On December 13, 2018 Veru Inc. (NASDAQ: VERU) reported its financial results for the fiscal (FY) 2018 fourth-quarter and full-year ended September 30, 2018 (Press release, Veru, DEC 13, 2018, View Source [SID1234532047]).

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"Our fiscal 2018 fourth-quarter and full-year financial results improved significantly driven by increased US demand for the FC2 Female Condom / FC2 Internal Condom (FC2) and improving gross profit," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. For the fiscal 2018 fourth quarter, net revenues increased 41% to $5.2 million and gross profit grew by 78% to $3.2 million over the prior-year period."

"We continue to see increasing US Rx demand and related improving gross profit for our FC2 product through the first two months of the current fiscal quarter as well. For example, US FC2 Rx net revenues were 15% of total global FC2 net revenues in all channels for FY 2018. Q4 FY 2018 US FC2 Rx net revenues were 67% of total US FC2 Rx net revenues for the full FY 2018. Already through the first two months of the current fiscal year 2019, US FC2 Rx net revenues are at 120% of Q4 FY 2018 US FC2 Rx net revenues.

The Company also was granted a significant tender award for FC2 from the Republic of South Africa, which could generate approximately $30 million of future net revenues spread over a three-year period. No orders from this new South African tender are reflected in the FY 2018 financial results.

"Importantly, Veru is rapidly transforming into a biopharmaceutical company with a strong focus on prostate cancer with several drugs under development to provide a continuum of care for these cancer patients. To that end, earlier this quarter we announced that we have begun enrolling patients for our zuclomiphene citrate Phase 2 clinical trial for the treatment of hot flashes caused by androgen deprivation therapy for men with advanced prostate cancer with "top line" results, or general summary data, expected in the first half of FY 2019.

"In addition, in November, we submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for VERU-111 (bisindole), a first-in-class, next generation, proprietary, oral tubulin inhibitor for the treatment of metastatic prostate cancer. We expect this drug to advance into an open label Phase 1b/2 clinical trial by no later than early January 2019. We also announced earlier this month that the first patient was dosed in our bioequivalence study of Tadalafil (Cialis) and Finasteride (PROSCAR) combination tablet for benign prostatic hyperplasia (BPH). This combination tablet is designed to improve patient compliance and convenience with bioequivalency results expected in January 2019.

"Regarding our existing portfolio of commercial products, we have expanded our FC2 presence in the US market by partnering with a leading telemedicine marketing and sales channel, as well as utilizing a contracted independent sales force. For PREBOOST we recently entered into a US distributor agreement with a premier and fast-growing men’s health and telemedicine company that discreetly sells men’s health products via the internet."

"In early October, just after the close of our fiscal year, we strengthened our balance sheet, completing an underwritten public stock offering that generated $9.2 million of net proceeds. We intend to use the proceeds for working capital and general corporate purposes, including research and development, clinical trials and marketing expenditures."

"In summary, our accomplishments over the past year further solidify our foundation and position Veru for future success. In the coming year, we look to build on these achievements with the planned submission to the FDA of New Drug Applications for Tadalafil and Finasteride combination tablets and Tamsulosin XR capsules and sprinkles. We look to continue our transformation into a biopharmaceutical company with a strong focus on prostate cancer treatment and prostate cancer supportive care with several drugs to provide a continuum of care for these patients."

Fiscal 2018 Fourth-Quarter Results

For the fiscal 2018 fourth-quarter, net revenues, which were primarily derived from sales of FC2, rose 41% to $5.2 million from $3.7 million for the fourth-quarter of fiscal 2017. Gross profit increased by 78% to $3.2 million, or 61% of net revenues, compared with $1.8 million, or 49% of net revenues, for the fourth-quarter of fiscal 2017. Operating expenses were $7.0 million compared with $4.6 million for the fourth-quarter of fiscal 2017. Non-operating income was $63 thousand compared with non-operating expenses of $32 thousand for the fourth-quarter of fiscal 2017. Income tax expense was $4.2 million compared with an income tax benefit of $0.1 million in the fourth-quarter of fiscal 2017. Net loss was $7.9 million, or $0.14 per share, compared with net loss attributable to common stockholders of $4.7 million, or $0.10 per share, for the fourth-quarter of fiscal 2017.

Fiscal 2018 Full-Year Results

For the fiscal 2018 full-year, net revenues, which were primarily derived from sales of FC2, climbed 16% to $15.9 million from $13.7 million for fiscal 2017. Gross profit increased 23% to $8.8 million, or 55% of net revenues, compared with $7.0 million, or 51% of net revenues, for fiscal 2017. Operating expenses were $29.7 million compared with $15.5 million for fiscal 2017. Non-operating expenses were $2.2 million compared with $0.1 million for fiscal 2017. Income tax expense was $0.9 million compared with an income tax benefit of $2.0 million in fiscal 2017. Net loss was $23.9 million, or $0.44 per share, compared with net loss attributable to common stockholders of $8.6 million, or $0.25 per share, for fiscal 2017.

As of September 30, 2018, cash (including restricted cash) was $3.8 million. Subsequent to September 30, 2018, the Company completed a stock offering that generated net proceeds of approximately $9.2 million after deducting underwriting discounts and commissions and expenses payable by the Company.

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, and asking to be joined into the 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 10126693. The replay will be available for one week, after which, the recording will be available via the company’s website at View Source