Veru Reports Fiscal 2019 Full-Year Net Revenues Doubled, Gross Profit Up 147%

On December 12, 2019 Veru Inc. (NASDAQ: VERU), The Prostate Cancer Company, an oncology and urology biopharmaceutical company developing novel medicines for the management of prostate cancer, reported that its fiscal 2019 full-year net revenues doubled to $31.8 million and gross profit increased 147% to $21.7 million (Press release, Veru, DEC 12, 2019, View Source [SID1234552306]).

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"For both the fiscal 2019 fourth quarter and full year, we continue to generate impressive increases to net revenues and gross profit compared with the prior year," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. "The robust ramp up of prescription as well as global public sector sales of FC2 and increased consumer demand for our PREBOOST/Roman Swipes product drove the significantly improved financial performance."

"I would like to highlight on the clinical development front, VERU-111 — our proprietary, oral, next generation, first-in-class, selective antitubulin – as it continues to show antitumor activity and no dose related toxicity in men with metastatic castration resistant prostate cancer. VERU-111 appears to be well tolerated with no evidence of neutropenia, neurotoxicity or allergic (hypersensitivity) reactions that typically occur with IV taxane chemotherapy. To date, our Phase 1b/2 clinical study has enrolled and dosed 33 patients from 4.5 mg per day up to 81 mg per day. The study will continue to enroll patients using increasing doses of VERU-111 until maximum tolerated dose is observed.

"Although this study was designed for determination of safety, we do see evidence of significant antitumor activity. Historical controls from the literature report that the time to imaging based tumor progression in men like those enrolled in our study averages about 2-3 months. In our Phase 1b/2, we have 20 men in the study that had the potential to be treated for 4.5 months. Even without having an optimal dose or dose schedule yet determined, there are 4 men who are still ongoing in the trial with no progression at 9.75, 8.4, 8.4 and 5.6 months. All of these men have prostate-specific antigen (PSA) reductions. We have another 6 men that progressed at 4.2 months. The patient who has reached 9.75 months had a PSA reduction of -63% and has had 2 of his cancerous lymph nodes shrink as measured by CT scan. Another patient in the study with stable disease stopped losing weight, reported that his fatigue resolved, and had a PSA reduction."

"Based on reports in the scientific literature, it appears that just like cabazitaxel, VERU-111 is a very active compound in metastatic castration resistant prostate cancer, and it seems to perform better than adding another androgen blocking agent in a similar patient population. VERU-111 appears to be well tolerated with a wide safety margin. Wide safety margin means that we are seeing anticancer activity at doses where we are not seeing drug toxicity. We plan to present full clinical results for this ongoing Phase 1b/2 at a future major scientific meeting.

Dr. Steiner added: "Since VERU-111 has signs of antitumor activity and an acceptable safety profile, we plan to expand and initiate in early 2020 three additional Phase 2 studies where we had demonstrated significant preclinical anticancer activity: metastatic pancreatic cancer, metastatic breast cancer and postchemotherapy (taxane) metastatic castration resistant prostate cancer. This clearly positions Veru as an oncology company with a novel oral agent that selectively targets alpha and beta subunits of tubulin."

"We also plan to submit the Investigation New Drug (IND) application for VERU-100 – our long-acting 3-month subcutaneous depot gonadotropin-releasing hormone (GnRH) antagonist for the treatment of hormone sensitive advanced prostate cancer – in early 2020. Regarding our Phase 2 clinical trial of zuclomiphene citrate, our proprietary drug to treat hot flashes caused by androgen deprivation therapy in men with advanced prostate cancer, we expect top line clinical data by no later than next month."

"Growing strong revenues from our base business will continue to support not only the current Phase 1b/2 VERU-111 oral selective antitubulin clinical trial and other VERU-111 Phase 2 clinical trials for different tumor types, but also the completion of the Phase 2 zuclomiphene citrate trial, and the planned Phase 2 VERU-100 3-month depot GnRH antagonist clinical trial in 2020. We are very pleased with the significant clinical progress we are making in advancing our entire product development program."

Full-Year Financial Highlights: Fiscal 2019 vs Fiscal 2018

Net revenues rose 100% to $31.8 million from $15.9 million;

Gross profit climbed 147% to $21.7 million, or 68% of net revenues, from $8.8 million, or 55% of net revenues;

FC2 US prescription revenue increased more than five-fold to $14.1 million from $2.4 million;

FC2 public sector net revenues were $16.8 million, a 25% increase from $13.5 million;

Operating loss significantly narrowed to $6.4 million from $20.9 million;

Net loss was $12.0 million, or $0.19 per share, compared with $23.9 million, or $0.44 per share; and,

At September 30, 2019, cash and accounts receivable were $11.3 million, an increase of $3.6 million from $7.7 million at the end of the prior year.

Fourth-Quarter Financial Highlights: Fiscal 2019 vs Fiscal 2018

Net revenues increased 68% to $8.7 million from $5.2 million;

Gross profit increased to $5.8 million, or 67% of net revenues, from $3.2 million, or 61% of net revenues;

FC2 US prescription net revenues increased nearly three-fold to $4.7 million from $1.6 million;

Operating loss significantly narrowed to $1.5 million from $3.8 million; and

Net loss was $3.1 million, or $0.05 per share, compared with $7.9 million, or $0.14 per share.

Based on our resources on hand and the anticipated performance of our commercial businesses together with already existing sources of capital, the Company believes that it has sufficient resources to execute our clinical drug trial programs through year end 2021.

Pharmaceutical Products Development Program Highlights

VERU-111. VERU-111 is an oral, next generation, first-in-class, selective small molecule that targets and binds to the alpha and beta antitubulin subunits of microtubules in cells. VERU-111 is 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, 33 men in total have received doses of VERU-111, with each separate cohort receiving a higher dose. In clinical observations, VERU-111 has been well-tolerated with a favorable safety profile, and no dose limiting toxicity has been observed. There has been no neutropenia, neurotoxicity, or allergic (hypersensitivity) reactions which typically occur with IV taxane chemotherapy. In some of the men whose PSA blood levels were rapidly rising, a marker of cancer progression, as well as bone scans and/or CT scans showing cancer lesions progression at enrollment, treatment with VERU-111 resulted in PSA stabilizations and reductions consistent with early promising signals of anticancer efficacy. Furthermore, some patients have also demonstrated arrested progression of CT and/or bone scan cancer lesions beyond 8 and 9 months. Once a dose limiting toxicity level has been reached, a dose will be selected for evaluation 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 global market of $4.5 billion annually. As VERU-111 has signs of antitumor activity and an acceptable safety profile, the Company plans to expand and initiate in early 2020 three additional Phase 2 studies where we had demonstrated significant preclinical anticancer activity: metastatic pancreatic cancer, metastatic breast cancer and postchemotherapy (taxane) metastatic castration resistant prostate cancer.

VERU-100. VERU-100 is a long-acting 3-month subcutaneous depot 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. Based on regulatory clarity obtained in the pre-IND meeting with the FDA in May 2019, the Company plans to submit the IND application for VERU-100 in early 2020. Androgen deprivation therapy for advanced prostate cancer is an established multi-billion-dollar 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, also known as vasomotor symptoms, are one of the main reasons why men want to stop androgen deprivation therapy. There have been no reports of gynecomastia, breast pain, or venothromboembolic events (blood clots in legs or lungs, or stroke) in the Intent to Treat safety database in the Phase 2 clinical study which are side effects commonly seen with off label use of steroidal estrogens and progestins for hot flashes in these patients. Top line clinical data results are expected by no later than next month. An independent market analysis sponsored by the Company estimates potential U.S. sales for zuclomiphene citrate to be between $600-800 million annually.

TADFIN (Tadalafil and Finasteride Combination Capsule). TADFIN is being developed for benign prostatic hyperplasia (BPH) and would be the first combination of a PDE5 inhibitor and 5 alpha reductase inhibitor. The Company had a successful preNDA meeting with the 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 the second half of 2020. BPH is an established multi-billion-dollar market.

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 10136891. The replay will be available for one week, after which, the recording will be available via the Company’s website at View Source