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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. Reports Improved Financial Performance and Progresses in Clinical Trials

In the first quarter, Veru Inc. reported a net loss of $5,300,000, or $0.26 per diluted common share, compared to a net loss of $8,900,000, or $0.61 per diluted common share in the prior year's quarter. The company's cash and cash equivalents stood at $33 million. Research and development expenses decreased to $1,300,000 from $5,700,000 in the year-ago quarter, primarily due to the wind-down of the Phase 2b quality trial. General and administrative expenses were $4.1 million.

Publication Date: Mar -09

📋 Highlights
  • FDA Approval Pathways: Two potential pathways for Novosarm—5% placebo-corrected weight loss at 52 weeks or clinically significant physical function improvement.
  • PLATO Clinical Study: Aims to assess 200 older patients with obesity, focusing on total body weight, fat/lean mass, physical function, and bone density.
  • R&D Cost Reduction: Q1 2026 expenses dropped to $1.3M from $5.7M YoY due to winding down prior trials.
  • Net Loss Improvement: Net loss decreased to $5.3M ($0.26/share) vs. $8.9M ($0.61/share) in prior-year quarter.

Financial Highlights

The company's financials show a significant reduction in research and development costs, which is a positive indicator. The actual EPS loss of $-0.26 was better than the estimated loss of $-0.47. The company's cash, cash equivalents, and restricted cash balance was $33,000,000 as of December 31, 2025, bolstered by a public offering that raised approximately $23,400,000 in net proceeds.

Clinical Trial Progress

Veru Inc. is making progress in its clinical trials, particularly with Novosarm in combination with semaglutide, showing promising results in weight loss and preserving lean mass and physical function. The company is planning to start a Phase 2b PLATO clinical study to evaluate Novosarm's effect on total body weight, fat mass, lean mass, physical function, bone mineral density, and safety. The FDA has provided regulatory clarity, suggesting two possible pathways for approval.

Valuation Metrics

Veru Inc.'s valuation metrics indicate a high level of uncertainty. The stock trades at a P/S Ratio of 160.46, indicating high expectations for future revenue growth. The EV/EBITDA ratio is negative, reflecting the company's current loss-making status. Analysts estimate next year's revenue growth at 50.0%. The 'P/E Ratio' is -2.62, 'P/B Ratio' is 1.35, 'Free Cash Flow Yield (%)' is -62.76, and 'ROE (%)' is -83.24, reflecting the company's challenging financial situation.

Future Outlook

The company's cash position is expected to be sufficient to fund operations through the interim analysis. The interim analysis will examine the efficacy of the treatment, and the results are expected to provide insight into the potential approval of the treatment. If the treatment shows a functional benefit, even with less than 5% weight loss, it could still be a basis for approval, according to the FDA's guidance.

3. NewsRoom

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Veru Enrolls First Patient in Phase 2b PLATEAU Clinical Trial of Enobosarm and Semaglutide Combination for High Quality Weight Loss

Mar -09

Source: globenewswire.com

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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

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

Stock-Card
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

1-Year Total Return ->

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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

1-Year Total Return ->

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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

1-Year Total Return ->

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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

2.47$

Current Price

2.47$

Potential

-0.00%

Expected Cash-Flows