Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company
with a focus on developing novel medicines for the management of
prostate and breast cancer, today announced 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.
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 BusinessAs 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 InformationCertain 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 DetailsInterested parties 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.
The call will also be available through a live, listen-only audio
broadcast via the Internet at www.verupharma.com. Listeners are
encouraged to visit the website at least 10 minutes prior to the
start of the scheduled presentation to register, download and
install any necessary software. A playback of the call will be
archived and accessible on the same website for at least three
months. A telephonic replay of the conference call will be
available, beginning the same day at approximately 12 p.m. (noon)
ET by dialing 877-344-7529 for U.S. callers, or 412-317-0088 from
outside the U.S., passcode 10154431, for one week.
About Veru Inc.Veru Inc. is an oncology
biopharmaceutical company with a focus on developing novel
medicines for the management of prostate cancer and breast cancer.
Veru’s prostate cancer pipeline includes: sabizabulin, an oral,
first-in-class, new chemical entity that targets the cytoskeleton
disruptor which in prostate cancer also disrupts androgen receptor
transport, is expected to commence this month a Phase 3 VERACITY
clinical trial in approximately 245 men for the treatment of
metastatic castration and androgen receptor targeting agent
resistant prostate cancer. VERU-100, a novel, proprietary GnRH
antagonist peptide long acting 3-month subcutaneous injection
formulation for androgen deprivation therapy, is expected to start
the planned Phase 2 clinical study this month and the Phase 3
clinical study is planned to initiate in Q4 2021 to treat hormone
sensitive metastatic prostate cancer. Veru’s breast cancer pipeline
includes: enobosarm, an oral, first-in-class, new chemical entity,
selective androgen receptor agonist that targets and activates the
androgen receptor, a tumor suppressor, to treat AR+ER+HER2-
metastatic breast cancer without unwanted masculinizing side
effects; Phase 3 ARTEST clinical trial to evaluate enobosarm in a
3rd line metastatic setting in approximately 210 subjects with
AR+ER+HER2- advanced breast cancer who have failed nonsteroidal
aromatase inhibitor, fulvestrant, and a CDK 4/6 inhibitor is
anticipated to commence Q2 2021. In a separate clinical development
program, 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 is also being evaluated for the treatment of
systemic chemotherapy including taxane resistant metastatic triple
negative breast cancer in a planned Phase 2b clinical study in
approximately 200 subjects expected to begin Q3 2021. Based on
positive Phase 2 results on the reduction of mortality, sabizabulin
will also be evaluated in a Phase 3 trial in approximately 300
subjects for the treatment of hospitalized patients with COVID-19
who are at high risk for acute respiratory distress syndrome with
enrollment starting in May 2021.
The Company’s Sexual Health Business commercial product is the
FC2 Female Condom® (internal condom) (“FC2”), an FDA-approved
product for dual protection against unintended pregnancy and the
transmission of sexually transmitted infections. The Company’s
Female Health Company Division markets and sells FC2 commercially
and in the public health sector both in the U.S. and globally. In
the U.S., FC2 is available by prescription through multiple
third-party telemedicine and internet pharmacy providers and retail
pharmacies. In the global public health sector, the Company markets
FC2 to entities, including ministries of health, government health
agencies, U.N. agencies, nonprofit organizations and commercial
partners, that work to support and improve the lives, health and
well-being of women around the world. The second potential product,
if approved, expected for the Sexual Health Business is TADFIN™
(tadalafil 5mg and finasteride 5mg) capsule for the administration
of tadalafil 5mg and finasteride 5mg combination formulation dosed
daily for benign prostatic hyperplasia (BPH). An NDA was filed by
FDA in April 2021 with a PDUFA date in December 2021. To learn more
about Veru products, please visit www.verupharma.com.
Forward-Looking StatementsThe statements in
this release that are not historical facts are "forward-looking
statements" as that term is defined in the Private Securities
Litigation Reform Act of 1995. Forward-looking statements in this
release include statements regarding the potential of sabizabulin
to combat COVID-19 and prevent deaths in patients with moderate to
severe COVID-19 disease who are at risk for ARDS, treat metastatic
castration and androgen receptor targeting agent resistant prostate
cancer, and taxane resistant metastatic triple negative breast
cancer, the potential for enobosarm to treat AR+ER+HER2- metastatic
breast cancer, the potential for VERU-100 as an androgen
deprivation therapy for advanced prostate cancer, and the potential
for TADFIN to treat BPH, whether past, current and future clinical
development and results and the Company’s NDA for TADFIN will
demonstrate sufficient efficacy and safety to secure FDA approval
of the Company's drug candidates, whether the drug candidates will
serve any unmet need, whether the enrollment or commencement
timelines of any of our studies will be met, statements about the
potential, timing and efficacy of the rest of the Company’s
development pipeline, including the ability of the Company to
successfully launch TADFIN, and what strategic alternatives the
Company may pursue regarding its Female Health Company
business.
These forward-looking statements are based on the Company’s
current expectations and subject to risks and uncertainties that
may cause actual results to differ materially, including
unanticipated developments in and risks related to: the development
of the Company's product portfolio and the results of clinical
trials possibly being unsuccessful or insufficient to meet
applicable regulatory standards or warrant continued development;
the ability to enroll sufficient numbers of subjects in clinical
trials and the ability to enroll subjects in accordance with
planned schedules; the ability to fund planned clinical
development; the timing of any submission to the FDA and any
determinations made by the FDA or any other regulatory authority;
the possibility that as vaccines become widely distributed the need
for new COVID-19 treatment candidates may be reduced or eliminated;
government entities possibly taking take actions that directly or
indirectly have the effect of limiting opportunities for
Sabizabulin as a COVID-19 treatment, including favoring other
treatment alternatives or imposing price controls on COVID-19
treatments; the Company's existing products and any future
products, if approved, possibly not being commercially successful;
the effects of the COVID-19 pandemic and measures to address the
pandemic on the Company’s clinical trials, supply chain and other
third-party providers, commercial efforts, and business development
operations; the ability of the Company to obtain sufficient
financing on acceptable terms when needed to fund development and
operations; demand for, market acceptance of, and competition
against any of the Company’s products or product candidates; new or
existing competitors with greater resources and capabilities and
new competitive product approvals and/or introductions; changes in
regulatory practices or policies or government-driven healthcare
reform efforts, including pricing pressures and insurance coverage
and reimbursement changes; the Company’s ability to successfully
commercialize any of its products, if approved; the Company’s
ability to protect and enforce its intellectual property; the
potential that delays in orders or shipments under government
tenders or the Company’s U.S. prescription business could cause
significant quarter-to-quarter variations in the Company’s
operating results and adversely affect its net revenues and gross
profit; the Company's reliance on its international partners and on
the level of spending by country governments, global donors and
other public health organizations in the global public sector; the
concentration of accounts receivable with our largest customers and
the collection of those receivables; the Company's production
capacity, efficiency and supply constraints and interruptions,
including potential disruption of production at the Company’s and
third party manufacturing facilities and/or of the Company’s
ability to timely supply product due to labor unrest or strikes,
labor shortages, raw material shortages, physical damage to the
Company’s and third party facilities, COVID-19 (including the
impact of COVID-19 on suppliers of key raw materials), product
testing, transportation delays or regulatory actions; costs and
other effects of litigation, including product liability claims;
the Company's ability to identify, successfully negotiate and
complete suitable acquisitions or other strategic initiatives; the
Company's ability to successfully integrate acquired businesses,
technologies or products; and other risks detailed from time to
time in the Company's press releases, shareholder communications
and Securities and Exchange Commission filings, including the
Company's Form 10-K for the fiscal year ended September 30, 2020
and subsequent quarterly reports on Form 10-Q. These documents are
available on the "SEC Filings" section of our website at
www.verupharma.com/investors. The Company disclaims any intent or
obligation to update these forward-looking statements.
Veru Inc.Condensed
Consolidated Balance
Sheets(unaudited)
|
|
|
|
|
|
|
March 31, |
|
September 30, |
|
2021 |
|
2020 |
|
|
Cash and cash equivalents |
$ |
136,675,153 |
|
$ |
13,588,778 |
Accounts receivable, net |
|
5,149,154 |
|
|
5,227,237 |
Inventory, net |
|
7,794,523 |
|
|
6,704,134 |
Prepaid expenses and other current assets |
|
6,432,823 |
|
|
1,494,541 |
Total current assets |
|
156,051,653 |
|
|
27,014,690 |
|
|
|
|
|
|
Deferred income taxes |
|
9,435,877 |
|
|
9,466,800 |
Intangible assets, net |
|
4,084,524 |
|
|
5,752,127 |
Goodwill |
|
6,878,932 |
|
|
6,878,932 |
Other assets |
|
4,700,263 |
|
|
2,431,126 |
Total assets |
$ |
181,151,249 |
|
$ |
51,543,675 |
|
|
|
|
|
|
Accounts payable |
$ |
5,722,391 |
|
$ |
2,812,673 |
Accrued research and development costs |
|
1,100,410 |
|
|
934,110 |
Accrued expenses and other current liabilities |
|
4,770,892 |
|
|
4,038,291 |
Credit agreement liability |
|
4,467,766 |
|
|
5,841,874 |
Residual royalty agreement liability, short-term portion |
|
2,805,741 |
|
|
1,100,193 |
Total current liabilities |
|
18,867,200 |
|
|
14,727,141 |
|
|
|
|
|
|
Residual royalty agreement liability, long-term portion |
|
5,911,983 |
|
|
5,617,494 |
Other liabilities |
|
876,060 |
|
|
1,087,724 |
Total liabilities |
|
25,655,243 |
|
|
21,432,359 |
|
|
|
|
|
|
Total stockholders'
equity |
|
155,496,006 |
|
|
30,111,316 |
Total liabilities and
stockholders' equity |
$ |
181,151,249 |
|
$ |
51,543,675 |
|
|
|
|
|
|
Veru Inc.Condensed
Consolidated Statements of
Operations(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months EndedMarch 31, |
|
Six Months EndedMarch 31, |
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
$ |
13,340,487 |
|
|
$ |
9,943,104 |
|
|
$ |
27,957,476 |
|
|
$ |
20,521,120 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
2,432,187 |
|
|
|
2,506,606 |
|
|
|
6,212,543 |
|
|
|
5,815,527 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
10,908,300 |
|
|
|
7,436,498 |
|
|
|
21,744,933 |
|
|
|
14,705,593 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
(12,379,710 |
) |
|
|
(7,736,176 |
) |
|
|
(22,439,344 |
) |
|
|
(16,789,664 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Gain on sale of PREBOOST® |
|
— |
|
|
|
— |
|
|
|
18,410,158 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income |
|
(1,471,410 |
) |
|
|
(299,678 |
) |
|
|
17,715,747 |
|
|
|
(2,084,071 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Non-operating expenses |
|
(1,352,881 |
) |
|
|
(643,971 |
) |
|
|
(3,234,035 |
) |
|
|
(2,241,422 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income before income
taxes |
|
(2,824,291 |
) |
|
|
(943,649 |
) |
|
|
14,481,712 |
|
|
|
(4,325,493 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense
(benefit) |
|
21,690 |
|
|
|
(133,140 |
) |
|
|
99,992 |
|
|
|
(209,883 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
$ |
(2,845,981 |
) |
|
$ |
(810,509 |
) |
|
$ |
14,381,720 |
|
|
$ |
(4,115,610 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per basic
common share outstanding |
$ |
(0.04 |
) |
|
$ |
(0.01 |
) |
|
$ |
0.20 |
|
|
$ |
(0.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted average common
shares outstanding |
|
75,175,077 |
|
|
|
65,367,493 |
|
|
|
72,717,621 |
|
|
|
65,202,103 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per diluted
common share outstanding |
$ |
(0.04 |
) |
|
$ |
(0.01 |
) |
|
$ |
0.18 |
|
|
$ |
(0.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Diluted weighted average
common shares outstanding |
|
75,175,077 |
|
|
|
65,367,493 |
|
|
|
80,654,070 |
|
|
|
65,202,103 |
|
Veru Inc.Condensed
Consolidated Statements of Cash
Flows(unaudited)
|
|
|
|
|
|
|
Six Months EndedMarch 31, |
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
Net income (loss) |
$ |
14,381,720 |
|
|
$ |
(4,115,610 |
) |
|
|
|
|
|
|
Adjustments to reconcile net
income (loss) to net cash used in operating activities |
|
(15,606,848 |
) |
|
|
3,951,890 |
|
|
|
|
|
|
|
Changes in operating assets
and liabilities |
|
(705,137 |
) |
|
|
(4,763,771 |
) |
|
|
|
|
|
|
Net cash used in operating
activities |
|
(1,930,265 |
) |
|
|
(4,927,491 |
) |
|
|
|
|
|
|
Net cash provided by (used in)
investing activities |
|
14,987,882 |
|
|
|
(54,680 |
) |
|
|
|
|
|
|
Net cash provided by financing
activities |
|
110,028,758 |
|
|
|
1,244,533 |
|
|
|
|
|
|
|
Net increase (decrease) in
cash |
|
123,086,375 |
|
|
|
(3,737,638 |
) |
|
|
|
|
|
|
Cash at beginning of
period |
|
13,588,778 |
|
|
|
6,295,152 |
|
|
|
|
|
|
|
Cash at end of period |
$ |
136,675,153 |
|
|
$ |
2,557,514 |
|
|
|
|
|
|
|
Veru Inc.Operating
Income (Loss) by Segment(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, 2021 |
|
Sexual Health Business |
|
Research & Development |
|
Corporate |
|
Total |
Net revenues |
|
|
|
|
|
|
|
|
|
|
|
FC2 |
$ |
13,340,487 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
13,340,487 |
|
PREBOOST® |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Total net revenues |
|
13,340,487 |
|
|
|
— |
|
|
|
— |
|
|
|
13,340,487 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
2,432,187 |
|
|
|
— |
|
|
|
— |
|
|
|
2,432,187 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
10,908,300 |
|
|
|
— |
|
|
|
— |
|
|
|
10,908,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
(979,295 |
) |
|
|
(7,741,348 |
) |
|
|
(3,659,067 |
) |
|
|
(12,379,710 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
$ |
9,929,005 |
|
|
$ |
(7,741,348 |
) |
|
$ |
(3,659,067 |
) |
|
$ |
(1,471,410 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, 2020 |
|
Sexual Health Business |
|
Research & Development |
|
Corporate |
|
Total |
Net revenues |
|
|
|
|
|
|
|
|
|
|
|
FC2 |
$ |
9,522,271 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
9,522,271 |
|
PREBOOST® |
|
420,833 |
|
|
|
— |
|
|
|
— |
|
|
|
420,833 |
|
Total net revenues |
|
9,943,104 |
|
|
|
— |
|
|
|
— |
|
|
|
9,943,104 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
2,506,606 |
|
|
|
— |
|
|
|
— |
|
|
|
2,506,606 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
7,436,498 |
|
|
|
— |
|
|
|
— |
|
|
|
7,436,498 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
(1,102,612 |
) |
|
|
(3,884,272 |
) |
|
|
(2,749,292 |
) |
|
|
(7,736,176 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
$ |
6,333,886 |
|
|
$ |
(3,884,272 |
) |
|
$ |
(2,749,292 |
) |
|
$ |
(299,678 |
) |
Veru Inc.Operating
Income (Loss) by Segment(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended March 31, 2021 |
|
Sexual Health Business |
|
Research & Development |
|
Corporate |
|
Total |
Net revenues |
|
|
|
|
|
|
|
|
|
|
|
FC2 |
$ |
27,094,645 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
27,094,645 |
|
PREBOOST |
|
862,831 |
|
|
|
— |
|
|
|
— |
|
|
|
862,831 |
|
Total net revenues |
|
27,957,476 |
|
|
|
— |
|
|
|
— |
|
|
|
27,957,476 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
6,212,543 |
|
|
|
— |
|
|
|
— |
|
|
|
6,212,543 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
21,744,933 |
|
|
|
— |
|
|
|
— |
|
|
|
21,744,933 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
(1,900,992 |
) |
|
|
(13,600,185 |
) |
|
|
(6,938,167 |
) |
|
|
(22,439,344 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Gain on sale of PREBOOST® |
|
— |
|
|
|
— |
|
|
|
18,410,158 |
|
|
|
18,410,158 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
$ |
19,843,941 |
|
|
$ |
(13,600,185 |
) |
|
$ |
11,471,991 |
|
|
$ |
17,715,747 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended March 31, 2020 |
|
Sexual Health Business |
|
Research & Development |
|
Corporate |
|
Total |
Net revenues |
|
|
|
|
|
|
|
|
|
|
|
FC2 |
$ |
19,947,195 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
19,947,195 |
|
PREBOOST |
|
573,925 |
|
|
|
— |
|
|
|
— |
|
|
|
573,925 |
|
Total net revenues |
|
20,521,120 |
|
|
|
— |
|
|
|
— |
|
|
|
20,521,120 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
5,815,527 |
|
|
|
— |
|
|
|
— |
|
|
|
5,815,527 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
14,705,593 |
|
|
|
— |
|
|
|
— |
|
|
|
14,705,593 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
(2,402,644 |
) |
|
|
(9,174,131 |
) |
|
|
(5,212,889 |
) |
|
|
(16,789,664 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Gain on sale of PREBOOST® |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
$ |
12,302,949 |
|
|
$ |
(9,174,131 |
) |
|
$ |
(5,212,889 |
) |
|
$ |
(2,084,071 |
) |
Veru Inc.Reconciliation
of GAAP Reported to Non-GAAP Adjusted
Information(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months EndedMarch 31, |
|
Six Months Ended March 31, |
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Operating (loss)
income reconciliation: |
|
|
|
|
|
|
|
|
|
|
|
GAAP operating (loss)
income |
$ |
(1,471,410 |
) |
|
$ |
(299,678 |
) |
|
$ |
17,715,747 |
|
|
$ |
(2,084,071 |
) |
Gain on sale of PREBOOST® |
|
— |
|
|
|
— |
|
|
|
(18,410,158 |
) |
|
|
— |
|
Non-GAAP adjusted operating
loss |
$ |
(1,471,410 |
) |
|
$ |
(299,678 |
) |
|
$ |
(694,411 |
) |
|
$ |
(2,084,071 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
reconciliation: |
|
|
|
|
|
|
|
|
|
|
|
GAAP net (loss) income |
$ |
(2,845,981 |
) |
|
$ |
(810,509 |
) |
|
$ |
14,381,720 |
|
|
$ |
(4,115,610 |
) |
Gain on sale of PREBOOST® |
|
— |
|
|
|
— |
|
|
|
(18,410,158 |
) |
|
|
— |
|
Non-GAAP adjusted net
loss |
$ |
(2,845,981 |
) |
|
$ |
(810,509 |
) |
|
$ |
(4,028,438 |
) |
|
$ |
(4,115,610 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per
diluted common share outstanding reconciliation: |
|
|
|
|
|
|
|
|
|
|
|
GAAP net (loss) income per
diluted common share outstanding |
$ |
(0.04 |
) |
|
$ |
(0.01 |
) |
|
$ |
0.18 |
|
|
$ |
(0.06 |
) |
Gain on sale of PREBOOST® |
|
— |
|
|
|
— |
|
|
|
(0.23 |
) |
|
|
— |
|
Effect of antidilutive shares |
|
— |
|
|
|
— |
|
|
|
(0.01 |
) |
|
|
— |
|
Non-GAAP adjusted net loss per
diluted common share outstanding |
$ |
(0.04 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
GAAP diluted weighted average
common shares outstanding |
|
75,175,077 |
|
|
|
65,367,493 |
|
|
|
80,654,070 |
|
|
|
65,202,103 |
|
Potentially dilutive shares that are antidilutive due to net
loss |
|
— |
|
|
|
— |
|
|
|
(7,936,449 |
) |
|
|
— |
|
Non-GAAP diluted weighted
average common shares outstanding |
|
75,175,077 |
|
|
|
65,367,493 |
|
|
|
72,717,621 |
|
|
|
65,202,103 |
|
Contact: |
|
|
|
Sam Fisch |
|
|
800-972-0538 |
Director of Investor Relations |
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