Veru(US:VERU)2023-02-09 19:55Financial 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].