Veru Inc. Files Amended 10-K for Fiscal Year Ended September 30, 2023

TL;DR

<b>Veru Inc. has filed an amended 10-K report for the fiscal year ending September 30, 2023, providing updated financial and business information.</b>

AI Summary

VERU INC. (VERU) filed a Amended Annual Report (10-K/A) with the SEC on April 1, 2024. Veru Inc. filed an amended 10-K for the fiscal year ending September 30, 2023. The company's fiscal year end is September 30. Veru Inc. was formerly known as The Female Health Co. and Wisconsin Pharmacal Company Inc. The company's business address is in Miami, Florida. The filing is related to the 1934 Act and has SEC file number 001-13602.

Why It Matters

For investors and stakeholders tracking VERU INC., this filing contains several important signals. This amended filing ensures that Veru Inc.'s financial reporting for FY2023 is up-to-date and compliant with SEC regulations. The historical name changes indicate a corporate evolution, which may be relevant for understanding the company's strategic shifts and market positioning over time.

Risk Assessment

Risk Level: low — VERU INC. shows low risk based on this filing. The filing is an amendment to a 10-K, suggesting it's a routine update or correction rather than a response to a new, significant event.

Analyst Insight

Review the specific amendments within the 10-K filing to understand any changes in financial reporting, business operations, or risk factors.

Key Numbers

• 20230930 — Fiscal Year End (CONFORMED PERIOD OF REPORT)
• 20240401 — Filing Date (FILED AS OF DATE)
• 001-13602 — SEC File Number (SEC FILE NUMBER)
• 2834 — SIC Code (STANDARD INDUSTRIAL CLASSIFICATION)

Key Players & Entities

• VERU INC. (company) — CONFORMED NAME
• 20230930 (date) — CONFORMED PERIOD OF REPORT
• 20240401 (date) — FILED AS OF DATE
• FEMALE HEALTH CO (company) — FORMER COMPANY
• WISCONSIN PHARMACAL COMPANY INC (company) — FORMER COMPANY
• MIAMI (location) — CITY
• FL (location) — STATE
• 33127 (postal_code) — ZIP

FAQ

Industry Context

Veru Inc. operates in the pharmaceutical preparations industry, focusing on developing and commercializing medical therapies.

Regulatory Implications

The filing is an amended 10-K, indicating compliance with the Securities Exchange Act of 1934, which governs public company reporting.

What Investors Should Do

1. Analyze the specific changes made in the amended 10-K filing.
2. Assess the impact of any disclosed information on Veru Inc.'s current financial standing and future prospects.
3. Monitor future filings for any further updates or developments related to the company's business and financial performance.

Year-Over-Year Comparison

This is an amended 10-K filing for the fiscal year ended September 30, 2023, suggesting updates or corrections to previously submitted information.

Key Financial Figures

• $0.01 — nge on which registered Common stock, $0.01 par value VERU Nasdaq Capital Marke
• $1.16 — he registrant's common stock, which was $1.16. Table of Contents There were 93,67
• $0.1 million — esult of this restatement there is: a $0.1 million and a $0.3 million increase in research
• $0.3 million — tement there is: a $0.1 million and a $0.3 million increase in research and development ex
• $0.6 million — viously reported financial results; a $0.6 million and $0.8 million decrease in prepaid re
• $0.8 million — financial results; a $0.6 million and $0.8 million decrease in prepaid research and develo
• $1.6 million — er 30, 2023 and 2022, respectively; a $1.6 million decrease in accounts payable as of Sept
• $2.7 million — ptember 30, 2023 and a $0.8 million and $2.7 million decrease in accrued research and develo
• $2.2 million — er 30, 2023 and 2022, respectively; a $2.2 million decrease in the opening balance of accu

Filing Documents

• veru-20230930x10ka.htm (10-K/A) — 4565KB
• veru-20230930xex23_1.htm (EX-23.1) — 5KB
• veru-20230930xex31_1.htm (EX-31.1) — 15KB
• veru-20230930xex31_2.htm (EX-31.2) — 15KB
• veru-20230930xex32_1.htm (EX-32.1) — 11KB
• 0000863894-24-000006.txt (&nbsp;) — 18405KB
• veru-20230930.xsd (EX-101.SCH) — 78KB
• veru-20230930_cal.xml (EX-101.CAL) — 94KB
• veru-20230930_def.xml (EX-101.DEF) — 315KB
• veru-20230930_lab.xml (EX-101.LAB) — 558KB
• veru-20230930_pre.xml (EX-101.PRE) — 537KB
• veru-20230930x10ka_htm.xml (XML) — 4621KB

, Item 1A. "Risk Factors";

Part I, Item 1A. "Risk Factors";

, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations";

Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations";

, Item 8. "Financial Statements and Supplementary Data";

Part II, Item 8. "Financial Statements and Supplementary Data";

, Item 9A. "Controls and Procedures"; and

Part II, Item 9A. "Controls and Procedures"; and

, Item 15. "Exhibits and Financial Statement Schedules."

Part IV, Item 15. "Exhibits and Financial Statement Schedules." In addition, this Form 10-K/A updates the signature page. In accordance with Rule 12b-15 under the Securities Exchange Act of 1934, the Company is also including with this Form 10-K/A new certifications required by Sections 302 and 906 of the Sarbanes-Oxley Act of 2022 from the Company's Chief Executive Officer (as principal executive officer) and Chief Financial Officer (as principal financial officer) dated as of the filing date of this Form 10-K/A (included in Part IV, Item 15. "Exhibits and Financial Statement Schedules" and attached as Exhibits 31.1, 31.2, 32.1, and 32.2). Except as described above, this Form 10-K/A is presented as of the date of the Original Form 10-K and does not substantively amend, update or change any other items or disclosures contained in the Original Form 10-K. Accordingly, this Form 10-K/A does not reflect or purport to reflect any information or events occurring subsequent to December 8, 2023, the filing date of the Original Form 10-K, unless specifically noted herein, or otherwise modify or update those disclosures affected by subsequent events, except to the extent they are otherwise required to be included and discussed herein. Among other things, forward-looking statements made in the Original Form 10-K have not been revised to reflect events, results or developments that occurred or facts that became known to the Company after the date of the Original Form 10-K, other than the restatement. Accordingly, this Form 10-K/A should be read in conjunction with the Company's filings with the SEC that were made after the filing of the Original Form 10-K, including any amendments to those filings. Table of Contents VERU INC. INDEX PART I Page Item 1A. Risk Factors (Restated) 9 PART II Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations (Restated)

Management's Discussion and Analysis of Financial Condition and Results of Operations (Restated) 41 Item 8.

Financial Statements and Supplementary Data (Restated)

Financial Statements and Supplementary Data (Restated) 55 Item 9A.

Controls and Procedures (Restated)

Controls and Procedures (Restated) 55 PART IV Item 15. Exhibits and Financial Statement Schedules 58 Item 16. Form 10-K Summary 62

Signatures

Signatures 63 _________________ As used in this report, the terms "we," "us," "our," "Veru" and the "Company" mean Veru Inc. and its subsidiaries collectively, unless the context indicates another meaning, and the term "common stock" means shares of our common stock, par value of $0.01 per share. All trademarks, service marks or trade names appearing in this report are the property of their respective owners. We do not intend the use or display of other companies' trade names, trademarks, or service marks to imply a relationship with, or endorsement or sponsorship of or by, any of these other companies 2 Table of Contents

FORWARD LOOKING STATEMENTS

FORWARD LOOKING STATEMENTS Certain statements included in this Annual Report on Form 10-K which are not statements of historical fact are intended to be, and are hereby identified as, "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about our financial condition or business, our development and commercialization plans relating to our product candidates and products, including any potential development or commercialization of enobosarm initially as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a glucagon-like peptide-1 receptor agonist ("GLP-1 RA") who are at-risk for developing muscle atrophy and muscle weakness, enobosarm for certain breast cancer patients, and sabizabulin for viral-induced acute respiratory distress syndrome ("ARDS") indications, the outlook for growth in our FC2 business through telehealth customers, our portal and the global public health sector, future financial and operating results, plans, objectives, expectations and intentions, costs and expenses, royalty payments, outcome of litigation and other contingencies, financial condition, results of operations, liquidity, cost savings, our ability to continue as a going concern, future ordering patterns of our customers, objectives of management, business strategies, clinical trial timing, plans and results, the achievement of clinical and commercial milestones, the advancement of our technologies and our products and drug candidates, and other statements that are not historical facts. You can identify forward-looking statements by the use of words or phrases such as "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" or the negative of those terms or other words of similar meaning. These statements are based upon ou

Risk Factors

Item 1A. Risk Factors Our business is subject to a number of risks of which you should be aware before making an investment decision. The following summary highlights some of the risks y ou should consider with respect to our business and prospects. This summary is not complete and the risks summarized below are not the only risks we face. For a more complete understanding of the risks related to our business and an investment in our common stock, we encourage you to read and consider the more detailed discussion of these highlighted risks, which discussion immediately follows this summary. A summary of the material risks that may affect our business, operating results and financial condition include, but are not necessarily limited to, those relating to: Risks Related to the Regulation and Commercialization of Our Products and Drug Candidates We have limited experience in obtaining regulatory approval or emergency use authorization for a drug. We could experience delays in our planned clinical trials. Our clinical trials may be suspended or discontinued. We could experience delays or unanticipated costs in connection with our planned Phase 2b clinical trial of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness if the FDA does not accept our trial design. 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 and we rely on third party manufacturers for our marketed products. Disruptions to or significantly increased costs associated with transportation and other distribution channels for our products may adversely affect our margins and profitability. Changes in law could have a negative impact on the approval of our drug c

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