Veru Reports Fiscal 2018 Third Quarter Financial Results
GlobeNewswire•August 14, 2018
-- Investigational New Drug Application with the FDA Accepted for Phase 2 Study of Zuclomiphene --
-- VERU-111 Preclinical Efficacy Data in Four Different Cancers Presented at American Society of Clinical Oncology (ASCO) Annual Meeting –
-- FC2 Female Condom Business Has Strong Quarter in Net Revenues --
-- Company to Host Investor Conference Call on Tuesday, Aug. 14, 2018, at 8 a.m. ET --
MIAMI, Aug. 14, 2018 (GLOBE NEWSWIRE) -- Veru Inc. ( VERU), an oncology and urology biopharmaceutical company, today announced its financial results for the fiscal 2018 third quarter ended June 30, 2018.
“We have made strong progress in this quarter advancing our pipeline of proprietary prostate cancer product candidates and suite of urology specialty pharmaceuticals,” commented Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer. “We look forward to enrolling the first patient in the Phase 2 trial of zuclomiphene (aka cis-clomiphene) to treat hot flashes caused by prostate cancer hormone therapy during the fiscal fourth quarter of 2018. Within this calendar year, we expect to conduct the bioequivalence studies for new formulation product candidates tamsulosin DRS granules and XR capsules, as well as tadalafil-finasteride combination tablets. Our product candidates address unmet medical needs in prostate cancer, prostate cancer supportive care, and urology which are multibillion dollar markets.”
“With regard to our financial results: net revenues, which are primarily derived from product sales of FC2 Female Condoms®, increased 28% in the third quarter of fiscal 2018 over the comparable prior year period and more than doubled from the preceding quarter. We are expecting the South African government to announce soon the results of the tender award for 40 million female condoms per year -- a total of 120 million units over the full three-year tender time period — and we are confident that we will receive a substantial portion of the award.”" data-reactid="17">“With regard to our financial results: net revenues, which are primarily derived from product sales of FC2 Female Condoms®, increased 28% in the third quarter of fiscal 2018 over the comparable prior year period and more than doubled from the preceding quarter. We are expecting the South African government to announce soon the results of the tender award for 40 million female condoms per year -- a total of 120 million units over the full three-year tender time period — and we are confident that we will receive a substantial portion of the award.”
Summary of Accomplishments During FY Q3
In June 2018, the Company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for a Phase 2 clinical study of zuclomiphene for the treatment of hot flashes in men with advanced prostate cancer who are receiving hormone therapy, which has been accepted. Also in June, the U.S. Patent and Trademark Office issued Patent No. 9,913,815, which provides protection until 2035 for the use of zuclomiphene in men with prostate cancer as a method of treating and preventing side effects caused by androgen deprivation therapy (ADT), including hot flashes, loss of bone mineral density and bone fractures.
In May 2018, preclinical results for VERU-111, a novel oral alpha and beta tubulin inhibitor with potential for development in the treatment of prostate and other cancer types, were featured in a moderated poster session at the 2018 American Urological Association Annual Meeting. In June 2018, preclinical results showing the efficacy of VERU-111 in four different cancer models (novel androgen blocking agent resistant human prostate cancer, a paclitaxel sensitive and resistant triple negative breast cancer, as well as ovarian cancer and pancreatic cancer) were presented as part of the American Society of Clinical Oncology (ASCO) Annual Meeting.
Fiscal Third Quarter Results: 2018 vs. 2017
For the third quarter of fiscal 2018, net revenues increased to $5.5 million from $4.3 million for the third quarter of fiscal 2017. Gross profit rose to $3.1 million, or 56% of net revenues, from $2.3 million, or 53% of net revenues, for the third quarter of fiscal 2017. Operating expenses were $8.0 million compared with $3.6 million. Net loss was $7.9 million, or $0.15 per share, compared with $0.8 million, or $0.03 per share, for the third quarter of fiscal 2017.
Significant quarter-to-quarter variations in the Company’s results have historically resulted from the timing and shipment of large orders rather than from any fundamental changes in the business or the underlying demand for female condoms.
Conference Call Event Details
Veru Inc. will host a conference call on Tuesday, Aug. 14, 2018, at 8 a.m. Eastern Time to review the company’s performance. Interested investors may access the call by dialing 800-341-1602 from the U.S. or 412-902-6706 from outside the U.S. and asking to be joined into the Veru Inc. call.
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