World

Veru Experiences Robust Second-Quarter Monetary Outcomes Primarily based on Document Excessive FC2 Prescription Revenues

— First Affected person to Be Enrolled this Week in Section 3 Scientific Trial of Sabizabulin
(VERU-111) in Excessive Threat Hospitalized COVID-19 Sufferers–

–New Drug Utility Accepted for Assessment by FDA for Proprietary TADFIN Day by day Oral Dosing Mixture for BPH; PDUFA Date December 2021–

–Firm Poised to Enroll First Affected person in Section 3 VERACITY Scientific Trial of Sabizabulin for Metastatic Castration and AR Focusing on Agent Resistant Prostate Most cancers Later this Month–

–Firm Anticipates Enrolling First Affected person in Section 2 Scientific Trial of VERU-100 Novel Lengthy-Appearing GnRH Antagonist Depot as Androgen Deprivation Remedy for Superior Prostate Most cancers Later this Month–

–Firm to Host Investor Convention Name In the present day at 8 a.m. ET–

MIAMI, Could 12, 2021 (GLOBE NEWSWIRE) — Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical firm with a give attention to growing novel medicines for the administration of prostate and breast most cancers, at present introduced that web revenues elevated 34% and gross revenue rose 47% for its fiscal 2021 second quarter ended March 31, 2021, attributable to document excessive quarterly FC2 US prescription web revenues.

Second Quarter Monetary Highlights: Fiscal 2021 vs Fiscal 2020

  • Web revenues elevated 34% to $13.3 million from $9.9 million

  • FC2 prescription web revenues climbed 48% to $10.3 million from $7.0 million

  • Gross revenue rose 47% to $10.9 million from $7.4 million

  • Gross margin elevated to 82% of web revenues from 75% of web revenues

  • Working loss was $1.5 million versus $0.3 million

  • Web loss was $2.8 million, or $0.04 per share, in contrast with $0.8 million, or $0.01 per share.

12 months-to-Date Monetary Highlights: Fiscal 2021 vs Fiscal 2020

  • Web revenues elevated 36% to $28.0 million from $20.5 million, a document excessive for the six-month interval ended March 31, 2021

  • FC2 prescription web revenues climbed 49% to $19.4 million from $13.0 million

  • Gross revenue rose 48% to $21.7 million from $14.7 million

  • Gross margin elevated to 78% of web revenues from 72% of web revenues

  • Working revenue was $17.7 million, which incorporates an $18.4 million acquire on the December 2020 sale of the PREBOOST enterprise. Adjusted working loss, which excludes the acquire on the sale of the PREBOOST enterprise, was $0.7 million versus $2.1 million

  • Web revenue, which incorporates the acquire on the sale of the PREBOOST enterprise, was $14.4 million and diluted EPS was $0.18. Adjusted web loss, which excludes the acquire on the sale of the PREBOOST enterprise, was $4.0 million in contrast with $4.1 million and adjusted diluted loss per share was $0.06, which remained in line with fiscal 2020.

Stability Sheet Data

  • Money and money equivalents had been $136.7 million as of March 31, 2021 versus $13.6 million as of September 30, 2020

  • Web accounts receivable had been $5.1 million as of March 31, 2021 versus $5.2 million as of September 30, 2020.

“We reported one other nice quarter largely based mostly on all-time document excessive quarterly FC2 web revenues from the U.S. prescription channel,” stated Mitchell Steiner, M.D., Chairman, President and Chief Govt Officer of Veru Inc. “We additionally will probably be enrolling our first affected person in our Section 3 medical trial of sabizabulin in excessive threat hospitalized COVID-19 sufferers this week. Due to sabizabulin’s anti-inflammatory and anti-viral properties and its favorable security profile, we expect sabizabulin may very well be that desperately wanted oral therapeutic to stop deaths in hospitalized sufferers with reasonable to extreme COVID-19 illness who’re in danger for Acute Respiratory Misery Syndrome (ARDS). COVID-19 stays a severe menace worldwide and efficient remedies are desperately wanted.”

Dr. Steiner famous: “We’re advancing our novel oral drug candidates for the remedy of prostate and breast superior cancers. We plan this month to enroll our first affected person within the Section 3 VERACITY medical trial of sabizabulin for metastatic castration and androgen receptor concentrating on agent resistant prostate most cancers. We plan to additionally enroll this month our first affected person within the Section 2 medical trial of VERU-100, a novel long-acting GnRH antagonist injection formulation for androgen deprivation remedy. Subsequent month, the Section 3 ARTEST enobosarm for 3rd line AR+ER+ metastatic breast most cancers can be anticipated to start out enrolling. We at the moment are a strong late medical stage oncology biopharmaceutical firm with novel drug candidates in improvement.”

Pharmaceutical Pipeline Highlights:

Sabizabulin (VERU-111) a Novel Oral Agent for the Therapy of Hospitalized COVID-19 Sufferers at Excessive Threat for Acute Respiratory Misery Syndrome (ARDS)- Section 3 Scientific Examine.

We anticipate to enroll our first affected person inside a couple of days in our Section 3 medical trial of sabizabulin, a novel as soon as a day orally dosed small molecule that has each broad anti-viral and anti inflammatory actions which can serve a two-pronged strategy to the remedy of COVID-19 virus an infection and the following debilitating inflammatory results that result in ARDS and demise, in excessive threat hospitalized COVID-19 sufferers. The Section 3 medical trial is a double-blind, multicenter, multinational, randomized (2:1), placebo-controlled trial evaluating each day oral doses of 9 mg sabizabulin for as much as 21 days versus placebo in 300 hospitalized sufferers (200 topics will probably be handled with sabizabulin and 100 topics will obtain placebo/customary of care) who examined optimistic for the SARS-CoV-2 virus and who’re at excessive threat for ARDS. Due to higher oral bioavailability, the systemic blood ranges from the 9 mg sabizabulin dosage are just like the 18 mg sabizabulin formulation used within the Section 2 medical examine. Topics within the sabizabulin and placebo arms may even be allowed to obtain customary of care. The first efficacy endpoint will probably be proportion of sufferers that die on examine as much as Day 60. Secondary endpoints will embody the proportion of sufferers with out respiratory failure, days in ICU, WHO Ordinal Scale for Scientific Enchancment change from baseline, days on mechanical ventilations, days within the hospital, and viral load. The examine will probably be carried out in the USA, Brazil, Argentina, Mexico, and Colombia. Enrollment is focused to be accomplished by calendar year-end.

In February of this yr, the Firm introduced optimistic medical outcomes from the Section 2 trial evaluating sabizabulin for the remedy of hospitalized sufferers with COVID-19 who had been at excessive threat for ARDS. We carried out a double-blind, randomized, placebo-controlled Section 2 medical trial evaluating each day oral as soon as a day dosing of sabizabulin 18 mg versus placebo in roughly 40 hospitalized COVID-19 sufferers who had been at excessive threat for ARDS. This trial was carried out in 5 websites throughout the USA. Sufferers that had been hospitalized with documented proof of COVID-19 an infection with signs and who had been at excessive threat for ARDS had been enrolled. Topics obtained both sabizabulin 18 mg or placebo in addition to customary of look after 21 days or till launched from hospital. The first efficacy endpoint was the proportion of sufferers that had been alive with out respiratory failure at Day 29. For the first endpoint within the modified intent to deal with inhabitants, sabizabulin in comparison with placebo had a statistically vital and clinically significant 81% relative discount in demise or respiratory failure at Day 29. With respect to secondary endpoints, sabizabulin had a statistically vital 82% relative discount in affected person mortality and statistically vital discount in days in ICU; there was additionally a lower in days on mechanical air flow versus placebo. Sabizabulin was nicely tolerated with a great security profile.

Sabizabulin a Novel, Oral, Androgen Receptor Transport Disruptor for the Therapy of Metastatic Castration and Androgen Receptor Focusing on Agent Resistant Prostate Most cancers – Section 3 VERACITY Scientific Examine.

Sabizabulin is a novel, oral, new chemical entity that targets microtubules within the cytoskeleton to disrupt androgen receptor transport. We anticipate enrolling sufferers this month into the open label, randomized (2:1), multicenter Section 3 VERACITY medical trial of sabizabulin 32 mg versus an alternate androgen receptor concentrating on agent for the remedy of chemotherapy naïve males with metastatic castration resistant prostate most cancers who’ve failed at the least one androgen receptor concentrating on agent. Primarily based on the just lately carried out Section 2 PK examine, the blood ranges of the Section 3 medical trial sabizabulin 32 mg drug dose formulation are just like the Section 1b/2 VERU-111 63 mg dosage formulation. The first endpoint is median radiographic development free survival. The Section 3 VERACITY medical trial is anticipated to enroll roughly 245 sufferers.

Within the Section 1b /Section 2 medical trial in metastatic castration and androgen receptor concentrating on agent resistant prostate most cancers, persistent each day administration of sabizabulin was nicely tolerated with a great security profile. There was additionally proof of efficacy together with PSA declines and goal and sturdy tumor responses (partial and full responses).

VERU-100, a Novel, Proprietary Lengthy-Appearing Gonadotropin-Releasing Hormone (GnRH) Antagonist Peptide, 3-Month Subcutaneous Depot Formulation, for Androgen Deprivation Remedy of Superior Prostate Most cancers – Section 2 Scientific Examine.

We anticipate initiation of the Section 2 medical trial of VERU-100 androgen deprivation remedy for hormone delicate superior prostate most cancers this month. The Section 2 VERU-100 medical trial is anticipated to enroll roughly 35 sufferers. VERU-100 formulation is designed to deal with the present limitations of commercially accessible ADT. Androgen deprivation remedy is at the moment the mainstay of superior prostate most cancers remedy and is used as a basis of remedy all through the course of the illness whilst different endocrine, chemotherapy, or radiation remedies are added or stopped. Particularly, VERU-100 is a persistent, long-acting GnRH antagonist peptide administered as a small quantity, three-month depot subcutaneous injection with out a loading dose. VERU-100 instantly suppresses testosterone with no testosterone surge upon preliminary or repeated administration, an issue that happens with at the moment authorized luteinizing hormone-releasing hormone (LHRH) agonists used for ADT. There aren’t any GnRH antagonist depot injectable formulations commercially authorized past a one-month injection. A Section 3 registration medical trial in roughly 100 males is anticipated to start within the second half of calendar yr 2021.

Enobosarm a Novel Oral Selective Androgen Receptor Focused Agonist, for the Therapy of Androgen Receptor Constructive (AR+), Estrogen Receptor Constructive (ER+) and Human Epidermal Development Issue Receptor 2 Destructive (HER2-) Metastatic Breast Most cancers – Section 3 ARTEST Scientific Examine and Section 2 Enobosarm Mixture Examine.

We anticipate to start our pivotal enobosarm Section 3 ARTEST medical examine within the second quarter of calendar yr 2021. Enobosarm is the primary new class of concentrating on endocrine remedy in superior breast most cancers in a long time. Enobosarm is an oral, new chemical entity, selective androgen receptor agonist that targets and prompts the androgen receptor (AR), a tumor suppressor, in AR+ER+HER2- metastatic breast most cancers with out the undesirable masculinizing unintended effects. Enobosarm has in depth nonclinical and medical expertise having been evaluated in 25 separate medical research in roughly 1,450 handled topics, together with three Section 2 medical research in superior breast most cancers involving greater than 250 sufferers. Within the two Section 2 medical research carried out in girls with AR+ER+HER2- metastatic breast most cancers, enobosarm demonstrated vital antitumor efficacy in closely pretreated cohorts that failed estrogen receptor concentrating on brokers, chemotherapy, and/or CDK 4/6 inhibitors and was nicely tolerated with a positive security profile. Within the fourth quarter of calendar 2020, the FDA agreed to the Section 3 multicenter, worldwide, open label, and randomized (1:1) ARTEST registration medical trial design to guage the efficacy and security of enobosarm monotherapy versus doctor’s alternative of both exemestane or a SERM as an lively comparator for the remedy of metastatic AR+ER+HER2- breast most cancers in roughly 210 sufferers who’ve failed a nonsteroidal aromatase inhibitor, fulvestrant and a CDK4/6 inhibitor (third line remedy in a metastatic setting) The first endpoint is median radiographic progression-free survival. In a separate medical improvement program, enobosarm together with abemaciclib, CDK4/6 inhibitor, will probably be evaluated in a 2nd line metastatic setting in AR+ER+ metastatic breast most cancers. A Section 2 examine to guage the efficacy and security of enobosarm together with CDK 4/6 inhibitor (abemaciclib) in comparison with estrogen receptor blocking agent (Energetic Management ) for the remedy of AR+ER+HER2- metastatic breast most cancers in sufferers which have failed an estrogen receptor blocking agent plus a CDK 4/6 inhibitor (palbociclib) is anticipated to start in calendar Q3 2021.

Sabizabulin a Novel, Oral, Cytoskeleton Disruptor Agent for the Therapy of Systemic Chemotherapy together with Taxane Resistant Metastatic Triple Destructive Breast Most cancers – Section 2b Scientific Examine.

Sabizabulin can be being evaluated for the remedy of taxane chemotherapy resistant metastatic triple destructive breast most cancers in a deliberate Section 2b medical examine in roughly 200 girls anticipated to start in calendar Q3 2021. Metastatic triple destructive breast most cancers is an aggressive type of breast most cancers that happens in roughly 15% of all breast cancers. This type of breast most cancers doesn’t specific ER, progesterone receptor (PR), or HER2 and is proof against endocrine therapies. The primary line of remedy normally consists of mixture chemotherapy which incorporates IV taxane chemotherapy. Virtually all girls will finally develop taxane resistance. Sabizabulin is an oral, first-in-class, new chemical entity that targets and inhibits microtubules to disrupt the cytoskeleton. Sabizabulin is just not a substrate for P-glycoprotein drug resistance protein. Over expression of P-glycoprotein is a typical mechanism that ends in taxane resistance in triple destructive breast most cancers. Preclinical research in human triple destructive breast most cancers grown in animal fashions exhibit that sabizabulin considerably inhibits most cancers proliferation, migration, metastases, and invasion of triple destructive breast most cancers cells and tumors which have develop into proof against paclitaxel (taxane). Utilizing the security data from the Section 1b and Section 2 sabizabulin prostate most cancers medical research, the Firm plans to satisfy with the FDA and to start a 3 cohort Section 2b medical examine in calendar Q3 2021 to guage oral each day dosing of sabizabulin monotherapy, TRODELVY® monotherapy, and sabizabulin + TRODELVY mixture remedy in roughly 200 girls with metastatic triple destructive breast most cancers which have develop into proof against at the least 2 systemic chemotherapies together with a taxane.

TADFIN™ (Tadalafil 5mg and Finasteride 5mg Mixture Capsule) for the Therapy of Decrease Urinary Tract Signs Brought on by Benign Prostatic Hyperplasia (BPH) – NDA Filed by FDA; PDUFA Date December 2021.

TADFIN (tadalafil 5mg and finasteride 5mg mixture capsule) was developed to deal with urinary tract signs attributable to BPH. Tadalafil (CIALIS®) is at the moment authorized for remedy of BPH and erectile dysfunction and finasteride is at the moment authorized for remedy of BPH (finasteride 5mg PROSCAR®) and male sample hair loss (finasteride 1mg PROPECIA®). The co-administration of tadalafil and finasteride has been proven to be more practical for the remedy of BPH than finasteride alone with the extra advantage of ameliorating erectile dysfunction. An NDA for TADFIN has been accepted for overview by FDA with a PDUFA date in December 2021. If authorized, TADFIN is anticipated to be marketed and distributed by telemedicine and telepharmacy teams.

Legacy Feminine Well being Enterprise
As beforehand introduced, the Firm continues to discover the complete vary of strategic alternate options for its legacy Feminine Well being Firm Enterprise, which markets the FC2 Feminine Condom® (Inside Condom), together with persevering with to function the enterprise.

Non-GAAP Monetary Data
Sure monetary outcomes for fiscal years 2021 and 2020 are introduced on each a reported and a non-GAAP, adjusted foundation. Reported outcomes had been ready in accordance with U.S. GAAP and embody all income and bills acknowledged through the interval. The non-GAAP outcomes are adjusted to exclude the one-time acquire on sale of PREBOOST within the first quarter of fiscal yr 2021. Administration believes non-GAAP monetary measures present helpful data to buyers relating to the Firm’s outcomes of operations and help administration, analysts, and buyers in evaluating the efficiency of the Firm’s enterprise. Non-GAAP monetary measures must be thought-about along with, and never as an alternative choice to, measures of economic efficiency ready in accordance with GAAP. The Firm has reconciled these non-GAAP monetary measures to the closest reported GAAP measures within the reconciliation desk beneath.

Occasion Particulars
events might entry the decision by dialing 800-341-1602 from the U.S. or 412-902-6706 from exterior the U.S. and asking to be joined into the Veru Inc. name. The decision may even be accessible by way of a stay, listen-only audio broadcast by way of the Web at www.verupharma.com. Listeners are inspired to go to the web site at the least 10 minutes previous to the beginning of the scheduled presentation to register, obtain and set up any essential software program. A playback of the decision will probably be archived and accessible on the identical web site for at the least three months. A telephonic replay of the convention name will probably be accessible, starting the identical day at roughly 12 p.m. (midday) ET by dialing 877-344-7529 for U.S. callers, or 412-317-0088 from exterior the U.S., passcode 10154431, for one week.

About Veru Inc.
Veru Inc. is an oncology biopharmaceutical firm with a give attention to growing novel medicines for the administration of prostate most cancers and breast most cancers. Veru’s prostate most cancers pipeline consists of: sabizabulin, an oral, first-in-class, new chemical entity that targets the cytoskeleton disruptor which in prostate most cancers additionally disrupts androgen receptor transport, is anticipated to start this month a Section 3 VERACITY medical trial in roughly 245 males for the remedy of metastatic castration and androgen receptor concentrating on agent resistant prostate most cancers. VERU-100, a novel, proprietary GnRH antagonist peptide lengthy performing 3-month subcutaneous injection formulation for androgen deprivation remedy, is anticipated to start out the deliberate Section 2 medical examine this month and the Section 3 medical examine is deliberate to provoke in This autumn 2021 to deal with hormone delicate metastatic prostate most cancers. Veru’s breast most cancers pipeline consists of: enobosarm, an oral, first-in-class, new chemical entity, selective androgen receptor agonist that targets and prompts the androgen receptor, a tumor suppressor, to deal with AR+ER+HER2- metastatic breast most cancers with out undesirable masculinizing unintended effects; Section 3 ARTEST medical trial to guage enobosarm in a 3rd line metastatic setting in roughly 210 topics with AR+ER+HER2- superior breast most cancers who’ve failed nonsteroidal aromatase inhibitor, fulvestrant, and a CDK 4/6 inhibitor is anticipated to start Q2 2021. In a separate medical improvement program, a Section 2 examine to guage the efficacy and security of enobosarm together with CDK 4/6 inhibitor (abemaciclib) in comparison with estrogen receptor blocking agent (Energetic Management) for the remedy of AR+ER+HER2- metastatic breast most cancers in sufferers which have failed an estrogen receptor blocking agent plus a CDK 4/6 inhibitor (palbociclib) is anticipated to start in calendar Q3 2021. Sabizabulin can be being evaluated for the remedy of systemic chemotherapy together with taxane resistant metastatic triple destructive breast most cancers in a deliberate Section 2b medical examine in roughly 200 topics anticipated to start Q3 2021. Primarily based on optimistic Section 2 outcomes on the discount of mortality, sabizabulin may even be evaluated in a Section 3 trial in roughly 300 topics for the remedy of hospitalized sufferers with COVID-19 who’re at excessive threat for acute respiratory misery syndrome with enrollment beginning in Could 2021.

The Firm’s Sexual Well being Enterprise industrial product is the FC2 Feminine Condom® (inside condom) (“FC2”), an FDA-approved product for twin safety in opposition to unintended being pregnant and the transmission of sexually transmitted infections. The Firm’s Feminine Well being Firm Division markets and sells FC2 commercially and within the public well being sector each within the U.S. and globally. Within the U.S., FC2 is accessible by prescription by way of a number of third-party telemedicine and web pharmacy suppliers and retail pharmacies. Within the world public well being sector, the Firm markets FC2 to entities, together with ministries of well being, authorities well being businesses, U.N. businesses, nonprofit organizations and industrial companions, that work to assist and enhance the lives, well being and well-being of ladies world wide. The second potential product, if authorized, anticipated for the Sexual Well being Enterprise is TADFIN (tadalafil 5mg and finasteride 5mg) capsule for the administration of tadalafil 5mg and finasteride 5mg mixture formulation dosed each day for benign prostatic hyperplasia (BPH). An NDA was filed by FDA in April 2021 with a PDUFA date in December 2021. To study extra about Veru merchandise, please go to www.verupharma.com.

Ahead-Trying Statements
The statements on this launch that aren’t historic info are “forward-looking statements” as that time period is outlined within the Non-public Securities Litigation Reform Act of 1995. Ahead-looking statements on this launch embody statements relating to the potential of sabizabulin to fight COVID-19 and forestall deaths in sufferers with reasonable to extreme COVID-19 illness who’re in danger for ARDS, deal with metastatic castration and androgen receptor concentrating on agent resistant prostate most cancers, and taxane resistant metastatic triple destructive breast most cancers, the potential for enobosarm to deal with AR+ER+HER2- metastatic breast most cancers, the potential for VERU-100 as an androgen deprivation remedy for superior prostate most cancers, and the potential for TADFIN to deal with BPH, whether or not previous, present and future medical improvement and outcomes and the Firm’s NDA for TADFIN will exhibit ample efficacy and security to safe FDA approval of the Firm’s drug candidates, whether or not the drug candidates will serve any unmet want, whether or not the enrollment or graduation timelines of any of our research will probably be met, statements in regards to the potential, timing and efficacy of the remainder of the Firm’s improvement pipeline, together with the power of the Firm to efficiently launch TADFIN, and what strategic alternate options the Firm might pursue relating to its Feminine Well being Firm enterprise.

These forward-looking statements are based mostly on the Firm’s present expectations and topic to dangers and uncertainties which will trigger precise outcomes to vary materially, together with unanticipated developments in and dangers associated to: the event of the Firm’s product portfolio and the outcomes of medical trials probably being unsuccessful or inadequate to satisfy relevant regulatory requirements or warrant continued improvement; the power to enroll ample numbers of topics in medical trials and the power to enroll topics in accordance with deliberate schedules; the power to fund deliberate medical improvement; the timing of any submission to the FDA and any determinations made by the FDA or every other regulatory authority; the likelihood that as vaccines develop into broadly distributed the necessity for brand new COVID-19 remedy candidates could also be decreased or eradicated; authorities entities probably taking take actions that instantly or not directly have the impact of limiting alternatives for Sabizabulin as a COVID-19 remedy, together with favoring different remedy alternate options or imposing worth controls on COVID-19 remedies; the Firm’s current merchandise and any future merchandise, if authorized, probably not being commercially profitable; the consequences of the COVID-19 pandemic and measures to deal with the pandemic on the Firm’s medical trials, provide chain and different third-party suppliers, industrial efforts, and enterprise improvement operations; the power of the Firm to acquire ample financing on acceptable phrases when wanted to fund improvement and operations; demand for, market acceptance of, and competitors in opposition to any of the Firm’s merchandise or product candidates; new or current opponents with better sources and capabilities and new aggressive product approvals and/or introductions; modifications in regulatory practices or insurance policies or government-driven healthcare reform efforts, together with pricing pressures and insurance coverage protection and reimbursement modifications; the Firm’s means to efficiently commercialize any of its merchandise, if authorized; the Firm’s means to guard and implement its mental property; the potential that delays in orders or shipments beneath authorities tenders or the Firm’s U.S. prescription enterprise might trigger vital quarter-to-quarter variations within the Firm’s working outcomes and adversely have an effect on its web revenues and gross revenue; the Firm’s reliance on its worldwide companions and on the extent of spending by nation governments, world donors and different public well being organizations within the world public sector; the focus of accounts receivable with our largest prospects and the gathering of these receivables; the Firm’s manufacturing capability, effectivity and provide constraints and interruptions, together with potential disruption of manufacturing on the Firm’s and third get together manufacturing amenities and/or of the Firm’s means to well timed provide product on account of labor unrest or strikes, labor shortages, uncooked materials shortages, bodily harm to the Firm’s and third get together amenities, COVID-19 (together with the influence of COVID-19 on suppliers of key uncooked supplies), product testing, transportation delays or regulatory actions; prices and different results of litigation, together with product legal responsibility claims; the Firm’s means to establish, efficiently negotiate and full appropriate acquisitions or different strategic initiatives; the Firm’s means to efficiently combine acquired companies, applied sciences or merchandise; and different dangers detailed once in a while within the Firm’s press releases, shareholder communications and Securities and Alternate Fee filings, together with the Firm’s Kind 10-Ok for the fiscal yr ended September 30, 2020 and subsequent quarterly reviews on Kind 10-Q. These paperwork can be found on the “SEC Filings” part of our web site at www.verupharma.com/investors. The Firm disclaims any intent or obligation to replace these forward-looking statements.

Veru Inc.
Condensed Consolidated Stability Sheets
(unaudited)

March 31,

September 30,

2021

2020

Money and money equivalents

$

136,675,153

$

13,588,778

Accounts receivable, web

5,149,154

5,227,237

Stock, web

7,794,523

6,704,134

Pay as you go bills and different present property

6,432,823

1,494,541

Whole present property

156,051,653

27,014,690

Deferred revenue taxes

9,435,877

9,466,800

Intangible property, web

4,084,524

5,752,127

Goodwill

6,878,932

6,878,932

Different property

4,700,263

2,431,126

Whole property

$

181,151,249

$

51,543,675

Accounts payable

$

5,722,391

$

2,812,673

Accrued analysis and improvement prices

1,100,410

934,110

Accrued bills and different present liabilities

4,770,892

4,038,291

Credit score settlement legal responsibility

4,467,766

5,841,874

Residual royalty settlement legal responsibility, short-term portion

2,805,741

1,100,193

Whole present liabilities

18,867,200

14,727,141

Residual royalty settlement legal responsibility, long-term portion

5,911,983

5,617,494

Different liabilities

876,060

1,087,724

Whole liabilities

25,655,243

21,432,359

Whole stockholders’ fairness

155,496,006

30,111,316

Whole liabilities and stockholders’ fairness

$

181,151,249

$

51,543,675

Veru Inc.
Condensed Consolidated Statements of Operations
(unaudited)

Three Months Ended
March 31,

Six Months Ended
March 31,

2021

2020

2021

2020

Web revenues

$

13,340,487

$

9,943,104

$

27,957,476

$

20,521,120

Value of gross sales

2,432,187

2,506,606

6,212,543

5,815,527

Gross revenue

10,908,300

7,436,498

21,744,933

14,705,593

Working bills

(12,379,710

)

(7,736,176

)

(22,439,344

)

(16,789,664

)

Acquire on sale of PREBOOST®

18,410,158

Working (loss) revenue

(1,471,410

)

(299,678

)

17,715,747

(2,084,071

)

Non-operating bills

(1,352,881

)

(643,971

)

(3,234,035

)

(2,241,422

)

(Loss) revenue earlier than revenue taxes

(2,824,291

)

(943,649

)

14,481,712

(4,325,493

)

Earnings tax expense (profit)

21,690

(133,140

)

99,992

(209,883

)

Web (loss) revenue

$

(2,845,981

)

$

(810,509

)

$

14,381,720

$

(4,115,610

)

Web (loss) revenue per fundamental widespread share excellent

$

(0.04

)

$

(0.01

)

$

0.20

$

(0.06

)

Fundamental weighted common widespread shares excellent

75,175,077

65,367,493

72,717,621

65,202,103

Web (loss) revenue per diluted widespread share excellent

$

(0.04

)

$

(0.01

)

$

0.18

$

(0.06

)

Diluted weighted common widespread shares excellent

75,175,077

65,367,493

80,654,070

65,202,103

Veru Inc.
Condensed Consolidated Statements of Money Flows
(unaudited)

Six Months Ended
March 31,

2021

2020

Web revenue (loss)

$

14,381,720

$

(4,115,610

)

Changes to reconcile web revenue (loss) to web money utilized in working actions

(15,606,848

)

3,951,890

Modifications in working property and liabilities

(705,137

)

(4,763,771

)

Web money utilized in working actions

(1,930,265

)

(4,927,491

)

Web money offered by (utilized in) investing actions

14,987,882

(54,680

)

Web money offered by financing actions

110,028,758

1,244,533

Web enhance (lower) in money

123,086,375

(3,737,638

)

Money at starting of interval

13,588,778

6,295,152

Money at finish of interval

$

136,675,153

$

2,557,514

Veru Inc.
Working Earnings (Loss) by Phase
(unaudited)

Three Months Ended March 31, 2021

Sexual Well being
Enterprise

Analysis &
Growth

Company

Whole

Web revenues

FC2

$

13,340,487

$

$

$

13,340,487

PREBOOST®

Whole web revenues

13,340,487

13,340,487

Value of gross sales

2,432,187

2,432,187

Gross revenue

10,908,300

10,908,300

Working bills

(979,295

)

(7,741,348

)

(3,659,067

)

(12,379,710

)

Working revenue (loss)

$

9,929,005

$

(7,741,348

)

$

(3,659,067

)

$

(1,471,410

)

Three Months Ended March 31, 2020

Sexual Well being
Enterprise

Analysis &
Growth

Company

Whole

Web revenues

FC2

$

9,522,271

$

$

$

9,522,271

PREBOOST®

420,833

420,833

Whole web revenues

9,943,104

9,943,104

Value of gross sales

2,506,606

2,506,606

Gross revenue

7,436,498

7,436,498

Working bills

(1,102,612

)

(3,884,272

)

(2,749,292

)

(7,736,176

)

Working revenue (loss)

$

6,333,886

$

(3,884,272

)

$

(2,749,292

)

$

(299,678

)

Veru Inc.
Working Earnings (Loss) by Phase
(unaudited)

Six Months Ended March 31, 2021

Sexual Well being
Enterprise

Analysis &
Growth

Company

Whole

Web revenues

FC2

$

27,094,645

$

$

$

27,094,645

PREBOOST

862,831

862,831

Whole web revenues

27,957,476

27,957,476

Value of gross sales

6,212,543

6,212,543

Gross revenue

21,744,933

21,744,933

Working bills

(1,900,992

)

(13,600,185

)

(6,938,167

)

(22,439,344

)

Acquire on sale of PREBOOST®

18,410,158

18,410,158

Working revenue (loss)

$

19,843,941

$

(13,600,185

)

$

11,471,991

$

17,715,747

Six Months Ended March 31, 2020

Sexual Well being
Enterprise

Analysis &
Growth

Company

Whole

Web revenues

FC2

$

19,947,195

$

$

$

19,947,195

PREBOOST

573,925

573,925

Whole web revenues

20,521,120

20,521,120

Value of gross sales

5,815,527

5,815,527

Gross revenue

14,705,593

14,705,593

Working bills

(2,402,644

)

(9,174,131

)

(5,212,889

)

(16,789,664

)

Acquire on sale of PREBOOST®

Working revenue (loss)

$

12,302,949

$

(9,174,131

)

$

(5,212,889

)

$

(2,084,071

)

Veru Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Data
(unaudited)

Three Months Ended
March 31,

Six Months Ended
March 31,

2021

2020

2021

2020

Working (loss) revenue reconciliation:

GAAP working (loss) revenue

$

(1,471,410

)

$

(299,678

)

$

17,715,747

$

(2,084,071

)

Acquire on sale of PREBOOST®

(18,410,158

)

Non-GAAP adjusted working loss

$

(1,471,410

)

$

(299,678

)

$

(694,411

)

$

(2,084,071

)

Web (loss) revenue reconciliation:

GAAP web (loss) revenue

$

(2,845,981

)

$

(810,509

)

$

14,381,720

$

(4,115,610

)

Acquire on sale of PREBOOST®

(18,410,158

)

Non-GAAP adjusted web loss

$

(2,845,981

)

$

(810,509

)

$

(4,028,438

)

$

(4,115,610

)

Web (loss) revenue per diluted widespread share excellent reconciliation:

GAAP web (loss) revenue per diluted widespread share excellent

$

(0.04

)

$

(0.01

)

$

0.18

$

(0.06

)

Acquire on sale of PREBOOST®

(0.23

)

Impact of antidilutive shares

(0.01

)

Non-GAAP adjusted web loss per diluted widespread share excellent

$

(0.04

)

$

(0.01

)

$

(0.06

)

$

(0.06

)

GAAP diluted weighted common widespread shares excellent

75,175,077

65,367,493

80,654,070

65,202,103

Probably dilutive shares which are antidilutive on account of web loss

(7,936,449

)

Non-GAAP diluted weighted common widespread shares excellent

75,175,077

65,367,493

72,717,621

65,202,103

Contact:

Sam Fisch

800-972-0538

Director of Investor Relations

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