--FY21 Net Revenues Increase 44% to $61 Million and Gross Profit Increases 56% to $48 Million, Achieving New Historical Highs--
--Phase 3 Sabizabulin COVID-19 Clinical Study for Treatment of Hospitalized Moderate to Severe COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome Being Conducted in US, Mexico, South America, and Europe; Clinical Results Expected 1H 2022--
--Expansive Breast Cancer Program Continues Its Rapid Advance; Four Late-Stage Clinical Studies Enrolling or Planned in Metastatic Breast Cancer--
--Phase 3 VERACITY Clinical Study of Oral, Targeted, Cytoskeleton Disruptor Sabizabulin for Metastatic Castration Resistant Prostate Cancer Enrolling--
--Phase 2 Dose Finding Clinical Study of VERU-100 Long-Acting GnRH Antagonist Peptide, SubQ, 3-Month, Depot Injection for Advanced Hormone Sensitive Prostate Cancer Enrolling--
--ENTADFI, a New Treatment for Benign Prostatic Hyperplasia, PDUFA Date is On Track for this Month--
--Company to Host Investor Conference Call Today at 8 AM ET--
MIAMI, Dec. 02, 2021 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of breast and prostate cancer, today announced that fiscal 2021 full-year net revenues increased 44% to $61 million and gross profit increased 56% to $48 million, achieving new historical highs.
Fourth-Quarter Financial Highlights: Fiscal 2021 vs Fiscal 2020
- Net revenues increased 33% to $15.6 million from $11.7 million
- FC2 prescription net revenues climbed 55% to $13.6 million from $8.7 million
- Gross profit rose 29% to $12.3 million from $9.6 million
- Gross margin was 79% of net revenues compared with 81% of net revenues
- Operating loss was $1.9 million versus $11.3 million. Operating loss in the fiscal 2020 period included a $14.1 million non-cash impairment charge.
- Net loss was $4.3 million, or $0.05 per share, compared with $11.8 million, which included a non-cash impairment charge of $14.1 million related to intangible assets or $0.17 per share.
Full-Year Financial Highlights: Fiscal 2021 vs Fiscal 2020
- Net revenues increased 44% to $61.3 million from $42.6 million, a record high when compared to any prior fiscal year
- FC2 prescription net revenues climbed 71% to $46.5 million from $27.1 million
- Gross profit rose 56% to $47.9 million from $30.8 million
- Gross margin increased to 78% of net revenues from 72% of net revenues
- Operating income was $13.0 million, which included an $18.4 million gain on the December 2020 sale of the PREBOOST business, compared with operating loss of $14.7 million, which included the $14.1 million non-cash impairment charge.
- Net income, which included the gain on the sale of the PREBOOST business, was $7.4 million and diluted EPS was $0.09 compared with net loss of $19.0 million and diluted loss per share of $0.28, which included the non-cash impairment charge.
Balance Sheet Information
- Cash and cash equivalents were $122.4 million as of September 30, 2021 versus $13.6 million as of September 30, 2020
- Net accounts receivable were $8.8 million as of September 30, 2021 versus $5.2 million as of September 30, 2020
“Once again we’ve reported new historical highs for full fiscal year net revenues and gross profit based on the robust growth of our US FC2 prescription business,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru Inc. “On a sobering note, US and global COVID-19 hospitalizations and deaths are on the rise again. The identification of the omicron variant and the possibility that the current vaccines and antibody drugs may not be as effective against this variant means that drugs to treat severe COVID-19 are desperately needed. The mechanism of drug action of sabizabulin is that it disrupts microtubule intracellular transport of the coronavirus, a process that will still be required by new variants or strains of COVID-19, including omicron, to cause infection. While there have been recent developments evaluating molnupiravir and PAXLOVID (PF-07321332; ritonavir) for the treatment of unhospitalized patients with mild to moderate COVID-19 at a relatively lower risk of dying, sabizabulin is being developed for hospitalized patients with a high risk of death. In our positive Phase 2 clinical study in hospitalized COVID-19 patients at risk for acute respiratory distress syndrome, sabizabulin treatment resulted in an 82% relative reduction in death compared to placebo. If our Phase 2 clinical results are replicated to any significant degree in our global Phase 3 clinical study, we believe sabizabulin would fill a significant current unmet medical need for hospitalized patients. In our global Phase 3 clinical study of sabizabulin we are enrolling 300 hospitalized patients with moderate to severe COVID-19 who are at high risk for Acute Respiratory Distress Syndrome. We expect to have clinical results in the first half of calendar 2022. "These strong financial results have also enabled us to continue to advance our deep late clinical stage drug pipeline portfolio. We are heavily committed to developing our drug candidate assets in breast and prostate cancer. In our breast cancer program, we are addressing 3rd line treatment of ER+ metastatic breast cancer through two separate studies with patient populations depending on the AR expression in the breast cancer tissue. Targeting patients whose AR expression in breast cancer is ≥ 40% AR, we are enrolling the Phase 3 ARTEST clinical study to evaluate enobosarm monotherapy. Targeting patients whose AR breast cancer expression is