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Trevi Therapeutics (TRVI)
:TRVI
US Market

Trevi Therapeutics (TRVI) AI Stock Analysis

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Trevi Therapeutics

(NASDAQ:TRVI)

55Neutral
Trevi Therapeutics shows promise with significant clinical progress and a strong cash position, essential for sustaining operations in a pre-revenue phase. However, ongoing financial losses and valuation risks temper the outlook. The stock's technical indicators suggest strong momentum, but investors should be cautious due to potential volatility and financial risks inherent in early-stage biotechnology companies.
Positive Factors
Clinical Trial Success
The company recently announced positive data from their Phase 2a trial in refractory chronic cough (RCC).
Financial Stability
Trevi has a cash position of $107.6 million, providing financial stability to complete ongoing trials, though additional funds will be needed for future phases.
Regulatory and Market Position
Upcoming catalysts include major data releases from ongoing studies and key regulatory meetings, which could positively influence the company's future prospects.
Negative Factors
Funding Needs
Trevi has a cash position of $107.6 million, providing financial stability to complete ongoing trials, though additional funds will be needed for future phases.
Market Competition
Management provided insights on competitor programs, enhancing understanding of Haduvio's position in the broader landscape of IPF and RCC.
Trial Discontinuation Concerns
Management reaffirmed that blinded discontinuation rates in the CORAL trial have tracked in the single-digit percentage range, compared to mid-teens in previous studies.

Trevi Therapeutics (TRVI) vs. S&P 500 (SPY)

Trevi Therapeutics Business Overview & Revenue Model

Company DescriptionTrevi Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. The company is developing Haduvio, an oral extended-release formulation of nalbuphine, which is in phase IIb/III clinical trial for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis. It has a license agreement with Endo Pharmaceuticals Inc. to develop and commercialize products incorporating nalbuphine hydrochloride in any formulation. The company was incorporated in 2011 and is headquartered in New Haven, Connecticut.
How the Company Makes MoneyTrevi Therapeutics primarily makes money through the development and potential commercialization of its lead product candidate, Haduvio. Revenue is anticipated to be generated from product sales once Haduvio receives regulatory approval and is launched in the market. The company may also explore partnerships and licensing agreements with larger pharmaceutical companies to enhance its distribution capabilities and reach. Additionally, Trevi might earn revenue from milestone payments or royalties associated with such partnerships. However, as a clinical-stage company, Trevi Therapeutics currently does not have any products on the market and relies on funding from investors to support its research and development activities.

Trevi Therapeutics Financial Statement Overview

Summary
Trevi Therapeutics is in a typical growth stage for a biotech company, with no revenue and reliance on external financing for operations. While the strong cash position and low debt levels are positives, the ongoing operating losses and negative cash flow highlight the financial risks associated with pre-revenue biotech firms. Continued access to capital will be crucial for its long-term viability.
Income Statement
10
Very Negative
The company has consistently reported zero revenue over the past years, which is typical for early-stage biotechnology firms focusing on R&D. However, this leads to negative net income and operating losses, reflected in the negative EBIT and EBITDA. The lack of revenue growth and persistent losses are significant weaknesses.
Balance Sheet
50
Neutral
Trevi Therapeutics maintains a strong cash position relative to its debt, indicating good liquidity. The debt-to-equity ratio is low, suggesting limited reliance on debt financing. However, the equity ratio has been declining, indicating increasing liabilities relative to assets, which could be a risk if unaddressed.
Cash Flow
30
Negative
The company has negative free cash flow, primarily due to its operating losses, which is common in the biotechnology industry during the development phase. Despite this, cash flow from financing remains positive, suggesting reliance on external funding to sustain operations. This presents a risk if future financing becomes less accessible.
Breakdown
Dec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
0.000.000.000.000.00
Gross Profit
0.00-123.00K-43.00K-50.00K-47.00K
EBIT
-51.52M-33.92M-29.91M-32.48M-32.49M
EBITDA
-51.52M-33.80M-29.86M-32.43M-32.44M
Net Income Common Stockholders
-47.91M-29.07M-29.15M-33.94M-32.76M
Balance SheetCash, Cash Equivalents and Short-Term Investments
107.62M82.97M12.59M36.83M45.00M
Total Assets
110.90M89.40M123.02M38.48M47.13M
Total Debt
1.03M1.34M9.18M14.63M14.21M
Net Debt
-33.06M-31.06M-3.41M-22.20M-30.79M
Total Liabilities
11.26M6.86M15.56M21.40M19.85M
Stockholders Equity
99.64M82.55M107.46M17.07M27.28M
Cash FlowFree Cash Flow
-38.29M-31.85M-28.33M-28.95M-29.03M
Operating Cash Flow
-38.26M-31.71M-28.18M-28.95M-29.00M
Investing Cash Flow
-21.53M59.43M-107.37M0.00-32.00K
Financing Cash Flow
61.48M-7.91M111.31M20.77M16.72M

Trevi Therapeutics Technical Analysis

Technical Analysis Sentiment
Positive
Last Price6.07
Price Trends
50DMA
5.48
Positive
100DMA
4.61
Positive
200DMA
3.81
Positive
Market Momentum
MACD
0.09
Positive
RSI
54.44
Neutral
STOCH
78.14
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For TRVI, the sentiment is Positive. The current price of 6.07 is above the 20-day moving average (MA) of 6.03, above the 50-day MA of 5.48, and above the 200-day MA of 3.81, indicating a bullish trend. The MACD of 0.09 indicates Positive momentum. The RSI at 54.44 is Neutral, neither overbought nor oversold. The STOCH value of 78.14 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for TRVI.

Trevi Therapeutics Risk Analysis

Trevi Therapeutics disclosed 72 risk factors in its most recent earnings report. Trevi Therapeutics 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

Trevi 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
57
Neutral
$632.35M-182.71%432.03%14.41%
55
Neutral
$586.86M-52.59%-60.26%
54
Neutral
$548.16M-4.99%20.69%-5.94%
51
Neutral
$5.20B3.18-40.80%2.96%17.66%1.94%
49
Neutral
$500.59M-23.34%47.92%17.84%
48
Neutral
$656.98M-32.60%351.48%80.10%
37
Underperform
$764.53M-54.14%6.99%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
TRVI
Trevi Therapeutics
6.07
3.22
112.98%
PRTA
Prothena
9.54
-11.02
-53.60%
RCKT
Rocket Pharmaceuticals
6.97
-16.70
-70.55%
ANAB
AnaptysBio
21.58
2.40
12.51%
DNTH
Dianthus Therapeutics
21.87
-1.55
-6.62%
PHAR
Pharming Group
8.39
-1.21
-12.60%

Trevi Therapeutics Earnings Call Summary

Earnings Call Date: Mar 18, 2025 | % Change Since: -7.47% | Next Earnings Date: May 8, 2025
Earnings Call Sentiment Positive
The earnings call highlighted significant clinical successes and a strong financial position, but increased losses and expenses present challenges. Overall, the positive clinical outcomes suggest a promising outlook for the company despite the financial setbacks.
Highlights
Positive Data Readouts
Trevi Therapeutics reported three positive data readouts in 2024, including the Human Abuse Potential study, the Sample Size Re-Estimation, and the RIVER study, indicating strong clinical progress for Haduvio.
Successful Human Abuse Potential Study
The Human Abuse Potential study showed statistically significant lower relative drug liking for nalbuphine compared to butorphanol, supporting its continued unscheduled status by the DEA.
RIVER Study Success
The RIVER study in RCC patients achieved a statistically significant reduction in 24-hour objective cough frequency, with a 57% placebo-adjusted change from baseline.
Financial Stability
Trevi completed a $50 million unwritten offering, resulting in cash, cash equivalents, and marketable securities totaling $107.6 million, providing a cash runway into the second half of 2026.
Lowlights
Increased Net Loss
The net loss for Q4 2024 was $11.4 million, up from $7.8 million in Q4 2023, primarily due to increased R&D expenses.
Higher R&D Expenses
R&D expenses increased to $9.3 million in Q4 2024 from $6.5 million in Q4 2023, driven by clinical trial costs and personnel expenses.
Higher G&A Expenses
G&A expenses rose to $2.9 million in Q4 2024 from $2.4 million in the same period in 2023, attributed to increased stock-based compensation and personnel expenses.
Company Guidance
During the Trevi Therapeutics Fourth Quarter and Year End 2024 Earnings Conference Call, the company provided detailed guidance on the progress and future plans for their lead drug, Haduvio. Trevi reported a net loss of $11.4 million for Q4 2024, compared to $7.8 million in the prior year, with R&D expenses rising to $9.3 million. The company successfully completed several clinical trials, including the Human Abuse Potential study, the CORAL study in IPF chronic cough, and the RIVER study in refractory chronic cough, with trials conducted across 11 countries. Trevi's cash reserves stood at $107.6 million, which includes a $50 million offering completed in December. The company’s cash runway extends into the second half of 2026, with expected quarterly cash burn of $12 million to $14 million in the first two quarters of 2025. Upcoming milestones include a Phase 2b readout for the CORAL trial expected in Q2 2025, and plans for an End-of-Phase 2 meeting with the FDA by the end of 2025. The company is also preparing for the next RCC trial while continuing to develop Haduvio for IPF and RCC.
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.