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VERU Veru

Veru, Inc. is an oncology and urology biopharmaceutical company. It develops medicines for prostate cancer treatment and prostate cancer supportive care as well as urology specialty pharmaceuticals. Its oncology drug candidates includes VERU-111, an oral alpha and beta tubulin inhibitor, which is in a phase 1b/2 study for the treatment of metastatic castration resistant prostate cancer; Zuclomiphene citrate, which is in a phase 2 clinical trial for the treatment of hot flashes in men undergoing prostate cancer hormonal therapies; and VERU-100, a long-acting GnRH antagonist 3 month subcutaneous depot, planned phase 2 clinical trial for the treatment of hormone sensitive advanced prostate cancer. The company’s urology specialty pharmaceutical drug candidate is TADFIN, a tadalafil and finasteride combination oral capsule, for the treatment of men with benign prostatic hyperplasia. Its commercial products include the FC2 Female/Internal condom for prevention of pregnancy and sexually transmitted infections and PREBOOST 4% benzocaine wipes for the prevention of premature ejaculation marketed as Roman Swipes by getroman.com. The company was founded by William R. Gargiulo Jr. and O.B. Parrish in 1996 and is headquartered in Miami, FL.

Company profile

Ticker
VERU
Exchange
Website
CEO
Mitchell Steiner
Employees
Incorporated
Location
Fiscal year end
Former names
FEMALE HEALTH CO
SEC CIK
IRS number
391144397

VERU stock data

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Press releases

Pro users get this 30m faster
Veru Enrolls First Patient in Phase 3 VERACITY Clinical Trial of Sabizabulin (VERU-111) in Metastatic Castration Resistant and Androgen Receptor Targeting Agent Resistant Prostate Cancer
25 Jun 21
--Sabizabulin is a novel oral androgen receptor transport disruptor---- In Phase 1b/2 clinical study, sabizabulin was well tolerated with significant antitumor efficacy in metastatic castration resistant prostate cancer
Veru Announces Positive Phase 2 Clinical Data: Efficacy of Enobosarm Therapy Correlates with Androgen Receptor Levels in AR+ER+HER2- Metastatic Breast Cancer Presented at the 2021 ASCO Annual Meeting
7 Jun 21
-- In Phase 2 study, enobosarm, an oral selective androgen receptor (AR) agonist, had the most significant antitumor effects in heavily pretreated AR+ER+ metastatic breast cancer subjects with ≥ 40% AR expression in
Veru Announces Positive Phase 1b/2 Clinical Study Update for Sabizabulin (VERU-111) in Men with Metastatic Castration Resistant Prostate Cancer Presented at the 2021 ASCO Annual Meeting
7 Jun 21
-- Sabizabulin, an oral selective cytoskeleton disruptor, demonstrated good safety, significant evidence of antitumor efficacy, and that chronic administration is feasible in ongoing Phase 1b/2 study of 80 men -- --
Veru Announces Acceptance of Two Abstracts for Presentation at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting
24 May 21
Veru Enrolls First Patient in Phase 3 Clinical Trial of Sabizabulin (VERU-111) in High Risk Hospitalized COVID-19 Patients
19 May 21

Investment data

Data from SEC filings
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Calendar

12 May 21
27 Jul 21
30 Sep 21
Quarter (USD)
Mar 21 Dec 20 Sep 20 Jun 20
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Sep 20 Sep 19 Sep 18 Sep 17
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Financial data from Veru earnings reports.

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
16 Jun 21 Fisch Harry Common Stock Sell Dispose S No No 8.353 100,000 835.3K 764,025
14 May 21 Lucy Lu Common Stock Option Common Stock Grant Aquire A No No 7.56 70,000 529.2K 70,000
23 Mar 21 Grace Hyun Common Stock Option Common Stock Grant Aquire A No No 13.05 5,000 65.25K 5,000
10 Mar 21 Grace Hyun Common Stock Buy Aquire P No No 14.09 3,500 49.32K 14,790

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

33.5% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 112 84 +33.3%
Opened positions 43 84 -48.8%
Closed positions 15 0 NEW
Increased positions 36 0 NEW
Reduced positions 26 0 NEW
13F shares
Current Prev Q Change
Total value 4.32B 5.48B -21.2%
Total shares 26.69M 19.7M +35.5%
Total puts 854.68K 534.2K +60.0%
Total calls 1.29M 620.2K +108.5%
Total put/call ratio 0.7 0.9 -23.3%
Largest owners
Shares Value Change
Perceptive Advisors 4.45M $47.96M +37.0%
BLK Blackrock 3.93M $42.3M +4.3%
Vanguard 3.01M $32.44M -18.0%
Cormorant Asset Management 3M $32.33M NEW
MS Morgan Stanley 1.04M $11.18M +339.9%
IVZ Invesco 967.12K $10.42M -9.0%
Geode Capital Management 936.17K $10.09M +21.4%
STT State Street 872.08K $9.4M +2.5%
AWM Investment 700K $7.54M +75.0%
Citadel Advisors 658.14K $7.09M +1291.4%
Largest transactions
Shares Bought/sold Change
Cormorant Asset Management 3M +3M NEW
Perceptive Advisors 4.45M +1.2M +37.0%
MS Morgan Stanley 1.04M +801.4K +339.9%
Vanguard 3.01M -661.44K -18.0%
Citadel Advisors 658.14K +610.84K +1291.4%
Renaissance Technologies 546.2K +524.91K +2465.0%
Ophir Asset Management Pty 593.36K -504.34K -45.9%
D. E. Shaw & Co. 409.08K +409.08K NEW
AWM Investment 700K +300K +75.0%
Pinz Capital Management 272.34K +272.34K NEW

Financial report summary

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Competition
CanadaAcer TherapeuticsHCIAllergan
Risks
  • Risks Related to the Regulation and Commercialization of Our Products and Drug Candidates
  • We have no experience in obtaining regulatory approval for a drug.
  • We could experience delays in our planned clinical trials.
  • Our clinical trials may be suspended or discontinued.
  • We may be subject to risks relating to collaboration with third parties.
  • We intend to rely on CROs to conduct our research and development activities.
  • We expect to rely on third party manufacturers for our drug candidates.
  • Changes in law could have a negative impact on the approval of our drug candidates.
  • We may fail or elect not to commercialize our drug candidates.
  • We are subject to extensive and costly governmental regulation, including healthcare reform measures that may negatively impact sales of FC2.
  • We could experience misconduct by our employees.
  • Coverage and reimbursement may not be available for our products.
  • We may not be able to gain and retain market acceptance for our drug candidates.
  • Our drug products may be subject to governmental pricing controls.
  • Third parties may obtain FDA regulatory exclusivity to our detriment.
  • Risks Related to Our Financial Position and Need for Capital
  • Additional financing will be needed to support our development activities.
  • COVID-19 and its impact on the economic environment and capital markets could adversely affect our access to capital when needed.
  • If we fail to obtain additional capital, we may need to reduce the scope of our development programs or we could be forced to share our rights to technologies with third parties on terms that may not be favorable to us.
  • Our application for our PPP Loan could in the future be determined to have been impermissible or could result in damage to our reputation.
  • Risks Related to Our Business
  • The COVID-19 pandemic has disrupted, and may continue to disrupt, our operations and the operations of our suppliers and customers.
  • Our FC2 business may be affected by contracting risks with government and other international health agencies.
  • The FDA issued a final order reclassifying female condoms as Class II medical devices, which may result in increased competition for FC2 in the U.S. market.
  • We may experience intense competition.
  • We may not be able to successfully implement our strategy to grow sales of FC2 in the U.S. market.
  • We may not be able to sustain price levels for sales of FC2 in the U.S. market.
  • An inability to identify or complete future acquisitions could adversely affect our future growth.
  • We may experience difficulties in integrating strategic acquisitions.
  • Disruptions from an exit of the United Kingdom from the European Union could adversely affect our business and results of operations.
  • Increases in the cost of raw materials, labor, and other costs used to manufacture FC2 could increase our cost of sales and reduce our gross margins.
  • Currency exchange rate fluctuations could increase our expenses.
  • We rely on a single facility to manufacture FC2, which subjects us to the risk of supply disruptions.
  • Uncertainty and adverse changes in the general economic conditions may negatively affect our business.
  • Material adverse or unforeseen legal judgments, fines, penalties, or settlements could have an adverse impact on our profits and cash flows.
  • Any failure to comply with the FCPA and similar anti-bribery laws in non-U.S. jurisdiction could materially adversely affect our business and result in civil and/or criminal sanctions.
  • We will need to increase the size and complexity of our organization in the future, and we may experience difficulties in executing our growth strategy and managing any growth.
  • Our credit agreement contains debt covenants which restrict our current and future operations, including our ability to take certain actions.
  • Uncertainties in the interpretation and application of tax rules in the various jurisdictions in which we operate could materially affect our deferred tax assets, tax obligations and effective tax rate.
  • Risks Relating to Our Intellectual Property
  • We may be unable to protect the proprietary nature of the intellectual property covering our products.
  • Our or our licensors’ patents may expire or be invalidated, found to be unenforceable, narrowed or otherwise limited or our or our licensors’ patent applications may not result in issued patents or may result in patents with narrow, overbroad, or unenforceable claims.
  • We are dependent in part on some license relationships.
  • We may face claims that our intellectual property infringes on the intellectual property rights of third parties. If we infringe intellectual property rights of third parties, it may increase our costs or prevent us from being able to commercialize our product candidates.
  • We must submit patent certifications in connection with the 505(b)(2) FDA regulatory pathway.
  • We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of our competitors.
  • We may need to file lawsuits or take other actions to protect or enforce our intellectual property rights.
  • We may fail to protect the confidentiality of commercially sensitive information.
  • Risks Related to Ownership of Our Common Stock
  • Ownership in our common stock is highly concentrated and your ability to influence corporate matters may be limited as a result.
  • We incurred a charge to earnings in fiscal 2020 resulting from the APP Acquisition, and additional charges to earnings resulting from the APP Acquisition in the future may cause our operating results to suffer.
  • If we fail to maintain effective internal control over financial reporting, our ability to produce accurate financial statements or comply with applicable regulations could be impaired.
  • The trading price of our common stock has been volatile, and investors in our common stock may experience substantial losses.
  • If our stock price declines, our common stock may be subject to delisting from the NASDAQ Capital Market.
  • A substantial number of shares may be sold in the market, which may depress the market price for our common stock.
  • Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be our shareholders’ sole source of gain.
Management Discussion
  • The Company generated net revenues of $13.3 million and net loss of $2.8 million, or $0.04 per basic and diluted common share, for the three months ended March 31, 2021, compared to net revenues of $9.9 million and net loss of $0.8 million, or $(0.01) per basic and diluted common share, for the three months ended March 31, 2020. Net revenues increased 34% over the prior period.
  • FC2 net revenues increased 40% year over year. There was a 19% increase in total FC2 unit sales and an increase in FC2 average sales price per unit of 18%. The principal factor for the increase in the FC2 average sales price per unit compared to prior period was the change in the sales mix with the U.S. prescription channel representing 77% of total FC2 net revenues in the current year period compared to 73% of total FC2 net revenues in the prior year period. The Company experienced an increase of 48% in FC2 net revenues in the U.S. prescription channel and an increase of 18% in FC2 net revenues in the global public health sector.
  • Cost of sales decreased to $2.4 million in the three months ended March 31, 2021 from $2.5 million in the three months ended March 31, 2020, primarily due to higher labor and transportation costs in the fiscal 2020 period, partially offset by an increase in unit sales.
Content analysis
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H.S. junior Avg
New words: Argentina, blood, CDK, Colombia, disruptor, dosage, ICU, masculinizing, Mexico, monotherapy, multicenter, population, sabizabulin, SERM, telepharmacy
Removed: alpha, beta, clarity, opportunistic, pursuing, recommended, ROU, stage, supporting, tubulin