Veru Inc. Nasdaq:VERU | --- | --- | --- | --- | |--------------------------------------------------------------------------------------------------------------|-------|-------|-------| | | | | | | | | | | | The Prostate Cancer Company Novel Medicines | | | | | Veru Corporate Presentation Morgan Stanley 18 th Annual Global Healthcare Conference September 14-18, 2020 | | | | Forward looking statements This communication contains forward-looking statements within the meaning of the Private Securities Litigatio ...

[Forward Looking Statements](index=4&type=section&id=Forward%20Looking%20Statements) This section outlines the nature of forward-looking statements and highlights key business and operational risks - This section identifies forward-looking statements within the report, which are subject to known and unknown risks and uncertainties, cautioning that actual results may differ materially from expectations[10](index=10&type=chunk) - Key risk factors highlighted include potential delays in clinical trials due to COVID-19, financing risks, challenges in developing a COVID-19 treatment, and risks related to product demand and manufacturing[10](index=10&type=chunk)[11](index=11&type=chunk) [PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This part presents the unaudited condensed consolidated financial statements and management's analysis of financial condition and results of operations [Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) The unaudited financial statements show increased assets and revenues, persistent net losses, and reliance on financing for cash flow [Unaudited Condensed Consolidated Balance Sheets](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) Total assets and stockholders' equity increased, driven primarily by a significant rise in cash and cash equivalents Condensed Consolidated Balance Sheet Data (in thousands) | Balance Sheet Item | June 30, 2020 | September 30, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $15,394 | $6,295 | | Total current assets | $26,859 | $16,807 | | Total assets | $65,188 | $53,629 | | **Liabilities & Equity** | | | | Total current liabilities | $17,373 | $14,020 | | Total liabilities | $23,909 | $21,296 | | Total stockholders' equity | $41,279 | $32,333 | [Unaudited Condensed Consolidated Statements of Operations](index=8&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) Net revenues grew for both three and nine-month periods, though the company continued to report a net loss Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Nine Months Ended June 30, 2020 | Nine Months Ended June 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Net revenues | $10,322 | $9,727 | $30,843 | $23,075 | | Gross profit | $6,519 | $6,571 | $21,225 | $15,824 | | Research and development | $4,436 | $4,866 | $13,667 | $10,139 | | Operating loss | $(1,393) | $(1,842) | $(3,477) | $(4,978) | | Net loss | $(3,025) | $(2,774) | $(7,141) | $(8,957) | | Net loss per share | $(0.05) | $(0.04) | $(0.11) | $(0.14) | [Unaudited Condensed Consolidated Statements of Cash Flows](index=13&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Financing activities provided the primary source of cash, offsetting cash used in operations and leading to a net cash increase Cash Flow Summary (in thousands) | Cash Flow Activity | Nine Months Ended June 30, 2020 | Nine Months Ended June 30, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,589) | $(4,530) | | Net cash used in investing activities | $(73) | $(75) | | Net cash provided by financing activities | $10,762 | $8,885 | | **Net increase in cash** | **$9,099** | **$4,280** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=15&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies, revenue breakdowns, financing agreements, and the receipt of a PPP loan - The company believes its current cash position and ability to secure financing are **adequate to fund planned operations for the next 12 months**[43](index=43&type=chunk) - On June 26, 2020, the company entered into a **new common stock purchase agreement with Aspire Capital for up to $23.9 million**, replacing a prior agreement[87](index=87&type=chunk)[91](index=91&type=chunk)[92](index=92&type=chunk) - In April 2020, the company received a **Paycheck Protection Program (PPP) loan of approximately $540,000**, which it expects to be forgiven[122](index=122&type=chunk) Net Revenues by Product and Channel (in thousands) | Revenue Source | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Nine Months Ended June 30, 2020 | Nine Months Ended June 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | FC2 Public health sector | $4,254 | $4,906 | $11,198 | $13,040 | | FC2 U.S. prescription channel | $5,392 | $4,378 | $18,395 | $9,412 | | PREBOOST® | $676 | $443 | $1,250 | $623 | | **Total Net Revenues** | **$10,322** | **$9,727** | **$30,843** | **$23,075** | Operating Income (Loss) by Segment (in thousands) | Segment | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Nine Months Ended June 30, 2020 | Nine Months Ended June 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Commercial | $5,264 | $5,619 | $17,609 | $11,425 | | Research and development | $(4,853) | $(4,436) | $(13,550) | $(10,104) | | Corporate | $(2,252) | $(2,576) | $(7,536) | $(6,300) | | **Total Operating Loss** | **$(1,393)** | **$(1,842)** | **$(3,477)** | **$(4,978)** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=46&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its biopharmaceutical pipeline, the operational impact of COVID-19, and financial results, highlighting revenue growth and liquidity sources [Overview and COVID-19 Impact](index=46&type=section&id=Overview%20and%20COVID-19%20Impact) The company outlines its biopharmaceutical focus and details the operational impact of the COVID-19 pandemic, including a temporary facility shutdown - The company's prostate cancer pipeline includes **VERU-111** (also for COVID-19), **VERU-100**, and **Zuclomiphene Citrate**[129](index=129&type=chunk)[130](index=130&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk) - The sole manufacturing facility for FC2 in Malaysia was **temporarily shut down** on March 16, 2020, but returned to 100% staffing by May 4, 2020[141](index=141&type=chunk) - During the quarter ended June 30, 2020, the COVID-19 pandemic **did not have a material net impact** on consolidated operating results, but significant uncertainty remains[142](index=142&type=chunk)[144](index=144&type=chunk) [Results of Operations](index=54&type=section&id=Results%20of%20Operations) Revenue increased for both the three and nine-month periods, driven by strong growth in the FC2 U.S. prescription channel - Growth in FC2 net revenues was primarily driven by the U.S. prescription channel, which saw a **95% increase** for the nine months ended June 30, 2020[173](index=173&type=chunk) Financial Performance Comparison: Q3 2020 vs Q3 2019 | Metric | Q3 2020 | Q3 2019 | Change | | :--- | :--- | :--- | :--- | | Net Revenues | $10.3M | $9.7M | +6% | | Gross Profit | $6.5M | $6.6M | -1.5% | | Gross Margin | 63% | 68% | -5 p.p. | | Net Loss | $3.0M | $2.8M | +7% | Financial Performance Comparison: Nine Months 2020 vs 2019 | Metric | Nine Months 2020 | Nine Months 2019 | Change | | :--- | :--- | :--- | :--- | | Net Revenues | $30.8M | $23.1M | +34% | | Gross Profit | $21.2M | $15.8M | +34% | | Gross Margin | 69% | 69% | 0 p.p. | | Net Loss | $7.1M | $9.0M | -21% | [Liquidity and Sources of Capital](index=58&type=section&id=Liquidity%20and%20Sources%20of%20Capital) The company's cash position improved significantly due to financing activities, which are deemed sufficient for near-term operations - **Cash and cash equivalents increased from $6.3 million to $15.4 million** between September 30, 2019, and June 30, 2020[182](index=182&type=chunk) - Net cash from financing activities for the nine-month period was **$10.8 million**, primarily from **$13.4 million in share sales** to Aspire Capital[189](index=189&type=chunk) - The company entered a **new common stock purchase agreement with Aspire Capital for up to $23.9 million** on June 26, 2020[196](index=196&type=chunk)[197](index=197&type=chunk) - In April 2020, the company received a **$0.5 million PPP loan**, which it expects to be fully forgiven[198](index=198&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=64&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company reports no material changes to its market risk exposure since the last annual report - There have been **no material changes** to the company's market risk exposures since September 30, 2019[202](index=202&type=chunk) [Controls and Procedures](index=64&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal controls - Management concluded that the company's disclosure controls and procedures were **effective as of June 30, 2020**[203](index=203&type=chunk) - **No material changes** in internal control over financial reporting occurred during the most recent fiscal quarter[204](index=204&type=chunk) [PART II. OTHER INFORMATION](index=65&type=section&id=PART%20II.%20OTHER%20INFORMATION) This part covers legal proceedings, updated risk factors, and other corporate governance matters [Legal Proceedings](index=65&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently party to any material pending legal proceedings - As of the filing date, the company is **not involved in any material pending legal proceedings**[206](index=206&type=chunk) [Risk Factors](index=66&type=section&id=Item%201A.%20Risk%20Factors) This section updates risk factors, focusing on challenges related to the COVID-19 pandemic and the company's PPP loan - The COVID-19 pandemic may **make it difficult to recruit patients for clinical trials**, potentially delaying drug candidate advancement[208](index=208&type=chunk) - **Disruptions at the FDA** due to the pandemic could delay or prevent the approval of new drugs[210](index=210&type=chunk) - The company's pursuit of **VERU-111 as a COVID-19 treatment is at an early stage** and may not be successful[216](index=216&type=chunk) - The company's application for its PPP loan could be determined to have been impermissible, potentially leading to **penalties and reputational damage**[218](index=218&type=chunk)[219](index=219&type=chunk) [Other Information](index=72&type=section&id=Item%205.%20Other%20Information) The company's Board of Directors was expanded with the appointment of a new independent director - On August 11, 2020, the **Board of Directors was expanded from five to six members**, and Grace Hyun, M.D. was appointed to fill the vacancy[221](index=221&type=chunk) [Exhibits](index=73&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including material contracts and certifications

Financial Data and Key Metrics Changes - For Q3 fiscal year 2020, net revenues increased by 6% to $10.3 million from $9.7 million in the prior year [28] - Year-to-date fiscal 2020 net revenues were up 34% to $30.8 million from $23.1 million in the prior year period [32] - The company reported a net loss of $3 million, or $0.05 per diluted common share, compared to a net loss of $2.8 million, or $0.04 per diluted common share in the prior year third quarter [31] Business Line Data and Key Metrics Changes - The U.S. FC2 prescription business saw net revenues up 23% to $5.4 million from $4.4 million in the prior year third quarter [28] - Net revenue from the public health sector business was $4.3 million compared to $4.9 million in the prior year third quarter [28] - FC2 unit sales declined slightly by 3% to 10.5 million units from 10.9 million units in the prior year third quarter [28] Market Data and Key Metrics Changes - The global market for prostate cancer treatments is estimated to represent about $5 billion annually, with no FDA-approved drugs for the indication targeted by VERU-111 [12] - The androgen deprivation therapy market is valued at $2.8 billion globally, with a shift towards GnRH antagonists over LHRH agonists [17] Company Strategy and Development Direction - The company is focused on developing novel medicines for prostate cancer, with plans for two Phase 3 registration trials in 2021 [7] - The transformation into an oncology biopharmaceutical company is nearly complete, supported by a growing revenue-generating sexual health business [41] - The company plans to submit an NDA for TADFIN, a combination of Tadalafil and Finasteride for BPH, by late 2020 [7] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued revenue growth and the ability to invest in clinical development programs due to strong performance in the sexual health business [39] - The company anticipates a steady flow of positive news regarding clinical trials and expects to start the Phase 3 registration study in early 2021 [39][40] Other Important Information - The company received positive FDA input for the proposed Phase 3 trial program for VERU-111, which is designed to evaluate efficacy and safety in men with metastatic castration-resistant prostate cancer [11] - The FC2 manufacturing facility in Malaysia has resumed operations, consistent with pre-COVID-19 volumes [29] Q&A Session Summary Question: Will there be new data presented for VERU-111 at ESMO? - Yes, additional efficacy and safety data will be presented, including tumor response images [44] Question: Is there a chance of getting emergency use authorization for the COVID program? - While some believe it is possible, the company is more likely to proceed with a Phase 3 study depending on the outcomes [48] Question: Will the commercial business be sufficient to fund operations? - The commercial business is expected to generate substantial revenue, potentially funding a significant portion of the Phase 3 trials [55] Question: Are there plans to add more products to the commercial business? - Yes, the company is considering adding more products to leverage the telemedicine channel for additional revenue [59]

Veru Inc. Nasdaq:VERU | --- | --- | --- | --- | |----------------------------------------------|-------|-------|-------| | | | | | | | | | | | The Prostate Cancer Company Novel Medicines | | | | | Veru Corporate Presentation June 2020 | | | | Forward looking statements This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks o ...

Veru Inc. (NASDAQ:VERU) Q2 2020 Earnings Conference Call May 13, 2020 8:00 AM ET Company Participants Sam Fisch - Director, Investor Relations Mitchell Steiner - Chairman, President & Chief Executive Officer Michele Greco - Chief Financial Officer & Chief Accounting Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald Leland Gershell - Oppenheimer Yi Chen - H.C. Wainwright Peter McMullin - Peter McMullin Consulting Operator Good morning, ladies and gentlemen, and welcome to Veru Inc.'s In ...

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 ...