On May 12, 2021 Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, reported that net revenues increased 34% and gross profit rose 47% for its fiscal 2021 second quarter ended March 31, 2021, attributable to record high quarterly FC2 US prescription net revenues (Press release, Veru, MAY 12, 2021, View Source [SID1234579883]).
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Second Quarter Financial Highlights: Fiscal 2021 vs Fiscal 2020
Net revenues increased 34% to $13.3 million from $9.9 million
FC2 prescription net revenues climbed 48% to $10.3 million from $7.0 million
Gross profit rose 47% to $10.9 million from $7.4 million
Gross margin increased to 82% of net revenues from 75% of net revenues
Operating loss was $1.5 million versus $0.3 million
Net loss was $2.8 million, or $0.04 per share, compared with $0.8 million, or $0.01 per share.
Year-to-Date Financial Highlights: Fiscal 2021 vs Fiscal 2020
Net revenues increased 36% to $28.0 million from $20.5 million, a record high for the six-month period ended March 31, 2021
FC2 prescription net revenues climbed 49% to $19.4 million from $13.0 million
Gross profit rose 48% to $21.7 million from $14.7 million
Gross margin increased to 78% of net revenues from 72% of net revenues
Operating income was $17.7 million, which includes an $18.4 million gain on the December 2020 sale of the PREBOOST business. Adjusted operating loss, which excludes the gain on the sale of the PREBOOST business, was $0.7 million versus $2.1 million
Net income, which includes the gain on the sale of the PREBOOST business, was $14.4 million and diluted EPS was $0.18. Adjusted net loss, which excludes the gain on the sale of the PREBOOST business, was $4.0 million compared with $4.1 million and adjusted diluted loss per share was $0.06, which remained consistent with fiscal 2020.
Balance Sheet Information
Cash and cash equivalents were $136.7 million as of March 31, 2021 versus $13.6 million as of September 30, 2020
Net accounts receivable were $5.1 million as of March 31, 2021 versus $5.2 million as of September 30, 2020.
"We reported another great quarter largely based on all-time record high quarterly FC2 net revenues from the U.S. prescription channel," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru Inc. "We also will be enrolling our first patient in our Phase 3 clinical trial of sabizabulin in high risk hospitalized COVID-19 patients this week. Because of sabizabulin’s anti-inflammatory and anti-viral properties and its favorable safety profile, we think sabizabulin could be that desperately needed oral therapeutic to prevent deaths in hospitalized patients with moderate to severe COVID-19 disease who are at risk for Acute Respiratory Distress Syndrome (ARDS). COVID-19 remains a serious threat worldwide and effective treatments are desperately needed."
Dr. Steiner noted: "We are advancing our novel oral drug candidates for the treatment of prostate and breast advanced cancers. We plan this month to enroll our first patient in the Phase 3 VERACITY clinical trial of sabizabulin for metastatic castration and androgen receptor targeting agent resistant prostate cancer. We plan to also enroll this month our first patient in the Phase 2 clinical trial of VERU-100, a novel long-acting GnRH antagonist injection formulation for androgen deprivation therapy. Next month, the Phase 3 ARTEST enobosarm for 3rd line AR+ER+ metastatic breast cancer is also expected to start enrolling. We are now a solid late clinical stage oncology biopharmaceutical company with novel drug candidates in development."
Pharmaceutical Pipeline Highlights:
Sabizabulin (VERU-111) a Novel Oral Agent for the Treatment of Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS)- Phase 3 Clinical Study.
We expect to enroll our first patient within a few days in our Phase 3 clinical trial of sabizabulin, a novel once a day orally dosed small molecule that has both broad anti-viral and anti-inflammatory activities which may serve a two-pronged approach to the treatment of COVID-19 virus infection and the subsequent debilitating inflammatory effects that lead to ARDS and death, in high risk hospitalized COVID-19 patients. The Phase 3 clinical trial is a double-blind, multicenter, multinational, randomized (2:1), placebo-controlled trial evaluating daily oral doses of 9 mg sabizabulin for up to 21 days versus placebo in 300 hospitalized patients (200 subjects will be treated with sabizabulin and 100 subjects will receive placebo/standard of care) who tested positive for the SARS-CoV-2 virus and who are at high risk for ARDS. Because of better oral bioavailability, the systemic blood levels from the 9 mg sabizabulin dosage are similar to the 18 mg sabizabulin formulation used in the Phase 2 clinical study. Subjects in the sabizabulin and placebo arms will also be allowed to receive standard of care. The primary efficacy endpoint will be proportion of patients that die on study up to Day 60. Secondary endpoints will include the proportion of patients without respiratory failure, days in ICU, WHO Ordinal Scale for Clinical Improvement change from baseline, days on mechanical ventilations, days in the hospital, and viral load. The study will be conducted in the United States, Brazil, Argentina, Mexico, and Colombia. Enrollment is targeted to be completed by calendar year-end.
In February of this year, the Company announced positive clinical results from the Phase 2 trial evaluating sabizabulin for the treatment of hospitalized patients with COVID-19 who were at high risk for ARDS. We conducted a double-blind, randomized, placebo-controlled Phase 2 clinical trial evaluating daily oral once a day dosing of sabizabulin 18 mg versus placebo in approximately 40 hospitalized COVID-19 patients who were at high risk for ARDS. This trial was conducted in 5 sites across the United States. Patients that were hospitalized with documented evidence of COVID-19 infection with symptoms and who were at high risk for ARDS were enrolled. Subjects received either sabizabulin 18 mg or placebo as well as standard of care for 21 days or until released from hospital. The primary efficacy endpoint was the proportion of patients that were alive without respiratory failure at Day 29. For the primary endpoint in the modified intent to treat population, sabizabulin compared to placebo had a statistically significant and clinically meaningful 81% relative reduction in death or respiratory failure at Day 29. With respect to secondary endpoints, sabizabulin had a statistically significant 82% relative reduction in patient mortality and statistically significant reduction in days in ICU; there was also a decrease in days on mechanical ventilation versus placebo. Sabizabulin was well tolerated with a good safety profile.
Sabizabulin a Novel, Oral, Androgen Receptor Transport Disruptor for the Treatment of Metastatic Castration and Androgen Receptor Targeting Agent Resistant Prostate Cancer – Phase 3 VERACITY Clinical Study.
Sabizabulin is a novel, oral, new chemical entity that targets microtubules in the cytoskeleton to disrupt androgen receptor transport. We anticipate enrolling patients this month into the open label, randomized (2:1), multicenter Phase 3 VERACITY clinical trial of sabizabulin 32 mg versus an alternative androgen receptor targeting agent for the treatment of chemotherapy naïve men with metastatic castration resistant prostate cancer who have failed at least one androgen receptor targeting agent. Based on the recently conducted Phase 2 PK study, the blood levels of the Phase 3 clinical trial sabizabulin 32 mg drug dose formulation are similar to the Phase 1b/2 VERU-111 63 mg dosage formulation. The primary endpoint is median radiographic progression free survival. The Phase 3 VERACITY clinical trial is expected to enroll approximately 245 patients.
In the Phase 1b /Phase 2 clinical trial in metastatic castration and androgen receptor targeting agent resistant prostate cancer, chronic daily administration of sabizabulin was well tolerated with a good safety profile. There was also evidence of efficacy including PSA declines and objective and durable tumor responses (partial and complete responses).
VERU-100, a Novel, Proprietary Long-Acting Gonadotropin-Releasing Hormone (GnRH) Antagonist Peptide, 3-Month Subcutaneous Depot Formulation, for Androgen Deprivation Therapy of Advanced Prostate Cancer – Phase 2 Clinical Study.
We anticipate initiation of the Phase 2 clinical trial of VERU-100 androgen deprivation therapy for hormone sensitive advanced prostate cancer this month. The Phase 2 VERU-100 clinical trial is expected to enroll approximately 35 patients. VERU-100 formulation is designed to address the current limitations of commercially available ADT. Androgen deprivation therapy is currently the mainstay of advanced prostate cancer treatment and is used as a foundation of treatment throughout the course of the disease even as other endocrine, chemotherapy, or radiation treatments are added or stopped. Specifically, VERU-100 is a chronic, long-acting GnRH antagonist peptide administered as a small volume, three-month depot subcutaneous injection without a loading dose. VERU-100 immediately suppresses testosterone with no testosterone surge upon initial or repeated administration, a problem that occurs with currently approved luteinizing hormone-releasing hormone (LHRH) agonists used for ADT. There are no GnRH antagonist depot injectable formulations commercially approved beyond a one-month injection. A Phase 3 registration clinical trial in approximately 100 men is anticipated to begin in the second half of calendar year 2021.
Enobosarm a Novel Oral Selective Androgen Receptor Targeted Agonist, for the Treatment of Androgen Receptor Positive (AR+), Estrogen Receptor Positive (ER+) and Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer – Phase 3 ARTEST Clinical Study and Phase 2 Enobosarm Combination Study.
We expect to commence our pivotal enobosarm Phase 3 ARTEST clinical study in the second quarter of calendar year 2021. Enobosarm is the first new class of targeting endocrine therapy in advanced breast cancer in decades. Enobosarm is an oral, new chemical entity, selective androgen receptor agonist that targets and activates the androgen receptor (AR), a tumor suppressor, in AR+ER+HER2- metastatic breast cancer without the unwanted masculinizing side effects. Enobosarm has extensive nonclinical and clinical experience having been evaluated in 25 separate clinical studies in approximately 1,450 treated subjects, including three Phase 2 clinical studies in advanced breast cancer involving more than 250 patients. In the two Phase 2 clinical studies conducted in women with AR+ER+HER2- metastatic breast cancer, enobosarm demonstrated significant antitumor efficacy in heavily pretreated cohorts that failed estrogen receptor targeting agents, chemotherapy, and/or CDK 4/6 inhibitors and was well tolerated with a favorable safety profile. In the fourth quarter of calendar 2020, the FDA agreed to the Phase 3 multicenter, international, open label, and randomized (1:1) ARTEST registration clinical trial design to evaluate the efficacy and safety of enobosarm monotherapy versus physician’s choice of either exemestane or a SERM as an active comparator for the treatment of metastatic AR+ER+HER2- breast cancer in approximately 210 patients who have failed a nonsteroidal aromatase inhibitor, fulvestrant and a CDK4/6 inhibitor (3rd line treatment in a metastatic setting) The primary endpoint is median radiographic progression-free survival. In a separate clinical development program, enobosarm in combination with abemaciclib, CDK4/6 inhibitor, will be evaluated in a 2nd line metastatic setting in AR+ER+ metastatic breast cancer. A Phase 2 study to evaluate the efficacy and safety of enobosarm in combination with CDK 4/6 inhibitor (abemaciclib) compared to estrogen receptor blocking agent (Active Control ) for the treatment of AR+ER+HER2- metastatic breast cancer in patients that have failed an estrogen receptor blocking agent plus a CDK 4/6 inhibitor (palbociclib) is expected to commence in calendar Q3 2021.
Sabizabulin a Novel, Oral, Cytoskeleton Disruptor Agent for the Treatment of Systemic Chemotherapy including Taxane Resistant Metastatic Triple Negative Breast Cancer – Phase 2b Clinical Study.
Sabizabulin is also being evaluated for the treatment of taxane chemotherapy resistant metastatic triple negative breast cancer in a planned Phase 2b clinical study in approximately 200 women expected to begin in calendar Q3 2021. Metastatic triple negative breast cancer is an aggressive form of breast cancer that occurs in approximately 15% of all breast cancers. This form of breast cancer does not express ER, progesterone receptor (PR), or HER2 and is resistant to endocrine therapies. The first line of treatment usually includes combination chemotherapy which includes IV taxane chemotherapy. Almost all women will eventually develop taxane resistance. Sabizabulin is an oral, first-in-class, new chemical entity that targets and inhibits microtubules to disrupt the cytoskeleton. Sabizabulin is not a substrate for P-glycoprotein drug resistance protein. Over expression of P-glycoprotein is a common mechanism that results in taxane resistance in triple negative breast cancer. Preclinical studies in human triple negative breast cancer grown in animal models demonstrate that sabizabulin significantly inhibits cancer proliferation, migration, metastases, and invasion of triple negative breast cancer cells and tumors that have become resistant to paclitaxel (taxane). Using the safety information from the Phase 1b and Phase 2 sabizabulin prostate cancer clinical studies, the Company plans to meet with the FDA and to commence a three cohort Phase 2b clinical study in calendar Q3 2021 to evaluate oral daily dosing of sabizabulin monotherapy, TRODELVY monotherapy, and sabizabulin + TRODELVY combination therapy in approximately 200 women with metastatic triple negative breast cancer that have become resistant to at least 2 systemic chemotherapies including a taxane.
TADFIN (Tadalafil 5mg and Finasteride 5mg Combination Capsule) for the Treatment of Lower Urinary Tract Symptoms Caused by Benign Prostatic Hyperplasia (BPH) – NDA Filed by FDA; PDUFA Date December 2021.
TADFIN (tadalafil 5mg and finasteride 5mg combination capsule) was developed to treat urinary tract symptoms caused by BPH. Tadalafil (CIALIS) is currently approved for treatment of BPH and erectile dysfunction and finasteride is currently approved for treatment of BPH (finasteride 5mg PROSCAR) and male pattern hair loss (finasteride 1mg PROPECIA). The co-administration of tadalafil and finasteride has been shown to be more effective for the treatment of BPH than finasteride alone with the additional benefit of ameliorating erectile dysfunction. An NDA for TADFIN has been accepted for review by FDA with a PDUFA date in December 2021. If approved, TADFIN is expected to be marketed and distributed by telemedicine and telepharmacy groups.
Legacy Female Health Business
As previously announced, the Company continues to explore the full range of strategic alternatives for its legacy Female Health Company Business, which markets the FC2 Female Condom (Internal Condom), including continuing to operate the business.
Non-GAAP Financial Information
Certain financial results for fiscal years 2021 and 2020 are presented on both a reported and a non-GAAP, adjusted basis. Reported results were prepared in accordance with U.S. GAAP and include all revenue and expenses recognized during the period. The non-GAAP results are adjusted to exclude the one-time gain on sale of PREBOOST in the first quarter of fiscal year 2021. Management believes non-GAAP financial measures provide useful information to investors regarding the Company’s results of operations and assist management, analysts, and investors in evaluating the performance of the Company’s business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. The Company has reconciled these non-GAAP financial measures to the nearest reported GAAP measures in the reconciliation table below.
Event Details
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