Full Press Release Details
Veru Reports Record Fiscal 2020 Fourth Quarter and
Record Full-Year Financial Results
FY20 Full-Year Net Revenues and Gross Profit Achieve Historical Highs
of $43 Million and $31 Million, Respectively
Robust Growing Prescription Sales of FC2 Key Growth Driver;
Product Sales Expected to Continue Strong Upward Trajectory
Company s Late Clinical Stage Oncology Drug Pipeline Advancing
Company Sells PREBOOST Business for $20 Million
Company to Host Investor Conference Call Today at 8 AM ET
MIAMI December 9, 2020 Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing
novel medicines for the management of cancer, today announced record net revenues and gross profit for its fiscal 2020 fourth quarter and full year ended September 30, 2020.
Fourth-Quarter Financial Highlights: Fiscal 2020 vs Fiscal 2019
Full-Year Financial Highlights: Fiscal
We reported stellar financial results for both the fiscal 2020 fourth quarter and full year largely
driven by strong sales of our FC2 product, said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer. In particular, prescription sales of FC2 sharply increased, helping to raise our gross margin in the recently
completed fourth quarter to more than 81% of total net revenues. We anticipate further growth of prescription FC2 sales in the coming year.
Company Sells PREBOOST Business
completed the sale of its PREBOOST for the treatment of premature ejaculation business to Roman Health Ventures Inc. for $20 million in cash, consisting of $15 million paid at
closing, $2.5 million payable 12 months after closing and $2.5 million payable 18 months after closing.
transaction, along with current cash and anticipated cash flow from operations, are expected to be sufficient to self-fund our existing drug product development program, without the need for a new equity financing, until at least the end of fiscal
year 2022, said Dr. Steiner. We plan to continue to generate robust growing revenues from our sexual health business which as a standalone business would be very valuable. Coming off a record year of $42.6 million in net
revenues with a gross margin of 72%, and expecting another record year in fiscal year 2021, we could have options to monetize the business as we did with the PREBOOST business.
Veru has evolved into a late clinical stage oncology drug development and commercialization company, having made excellent progress on our development
program. Our multiple drug candidates continue to advance, and we are confident that we will achieve significant milestones in 2021. The Company expects it will have sufficient resources generated from our sexual health business and existing sources
of cash to fund clinical development of all our registration clinical trials without the need for new equity financing through the end of fiscal year 2022.
Some Pharmaceutical Pipeline Recent Highlights:
Company expects to issue a news release later today with a more detailed update on its pipeline of late clinical stage drug candidates including the in-licensing of a novel late clinical stage breast cancer
drug product entering a Phase 3 clinical trial.
5mg and Finasteride 5mg Combination Capsule) for the Treatment of Lower Urinary Tract Symptoms Caused by Benign Prostatic Hyperplasia (BPH)
The Company had a successful pre-NDA meeting with the FDA last year and the 12-month stability testing on three manufacturing / commercial batches required by the FDA is being completed. We expect to submit the NDA for
TADFYN in the first quarter of calendar year 2021 and plan to launch, if approved, via telemedicine channels in late calendar year 2021.
VERU-111 for Metastatic Castration and Androgen Targeting Agent Resistant Prostate Cancer
In September, the Company announced that it had fully enrolled a Phase 2 clinical trial of VERU-111, its novel, oral,
targeting alpha and beta tubulin of microtubules to disrupt the cytoskeleton (cytoskeleton disruptor for metastatic castration and androgen receptor targeting agent resistant prostate cancer. In both the Phase 1b study (n=39) and in the Phase 2
study (n=41), VERU-111 63mg oral daily continuous dosing for 21 day cycles has been well tolerated with no reports of neutropenia and neutrotoxicity and has demonstrated promising efficacy with evidence of PSA
declines and objective and durable tumor responses. The Company has received input from the FDA and anticipates initiating a Phase 3 VERU-111 VERACITY registration clinical trial during the first quarter of
VERU-100 Androgen Deprivation Therapy for Advanced Prostate
VERU-100 is a long-acting GnRH antagonist peptide formulation administered as a small volume,
three-month depot subcutaneous injection without a loading dose. There are no GnRH antagonist depot injectable formulations commercially approved beyond a one-month duration. The Company anticipates initiating
a Phase 2 trial to evaluate VERU-100 dosing in the first quarter of calendar year 2021 and a Phase 3 registration clinical trial during the second half of calendar year 2021.
VERU-111 COVID-19: Phase 2 Clinical Trial
The Company is also developing VERU-111 for COVID-19 patients at high risk for
acute respiratory distress syndrome (ARDS). The drug s dual antiviral and anti-inflammatory action has the potential to broadly treat the cytokine storm associated with high COVID-19 mortality rates. The
Company is close to completing enrollment of a Phase 2 clinical trial to assess the efficacy of VERU-111 in combating COVID-19 in patients at high risk for ARDS.
During the fourth quarter the Company
took a one-time, non-cash impairment charge of $14.1 million related to in process research and development associated with the financial accounting for the Aspen
Park Pharmaceuticals, Inc. acquisition, all as further described in the Company s Form 10-K for the fiscal year ended September 30, 2020. The non-cash charge
is primarily related to the Company s decision to prioritize clinical development for late clinical stage oncology drug development candidates with greater market differentiation, larger markets, and higher profit potential.
Non-GAAP Financial Information
Certain financial results for fiscal years 2020 and 2019 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, non-cash impairment charge in the fourth quarter of fiscal year 2020. 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.
Veru 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 10149625, for one week.
Company does not expect to update the guidance provided above regarding its expectation that it will not need a new equity financing. The Company notes that the statements of future performance made in this release are based upon current
expectations and are subject to factors that could cause actual results to differ materially from those suggested here, including those factors set forth in the Safe Harbor Statement below.
Veru Inc. is an oncology biopharmaceutical company with a focus on developing novel medicines for the management of 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 to disrupt the cytoskeleton (cytoskeleton disruptor).
VERU-111 is being evaluated in open label Phase 1b and Phase 2 clinical trials in men with metastatic castration and androgen receptor targeting agent resistant prostate cancer. The Phase 1b clinical study
completed enrollment of 39 men and is ongoing. The Phase 2 clinical trial has completed the enrollment of 41 men who have metastatic castration resistant prostate cancer and who have also become resistant to at least one novel androgen receptor
targeting agent, such as abiraterone, enzalutamide, or apalutamide but prior to IV chemotherapy, and is ongoing. 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. VERU-100 is a long-acting gonadotropin-releasing hormone (GnRH) antagonist administered as a small volume, 3-month depot subcutaneous injection without a loading dose. VERU-100 immediately suppresses testosterone with no testosterone surge upon initial or repeated administration
a problem which occurs with currently approved luteinizing hormone-releasing hormone (LHRH) agonists used for ADT. There are no GnRH antagonists commercially approved beyond a one-month injection. A
Phase 2 trial to evaluate VERU-100 dosing is anticipated to begin in the first quarter of calendar year 2021. 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 Company is planning for an End of Phase 2 meeting with the FDA. VERU-111 is also being evaluated in a Phase 2 clinical
trial to assess the efficacy of VERU-111 in combating COVID-19 in subjects at high risk for ARDS.
Veru is also advancing the Tadalafil and Finasteride combination capsule (TADFYN ) for the
administration of tadalafil 5mg and finasteride 5mg oral daily dosing 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 Company had a successful pre-NDA meeting with the FDA last year and the 12-month stability testing on three
manufacturing/commercial batches required by FDA is being completed. The Company expects to submit the NDA for TADFYN in the first quarter of calendar year 2021 and plans to launch, if
approved, via telemedicine channels in late calendar year 2021.
The Company s 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, retail pharmacies, as well as OTC via the Company s website at www.fc2.us.com. 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 Company s anticipation
that it will not need new equity financing until at least the end of fiscal year 2022, options to monetize the FC2 business, the regulatory pathway to secure FDA approval of the Company s drug candidates, the anticipated timeframe for clinical
studies and FDA submissions, clinical study results including potential benefits and the absence of adverse events, and the expectation of further growth of prescription FC2 sales. 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; 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; 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