Agreement reached with FDA on confirmatory Phase 3 clinical trial design for sabizabulin treatment of hospitalized COVID-19 adult patients at high risk for acute respiratory distress syndrome (ARDS), including two planned interim efficacy analyses
ENTADFI(R) product sold for $20 million, plus up to an additional potential $80 million from sales milestones
Common stock purchase agreement with Lincoln Park Capital for up to $100 million provides financial flexibility
Company reported positive preclinical data for sabizabulin for influenza induced ARDS and for poxvirus
Company to host conference call and webcast today at 8:00 a.m. ET
Company's and third party facilities, COVID-19 (including the impact of COVID-19 on suppliers of key raw materials), product testing, transportation delays or regulatory actions; costs and other effects of litigation, including product liability claims and securities litigation; the Company's ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company's ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company's press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the fiscal year ended September 30, 2022 and subsequent quarterly reports on Form 10-Q. These documents are available on the "SEC Filings" section of our website at www.verupharma.com/investors. The Company disclaims any intent or obligation to update these forward-looking statements.
FINANCIAL SCHEDULES FOLLOW
Veru Inc. Condensed Consolidated Balance Sheets (unaudited) March 31, September 30, 2023 2022 ----------- ----------------- Cash and cash equivalents $23,498,371 $ 80,190,675 Accounts receivable, net 4,205,967 3,550,895 Inventories, net 7,665,194 8,618,944 Prepaid expenses and other current assets 7,918,745 12,408,960 ---------- ----------- Total current assets 43,288,277 104,769,474 Plant and equipment, net 1,519,789 1,185,766 Operating lease right-of-use assets 4,675,739 4,786,915 Deferred income taxes 13,070,469 12,965,985 Intangible assets, net 41,667 3,977,381 Goodwill 6,878,932 6,878,932 Other assets 778,697 1,561,564 ---------- ----------- Total assets $70,253,570 $ 136,126,017 ========== =========== Accounts payable $17,237,474 $ 22,003,394 Accrued research and development costs 13,786,241 9,071,503 Accrued expenses and other current liabilities 6,881,260 9,193,637 Residual royalty agreement liability, short-term portion 1,354,823 1,169,095 ---------- ----------- Total current liabilities 39,259,798 41,437,629 Residual royalty agreement liability, long-term portion 10,257,325 9,656,441 Operating lease liability, long-term portion 3,987,612 4,093,667 Other liabilities 32,933 99,644 ---------- ----------- Total liabilities 53,537,668 55,287,381 Total stockholders' equity 16,715,902 80,838,636 ---------- ----------- Total liabilities and stockholders' equity $70,253,570 $ 136,126,017 ========== =========== Veru Inc. Condensed Consolidated Statements of Operations (unaudited) Three Months Ended Six Months Ended March 31, March 31, ---------------------------- ------------------------------ 2023 2022 2023 2022 ------------ ------------ ------------ ------------ Net revenues $ 6,585,967 $ 13,028,394 $ 9,093,761 $ 27,163,526 Cost of sales 2,493,892 1,853,116 4,299,631 4,146,166 ----------- ----------- ----------- ----------- Gross profit 4,092,075 11,175,278 4,794,130 23,017,360 Operating expenses: Research and development 22,864,633 15,541,104 41,608,982 25,622,265 Selling, general and administrative 12,834,494 7,401,138 30,380,359 14,126,344 Provision for (recovery of) credit losses 3,911,714 (2,000) 3,911,714 (4,000) Impairment of intangible assets 3,900,000 -- 3,900,000 -- ----------- ----------- ----------- ----------- Total operating expenses 43,510,841 22,940,242 79,801,055 39,744,609 ----------- ----------- ----------- ----------- Operating loss (39,418,766) (11,764,964) (75,006,925) (16,727,249) Non-operating income (expenses) 559,301 (2,440,316) (762,997) (3,743,382) ----------- ----------- ----------- ----------- Loss before income taxes (38,859,465) (14,205,280) (75,769,922) (20,470,631) Income tax (benefit) expense (66,559) (27,450) (134,837) 87,205 ----------- ----------- ----------- ----------- Net loss $(38,792,906) $(14,177,830) $(75,635,085) $(20,557,836) =========== =========== =========== =========== Net loss per basic and diluted common shares outstanding $ (0.48) $ (0.18) $ (0.94) $ (0.26) Basic and diluted weighted average common shares outstanding 80,834,453 80,052,504 80,695,046 80,037,675 Veru Inc. Condensed Consolidated Statements of Cash Flows (unaudited) Six Months Ended March 31, ------------------------------ 2023 2022 ------------ ------------ Net loss $(75,635,085) $(20,557,836) Adjustments to reconcile net loss to net cash used in operating activities 17,792,692 6,659,447 Changes in operating assets and liabilities (2,247,306) 1,293,920 ----------- ----------- Net cash used in operating activities (60,089,699) (12,604,469) Net cash (used in) provided by investing activities (427,152) 2,012,566 Net cash provided by financing activities 3,824,547 247,873 ----------- ----------- Net decrease in cash (56,692,304) (10,344,030) Cash at beginning of period 80,190,675 122,359,535 ----------- ----------- Cash at end of period $ 23,498,371 $112,015,505 =========== =========== |
