduction in operating expenses to $3.7 million for Q1 2025 from $6.2 million in the same period in 2024, with a net loss of $4.9 million on a GAAP basis. The company ended March 2025 with $12.7 million in cash and cash equivalents, with a cash runway extended into 2026, alongside recent fundraisings totaling $5.2 million in April 2025. They also highlighted the elimination of a significant amount of debt through the repayment of exchangeable notes.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.