On August 8, 2019 Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company developing novel medicines for prostate cancer treatment and prostate cancer supportive care, reported its financial results for its fiscal 2019 third quarter ended June 30, 2019 (Press release, Veru, AUG 8, 2019, View Source [SID1234538384]).

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Business and Operational Highlights

VERU-111. VERU-111 is an oral, first-in-class, alpha and beta antitubulin being evaluated in a Phase 1b/2 clinical trial in men who have metastatic prostate cancer and whose disease is resistant to both castration and novel androgen blocking agents (abiraterone or enzalutamide). The objective of this clinical trial is to determine the dose limiting toxicity of VERU-111. At this point we have dosed 6 cohorts (18 men total) with escalating doses of VERU-111. In clinical observations, VERU-111 is well-tolerated with a favorable safety profile and no dose limiting toxicity has been observed. In some of the men whose PSA blood level was rapidly rising at enrollment, a marker of cancer progression, we have observed that VERU-111 treatment resulted in PSA stabilizations and reductions consistent with early promising signals of anticancer efficacy. Once we have reached a dose level that has dose limiting toxicity, we will be able to select the dose that will be evaluated in the Phase 2 clinical study. There are no drugs that are FDA approved to treat men who have both castration and novel androgen blocking agent resistant prostate cancer and which are also prechemotherapy (chemotherapy naïve), representing an estimated $4.5 billion annual global market.

Zuclomiphene Citrate. Zuclomiphene Citrate is a novel, proprietary, oral, nonsteroidal, estrogen receptor agonist being evaluated as a treatment for hot flashes caused by androgen deprivation therapy for men with advanced prostate cancer. Hot flashes are one of the main reasons why men want to stop androgen deprivation therapy. Approximately 100 men will be randomized in the Phase 2 clinical trial evaluating 2 doses (10mg and 50mg) of oral zuclomiphene versus placebo. Top line results expected late Summer/early Fall 2019. Based on an independent market analysis sponsored by the Company, expected U.S. sales potential for zuclomiphene citrate is estimated to exceed $600 million annually.

VERU-100. VERU-100 is a long-acting gonadotropin-releasing hormone (GnRH) antagonist for the treatment of hormone sensitive advanced prostate cancer. Currently, there are no GnRH antagonists commercially approved beyond 1 month, which would make VERU-100, if approved, the only commercially available GnRH antagonist 3-month depot. Recently, we added this proprietary internally developed peptide drug candidate to the Company’s late-stage drug development pipeline. Based on regulatory clarity obtained in the preIND meeting with FDA in May 2019, we plan to initiate a Phase 2 clinical study in early 2020 after GMP manufacturing of VERU-100. Androgen deprivation therapy for advanced prostate cancer is an established multi-billion-dollar global market.

TADFIN (Tadalafil and Finasteride Combination Capsule). TADFIN is being developed for BPH and would be the first combination of a PDE5 inhibitor and 5 alpha reductase inhibitor. The Company had a successful preNDA meeting with FDA in May 2019. After the Company has 12-month stability data on manufacturing batches, the Company will submit an NDA for TADFIN which is expected in Summer of 2020. BPH is an established multi-billion-dollar market.

"We are delivering on our strategy of providing multiple prostate cancer and prostate cancer supportive care medicines for the continuum of prostate cancer care," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. "We are pleased with the clinical progress we are making in advancing our product development program and in adding a high value, late stage drug candidate that complements our existing portfolio."

Highlights Third-Quarter Financial Results: Fiscal 2019 vs Fiscal 2018

Net revenues increased 77% to $9.7 million from $5.5 million;

Gross profit more than doubled to $6.6 million, or 68% of net revenues, from $3.1 million, or 56% of net revenues;

FC2 US prescription net revenues increased more than tenfold to $4.4 million from $0.4 million;

Operating loss significantly narrowed to $1.8 million from $5.0 million; and

Net loss was $2.8 million, or $0.04 per share, compared with $7.9 million, or $0.15 per share.

Highlights Year-to-Date Financial Results: Fiscal 2019 vs Fiscal 2018

Net revenues rose 116% to $23.1 million from $10.7 million;

Gross profit climbed 183% to $15.8 million, or 69% of net revenues, from $5.6 million, or 52% of net revenues;

FC2 US prescription net revenues increased over tenfold to $9.4 million from $0.83 million;

FC2 public sector net revenues were $13.0 million, a 33% increase from $9.8 million;

Operating loss significantly narrowed to $5.0 million from $17.1 million (fiscal 2018 year to date included a $4.0 million loss for the settlement of Brazilian receivables); and

Net loss was $9.0 million, or $0.14 per share, compared with $16.0 million, or $0.30 per share.

"For the fiscal 2019 third quarter, we had impressive increases to net revenues and to gross profit which combined to substantially improve our bottom line," said Dr. Steiner. "Key contributors to the quarter’s performance included the continued significant ramp up of prescription sales of FC2 and the increased consumer demand for our PREBOOST/Roman Swipes. As our revenue base has grown to include increased FC2 prescription sales, our gross profit has risen substantially. The robust growth of the US FC2 prescription business remains noteworthy as it allows us to be less reliant on traditional intermittent ordering patterns typically seen in our FC2 public sector business. All of these factors combined to significantly narrow our operating loss for the quarter compared with the prior year period, which allows us to continue to invest in our multiple prostate cancer drug candidate clinical development efforts."

Financial Outlook

The Company reiterated its fiscal 2019 full year guidance of net revenues between $29 and 32 million, which represents a 95% increase over full year fiscal 2018, and gross margin of approximately 66%.

The Company does not expect to update the guidance for the full year fiscal 2019 provided above before the release announcing results for its fiscal 2019 year end. The Company notes that the statements of future performance made in this release, including the guidance for the full year fiscal 2019, are based upon current expectations and are subject to factors that could cause actual results to differ materially from those suggested here, including those factors set forth in the "Safe Harbor" Statement below.

Conference Call 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. In addition, investors may access a replay of the conference call the same day beginning at approximately noon Eastern Time by dialing 877-344-7529 for U.S. callers, or 412-317-0088 from outside the U.S., passcode 10133960. The replay will be available for one week, after which, the recording will be available via the Company’s website at View Source