On February 13, 2019 Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company developing novel medicines for the prostate cancer continuum of care and urology specialty pharmaceuticals, reported financial results and business highlights for its fiscal 2019 first quarter ended December 31, 2018 (Press release, Veru, FEB 13, 2019, View Source [SID1234533313]).
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Fiscal 2019 First Quarter Financial Results
Company net revenues up 146% to $6.4 million from $2.6 million in the prior-year first quarter. Company reported FC2 Female Condom / FC2 Internal Condom (FC2) sales growth in both its prescription business and in its public sector business;
Company gross profit up 254% to $4.6 million from $1.3 million in the prior-year first quarter;
Company gross margin increased to 73% from 51% in the prior-year first quarter;
FC2 prescription business net revenues up 1,500% to $2.4 million from $0.15 million in the prior-year first quarter. Compound Annual Growth Rate (CAGR) of 100% over last five quarters for net revenues of FC2 prescription business;
FC2 public sector business net revenues up 60% to $3.9 million from $2.4 million in the prior-year first quarter;
CAGR of 25% over the last five quarters for net revenues of total FC2 business;
Commercial Segment (FC2, PREBOOST and drug commercialization costs) operating income was $3.7 million versus $0.1 million in the prior-year first quarter;
Operating loss significantly narrowed by 86% to $1.0 million from $7.4 million in the fiscal 2018 first quarter (the fiscal 2018 first quarter included a $3.8 million loss for the settlement of Brazilian receivables); and
Net loss of $2.1 million, or $0.03 per share, was significantly less than $4.3 million, or $0.08 per share, in the first quarter of fiscal 2018.
"We are pleased to report strong financial results in the fiscal 2019 first quarter, including excellent topline growth, substantially higher gross profit and a significantly lower operating loss," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru Inc. "The improvement was driven by increased sales of FC2 in our prescription business as well as in our public sector business. We recently changed the sales strategy of our FC2 prescription business, which has a higher gross margin, making the growth of that part of our business particularly gratifying. Growing prescription sales of FC2 should help smooth out some of the fluctuations in total FC2 net revenues that we have historically seen due to ordering patterns related to our FC2 public sector business."
Recent Business and Operational Highlights
Announced the Company’s strategy to become known as "the prostate cancer company" and to provide a "continuum of care" for prostate cancer patients. Prostate cancer remains the second most frequent cause of cancer deaths in men and drugs to manage prostate cancer are large market opportunities. Our drug development and drug commercial activities will largely align with the clinical management of prostate cancer patients. Anticipated revenue from our urology specialty pharma business and existing commercial products will help to support these efforts; .
Initiated a Phase 1b/2 clinical trial and enrolled patients for VERU-111, a novel, proprietary, next generation, first-in-class oral selective antitubulin agent that targets and disrupts alpha and beta tubulin for advanced prostate cancer and potentially other cancers, with clinical data expected in 2019. Drugs for advanced prostate cancer currently have over $3 billion in U.S. annual sales;
Initiated a Phase 2 clinical trial and enrolled patients for zuclomiphene citrate, a novel, proprietary, oral, nonsteroidal, estrogen receptor agonist to treat hot flashes caused by androgen deprivation therapy, or hormone treatment for men with advanced prostate cancer; top line results expected Summer 2019. Based on an independent market analysis sponsored by the Company, the Company estimates the U.S. market potential for zuclomiphene citrate is over $600 million annually;
Completed a successful bioavailability and bioequivalence clinical trial for the Company’s proprietary tadalafil and finasteride combination tablet (TADFIN) for benign prostatic hyperplasia with a New Drug Application (NDA) to be submitted in 2019 and approval expected in 2020. BPH is an established multi-billion-dollar market;
Signed a multi-year exclusive supply and distribution agreement to supply the Company’s PREBOOST premature ejaculation wipes to Roman Health Ventures Inc., a premier and fast-growing men’s health and telemedicine company that discreetly sells men’s health products via the internet;
Four abstracts accepted for presentation for VERU-111 and zuclomiphene citrate at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium in February 2019;
Three abstracts accepted for presentation for VERU-111 at the European Association of Urology Congress in March 2019; and
One abstract accepted for presentation for VERU-111 at the American Urological Association Annual Meeting in May 2019.
"We are focused on advancing our pipeline of drug candidates for the continuum of care for prostate cancer, which have a combined addressable market of multiple billions of dollars, noted Dr. Steiner. We continue to run a lean operation, with our existing commercial businesses helping to fund the development of our prostate cancer and our urology specialty pharmaceuticals. Even after costs associated with all of our pharmaceutical clinical development programs in the most recently completed quarter, our operating loss significantly narrowed to approximately a $1 million loss for the quarter. Anticipated strong growth in revenues from our current commercial products combined with anticipated new revenue from our TADFIN for BPH, which we expect to launch in 2020, should allow us to continue to significantly invest in our prostate cancer proprietary pharmaceuticals, to seek strong commercialization partnerships, and to access large, well-established urology and prostate cancer markets around the globe."
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 12 p.m. (noon) ET by dialing 877-344-7529 for US callers, or 412-317-0088 from outside the U.S., passcode 10128045. The replay will be available for one week, after which, the recording will be available via the Company’s website at View Source