Veru (VERU) AI Stock Analysis

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Veru

(NASDAQ:VERU)

Rating:50Neutral

Price Target:

$0.50

▼(-15.25%Downside)

Veru's overall stock score reflects substantial financial and operational challenges, offset partially by promising clinical and regulatory prospects. While the technical analysis provides some short-term optimism, poor valuation and financial performance are significant concerns. The need for additional funding and cash flow issues further weigh on the stock's potential.

Positive Factors

Clinical Study Success

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.

Potential Partnerships

Positive results from the QUALITY trial could help the company secure a partnership before advancing enobosarm into a pivotal program for the treatment of obesity.

Strategic Business Moves

VERU has strategically monetized its FC2 female condom business for $18M to focus solely on enobosarm's development.

Negative Factors

Market Competition

The ease of administration for enobosarm (an oral drug) compares favorably to other competing treatment options that require intravenous administration.

Stock Volatility

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.

Study Challenges

The ongoing Phase 2b QUALITY trial of enobosarm in combination with Wegovy (semaglutide) for the treatment of sarcopenic obesity is on track to report topline data in January 2025.

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

Market Cap

$86.48M

Dividend YieldN/A

Average Volume (3M)3.98M

Price to Earnings (P/E)―

Beta (1Y)0.36

Revenue Growth-21.28%

EPS Growth36.26%

CountryUS

Employees210

SectorHealthcare

Sector Strength47

IndustryBiotechnology

Share Statistics

EPS (TTM)-0.05

Shares Outstanding146,583,920

10 Day Avg. Volume3,520,294

30 Day Avg. Volume3,979,820

Financial Highlights & Ratios

PEG Ratio<0.01

Price to Book (P/B)11.42

Price to Sales (P/S)0.00

P/FCF Ratio-19.13

Enterprise Value/Market Cap9.92

Enterprise Value/Revenue15.23

Enterprise Value/Gross Profit213.09

Enterprise Value/Ebitda-5.66

Forecast

1Y Price Target

$4.00

Price Target Upside577.97% Upside

Rating ConsensusModerate Buy

Number of Analyst Covering0

Veru Business Overview & Revenue Model

Company DescriptionVeru Inc. is a biopharmaceutical company that focuses on the development and commercialization of novel medicines for the management of prostate cancer and other cancers. The company is also involved in the development of pharmaceuticals for the prevention of COVID-19. Veru operates primarily in the United States and its core products and services include oncology drug candidates and pharmaceutical products in the sexual health sector.

How the Company Makes MoneyVeru Inc. generates revenue through the development and commercialization of pharmaceutical products. The company's key revenue streams include sales from its proprietary drug products and potential royalties and milestone payments from partnerships and collaborations in the pharmaceutical industry. Veru's oncology drug candidates, which are in various stages of clinical development, present potential future revenue streams upon successful approval and commercialization. Additionally, the company engages in strategic partnerships and licensing agreements that can contribute significantly to its earnings.

Veru Earnings Call Summary

Earnings Call Date:May 08, 2025

(Q2-2025)

% Change Since: 18.00%|

Next Earnings Date:Aug 07, 2025

Earnings Call Sentiment Neutral

The earnings call presented several positive developments, such as successful Phase 2b study results for enobosarm and financial improvements in net loss from continuing operations. However, the company faces challenges with increased R&D costs, a significant decrease in cash reserves, and a net loss on the sale of the FC2 business. While there are promising regulatory and clinical catalysts ahead, the need for additional funding is a concern.

Q2-2025 Updates

Positive Updates

Positive Phase 2b Study Results for Enobosarm

The Phase 2b quality clinical study demonstrated that enobosarm combined with GLP-1 receptor agonists resulted in a 71% preservation of total lean body mass in patients, with a p-value of 0.002. The enobosarm 3 mg dose showed a 99% mean relative reduction in loss of lean mass, with a p-value of less than 0.001.

Improved Body Composition and Physical Function

Enobosarm treatment resulted in a 46% greater relative loss of fat mass compared to placebo plus semaglutide over 15 weeks, with a p-value of 0.014. There was also a significant reduction in the proportion of patients experiencing a decline in physical function, with a 62.4% relative reduction in the enobosarm 3 mg group, compared to placebo.

Financial Improvement

Net loss from continuing operations decreased from $8.7 million to $7.9 million compared to the prior year's quarter. Additionally, the sale of the FC2 female condom business generated net proceeds of approximately $16.3 million.

Regulatory and Clinical Catalysts

Upcoming catalysts include results of unblinded safety data for Phase 2b, efficacy and safety results for the Phase 2b extension study, and expected regulatory clarity from an end-of-Phase 2 FDA meeting in Q3 2025.

Negative Updates

Increased R&D Costs

Research and development costs increased from $3 million to $3.9 million for the quarter and from $4.6 million to $9.6 million for the six months ended March 31, 2025, primarily due to expenses related to the enobosarm Phase 2b quality clinical study.

Cash Position and Funding Needs

The company reported a decrease in cash, cash equivalents, and restricted cash from $24.9 million to $20 million as of March 31, 2025. The company will need additional capital to support its drug development candidates, as current cash is only sufficient to last into Q4 2025.

Loss on Sale of FC2 Business

The sale of the FC2 female condom business resulted in a net loss of $4.2 million due to the difference between estimated net proceeds and the total carrying value of the business.

Company Guidance

During Veru Inc.'s Q2 fiscal year 2025 investor call, the company provided detailed guidance on its ongoing clinical programs, particularly focusing on their obesity program. The discussion highlighted the progress of Enobosarm, an oral selective androgen receptor modulator, in combination with semaglutide for weight management in older patients. A Phase 2b study showed that Enobosarm, when combined with semaglutide, led to a 71% preservation of total lean body mass, with a significant p-value of 0.002, and a 99% mean relative reduction in loss of lean mass for the 3 mg dose group (p<0.001). The study also reported a 46% greater relative loss of fat mass in the Enobosarm 6 mg group compared to placebo (p=0.014), with a notable shift in body composition favoring fat loss. The company plans to advance into a Phase 3 clinical program, with the primary endpoint focused on physical function improvements, and expects regulatory clarity following an upcoming end-of-Phase 2 FDA meeting. Additionally, Veru announced the development of a novel modified-release oral Enobosarm formulation, anticipated to be available for Phase 3 studies and commercialization, with patent protection expected until 2045. Financially, Veru reported a net loss of $7.9 million for continuing operations, with cash and equivalents totaling $20 million as of March 31, 2025, and emphasized the need for additional capital to support ongoing drug development efforts.

Veru Financial Statement Overview

Summary

Veru faces significant financial challenges, with declining revenues and substantial net losses leading to a negative net profit margin of -260.8% TTM. Despite a positive gross profit margin, operational inefficiencies are evident through negative EBIT and EBITDA margins. The balance sheet shows moderate debt levels but a negative return on equity, indicating poor profitability from its equity base. Additionally, negative operating and free cash flow highlight cash generation issues.

Income Statement

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

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

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	TTM	Sep 2024	Sep 2023	Sep 2022	Sep 2021	Sep 2020
Income Statement
Total Revenue	10.61M	16.89M	16.30M	39.35M	61.26M	42.59M
Gross Profit	4.03M	5.85M	7.57M	30.59M	47.93M	30.79M
EBITDA	-36.83M	-36.20M	-89.98M	-79.23M	9.75M	-14.65M
Net Income	-36.35M	-37.80M	-93.15M	-83.78M	7.39M	-18.97M
Balance Sheet
Total Assets	32.67M	60.42M	50.02M	136.13M	178.15M	51.54M
Cash, Cash Equivalents and Short-Term Investments	20.02M	24.92M	9.63M	80.19M	122.36M	13.59M
Total Debt	3.39M	13.86M	14.41M	14.92M	12.63M	14.14M
Total Liabilities	11.62M	28.10M	30.34M	55.29M	25.85M	21.43M
Stockholders Equity	21.05M	32.32M	19.68M	80.84M	152.29M	30.11M
Cash Flow
Free Cash Flow	-29.20M	-21.84M	-88.68M	-48.24M	-15.95M	-2.04M
Operating Cash Flow	-29.08M	-21.68M	-88.01M	-47.51M	-15.57M	-1.93M
Investing Cash Flow	18.58M	146.21K	6.33M	4.27M	14.62M	-105.76K
Financing Cash Flow	-4.22M	36.83M	11.11M	1.07M	109.72M	9.33M

Veru Technical Analysis

Technical Analysis Sentiment

Negative

Last Price0.59

Price Trends

50DMA

0.56

Positive

100DMA

0.55

Positive

200DMA

0.65

Negative

Market Momentum

MACD

0.01

Positive

RSI

46.93

Neutral

STOCH

10.49

Positive

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For VERU, the sentiment is Negative. The current price of 0.59 is below the 20-day moving average (MA) of 0.62, above the 50-day MA of 0.56, and below the 200-day MA of 0.65, indicating a neutral trend. The MACD of 0.01 indicates Positive momentum. The RSI at 46.93 is Neutral, neither overbought nor oversold. The STOCH value of 10.49 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative 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 (46)

Financial Indicators

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
IMDX	51 Neutral	$86.94M	―	-428.96%	―	178.08%	86.04%
VERU	50 Neutral	$86.48M	―	-88.03%	―	-21.28%	36.26%
Sector *	46 Neutral	C$192.85M	-4.28	-8.56%	2.83%	13.52%	-1.74%
TNYA	36 Underperform	$98.09M	―	-76.21%	―	―	23.55%
BDTX	33 Underperform	$133.63M	40.19	4.14%	―	―	33.97%
ELTX	30 Underperform	$123.50M	―	-744.59%	―	―	27.65%

* Healthcare Sector Average

Performance Comparison

VERU

Veru

0.58

-0.33

-36.26%

IMDX

Insight Molecular Diagnostics

3.04

-0.02

-0.65%

BDTX

Black Diamond Therapeutics

2.60

-1.84

-41.44%

ELTX

Elicio Therapeutics

7.85

4.17

113.32%

TNYA

Tenaya Therapeutics

0.61

-2.30

-79.04%

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

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: Jun 28, 2025