Veru Inc. Nasdaq:VERU | --- | --- | --- | --- | |-----------------------------------------------------------------------------------------------|-------|-------|-------| | | | | | | | | | | | | | | | | Oncology Biopharmaceutical Company Focused on Breast Cancer and Prostate Cancer | | | | | Veru Corporate Presentation Oppenheimer 32nd Annual Healthcare Conference March 15-17, 2022 | | | | Forward looking statements This communication contains forward-looking statements within the meaning of the Private Secu ...

Veru Inc. (NASDAQ:VERU) Q1 2022 Earnings Conference Call February 9, 2022 8:00 AM ET Company Participants Samuel Fisch - Executive Director of Investor Relations and Corporate Communications Mitchell Steiner - Chairman, President and Chief Executive Officer Michele Greco - Chief Financial Officer and Chief Administrative Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald & Co. Leland Gershell - Oppenheimer & Co. Christopher Howerton - Jefferies LLC Yi Chen - H.C. Wainwright & Co., LLC K ...

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 (State of Incorporation) (I.R.S. Employer Identification No.) 48 NW 25 Street, Suite 102, Miami, FL 33127 (Address of Principal Executive Offices) (Zip Code) 305-509-6897 (Registrant's Telephone Number, Including Area Code) N/A (Former Name, Former Address and Former Fiscal Year, if Changed Since Last ...

Financial Data and Key Metrics Changes - The company achieved record net revenues of $61.3 million for fiscal year 2021, a 44% increase from $42.6 million in the prior year [66][73] - For Q4 2021, net revenues increased by 33% to $15.6 million from $11.7 million in the prior year [60] - Gross profit for Q4 was $12.3 million, representing 79% of net revenues, compared to $9.6 million or 81% in the prior year [61] - The company reported a net loss of $4.3 million or $0.05 per diluted share for Q4 2021, an improvement from a net loss of $11.8 million or $0.17 per diluted share in the prior year [65] Business Line Data and Key Metrics Changes - Revenue from the U.S. prescription business increased by 71% to $46.5 million from $27.1 million in the prior year [67] - The sexual health division, particularly the FC2 product, saw significant growth, with net revenues up 55% to $13.6 million in Q4 2021 [60][66] - The global public health sector business generated $13.9 million in net revenue for the fiscal year [66] Market Data and Key Metrics Changes - The company is focusing on large market opportunities in breast and prostate cancers, with ongoing clinical trials and product development [76][81] - The emergence of new COVID-19 variants has created a heightened demand for effective treatments, positioning the company’s drug sabizabulin as a potential solution for hospitalized patients [11][13] Company Strategy and Development Direction - The company is transitioning into a late-stage oncology biopharmaceutical firm, focusing on developing treatments for breast and prostate cancers [6][76] - The strategy includes leveraging revenues from the sexual health division to fund clinical development of oncology drug candidates [80] - Plans for fiscal year 2022 include conducting four late-stage clinical studies for metastatic breast cancer and advancing prostate cancer programs [37][38] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for fiscal year 2022, anticipating another record year driven by ongoing clinical programs and product launches [78][79] - The company is committed to addressing significant unmet medical needs in oncology while also pursuing opportunities in COVID-19 treatment [81] Other Important Information - The company has a strong cash position of $122.4 million as of September 30, 2021, which supports its clinical development initiatives [74] - The FDA has provided a safe to proceed letter for the Phase 2b study of sabizabulin, indicating no further hurdles before starting the study [85] Q&A Session Summary Question: What control arm is able to be dosed with for Sabizabulin in COVID studies? - The control arm allows for standard of care treatments such as dexamethasone and remdesivir, with patients randomized to either sabizabulin or placebo [92] Question: Are there any other hurdles to overcome before starting the Phase 2b study for Sabizabulin? - There are no other hurdles; the company is currently setting up the study and preparing for recruitment [85][90] Question: Is the Companion Diagnostic AR Test being developed for the ARTEST study? - The current test used is an AR CLIA test, with plans to transition to the commercial test developed by Roche Ventana during the ARTEST study [115][116]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) þ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2021 o 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 ...

Financial Highlights - Veru's FY2020 net revenues were $426 million[5] - Veru's FYTD 2021 net revenues reached $456 million with a gross profit of $356 million[5] - The sexual health business generated $328 million in operating income FYTD 2021[5] - FC2 Female Condom's FY2020 net revenues were $406 million, and FYTD 2021 net revenues were $448 million[5] - Veru's cash reserves stood at $1232 million as of June 30, 2021[5] Drug Pipeline & Clinical Trials - Sabizabulin (32mg) is in Phase 3 clinical trials for metastatic castration and AR targeting agent resistant prostate cancer[10, 11] - VERU-100 is in Phase 2 clinical trials for hormone-sensitive advanced prostate cancer[10, 11] - Enobosarm is planned for a Phase 3 trial in Q3 2021 for AR+ER+HER2- metastatic breast cancer (3rd line metastatic)[10, 44] - Sabizabulin (9mg) is in Phase 3 clinical trials for hospitalized COVID-19 patients at high risk for ARDS[4, 10, 94] - TADFIN™ for BPH has a PDUFA date in December 2021[4, 100]

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 ...