Veru Inc. Nasdaq:VERU | --- | --- | --- | --- | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-------|-------| | | | | | | Oncology Biopharmaceutical Company Focused on Prostate Cancer and Breast Cancer H.C. Wainwright 23 rd Annual Global Investment Conference September 13 – September 15, 2021 | | | | Forward looking statements This communication contains forward-loo ...

Veru, Inc. (NASDAQ:VERU) Q3 2021 Earnings Conference Call August 12, 2021 8:00 AM ET Company Participants Samuel Fisch - Director, IR Michele Greco - CFO & Chief Administrative Officer Mitchell Steiner - Chairman, President & CEO Conference Call Participants Brandon Folkes - Cantor Fitzgerald & Co. Christopher Howerton - Jefferies Yi Chen - H.C. Wainwright & Co. Kumaraguru Raja - Brookline Capital Markets Alexandra Heller - Oppenheimer Operator Good morning, ladies and gentlemen, and welcome to Veru Inc. In ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) Commission File Number 1-13602 Veru Inc. (Exact Name of Registrant as Specified in its Charter) Wisconsin 39-1144397 48 NW 25 Street, Suite 102, Miami, FL 33127 (Address of Principal Executive Offices) (Zip Code) (State of Incorporation) (I.R.S. Employer Identification No.) 305-509-6897 (Registrant's Telephone Number, Including Area Code) N/A Indicate by check mark whether the registrant is a shell company (as deter ...

Veru Inc. Nasdaq:VERU | --- | --- | --- | --- | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-------|-------| | | | | | | Oncology Biopharmaceutical Company Focused on Prostate Cancer and Breast Cancer Veru Corporate Presentation Jefferies Virtual Healthcare Conference June 1 – June 4, 2021 | | | | Forward looking statements This communication contains forward-looking st ...

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 ...