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Veru (VERU)
NASDAQ:VERU

Veru (VERU) AI Stock Analysis

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Veru

(NASDAQ:VERU)

44Neutral
Veru is facing substantial financial and operational challenges, with declining revenues, negative profitability, and cash flow issues. While promising clinical results and strategic shifts provide some optimism, the stock's technical indicators and valuation metrics remain weak. These factors collectively suggest a cautious outlook.
Positive Factors
Clinical trial progress
The Ph. IIb QUALITY study has achieved full enrollment of over 150 patients, with top-line data expected to provide insights into enobosarm's effectiveness.
Product differentiation
Enobosarm's selective targeting of musculoskeletal androgen receptors differentiates it from other treatments, reducing negative effects associated with testosterone and anabolic steroids.
Strategic business focus
VERU has strategically monetized its FC2 female condom business for $18M to focus solely on enobosarm's development.
Negative Factors
Financial outlook
The company may need to raise additional capital within the next 12 months, in our view.
Initial trial results
A significant intra-day stock sell-off was attributed to the lack of meaningful weight loss benefits observed during the initial period of the study.

Veru (VERU) vs. S&P 500 (SPY)

Veru Business Overview & Revenue Model

Company DescriptionVeru Inc., an oncology biopharmaceutical company, focuses on developing medicines for the management of cancers. Its commercial products comprise FC2 female condom/internal condom for the dual protection against unintended pregnancy and the transmission of sexually transmitted infections for ministries of health, government health agencies, U.N. agencies, nonprofit organizations, and commercial partners. The company's development drug candidates include Enobosarm, an oral selective androgen receptor agonist that is in phase III clinical trial for the treatment of AR+ ER+ HER2- metastatic breast cancer; Sabizabulin, which is phase IIb clinical trial for the treatment of AR+ ER+ HER2- metastatic breast cancer; Enobosarm + abemaciclib combination therapy, which is in phase III clinical trial for the treatment of AR+ ER+ HER2- metastatic breast cancer; and Sabizabulin + enobosarm combination therapy, an oral targeted cytoskeleton disruptor plus selective androgen receptor agonist, which is in phase II clinical trial for the treatment of metastatic triple negative breast cancer. Its drug candidates also comprise Sabizabulin, which is in Phase II clinical trial for the treatment of metastatic castration and androgen receptor targeting agent resistant prostate cancer; VERU-100, a GnRH antagonist peptide injection, which is in Phase II clinical trial for the treatment of advanced hormone sensitive prostate cancer; Zuclomiphene Citrate, which is in Phase II clinical trial for treating hot flashes; and Sabizabulin, which is in phase III clinical trial for the treatment of SARS-CoV-2 in subjects at high risk for acute respiratory distress syndrome. In addition, the company is advancing a new drug formulation for the treatment of men with lower urinary tract symptoms from an enlarged prostate. The company was formerly known as The Female Health Company and changed its name to Veru Inc. in July 2017. Veru Inc. was incorporated in 1971 and is headquartered in Miami, Florida.
How the Company Makes MoneyVeru Inc. generates revenue through the sale of its pharmaceutical products, particularly those focused on oncology and urology. The company's revenue streams include the commercialization of its FDA-approved drugs and the development of new therapies that are in various stages of clinical trials. Veru also engages in strategic partnerships and licensing agreements to enhance its product pipeline and expand its market reach. Additionally, the company may receive milestone payments and royalties from collaborations with other pharmaceutical companies.

Veru Financial Statement Overview

Summary
Veru's financial performance is challenged by declining revenues and operational inefficiencies. Despite a low debt-to-equity ratio, the company struggles with negative profitability metrics, necessitating strategic revisions to improve financial health.
Income Statement
41
Neutral
Veru's income statement reveals significant challenges with profitability. The company has experienced declining revenues, with a 12.7% decrease from the previous year, and a negative net profit margin of -260.8% TTM due to substantial net losses. Although gross profit margin remains positive at 31.9%, the EBIT and EBITDA margins are severely negative, indicating operational inefficiencies. This suggests that Veru is struggling to manage its operating expenses effectively in relation to its revenue.
Balance Sheet
54
Neutral
Veru maintains a relatively moderate debt-to-equity ratio of 0.13 TTM, indicating a conservative approach to leveraging. The equity ratio is 66.9%, which showcases a strong reliance on equity financing and a robust capital base. However, the return on equity is negative at -144.4% TTM, reflecting the company's inability to generate profits from its equity base. This highlights a need for improvement in generating returns for shareholders.
Cash Flow
38
Negative
The cash flow statement shows that Veru is facing challenges with cash generation, having negative operating cash flow and free cash flow in the TTM period. The free cash flow to net income ratio is negative, indicating that the company is not converting its net income into free cash flow. This raises concerns about Veru's ability to sustain its operations and invest in future growth without additional financing.
Breakdown
TTMSep 2024Sep 2023Sep 2022Sep 2021Sep 2020
Income StatementTotal Revenue
14.75M16.89M16.30M39.35M61.26M42.59M
Gross Profit
4.70M5.85M7.57M30.59M47.93M30.79M
EBIT
-39.28M-36.92M-93.78M-83.22M-5.44M-14.75M
EBITDA
-38.97M-36.20M-89.98M-79.23M9.75M-14.65M
Net Income Common Stockholders
-38.47M-37.80M-93.15M-83.78M7.39M-18.97M
Balance SheetCash, Cash Equivalents and Short-Term Investments
5.17M24.92M9.63M80.19M122.36M13.59M
Total Assets
16.50M60.42M50.02M136.13M178.15M51.54M
Total Debt
20.02K3.99M14.41M14.92M12.63M14.14M
Net Debt
-5.15M-20.93M4.78M-65.27M-109.73M547.57K
Total Liabilities
4.50M28.10M30.34M55.29M25.85M21.43M
Stockholders Equity
12.00M32.32M19.68M80.84M152.29M30.11M
Cash FlowFree Cash Flow
-27.15M-21.84M-88.68M-48.24M-15.95M-2.04M
Operating Cash Flow
-26.99M-21.68M-88.01M-47.51M-15.57M-1.93M
Investing Cash Flow
17.39M146.21K6.33M4.27M14.62M-105.76K
Financing Cash Flow
-4.37M36.83M11.11M1.07M109.72M9.33M

Veru Technical Analysis

Technical Analysis Sentiment
Neutral
Last Price0.54
Price Trends
50DMA
0.53
Positive
100DMA
0.63
Negative
200DMA
0.73
Negative
Market Momentum
MACD
>-0.01
Positive
RSI
50.29
Neutral
STOCH
37.57
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For VERU, the sentiment is Neutral. The current price of 0.54 is below the 20-day moving average (MA) of 0.54, above the 50-day MA of 0.53, and below the 200-day MA of 0.73, indicating a neutral trend. The MACD of >-0.01 indicates Positive momentum. The RSI at 50.29 is Neutral, neither overbought nor oversold. The STOCH value of 37.57 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for VERU.

Veru Risk Analysis

Veru disclosed 57 risk factors in its most recent earnings report. Veru 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

Veru Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
51
Neutral
$5.20B3.18-40.80%2.96%17.66%1.94%
44
Neutral
$78.20M-80.11%-7.43%69.03%
36
Underperform
$74.52M-95.69%23.55%
OCOCX
34
Underperform
$82.37M-910.86%25.15%81.47%
33
Underperform
$84.45M-69.67%33.97%
30
Underperform
$80.57M-9999.00%27.65%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
VERU
Veru
0.54
-0.74
-57.81%
OCX
OncoCyte
2.92
0.46
18.70%
BDTX
Black Diamond Therapeutics
1.56
-3.45
-68.86%
ELTX
Elicio Therapeutics
5.05
-4.17
-45.23%
TNYA
Tenaya Therapeutics
0.45
-4.00
-89.89%
TELO
Telomir Pharmaceuticals, Inc.
2.60
-3.22
-55.33%

Veru Earnings Call Summary

Earnings Call Date: Feb 13, 2025 | % Change Since: -1.82% | Next Earnings Date: May 7, 2025
Earnings Call Sentiment Neutral
The earnings call highlighted significant progress in clinical trials with enobosarm, showcasing positive results in muscle preservation and fat loss. The strategic sale of the FC2 business and financial gains from debt extinguishment were also notable. However, financial challenges such as the loss on sale of the FC2 business, increased R&D costs, negative cash flow, and limited cash runway were concerning.
Highlights
Successful Phase 2b QUALITY Clinical Study
The Phase 2b QUALITY clinical study showed positive top line results for enobosarm, meeting its primary endpoint with a 71% relative reduction in lean mass loss (p-value of 0.002). The enobosarm 3-milligram dose achieved a greater than 99% mean relative reduction in lean mass loss (p-value < 0.001).
Enobosarm's Impact on Fat Loss
Enobosarm treatment resulted in a 46% greater relative loss of fat mass compared to placebo plus semaglutide group at 16 weeks (p-value of 0.014). The enobosarm 3-milligram dose led to a 99.1% fat loss.
Improvement in Physical Function
The enobosarm plus semaglutide group showed a 54.4% mean relative reduction in the proportion of subjects losing at least 10% stair climb power compared to the placebo group (p-value of 0.0049).
Strategic Focus on Biopharmaceutical Development
Veru sold its FC2 female condom business for $18 million, allowing the company to focus on drug development.
Financial Gains from Debt Extinguishment
Veru recorded a gain on extinguishment of debt of $8.6 million related to the termination of the residual royalty agreement.
Lowlights
Loss on Sale of FC2 Business
Veru experienced a $4.2 million loss on the sale of the FC2 female condom business, with net proceeds of $16.4 million compared to a total carrying value of $20.6 million.
Increased Research and Development Costs
Research and development costs increased significantly to $5.7 million from $1.7 million in the prior quarter, primarily due to expenses related to the enobosarm Phase 2b QUALITY clinical study.
Negative Cash Flow from Operations
Veru reported negative cash flow from operations, using $11.3 million for operating activities in the last quarter compared to $6 million in the prior period.
Limited Cash Runway
The company's current cash is not sufficient to fund operations for the next 15 months, although it can support activities until the end of the calendar year.
Company Guidance
During the recent investor conference call, Veru Inc. provided comprehensive guidance on its clinical progress and financial status. The company reported positive top-line results from the Phase 2b QUALITY study, demonstrating enobosarm's efficacy in preserving lean mass and augmenting fat loss in older obese patients, with a 71% relative reduction in lean mass loss and a p-value of 0.002. The 3 mg dose of enobosarm plus semaglutide showed a 99% mean relative reduction in lean mass loss (p-value <0.001) and a 46% greater relative loss of fat mass with the 6 mg dose compared to placebo plus semaglutide (p-value = 0.014). Veru also highlighted its strategic shift towards biopharmaceuticals following the sale of its FC2 female condom business, which generated net proceeds of $16.4 million. Financially, Veru reported a net loss of $1.8 million from continuing operations, with a total cash balance of $26.6 million as of December 31, 2024. The company plans to pursue a Phase III study for enobosarm, leveraging its promising Phase 2b results, and is exploring the development of sabizabulin for treating inflammation in atherosclerotic cardiovascular disease.

Veru Corporate Events

Shareholder MeetingsBusiness Operations and Strategy
Veru Inc. Shareholders Approve Equity Plan Amendment
Positive
Mar 14, 2025

On March 13, 2025, Veru Inc. held its Annual Meeting of Shareholders, where the shareholders approved an amendment to the 2018 Equity Incentive Plan, increasing the number of shares of the Company’s Common Stock authorized for issuance from 18,500,000 to 26,000,000. Additionally, the shareholders elected directors for the upcoming term and ratified the appointment of Cherry Bekaert LLP as the Company’s independent registered public accounting firm for the fiscal year ending September 30, 2025. These decisions reflect Veru Inc.’s strategic efforts to enhance its equity incentive offerings and ensure strong governance and financial oversight.

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.