Financial Data and Key Metrics Changes - The company reported total net revenues of $9.9 million for Q2 fiscal year 2020, up 43% from $7 million in the prior year second quarter [55] - Gross profit increased by 61% to $7.4 million from $4.6 million in the prior year second quarter, with gross margin rising to 75% from 66% [55][56] - The net loss for Q2 fiscal 2020 was $811,000 or $0.01 per diluted common share, compared to a net loss of $4 million or $0.06 per diluted common share in the prior year [58] Business Line Data and Key Metrics Changes - The U.S. prescription business generated $7 million in revenue for Q2 fiscal year 2020, a 168% increase from $2.6 million in the prior year [48][55] - Net revenue from PREBOOST/Roman swipes was $574,000 compared to $180,000 in the prior year period [60] - The commercial segment, including FC2, PREBOOST/Roman swipes, and drug commercialization costs, saw net revenues increase to $9.9 million, up from $7 million in Q2 fiscal year 2019 [49] Market Data and Key Metrics Changes - The company won 75% of a South African tender, representing up to $120 million over three years, translating to approximately $10.4 million in revenue per year [56] - The global market for advanced prostate cancer drugs, including oral drugs like abiraterone and enzalutamide, was over $6 billion in 2018, with the target market for VERU-111 estimated at $5 billion annually [24][23] Company Strategy and Development Direction - The company is focusing on accelerating the clinical development of VERU-111 for metastatic castration-resistant prostate cancer, shifting resources from other Phase 2 studies to prioritize this [21] - The strategy includes obtaining FDA agreement on the Phase III registration trial design for VERU-111, which is aimed at addressing an unmet medical need [20][68] - The company plans to submit an NDA for TADFIN, which is expected to provide additional revenue streams [51][67] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued revenue growth, expecting strong performance for the remainder of fiscal year 2020 and early fiscal year 2021 [66][67] - The company anticipates a steady flow of positive news regarding clinical programs, including updates on VERU-111 and VERU-100 [69] - Management highlighted the importance of regulatory clarity from the FDA and EMA for the clinical trial design of VERU-111 [68] Other Important Information - The company has a cash balance of $2.6 million as of March 31, 2020, down from $6.3 million at the end of the previous fiscal year [63] - The company has net operating loss carry-forwards of $42.7 million for U.S. federal tax purposes, which can be utilized to offset future taxable income [62] Q&A Session Summary Question: Can you elaborate on the Phase III design for VERU-111? - Management indicated that the Phase III trial design will likely involve 250 to 300 patients, with an endpoint of imaging-based progression-free survival, similar to other studies [75][79] Question: Will the COVID-19 program use the same dose as oncology? - The COVID-19 program will use a lower dose of 18 milligrams compared to the 63 milligrams used for oncology [95] Question: How might VERU-111 be moved earlier in the treatment paradigm for advanced prostate cancer? - Management confirmed that it is possible to move VERU-111 earlier in the treatment paradigm due to its favorable side effect profile, allowing urologists to manage patients effectively [99]

Financial Performance - The Company has incurred quarterly operating losses since Q4 of fiscal 2016 and anticipates continued cash consumption and substantial net losses as it develops drug candidates[38]. - The comprehensive loss for the three and six months ended March 31, 2020, is equivalent to the reported net loss[32]. - Total net revenues for the three months ended March 31, 2020, were $9,943,104, a 42.5% increase from $6,976,115 in the same period of 2019[51]. - For the six months ended March 31, 2020, total net revenues reached $20,521,120, compared to $13,347,924 for the same period in 2019, reflecting a 54.1% growth[51]. - Revenue from the U.S. prescription channel for the three months ended March 31, 2020, was $6,952,627, a 168.5% increase from $2,594,271 in the same period of 2019[51]. - FC2 net revenues increased by 39% year over year to $9.9 million for the three months ended March 31, 2020, compared to $7.0 million for the same period in 2019[153]. - FC2 net revenues represented 96% of total net revenues for the three months ended March 31, 2020, with a 30% decrease in total unit sales and a 98% increase in average sales price per unit[154]. - The Company anticipates potential revenue challenges due to pricing pressure from large global agencies and donor governments in the developed world[157]. Cash Position and Financing - The Company believes its current cash position and expected sales from commercial products are adequate to fund operations for the next 12 months[39]. - Cash on hand at March 31, 2020, was $2.6 million, down from $6.3 million at September 30, 2019, with working capital decreasing to $0.6 million[172]. - The Company intends to pursue equity or debt financing opportunistically, which may include selling common stock under its common stock purchase agreement[39]. - The Company plans to pursue various financing alternatives, including equity financing and debt financing, to support operations for the next 12 months[174]. - The Company received net proceeds of approximately $9.9 million from a $10.0 million term loan under the Credit Agreement established on March 5, 2018[70]. - The Company was approved for a $0.5 million loan under the U.S. Small Business Administration's Paycheck Protection Program, with the potential for full forgiveness if funds are used for payroll costs, rent, and utilities[187]. Operational Challenges and COVID-19 Impact - The Company is closely monitoring the impact of the COVID-19 pandemic on its operations, with no material adverse effects reported in Q1 2020[120]. - The COVID-19 pandemic has caused significant disruptions, including the temporary closure of the manufacturing facility in Malaysia[136]. - Significant uncertainty remains regarding the impact of COVID-19 on operations and clinical trials, with potential delays in recruitment and trial initiation[137]. - The Company has not terminated any employees in the U.S. due to the COVID-19 pandemic, intending to use the PPP Loan proceeds for salaries and other expenses[187]. Research and Development - The Phase 1b portion of the VERU-111 trial enrolled 39 men, with 75% showing decreases in PSA levels after treatment[123]. - The maximum tolerated dose (MTD) of VERU-111 was determined to be 72 mg, with 3 out of 11 men experiencing reversible Grade 3 diarrhea[123]. - The Company plans to advance zuclomiphene citrate to a Phase 3 clinical trial in late 2020 after successful Phase 2 results[124]. - VERU-100 is a long-acting GnRH antagonist designed for advanced prostate cancer treatment, anticipated to enter Phase 2 study in Q3 2020[125]. - The Phase 2 clinical trial for VERU-111, targeting COVID-19, will involve 40 hospitalized patients and evaluate daily oral doses for 21 days[126]. - The Company is actively seeking grant funding to expedite the clinical development of VERU-111 for COVID-19[126]. Assets and Liabilities - As of March 31, 2020, the Company's financial liabilities measured at fair value included embedded derivatives classified within Level 3 of the fair value hierarchy, with an ending balance of $3,550,000[45]. - The change in fair value of derivative liabilities for the six months ended March 31, 2020, was a decrease of $75,000 compared to an increase of $403,000 for the same period in 2019[45]. - The Company had approximately $508,000 in contract liabilities as of March 31, 2020, up from $249,000 at September 30, 2019[51]. - Accounts receivable, net, increased to $5,802,016 as of March 31, 2020, from $5,021,057 at September 30, 2019[55]. - Inventory, net, rose to $6,016,323 as of March 31, 2020, compared to $3,647,406 at September 30, 2019[63]. - The Company reported total intangible assets of $20,900,000 as of March 31, 2020, with no change from September 30, 2019[67]. - Goodwill remained unchanged at $6.9 million as of March 31, 2020, consistent with the balance at September 30, 2019[69]. - The Company has a net deferred tax asset of $8.34 million as of March 31, 2020[116]. Shareholder and Stock Information - The Company sold a total of 4,417,010 shares of common stock to Aspire Capital, generating proceeds of $9.1 million as of March 31, 2020[90]. - During the six months ended March 31, 2020, the Company sold 300,000 shares of common stock to Aspire Capital, resulting in proceeds of $1.2 million[89]. - As of March 31, 2020, the Company had 5,876,321 shares available for issuance under the 2018 Equity Incentive Plan, which allows for a total of 11.0 million shares[93]. - The total intrinsic value of options exercised during the six months ended March 31, 2020, was approximately $1.1 million, significantly higher than $48,000 for the same period in 2019[98]. - Share-based compensation expenses for the three months ended March 31, 2020, totaled $681,680, compared to $496,209 for the same period in 2019, reflecting a 37.2% increase[92]. - The Company recorded share-based compensation expenses in research and development of $184,627 for the three months ended March 31, 2020, compared to $81,005 for the same period in 2019, marking a 128.5% increase[92].

Financial Data and Key Metrics Changes - The company reported Q1 fiscal year 2020 revenue of $10.6 million, up 66% from $6.4 million in Q1 fiscal year 2019 [24] - Gross profit increased to $7.3 million with a gross margin of 69%, compared to $4.6 million and a gross margin of 73% in the prior year [30] - The net loss for the quarter was $3.3 million or $0.05 per share, compared to a net loss of $2.1 million or $0.03 per share in the prior year [32] Business Line Data and Key Metrics Changes - FC2 unit sales totaled $10.1 million, up 36% from $7.4 million in the prior year [27] - Prescription business revenue was $6.1 million, an increase of 148% from $2.4 million in the prior year [28] - Revenue from PREBOOST/Roman Swipes was $153,000, compared to $47,000 in the prior year [28] Market Data and Key Metrics Changes - The global market for prostate cancer management is estimated to be a multibillion-dollar market, with a specific focus on unmet medical needs [7] - The market for patients who have failed novel androgen blocking agents is estimated to represent a $4.5 billion annual global market [10] - The peak U.S. revenue potential for zuclomiphene is projected to be between $580 million to $630 million [20] Company Strategy and Development Direction - The company aims to be the leading provider of prostate cancer treatments, focusing on developing and commercializing products to address unmet medical needs [6][7] - Plans to expand the clinical program of VERU-111 into Phase 2 studies with additional tumor types are underway [15] - The company intends to submit an NDA for TADFIN by the end of 2020, which is expected to be its first pharmaceutical urology asset to move into commercialization [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued revenue growth and the potential for a record year in fiscal 2020 [35] - The company anticipates a steady flow of positive news regarding clinical trials and product development over the next year [36] - Management highlighted the importance of the telemedicine sales channel for FC2, which has significantly contributed to revenue growth without traditional marketing costs [60] Other Important Information - Research and development costs increased to $5.3 million from $2.4 million in the prior year, reflecting the advancement of multiple drug candidates [31] - The company has a net operating loss carry-forward for U.S. federal tax purposes of $42.7 million [32] - The cash balance as of December 31, 2019, was $4.2 million, down from $6.3 million at the end of the previous quarter [33] Q&A Session Summary Question: Can you provide more details on the baseline characteristics of the four men on VERU-111 who responded well? - Management noted that the patients typically had bone metastasis or lymph node involvement, which is common in prostate cancer cases [40] Question: What is the competitive environment for VERU-111 in the prostate cancer market? - Management indicated that there are currently no approved drugs for patients who fail ADT and one of the androgen blocking agents, positioning VERU-111 favorably in the market [41] Question: How should we think about operating expenditure for the rest of the year? - Management stated that revenues and gross profits are expected to meet operational needs, allowing for continued investment in promising programs [46] Question: What are the two to three indications being considered for VERU-111? - Management mentioned pancreatic cancer, breast cancer, and post-taxane prostate cancer as potential indications [51] Question: What is the expected sample size for the Phase 3 study of zuclomiphene? - Management indicated that the study would likely involve about 240 to 260 patients, with a 12-week treatment period [53]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2019 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 1-13602 Veru Inc. (Exact Name of Registrant as Specified in its Charter) Wisconsin 39-1144397 48 NW 25 th Street, Suite 102, Miami, ...

Financial Data and Key Metrics Changes - The company reported significant progress in its clinical development and commercialization efforts, with a focus on prostate cancer treatment and supportive care [6][22] - R&D expenses increased from $10.8 million in 2018 to $13.7 million in 2019, while SG&A expenses remained relatively flat year-to-year [42] Business Line Data and Key Metrics Changes - The company is advancing its prostate cancer drug pipeline, particularly with the VERU-111 clinical trial, which targets metastatic castration-resistant prostate cancer patients [7][21] - The company plans to expand the clinical program of VERU-111 to include additional tumor types, including metastatic pancreatic cancer and metastatic breast cancer [21][22] Market Data and Key Metrics Changes - The markets for prostate cancer treatment and supportive care are established multi-billion dollar markets, positioning the company uniquely to address unmet medical needs [6][22] - The company has secured partnerships and demonstrated robust revenue growth from its commercial products, including PREBOOST/Roman Swipes and FC2 [22] Company Strategy and Development Direction - The company aims to be the leading provider of prostate cancer treatments, focusing on developing and commercializing products that address unmet medical needs [6][22] - The strategy includes expanding into additional cancer types based on preclinical data showing efficacy [21][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing clinical trials and the potential for significant anti-tumor activity with VERU-111, noting a wide safety margin [20][28] - The company anticipates continued revenue growth from its commercial products and plans to reassess its financial position by the end of 2021 [75] Other Important Information - The company has not yet reached a maximum tolerated dose for VERU-111, allowing for flexibility in dose selection for future trials [28][40] - The company is actively pursuing partnerships for its products, particularly in Europe and South America [77] Q&A Session Summary Question: Can you provide details on the cohorts with varying response times in the trial? - Management explained that the trial design allows for dose adjustments based on patient response, and they are encouraged by the results seen so far [25][26] Question: How will dose selection be approached for upcoming Phase 2 trials? - Management indicated that they will select a dose in the upper range of what has been tested, based on observed activity and safety [28][29] Question: What are the expected operating expenses for 2020? - R&D expenses are expected to continue increasing, while SG&A expenses will remain stable [42] Question: What is the status of the contracts in Brazil and South Africa? - Management reported increased orders from Brazil and a potential extension of the contract in South Africa, indicating positive revenue expectations [58][60] Question: What is the timeline for getting products to market? - Management outlined expected timelines for product launches, with VERU-111 anticipated for 2022-2023 and zuclomiphene for 2022 [83]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2019 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 1-13602 Veru Inc. (Name of registrant as specified in its charter) Wisconsin 39-1144397 (State or other jurisdiction of incorporation or or ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 1-13602 Veru Inc. (Exact Name of Registrant as Specified in its Charter) Wisconsin 39-1144397 (State of Incorporation) (I.R.S. Employer ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 1-13602 Veru Inc. (Exact Name of Registrant as Specified in its Charter) Wisconsin 39-1144397 4400 Biscayne Boulevard, Suite 888 Miami, ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2018 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 1-13602 Veru Inc. (Name of registrant as specified in its charter) Wisconsin 39-1144397 (State of Incorporation) (I.R.S. Employer Id ...