On August 13, 2020 Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer, reported that net revenues for its fiscal 2020 third quarter ended June 30, 2020 increased to $10.3 million, based on sharply higher U.S. prescription sales of FC2 (Press release, Veru, AUG 13, 2020, View Source [SID1234563571]).
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Third-Quarter Financial Highlights: Fiscal 2020 vs Fiscal 2019
Net revenues increased 6% to $10.3 million from $9.7 million
FC2 U.S. prescription sales climbed 23% to $5.4 million from $4.4 million
Gross profit was $6.5 million, or 63% of net revenues, compared with $6.6 million, or 68% of net revenues
Operating loss narrowed to $1.4 million from $1.8 million
Net loss was $3.0 million, or $0.05 per share, compared with $2.8 million, or $0.04 per share
Year-to-Date Financial Highlights: Fiscal 2020 vs Fiscal 2019
Net revenues rose 34% to $30.8 million from $23.1 million
FC2 U.S. prescription sales increased 95% to $18.4 million from $9.4 million
Gross profit of $21.2 million, or 69% of net revenues, significantly improved from $15.8 million, or 69% of net revenues
Balance Sheet Information
Cash and cash equivalents were $15.4 million as of June 30, 2020 versus $2.6 million as of March 31, 2020
Net accounts receivable were $4.1 million as of June 30, 2020 versus $5.8 million as of March 31, 2020
"Strong U.S. prescription sales of FC2, along with a solid contribution from PREBOOST / Roman Swipes and lower operating expenses, fueled our improved financial performance over last year’s fiscal third quarter and our substantial Year-to-Date growth in revenues and gross profit," said Mitchell Steiner, MD, Chairman, President and Chief Executive Officer of Veru Inc. "Our continued robust growth validates the strategic decision we made almost 3 years ago to utilize the growing telemedicine channel. We are pleased not only with our overall financial results, but also that our commercial sexual health business continues to generate significant funding to invest in the advancement of our clinical development programs."
Pharmaceutical Pipeline Recent Highlights:
VERU-111 for Metastatic Castration Resistant Prostate Cancer
In July the Company announced that it had received input from the U.S. Food and Drug Administration (FDA) on its pivotal Phase 3 trial design for VERU-111, an oral, first-in-class, novel alpha and beta tubulin targeting drug candidate being evaluated for the treatment of metastatic castration and novel androgen receptor targeting agent resistant prostate cancer.
"We received positive FDA input, agreement, and regulatory guidance regarding the design of the pivotal Phase 3 registration clinical trial for VERU-111," said Dr. Steiner. "We received clarity on a number of items including: the proposed indication of metastatic castration and novel androgen receptor targeting agent resistant prostate cancer, which is prior to IV chemotherapy population, being acceptable; an open label, randomized, active control study using an alternative novel androgen receptor targeting agent as the active control is reasonable; and a primary endpoint for the trial of radiographic progression-free survival. This last item is especially important because by allowing radiographic progression-free survival as an endpoint the sample size for the Phase 3 study could be potentially between 200 and 300 men. We plan to submit the final Phase 3 protocol to FDA in the fourth quarter of the current calendar year."
Dr. Steiner added: "Patient enrollment of the Phase 2 trial is nearing completion and we are already observing some significant PSA declines. We anticipate commencing the global Phase 3 pivotal clinical study in the first quarter of calendar year 2021. As this study will be conducted in the U.S. and globally, we plan to get input from the European Medicines Agency (EMA) as well."
In July the Company also announced that the clinical results from its Phase 1b/2 study of VERU-111 have been accepted for oral presentation at the prestigious European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 to be held September 19-21, 2020.
VERU-100 for Hormone Sensitive Advanced Prostate Cancer Phase 2 Clinical Trial
VERU-100, a long acting gonadotropin antagonist peptide 3-month depot formulation, GMP manufacturing is progressing and an IND expected to be submitted next quarter. The Phase 2 dose finding clinical study should start late calendar year Q4 2020 and a Phase 3 pivotal registration clinical study is expected to commence in the second half of calendar year 2021.
VERU-111 COVID-19: Phase 2 Clinical Trial
As previously announced, the Company is developing VERU-111 which has potentially both antiviral and anti-inflammatory dual action to broadly treat the cytokine storm which is associated with high COVID-19 mortality rates. The Company received FDA permission to initiate a Phase 2 clinical trial to assess the efficacy of VERU-111 in combating COVID-19 in patients at high risk for acute respiratory distress syndrome (ARDS). We recently reported the results of an in vitro study conducted by a team of researchers at the University of Tennessee Health Science Center to determine if VERU-111 can suppress toxic shock levels of these key cytokines of the cytokine storm. At a concentration that represents the blood levels of VERU-111 observed in clinically dosed patients, VERU-111 (40 nM) highly significantly reduced the production of key cytokines known to be involved with COVID-19 cytokine storm: TNFα (-31%), IL-1α (-123%), IL-1β(-97%), IL-6 (-85%), and IL-8 homologue (-96%), all p values were (p<0.001). This reduction was similar to, or greater than, depending on the specific cytokine, to that observed with dexamethasone (10nM), a steroid and a known inhibitor of cytokine production during inflammation. Suppression of these key cytokines may be an effective way to prevent clinical deterioration of patients with COVID-19 to ARDS.
The Phase 2 clinical trial is a double-blind randomized (1:1) placebo-controlled trial evaluating daily oral doses of 18 mg VERU-111 for 21 days versus placebo in 40 hospitalized COVID-19 patients who are at high risk for ARDS. The primary efficacy endpoint is the proportion of subjects that are alive without respiratory distress at Day 29. Secondary endpoints include measures of improvements on the WHO Disease Severity Scale (8-point ordinal scale), which captures COVID-19 disease symptoms and signs, including hospitalization to progression of pulmonary symptoms to mechanical ventilation, as well as improving overall survival.
Event Details
Veru Inc. will host a conference call today at 8 a.m. ET 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. The call will also be available through a live, listen-only audio broadcast via the Internet at www.verupharma.com. A playback of the call will be archived and accessible on the same website for at least three months. A telephonic replay of the conference call will be available, beginning the same day at approximately 12 p.m. (noon) ET by dialing 877-344-7529 for U.S. callers, or 412-317-0088 from outside the U.S., passcode 10146652, for one week.