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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.'s Q3 FY2025 Earnings: A Step Closer to Chronic Weight Loss Management Breakthrough

Veru Inc. reported a net loss for continuing operations of $0.5 per share, beating estimates of $0.55 per share. The company's revenue growth is not a key focus as it is still in the development stage, and its financial performance is largely driven by research and development expenses, which decreased to $24.6 million for the nine months ending June 30, 2025, from $17.3 million in the previous period, mainly due to the completion of the Phase 2b study for Inovasaram. The company's cash, cash equivalents, and restricted cash stood at $15 million as of June 30, 2025.

Publication Date: Sep -02

📋 Highlights
  • Clinical Efficacy Highlighted:: Inovasaram achieved 100% lean mass preservation and 42% greater fat loss vs. placebo at highest dose.
  • Weight Maintenance Success:: Phase 2b extension showed 75% reduction in body weight regain post-semaglutide discontinuation.
  • Financial Strategy Shift:: $16.3M net cash from FC2 sale (with $4.3M loss) to fund drug development exclusively.
  • Liquidity Position:: Cash reserves fell to $15M (from $24.9M) with $24.6M operational cash burn YTD.
  • Phase 3 Funding Needs:: Requires $40M for enobesartan trial targeting 400 patients, pending FDA design approval.

Financial Performance and Funding

The sale of the FC2 female condom business resulted in a net cash proceeds of $16.3 million, which will be used to support the company's drug development programs. Despite this, the company's cash burn rate remains a concern, with $24.6 million used in operating activities during the nine months ending June 30, 2025. The company's current cash balance is expected to be sufficient to operate through the end of the calendar year, but additional capital will be needed beyond that point. With a 'P/S Ratio' of 7.27 and 'EV/EBITDA' of -1.06, investors are pricing in a high level of uncertainty regarding the company's future prospects.

Inovasaram's Progress and Future Plans

The Phase 2b clinical trial results for Inovasaram demonstrated significant promise in preserving lean mass and enhancing fat loss in older patients receiving semaglutide for weight management. The company is now preparing for Phase III clinical trials and is awaiting regulatory clarity from an FDA end-of-Phase 2 meeting. A novel modified-release oral formulation of Inovasaram is being developed for commercialization, which could potentially provide a competitive edge in the market.

Enobesartan's Development and Potential

The company is also making progress with enobesartan, a treatment for obesity-related muscle and bone loss, which has shown promise in Phase 2b trials. The company is awaiting FDA feedback on its Phase 3 trial design, which is expected to involve 400 patients in two arms, and anticipates starting the trial within the next 18 months. With an estimated $40 million required to fund the Phase 3 trial, the company's ability to secure additional funding will be crucial to its success.

3. NewsRoom

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Veru to Present Two Abstracts at ObesityWeek 2025

Oct -31

Source: globenewswire.com

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Veru Announces Proposed Public Offering

Oct -29

Source: globenewswire.com

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Veru Announces Successful FDA Meeting Providing Regulatory Clarity for Enobosarm for Muscle Preservation in Combination with GLP-1 RA for Greater Weight Loss in the Treatment of Obesity

Sep -23

Source: globenewswire.com

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Veru Announces Novel Modified-Release Oral Formulation for Enobosarm

Aug -15

Source: zacks.com

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Veru Inc. (VERU) Q3 2025 Earnings Call Transcript

Aug -12

Source: seekingalpha.com

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Veru Reports Fiscal 2025 Third Quarter Financial Results and Clinical Program Progress

Aug -12

Source: globenewswire.com

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Veru Announces Selection of Novel Modified Release Oral Enobosarm Formulation for Chronic Weight Loss Management Following Pharmacokinetic Clinical Study

Aug -11

Source: globenewswire.com

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Veru Announces Reverse Stock Split

Aug -06

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: 4.4/10

Value: 6.8

Growth: 4.3

Quality: 5.0

Yield: 0.0

Momentum: 9.5

Volatility: 0.7

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Travere Therapeutics

A-Score: 3.9/10

Value: 6.2

Growth: 2.3

Quality: 3.8

Yield: 0.0

Momentum: 9.0

Volatility: 2.0

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Bluebird Bio

A-Score: 3.6/10

Value: 9.8

Growth: 3.6

Quality: 5.1

Yield: 0.0

Momentum: 0.0

Volatility: 3.3

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Veru

A-Score: 2.9/10

Value: 6.6

Growth: 0.9

Quality: 4.0

Yield: 0.0

Momentum: 5.0

Volatility: 0.7

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Lyra Therapeutics

A-Score: 2.5/10

Value: 6.4

Growth: 4.7

Quality: 3.4

Yield: 0.0

Momentum: 0.5

Volatility: 0.0

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Gain Therapeutics

A-Score: 2.2/10

Value: 6.0

Growth: 1.6

Quality: 3.5

Yield: 0.0

Momentum: 1.0

Volatility: 1.3

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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

2.44$

Current Price

2.44$

Potential

-0.00%

Expected Cash-Flows