Financial Data and Key Metrics Changes - Overall net revenues increased by 34% to $13.3 million from $9.9 million in the prior-year second quarter [75] - Gross profit was $10.9 million or 82% of net revenue compared to $7.4 million or 75% of net revenues in the prior-year quarter [76] - The bottom line for the second quarter fiscal 2021 was a net loss of $2.8 million or $0.04 per diluted common share compared to a net loss of $811,000 or $0.01 per diluted common share in the prior-year second quarter [78] Business Line Data and Key Metrics Changes - The US prescription business reported record quarterly sales of $10.3 million, an increase of 48% from $7 million in the prior-year second quarter [75] - Net revenue from the US prescription business was up 49% to $19.4 million from $13 million in the prior-year period [80] - Operating expenses for the quarter increased to $12.4 million compared to the prior-year quarter of $7.7 million, driven primarily by research and development costs [77] Market Data and Key Metrics Changes - The global public sector business was up 11% to $7.7 million [80] - The company sold 171,900 units year-to-date in fiscal 2020 compared to 247,200 units year-to-date in fiscal 2021, an increase of 44% [74] Company Strategy and Development Direction - The company is focused on transforming into a late clinical-stage oncology biopharmaceutical company, supported by revenue from its sexual health business [88] - Plans to enroll potentially up to five registration studies and two Phase II studies in the calendar year, including studies for prostate and breast cancer [93] - The company continues to explore strategic alternatives regarding its legacy female health business [92] Management's Comments on Operating Environment and Future Outlook - The company expects to have a record year in revenue based on year-to-date performance [91] - Management believes that the strong cash position will allow substantial investment in clinical development programs [91] - The company is committed to pursuing the COVID-19 indication despite it not being a primary focus [68] Other Important Information - The company has net operating loss carryforwards for US federal tax purposes of $41.7 million [84] - The company plans to launch TADFIN via third-party telemedicine channels if approved, which should provide near-term revenue [71] Q&A Session All Questions and Answers Question: Could you give us just a little more color in terms of what the impetus was to reformulate the drug? - The reformulation was aimed at improving oral bioavailability, and no further operational work is required for the upcoming clinical trials [99][100] Question: Is there an expectation that there will be some cut-off of AR expression for the enobosarm development program? - There is indeed a correlation between AR expression levels and treatment efficacy, and data supporting this will be presented at the ASCO meeting [101][106]

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, 2021 ☐ 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 Identification No.) th Street, Suite 102, Miami, FL 33127 UNITED STATES ...

Veru Inc. Nasdaq:VERU | --- | --- | --- | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-------| | | | | | | | | | Oncology Biopharmaceutical Company Focused on Prostate Cancer and Breast Cancer Veru Corporate Presentation Oppenheimer 31st Annual Healthcare Conference March 16-17, 2021 | | | Forward looking statements This communication contains forward-looking statemen ...

Financial Data and Key Metrics Changes - The company reported a record net revenue of $14.6 million for Q1 fiscal year 2021, up 38% from $10.6 million in the prior-year quarter [38] - Gross profit increased to $10.8 million, representing 74% of net revenues, compared to $7.3 million or 69% in the prior year [38] - Operating income for the quarter was $19.2 million, a significant increase from an operating loss of $1.8 million in the prior year, primarily due to an $18.4 million gain on the sale of the PREBOOST business [39] - Net income was $17.2 million or $0.023 per diluted share, compared to a net loss of $3.3 million or $0.05 per diluted share in the prior year [40] Business Line Data and Key Metrics Changes - The US FC2 prescription business generated net revenues of $9.1 million in Q1 fiscal year 2021, up 50% from $6.1 million in Q1 fiscal year 2020 [8] - The public sector business saw an increase in net revenues to $4.7 million from $4.4 million in the prior year quarter [38] - The PREBOOST business generated $863,000 in revenues through the sale date, compared to $153,000 in the prior year quarter [38] Market Data and Key Metrics Changes - The company anticipates launching TADFIN, a combination capsule for treating lower urinary tract infections, with an NDA submission expected soon [10] - The company is focused on developing oral therapies for advanced prostate and breast cancers, with plans for multiple registration clinical trials in 2021 [10][11] Company Strategy and Development Direction - The company aims to transform into a late clinical-stage oncology biopharmaceutical company, focusing on novel medicines for prostate and breast cancers [42] - The company plans to leverage cash generated from its sexual health business to fund clinical development of oncology drug candidates [7][45] - The company is committed to advancing Veru-111 into a Phase 3 clinical study for COVID-19, despite it not being the primary focus [36][45] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued growth trajectory of the sexual health business, which supports the funding of clinical trials [41] - The company expects another record year in fiscal year 2021, with potential options to monetize its business further [45] - Management highlighted the importance of Veru-111 as a broad-spectrum antiviral and anti-inflammatory agent in the context of the ongoing COVID-19 pandemic [36][56] Other Important Information - The company has sufficient resources to fund all planned registration clinical trials, with a cash balance of $30.9 million as of December 31, 2020 [40][41] - The company received a waiver for the FDA PDUFA fees for the NDA submission of TADFIN, amounting to approximately $2.4 million [9] Q&A Session Summary Question: Can you help us think about Veru-111's position in the market? - Management explained that Veru-111 disrupts the microtubule trafficking system, making it a broad-spectrum antiviral, and they are prepared to collect data on mutant strains during the Phase 3 trial [50][51] Question: Was the record quarter primarily driven by US prescription sales? - Management confirmed that the record quarter was primarily driven by US prescription sales, which increased by 50% [61] Question: What are the expectations for TADFIN sales once launched? - Management indicated uncertainty regarding TADFIN sales but noted the potential for significant market reach through telemedicine [63] Question: When can we expect top-line results from the Phase 2 trial of Veru-111 in prostate cancer? - Management did not provide a specific timeline for the Phase 2 trial results but emphasized the importance of the data for the Phase 3 trial [65]

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, 2020 ☐ 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. Emplo ...

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, 2020 ☐ 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 ...

Veru, Inc. (NASDAQ:VERU) Q4 2020 Earnings Conference Call December 9, 2020 8:00 AM ET Company Participants Sam Fisch - Director, IR Mitchell Steiner - Chairman, CEO, and President Michele Greco - CFO and CAO Conference Call Participants Brandon Folkes - Cantor Fitzgerald Yi Chen - H.C. Wainwright Leland Gershell - Oppenheimer Kumar Raja - Brookline Capital Markets Peter McMullin - Peter McMullin Consulting Operator Good morning, ladies and gentlemen, and welcome to Veru, Inc.'s Investors Conference Call. Al ...

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]