Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical
company focused on developing novel medicines for the treatment of
breast cancer and for SARS-CoV-2 and other viral ARDS-related
diseases, today announced financial results for its fiscal 2023
second quarter and provided a business update.
“This past quarter, we prioritized our clinical development
program to focus on those indications with the largest market
opportunities and with the potential for meaningful Phase 3
clinical data results in 2024 for both enobosarm for 2nd line AR+
ER+ HER2- metastatic breast cancer and sabizabulin for SARS-CoV-2
viral ARDS,” said Mitchell Steiner, M.D., Chairman, President, and
Chief Executive Officer of Veru. “As part of this prioritization,
we are planning to also expand enobosarm into bone-only, metastatic
breast cancer and sabizabulin into influenza-induced ARDS.”
Dr. Steiner added, “On the regulatory front, we received FDA
clarity to continue advancing our ENABLAR-2 Phase 2b/3 clinical
trial for metastatic breast cancer and agreement to pursue our
confirmatory Phase 3 clinical trial for hospitalized COVID-19 adult
patients at high risk for ARDS. We also reduced our cash burn rate,
and in parallel, we increased available capital through the
completed ENTADFI sale and the Lincoln Park Capital transaction. We
are also seeking partnerships for both our clinical drug
candidates. In addition, we continue to invest in Veru’s FC2 Female
Condom® telemedicine portal and establish partnerships to grow our
FC2 prescription business in the U.S.”
Breast Cancer Program Updates
Enobosarm, a Novel Oral Selective Androgen Receptor
Agonist, and Abemaciclib, a CDK 4/6 Inhibitor, Combination Therapy
for the 2nd Line Treatment of AR+ ER+
HER2- Metastatic Breast Cancer
In March 2023, the Company made the strategic decision to focus
on the ENABLAR-2 Phase 2b/3 trial (combination of enobosarm +
abemaciclib). The decision to focus on an earlier line of treatment
is supported by the larger target patient population in a second
line metastatic setting for AR+ ER+ HER2- breast cancer patients.
On March 30, 2023, the Company met with the FDA to gain
further regulatory clarity for the ongoing Phase 2b/3 clinical
trial design and program. The Phase 2b/3 study has been amended to
accommodate the FDA’s latest recommendations to support a potential
registration. In the first stage of the trial, the dose of
enobosarm in the abemaciclib combination is being optimized and the
efficacy and safety of the combination therapy is being assessed
compared to an estrogen blocking agent. The primary endpoint for
stage 1 of the study is objective response rate (ORR), an endpoint
that the FDA recognizes as an appropriate surrogate endpoint for
clinical benefit for a possible accelerated approval. In Stage 2 of
the Phase 2b/3 study, we plan to enroll approximately 210 subjects
in a multicenter, open label, randomized (1:1), active control
clinical study, to evaluate the efficacy and safety of enobosarm
plus abemaciclib combination therapy versus an alternative estrogen
blocking agent (SERD or an aromatase inhibitor) in subjects with
AR+ ER+ HER2- metastatic breast cancer who have failed a
CDK4/6 inhibitor plus an estrogen blocking agent (non-steroidal
aromatase inhibitor or SERD). The primary endpoint is progression
free survival. The regulatory strategy and clinical design for the
Phase 2b/3 ENABLAR-2 clinical study could yield an accelerated
approval from stage 1 and full approval from stage 2 for the 2nd
line abemaciclib and enobosarm combination treatment of AR+ ER+
HER2- metastatic breast cancer. We anticipate having clinical data
for the Phase 2b/3 ENABLAR-2 study in 2024. We have a collaboration
and supply agreement with Eli Lilly and Company.
Enobosarm, a Novel Oral Selective Androgen Receptor
Agonist, for the Treatment of Bone-only Nonmeasurable ER+ HER2-
Metastatic Breast Cancer
The Company is planning a Phase 2b/3 study in bone-only
nonmeasurable hormone receptor and HER2- metastatic breast cancer
with enobosarm. Enobosarm has the ability to build both cortical
and trabecular bone and muscle in clinical and/or nonclinical
models, which may reduce the incidence of skeletal related events
caused by bone metastases and positively impact quality of life for
patients.
Infectious Disease: Viral Induced Acute
Respiratory Distress Syndrome (ARDS) Program
Updates
Sabizabulin, a Novel Oral Microtubule
Disruptor, for the Treatment of Hospitalized Moderate to Severe
COVID-19 Patients at High Risk for ARDS
In February 2023, the FDA declined to grant at this time an
Emergency Use Authorization (EUA) for sabizabulin for hospitalized
COVID-19 patients at high risk for ARDS because of the possibility
of unknown influences or uncertainties in the study. Nonetheless,
in communicating its decision, the FDA remains committed to working
with the Company for the future development of sabizabulin.
In April 2023, the Company met with the FDA and reached an
agreement on the trial design and path forward for a confirmatory
Phase 3 study, which will include 408 subjects with a primary
endpoint of all-cause mortality at Day 60. In addition, the study’s
treatment population is expanded to include all hospitalized
patients that require oxygen (WHO-4, WHO-5 and WHO-6) with no
requirement to have a comorbidity. In order to get a potentially
efficacious drug to patients in an efficient time frame, two
planned interim efficacy analyses will be conducted: As requested
by FDA, the first planned interim analysis will occur when 204
patients (50%) have completed the Day 60 primary efficacy endpoint,
and the second planned interim analysis is expected to occur when
290 patients (71%) have completed the Day 60 primary efficacy
endpoint. If either of the interim efficacy analyses meets the
statistical significance criteria, the trial could be stopped for
efficacy. Should the pre-specified primary efficacy endpoint
analysis demonstrate a statistically significant effect on
all-cause mortality favoring sabizabulin, the Company may consider
a new request for an EUA and/or a submission of an NDA, “as the
Company would potentially have two adequate and well controlled
trials for review.” The confirmatory Phase 3 clinical trial is
expected to enroll in the second half of 2023, and the first
planned interim analysis is expected to be conducted in 2024.
Sabizabulin, a Novel Oral Microtubule
Disruptor, for the Treatment of Hospitalized Moderate to Severe
Influenza Patients at High Risk for ARDS
In April 2023, the Company announced preclinical results of
sabizabulin demonstrating robust anti-inflammatory activity with
improved outcomes in an Influenza-Induced Pulmonary Inflammation
Mouse ARDS model. As a result, Veru is planning a Phase 3 study of
sabizabulin in hospitalized influenza patients at high risk for
ARDS.
Sabizabulin, a Novel Oral Microtubule
Disruptor, for the Treatment of Viruses that Pose
Serious Worldwide Global Threats
In April 2023, the Company announced preclinical in vitro study
results that demonstrate sabizabulin prevented both the release of
Vaccinia poxvirus from infected cells and the spread of Vaccinia
poxvirus to healthy cells. As a result, Veru is planning a
pre-Investigational New Drug (IND) meeting with the FDA to discuss
the development of sabizabulin for smallpox virus and Ebola virus
under the Animal Rules FDA regulatory approval pathway.
Urev - Sexual Health Program
Updates
FC2 Female Condom®
(internal condom)
In April 2023, the Company entered into a supply agreement with
Afaxys Group Services, LLC (AGS), a healthcare company, to offer
FC2 Female Condom® through the AGS Group Purchasing Organization
(GPO) for up to 31 million individuals that depend on public health
centers for essential healthcare.
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.
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.
Corporate Updates
In May 2023, the Company entered into a common stock purchase
agreement (Agreement) with Lincoln Park Capital Fund (LPC). Under
the terms of the Agreement, LPC has committed to purchase up to
$100 million of Veru’s common stock at Veru’s sole discretion from
time to time over a 36-month period.
Second Quarter Financial Summary: Fiscal 2023 vs Fiscal
2022
- Net revenues decreased to $6.6 million from $13.0 million
- Gross profit decreased to $4.1 million from $11.2 million
- Research and development expenses increased to $22.9 million
from $15.5 million
- Selling, general and administrative expenses increased to $12.8
million from $7.4 million
- Operating loss, which included an impairment charge of $3.9
million and a provision for credit losses of $3.9 million, was
$39.4 million versus $11.8 million
- Net loss was $38.8 million, or $0.48 per share, compared to
$14.2 million, or $0.18 per share
Year-to-Date Financial Summary: Fiscal 2023 vs Fiscal
2022
- Net revenues decreased to $9.1 million from $27.2
million
- Gross profit decreased to $4.8 million from $23.0 million
- Research and development expenses increased to $41.6 million
from $25.6 million
- Selling, general and administrative expenses increased to $30.4
million from $14.1 million
- Operating loss, which included an impairment charge of $3.9
million and a provision for credit losses of $3.9 million, was
$75.0 million versus $16.7 million
- Net loss was $75.6 million, or $0.94 per share, compared to
$20.6 million, or $0.26 per share.
- The net loss for the Company
increased by $55 million for the current period. The main reason
for the increase in the net loss relates to the Company preparing
for the potential launch of sabizabulin for COVID-19 in the U.S.
and outside the U.S. This required building a commercial team,
engaging vendors to assist with the commercial launch, and
manufacturing drug product for the launch upon EUA approval as
required by the FDA. Since the declination, the majority of
the employees hired for the commercial team have been terminated
and the commercial launch sales and marketing related vendor
contracts have been cancelled.
Balance Sheet Information
- Cash and cash equivalents were $23.5 million as of March 31,
2023 versus $80.2 million as of September 30, 2022. Subsequent to
the Company’s Fiscal Year 2023 second quarter, and as previously
disclosed, Frost Gamma Investments Trust acquired $5 million of
Company common stock in a private placement, and the Company sold
its ENTADFI product to Blue Water Biotech for $6 million upfront,
$14 million in notes receivable, and up to an additional $80
million if certain ENTADFI sales milestones are achieved.
- Net accounts receivable were $4.2 million as of March 31, 2023
versus $3.6 million as of September 30, 2022
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 May 11, 2023 at
approximately 12:00 p.m. ET by dialing 1-877-344-7529 (domestic) or
1-412-317-0088 (international) passcode 1592419 for one week.
About Veru Inc.Veru is a late clinical stage
biopharmaceutical company focused on developing novel medicines for
the treatment of breast cancer and for SARS-CoV-2 and other viral
ARDS-related diseases. Veru also has a commercial sexual health
division called Urev that is comprised of the FC2 Female Condom®
(internal condom), for the dual protection against unplanned
pregnancy and sexually transmitted infections which is sold in the
U.S. and globally.
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 2b/3 study of enobosarm in combination with abemaciclib for
the 2nd line treatment of AR+ ER+ HER2 metastatic breast cancer,
the Phase 2b/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 any potential EUA or
NDA would be grated; whether and when the Company will meet with
BARDA regarding any potential partnering opportunities and whether
those efforts will be successful; whether and how the Company will
fund the planned Phase 3 studies of sabizabulin in influenza, pox
virus and COVID-19; whether and when the Company will expand the
study of sabizabulin into other ARDS indications; whether the
current and future clinical development efforts of the Company,
including all studies of sabizabulin in infectious disease
indications and enobosarm in oncology indications, and any of their
results will demonstrate sufficient efficacy and safety and
potential benefits to secure FDA approval of any of the Company’s
drug candidates; whether the drug candidates will be approved for
the targeted line of therapy; whether sabizabulin will become a
treatment for broad ARDS; whether the Company’s FC2 telemedicine
portal sales will grow or replace prior revenue from the U.S.
prescription sales of FC2; whether the Company will recover any of
the monies owed it by The Pill Club; whether and when the Company
will receive the remaining installments from Blue Water in
connection with the sale of ENTADFI or will receive any of the
potential sales milestones related thereto; whether, when and how
many shares may be sold under the Lincoln Park Capital Fund equity
line; and whether the Company’s current cash will be sufficient to
fund its planned or expected operations. 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 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 treatment, including
favoring other treatment alternatives or imposing price controls on
COVID-19 treatments; the Company’s existing products, including FC2
and ENTADFI and, if authorized, sabizabulin, 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 studies, 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; 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, and development costs; 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 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) |
|
|
March 31, |
|
September 30, |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
23,498,371 |
|
|
$ |
80,190,675 |
|
Accounts receivable, net |
|
4,205,967 |
|
|
|
3,550,895 |
|
Inventories, net |
|
7,665,194 |
|
|
|
8,618,944 |
|
Prepaid expenses and other current assets |
|
7,918,745 |
|
|
|
12,408,960 |
|
Total current assets |
|
43,288,277 |
|
|
|
104,769,474 |
|
|
|
|
|
|
|
|
|
Plant and equipment, net |
|
1,519,789 |
|
|
|
1,185,766 |
|
Operating lease right-of-use assets |
|
4,675,739 |
|
|
|
4,786,915 |
|
Deferred income taxes |
|
13,070,469 |
|
|
|
12,965,985 |
|
Intangible assets, net |
|
41,667 |
|
|
|
3,977,381 |
|
Goodwill |
|
6,878,932 |
|
|
|
6,878,932 |
|
Other assets |
|
778,697 |
|
|
|
1,561,564 |
|
Total assets |
$ |
70,253,570 |
|
|
$ |
136,126,017 |
|
|
|
|
|
|
|
|
|
Accounts payable |
$ |
17,237,474 |
|
|
$ |
22,003,394 |
|
Accrued research and development costs |
|
13,786,241 |
|
|
|
9,071,503 |
|
Accrued expenses and other current liabilities |
|
6,881,260 |
|
|
|
9,193,637 |
|
Residual royalty agreement liability, short-term portion |
|
1,354,823 |
|
|
|
1,169,095 |
|
Total current liabilities |
|
39,259,798 |
|
|
|
41,437,629 |
|
|
|
|
|
|
|
|
|
Residual royalty agreement liability, long-term portion |
|
10,257,325 |
|
|
|
9,656,441 |
|
Operating lease liability, long-term portion |
|
3,987,612 |
|
|
|
4,093,667 |
|
Other liabilities |
|
32,933 |
|
|
|
99,644 |
|
Total liabilities |
|
53,537,668 |
|
|
|
55,287,381 |
|
|
|
|
|
|
|
|
|
Total stockholders' equity |
|
16,715,902 |
|
|
|
80,838,636 |
|
Total liabilities and stockholders' equity |
$ |
70,253,570 |
|
|
$ |
136,126,017 |
|
|
|
|
|
|
|
|
|
Veru Inc. Condensed Consolidated
Statements of Operations (unaudited) |
|
|
Three Months Ended March 31, |
|
Six Months Ended March 31, |
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
$ |
6,585,967 |
|
|
$ |
13,028,394 |
|
|
$ |
9,093,761 |
|
|
$ |
27,163,526 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
2,493,892 |
|
|
|
1,853,116 |
|
|
|
4,299,631 |
|
|
|
4,146,166 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
4,092,075 |
|
|
|
11,175,278 |
|
|
|
4,794,130 |
|
|
|
23,017,360 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
22,864,633 |
|
|
|
15,541,104 |
|
|
|
41,608,982 |
|
|
|
25,622,265 |
|
Selling, general and administrative |
|
12,834,494 |
|
|
|
7,401,138 |
|
|
|
30,380,359 |
|
|
|
14,126,344 |
|
Provision for (recovery of) credit losses |
|
3,911,714 |
|
|
|
(2,000 |
) |
|
|
3,911,714 |
|
|
|
(4,000 |
) |
Impairment of intangible assets |
|
3,900,000 |
|
|
|
— |
|
|
|
3,900,000 |
|
|
|
— |
|
Total operating expenses |
|
43,510,841 |
|
|
|
22,940,242 |
|
|
|
79,801,055 |
|
|
|
39,744,609 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(39,418,766 |
) |
|
|
(11,764,964 |
) |
|
|
(75,006,925 |
) |
|
|
(16,727,249 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Non-operating income (expenses) |
|
559,301 |
|
|
|
(2,440,316 |
) |
|
|
(762,997 |
) |
|
|
(3,743,382 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
(38,859,465 |
) |
|
|
(14,205,280 |
) |
|
|
(75,769,922 |
) |
|
|
(20,470,631 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Income tax (benefit) expense |
|
(66,559 |
) |
|
|
(27,450 |
) |
|
|
(134,837 |
) |
|
|
87,205 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(38,792,906 |
) |
|
$ |
(14,177,830 |
) |
|
$ |
(75,635,085 |
) |
|
$ |
(20,557,836 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per basic and diluted common shares outstanding |
$ |
(0.48 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.94 |
) |
|
$ |
(0.26 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted average common shares outstanding |
|
80,834,453 |
|
|
|
80,052,504 |
|
|
|
80,695,046 |
|
|
|
80,037,675 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Veru Inc. Condensed Consolidated
Statements of Cash Flows (unaudited) |
|
|
Six Months Ended March 31, |
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
Net loss |
$ |
(75,635,085 |
) |
|
$ |
(20,557,836 |
) |
|
|
|
|
|
|
Adjustments to reconcile net loss to net cash used in operating
activities |
|
17,792,692 |
|
|
|
6,659,447 |
|
|
|
|
|
|
|
Changes in operating assets and liabilities |
|
(2,247,306 |
) |
|
|
1,293,920 |
|
|
|
|
|
|
|
Net cash used in operating activities |
|
(60,089,699 |
) |
|
|
(12,604,469 |
) |
|
|
|
|
|
|
Net cash (used in) provided by investing activities |
|
(427,152 |
) |
|
|
2,012,566 |
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
3,824,547 |
|
|
|
247,873 |
|
|
|
|
|
|
|
Net decrease in cash |
|
(56,692,304 |
) |
|
|
(10,344,030 |
) |
|
|
|
|
|
|
Cash at beginning of period |
|
80,190,675 |
|
|
|
122,359,535 |
|
|
|
|
|
|
|
Cash at end of period |
$ |
23,498,371 |
|
|
$ |
112,015,505 |
|
Investor Contact: Samuel Fisch Executive Director,
Investor Relations and Corporate Communications Email:
veruinvestor@verupharma.com
Media Contact: Hannah Gendel Manager, Corporate
Communications Email: media@verupharma.com
Veru (NASDAQ:VERU)
Historical Stock Chart
From Jun 2024 to Jul 2024
Veru (NASDAQ:VERU)
Historical Stock Chart
From Jul 2023 to Jul 2024