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EX - 99.1 2 d118003dex991.htm EX - 99.1 veru Exhibit 99.1 Contact : Sam Fisch Director of Investor Relations Veru Reports Strong Second - Quarter Financial Results Based on Record High FC2 Prescription Revenues First Patient to Be Enrolled this Week in Phase 3 Clinical Trial of Sabizabulin ( VERU - 111 ) in High Risk Hospitalized COVID - 19 Patients— 800-972-0538 --New Drug Application Accepted for Review by FDA for Proprietary TADFIN Daily Oral Dosing Combination for BPH ; PDUFA Date December 2021- -Company Poised to Enroll First Patient in Phase 3 VERACITY Clinical Trial of Sabizabulin for Metastatic Castration and AR Targeting Agent Resistant Prostate Cancer Later this Month- -Company Anticipates Enrolling First Patient in Phase 2 Clinical Trial of VERU - 100 Novel Long - Acting GnRH Antagonist Depot as Androgen Deprivation Therapy for Advanced Prostate Cancer Later this Month- -Company to Host Investor Conference Call Today at 8 a.m. ET-- MIAMI - May 12 , 2021 - Veru Inc. ( NASDAQ : VERU ) , an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer , today announced that net revenues increased 34 % and gross profit rose 47 % for its fiscal 2021 second quarter ended March 31 , 2021 , attributable to record high quarterly FC2 US prescription net revenues . Second Quarter Financial Highlights : Fiscal 2021 vs Fiscal 2020 • Net revenues increased 34 % to $ 13.3 million from $ 9.9 million FC2 prescription net revenues climbed 48 % to $ 10.3 million from $ 7.0 million • Gross profit rose 47 % to $ 10.9 million from $ 7.4 million • Gross margin increased to 82 % of net revenues from 75 % of net revenues Operating loss was $ 1.5 million versus $ 0.3 million Net loss was $ 2.8 million , or $ 0.04 per share , compared with $ 0.8 million , or $ 0.01 per share . Year - to - Date Financial Highlights : Fiscal 2021 vs Fiscal 2020 • Net revenues increased 36 % to $ 28.0 million from $ 20.5 million , a record high for the six - month period ended March 31 , 2021 FC2 prescription net revenues climbed 49 % to $ 19.4 million from $ 13.0 million • Gross profit rose 48 % to $ 21.7 million from $ 14.7 million • Gross margin increased to 78 % of net revenues from 72 % of net revenues Operating income was $ 17.7 million , which includes an $ 18.4 million gain on the December 2020 sale of the PREBOOST business . Adjusted operating loss , which excludes the gain on the sale of the PREBOOST business , was $ 0.7 million versus $ 2.1 million