Clinical Trials and Drug Development - Sabizabulin treatment resulted in a statistically significant 51.6% relative reduction in deaths compared to placebo in a Phase 3 study involving 204 hospitalized COVID-19 patients at high risk for ARDS and death [331]. - The FDA agreed that no additional efficacy or safety studies were required to support an Emergency Use Authorization (EUA) application for sabizabulin based on the positive Phase 3 study results [332]. - The UK’s MHRA and Australia’s TGA have expedited the review and registration of sabizabulin for emergency use in hospitalized COVID-19 patients at high risk for ARDS [333]. - The Company is conducting a Phase 3 clinical study (ENABLAR-2) to evaluate the efficacy and safety of enobosarm plus abemaciclib in approximately 186 subjects with AR+ ER+ HER2- metastatic breast cancer [339]. - The Phase 3 VERACITY study is enrolling approximately 245 men with metastatic castration-resistant prostate cancer to evaluate sabizabulin 32mg [341]. Financial Performance - The Company generated net revenues of $39.4 million in fiscal 2022, a 36% decrease from $61.3 million in fiscal 2021, with a net loss of $83.8 million [374]. - FC2 net revenues decreased by 35% year over year, with a 44% decrease in total unit sales and a 17% increase in average sales price per unit [375]. - Research and development expenses increased by 116% to $70.6 million in fiscal 2022 from $32.7 million in fiscal 2021, driven by multiple ongoing clinical trials [378]. - Selling, general and administrative expenses rose by 109% to $43.2 million in fiscal 2022, primarily due to increased personnel costs and commercialization efforts [380]. - The gross profit margin for fiscal 2022 was 78% of net revenues, consistent with fiscal 2021, despite a decrease in gross profit to $30.6 million [377]. Cash Flow and Investments - Cash and cash equivalents decreased to $80.2 million as of September 30, 2022, down from $122.4 million a year earlier, reflecting increased R&D expenditures [385]. - The company used cash of $47.5 million in operating activities for fiscal 2022, with a net loss of $83.8 million [389]. - Net cash from investing activities was $4.3 million in fiscal 2022, primarily from $5.0 million received on notes receivable from the sale of the PREBOOST business [391]. - Net cash provided by financing activities in fiscal 2022 was $1.1 million, mainly from stock option exercises [393]. - The company completed a public offering of 7,419,354 shares at $15.50 per share, generating net proceeds of $108.0 million in February 2021 [394]. Inventory and Product Availability - The Company has maintained sufficient inventory of FC2 to meet expected customer demand despite temporary disruptions due to COVID-19 [356]. - The Company has launched its own dedicated direct-to-patient telemedicine platform to drive sales growth [360]. - The Company is working to restore ordering patterns in the U.S. prescription channel through increased marketing efforts and new distribution partnerships [375]. - The decrease in FC2 net revenues in the global public health sector was primarily due to the absence of significant sales from Brazil and South Africa tenders in fiscal 2022 [375]. Market and Operational Risks - The Company has experienced increased costs in products, supplies, salaries, and general administrative expenses due to inflation, leading to price increases where possible [416]. - The Company's exposure to market risk is primarily related to fluctuations in raw material commodity prices, particularly nitrile polymer, and foreign currency exchange rate risk [417]. - The U.K. and Malaysia subsidiaries adopted the U.S. dollar as their functional currency, reducing foreign currency risk and stabilizing operating results [417]. - The Company may face pricing concessions or financial accommodations requests from distributors due to currency fluctuations impacting their operations [417]. Accounting and Valuation - IPR&D assets are considered indefinite-lived until project completion or abandonment, and are tested for impairment during this period [414]. - The valuation process for IPR&D assets is complex, requiring significant input and judgment regarding future volume, revenue, and expense growth rates [414]. - The Company has adopted recent accounting pronouncements, with additional information available in Note 1 of the financial statements [415].

Veru Inc. (NASDAQ:VERU) Q4 2022 Earnings Conference Call December 5, 2022 8:00 AM ET Company Participants Sam Fisch - Executive Director, Investor Relations, and Corporate Communications Mitchell Steiner - Chairman, Chief Executive Officer and President Michele Greco - Chief Financial Officer and Chief Administrative Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald Leland Gershell - Oppenheimer Chris Howerton - Jefferies Yi Chen - H.C. Wainwright Operator Good morning, ladies and gent ...

Veru Inc. Nasdaq:VERU | --- | --- | --- | --- | |---------------------------------------------------------------------------------------------------|-------|-------|-------| | | | | | | | | | | | Biopharmaceutical Company focused on Infectious Disease and Oncology | | | | | Veru Corporate Presentation Cantor Oncology, Hematology & HemeOnc Conference September 28, 2022 | | | | Forward looking statements The statements in this release that are not historical facts are "forward-looking statements" as that term ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) Commission File Number 1-13602 Veru Inc. (Exact Name of Registrant as Specified in its Charter) Wisconsin 39-1144397 (Registrant's Telephone Number, Including Area Code) N/A (Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report) Securities registered pursuant to Section 12(b) of the Act: 2916 N. Miami Avenue, Suite 1000, Miami, FL 33127 (Address of Principal Executive Offices) (Zip Code) ...

Veru Inc. (NASDAQ:VERU) Q3 2022 Earnings Conference Call August 11, 2022 8:00 AM ET Company Participants Samuel Fisch - Executive Director, IR & Corporate Communications Mitchell Steiner - Chairman, President & CEO Michele Greco - CFO & Chief Administrative Officer Gary Barnette - Chief Scientific Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald Leland Gershell - Oppenheimer Chris Howerton - Jefferies Yi Chen - H.C. Wainwright Operator Good morning, ladies and gentlemen, and welcome t ...

Veru Inc. Nasdaq:VERU | --- | --- | --- | --- | |-------|-------|-------|-------| | | | | | | | | | | | | | | | Forward looking statements The statements in this release that are not historical facts are "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements regarding: whether and when the Company will submit an EUA application, or receive an emergency use authorization or any approval from F ...

Veru Inc. Nasdaq:VERU | --- | --- | --- | --- | |------------------------------------------------------------------------------------------|-------|-------|-------| | | | | | | Biopharmaceutical Company Focused on COVID-19 and Oncology | | | | | Veru Corporate Presentation H.C. Wainwright Global Investment Conference May 23-26, 2022 | | | | Forward looking statements The statements in this release that are not historical facts are "forward-looking statements" as that term is defined in the Private Securitie ...

Call End: 09:01 Veru Inc. (NASDAQ:VERU) Q2 2022 Earnings Conference Call May 12, 2022 8:00 AM ET Company Participants Samuel Fisch - Executive Director, Investor Relations and Corporate Communications Mitchell Steiner - Chairman, President and Chief Executive Officer Michele Greco - Chief Financial Officer and Chief Administrative Officer Gary Barnette - Chief Scientific Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald Chris Howerton - Jefferies Leland Gershell - Oppenheimer Yi Chen - ...

FORM 10-Q (Mark One) Commission File Number 1-13602 Veru Inc. (Exact Name of Registrant as Specified in its Charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Wisconsin 39-1144397 (State of Incorporation) (I.R.S. Employer Identification No.) 2916 N. Miami Avenue, Suite 1000, Miami, FL 33127 (Address of Principal Executive Offices) (Zip Code) N/A (Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report) Securities registered pursuant to Section 12(b) of ...

Veru Inc. Nasdaq:VERU | --- | --- | --- | --- | |-------------------------------------------------------------|-------|-------|-------| | | | | | | | | | | | Biopharmaceutical Company Focused on COVID-19 and Oncology | | | | | Veru Corporate Presentation May 2022 | | | | Forward looking statements This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of forward-looking words o ...