Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical
company focused on developing novel medicines for metastatic breast
cancer and for viral induced acute respiratory distress syndrome
(ARDS), today announced financial results for its fiscal 2023 third
quarter and provided a business update.
“This quarter was marked by important Company efforts to seek
additional regulatory clarity from FDA regarding our two lead
development programs, enobosarm and sabizabulin and to secure
funding sources,” said Mitchell Steiner, M.D., Chairman, President,
and Chief Executive Officer of Veru. “We recently received further
FDA regulatory clarity on the first stage of the Phase 3 ENABLAR-2
clinical trial design in order to add enobosarm alone as well as
enobosarm in combination with abemaciclib as a 2nd line treatment
for metastatic breast cancer with objective tumor response rates
(ORR) as the primary endpoint. If ORR improvement is significant,
we plan to pursue the accelerated approval pathway. As for
sabizabulin, although there is a new summer and expected
fall/winter COVID-19 surge, we believe that sabizabulin, as a broad
antiviral and anti-inflammatory agent, may address viral lung
infections and ARDS caused by other common viruses as well.
Accordingly, we plan to discuss with FDA expanding the sabizabulin
Phase 3 confirmatory study to include all hospitalized adult
patients who have any kind of viral induced lung infection
(influenza and RSV in addition to COVID) requiring supplemental
oxygen and who are at risk for ARDS. FDA has granted this meeting
for September 2023. Viral induced pneumonia and lung infection is a
leading cause of hospitalization in the U.S. according to the
American Thoracic Society. In the U.S. alone, it is common to
see well over 2 million hospitalizations annually from viral
induced lung infections.”
Dr. Steiner added: “During the quarter, we continued to make
great progress on reducing our cash burn as we focus on our
prioritized Phase 3 clinical programs. The Company’s cash burn
during the quarter was $7.3 million, a $16.1 million reduction
compared to the prior quarter. We also increased available capital
through the completed $20 million ENTADFI sale and the $100 million
Lincoln Park Capital Fund common stock purchase agreement. I am
also excited to report that our sexual health business is making
great progress with the FC2 Female Condom® telehealth platform
prescription business in the U.S. which has turned around and is
growing to provide additional cash that we can invest, as we have
done historically, in our two Phase 3 clinical development programs
for large market opportunities.”
Oncology Program Update:
The Company’s oncology drug pipeline is focused on the
clinical development of enobosarm, an oral selective androgen
receptor agonist, for the 2nd
line treatment of metastatic breast cancer.
Enobosarm is a new kind of endocrine therapy for advanced breast
cancer. Enobosarm is an oral, new chemical entity, selective
androgen receptor agonist that activates the androgen receptor (AR)
in AR+ ER+ HER2- metastatic breast cancer, which
suppresses tumor growth without the unwanted masculinizing side
effects and increases in hematocrit seen with androgens.
Phase 3 clinical ENABLAR-2 study – Enobosarm +/-
abemaciclib (CDK 4/6 inhibitor) combination versus estrogen
blocking agent (active control) as a 2nd line treatment for
AR+ ER+ HER2- metastatic breast cancer.
On March 30, 2023, the Company met with the FDA to gain
further agreement on Phase 3 clinical trial design and program. The
Phase 3 study has been amended to accommodate the FDA’s latest
recommendations to support registration as a second line treatment
for patients with AR+ ER+ HER2- metastatic breast cancer
who have tumor progression while receiving a CDK 4/6 inhibitor plus
an estrogen blocking agent (nonsteroidal aromatase inhibitor or
selective estrogen receptor degrader). The Phase 3 ENABLAR-2 study
has 2 distinct study stages:
In Stage 1 of the Phase 3 study which will enroll 160 patients,
the objectives are to optimize the dose of enobosarm in the
abemaciclib combination and to assess the efficacy of enobosarm as
a monotherapy compared to an estrogen blocking agent active
control. The primary endpoint for Stage 1 is ORR. The Stage 1
initial run-in enrolled 3 patients to assess the safety and
pharmacokinetics of the abemaciclib + enobosarm 9mg combination. In
this run-in portion, there were no drug-to-drug interactions
between abemaciclib and enobosarm, and there were no new safety
findings. Further, the early preliminary clinical results showed 2
partial responses and 1 stable disease in the first 3 patients
based on local assessments, and all patients have been on study for
over 9 months. Our current plan is to have Phase 3 Stage 1 clinical
results by late 2024 or early 2025. If enobosarm monotherapy or
abemaciclib + enobosarm combination therapy compared to estrogen
blocking agent (active control) demonstrates significant
improvement in ORR, which is considered a surrogate endpoint for
clinical benefit, then the Company plans to meet with the FDA to
consider an accelerated approval regulatory pathway based on the
clinical data from the Stage 1 portion of the Phase 3 study.
In Stage 2 of the Phase 3 study, we plan to enroll approximately
200 subjects in a multicenter, open label, randomized (1:1), active
control clinical study, to evaluate the efficacy and safety of
enobosarm with or without abemaciclib therapy (depending on the
outcome of Stage 1) versus an alternative estrogen blocking agent
(selective estrogen receptor degrader or an aromatase inhibitor) in
subjects with AR+ ER+ HER2- metastatic breast cancer who
have failed a CDK 4/6 inhibitor plus an estrogen blocking agent
(nonsteroidal aromatase inhibitor or selective estrogen receptor
degrader). The primary endpoint for Stage 2 of the Phase 3 study is
progression-free survival.
In January 2022, Veru entered into a clinical trial
collaboration and supply agreement through which Eli Lilly supplies
abemaciclib for the ENABLAR-2 trial.
Infectious Disease: Viral Induced Acute
Respiratory Distress Syndrome (ARDS) Program
Updates
We have agreement with FDA on the design of the Phase 3
confirmatory COVID-19 study, but given the current COVID-19
landscape and unmet need for other types of viral induced ARDS in
general, the Company now plans to meet with the FDA to reach
agreement on the design of a proposed expanded Phase 3 confirmatory
study evaluating sabizabulin 9mg for the treatment of hospitalized
adult patients who have any viral lung infection, including
SARS-CoV-2, Influenza A and B, Respiratory Syncytial Virus (RSV)
and other viruses, and who require oxygen support and are at high
risk for ARDS. The FDA has granted this meeting with Veru for
September 2023.
The Company is developing sabizabulin 9mg, a novel oral
microtubule disruptor, which has both host targeted antiviral and
broad anti-inflammatory properties, as a two-pronged approach to
the treatment of hospitalized patients with viral lung infection at
high risk for ARDS and death. The Company has completed positive
Phase 2 and positive Phase 3 COVID-19 clinical studies that have
demonstrated that sabizabulin treatment resulted in a mortality
benefit in hospitalized moderate to severe patients with COVID-19
viral lung infection at high risk for ARDS and death. On
April 27, 2023, the Company met with the FDA and reached
agreement on the design of the Phase 3 confirmatory COVID-19
clinical trial to evaluate sabizabulin treatment of hospitalized
moderate to severe COVID-19 patients who are at high risk for ARDS
and the path forward to submit a new EUA application and/or
NDA.
On April 4, 2023, Veru announced positive results from a
sabizabulin animal study conducted by a team of researchers at
Labcorp Early Development Laboratories, Ltd, United Kingdom. The
purpose of the study was to evaluate the efficacy of sabizabulin in
the influenza H1N1 pulmonary inflammation mouse ARDS model. In the
final study report, sabizabulin significantly reduced key cytokines
involved in ARDS in H1N1 influenza pulmonary inflammation murine
ARDS model. This positive preclinical influenza animal study
further supports the potential use of sabizabulin as a broad
antiviral and anti-inflammatory agent for viral induced ARDS.
As viruses that cause viral lung infection and ARDS do so in a
similar way, the Company believes sabizabulin has the potential to
be a treatment for all types of viral lung infections in
hospitalized adult patients on oxygen who are at high risk for ARDS
and death - not only SARS-CoV-2, but also influenza A or B, RSV,
and other viruses. Although we have reached agreement with the FDA
for the design of Phase 3 confirmatory COVID-19 clinical trial, the
Company now plans to meet with the FDA again to reach agreement on
the design of a proposed expanded Phase 3 confirmatory study
evaluating sabizabulin 9mg for the treatment of hospitalized adult
patients who have any kind of viral lung infection and on oxygen
support who are at high risk for ARDS. The FDA has granted a
meeting with Veru for September 2023. If we reach agreement with
the FDA on the proposed ARDS sabizabulin study, we would not pursue
the Phase 3 confirmatory COVID-19 only study or the influenza A or
B only study.
Sabizabulin, as a host directed therapeutic, has been
selected as a finalist drug candidate for consideration by The
Influenza & Emerging Infectious Diseases Division of BARDA
(The Biomedical Advanced Research and Development
Authority of the U.S. Department of Health and Human Services) for
a planned large multicenter, placebo-controlled
clinical trial in hospitalized adult patients with ARDS. A decision
by BARDA for final selection is expected during calendar Q4
2023. This clinical trial sponsored by BARDA plans to
evaluate the safety and efficacy of up to 3 novel threat-agnostic
and host-directed therapeutics representing different mechanisms of
action that could address ARDS caused by known and unknown health
security threats such as pandemic influenza, COVID-19, other
emerging infectious diseases, and chemical, biological,
radiological, and nuclear incidents.
Sabizabulin, a Novel Oral Microtubule
Disruptor, for the Treatment of Viruses that Pose
Serious Worldwide Global Threats
On April 11, 2023, Veru announced positive results from a
preclinical in vitro study conducted by a team of researchers led
by Brian M. Ward, Ph.D., Associate Professor of Microbiology and
Immunology, University of Rochester School of Medicine and
Dentistry, Rochester, New York. The preclinical study evaluated the
effects of sabizabulin against the prototypical poxvirus, vaccinia
virus, which demonstrated that sabizabulin prevented both the
release of poxvirus from infected cells and the spread of poxvirus
to healthy cells. The Company plans to have preIND meetings with
the FDA to discuss Animal Rule regulatory requirements for
assessing the efficacy of sabizabulin for smallpox virus as well as
Ebola virus. The smallpox virus pre-IND meeting has been granted
and will take place in August 2023. Clinical human efficacy trials
of drugs for preventing or treating viral infections, such as
smallpox are not feasible and challenge studies in healthy subjects
are unethical. Therefore, drugs for these indications are generally
developed and approved under a regulatory pathway commonly referred
to as the Animal Rule (21 CFR part 314, subpart I, for drugs and 21
CFR part 601, subpart H, for biologics). The FDA may grant
marketing approval based on adequate and well-controlled animal
efficacy studies when the results of those studies establish that
the drug is reasonably likely to produce clinical benefit in
humans.
Urev - Sexual Health Program Updates
ENTADFI® (finasteride
and tadalafil) capsules for oral use, a New Treatment for Benign
Prostatic Hyperplasia (BPH)
In April 2023, the Company sold ENTADFI®, an FDA-approved oral,
once daily product for BPH for men with an enlarged prostate
experiencing the signs and symptoms of BPH for up to 26 weeks, to
Blue Water Biotech for $20 million ($6 million upfront and the
remaining $14 million in installments through Fiscal Year 2024),
with the potential for up to an additional $80 million from sales
milestones.
FC2 Female Condom®
(internal condom)
The Company sells FC2 in both the U.S. commercial sector and in
the public health sector both in the U.S. and globally. FC2 is the
only FDA approved female (internal) condom in the US. FC2 is a
well-established business that has sold over 750 million female
condoms worldwide. Since 2017, FC2 has generated over $213 million
of net revenue. We have and plan to continue to invest the profits
from the FC2 business to help fund the clinical development of our
drug candidates, enobosarm and sabizabulin.
Telehealth is an important commercial strategy in the U.S. for
access to birth control products especially FC2 as a nonhormonal
and latex free option to prevent pregnancy and transmission of
sexually transmitted infections. In order to maximize its reach and
to have more direct control of the promotion, distribution, and
sales of FC2, the Company made the decision last year to launch its
own independent, FC2-dedicated telehealth digital portal. The
Company continues to invest in and grow its direct to patient
telehealth portal as well as adding new telehealth and internet
fulfillment pharmacy partners to provide coverage in all 50 states
in the U.S.
Having taken the time to refine our marketing, drive operational
improvements, and enhance the patient experience during the initial
launch phase over the last nine months, there are increasing new
prescriptions being written and filled through our FC2 telehealth
portal. During the third quarter of fiscal 2023, we saw our
acquisition costs remain stable with new prescriptions growing over
115%, providing prescriptions to approximately 4,400 patients in
total. We believe these results support our strategy and
demonstrate high demand for FC2. We plan to continue to grow and
deepen our investment in a profitable way by further expanding our
presence both in social media channels and online search.
In the U.S. public sector, the company has seen an 115% increase
in volume for the third quarter fiscal 2023 versus the third
quarter fiscal 2022. This growth is attributable to key US public
sector partnerships including the Company’s recent announcement in
April 2023 that it has entered into a Purchasing Agreement with
Afaxys Group Services, LLC (AGS), the #1 provider of oral and
emergency contraceptives in US clinics.
In the global public health sector outside the U.S., 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. We are currently
supplying a large multi-year South African tender for female
condoms, which is expected to continue until 2025 and have seen
sales grow in the current year as the current tender launched. We
also expect a formal Brazil tender process to commence later this
year.
Corporate Updates
In June 2023, the Company announced that The University of
Tennessee Health Science Center (UTHSC), oncology drug discovery
research partner to Veru Inc., secured two additional grants to
develop oncology therapeutics for indications of high unmet need.
UTHSC was awarded $924,000 from the U.S. Department of Defense
(DoD) and $3,074,470 from the National Cancer Institute’s Research
Project Grant (NCI R01). These two new grants awarded to UTHSC
bring the university’s aggregate oncology funding related to this
project to over $10 million.
In May 2023, the Company entered into a common stock purchase
agreement for the purchase of up to $100 million with Lincoln Park
Capital Fund. In May 2023, the Company also entered into a common
stock open market sale agreement (At-the-Market facility) with
Jefferies LLC for the sale of up to $75 million.
Third Quarter Financial Summary: Fiscal 2023 vs Fiscal
2022
- Net revenues decreased to $3.3 million from $9.6 million
- Gross profit decreased to $1.2 million from $7.1 million
- Research and development expenses decreased to $2.9 million
from $18.1 million
- Selling, general and administrative expenses increased to $10.9
million from $10.8 million
- Operating income, which included a gain on the sale of the
Company’s ENTADFI assets of $17.5 million, was $4.9 million versus
operating loss of $21.8 million
- Net income was $6.3 million, or $0.07 per share, compared to
net loss of $22.2 million, or $0.28 per share
Year-to-Date Financial Summary: Fiscal 2023 vs Fiscal
2022
- Net revenues decreased to $12.4 million from $36.8
million
- Gross profit decreased to $6.0 million from $30.1 million
- Research and development expenses increased to $44.5 million
from $43.8 million
- Selling, general and administrative expenses increased to $41.3
million from $24.9 million
- Operating loss, which included an impairment charge of $3.9
million, a provision for credit losses of $3.9 million, and a gain
on the sale of the Company’s ENTADFI assets of $17.5 million, was
$70.1 million versus $38.6 million
- Net loss was $69.3 million, or $0.83 per share, compared to
$42.8 million, or $0.53 per share
Balance Sheet Information
- Cash and cash equivalents were $16.2 million as of June 30,
2023 versus $80.2 million as of September 30, 2022
- Net accounts receivable were $5.1 million as of June 30, 2023
versus $3.6 million as of September 30, 2022
- Notes receivable, gross of imputed interest, from the sale of
the Company’s ENTADFI assets are $14.0 million as of June 30,
2023
Event DetailsThe audio webcast will be
accessible under “Investor Kit” in the Investors page of the
Company’s website at www.verupharma.com. To join the conference
call via telephone, please dial 1-800-341-1602 (domestic) or
1-412-902-6706 (international) and ask to join the Veru Inc. call.
An archived version of the audio webcast will be available for
replay on the Company’s website for approximately three months. A
telephonic replay will be available on August 10, 2023 at
approximately 12:00 p.m. ET by dialing 1-877-344-7529 (domestic) or
1-412-317-0088 (international) passcode 1699199 for one week.
About Veru Inc.Veru is a late clinical stage
biopharmaceutical company focused on developing novel medicines for
breast cancer and for viral ARDS.
Oncology program: advanced breast cancer
The Company’s late-stage breast cancer development portfolio
comprises enobosarm, a selective androgen receptor targeting
agonist.
- Enrolling Phase 3 clinical ENABLAR-2 study – enobosarm +/-
abemaciclib combination versus estrogen blocking agent (active
control) as a 2nd line treatment in AR+ ER+ HER2-
metastatic breast cancer. The Company and Eli Lilly and Company
have entered into a clinical study collaboration and supply
agreement for the ENABLAR-2 study. Lilly supplies Verzenio®
(abemaciclib).
Infectious disease program focuses on
viruses that pose serious worldwide global threat
- COVID-19: Sabizabulin is an
oral, first-in-class, new chemical entity, microtubule disruptor
that has dual anti-inflammatory and host mediated antiviral
properties. Veru has conducted a positive double-blind, randomized,
placebo-controlled Phase 3 COVID-19 clinical trial in 204
hospitalized moderate to severe COVID-19 patients at high risk for
ARDS and death. The primary endpoint was the proportion of deaths
by Day 60. Treatment with sabizabulin resulted in a clinically
meaningful and statistically significant 51.6% relative reduction
in deaths (p=0.0046) and was well tolerated. FDA granted Fast Track
designation to the Company’s COVID-19 program in January
2022. In April 2023, the Company reached agreement with FDA on
design of the Phase 3 confirmatory COVID-19 clinical trial to
evaluate sabizabulin in hospitalized moderate to severe COVID-19
patients at high risk for ARDS. Although the Company has reached
agreement with FDA for the design of Phase 3 confirmatory COVID-19
clinical trial, the Company now plans to meet with FDA to reach
agreement on the design of a proposed expanded Phase 3 confirmatory
study evaluating sabizabulin 9mg for the treatment of hospitalized
adult patients who have and type of viral lung infection and on
oxygen support who are at high risk for ARDS and death. The FDA has
granted a meeting with Veru for September 2023.
- Smallpox and Ebola viruses: The Company is
planning a pre-IND meeting with FDA to discuss the development of
sabizabulin for smallpox virus and Ebola virus under the Animal
Rule FDA regulatory approval pathway. A preIND meeting has been
granted for smallpox virus in August 2023.
Sexual health program – Urev
Veru has a commercial sexual health division called Urev that is
comprised of FC2 Female Condom® (internal condom), for the dual
protection against unplanned pregnancy and the transmission of
sexually transmitted infections which is sold in the U.S. and
globally. The Company made the decision last year to launch its own
independent, FC2-dedicated direct to patient telehealth and
pharmacy services portal. The Company continues to invest in and
grow its direct to patient telemedicine portal and is focused on
executing new contracts with additional telemedicine and internet
fulfillment pharmacy partners to provide coverage in all 50 states
in the U.S.
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 planned design,
enrollment, timing, commencement, interim and full data readout
timing, scope, regulatory pathways, and results of the Company’s
current and planned clinical trials, including the confirmatory
Phase 3 study of sabizabulin for certain COVID-19 patients, the
Phase 3 study of enobosarm in combination with abemaciclib for the
2nd line treatment of AR+ ER+ HER2 metastatic breast cancer, the
Phase 3 study of enobosarm in bone-only non-measurable hormone
receptor and HER2- metastatic breast cancer, the Phase 3 study of
sabizabulin in hospitalized influenza patients at high risk of
ARDS, and studies of sabizabulin in smallpox virus and Ebola virus,
and whether any of such studies will meet any of its primary or
secondary endpoint; whether and when any of the planned interim
analyses in the planned Phase 3 confirmatory study of sabizabulin
for certain COVID patients will occur and what the results of any
such interim analyses will be; whether the results of such interim
analyses or the completed confirmatory Phase 3 study or any other
interim data will be sufficient to support a new EUA application or
an NDA; whether and when the Company will expand the study of
sabizabulin into other ARDS indications; whether and when the
Company will receive the future installment payments of the ENTADFI
purchase price or sales milestone payments; and the outlook for
growth in the Company's FC2 business through telehealth customers,
our direct to patient telehealth portal and the global public
health sector. 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 studies possibly being unsuccessful or insufficient to
meet applicable regulatory standards or warrant continued
development; the ability to enroll sufficient numbers of subjects
in clinical studies and the ability to enroll subjects in
accordance with planned schedules; the ability to fund planned
clinical development as well as other operations of the Company;
the timing of any submission to the FDA or any other regulatory
authority and any determinations made by the FDA or any other
regulatory authority; the possibility that as vaccines, anti-virals
and other treatments become widely distributed the need for new
COVID-19 or other ARDS treatment candidates may be reduced or
eliminated; government entities possibly taking actions that
directly or indirectly have the effect of limiting opportunities
for sabizabulin as a COVID-19 or other ARDS treatment, including
favoring other treatment alternatives or imposing price controls on
COVID-19 or other ARDS treatments; the Company’s existing products,
including FC2 and, if authorized, sabizabulin, and any future
products, if approved, possibly not being commercially successful;
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; risks relating to the Company's
development of its own dedicated direct to patient telemedicine and
telepharmacy services platform, including the Company's lack of
experience in developing such a platform, potential regulatory
complexity, development costs, and market awareness and acceptance
of any telehealth platform we develop; risks relating to our
ability to increase sales of FC2 after significant declines in
recent periods due to telehealth industry consolidation and the
bankruptcy of a large telehealth customer; 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, product testing, transportation delays or
regulatory actions; costs and other effects of litigation,
including product liability claims and securities litigation; 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, 2022 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.
|
|
FINANCIAL SCHEDULES FOLLOW |
|
Veru Inc. |
Condensed Consolidated Balance Sheets |
(unaudited) |
|
|
June 30, |
|
September 30, |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
16,213,136 |
|
|
$ |
80,190,675 |
|
Accounts receivable, net |
|
5,082,878 |
|
|
|
3,550,895 |
|
Notes receivable, short-term portion |
|
8,536,535 |
|
|
|
— |
|
Inventories, net |
|
6,489,968 |
|
|
|
8,618,944 |
|
Prepaid expenses and other current assets |
|
6,898,647 |
|
|
|
12,408,960 |
|
Total current assets |
|
43,221,164 |
|
|
|
104,769,474 |
|
|
|
|
|
|
|
|
|
Plant and equipment, net |
|
1,492,183 |
|
|
|
1,185,766 |
|
Operating lease right-of-use assets |
|
4,495,336 |
|
|
|
4,786,915 |
|
Deferred income taxes |
|
13,098,090 |
|
|
|
12,965,985 |
|
Intangible assets, net |
|
23,810 |
|
|
|
3,977,381 |
|
Goodwill |
|
6,878,932 |
|
|
|
6,878,932 |
|
Notes receivable, long-term portion |
|
4,437,850 |
|
|
|
— |
|
Other assets |
|
1,548,049 |
|
|
|
1,561,564 |
|
Total assets |
$ |
75,195,414 |
|
|
$ |
136,126,017 |
|
|
|
|
|
|
|
|
|
Accounts payable |
$ |
18,118,594 |
|
|
$ |
22,003,394 |
|
Accrued research and development costs |
|
1,112,788 |
|
|
|
9,071,503 |
|
Accrued expenses and other current liabilities |
|
7,392,905 |
|
|
|
9,193,637 |
|
Residual royalty agreement liability, short-term portion |
|
1,061,893 |
|
|
|
1,169,095 |
|
Total current liabilities |
|
27,686,180 |
|
|
|
41,437,629 |
|
|
|
|
|
|
|
|
|
Residual royalty agreement liability, long-term portion |
|
9,276,735 |
|
|
|
9,656,441 |
|
Operating lease liability, long-term portion |
|
3,805,137 |
|
|
|
4,093,667 |
|
Other liabilities |
|
40,111 |
|
|
|
99,644 |
|
Total liabilities |
|
40,808,163 |
|
|
|
55,287,381 |
|
|
|
|
|
|
|
|
|
Total stockholders'
equity |
|
34,387,251 |
|
|
|
80,838,636 |
|
Total liabilities and
stockholders' equity |
$ |
75,195,414 |
|
|
$ |
136,126,017 |
|
|
|
|
|
|
|
|
|
Veru Inc. |
Condensed Consolidated Statements of
Operations |
(unaudited) |
|
|
Three Months EndedJune 30, |
|
Nine Months EndedJune 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
$ |
3,341,185 |
|
|
$ |
9,602,195 |
|
|
$ |
12,434,946 |
|
|
$ |
36,765,721 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
2,110,567 |
|
|
|
2,533,572 |
|
|
|
6,410,198 |
|
|
|
6,679,738 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
1,230,618 |
|
|
|
7,068,623 |
|
|
|
6,024,748 |
|
|
|
30,085,983 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
2,925,171 |
|
|
|
18,133,412 |
|
|
|
44,534,153 |
|
|
|
43,755,677 |
|
Selling, general and administrative |
|
10,902,916 |
|
|
|
10,761,486 |
|
|
|
41,283,275 |
|
|
|
24,887,830 |
|
Provision for (recovery of) credit losses |
|
— |
|
|
|
(2,500 |
) |
|
|
3,911,714 |
|
|
|
(6,500 |
) |
Impairment of intangible assets |
|
— |
|
|
|
— |
|
|
|
3,900,000 |
|
|
|
— |
|
Total operating expenses |
|
13,828,087 |
|
|
|
28,892,398 |
|
|
|
93,629,142 |
|
|
|
68,637,007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on sale of ENTADFI®
assets |
|
17,456,814 |
|
|
|
— |
|
|
|
17,456,814 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
|
4,859,345 |
|
|
|
(21,823,775 |
) |
|
|
(70,147,580 |
) |
|
|
(38,551,024 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-operating income
(expenses) |
|
1,512,410 |
|
|
|
(234,198 |
) |
|
|
749,413 |
|
|
|
(3,977,580 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income
taxes |
|
6,371,755 |
|
|
|
(22,057,973 |
) |
|
|
(69,398,167 |
) |
|
|
(42,528,604 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense
(benefit) |
|
57,551 |
|
|
|
137,603 |
|
|
|
(77,286 |
) |
|
|
224,808 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
$ |
6,314,204 |
|
|
$ |
(22,195,576 |
) |
|
$ |
(69,320,881 |
) |
|
$ |
(42,753,412 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per basic
common shares outstanding |
$ |
0.07 |
|
|
$ |
(0.28 |
) |
|
$ |
(0.83 |
) |
|
$ |
(0.53 |
) |
Basic weighted average common
shares outstanding |
|
88,266,152 |
|
|
|
80,088,431 |
|
|
|
83,218,748 |
|
|
|
80,054,594 |
|
Net income (loss) per diluted
common shares outstanding |
$ |
0.07 |
|
|
$ |
(0.28 |
) |
|
$ |
(0.83 |
) |
|
$ |
(0.53 |
) |
Diluted weighted average
common shares outstanding |
|
88,301,516 |
|
|
|
80,088,431 |
|
|
|
83,218,748 |
|
|
|
80,054,594 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Veru Inc. |
Condensed Consolidated Statements of Cash
Flows |
(unaudited) |
|
|
|
|
|
|
|
Nine Months EndedJune 30, |
|
2023 |
|
2022 |
|
|
|
|
|
|
Net loss |
$ |
(69,320,881 |
) |
|
$ |
(42,753,412 |
) |
|
|
|
|
|
|
Adjustments to reconcile net
loss to net cash used in operating activities |
|
3,599,367 |
|
|
|
9,529,631 |
|
|
|
|
|
|
|
Changes in operating assets
and liabilities |
|
(12,799,840 |
) |
|
|
6,597,275 |
|
|
|
|
|
|
|
Net cash used in operating
activities |
|
(78,521,354 |
) |
|
|
(26,626,506 |
) |
|
|
|
|
|
|
Net cash provided by investing
activities |
|
5,547,174 |
|
|
|
4,415,755 |
|
|
|
|
|
|
|
Net cash provided by financing
activities |
|
8,996,641 |
|
|
|
401,826 |
|
|
|
|
|
|
|
Net decrease in cash |
|
(63,977,539 |
) |
|
|
(21,808,925 |
) |
|
|
|
|
|
|
Cash at beginning of
period |
|
80,190,675 |
|
|
|
122,359,535 |
|
|
|
|
|
|
|
Cash at end of period |
$ |
16,213,136 |
|
|
$ |
100,550,610 |
|
|
|
|
|
|
|
Investor and Media Contact:Samuel FischExecutive Director,
Investor Relations and Corporate CommunicationsEmail:
veruinvestor@verupharma.com
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