UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) Commission File Number 1-13602 | | | (Exact Name of Registrant as Specified in its Charter) Wisconsin 39-1144397 2916 N. Miami Avenue, Suite 1000, Miami, FL 33127 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: | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | --- | --- | --- | | ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 305-509-6897 (Registrant's Telephone Number, Including Area Code) FORM 10-Q (Mark One) Commission File Number 1-13602 | | | (Exact Name of Registrant as Specified in its Charter) Wisconsin 39-1144397 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 ...

Financial Data and Key Metrics Changes - Overall net revenues for Q1 2023 were $2.5 million, a significant decrease from $14.1 million in the prior year quarter [47] - The operating loss for the quarter was $35.6 million, compared to $5 million in the prior year quarter, reflecting increased operating expenses and reduced revenues [52] - The net loss for the quarter was $36.8 million or $0.46 per diluted common share, compared to a net loss of $6.4 million or $0.08 per diluted common share in the prior year quarter [54] Business Line Data and Key Metrics Changes - Revenue from the US prescription business decreased to $163,000 from $11.6 million in the prior year period, attributed to challenges faced by telemedicine customers [47] - Net revenue for the global public health sector business was $2.3 million, slightly down from $2.6 million in the prior year period [48] - Gross profit was $700,000 or 28% of net revenues, down from $11.8 million or 84% of net revenues in the prior year period, primarily due to decreased sales in the US FC2 prescription business [48] Market Data and Key Metrics Changes - The company is seeing improvements in FC2 revenues in Q2 fiscal year 2023, indicating a potential recovery in sales [66] - The telemedicine sector and global public health orders had underperformed, but market conditions are improving [46] Company Strategy and Development Direction - The company is focused on developing sabizabulin for COVID-19 and other viral diseases, with plans to expand its investigation into other infectious disease indications [33][61] - The company has established a commercialization infrastructure for sabizabulin and is preparing for potential launches in the US and internationally [29][63] - There is a near-term strategy to drive FC2 sales through partnerships with telemedicine and internet pharmacy services [65] Management's Comments on Operating Environment and Future Outlook - Management emphasized the ongoing need for effective treatments for COVID-19, highlighting the mortality rates and the lack of adequate approved alternatives [60][61] - The company is in a holding pattern regarding clinical trials while awaiting regulatory decisions on sabizabulin [62] - Management expressed confidence in the potential for sabizabulin to address unmet medical needs in ARDS and other viral infections [88] Other Important Information - The company has paused some spending and is evaluating clinical trial priorities to conserve cash while awaiting regulatory decisions [44][62] - The cash balance as of December 31, 2022, was $46.9 million, with net working capital of $32.9 million [55] Q&A Session Summary Question: What gives you confidence that HHS won't follow the White House in winding down the COVID emergency? - Management clarified that HHS governs the FDA and has its own emergency declaration, which remains in effect despite the White House's plans [70][71] Question: Can you elaborate on the cash situation and spending pause? - Management indicated that spending was ramped up in anticipation of EUA approval but has since been paused to conserve cash while awaiting regulatory decisions [72][73] Question: Are you pulling back on enrollment in oncology trials? - Management confirmed that enrollment timelines may be extended as they evaluate cash flow and prioritize trials [78][80] Question: Can the company advance Sabizabulin into a clinical trial for ARDS excluding COVID-19 patients? - Management acknowledged the potential to explore ARDS indications but emphasized the need to wait for regulatory clarity [87][90] Question: Do you expect FC2 sales to return to previous levels? - Management noted that they are starting to see revenues return to previous levels, contingent on resolving customer issues [93] Question: Is it correct that Veru may terminate one of the ongoing breast cancer or prostate cancer trials due to budgeting priorities? - Management stated that no decisions have been made yet, but they are looking at all options to prioritize trials that are closest to completion [95][96]

Financial Performance - For the three months ended December 31, 2022, net revenues were $2,507,794, a decrease of 82.3% compared to $14,135,132 for the same period in 2021[40]. - Sales of FC2 in the U.S. prescription channel generated $163,004, down from $11,574,266 in the prior year, while global public health sector sales were $2,336,997, compared to $2,560,866 in 2021[40]. - The company reported a net loss for the three months ended December 31, 2022, amounting to $(68,278) compared to a net income of $114,655 in the same period of 2021[95]. - Gross profit decreased to $0.7 million for the three months ended December 31, 2022, with a gross profit margin of 28%, down from 84% in the prior year[132]. - Operating activities used cash of $34.5 million in the three months ended December 31, 2022, compared to $8.7 million in the same period in 2021[141]. Cash Flow and Liquidity - The company anticipates continued cash consumption and losses as it develops and commercializes drug candidates, with current cash expected to fund operations for the next 12 months[30][31]. - The Company had cash and cash equivalents of $46.9 million as of December 31, 2022, down from $80.2 million at September 30, 2022[138]. - The company plans to pursue opportunistic financing alternatives, including equity and debt financing, to support its operations[31]. Accounts Receivable and Inventory - As of December 31, 2022, accounts receivable net balance was $3,864,310, an increase from $3,550,895 at September 30, 2022[44]. - Two customers accounted for 76% of net accounts receivable as of December 31, 2022, compared to 83% at September 30, 2022[45]. - As of December 31, 2022, net inventories amounted to $8,732,627, an increase of 1.32% from $8,618,944 on September 30, 2022[51]. Research and Development - Research and development expenses increased to $18.7 million for the three months ended December 31, 2022, up from $10.1 million in the same period in 2021[133]. - The Phase 3 clinical study of sabizabulin demonstrated a statistically significant 55.2% relative reduction in deaths compared to placebo in hospitalized COVID-19 patients at high risk for ARDS[100]. - The company is currently enrolling approximately 210 patients in a Phase 3 trial for enobosarm as a treatment for AR+ER+HER2- metastatic breast cancer[107]. - The company plans to conduct a confirmatory Phase 3 clinical study for sabizabulin to support full regulatory applications in multiple regions[105]. Shareholder Equity and Stock Options - The company reported a significant increase in stockholder equity as reflected in the unaudited condensed consolidated statements[101]. - The total intrinsic value of options exercised during the three months ended December 31, 2022, was approximately $355,000, compared to $447,000 for the same period in 2021[79]. - The Company had unrecognized compensation expense of approximately $49.6 million related to unvested stock options, expected to be recognized over a weighted average period of 2.2 years[80]. Regulatory and Compliance - The company has filed certifications pursuant to the Sarbanes-Oxley Act of 2002 by both the CEO and CFO, ensuring compliance and accuracy in financial reporting[31.1][31.2]. - The company’s leadership is committed to maintaining compliance with SEC regulations, as evidenced by the signing of the report by the CEO and CFO[165][167]. - The company’s financial documents are designed to meet the requirements of the Securities Exchange Act of 1934, ensuring regulatory adherence[165]. Corporate Governance - The company has undergone multiple amendments to its articles of incorporation, indicating ongoing corporate governance adjustments[3.1][3.2][3.3][3.4][3.5][3.6][3.7]. - The company’s amendments to its corporate structure reflect strategic decisions aimed at enhancing shareholder value and operational flexibility[3.8]. Market and Risk Factors - The company continues to face the same risk factors disclosed in its Annual Report for the fiscal year ended September 30, 2022, with no material changes[159]. - There have been no material changes to the Company's market risk exposure since September 30, 2022[154].

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 ...