tiprankstipranks
Trending News
More News >
Iterum Therapeutics (ITRM)
:ITRM
US Market
Advertisement

Iterum Therapeutics (ITRM) AI Stock Analysis

Compare
906 Followers

Top Page

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
Market Need
ORLYNVAH is positioned to address a significant unmet need in the UTI space for safe and effective antibiotics.
Product Launch
The commercial launch of ORLYNVAH is set to take place by the end of August, with support from a partnership with EVERSANA for sales and commercial operations in the US.
Product Superiority
ORLYNVAH has demonstrated superiority to conventional antibiotics in late-stage clinical trials, providing a strong competitive edge.
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 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 Earnings Call Summary

Earnings Call Date:Aug 05, 2025
(Q2-2025)
|
% Change Since: |
Next Earnings Date:Nov 07, 2025
Earnings Call Sentiment Neutral
The earnings call highlights significant progress with the early launch of ORLYNVAH, a large addressable market, secured manufacturing, extended financial flexibility, and strong market protection. However, increased operating expenses, rising net loss, and the need for additional share authorization highlight financial challenges. There is a balanced sentiment with notable achievements and challenges.
Q2-2025 Updates
Positive Updates
Early Launch of ORLYNVAH
Iterum Therapeutics expects to launch ORLYNVAH on August 20, ahead of the previously announced timeline, marking the first new branded product in the uncomplicated urinary tract infection space in over 25 years.
Large Addressable Market for ORLYNVAH
The U.S. uncomplicated urinary tract infection market generates approximately 40 million prescriptions annually, with about 26 million for at-risk patients, representing a significant addressable market for ORLYNVAH.
Commercial Supply and Manufacturing Agreement
Iterum has executed a commercial supply agreement with ACS Dobfar in Italy, securing a world-class FDA-approved manufacturer for ORLYNVAH with a shelf life of 6 years, satisfying commercial requirements into mid- to late 2026.
Extension of Regulatory Payment to Pfizer
The $20 million regulatory payment to Pfizer has been extended from 2026 to 2029, easing near-term financial obligations and allowing more revenue for commercialization.
Market Exclusivity and Patent Protection
ORLYNVAH has market exclusivity until 2034 and patents extending to 2041, providing a long runway to create value.
Negative Updates
Increased Operating Expenses
Total operating expenses rose to $5.5 million in Q2 2025 from $4 million in Q2 2024, primarily due to higher G&A costs related to pre-commercialization activities.
Net Loss Increase
Net loss on a non-GAAP basis increased to $5.1 million in Q2 2025 compared to $3.8 million in Q2 2024, driven by higher G&A spending.
Cash Position and Share Authorization
Cash and equivalents were $13 million at the end of June 2025. The company seeks authorization for an additional 80 million shares to ensure financial flexibility, which may indicate potential dilution concerns.
Company Guidance
During the Iterum Therapeutics Second Quarter 2025 Financial Results and Business Update Call, the company provided guidance on several key metrics related to the commercialization of ORLYNVAH. The launch of ORLYNVAH in the U.S. is expected around August 20, slightly ahead of schedule. The market for uncomplicated urinary tract infections in the U.S. generates approximately 40 million prescriptions annually, with about 26 million being for at-risk patients. Iterum plans to target 20 geographic territories initially, focusing on high-value prescribers and areas with significant antibiotic resistance. The pricing for ORLYNVAH is set between $1,400 and $4,700 per course of treatment. The company has secured a commercial supply agreement with ACS Dobfar and expects its current stock to meet demand until mid- to late 2026. Financially, Iterum reported a net loss of $6.5 million for the second quarter of 2025, with operating expenses increasing to $5.5 million due to pre-commercialization activities. The company had $13 million in cash and equivalents at the end of June and anticipates these funds will support operations into 2026. Additionally, Iterum plans to seek shareholder approval for an increase in authorized share capital to ensure financial flexibility.

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
Negative
Last Price0.68
Price Trends
50DMA
0.83
Negative
100DMA
0.93
Negative
200DMA
1.26
Negative
Market Momentum
MACD
-0.05
Positive
RSI
40.89
Neutral
STOCH
23.98
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 0.68 is below the 20-day moving average (MA) of 0.74, below the 50-day MA of 0.83, and below the 200-day MA of 1.26, indicating a bearish trend. The MACD of -0.05 indicates Positive momentum. The RSI at 40.89 is Neutral, neither overbought nor oversold. The STOCH value of 23.98 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 (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
58
Neutral
$60.24M-1738.36%-35.29%45.18%
54
Neutral
$36.27M-277.74%536.44%63.68%
51
Neutral
$7.95B-0.40-42.50%2.21%22.29%-1.85%
35
Underperform
$30.29M607.06%57.08%
27
Underperform
$83.85M-328.04%42.29%
$30.64M
$43.49M-100.72%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ITRM
Iterum Therapeutics
0.68
-0.40
-37.04%
CVM
Cel-Sci
10.49
-21.31
-67.01%
CLNN
Clene
6.03
0.28
4.87%
XLO
Xilio Therapeutics
0.70
-0.10
-12.50%
CAMP
CAMP4 Therapeutics Corporation
1.52
-8.23
-84.41%
RADX
Radiopharm Theranostics Limited Sponsored ADR
5.75
1.12
24.19%

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