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Iterum Therapeutics Plc (ITRM)
NASDAQ:ITRM
US Market
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Iterum Therapeutics (ITRM) AI Stock Analysis

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ITRM

Iterum Therapeutics

(NASDAQ:ITRM)

Rating:35Underperform
Price Target:
Iterum Therapeutics faces significant financial challenges with ongoing net losses and cash flow issues, despite positive developments such as FDA approval of ORLYNVAH. The technical indicators suggest weak market momentum, and valuation metrics reflect poor investment attractiveness. The potential market for ORLYNVAH and improved financial performance are notable positives, but strategic uncertainties and financial obligations weigh heavily on the stock's outlook.
Positive Factors
Clinical Superiority
ORLYNVAH has demonstrated superiority to conventional antibiotics in late-stage clinical trials, providing a strong competitive edge.
FDA Approval
ORLYNVAH has received a good label from the FDA, covering treatment for adult women with limited or no alternative oral antibacterial options.
Product Launch
The commercial launch of ORLYNVAH is set to take place with support from a partnership with EVERSANA for sales and commercial operations in the US.
Negative Factors
Financial Performance
Iterum reported 1Q25 results with a net loss of ($4.9M) and ended the period with $12.7M in cash, excluding additional financing.
Market 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)

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 Earnings Call Summary

Earnings Call Date:Aug 05, 2025
(Q2-2025)
|
% Change Since: 15.49%|
Next Earnings Date:Nov 07, 2025
Earnings Call Sentiment Neutral
The earnings call reflects a positive outlook with the impending launch of ORLYNVAH, a strong strategic plan, and extended financial and market protections. However, increased operating expenses and net loss along with potential shareholder dilution present challenges.
Q2-2025 Updates
Positive Updates
Upcoming Launch of ORLYNVAH
Iterum Therapeutics is set to launch ORLYNVAH around August 20, 2025, ahead of the previously announced timeline. This is significant as it will be the first new branded product launched in the uncomplicated urinary tract infection space in over 25 years.
Market Potential and Addressable Market
The uncomplicated urinary tract infection market in the U.S. generates approximately 40 million prescriptions annually. ORLYNVAH targets at-risk patients, approximately 26 million prescriptions annually, who are most in need of new therapies.
Strategic Geographic Launch Plan
The first phase of the launch will cover 20 targeted geographic territories in 7 states with a focus on high-value physician prescribers. These include New York, New Jersey, Connecticut, Pennsylvania, Georgia, Florida, and Texas.
Strong Manufacturing and Supply Agreement
Iterum has executed a commercial supply agreement with ACS Dobfar, a leading manufacturer, ensuring a world-class FDA-approved manufacturer for ongoing production. The current stock is expected to satisfy commercial requirements into mid-to-late 2026.
Extended Market Exclusivity and Patent Protection
ORLYNVAH has been granted market exclusivity in the U.S. until October 2034, with patents scheduled to expire between 2039 and 2041, providing a long runway for value creation.
Financial Extension Agreement with Pfizer
The $20 million regulatory payment to Pfizer has been extended to October 2029, removing a near-term financial obligation and allowing more revenue to be used for ORLYNVAH commercialization.
Negative Updates
Increased Operating Expenses
Total operating expenses increased to $5.5 million in Q2 2025 from $4 million in Q2 2024, largely due to higher G&A expenses related to pre-commercialization activities.
Net Loss Increase
The net loss on a U.S. GAAP basis was $6.5 million for Q2 2025 compared to $5 million in Q2 2024. On a non-GAAP basis, the net loss increased to $5.1 million from $3.8 million year-over-year.
Shareholder Vote for Additional Shares
The company is seeking shareholder authorization for an additional 80 million shares, a 100% increase, to ensure financial flexibility, which could indicate potential dilution concerns for shareholders.
Company Guidance
During the Iterum Therapeutics Second Quarter 2025 Financial Results and Business Update Call, the company provided several key metrics and guidance on their upcoming plans. The company anticipates launching ORLYNVAH in the U.S. on or around August 20, 2025, targeting the large uncomplicated urinary tract infection market, which generates approximately 40 million prescriptions annually. Iterum's initial focus will be on 20 geographic territories across seven states, targeting 2,300 high-value physicians who are estimated to write between 1 million and 2 million prescriptions annually. Their market access strategy aims to secure payer coverage and set the wholesaler acquisition cost between $1,400 and $4,700 per treatment course. Iterum has successfully secured a commercial supply agreement with ACS Dobfar and extended a $20 million payment to Pfizer to 2029. Financially, the company recorded a net loss of $6.5 million for Q2 2025 and expects its current cash reserves to fund operations into 2026. They are also seeking shareholder approval to authorize an additional 80 million shares to ensure financial flexibility for future strategic objectives.

Iterum Therapeutics Financial Statement Overview

Summary
Iterum Therapeutics is struggling financially with consistent net losses, negative cash flows, and a weak balance sheet. The lack of revenue and profitability, coupled with financial instability, underlines significant challenges the company must address. Strategic realignment and operational improvements are essential to achieve a turnaround and create long-term value.
Income Statement
20
Very Negative
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.
Balance Sheet
15
Very Negative
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.
Cash Flow
25
Negative
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.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue0.000.000.000.000.000.00
Gross Profit-1.28M-254.00K-1.75M-1.80M-2.10M-161.00K
EBITDA-20.38M-18.70M-34.58M-39.97M-83.20M-36.01M
Net Income-24.08M-24.77M-38.37M-44.43M-91.56M-52.01M
Balance Sheet
Total Assets34.01M44.59M26.26M66.83M91.51M32.79M
Cash, Cash Equivalents and Short-Term Investments13.03M24.13M23.93M60.84M81.34M14.51M
Total Debt32.56M45.53M18.96M28.47M24.90M35.85M
Total Liabilities37.90M48.68M32.66M38.83M41.27M83.35M
Stockholders Equity-3.89M-4.08M-6.40M28.00M50.23M-50.56M
Cash Flow
Free Cash Flow-15.04M-26.77M-39.34M-18.54M-15.90M-54.54M
Operating Cash Flow-15.04M-26.77M-39.33M-18.47M-15.84M-54.53M
Investing Cash Flow6.80M18.21M23.34M13.96M-54.59M-11.00K
Financing Cash Flow15.91M26.69M1.03M-1.82M83.13M64.47M

Iterum Therapeutics Technical Analysis

Technical Analysis Sentiment
Neutral
Last Price0.82
Price Trends
50DMA
0.91
Negative
100DMA
1.00
Negative
200DMA
1.31
Negative
Market Momentum
MACD
-0.04
Negative
RSI
50.79
Neutral
STOCH
83.04
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ITRM, the sentiment is Neutral. The current price of 0.82 is above the 20-day moving average (MA) of 0.77, below the 50-day MA of 0.91, and below the 200-day MA of 1.31, indicating a neutral trend. The MACD of -0.04 indicates Negative momentum. The RSI at 50.79 is Neutral, neither overbought nor oversold. The STOCH value of 83.04 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral 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 (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
60
Neutral
$67.02M-69.96%-99.64%-59.17%
51
Neutral
$7.44B-0.20-46.00%2.27%22.80%-2.27%
48
Neutral
$59.44M-181.84%-32.11%88.12%
48
Neutral
$131.95M10.83-94.59%-67.67%-390.60%
44
Neutral
$29.43M0.66-207.22%5721.31%-671.01%
38
Underperform
$104.13M<0.01%
35
Underperform
$34.52M607.06%57.08%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ITRM
Iterum Therapeutics
0.82
-0.40
-32.79%
FBIO
Fortress Biotech
1.96
0.06
3.16%
OTLK
Outlook Therapeutics
2.43
-5.25
-68.36%
SPRO
Spero Therapeutics
1.98
0.77
63.64%
XFOR
X4 Pharmaceuticals
3.14
-15.83
-83.45%
RPTX
Repare Therapeutics
1.56
-1.44
-48.00%

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
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.Date of analysis: Apr 30, 2025