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 38% and gross profit rose 49% for its fiscal 2021 first
quarter ended December 31, 2020, setting new quarterly records for
its second consecutive quarter and entering its fourth year of
revenue growth.
First-Quarter Financial Highlights: Fiscal 2021 vs
Fiscal 2020
- Net revenues increased 38% to $14.6 million from $10.6
million
- FC2 prescription net revenues climbed 50% to $9.1 million from
$6.1 million
- Gross profit rose 49% to $10.8 million from $7.3 million
- Gross margin increased to 74% of net revenues from 69% of net
revenues
- Operating income was $19.2 million, which includes an $18.4
million gain on sale of the PREBOOST® business. Adjusted operating
income, which excludes the gain on sale of PREBOOST, was $0.8
million versus an operating loss of $1.8 million
- Net income, which includes the gain on sale of PREBOOST, was
$17.2 million and diluted EPS was $0.23. Adjusted net loss, which
excludes the gain on sale of PREBOOST, was $1.2 million compared
with $3.3 million and adjusted diluted loss per share was $0.02,
compared with $0.05 per share.
Balance Sheet Information
- Cash and cash equivalents were $30.9 million as of December 31,
2020 versus $13.6 million as of September 30, 2020
- Net accounts receivable were $4.2 million as of December 31,
2020 versus $5.2 million as of September 30, 2020
“During this quarter we reported another consecutive quarterly
record both in net revenues and in gross profit driven primarily by
the 50% growth in prescription sales of FC2,” said Mitchell
Steiner, M.D., Chairman, President and Chief Executive Officer of
Veru. “We plan to submit the TADFIN NDA next week which, if
approved by the FDA, will add to the already significant cash being
generated by the FC2 business to invest in the clinical development
of our late-stage prostate and breast cancer drug pipeline. We are
off to a great start for fiscal 2021.”
“Furthermore, I could not be more pleased with Veru’s progress
in developing new and novel oral therapies to treat both prostate
and breast advanced cancers that have become resistant to current
endocrine therapies, but prior to proceeding to IV chemotherapy. We
are excited to be driving our prostate cancer drug candidates,
VERU-111 and VERU-100, as well as our breast cancer drug
candidates, Enobosarm and VERU-111 for triple negative breast
cancer, into registration clinical studies. Now with the positive
clinical efficacy and safety results from the Phase 2 clinical
study that evaluated VERU-111 treatment in hospitalized patients
with COVID-19 and at high risk for ARDS, Veru anticipates the
potential for five registration clinical trials for one COVID-19
and four oncology indications to commence in calendar year
2021.”
Pharmaceutical Pipeline Highlights:
TADFIN™ (Tadalafil 5mg
and Finasteride 5mg Combination Capsule) for the Treatment of Lower
Urinary Tract Symptoms Caused by Benign Prostatic Hyperplasia
(BPH)We expect to submit the NDA for TADFIN next
week. We received a waiver of the FDA NDA PDUFA filing fees as a
first-time filer worth approximately $2.4 million in cost savings.
We plan to launch TADFIN, which contains finasteride (approved for
BPH) and tadalafil (approved for BPH and erectile dysfunction), for
the indication to treat BPH, if approved by FDA. We intend to
launch TADFIN through third-party telemedicine sales channels and
not have to invest in our own TADFIN sales organization. This is
the same sales model that has been successful for FC2, and
previously, for PREBOOST.VERU-111, a Novel, Oral, Targeted
Cytoskeleton Disruptor, for the Treatment of Metastatic Castration
and Androgen Receptor Targeting Agent Resistant Prostate
Cancer
The Phase 2 clinical trial of VERU-111 for the treatment of
metastatic castration and androgen receptor targeting agent
resistant prostate cancer is fully enrolled. Although the study is
still ongoing, daily chronic drug administration continues to
appear feasible and safe. At 63mg daily continuous oral once-a-day
dosing, there were no reports of neutropenia, a single report of
minor neurotoxicity, and manageable and fewer cases of low-grade
diarrhea. Like the Phase 1b, we have observed efficacy results
including PSA declines as well as objective and durable tumor
responses including complete and partial responses. We will be
presenting updated clinical results for the Phase 1b and as well as
an update on the Phase 2 clinical trials at the ASCO Genitourinary
Cancers Symposium: “Abstract 325053: Clinical study of
VERU-111, an oral cytoskeletal disruptor, in metastatic
castration-resistant prostate cancer who failed an androgen
receptor targeting agent” by Dr. Mark Markowski, Assistant
Professor of Oncology, Johns Hopkins Kimmel Comprehensive Cancer
Center, taking place February 11th-13th, 2021.
The Company has submitted its Phase 3 clinical registration
protocol to evaluate VERU-111 for the treatment of men with
metastatic castration resistant prostate cancer who have failed one
androgen receptor targeting agent, but prior to IV chemotherapy.
The Company anticipates starting the VERACITY Phase 3 study in the
first quarter of calendar year 2021.
VERU-100, a Novel, Proprietary
Long-Acting Gonadotropin-Releasing Hormone (GnRH) Antagonist
Peptide, 3-Month Subcutaneous Depot Formulation, for
Androgen Deprivation Therapy (ADT) for Advanced Prostate
Cancer
VERU-100 is designed to address the current limitations of
commercially available androgen deprivation therapies. ADT is
currently the mainstay of advanced prostate cancer treatment and
used as a foundation of treatment throughout the course of the
disease. Furthermore, ADT is continued even as other endocrine,
chemotherapy, and/or radiation treatments are added or stopped. The
specific target product profile for 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 is expected to immediately suppress testosterone with no
testosterone surge upon initial or repeated administration, a
concern that occurs with currently approved luteinizing
hormone-releasing hormone agonists used for ADT. There are no GnRH
antagonist depot injectable formulations commercially approved for
treatment beyond a one-month duration. A Phase 2 study to evaluate
VERU-100 dosing is anticipated to begin the first half of
calendar year 2021 and the Phase 3 registration study in
approximately 100 men is anticipated to start in the second half of
calendar year 2021.
Enobosarm, Selective AR Targeted Agent, to Treat
Estrogen Receptor Targeted Agent and CDK4/6 Inhibitor Resistant
AR+/ ER+/HER2- Metastatic Breast Cancer
Enobosarm, our oral, first-in-class, new chemical entity, is a
selective androgen receptor targeted activating agent that is being
developed for the treatment of AR+/ER+/HER2- metastatic breast
cancer, that has become resistant to estrogen endocrine therapy and
CDK 4/6 inhibitors, but prior to IV chemotherapy. Enobosarm, by
targeting and activating the AR which is present in up to 85% of
advanced ER+ positive breast cancers, represents the first new
class of targeting endocrine therapy in advanced breast cancer in
decades. The androgen receptor acts as a tumor suppressor in ER+
breast cancer. Enobosarm activates the AR in breast cancer to
inhibit AR+ ER+ breast cancer cell proliferation and tumor growth
including when ER+ breast cancer has become resistant to estrogen
receptor targeting agents and CDK 4/6 inhibitors. Enobosarm could
have additional beneficial clinical properties. For example,
preclinical studies have shown that enobosarm builds and heals
cortical and trabecular bone with the potential to treat
osteoporosis and skeletal related cancer events. Enobosarm has also
been shown to build muscle, to reduce fat, and to improve physical
function in clinical studies involving elderly subjects and
patients with cancer cachexia, including breast cancer.
Furthermore, the tissue selectivity of enobosarm also results in a
favorable side effect profile with no masculinization (facial hair
and acne), no increase in hematocrit, and no liver toxicity. Two
positive Phase 2 studies involving approximately 150 women with
AR+/ER+ metastatic breast cancer have been conducted. Enobosarm AR
targeted treatment demonstrated favorable clinical benefit rates,
objective and durable tumor responses in women with heavily
pretreated estrogen receptor targeted resistant AR+ ER+ metastatic
breast cancer. Quality of life measurements demonstrated overall
improvement including mobility, anxiety/depression and pain.
Enobosarm appears safe and well tolerated without virilizing
effects, increase in hematocrit, or liver toxicity.
FDA agreed to our enobosarm Phase 3 registration clinical trial
to evaluate the efficacy and safety of enobosarm 9mg versus an
active control (either exemestane or tamoxifen) 2:1 randomization
for the treatment of metastatic AR+/ER+/HER2- breast cancer in
approximately 240 patients who have failed a nonsteroidal aromatase
inhibitor (anastrozole or letrozole), fulvestrant, and a CDK4/6
inhibitor. The Phase 3 study will be called the ARTEST study. The
primary endpoint is radiographic progression-free survival. Our
enobosarm key opinion leaders have been particularly intrigued by
the preclinical data that showed that the combination of enobosarm
and a CDK4/6 inhibitor restored CDK4/6 sensitivity in AR+/ER+
metastatic breast cancer that was resistant to both estrogen
receptor targeted agents and CDK4/6 inhibitors, which is the target
patient population in our planned Phase 3 ARTEST clinical study.
Consequently, we plan to add a third arm to our Phase 3 trial which
would be a combination of enobosarm plus a CDK 4/6 inhibitor. The
Phase 3 ARTEST trial will now have three treatment arms: enobosarm
alone, enobosarm in combination with a CDK4/6 inhibitor, and active
control of either exemestane or tamoxifen. The trial sample size
will remain the same at approximately 240 women but randomized
1:1:1 instead of the 2:1 in the previous Phase 2 clinical trial
design. The pivotal Phase 3, open label, randomized, active control
ARTEST study is anticipated to commence next quarter.
VERU-111 for Taxane Resistant Metastatic Triple Negative
Breast Cancer
Metastatic triple negative breast cancer (TNBC) is an aggressive
form of breast cancer that is present in approximately 15% of all
breast cancers. This form of breast cancer does not express ER, PR
or HER2 and is resistant to endocrine therapies. The first line of
treatment usually includes IV taxane chemotherapy. Almost all these
women will develop taxane resistance and could be a candidate for
VERU-111. Preclinical studies in human triple negative breast
cancer grown in animal models demonstrate that VERU-111
significantly inhibits cancer proliferation, migration, metastases,
and invasion of triple negative breast cancer cells and tumors that
have become resistant to paclitaxel, which is a taxane.
Using the safety information from the Phase 1b and Phase 2
VERU-111 prostate cancer clinical studies in a total of
approximately 80 men, we will meet with FDA in the first half of
calendar year 2021 to discuss Phase 2b clinical trial design for
possible accelerated approval for VERU-111 versus active control
Trodelvy for patients with taxane resistant triple negative breast
cancer, making the proposed trial a potential registration trial.
The Phase 2b clinical study is planned to commence in the second
half of calendar year 2021.
VERU-111 for COVID-19
This past Monday we announced positive results from the Phase 2
clinical trial evaluating VERU-111 for the treatment of
hospitalized patients with COVID-19 who were at high risk for acute
respiratory distress syndrome (ARDS). VERU-111 is a novel once a
day orally dosed small molecule that has both broad antiviral 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. We
conducted a double-blind, randomized, placebo-controlled Phase 2
clinical trial evaluating daily oral once a day dosing of VERU-111
18mg 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 VERU-111 18mg 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 hospitalized patients that had >1
dose of study drug, VERU-111 for COVID-19 treatment 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, VERU-111 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.
Furthermore, VERU-111 was well tolerated with a good safety
profile.
The Company has been granted an expedited End of Phase 2 meeting
with the FDA to discuss next steps including a Phase 3 clinical
registration trial design for the VERU-111 COVID-19 program. The
Company expects that this confirmatory study will have a similar
trial design as the Phase 2 study to evaluate daily oral doses of
VERU-111 versus placebo with the primary efficacy endpoint of
proportion of patients that are alive without respiratory failure
at Day 29. We expect the Phase 3 clinical trial will be conducted
in approximately 200 hospitalized patients who have COVID-19 and
are at high risk for ARDS. The Biomedical Advanced Research and
Development Authority of the US Department of Health and Human
Services (BARDA) has granted Veru a meeting to discuss possible
grant funding for the Phase 3 study and manufacturing scale up. We
plan to commence the VERU-111 for COVID-19 Phase 3 study in April
2021.
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 DetailsVeru 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. The call will also be available
through a live, listen-only audio broadcast via the Internet at
www.verupharma.com. 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 10151507, 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.
The Veru prostate cancer pipeline includes VERU-111, VERU-100, and
Zuclomiphene citrate. VERU-111 is an oral, first-in-class, new
chemical entity that targets, crosslinks, and disrupts alpha and
beta tubulin subunits of microtubules for the treatment of
metastatic castration and androgen receptor resistant prostate
cancer. VERU-100 is a novel, proprietary peptide formulation
designed to address the current limitations of commercially
available androgen deprivation therapies (ADT) for advanced
prostate cancer. Zuclomiphene citrate is an oral nonsteroidal
estrogen receptor agonist being developed to treat hot flashes, a
common side effect caused by ADT in men with advanced prostate
cancer. The Veru breast cancer pipeline includes enobosarm for
AR+/ER+/HER2- metastatic breast cancer and VERU-111 for taxane
resistant metastatic triple negative breast cancer. Enobosarm is an
oral, first-in-class, new chemical entity, selective androgen
receptor agonist that targets the androgen receptor in
AR+/ER+/HER2- metastatic breast cancer without unwanted virilizing
side effects. VERU-111 is also being advanced into Phase 3 for the
treatment of hospitalized patients with COVID-19 who are at high
risk for acute respiratory distress syndrome.
Veru is advancing a new drug formulation in its specialty
pharmaceutical pipeline addressing unmet medical needs in urology
such as the Tadalafil and Finasteride Combination (TADFIN™) for the
administration of tadalafil 5mg and finasteride 5mg combination
formulation dosed daily for benign prostatic hyperplasia (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 by finasteride alone. The Company expects
to submit the NDA for TADFIN™ next week. The Company’s Sexual
Health Business commercial product is the FC2 Female Condom®/ FC2
Internal Condom (“FC2”), an FDA-approved product for the 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. To learn more about Veru
products, please visit www.verupharma.com.
"Safe Harbor" statement under the Private Securities
Litigation Reform Act of 1995: The 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 regulatory pathway to
secure FDA approval of the Company's drug candidates, the
anticipated timeframe for clinical studies and FDA submissions,
preclinical and clinical study results including potential benefits
and the absence of adverse events and anticipated results of future
clinical trials, the anticipated design and scope for clinical
trials and FDA acceptance of such design and scope, and the ability
of the Company to successfully launch TADFIN and implement the
Company's sales plans for TADFIN. Any forward-looking statements in
this release are based upon the Company's current plans and
strategies and reflect the Company's current assessment of the
risks and uncertainties related to its business and are made as of
the date of this release. The Company assumes no obligation to
update any forward-looking statements contained in this release
because of new information or future events, developments or
circumstances. Such forward-looking statements are subject to known
and unknown risks, uncertainties and assumptions. If any such risks
or uncertainties materialize or if any of the assumptions prove
incorrect, our actual results could differ materially from those
expressed or implied by such statements. Factors that may cause
actual results to differ materially from those contemplated by such
forward-looking statements include, but are not limited to, the
following: risks related to the development of the Company's
product portfolio, including clinical trials, regulatory approvals
and time and cost to bring to market; potential delays in the
timing of and results from clinical trials and studies, including
potential delays in the recruitment of patients and their ability
to effectively participate in such trials and studies due to
COVID-19, and the risk that such results will not support marketing
approval and commercialization; potential delays in the timing of
any submission to the FDA and regulatory approval of products under
development and the risk that disruptions at the FDA caused by the
COVID-19 pandemic may delay the review of submissions or approvals
for new drugs; the risk of a delay or failure in reaching agreement
with the FDA on the design of a clinical trial or in obtaining
authorization to commence a clinical trial; preclinical or clinical
results or early data from clinical trials may not be replicated or
continue to occur in additional trials or may not otherwise support
further development in the specified product candidate or at all;
our pursuit of a COVID-19 treatment candidate is at an early stage
and we may be unable to develop a drug that successfully treats the
virus in a timely manner, if at all; risks related to our
commitment of financial resources and personnel to the development
of a COVID-19 treatment which may cause delays in or otherwise
negatively impact our other development programs, despite
uncertainties about the longevity and extent of COVID-19 as a
global health concern and the possibility that as vaccines become
widely distributed the need for new COVID-19 treatment candidates
may be reduced or eliminated; government entities may take actions
that directly or indirectly have the effect of limiting
opportunities for VERU-111 as a COVID-19 treatment, including
favoring other treatment alternatives or imposing price controls on
COVID-19 treatments; the risk that the Company's products may not
be commercially successful; risks related to the impact of the
COVID-19 pandemic on our business, the nature and extent of which
is highly uncertain and unpredictable; risks relating to the
ability of the Company to obtain sufficient financing on acceptable
terms when needed to fund development and operations, including our
ability to secure timely grant or other funding to develop VERU-111
as a potential COVID-19 treatment; product demand and market
acceptance; competition in the Company's markets and therapeutic
areas and the risk of new or existing competitors with greater
resources and capabilities and new competitive product approvals
and/or introductions; the risk that the Company will be affected by
regulatory developments, including a reclassification of products;
price erosion, both from competing products and increased
government pricing pressures; manufacturing and quality control
problems; compliance and regulatory matters, including costs and
delays resulting from extensive governmental regulation, and
effects of healthcare insurance and regulation, including
reductions in reimbursement and coverage or reclassification of
products; some of the Company's products are in development and the
Company may fail to successfully commercialize such products; risks
related to intellectual property, including the uncertainty of
obtaining patents, the effectiveness of the patents or other
intellectual property protections and ability to enforce them
against third parties, the uncertainty regarding patent coverages,
the possibility of infringing a third party’s patents or other
intellectual property rights, and licensing risks; government
contracting risks, including the appropriations process and funding
priorities, potential bureaucratic delays in awarding contracts,
process errors, politics or other pressures, and the risk that
government tenders and contracts may be subject to cancellation,
delay, restructuring or substantial delayed payments; the risk 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; a
governmental tender award indicates acceptance of the bidder's
price rather than an order or guarantee of the purchase of any
minimum number of units, and as a result government ministries or
other public sector customers may order and purchase fewer units
than the full maximum tender amount or award; penalties and/or
debarment for failure to satisfy tender awards; 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; risks related to
concentration of accounts receivable with our largest customers and
the collection of those receivables; the economic and business
environment and the impact of government pressures; risks involved
in doing business on an international level, including currency
risks, regulatory requirements, political risks, export
restrictions and other trade barriers; 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; risks related
to the 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 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.
FINANCIAL SCHEDULES FOLLOW
Veru Inc.Condensed
Consolidated Balance
Sheets(unaudited)
|
|
|
|
|
|
|
December 31, |
|
September 30, |
|
2020 |
|
2020 |
|
|
Cash and cash equivalents |
$ |
30,921,496 |
|
$ |
13,588,778 |
Accounts receivable, net |
|
4,155,792 |
|
|
5,227,237 |
Inventory, net |
|
6,665,908 |
|
|
6,704,134 |
Prepaid expenses and other current assets |
|
5,824,110 |
|
|
1,494,541 |
Total current assets |
|
47,567,306 |
|
|
27,014,690 |
|
|
|
|
|
|
Deferred income taxes |
|
9,429,298 |
|
|
9,466,800 |
Intangible assets, net |
|
4,102,381 |
|
|
5,752,127 |
Goodwill |
|
6,878,932 |
|
|
6,878,932 |
Other assets |
|
4,810,560 |
|
|
2,431,126 |
Total assets |
$ |
72,788,477 |
|
$ |
51,543,675 |
|
|
|
|
|
|
Accounts payable |
$ |
3,274,856 |
|
$ |
2,812,673 |
Accrued research and development costs |
|
1,862,366 |
|
|
934,110 |
Accrued expenses and other current liabilities |
|
4,654,684 |
|
|
4,038,291 |
Credit agreement liability |
|
5,331,809 |
|
|
5,841,874 |
Residual royalty agreement liability, short-term portion |
|
1,938,817 |
|
|
1,100,193 |
Total current liabilities |
|
17,062,532 |
|
|
14,727,141 |
|
|
|
|
|
|
Residual royalty agreement liability, long-term portion |
|
5,985,728 |
|
|
5,617,494 |
Other liabilities |
|
992,084 |
|
|
1,087,724 |
Total liabilities |
|
24,040,344 |
|
|
21,432,359 |
|
|
|
|
|
|
Total stockholders'
equity |
|
48,748,133 |
|
|
30,111,316 |
Total liabilities and
stockholders' equity |
$ |
72,788,477 |
|
$ |
51,543,675 |
|
|
|
|
|
|
Veru Inc.Condensed
Consolidated Statements of
Operations(unaudited)
|
|
|
|
|
|
|
Three Months EndedDecember
31, |
|
2020 |
|
2019 |
|
|
|
|
|
|
Net revenues |
$ |
14,616,989 |
|
|
$ |
10,578,016 |
|
|
|
|
|
|
|
Cost of sales |
|
3,780,356 |
|
|
|
3,308,921 |
|
|
|
|
|
|
|
Gross profit |
|
10,836,633 |
|
|
|
7,269,095 |
|
|
|
|
|
|
|
Operating expenses |
|
(10,059,634 |
) |
|
|
(9,053,488 |
) |
|
|
|
|
|
|
Gain on sale of PREBOOST |
|
18,410,158 |
|
|
|
— |
|
|
|
|
|
|
|
Operating income (loss) |
|
19,187,157 |
|
|
|
(1,784,393 |
) |
|
|
|
|
|
|
Non-operating expenses |
|
(1,881,154 |
) |
|
|
(1,597,451 |
) |
|
|
|
|
|
|
Income (loss) before income
taxes |
|
17,306,003 |
|
|
|
(3,381,844 |
) |
|
|
|
|
|
|
Income tax expense
(benefit) |
|
78,302 |
|
|
|
(76,743 |
) |
|
|
|
|
|
|
Net income (loss) |
$ |
17,227,701 |
|
|
$ |
(3,305,101 |
) |
|
|
|
|
|
|
Net income (loss) per basic
common share outstanding |
$ |
0.25 |
|
|
$ |
(0.05 |
) |
|
|
|
|
|
|
Basic weighted average common
shares outstanding |
|
70,313,589 |
|
|
|
65,038,511 |
|
|
|
|
|
|
|
Net income (loss) per diluted
common share outstanding |
$ |
0.23 |
|
|
$ |
(0.05 |
) |
|
|
|
|
|
|
Diluted weighted average
common shares outstanding |
|
75,799,037 |
|
|
|
65,038,511 |
|
Veru Inc.Condensed
Consolidated Statements of Cash
Flows(unaudited)
|
|
|
|
|
|
|
Three Months EndedDecember
31, |
|
2020 |
|
2019 |
|
|
|
|
|
|
Net income (loss) |
$ |
17,227,701 |
|
|
$ |
(3,305,101 |
) |
|
|
|
|
|
|
Adjustments to reconcile net
income (loss) to net cash provided by (used in) operating
activities |
|
(16,697,883 |
) |
|
|
2,342,005 |
|
|
|
|
|
|
|
Changes in operating assets
and liabilities |
|
129,423 |
|
|
|
(1,547,406 |
) |
|
|
|
|
|
|
Net cash provided by (used in)
operating activities |
|
659,241 |
|
|
|
(2,510,502 |
) |
|
|
|
|
|
|
Net cash provided by (used in)
investing activities |
|
14,992,814 |
|
|
|
(21,807 |
) |
|
|
|
|
|
|
Net cash provided by financing
activities |
|
1,680,663 |
|
|
|
412,114 |
|
|
|
|
|
|
|
Net increase (decrease) in
cash |
|
17,332,718 |
|
|
|
(2,120,195 |
) |
|
|
|
|
|
|
Cash at beginning of
period |
|
13,588,778 |
|
|
|
6,295,152 |
|
|
|
|
|
|
|
Cash at end of period |
$ |
30,921,496 |
|
|
$ |
4,174,957 |
|
|
|
|
|
|
|
Veru Inc.Operating
Income (Loss) by Segment(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, 2020 |
|
Sexual HealthBusiness |
|
Research &Development |
|
Corporate |
|
Total |
Net revenues |
|
|
|
|
|
|
|
|
|
|
|
FC2 |
$ |
13,754,158 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
13,754,158 |
|
PREBOOST |
|
862,831 |
|
|
|
— |
|
|
|
— |
|
|
|
862,831 |
|
Total net revenues |
|
14,616,989 |
|
|
|
— |
|
|
|
— |
|
|
|
14,616,989 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
3,780,356 |
|
|
|
— |
|
|
|
— |
|
|
|
3,780,356 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
10,836,633 |
|
|
|
— |
|
|
|
— |
|
|
|
10,836,633 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
(925,854 |
) |
|
|
(5,858,837 |
) |
|
|
(3,274,943 |
) |
|
|
(10,059,634 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Gain on sale of PREBOOST |
|
— |
|
|
|
— |
|
|
|
18,410,158 |
|
|
|
18,410,158 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
$ |
9,910,779 |
|
|
$ |
(5,858,837 |
) |
|
$ |
15,135,215 |
|
|
$ |
19,187,157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, 2019 |
|
Sexual HealthBusiness |
|
Research &Development |
|
Corporate |
|
Total |
Net revenues |
|
|
|
|
|
|
|
|
|
|
|
FC2 |
$ |
10,424,924 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
10,424,924 |
|
PREBOOST |
|
153,092 |
|
|
|
— |
|
|
|
— |
|
|
|
153,092 |
|
Total net revenues |
|
10,578,016 |
|
|
|
— |
|
|
|
— |
|
|
|
10,578,016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
3,308,921 |
|
|
|
— |
|
|
|
— |
|
|
|
3,308,921 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
7,269,095 |
|
|
|
— |
|
|
|
— |
|
|
|
7,269,095 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
(1,300,032 |
) |
|
|
(5,289,859 |
) |
|
|
(2,463,597 |
) |
|
|
(9,053,488 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Gain on sale of PREBOOST |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
$ |
5,969,063 |
|
|
$ |
(5,289,859 |
) |
|
$ |
(2,463,597 |
) |
|
$ |
(1,784,393 |
) |
Veru Inc.Reconciliation
of GAAP Reported to Non-GAAP Adjusted
Information(unaudited)
|
|
|
|
|
|
|
Three Months EndedDecember
31, |
|
2020 |
|
|
2019 |
|
Operating income
(loss) reconciliation: |
|
|
|
|
|
GAAP operating income (loss) |
$ |
19,187,157 |
|
|
$ |
(1,784,393 |
) |
Gain on sale of PREBOOST |
|
(18,410,158 |
) |
|
|
— |
|
Non-GAAP adjusted operating
income (loss) |
$ |
776,999 |
|
|
$ |
(1,784,393 |
) |
|
|
|
|
|
|
Net income (loss)
reconciliation: |
|
|
|
|
|
GAAP net income (loss) |
$ |
17,227,701 |
|
|
$ |
(3,305,101 |
) |
Gain on sale of PREBOOST |
|
(18,410,158 |
) |
|
|
— |
|
Non-GAAP adjusted net
loss |
$ |
(1,182,457 |
) |
|
$ |
(3,305,101 |
) |
|
|
|
|
|
|
Net income (loss) per
diluted common share outstanding reconciliation: |
|
|
|
|
|
GAAP net income (loss) per
diluted common share outstanding |
$ |
0.23 |
|
|
$ |
(0.05 |
) |
Gain on sale of PREBOOST |
|
(0.24 |
) |
|
|
— |
|
Effect of antidilutive shares |
|
(0.01 |
) |
|
|
— |
|
Non-GAAP adjusted net loss per
diluted common share outstanding |
$ |
(0.02 |
) |
|
$ |
(0.05 |
) |
|
|
|
|
|
|
GAAP diluted weighted average
common shares outstanding |
|
75,799,037 |
|
|
|
65,038,511 |
|
Potentially dilutive shares that are antidilutive due to net
loss |
|
(5,485,448 |
) |
|
|
— |
|
Non-GAAP diluted weighted
average common shares outstanding |
|
70,313,589 |
|
|
|
65,038,511 |
|
Contact:
Sam Fisch800-972-0538Director of Investor
Relations
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