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1. Company Snapshot

1.a. Company Description

Veru 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.

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1.b. Last Insights on VERU

Veru Inc.'s recent performance has been negatively impacted by the mixed results from its Phase 2b QUALITY clinical study of enobosarm for weight reduction. Despite meeting the primary endpoint of preserving lean mass, the stock plummeted due to concerns over the study's results. Additionally, the company's Q4 loss, albeit smaller than expected, and the sale of its FC2 Female Condom business for $18 million may have also contributed to the negative sentiment.

1.c. Company Highlights

2. Veru Inc. Posts Loss Narrower Than Expected, Progresses with Enobosarm Development

Veru Inc. reported a net loss from continuing operations of $15.7 million, or $1.07 per diluted common share, for the fiscal year ended September 30, 2025, compared to a net loss of $35.3 million, or $2.61 per diluted common share, in the prior year. The actual EPS came out at -$1.07 relative to estimates is not available but we can compare to last year same loss per share was -$2.61. The research and development costs increased to $15.6 million, while selling, general, and administrative expenses decreased to $19.9 million. The company's cash, cash equivalents, and restricted cash balance was $15.8 million as of September 30, 2025. Subsequent to September 30, 2025, the company completed a public offering that resulted in net proceeds of approximately $23.4 million.

Publication Date: Dec -23

📋 Highlights
  • Lean Mass Preservation: Enobosarm 3mg + semaglutide demonstrated 100% average preservation of total lean mass at 16 weeks, outperforming placebo + semaglutide.
  • Fat Loss Advantage: The 3mg enobosarm group achieved 12% greater fat loss compared to placebo + semaglutide at 16 weeks.
  • Cash Position: Post-public offering in October 2025, cash reserves rose to $23.4M net proceeds, added to existing $15.8M balance as of September 30, 2025.
  • Net Loss Improvement: Fiscal 2025 net loss from continuing operations was $15.7M ($1.07/share) vs. $35.3M ($2.61/share) in prior year, reflecting operational efficiency.

Cash Position and Funding

The company's cash position is expected to be sufficient to fund operations through the interim analysis in the Phase IIb PLATEAU clinical study. The company used cash of $30 million for operating activities and generated cash from investing activities of $25.1 million for fiscal 2025. With the recent public offering, the company's financial position has been secured to move forward with the trial.

Enobosarm Development Progress

The company has made significant progress on its enobosarm program for sarcopenic obesity, a condition where patients have physical function issues and may not be able to take GLP-1 receptor agonists. The Phase IIb QUALITY clinical trial demonstrated that oral enobosarm could be a next-generation drug in combination with GLP-1 receptor agonist to make the weight loss journey more selective by losing fat while preserving lean mass. As the company's CEO mentioned, "Enobosarm has the potential to be a robust program" and "a strong footing for an oral agent that could be combined with big pharma's oral agents for weight loss."

Regulatory Discussions and Future Plans

The company expects flexibility around showing a certain degree of weight loss from muscle function. A 5% or greater placebo-corrected weight loss is a benchmark, and if achieved, secondary outcomes will be evaluated based on clinical meaningfulness. The company collected data on physical function, including clinical outcomes questionnaires and mobility disability assessments, to present a strong case for enobosarm's benefits.

Valuation Metrics

The company's valuation metrics are as follows: P/E Ratio is -1.03, P/B Ratio is 1.83, P/S Ratio is 5.52, and EV/EBITDA is -0.65. The stock's current valuation multiples indicate that the market is pricing in significant growth expectations. Analysts estimate next year's revenue growth at -3.0%, indicating a decline in revenue.

3. NewsRoom

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Veru Inc. (VERU) Q1 2026 Earnings Call Transcript

Feb -11

Source: seekingalpha.com

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Flora Growth (NASDAQ:FLGC) and Veru (NASDAQ:VERU) Financial Review

Feb -08

Source: defenseworld.net

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Veru to Report Fiscal 2026 First Quarter Financial Results on February 11th

Feb -04

Source: globenewswire.com

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Veru Inc. (VERU) Q4 2025 Earnings Call Transcript

Dec -17

Source: seekingalpha.com

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Veru Reports Fiscal Year 2025 Financial Results and Clinical Program Progress

Dec -17

Source: globenewswire.com

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Veru (NASDAQ:VERU) Share Price Crosses Below Two Hundred Day Moving Average – Here’s Why

Dec -16

Source: defenseworld.net

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Veru to Report Fiscal Year 2025 Financial Results on December 17th

Dec -10

Source: globenewswire.com

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Veru to Present Two Abstracts at ObesityWeek 2025

Oct -31

Source: globenewswire.com

4. Business Breakdown

4.a. Revenues by Country

4.b. Revenues by Segment

5. Expected revenues mid-term growth (9.95%)

6. Segments

Female Condom/FC2 Internal Condom

Expected Growth: 9.95%

The 9.95% growth of Female Condom/FC2 Internal Condom from Veru Inc. is driven by increasing awareness of women's reproductive health, rising demand for female-controlled contraception, and growing adoption in developing countries. Additionally, the product's ease of use, discreetness, and effectiveness in preventing STIs and unintended pregnancies contribute to its growing popularity.

Other

Expected Growth: 9.98%

Veru Inc.'s 9.98% growth is driven by increasing demand for its urology and oncology products, successful commercialization of its proprietary drug, and strategic partnerships. Additionally, the company's focus on research and development, expansion into new markets, and effective cost management have contributed to its growth momentum.

7. Detailed Products

FC2

FC2 is a male contraceptive gel that is applied topically to the penis to prevent pregnancy.

ENTADFI

ENTADFI is a prescription medication used to treat hypogonadism in adult males.

VERU-111

VERU-111 is an oral medication being developed to treat COVID-19 in hospitalized patients.

VERU-100

VERU-100 is a peptide-based therapeutic being developed to treat hospitalized patients with COVID-19.

VERU-115

VERU-115 is an oral medication being developed to treat acute respiratory distress syndrome (ARDS) in hospitalized patients.

8. Veru Inc.'s Porter Forces

Forces Ranking

Threat Of Substitutes

Veru Inc. has a moderate threat of substitutes due to the availability of alternative products in the market.

Bargaining Power Of Customers

Veru Inc. has a high bargaining power of customers due to the presence of a large number of customers with significant purchasing power.

Bargaining Power Of Suppliers

Veru Inc. has a low bargaining power of suppliers due to the presence of multiple suppliers and a competitive market.

Threat Of New Entrants

Veru Inc. has a moderate threat of new entrants due to the presence of barriers to entry and the need for significant capital investment.

Intensity Of Rivalry

Veru Inc. operates in a highly competitive market with a large number of players, leading to a high intensity of rivalry.

9. SWOT Analysis

Strength

Weaknesses

Opportunities

Threats

10. Capital Structure

10.a. Balance Sheet

10.b. Weighted Average Cost of capital

Value
Debt Weight 44.75%
Debt Cost 3.95%
Equity Weight 55.25%
Equity Cost 1.62%
WACC 2.66%
Leverage 81.01%

11. Quality Control: Veru Inc. passed 3 out of 9 key points

12.a Historical Valuation

12.b Price/Earnings Ratio

12.c Margin Valuation

12.d Peers Valuation

Peers Group Analysis

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Verve Therapeutics

A-Score: 4.9/10

Value: 6.9

Growth: 4.4

Quality: 5.0

Yield: 0.0

Momentum: 9.0

Volatility: 4.0

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Travere Therapeutics

A-Score: 4.0/10

Value: 6.2

Growth: 2.3

Quality: 3.6

Yield: 0.0

Momentum: 10.0

Volatility: 2.0

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Gain Therapeutics

A-Score: 3.7/10

Value: 6.0

Growth: 1.4

Quality: 3.5

Yield: 0.0

Momentum: 10.0

Volatility: 1.0

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Lyra Therapeutics

A-Score: 3.4/10

Value: 6.9

Growth: 4.7

Quality: 3.4

Yield: 0.0

Momentum: 5.0

Volatility: 0.7

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Veru

A-Score: 3.3/10

Value: 7.5

Growth: 2.3

Quality: 4.0

Yield: 0.0

Momentum: 5.0

Volatility: 1.0

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Bluebird Bio

A-Score: 3.2/10

Value: 9.8

Growth: 3.6

Quality: 5.2

Yield: 0.0

Momentum: 0.5

Volatility: 0.3

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Peers Metrics

12.e Scoring Insights

12.f DCF BETA

Parameters

Short Term Growth

Short term Time

Long-Term Growth

WACC

Target Price

2.48$

Current Price

2.48$

Potential

-0.00%

Expected Cash-Flows