Q4 2020 Veru Inc Earnings Call

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Good morning, ladies and gentlemen, and welcome to Peru, and investors Conference call.

Operator: Good morning, ladies and gentlemen, and welcome to Veru, Inc.'s Investors Conference Call. All participants will be in listen-only mode.

All participants will be in listen only mode.

Do you need assistance. Please signal a conference specialist by pressing the star keep all that buys euro.

Operator: If you need assistance, please signal a conference specialist by pressing the star key followed by zero. After this morning's discussion, there will be an opportunity to ask questions. Please note that this event is being recorded. I would now like to turn the conference over to Mr. Sam Fisch, Veru Inc.'s Director of Investor Relations. Please go ahead.

After this mornings discussion there will be an opportunity to ask questions.

Please note that this event is being recorded on.

I would now like to turn the conference over to Mr., Sam That's true <unk> director of Investor Relations. Please go ahead.

Good morning, the statements made on this conference call that are non historical in nature on.

Samuel Fisch: Good morning. The statements made on this conference call that are not historical in nature are forward-looking statements. Such forward-looking statements reflect the company's current assessment of the risks and uncertainties related to our business. Our actual results and future developments could differ materially from the results or developments expressed or implied in such forward-looking statements. Factors that may cause actual results or developments to differ materially include such things as the risks related to the development of the company's product portfolio and risks related to the ability of the company to obtain sufficient financing on acceptable terms, which we need to fund development and company operations. Risks relate to competition, government contracting risks, and other risks detailed in the company's press releases, shareholder communications, and securities and exchange commission filings.

Forward looking statements.

That's true and looking statements reflect the company's current assessment on.

The risks and uncertainties related to our businesses.

Our actual results and future developments could differ materially from the results or developments and such forward looking statements.

Factors that may cause actual results or developments to differ materially include such things as the risks related to the development of the company's product portfolio.

Risks related to the ability of the company to obtain sufficient financing on acceptable terms and need to fund development and company operations.

Risks relates a competition government contract and risks and other risk seats on the company's press releases shareholder communication and Securities and Exchange Commission filings.

For additional information regarding such risks the company urges you to review its 10-Q and 10-K SEC filings.

Mitchell S. Steiner: For additional information regarding such risks, the company urges you to review its 10-Q and 10-K SEC filings. I would now like to turn the conference over to Dr. Mitchell Steiner, Veru Inc.'s Chairman, CEO, and President. Thank you, Sam, and good morning.

I would now like to turn the conference over to Dr., Mitchell, Steiner, Everything's, Chairman and CEO and President and.

Thank you Sam and good morning with me on this morning's call, let Michele Greco CFO and CEO, Phil Greenberg Executive Vice President legal and you met Sam Fish director of Investor Relations. Thank you for joining our call we.

Mitchell S. Steiner: With me on this morning's call are Michele Greco, CFO and CAO, Phil Greenberg, Executive Vice President of Legal, and you've met Sam Fisch, Director of Investor Relations. Thank you for joining our call. We have made several important and exciting announcements this morning. It's been a busy quarter.

We have made several important and exciting announcements. This morning, it's been a busy quarter, we actually we actually released two separate press releases. This morning, our earnings release and an update on oncology drug pipeline. This morning, we will discuss these new announcements and its impact on various business strategy the clinical development of our drug pipeline.

Mitchell S. Steiner: We actually released two separate press releases this morning, our earnings release and an update on our oncology drug pipeline. This morning, we will discuss these new announcements and their impact on Veru's business strategy, the clinical development of our drug pipeline, and the commercialization of our products. We will also provide financial highlights for our record fourth fiscal quarter and record year-end fiscal year 2020.

And the commercialization of our products will also provide financial highlights were at record fourth fiscal quarter and record year end fiscal year 2020.

Beer has made the transformation into a later clinical stage oncology biopharmaceutical company focused on developing novel medicines for the management of two of the most prevalent cancers prostate cancer and breast cancer, we continue to invest cash generated from our sexual health commercial business and to the clinical development of our high value.

Mitchell S. Steiner: Veru has made the transformation into a late clinical stage oncology biopharmaceutical company focused on developing novel medicines for the management of two of the most prevalent cancers, prostate cancer and breast cancer. We continue to invest cash generated from our sexual health commercial business into the clinical development of our high-value oncology drug candidates so that our current shareholders can realize the maximum value of our oncology biopharmaceutical company. In fiscal year 2017, the year that the female health company acquired Aspen Park Pharmaceuticals to create Veru, the annual revenues were $13.7 million. And this year, I'm pleased to report that we had a record year of $42.6 million in revenue. In fact, we expect fiscal year 2021 revenue generation will continue to grow robustly for what could be another record year.

On college and drug candidates to their current shareholders can realize the maximum value of our oncology biopharmaceutical company.

In fiscal year 2017, the year that the female health company acquired Aspen Park Pharmaceuticals to create beard and the annual revenues were $13.7 million and this year I'm pleased to report and we had a record year of $42.6 million and revenue in fact, we expect fiscal year 2021 revenue.

New generation will continue to grow robustly bullet could be another record year we.

The competition is great and significant company milestone because we set a new commercial strategy for F. C. Two and launch free Booze, we focused on creating an FC to commercial sector and the U.S. and and do you actually watch FC Tusa prescription product to retail pharmacies and partner with multiple tele medicine and Internet pharmacy part.

Mitchell S. Steiner: We accomplished this great and significant company milestone because we set a new commercial strategy for FC2 and launched Preboost. We focused on creating an FC2 commercial sector in the US. In the US, we launched FC2 as a prescription product in retail pharmacies and partnered with multiple telemedicine and internet pharmacy partners. We decreased our reliance on the global public sector, which was volatile and inconsistent.

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We decreased our reliance on the global public sector, which was volatile and and consistent we launched Prepas, which is marketed online and the United States to a distributor arrangement on to the Roman Swipes brand name by women helps ventures incorporated well minis, and leading telematics and company that sells men's health products via the Internet web site.

Mitchell S. Steiner: We launched Preboost, which is marketed online in the United States through a distributor arrangement under the Roman Swipes brand name by Roman Health Ventures, Inc. Roman is a leading telemedicine company that sells men's health products via the internet website www.getroman.com. Preboost is also marketed in the U.S. through the bricks and mortar retail channel by Playboy Enterprises International as Playboy's

And he W. W get Roman dot com pre boost is also market in the U.S. to bricks and mortar retail channel by Playboy free International Playboy and enterprise and international as Playboys and to intimate white [noise] and.

Now lets focus on some of the financial highlights on various commercial segment, which made up and the F.C. too.

Mitchell S. Steiner: Now let's focus on some of the financial highlights of Veru's commercial segment, which is made up of FC2. Pre-Boost Roman Smides Playboy Intimate Wipes and Drug Commercialization Cost We had net revenues in the United States FC2 prescription business in Q4 fiscal year 2020 of $8.7 million compared to $4.7 million in Q4 fiscal year 2019, which is up 87%. Net revenues for fiscal year 2020 were $42.6 million compared to $31.8 million in fiscal year 2019, which was up 34 percent. In fact, gross profit for fiscal year 2020 was $30.8 million compared to fiscal year 2019 of $21.7 million, which was up 42 percent. Operating loss was $14.7 million, which included a $14.1 million impairment non-cash charge.

Pre boost well mix wise, Playboy intimate wipes and drug commercialization costs, we had net revenues and the United States FC FC tubes prescription business and Q4 fiscal year 2020 of $8.7 million compared to $4.7 million and Q4 fiscal year 2019, which is up 87%.

Net revenues for fiscal year, 2020, with $42.6 million compared to $31.8 million and fiscal year 2019, which was up 34% in fact gross profit for fiscal year, 2020 was $30.8 million compared dollars compared to fiscal year, 2019, and 21.7 million.

Hours, which was up 42% on.

Operating loss was 14.7 million, which includes a $14.1 million impairment non cash charge operating loss before adjustment for impairment was only $600000 all of fiscal year 2020, compared to a loss of $6.4 million and fiscal year 2019.

Mitchell S. Steiner: Operating loss before adjustment for impairment was only $600,000 for all of fiscal year 2020 compared to a loss of $6.4 million in fiscal year 2019. In fact, the operating profit for Q4 of fiscal year 2020 before adjustment for impairment was $2.8 million. Our compound annual growth rate since fiscal year 2017 has been 46%, and we're still growing this segment of our business. In fact, to give you a sense of our growth trajectory, for all of fiscal year 2019, we sold 159,000 units of FC2 in the U.S. prescription market, while in fiscal year 2020, we sold 342,000 units of FC2 in the U.S. prescription market, an increase of 115%. I'm pleased to report that we announced today that we sold our pre-boost business to Roman Health Ventures for $20 million, further strengthening our financial balance sheet.

In fact, the operating profit for Q4 fiscal year 2020 before adjustment for impairment was $2.8 million.

That was our compound annual growth rate since fiscal year 2017 has been 46% and we will continue we still growing this segment of our business in fact to give you a sense of our growth trajectory from all of fiscal year 2019, We sold 159000 units of FC too and the U.S. prescription market.

While fiscal year 2020, we sold 342000 units of FC too and the U.S. prescription market and increase of 115%.

I'm pleased to report.

That we announced today that we sold our pre boost business to Rome, and health ventures for $20 million further strengthening our financial balance sheet sets.

Sexual health business continues to generate record revenues and we expect robust and growing revenues from the sexual health business for another year and another record year in fiscal 2021.

Mitchell S. Steiner: The sexual health business continues to generate record revenues, and we expect robust and growing revenues from the sexual health business for another record year, fiscal 2021, which further enhances its potential value as a stand-alone business if the company were to decide to monetize this asset like we did with Preboost to streamline the company into a pure oncology biopharmaceutical company with significant cash resources. Tadfin, which is Tadalafil 5 mg Finasteride 5 mg Combination Capsule, is being developed to treat lower urinary tract symptoms caused by benign prostatic hyperplasia.

Which further enhances its potential value as a standalone business. If the company were to decide to monetize this asset like we did with pre boost to streamline the company into a pure oncology biopharmaceutical company with significant cash resources and.

And fin, which is to Dalafield five milligrams finasteride five milligrams combination capsule is being developed to treat lower here and eight track and symptoms caused by benign prosthetic hyperplasia, a copy have successful pre NDA meeting with FDA and the required one year stability testing on three manufacturing commercial batches is.

Mitchell S. Steiner: The company had a successful pre-NDA meeting with the FDA, and the required one-year stability testing on three manufacturing commercial batches is being completed. Consequently, we expect to submit the NDA for TADFIN in early calendar year 2021, with a launch, if approved, via telemedicine channels in late 2021. This will be another near-term source of additional revenue for Veru.

And completed.

Consequently, we expect to submit the NDA for Tad fan and early calendar year 2021, with a launch if approved via telemedicine channels. In late 2021. This will be another near term source of additional revenue revera.

Mitchell S. Steiner: Consequently, I am pleased to report that, based on current clinical development plans, we expect that the company will have sufficient resources generated from our sexual health business and existing sources of cash to fund the clinical development of all of the oncology drug programs that I will discuss without the need for new equity financing through the end of fiscal year 2022. By progressing our own pipeline and recently acquiring the worldwide rights to a phase three ready novel breast cancer drug, Veru has made the transformation into a late clinical stage oncology biopharmaceutical company focused on developing novel medicines for the management of two of the most prevalent cancers globally, prostate cancer and breast cancer. Prostate cancer is the most commonly diagnosed cancer in men, with an estimated 191,930 new cases and 33,330 deaths expected in 2020 in the United States.

Consequently I.

I am pleased to report that based on current clinical development plans, we expect that the company will have sufficient resources generated from our sexual health business and existing sources of cash to fund the clinical development of all of the oncology drug programs that I will discuss without the need for new equity financing through.

The end of fiscal year 2022.

By progressing our own pipeline and recently acquiring the worldwide rights to a phase three ready novel breast cancer drugs beer has made the transformation into a late clinical stage oncology biopharmaceutical company focused on developing novel medicines for the management of two of the most prevalent cancers globally.

Good day cancer and breast cancer.

Prostate cancer, and most commonly diagnosed cancer and men with an estimated 191930, new cases and 33230 debt is expected for 2020 in the United States. One in nine men is expected to develop prostate cancer and a lifetime prostate cancer has become a chronic disease.

Mitchell S. Steiner: One in nine men is expected to develop prostate cancer in a lifetime. Prostate cancer has become a chronic disease, with new challenges as it develops resistance to current drugs and spreads through the body, and as the patient suffers from the long-term side effects of prostate cancer treatments, like hot flashes, bone loss and fractures, loss of libido, erectile dysfunction, loss of muscle strength, and frailty. Breast cancer is the most commonly diagnosed cancer in women, with an estimated 276,480 new cases and 42,170 deaths expected in 2020 in the United States. Additionally, one in eight women is expected to develop invasive breast cancer in a lifetime. There are many different types of breast cancer with diverse clinical and molecular characteristics. The most common type is hormone receptor positive, where estrogen is one of the main drivers of breast cancer proliferation, tumor progression, and metastasis. Consequently, treatments that target the estrogen receptor are the mainstay of breast cancer therapy. But unfortunately, almost all women will eventually develop resistance to endocrine therapy.

With new challenges as prostate cancer developed resistance resistance to current drugs and spread through the body and as the patient suffers from the long term side effects and prostate cancer treatments like hot flashes bone loss and fractures loss of libido erectile dysfunction loss and muscle strength and frailty breast cancer is the most commonly died.

Diagnose cancer and women with an estimated 276400 and new 480, new cases, and 42170 deaths expected for 2020 in the United States, One and eight women is expected to develop and best invasive breast cancer and the lifetime.

There are many different types of breast cancer with diverse clinical molecular characteristics and most common type is hormone receptor positive with the ESRD, where estrogen is one of the main drivers of prostate and breast cancer, both ration tumor progression and metastasis, Consequently treatments that target the estrogen receptor or the mainstay.

Breast cancer therapy, but unfortunately, and almost all women will eventually develop resistance to endocrine therapies and alternative treatment approaches will be required including Ivy chemotherapy.

Mitchell S. Steiner: And alternative treatment approaches will be required, including IV chemotherapy. Another form of breast cancer that occurs in 15% of all breast cancers is called triple negative breast cancer. Triple negative breast cancer does not have an estrogen receptor or a progesterone receptor and does not make something called human epidermal growth factor 2, also known as HER2. As a consequence, triple negative breast cancer is an endocrine-resistant, aggressive cancer that grows and spreads faster than hormone-receptive positive breast cancer. Triple negative breast cancer also develops resistance to the currently used chemotherapy drugs like taxanes, and as such, alternative treatment options for triple negative breast cancer are very limited. Accordingly, we are dedicated to the development and commercialization of drug candidates to address unmet medical needs for prostate and breast cancer management, and we have made great progress.

Another form of breast cancer their careers and 15% of all breast cancers called triple negative breast cancer Triple negative breast cancer does not have and estrogen receptor progesterone receptor and does not make something called human epidermal growth factor to also known as her too and as a consequence triple negative breast cancers isn't endocrine resistance.

Aggressive cancer that grows and spreads fast and hormone receptor positive breast cancers triple negative breast cancer also developed resistance to the currently used chemotherapy drugs like taxanes and as such alternative treatment options with triple negative breast cancer or very limited.

Accordingly, we are dedicated to the development and commercialization and drug candidates to address unmet medical needs for prostate and breast cancer management and for which we have made great progress. We we are excited to advance our prostate cancer drug candidates fear 111, and grew 100 as well as our breast cancer drug.

Mitchell S. Steiner: We are excited to advance our prostate cancer drug candidates, Veru111 and Veru100, as well as our breast cancer drug candidates, which recently acquired an OBUS arm and a new additional indication for Veru111, into registration clinical studies. Veru anticipates the potential for four registration clinical trials before oncology indications commence in calendar year 2021. In prostate cancer, the company continues to make strong clinical progress, advancing Veru111 as a treatment for metastatic castration-resistant prostate cancer who have also become resistant to the androgen receptor targeting agent. First, an update on Veru111 for the treatment of men with metastatic castration-resistant prostate cancer who have also become resistant to the androgen receptor targeting agent. Veru-111 is an oral, first-in-class, new chemical entity that targets, cross-links, and disrupts the alpha and beta tubulin subunits of microtubules to disrupt the cytoskeleton. We're calling it a cytoskeleton disruptor.

And it's a recently acquired and Opus arm and the new additional indications of your 111 into registration clinical studies Vera.

Moving to anticipate the potential for for registration and clinical trials before oncology indications commencing in calendar year 2021.

And prostate cancer. The company continues to make strong clinical progress advancing Bureau, oneweb and as a treatment for metastatic castration, and and antigen receptor targeting age and resistant prostate cancer and beer and 100 for the for androgen deprivation therapy for advanced prostate cancer first and update on beer Oneweb and for the treatment of bandwidth.

Metastatic castration resistant prostate cancer, who have also become resistant to the androgen receptor targeting agent.

Very 111 is an oral first in class new chemical entity that targets cross links and disrupts the alpha and beta Tubulin sub units of microtubules to do swept the side the Skelton, we're calling and the side the skeleton descriptor.

Tier 111 is being evaluated and an open label phase one b and phase two clinical studies and men with metastatic castration and answering receptor targeting age and resistant prostate cancer and the phase one clinical study and completed enrollment and 39 man and his ongoing phase one B study has yielded promising efficacy and safety.

Mitchell S. Steiner: MIR-111 is being evaluated in open-label Phase 1b and Phase 2 clinical studies in men with metastatic castration and antigen receptor targeting agent resistant prostate cancer, and the Phase 1b clinical study completed enrollment of 39 men and is ongoing. The Phase 1b study has yielded promising efficacy and safety clinical results. Based on the Phase 1b study results, the recommended Phase 2 dose is 63 milligrams oral daily continuous dosing for 21 days. Daily chronic drug administration appears feasible and safe.

Clinical results based on the phase one B study results. The recommended phase two dose is 63 milligrams oral daily continuous dosing for 21 days daily chronic drug administration appears to be feasible and safe at the recommended phase two doses there were no reports and neutropenia neurotoxicity or grade three diarrhea.

Mitchell S. Steiner: At the recommended Phase 2 dose, there were no reports of neutropenia, neurotoxicity, or grade 3 diarrhea. The efficacy results showed PSA declines in responses as well as objective and durable tumor responses. Furthermore, the median treatment duration without cancer progression in men who have had at least four cycles of Veru-111 is greater than 11 months in September of 2020. The Phase 2 clinical study completed the enrollment of approximately 40 men with metastatic castrate-resistant prostate cancer who have also become resistant to an androgen receptor-targeting agent such as abiraterone, enzalutamide, or apalutamide but prior to proceeding to IV chemo. Although the study is still ongoing, daily chronic drug administration appears feasible and safe. At 63 milligrams daily continuous dosing, there were no reports of neutropenia, a single report of minor neurotoxicity, and manageable cases of diarrhea.

On the efficacy results show that show PSC declines of responses as well as objective and durable tumor responses. Furthermore, the median treatment duration without cancer progression and men have had at least four cycles of your 111 is greater than 11 months, we still have patients on the study.

In September 2020 day.

The phase two clinical study completed enrollment of approximately 40 men with metastatic castrate resistant prostate cancer. We have also become resistance and androgen receptor targeting agent such as apparatus zone, Enzalutamide and solidify the absolute divide the prior to proceeding to Ivy chemo and though the study is still ongoing daily cash.

On a truck administration appears to be feasible and safe and.

And 63 milligrams daily continuous dosing, two and no reported neutropenia single reported mine and or toxicity, and manageable cases, and diarrhea like to phase one b, we have observed efficacy results, including PSC declines and responses as well as objective and durable tumor responses we plan.

Mitchell S. Steiner: Like in Phase 1b, we have observed efficacy results including PSA declines and responses, as well as objective and durable tumor responses. We plan to report the results of the Phase 2 study in the first half of 2021. As we already have enough safety and efficacy data to select a dose for Vero111 and to proceed to a Phase III, the company had an FDA meeting in July of 2020 and received positive input from FDA on the pivotal Phase III trial design for Vero111. The company received regulatory clarity that the indication for treatment in men with metastatic castration-resistant prostate cancer who have failed one androgen-receptive targeting agent prior to IV chemotherapy was acceptable, that an open-label, randomized study using an alternative androgen receptor targeting agent as an active control is reasonable, and that the primary endpoint may be radiographic progression-free survival.

The report the results of the Phase II study in the first half of 2021.

As we have already and enough safety and efficacy data is selected dose Revere award on 11 and to proceed to a phase three the company had an FDA meeting in July of 2020, and we see positive and put them on FDA on the pivotal phase III trial design to veer away on 11, the company received regulatory clarity that to indicate.

And of treatment in men with metastatic castration resistant prostate cancer, we have failed one androgen receptor targeting age and the prior to Ivy chemotherapy was acceptable.

That an open label randomized study using alternative androgen receptor targeting age and as an active control is reasonable and that the primary endpoint may be radiographic progression free survival.

By allowing radiographic progression free survival as a primary endpoint sample size of the phase three clinical study could be potentially around 200 man.

Mitchell S. Steiner: By allowing radiographic progression-free survival as a primary endpoint, the sample size of the Phase III clinical study could potentially be around 200 men. The Phase III Pivotal Clinical Study will evaluate VERA-111 for men with metastatic castration-resistant prostate cancer who have become resistant to one androgen receptor targeting agent and will be called the Veracity Phase III Study. The company anticipates that the Veracity Phase III study will start in the first quarter of calendar year 2021. Next, I will update you on Veru100 as an androgen deprivation therapy for the palliative treatment of advanced prostate cancer. Veru100 is a novel proprietary long-acting gonadotropin-releasing hormone, GnRH antagonist peptide, three-month subcutaneous depot formulation designed to address the current limitations of commercially available androgen deprivation therapy, also known as ADT. Androgen deprivation therapy is currently the mainstay of advanced prostate treatment used as a foundation of treatment throughout the course of the disease.

The phase three pivotal clinical study will evaluate very well 11 for men with metastatic castration resistant prostate cancer. They have become resistant to one antigen receptor targeting agent and will be called the veracity phase three study comps.

The company anticipates that the Voracity phase three study and the first quarter anticipate starting the veracity phase III study in the first quarter of calendar year 2021.

Next I will update you on Veera 100, and androgen deprivation therapy for Italian to treatment of advanced prostate cancer Pier 100 is a novel proprietary long acting banana trope and releasing hormone GE and our age and Tackiness peptide three months of subcutaneous depot formulation designed to address.

The current limitations of commercially available androgen deprivation therapy is also known as 80 Ti androgen deprivation therapy is currently the mainstay of advanced prostate cancer treatments used as a foundation of treatment throughout the course and the disease. Furthermore, 80 Ti is continued as other endocrine.

Mitchell S. Steiner: Furthermore, ADT is continued as other endocrine chemotherapy or radiation treatments are added or stopped. Specifically, Veru 100 is a chronic, long-acting GNRH-antagonist peptide administered as a small-volume, three-month delayed subcutaneous injection without a loading dose. Veru 100 is expected to immediately suppress testosterone with no testosterone surge upon initial or repeated administration, a concern that occurs with currently approved glutonizing hormone-releasing hormone agonists used for ADT. The Phase 2 study to evaluate Veru 100 dosing is anticipated to begin early in the first quarter of calendar year 2021, and the registration phase 3 study in approximately 100 men is anticipated to start in the second half of calendar year 2021. We have been opportunistic.

Chemotherapy or radiation treatments are added per staffed.

Specifically veer 100 is a chronic long acting G and Ari GE and our age antagonists peptide administered as a small volume three months depots subcutaneous injection without a loading dose view on hand is expected to immediately suppressed testosterone with no testosterone surge upon initial repeated administration and concerned that occur.

As with currently approved utilizing hormone releasing hormone and.

Agonists used for 80 Ti there are no GE and our age antagonists depot injection injectable formulations commercially approved for treatment beyond one month duration.

A phase two study to evaluate your 100 dosing is anticipated to begin early in the first quarter of calendar year 2021, and the registration phase three studies and approximately 100 man is anticipated to start and second half of calendar year 2021.

We have been opportunistic and we added a new late stage late clinical stage breast cancer drug pipeline, which includes the novus arm and veer away and 11.

Mitchell S. Steiner: And we added a new late clinical stage breast cancer drug pipeline, which includes Inovasarm and Vero111. ANOVA's arm is a selective angina receptor targeting agonist being developed for the treatment of angina receptor positive, estrogen receptor positive, and HER2 negative metastatic breast cancer, but prior to IV chemotherapy. Veru has exclusively in-licensed full worldwide rights to Inovasarm from the University of Tennessee Research Foundation and the Ohio State Research Foundation

The Novus arm as a selective androgen receptor targeting agonists being developed for the treatment of androgen receptor positive estrogen receptor positive and hertwo negative metastatic breast cancer, but prior to Ivy chemotherapy.

True has exclusively in license flow worldwide right to know bizarre and from the University of Tennessee Research Foundation, and the Ohio State lease Research Foundation, and Novus arm is and oral first in class new chemical entity.

Mitchell S. Steiner: Inovasarm is an oral, first-in-class, new chemical entity, selective androgen receptor target at age 18. Our first indication for the clinical development of Inobosarum will be for the treatment of ER-positive, HER2-negative metastatic breast cancer prior to IV chemotherapy. NovoSarin, by targeting the antireceptor, which is present in up to 90% of advanced hormone receptor positive breast cancers, represents the first new class of endocrine therapies in advanced breast cancer in decades. Inovasarm has extensive non-clinical and clinical experience, having been evaluated in over 25 separate clinical studies in more than 2,100 subjects, including five prior Phase II clinical studies in advanced breast cancer involving more than 250 patients. Nobisarm binds to the androgen receptor in breast cancer tissue to inhibit AR-ER positive cancer cell proliferation and tumor growth. This has been seen in Phase II human clinical studies as well as in animal models. Unlike testosterone, Nobisarm cannot be aromatized to estrogen.

Selective androgen receptor targeted agent our first indication for the clinical development of Innovus arm will be for the treatment of your positive hertwo negative metastatic breast cancer, but prior to Ivy chemotherapy and.

No just on by targeting the and receptor which is present in up to 90% of advanced hormone receptor positive breast cancers represents the first new class of targeting endocrine therapies and advanced breast cancer and decades.

And no wish on has extensive nonclinical and clinical experience, having been evaluated and over 25 separate clinical studies and more than 20 and more than 2100 subjects, including five prior phase two clinical studies and advanced breast cancer involving more than 250 patients.

And no bust on bind to the Andrew receptor in breast cancer tissue to inhibit our IAR positive cancer cell proliferation and tumor growth. This scene and phase two human clinical studies as well as and animal models and like testosterone and Novus on cannot be aromatised estrogen and Novus arm has additional selective clinical properties.

Mitchell S. Steiner: Inovasarm has additional selective clinical properties that could have potential benefit in women with hormone receptor positive metastatic cancer. More specifically, preclinical studies have shown that Inovasarm builds and heals cortical and trabecular bone, with the potential to treat hormone treatment-induced osteoporosis and skeletal-related cancer events. Inovasarm has also been shown to build muscle, reduce fat, and improve physical function in clinical studies involving elderly subjects and patients with cancer cachexia, including breast cancer. Furthermore, the tissue selectivity of a novus arm also results in a favorable side effect profile, with no virilization, that is, facial hair and acne, no increase in hematocrit, and no liver toxicity.

And that it could have potential benefit and women with hormone receptor positive metastatic cancer more specifically preclinical studies have shown that innovus on builds and heels cortical and trabecular bone with a potential to treat treatment induced osteo hormone treatment induced osteoporosis and skeletal related cancer events.

And those aren't has also been shown to build muscle to reduce that to improve physical function and clinical studies involving elderly subjects and patients with cancer cachexia, including breast cancer.

Furthermore, the tissue selective reflectivity of and know SARM also results in a favorable side effect profile with no visualization thats facial hair and acting no increase in same adequate and the liver toxicity.

Science supporting the efficacy of and overtime and targeting the androgen receptor and hormone receptor positive advanced breast cancer will immediately be published in nature medicine by an independent group of breast cancer and experts.

Mitchell S. Steiner: Science supporting the efficacy of Inovasarm and targeting the antigen receptor and hormone receptor positive advanced breast cancer will be published in Nature Medicine by an independent group of breast cancer experts. In the two Phase II clinical studies evaluating Inovasarm in advanced AR-positive, ER-positive, HER2-negative breast cancer, Inovasarm, as an oral endocrine therapy, demonstrated significant antitumor efficacy in heavily pretreated cohorts and The first Phase II clinical study, G2-00801, was a single-arm study evaluating a 9-milligram oral daily dose of Inovasarum in a heavily pretreated, endocrine-resistant cohort of 22 patients with AR-positive, ER-positive, and HER2-negative advanced breast cancer. Patients participating in the study, on average, had three previous lines of endocrine therapy, and 68% had previous chem The clinical benefit rate at six months was 35.3%. The six-month Kaplan-Meier estimate for radiographic progression-free survival was 43.8%. Inovasone was well-tolerated without evidence of virilization, no increases in hematocrit, and no liver toxicity.

And the two phase two clinical studies, evaluating and Novus arm and and advance our positive you are positive hertwo negative breast cancer and Novus arm as an oral and two queen therapy demonstrated significant anti tumor efficacy and heavily pretreated cohort and was very well tolerated with a favorable side effect profile.

The first phase two clinical study G. Two 008 on one was a single arm study evaluating a nine milligram oral daily dose of and Novus arm and a heavily pretreated endocrine resistant cohort of 22 patients that they are positive year positive and her two negative advanced breast cancer pain.

And is participating in the study on average had three previous lines of endocrine therapy and 68% at previous chemotherapy. The clinical benefit rate at six months was 35.3% to six month Kaplan Meier estimate for radiographic progression free free survival was 43.8% and notice on was well tolerated without ever.

And and severe realization no increases and have adequate and no liver toxicity SEC.

The second phase two clinical study G. Two 008 on two was a two arm study evaluating nine milligrams and 18 milligrams of a notice on daily oral dosing and 136 women with ERP positive Hertwo negative advanced breast cancer patients. In this study will also heavily pretreated having failed.

Mitchell S. Steiner: The second Phase II clinical study, G200802, was a two-arm study evaluating 9 mg and 18 mg of Inovasarm daily oral doses in 136 women with ER-positive, HER2-negative advanced breast cancer. Patients in this study were also heavily pre-treated, having failed an average of four endocrine treatments, and 88% had received prior chemotherapy. The primary investigator for the study was Dr. Beth Ova-Moyer, founder and director of the Inflammatory Breast Cancer Program at Dana-Farber Cancer Institute in Boston, Massachusetts, and assistant professor of medicine at Harvard Medical School.

On an average of four and different treatments and 88% have received prior chemotherapy.

Primary investigator for this study with Dr., Beth Overmoyer founder and director of the inflammatory breast cancer program, and Dana Farber Cancer Institute, and Boston, Massachusetts, and assistant Professor of Medicine, and Harvard Medical School. The completed Phase II study results will be presented as a spotlight presentation at the.

Mitchell S. Steiner: The completed Phase II study results will be presented as a spotlight presentation at the San Antonio Breast Cancer Symposium tomorrow, December 10th, at 2.15 p.m. by Professor Carlo Palmieri, Professor of Translational Oncology and Medical Oncologist at the University of Liverpool. The abstract is number 811, and it's entitled, The Efficacy and Safety of the Novus Arm Selective Angioreceptor Modulator to Target Angioreceptors in Women with Advanced ER-positive, AR-positive breast cancer, final results from an international Phase II randomized study. Overall, these metastatic breast cancer clinical studies of anobis arm in heavily pre-treated subjects with hormone-receptor positive breast cancer strongly established the relevance of targeting the androgen receptor with a selective androgen receptor agonist, both for efficacy and safety, and with additional benefits. Owing to its high tissue selectivity, inobus arm increases muscle and physical function, decreases fat, improves bone strength, and lacks the androgenic adverse effects, including virilization, liver toxicity, and increased hematocrit.

San Antonio breast cancer Symposium Tomorrow December 10th at 215, P.M. by Professor Carlo Palmeri, Professor translational oncology and medical oncology and and medical oncologist and the University of Liverpool, the abstract as number 811 and is entitled the efficacy and safety and Novus arm and.

Selective and receptor modulators to treat to target and in receptor in women with advanced GR positive AR positive breast cancer final results from an international phase two randomized study.

Overall, these metastatic breast cancer clinical studies, and the Novus arm and heavily pre treated subjects with pharma and receptor positive breast cancer strongly establish the route relevance of targeting the and receptor with a selective androgen receptor agonist, both the efficacy and safety and with additional other Bennett.

It's going to it's high tissue, so activity and opus arm increases muscle on physical function decreases fat improves bone strength and lacks the Andrew janick.

Adverse effects, including visualization liver toxicity increases and Medicaid by targeting the androgen receptor and hormone receptor positive metastatic breast cancer and Novus arm introduces a novel endocrine therapy to patients with breast cancer that have exhausted and ocwen therapies targeting the estrogen receptor prior to Ivy.

Mitchell S. Steiner: By targeting the androgen receptor in hormone-receptive positive metastatic breast cancer, Inobus arm introduces a novel endocrine therapy to patients with breast cancer that have exhausted endocrine therapies targeting the estrogen receptor but prior to IV chemotherapy. The company met with FDA in October of 2020 to discuss the ANOVUS-ARM Clinical Breast Cancer Program. The FDA has agreed to the Phase III Registration Clinical Trial Study to evaluate the efficacy and safety of ANOVUS-ARM versus an active control, which will be either examestane or tamoxifen, physician's choice, for the treatment of metastatic ER-positive HER2-negative breast cancer in approximately 240 women that have failed a non-steroidal aromatase inhibitor, an astrazole or an electrozol The Phase III study will be called the ARTES study, or A-R-T-E-S-T study.

RFP.

The company met with FDA and October 2020 to discuss the Innovus on clinical breast cancer program. The FDA has agreed to the phase three registration clinical trial. This study to evaluate the efficacy and safety of a novus arm versus an active control, which will be either XML stain of tamoxifen fuzzy.

Patients choice for the treatment of metastatic ERP positive hertwo negative breast cancer and approximately 240 women that have failed a non steroidal and were on the taste inhibitor and thats resolved or letrozole for investment and a CDK four six inhibitor.

The phase three study will be called the artist study a R. T. S. T study the primary endpoint is radiographic progression free survival. The pivotal phase three open label randomized active controlled study is anticipated to commence in the first half of calendar year 2021.

Mitchell S. Steiner: The primary endpoint is radiographic progression-free survival. The pivotal Phase III open-label randomized active control study is anticipated to commence in the first half of calendar year 2021. It should be noted that Inovasarm has strong intellectual patent protection with U.S. Composition of Matter patents that expire in 2029 with a potential for a five-year patent extension for an NCE to 2034 and with method of use patents that will expire as early as 2033.

It should be noted.

That a novus arm had strong intellectual patent protection with us composition of matter patents that expire and 2029 with a potential for five year patent extension put in and CE 2034, and with method of use patents that will expire as early as 2033 and Novus arm is a large market opportunity as.

Mitchell S. Steiner: Inovasarm is a large market opportunity as it represents the first new class of targeted endocrine therapy in hormone-receptive positive advanced breast cancer in decades. Inovasarm targets the endocrine receptor in ER-positive HER2-negative metastatic breast cancer as a potential second-line and or third-line oral daily dosing endocrine therapy option in breast cancer patients that have exhausted endocrine therapies targeting the ester The global annual market for an oral agent in an ER endocrine-resistant setting is expected to be $6 billion. We have made a decision to advance VIRU-111 into a Phase IIb clinical study for the treatment of taxane-resistant metastatic triple negative breast cancer. As I mentioned, metastatic triple negative breast cancer is an aggressive form of breast cancer that is present in approximately 15% of all breast cancers. This form of breast cancer does not express the estrogen receptor, the progesterone receptor, or HER2, and is resistant to endocrine therapy. The first line of treatment usually includes IV taxing chemotherapy. However, almost all women will eventually develop taxing resistance.

It represents the first new class of targeted endocrine therapy, and hormone receptor positive breadth advanced breast cancer, and decades, and novus on targets and receptor and IAR positive hertwo negative metastatic breast cancer as a potential second line and or third line oral dose oral daily dosing endocrine therapy option.

And breast cancer patients that have exhausted endocrine therapies targeting the estrogen receptor, but prior to Ivy chemotherapy. The global annual market from an oral agent and and you are and Declan resistant settings expected to be $6 billion next.

We have made a decision to advance Bureau, 111 and to a phase Twob clinical study for the treatment of Taxane resistant metastatic triple negative breast cancer.

As I mentioned metastatic triple negative breast cancer is and aggressive form of breast cancer that represent and thats present, and approximately 15% of our breast cancers. This form of breast cancer. This non especially estrogen receptor the progesterone receptor, where her twod and her too and as resistant to endocrine therapies. The first line the treatment usually and includes and.

Taxane chemotherapy.

Most all women will eventually develop taxane resistance overexpression of peak like of protein pumps that cancer drug back out of the cancer. So to avoid cancer cell debt and this is a common mechanism that results and taxane resistance and triple negative breast cancer.

Mitchell S. Steiner: Overexpression of P-glycoprotein pumps that cancer drug back out of the cancer cell to avoid cancer cell death, and this is a common mechanism that results in taxa and resistance in triple negative breast cancer. Beer 111, on the other hand, is an oral cytoskeleton disruptor that cannot be pumped out of the cancer cell by P-glycoprotein drug resistance protein. Preclinical studies in human triple negative breast cancer grown in animal models demonstrate that Veru-111 significantly inhibits cancer proliferation, migration, metastasis, and invasion of triple negative breast cancer cells and tumors that have become resistant to Paclitaxel, which is a taxane. In fact, a poster is being presented this morning at 9 a.m. Eastern at the San Antonio Breast Cancer Symposium virtual meeting on the preclinical efficacy data entitled Veru-111 as an orally available tubulin inhibitor suppressing both taxane-sensitive and taxane-resistant triple negative breast cancer.

Tier 111 on the other hand as an oral.

Scientists Skelton disruptor cannot be pumped out of the cancer cell by people like a protein drug resistance protein preclinical studies and human triple negative breast cancer grown and animal models demonstrate that bureau on 11 significantly inhibits cancer proliferation migration and metastasis and invasion and triple negative breast cancer cells.

And tumors that become resistant to Paclitaxel, which is a taxane in fact, a posters being presented this morning at nine am eastern at the San Antonio breast cancer Symposium virtual meeting on the preclinical efficacy data and titled Veer, One on 11, as an orally available tubulin inhibitor suppress.

Both taxane sensitive and Taxane resistant triple negative breast cancer and this will be presented by Dr. Wei Lee at.

Mitchell S. Steiner: And this is going to be presented by Dr. Wei Li from the University of Tennessee Health Science Center. Using the safety information from the Phase 1b and Phase 2 VIR-111 prostate cancer clinical studies and a total of 80 men, we will meet with the FDA in the first half of calendar year 2021 to discuss the Phase 2 clinical trial design for possible accelerated approval for VIR-111 versus active control therapy for patients with taxane-resistant triple negative breast cancer, making the proposed trial a potential registration trial. The Phase IIb clinical studies plan to commence in the second half of the calendar year 2021. And as I mentioned, this would represent a second major clinical oncology indication for VERA 1.11. The number of new U.S. breast cancer cases in 2020 totaled 276,480, with triple negative breast cancer accounting for 10 to 15 percent of approximately 41,472 patients.

At the University of from the University of Tennessee Health Science Center.

Using the safety information from the phase one B and phase two view on 11 prostate cancer clinical studies and a total of 80 men, we will meet with the FDA and the first half of calendar year calendar 2021 to discuss the phase two clinical trial design for possible accelerated approval severe 111 versus active.

Neutral codell the per patients with taxane resistant triple negative breast cancer, making the proposed trial and potential registration trial.

The phase Twob clinical studies plan to commence in the second half of calendar year 2021, and as I mentioned. This this would represent a second major clinical oncology indication severe 111, the number of new us breast cancer cases in two.

2020 totaled 276480 with triple negative breast cancer accounting for 10% to 15% approximately 41472 patients. The majority of women will receive Ivy chemotherapy, including Taxanes. All of these will develop debt almost all of these will develop tax and resistance and will be a candidate's severe one lab.

Mitchell S. Steiner: The majority of women will receive IV chemotherapy, including taxanes. Almost all of these women will develop taxane resistance and will be a candidate for VERA 1.11. The annual U.S. market for taxane-resistant metastatic triple negative breast cancer is estimated to be over $1 billion, the company's other indications. 111 for the treatment of SARS-CoV-2 in subjects at high risk for acute respiratory distress.

And the annual us market, a taxane resistant metastatic triple negative breast cancers estimate to be over $1 billion.

The company's other indications include Veer 111 for the treatment of Sars koby to and subjects and high risk acute respiratory distress syndrome.

To Veer 111 is being done is being evaluated and phase two clinical trial to assess the efficacy of beer one Lebanon combating COVID-19 to prevent a Rgs Bureau, and 11 by targeting microtubules may have broad anti viral and strong anti inflammatory effects, including and potential to treat cytokine release syndrome, that's associated with high cobot.

Mitchell S. Steiner: So VERA-111 is being evaluated in a Phase II clinical trial to assess the efficacy of VERA-111 in combating COVID-19 to prevent ARDS. VERA-111, by targeting microtubules, may have broad antiviral and strong anti-inflammatory effects, including the potential to treat cytokine release syndrome that's associated with high COVID-19 mortality rates. VERA is currently enrolling a double-blind, randomized placebo-controlled Phase II clinical study evaluating daily doses of VERA-111 18 mg versus placebo for 21 days in 40 hospitalized patients who tested positive for SARS-CoV-2 virus and are at high risk for ARDS. The primary endpoint is the proportion of patients that are alive and without respiratory failure at day 22. Secondary endpoints include the measured improvements in the WHO disease severity scale, which is an eight-point ordinal scale that captures COVID-19 disease symptoms and signs, including hospitalization, progression of pulmonary symptoms, to mechanical ventilation, as well as death.

19 mortality rate.

Beer is currently rolling a double blind randomized placebo controlled phase two clinical study evaluating daily doses of Bureau, and 11 18 milligrams versus placebo for 21 days and 40 hospitalized patients who tested positive for Sars koby to virus and are at high rates. We are de EPS. The primary endpoint is the proportion.

Patients at alive and without respiratory failure at day 22 secondary endpoints include the measured improvements and the W. HL disease severity scale.

Which is an eight point ordinal scale and captures COVID-19 disease symptoms and signs, including hospitalization to progression of pulmonary symptoms to.

And mechanical ventilation as well as Deb.

Expect enrollment to be completed this month.

If the clinical results of the phase two clinical trial of positive the company intends to apply for grant funding from third party agencies and as you know COVID-19 is not worse than ever and no effective treatments have been found.

Mitchell S. Steiner: We expect enrollment to be completed this month. If the clinical results of the phase two clinical trial are positive, the company intends to apply for grant funding from third-party agencies. And as you know, COVID-19 is now worse than ever, and no effective treatments have been found. As for zuclomavine and other drugs that are not in oncology treatment, They are not oncology treatment drugs. Now that we have four late-stage studies for three drugs in four premium classes, the company has to even further focus and reprioritize resources to maximize shareholder value. So clomiphene citrate is an oral non-sterolesterone receptor agonist being developed to treat hot flashes, a common side effect caused by ADT in men with advanced prostate cancer.

As was true Colomer theme and the other drugs that are not and the oncology treatment.

They're not oncology treatment drugs now that we have for late stage clinical stage studies for three drugs and for premium.

Oncology treatment indications the company has to even further focus and reprioritized resources to maximize shareholder value to close and things to trades and oral non soy western receptor agonist being developed to treat hot flashes a common side effect caused by 80 team and with advanced prostate cancer, the company's planning and and the phase.

Mitchell S. Steiner: The company is planning an end-of-phase-two meeting with FDA and will assess the next steps after that meeting. In light of the promising progress of the prostate cancer and breast cancer late clinical stage programs to achieve the company's strategic objectives, we do not plan to further develop Tamsulos and DRS, Vero 722, and Vero 112 drug candidate assays. I will now turn the call over to Michele Greco, CFO, and CAO, to discuss the financial highlights.

Two meeting with FDA, we will assess the next steps after that meeting.

In light of the promising progress of the prostate cancer and breast cancer late clinical stage programs to achieve the company's strategic objectives. We do not plan to further develop Tam slows and Drs fear of 722 and view 112 drug candidate assets.

I will now turn the call over to Michele Greco CFO CEO to discuss the financial highlights Michelle.

Hey, good active seller and.

Dr. Steiner indicated we had a record breaking fourth quarter and a record breaking year.

Michele Greco: Thank you, Dr. Steiner. As Dr. Steiner indicated, we had a record-breaking fourth quarter and a record-breaking year. Let's start with our fourth quarter results for fiscal year 2020. Overall, net revenues were up 35% to $11.7 million from $8.7 million in the prior year's fourth quarter due to the growth in our US FC2 prescriptions. The company reported significant FD2 sales growth in its prescription business, with net revenues up 87% to $8.7 million from $4.7 million in the prior year fourth quarter. We are pleased with the overall net revenues. Despite the decline in FD2 unit sales to 5.3 million units from 9.8 million units in the prior year fourth quarter due to its decline in low-margin public health sector unit sales, net revenues for the public health sector were $2.2 million compared to $3.8 million in the prior year fourth quarter.

Let's start with our fourth quarter results for fiscal year 2020.

Overall net revenues were up 35% to $11.7 million from $8.7 million from the prior year fourth quarter EBITDA growth.

Growth in our USSTC prescription business.

The company reported significant FCC sales growth and a subscription business with net revenues up 87% $8.7 million from $4.7 million from the prior year fourth quarter.

We are pleased with the overall net revenue growth.

Despite the decline in Essex and unit sales to 5.3 million units from 9.8 million from the prior year fourth quarter.

Decline and low margin public health sector unit sales net.

Revenues for the public health sector were $2.2 million compared to $2.8 million from the prior year fourth quarter.

Overall gross profit was $9.6 million or 81% of net revenues compared to $5.8 million per 67% of net revenues from the prior year fourth quarter.

The increase and gross profit and gross margin and driven primarily by increased sales on a U.S. FCC perception business, partially offset by an increase and labor and equip.

Michele Greco: Overall gross profit was $9.6 million, or 81% of net revenues compared to $5.8 million, or 67% of net revenues in the prior year for a quarter. The increase in gross profit and gross margin is driven primarily by increased sales in our U.S. FC2 prescription business, partially offset by an increase in labor and equipment maintenance costs as we have ramped up production to meet demand. During the fourth quarter, we recorded a non-cash impairment charge of $14.1 million related to in-process research and development associated with the acquisition of Aspen Park Pharmaceuticals in fiscal 2017. The charge was primarily a result of deferred development timelines and the decision to cease development work on Tamsulos and DRS, Veru-722 for male infertility, and Veru-112 for gout. In response to management's strategic decision to prioritize the development of our premium oncology drug product candidates, which are highly differentiated, unique, new chemical entities or formulations, patent-protected drugs under development addressing larger and potentially more profitable markets, the impairment charge results in a book value of zero for these in-process research and development assets.

And that maintenance costs, and we Atlanta production to meet demand.

During the fourth quarter, we recorded a non cash impairment charge of $14.1 million related to and process research and development associated with the acquisition debt.

On Park Pharmaceuticals, and fiscal 2017.

The charges, primarily a result of deferred development timeline and the.

Decisions and development work on cancels and yes, there are 722 from mail and facility on their 112 per doubt on the Boston management's strategic decision to prioritize the development of our premium oncology drug product candidates, which are highly differentiated unique new chemical entities and call.

In relation.

Protective drugs on the development addressing larger and potentially more profitable markets.

Impairment charges up from a book value per euro for the on process research and development asset.

We remain on book value and other in process research and development assets acquired on the ATP acquisition and $3.9 million on.

Thats on Liberty and 2020, there was no impairment charge recorded in fiscal 2019.

Operating expenses for the quarter increased by $13.5 million to $20.8 million compared to the prior year fourth quarter and $7.3 million from.

Merely due to the non cash impairment charge of $14.1 million, excluding the effect on the impairment charge for the fourth quarter and we've got operating expenses of $6.7 million.

Michele Greco: The remaining book value of other in-process research and development assets acquired in the APP acquisition is $3.9 million as of September 30, 2020. There was no impairment charge recorded in fiscal 2019. Operating expenses for the quarter increased by $13.5 million to $20.8 million compared to the prior year fourth quarter of $7.3 million, primarily due to the non-cash impairment charge of $14.1 million. Excluding the effect of the impairment charge for the fourth quarter, we had operating expenses of $6.7 million, a reduction of $600,000 compared to the prior year period of $7.3 million. The operating loss for the quarter was $11.3 million.

And a 600.

Sales and dollar compared to the prior year period of $7.3 million.

Operating loss for the quarter was $11.3 million.

Well I think the effect of the impairment charge adjusted operating income was $2.8 million for the quarter compared to the operating loss from the prior year fourth quarter of $1.5 million.

Operating expenses were $1.7 million compared to $2 million and the prior year fourth quarter on price.

Nearly consisted of interest expense on change and the fair value of the derivative liability related to this and bentek royalty financing.

We entered the synthetic royalty financing during March and 28 team.

For the quarter, we recorded a tax benefit of $1.1 million compared to a benefit of $421000 from the prior year fourth quarter, yes.

Michele Greco: The effect of the impairment charge adjusted operating income was $2.8 million for the quarter compared to an operating loss in the prior year fourth quarter of $1.5 million. Non-operating expenses were $1.7 million compared to $2 million in the prior year fourth quarter and primarily consisted of interest expense and a change in the fair value of the derivative liability related to the synthetic royalty finance. We entered into the Synthetic Royalty financing during March of 2018. For the quarter, we recorded a TICS benefit of $1.1 million compared to a TICS benefit of $421,000 in the prior year fourth quarter. The effective tax rate for this quarter is 8.6% and 12.1% for the prior year quarter due to the recording of a valuation allowance against the net operating loss generated for the quarter in the U.S., which is most of the pre-tax loss for the period.

And the tax rate for this quarter, and 8.6% and 12.1 per cent for the prior year quarter due to recording of valuation allowances and the net operating loss generated for the quarter and the U.S., which is most of the pre tax loss for the period.

The bottom line results for the fourth quarter fiscal 2020 wells and net loss of $11.8 million or 17 cents per diluted common share compared to a net loss of $3.1 million.05 per diluted common share and the prior year quarter.

Turning to the results for the fiscal year ended September 32020.

Net revenues for the fiscal year 2020 were up 34% to a record $42.6 million from $31.8 million from the prior year.

Overall.

Sales totaled $32.8 million compared to 37.9 million units from the prior year.

Net revenue from the U.S. prescription business was up 93% to $27.1 million from $14.1 million from the prior year period net.

Michele Greco: The bottom line results for the fourth quarter of fiscal 2020 were a net loss of $11.8 million or $0.17 per diluted common share compared to a net loss of $3.1 million or $0.05 per diluted common share in the prior year fourth quarter. Turning to the results for the fiscal year ended September 30th, 2020. Net revenues for the fiscal year 2020 were up 34% to a record $42.6 million from $31.8 million in the prior year. Overall, FD2 unit sales totaled $32.8 million compared to $37.9 million in the prior year. Net revenue from the U.S. prescription business was up 93% to $27.1 million from $14.1 million in the prior year period. Net revenue for the public health sector business was $13.4 million compared to $16.8 million in the prior year.

Net revenue for the public sector business was $13.1 million compared to $16.8 million from the prior year.

Net revenue for print and increased to $2 million from $884000 from the prior year.

Gross profit was up 42% to $30.8 million from $21.7 million and the play.

Gross margin was 72% compared to 68% prior year growth.

Gross profit and gross margin compared to the prior year, despite the increases and cost of sales, resulting from increased labor transportation and equipment maintenance cost on them.

These costs incurred due to the temporary manufacturer and shutdown and Malaysia, and we ended the second quarter as a result of the COVID-19 from them.

FCC unit sales for fiscal year 2020 includes 5.8 million units and thought the EPA under the tender award and loss and August 2018 for a total of 129 units. We started shipping the orders from South Africa. During the third quarter of fiscal year 2019, and through the end of fiscal year 2020, we EPS.

Michele Greco: Net revenue for Preboost increased to $2 million from $884,000 in the prior year. Gross profit was up 42% to $30.8 million from $21.7 million in the prior year. Gross margin was 72% compared to 68% in the prior year.

Shipped 10.1 million units, we will continue shipping South Africa orders during fiscal year 2021.

Michele Greco: Gross profit and gross margin increased compared to the prior year despite the increases in cost of sales resulting from increased labor, transportation, and equipment maintenance costs and increased costs incurred due to the temporary manufacturing shutdown in Malaysia at the end of the second quarter as a result of the COVID-19 pandemic. FC2 unit sales for fiscal year 2020 include 5.8 million units to South Africa under the tender award announced in August 2018, for a total of 120 million units. We started shipping these orders from South Africa during the third quarter of fiscal year 2019, and through the end of fiscal year 2020, we have shipped 10.1 million units. We will continue shipping South African orders during fiscal year 2021. Operating expenses increased to $45.5 million compared to the prior year of $28.1 million, primarily due to a non-cash impairment charge of $14.1 million.

Operating expenses increased from $45.5 million compared to the prior year of $20.1 million, primarily due to the non cash impairment charge of $14.1 million.

Excluding the effect of the impairment charge for the year operating expenses were $31.4 million and increase compared to the prior year $28.1 million.

With $3.2 million due to increased research and development costs.

During the third quarter the company received to potentially forgivable loan of approximately $540000 under the Paycheck protection club and the carriers and forgive.

On the loan was treated like a government grant and recognized as a reduction in operating expenses and.

However, we were notified the long list, but given and full by the us small business administration.

Operating loss for the year was $14.7 million, excluding the effect of the impairment charge operating loss of $647000 compared to the operating loss and fiscal 2019 $6.4 million.

Non operating expenses were $5.3 million compared to $5.9 million and the prior year.

Michele Greco: Excluding the effect of the impairment charge for the year, operating expenses were $31.4 million, an increase compared to the prior year $28.1 million, with $3.2 million due to increased research and development costs. During the third quarter, the company received a potentially forgivable loan of approximately $540,000 under the Paycheck Protection Program of the CARES Act. The forgivable loan was treated like a government grant and recognized as a reduction in operating expenses.

Primarily consisted of interest expense and change and the fair value of the derivative liability related to the synthetic royalty financing.

For the year, we recorded a tax benefit of $1.1 million compared to $304000 from the prior year.

But the tax rate for this year was 5.4% compared to 2.5% in the prior year.

And due to recording a valuation allowance events and net operating loss generated during those years and in Europe.

Which represents the majority of the pre tax loss for the years.

Michele Greco: In November, we were notified the loan was forgiven in full by the U.S. Small Business Administration. Operating loss for the year was $14.7 million, excluding the effect of the impairment charge, an operating loss of $647,000 compared to the operating loss in fiscal 2019 of $6.4 million. Non-operating expenses were $5.3 million compared to $5.9 million in the prior year, which primarily consisted of interest expense and a change in the fair value of the derivative liabilities related to the synthetic royalty financing. For the year, we recorded a tax benefit of $1.1 million compared to $304,000 in the prior year. The effective tax rate for this year was 5.4% compared to 2.5% in the prior year and is due to reporting an evaluation allowance against the net operating loss generated during those years in the U.S., which represents the majority of the pre-tax loss for the year.

The company has net operating loss carry forwards from us, but on tech purposes, a $41.7 million with $13.5 million firing years through 2030 day and $28.2 million, which can be carry forward and definitely and our UK subsidiary has net operating loss carry forwards of 61 point.

$3 million, which do not expire.

The bottom line results for fiscal year 2020, with a net loss of $19 million.28 per diluted common share compared to a net loss of $12 million or 19 cents per day per.

For diluted common share and and tight.

Now looking at the balance sheet as of September 32020, our cash balance was $13.6 million and our accounts receivable balance was $5.2 million and net.

Working capital was $12.3 million at September 32020, compared to $2.8 million at September 32019, and.

And to the balance sheet after year end $15 million and cash from the recently announced sales pretty pleased with another $5 million as notes receivable to be collected over 18 months.

Michele Greco: The company has net operating loss carry-forwards for U.S. federal tax purposes of $41.7 million, with $13.5 million expiring in years through 2038 and $28.2 million which can be carried forward indefinitely. And our U.K. subsidiary has net operating loss carry-forwards of $61.3 million which do not expire. The bottom line result for fiscal year 2020 was a net loss of $19 million, or $0.28 per diluted common share, compared to a net loss of $12 million, or $0.19 per diluted common share, in the prior year.

Overall, we are delighted to see that.

Continued increases in sales and the U.S.

On business and look forward to increasing efforts and sales from both the prescription on global public health sector businesses.

Revenue sources continue to be important sources of funds to invest and not promising pharmaceutical clinical development program as we continue to transform our company and so and oncology biopharmaceutical company with a focus on developing novel medicine for the management prostate and breast cancer.

Now I'll turn the call back to Dr. Stein.

Michele Greco: Now looking at the balance sheet. As of September 30th, 2020, our cash balance was $13.6 million, and our accounts receivable balance was $5.2 million. Our net working capital was $12.3 million at September 30th, 2020, compared to $2.8 million at September 30th, 2019. Added to the balance sheet after year-end will be $15 million in cash from the recently announced sale of Preboost, with another $5 million as notes receivable to be collected over 18 months. Overall, we are delighted. We look forward to continued increases in sales in the U.S. FD2 prescription business and look forward to increasing FD2 sales in both the prescription and global public health sector businesses. These revenue sources continue to be important sources of funds to invest in our promising pharmaceutical clinical development program as we continue to transform our company into an oncology biopharmaceutical company with a focus on developing novel medical devices for the Management of Prostate and Breast Cancer. Now I'll turn the call back to Dr. Steiner.

Thank you Michelle.

We have enjoyed a record financial quarter and a record year, which has allowed us to significantly advance our clinical oncology programs. In fact, we are now into our third year growth and our FC to use prescription business with the improving performance of our sexual health business. We believe that we'll be able to substantially invest in the continued.

Clinical development of our prostate and breast cancer drug product candidates as well to submit the NDA and if approved commercially launched tat fin, which would provide even more revenue adding to the already growing revenues from FC too.

We have created a very valuable sexual health business, we had a profitable Q4 fiscal year 2024 the adjustment.

The impairment record revenue fiscal year, 2020, and sold pre boost with $20 million looking forward to fiscal year 2021, we expect our revenues to continue to be strong and growing towards yet another record year and to continue.

As a consequence, the company expects to have sufficient resources generated from our sexual health business and existing sources of cash to fund the clinical development of all of our currently planned registration clinical trials without the need for new equity financing through the end of fiscal year 2022.

Mitchell S. Steiner: Thank you, Michele. We have enjoyed a record financial quarter and a record year, which has allowed us to significantly advance our clinical oncology programs. In fact, we are now into our third year of growth in our FC2 US prescription business. With the improving performance of our sexual health business, we believe that we'll be able to substantially invest in the continued clinical development of our prostate and breast cancer drug product candidates, as well as to submit the NDA and, if approved, commercially launch Tadfin, which would provide even more revenue, adding to the already growing revenues from FC2. We have created a very valuable sexual health business. We had a profitable Q4 fiscal year 2020 before the adjustment for impairment, record revenue in fiscal year 2020, and sold pre-boots for $20 million.

With resources in place, we will continue to advance our lake clinical programs to and through the highest value point, which is enrolling phase III clinical studies and having phase three positive clinical results range.

Registration oncology clinical studies are ideal as they typically are single clinical studies with premium large global markets as such we anticipate a steady flow of important positive news severe over the next few months to one year.

Do we have for registration studies planned to commence in calendar year 2021, severe 111 per the metastatic castration resistant prostate cancer. We will report open label efficacy and safety clinical results of the phase Twob clinical trial and plan to submit the phase III pivotal trial protocol and start to Voracity phase two and.

Mitchell S. Steiner: Looking forward to fiscal year 2021, we expect our revenues to continue to be strong and growing towards yet another record year. As a consequence, the company expects to have sufficient resources generated from our sexual health business and existing sources of cash to fund the clinical development of all of our currently planned registration clinical trials without the need for new equity financing through the end of fiscal year 2022. With resources in place, we will continue to advance our late clinical programs to and through the highest value point, which is enrolling phase three clinical studies and having phase three positive clinical results. Registration oncology clinical studies are ideal as they typically are single clinical studies for premium large global markets. As such, we anticipate a steady flow of important positive news for Veru over the next few months to one year. Hence, we have four registration studies planned to commence in calendar year 2021. So, Veru-111 for metastatic castration resistant prostate cancer, we will report open-label efficacy and safety clinical results from the Phase IIb clinical trial.

Registration clinical trial calendar year, Q1, 2021, severe 100, our novel peptide GE and our age and Tackiness free month depot formulation for advanced prostate cancer, we will initiate a phase two clinical study in early calendar year 2021, and by second half and calendar year 2021 to start a phase three pivotal register.

Great and clinical study.

And opus armed the air targeting age and without the on wanted pyrolizing adverse side effects and our newest drug assets to treat GR positive hertwo negative metastatic breast cancer, we plan to commence our test.

Based on preclinical registration study and the first half of calendar year 2021.

Revere went on 11 per its second indication and triple negative breast cancer, we will meet with the FDA and first the first half of calendar year 2021 to discuss a phase twob trial design for possible accelerated approval severe and 111 versus true towards LD for patients with taxane resistant triple and triple negative breast cancer and phase.

To be clinical study is planned to commence in the second half of calendar year 2021.

Mitchell S. Steiner: We plan to submit the Phase III pivotal trial protocol and start the Veracity Phase III registration clinical trial in calendar year Q1 2021. For Veru-100, our novel peptide GnRH antagonist 3-month depot formulation for advanced prostate cancer, we will initiate the Phase II clinical study in early calendar year 2021 and by the second half of calendar year 2021 start a Phase III pivotal registration clinical study. We're AnobisArm, the AR targeting agent without the unwanted virilizing adverse side effects and our newest drug asset to treat ER positive HER2 negative metastatic breast cancer. We plan to commence the ART test phase three clinical registration study in the first half of calendar year 2021. 111 for its second indication in triple negative breast cancer.

Additional milestones will include we plan to complete the phase II clinical program from co with 19 in subjects and high risk free Rgs Smitti and da for Tat fan and we will continue to explore partnerships to license and or distribute and sell a drug products. We continue we plan to continue to generate robust.

Growing revenues for the sexual health business, which as a standalone business is very valuable coming off a record year of 42.6 million and revenue with gross margins of 72% and expecting another record year and fiscal year 2021, we could have options to monetize the business as we did the pre boost business.

Yes.

We have successfully transformed our company into a late clinical stage oncology biopharmaceutical company supported by a growing revenue cash generating sexual health business with that I will now open the call for questions operator.

Mitchell S. Steiner: We will meet with the FDA in the first half of calendar year 2021 to discuss a phase 2B trial design for possible accelerated approval for Veru 111 versus Trodelbe for patients with taxane-resistant triple negative breast cancer. The phase 2B clinical study is planned to commence in the second half of calendar year 2021. Additional milestones will include, we plan to complete the Phase II clinical program for COVID-19 in subjects at high risk for ARDS, submit the NDA for Tadfin, and we'll continue to explore partnerships to license and or distribute and sell a drug product. Additionally, we plan to continue to generate robust, growing revenues for the sexual health business, which, as a stand-alone business, is very valuable. Coming off a record year of $42.6 million in revenue, with gross margins of 72%, and expecting another record year in fiscal year 2021, we could have options to monetize the business as we did in the pre-boost period.

Ladies and gentlemen at this time, we believe we will begin the question and answer session.

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Once again that is star then one can rejoin the question queue, we will pause momentarily to assemble our roster.

So first question today comes from Brandon Folkes of Cantor Fitzgerald. Please go ahead.

Hi, Thanks for taking my questions and congratulations and on the progress and the deal.

Sorry from is this but can you just maybe elaborate little bit on the economics of the premium oncology skill and any color on upfront royalty.

And Mark maybe milestone and then just any color on the size of the trial you thinking for that product and.

Mitchell S. Steiner: We have successfully transformed our company into a late clinical stage oncology biopharmaceutical company supported by a growing revenue cash-generating sexual health business. With that, I'll now open the call to questions. Operator? Ladies and gentlemen, at this time, we will begin the question and answer session. To ask a question, you may press star and then one on your telephone keypad. If you are using a speakerphone, we ask that you please pick up your handset before pressing the keys to ensure the best sound quality.

And then maybe just one clarification question Theres cash runway through the end of 2020 to do not just contemplates and see to sales and the cash flow generation from that or do you contemplate any sale of assets and net cash on net thank you.

Okay. Good sales.

So.

So the first quarter.

So the first part has to do with and Novus arm and and have we disclosed any the deal terms and the answer is we it's undisclosed but it was it was it was a innovus apartments and late stage asset from the University of Tennessee, and Ohio State.

Operator: To withdraw your question, please press star, then two. We ask that you please limit yourself to one question and one follow-up. If you have further questions, you may re-enter the question queue. Once again, that is star, then one to rejoin the question queue.

So so I will tell you what I can tell you is that it's a very favorable deal for the company.

On that.

And includes very reasonable and milestones.

Operator: We will pause momentarily to assemble our roster. The first question today comes from Brandon Folkes of Cantor Fitzgerald. Please go ahead.

And and a low single digit.

Royalty on net sales so it's a very good deal for our company.

Brandon Richard Folkes: Hi, thanks for taking my questions and congratulations on all the progress and the deal. Sorry if I missed this, but can you just maybe elaborate a little bit on the economics of the premium oncology deal? Any color on the upfront royalty?

And.

But we Havent you haven't disclosed the rest of it is it's a good deal for the company given the size of the market and where we're going and I think everybody's going to be very very happy once we get past. This next trial, which gets you next question and that is have we told you about the size, we believe that the size of the and Novus arm.

Mitchell S. Steiner: and Mark Navy Milestones, and then just any color and the size of the trial you're thinking about for that product. And then maybe, just one sort of clarification question. This cash runway through the end of 2022, does that just contemplate FC2 sales and the cash flow generation from that? Or do you contemplate any sale of assets in that cash runway?

IAR positive hertwo negative metastatic trial and Ocwen resistant.

Women and it's going to be about 240 patients 240 patients is the number okay and that it's a one to one randomization. So it's not a huge study.

Mitchell S. Steiner: Thank you. Okay, good. So the first part has to do with Enobisarm, and have we disclosed any of the deal terms? And the answer is, it's undisclosed, but Enobisarm is a late-stage asset from the University of Tennessee at Ohio State.

And and Thats again, the single open label study should be sufficient for and if its successful for approval. So thats why were excited about it and interestingly with the other two and just to make a comment with the other 25 studies all of the studies that you would expect for phase one.

Mitchell S. Steiner: So what I can tell you is that it's a very favorable deal for the company, that it includes very reasonable milestones and a low single-digit royalty on net sales. So it's a very good deal for our company. But we haven't disclosed the rest of it, but it's a good deal for the company, given the size of the market and where we're going. And I think everybody's going to be very, very happy once we get past this next trial, which gets to your next question, and that is, have we told you about the size? We believe that the size of the Novosarum ER-positive, HER2-negative metastatic trial in endocrine-resistant women is going to be about 240 patients.

Like the drug drug interaction studies, the Qt studies.

Renal impairment liver impairment stuff.

Studies, all that has been done there is no qt issues food effect issues and it's a really nice clean.

Profile on this drug and so you can imagine for a cancer product, having that kind of clean profile. This could be very very attractive as another endocrine therapy for women that just want to avoid the toxic Ivy kimo as it relates to you and so that's why we're so excited by that it fits our model right you've got view on 11 kind of and.

Mitchell S. Steiner: Two hundred and forty patients is the number, okay? And it's a one-to-one randomization, so it's not a huge study. And again, a single open-label study should be sufficient for, and if it's successful, for approval. So that's why we're excited about it. And interestingly, just to make a comment, with the other 25 studies, all of the studies that you would expect for Phase I, like the drug-drug interaction studies, the QT studies, renal impairment, liver impairment studies, all that's been done. There are no QT issues, or fluid effect issues.

A very favorable side effect profile put aside a toxic to be used and in prostate cancers and oral agent before Ivy chemo. So same thing here on breast cancer and oral agent that can be used with a favorable toxicity profile, but efficacy and other benefits and muscle building and bone building and.

We'll see the data.

Tomorrow and that we presented at San Antonio and you will see is had a great side effect profile and quality of life Excedrin and before chemo. So that is so with this is a great space pre chemo space, It's a great space to be as it relates to the cash runway. The cash runway includes cash on hand and.

Mitchell S. Steiner: I mean, it's a really nice, clean profile on this drug. And so you can imagine, for a cancer product, having that kind of clean profile, this could be very, very attractive as another endocrine therapy for women that just want to avoid the toxic IV chemo. As it relates to you, and so that's why we're so excited about this. It fits our model, right?

And and.

We did we just sold pre boost with $20 million, which gives us 15 million and.

We've already closed and so we got 15 million and cash added to our balance sheet, plus we're going to get another $5 million and that's unconditional and non conditional on its just a note basically and so we don't have to hit anything to get that money over the next 18 months of which we'll get two and a half and within the year. Another two and a half six months after that so within the next 18 months and get a flow 20.

Mitchell S. Steiner: You know, I've got Vero111, which has a very favorable side-effect profile for a cytotoxic to be used in prostate cancer as an oral agent before IV chemo. So the same thing here, you know, breast cancer, an oral agent that can be used with a favorable toxicity profile but, you know, efficacy and other benefits for muscle building and bone building. And, you know, you'll see the data tomorrow that we present in San Antonio, and you'll see it's got a great side-effect profile and quality of life, et cetera, before chemo. So this is a great space; this pre-chemo space is a great space to be. As it relates to the cash runway, the cash runway includes cash on hand, and we did, you know, we just sold Preboost for $20 million, which gives us $15 million. We've already closed it, so we've got $15 million in cash added to our balance sheet, plus we're going to get another $5 million that's unconditional and non-conditional. It's just a note, basically.

And million, so and you put on those numbers together plus the growing FC to business.

Yes, the answer to your question is it will it.

And we feel comfortable going and running all of these all of our clinical development and including the potential for four or registration trials.

Through the end of fiscal year 2022, I wish we can guide beyond that but that's where the auditors tell is we can stop but.

But yes, we and still have money coming from the business and we're still and you know and Clint.

Clinical and clinical trials is.

Is is expensive, but if you think about it and we have four and would that save all four registration trials are going on the no bizarre and one I. Just told you is 240 patient beer one hundreds 100 patient. The Aviragen 11 is around 200 patients and then.

Mitchell S. Steiner: And so we don't have to hit anything to get that money over the next 18 months, of which we'll get two and a half, and within a year, another two and a half, six months after that. So within the next 18 months, we'll get a full, you know, $20 million. Yes, the answer to your question is we feel comfortable running all of our clinical development, including the potential for registration trials, through the end of fiscal year 2022. I wish we could go beyond that, but that's what the auditors told us we could.

Triple negative breast public 100, 150 patients you add all those together you still can be less than 500 patients for trials and.

Five to 600 patients with.

And you 567 to about five to 600 patients and you're not getting them on I wanted you to these trials will be done over 18 months to two years and so it's very manageable.

Particularly with the with the.

Revenues that we have coming in and cash on hand and.

Mitchell S. Steiner: But yeah, we're going to still have money coming from the business, and we're still – clinical trials are expensive, but if you think about it, let's say all four registration trials are going on, the ANOVUS-RM1, I just told you, is 240 patients, the VIRU-100 is 100 patients, 111 is around 200 patients, and then triple negative breasts, probably about 100, 150 patients. You add all those together, you're still going to be less than 500 patients for four trials. And you know, five to 600 patients, excuse me, about five to 600 patients, and you're not getting them all at once. These trials will be done over 18 months to two years, and so it's very manageable, particularly with the revenues that we have coming in and cash on hand. And so anyway, I think that answers your question. Great, thank you very much.

And so.

So anyway I think on answers your question.

All right. Thank you very much.

All right and Q.

And next question comes from E. Chen of H.C. Wainwright. Please go ahead.

Hi, Thank you for taking my question, Sir Congratulations from range licensing the Djukanovic. So on my first question is could you give us some more color on the on existing population on the GR positive hertwo negative breast cancer patients and the units and the new occur.

Each and every year and my second question is relative to the sales Force FC too could you provide us with some breakdown in terms of per good prescription sales versus public sales.

Thank you.

Operator: All right. The next question comes from Yi Chen of HC Wainwright. Please go ahead.

Yes, gentlemen have Michel answer the second question, which is you know FC to break down with.

Yi Chen: Hi, thank you for taking my questions and congratulations on the AIMS licensing of the new candidate. So my first question is, could you give us some more color on the existing population of ER-positive, HER2-negative breast cancer patients in the U.S. and the new occurrences every year? And my second question is related to the sales of FC2. Could you provide us with some breakdown in terms of private prescription sales versus public sales? Thank you. So I'm going to have Michele answer the second question, which is, you know, FC2 breakdowns with Rx versus public. Do you want public global or public U.S.? Both.

Rx versus probably went public global and public us about.

Oh, thank you.

Okay, and so while michelle's getting that I'll answer. Your first question, we have not said much about the market size of except to say that the market size is very similar to the CDK force six inhibitors, because the CDK force six inhibitors is a and the current it's a it's a therapy that's done in combination with the endocrine therapies.

And and so I will tell you that 85% of women. So if you can if you go back and look at the number of women and fresh brewed breast cancer that I quoted in my presentation, 85% of those women are going to have.

Mitchell S. Steiner: Both, thank you. Both, okay. All right, so while Michele's getting that, I'll answer your first question. We have not said much about the market size except to say that the market size is very similar to the CDK4-6 inhibitors because the CDK4-6 inhibitors is an endocrine therapy, you know; it's a therapy that's done in combination with endocrine therapy. And so I will tell you that 85% of women, so if you go back and look at the number of women with breast cancer that I quoted in my presentation, 85% of those women are going to have ER positive disease. So, automatically, that's our patient population. And 15% will have triple negative breast cancer, which will be ER negative. So it's 276,480 new cases a year, and 85% of those cases will be ER positive. So I would say, you know, we're going to continue to do the market research, but it ends up being about, by the time you take the metastatic cases, you're ending up with about 30,000 to 40,000 cases a year. And the good news is they're not dying.

Again I have you are positive growth.

To automatically thats, our patient population and and 15% will have triple negative breast cancer, which that will be our negative that's 276480, new cases, a year, which 85% of those cases will be our positive.

And.

So I would say.

We're going to continue to do the market research, but it ends up being and about timing.

Time, you take in the metastatic cases, you ending up at about.

30 to 40000 case.

Cases, a year and and the good news is they're not dying and with anyone therapy, you're continuing to treat them and they're looking for the next thing and the next and they're looking for chemo and so we're trying to take a step before that but we're going to continue to give you some more granularity on the on the market size, except to tell you.

That if were anything and we price like a CDK force six inhibitor, which is a surrogate if you will for that market.

That's a 6 billion dollar worldwide market right now and.

And we're going after those patients that fail and non steroidal implementation inhibitor, which is usually they get first to vest trend, which is what they get second and you get one and the other in combination of CDK force six inhibitor. So we could be the second line or third line. So that's still a big big piece of the pie and who would not want to take a net.

Mitchell S. Steiner: With endocrine therapy, you're continuing to treat them, and they're looking for the next thing, and the next thing they're looking for is IV chemo. And so we're trying to take a step before that. So we're going to continue to give you some more granularity on the market size, except to tell you that if we're anything, if we price like a CDK46 inhibitor, which is a surrogate, if you will, for that market, you know, that's a $6 billion worldwide market right now. And we're going after those patients that fail a non-steroidal rheumatase inhibitor, which is usually what they get first, and fluvestrin, which is what they get second, and they usually get one or the other in combination with a CDK46 inhibitor. So we could be either on the second line or the third line.

Other endoglin therapy that has and potential benefits besides.

And treating the tumor and not be visualizing and to avoid Ivy chemo. So I think it's going to be in a very attractive.

Area Ms.

Michelle do you would you like to answer the question on FC too.

Yes and.

The U.S. prescription channel on lean into.

Indicated revenues of $27.1 million.

And and and public sector.

Mitchell S. Steiner: So that's still a big piece of the pie. And who would not want to take another endocrine therapy that has some potential benefits besides treating the tumor and not be virilizing and avoid IV chemo? So I think it's going to be a very attractive area. Michele, would you like to answer the question on FC2? Sure. In the U.S.

The U.S., we had about 1.2 million on the Russell, we'll be at about 12.2 million per total 14.4 million on as we saw on we had sales of on 2 million from people sitting here.

Well that that 42.6 mobile.

Got it thank you.

Michele Greco: Prescription Channel, as we've indicated, revenues are $27.1 million. And in the public sector, the U.S., we had about $1.2 million. The rest of the world, we had about $12.2 million for a total of $13.4 million.

Okay.

Again, if you would like to ask a question. Please press Star then one day.

And your question. Please press Star then to the next question comes from Leland Gershell of Oppenheimer. Please go ahead.

Hi, Good morning, Mitch Thanks for taking my question.

Yi Chen: And as you saw, we had sales of around $2 million for pre-boost for the year. So that's our 42.6 million. Got it.

Wanted to ask on as the company continues to refine its profile and with the sale of pretty boost and also the.

Operator: Thank you. Again, if you would like to ask a question, please press star then 1. To withdraw your question, please press star then 2.

And as recognized by the impairment charge shifting.

Strategy away from some other assets and want to ask about any thoughts of perhaps monetizing the EPS you to business.

Leland James Gershell: The next question comes from Leland Gershell of Oppenheimer. Please go ahead. Good morning, Mitch.

Through a similar.

Similar type transaction and the interest you had there and then as a follow up thanks.

Yeah, Yeah, it's a good question and until.

Mitchell S. Steiner: Thanks for taking my question. Wanted to ask, as the company continues to refine its profile and with the sale of pre-boosts, and also the, as recognized by the impairment charge, shifting strategy away from some other assets, want to ask about any thoughts of perhaps monetizing the SC2 business through a similar-type transaction, any interest you've had there, and then a follow-up question. Yeah, it's a good question.

As I said, a couple of times during the day.

Third comment.

And the pre Booz models Gray model I mean, we were able to monetize pre boost and.

And see and see those resources for what's important to US which is at a company strategy, which is to be in the clinical development of premium oncology products and markets with a single study.

You can access those big markets globally, and and and so you know.

Mitchell S. Steiner: And so, as I said a couple of times during the paired comments, that the pre-boost model is a great model. I mean, we were able to monetize pre-boost and use those resources for what's important to us, which is a company strategy, which is to be in clinical development of premium oncology products for big markets. With a single study, you can access those big markets globally. And so that's what we needed to do. And so for smaller products, it doesn't make sense to put the resources behind them because the oncology products dwarf them in terms of potential. And so putting our bet and our confidence in the two prostate programs and the two breast cancer programs makes the most sense. With that said,

And that's what that's what we need to do and and so the smaller products does.

Does it make sense to put the resources behind it because this this the oncology products dwarf it in terms of the potential and and so putting that putting our bad debt and our confidence in the two.

Prostate programs and to breast cancer programs make the most sense with that said we.

We have also been able to do that and the model works I mean, we've been able to do that with primarily the money we are generating on our own and like we just monetize pre boost so it makes perfect sense that here. We are now at 42.6 million and revenue and I told you. The gross profit is up 72%. This is a very.

Mitchell S. Steiner: We have also been able to do that, and, you know, the model works. I mean, we've been able to do that with, you know, primarily the money we're generating on our own or, like, we just monetized Preboost, so it makes perfect sense that, you know, here we are now at 42.6 million in revenue, and, you know, I told you the gross profit is about 72 percent. This is a very valuable business, and, you know, as I mentioned in my other call, I don't even think our market cap is reflecting just the base business. Forget about the enterprise value of the drugs, and so I made the point that, you know, there's so much potential here, and to unlock that potential, we have to take a serious look at how to take the base business and create enough cash and cash resources so that we'd be I mean, Immunogenics just sold their product, Trodelvy. You know, they had an accelerated approval with 108 patients, and they got, you know, they finally, you know, just confirmed their phase three. One single product in triple negative breast cancer costs $21 billion. I mean, there are many examples.

This is a very valuable business and as I mentioned my other carling and thank our market cap is reflecting just the base business forget about the enterprise value of the of the drugs and and.

So I made the point that.

There is so much so much potential here and to unlock that potential and we will we have to take a serious look at.

How to have on how to how to how to take the base business.

And and create enough cash and cash resources, so that will be completely independent as we move forward independent financially as we move forward with going into these markets I mean, immunogenic and is sold their product procured the true delving.

They have accelerated approval with 108 patients and they got they finally this confirmed their phase three one single product and triple negative breast cancer is $21 billion I mean and as many examples of that I think there is a new and new it's a new set point now from oncology products, I mean, you're not seeing a $1 billion to be.

And our deals anymore. You are seeing 14 billion 20 billion. So that the neighborhood just got expense it for us to have four drugs.

Mitchell S. Steiner: I think there's a new, a new, you know, it's a new set point now for oncology products. I mean, you're not seeing $1 billion, $2 billion deals anymore. You're seeing, you know, $14 billion, $20 billion. So, you know, the neighborhood just got expensive.

That going for that neighborhood that kind of real estate that neighborhood is a big deal. So it makes sense to do.

And monetize yes, Q FC to business and away that allows us to preserve holding onto as much as possible the the drugs and and do that.

Mitchell S. Steiner: For us to have four drugs that are going for that neighborhood, you know? That kind of real estate in that neighborhood is a big deal. So it makes sense to, you know, monetize the FC2 business in a way that allows us to hold on to as much as possible the drugs and do that. And another way to say it is that we're always going to consider maximizing shareholder value and by unlocking the potential of FC2 and the pharmaceutical, you know, standalone pharmaceutical company versus, you know, a pure pharma play, or biotech play because that's what we are and we've got the, you know, we've got the new chemical entities, and we have the data and the trials to show that. So it's an exciting time for us, and we have to seriously consider, you know, how do we uncouple and unlock the value of the assets that we have.

And and and as and that and another way to say it is we're always going to consider and maximizing shareholder value and by unlocking the potential of FC too.

And and and the pharmaceutical Standalone pharmaceutical company versus you know.

A pure pure pharma play biotech play.

Because that's where we are and that we've got the new chemical entities and we have that the data and the trials to show that so it's an exciting time for us and and.

And we have to we have to seriously consider.

How do we on how do we on couple unlock the value of the assets that we have.

All right Great and then another question just on on types and with that product on track to come to market and better years time wanted to ask about.

Mitchell S. Steiner: All right, great. And then another question, just on tabs in with that product on track to come to market in about a year's time. Wanted to ask about just how the company is going to approach it given that it's going to be going through telemedicine and it's, you know, it's probably going to be seen as kind of a more convenient and better alternate to what are two, you know, generic products are taken together quite frequently. How did companies' new approach just make that product visible and grow awareness? What that will look like and how we should think about expenses. Yeah, Let me tell you how I'm thinking about that. It's a great question, okay?

Just how the company is going to approach given that it's going to be going through telemedicine and it's.

It's probably a you're going to be seen as kind of a more convenient and and better alternative to what are two generic drugs are taken together quite frequently how the company's new approach just making that.

Product visible growing awareness.

What that will look like and how we should think about expense associated with them.

Limitation on thinking about that great question, Okay, and I think what weve debt, we were able to tap into and we've been successful with FC too and with pre boost is we tap into detail on medicine market, Okay, and a tele medicine market is growing exponentially now, particularly because of cold and 19 and so what if.

Mitchell S. Steiner: And I think what we were able to tap into, and we've been successful with FC2 and with Preboost, is we tapped into the telemedicine market, okay? And the telemedicine market is growing exponentially now, particularly because of COVID-19. And so, you know, what would have taken 10 years is now happening in months.

Taken 10 years is now happening and months and and what is done is a whole world has moved away from I want to go to CBS and take two generic drugs with co pay to if I can punch a number on my phone and it can show up by Amazon. The next day discreetly than that we wonderful and so you'll see a lot of these per head.

Mitchell S. Steiner: And what it has done is the whole world has moved away from I want to go to CVS and take two generic drugs for a co-pay. If I can punch a number on my phone and it can show up discreetly by Amazon the next day, then that'd be wonderful. And so you'll see a lot of these for him, and other companies, you know, GetRoman and others, they're seeing, they're taking, you know, basically generic erectile dysfunction products, and they're selling the hell out of them, okay? And for some of these groups, they're seeing two, three hundred million in revenue. I mean, it's just unbelievable for what you and I would have called a generic product, okay?

James and Bill and other companies get moment and others there.

They are seeing that taking basically generic.

Erectile dysfunction products and they are selling the hell out of it okay and and for some of these groups, they're seeing to 300 million and revenue. Let me just unbelievable from what you and I would have called it which could be a generic product okay and so there is a completely untapped group.

Group of men in the case of TAPFIN.

Mitchell S. Steiner: And so there is a completely untapped group of men, in the case of Tad Finn, that if they have this available through telemarketing and it can be sent to their home discreetly, and we price it appropriately, that's the key thing: it's a whole new universe. Okay, and if I would have told you, I mean, with FC2, when we did marketing and selling with 12 salespeople, Okay, and they ran around there, you know, visiting OBGYN doctors. We got get 400 prescriptions a month. 12 people hit telemedicine. I don't know. We just reported 348,000 prescriptions this past year, and the year before that, 158,000 prescriptions. You don't realize the power of the internet.

That they had this available through telemarketing and and they can be sent to the home discreetly.

That and and we price it appropriately and that's the key thing that it's so it's and it's a whole new universe, Okay, and if I would have told you I went with FC too when we did marketing and selling with 12 salespeople, okay and they win and they ran around there.

Visiting there will be July and doctors, we got 400 prescriptions a month.

12 people.

Tell on Medicine, I don't know, we just reported with 348000 prescriptions and this past year and the year before that 158000 prescriptions you don't realize the power of the Internet, so and and by the way, we don't spend anything almost nothing on marketing and selling as a company and so that money can go into cash.

Mitchell S. Steiner: And, by the way, we don't spend almost nothing on marketing and selling as a company, so that money can go into drug development. So, same thing with Tad Fin.

On development, So same thing with test and when we don't have an appetite to set up a marketing and selling salesforce to sell Pat fan. We think the advantage of tat fan is going to be on discrete and this convenience and and being able to get it into telemedicine and and and.

Mitchell S. Steiner: We don't have an appetite to set up a marketing and sales sales force to sell Tad Fin. We think the advantage of Tad Fin is going to be discreteness, convenience, and being able to get it through telemedicine and not use our marketing and selling dollars to do that as a company but let our partners do that. And I can tell you we're an active partner in the discussions around Tadfin internationally and nationally. And it will be great for us because, again, we've got to keep our eye on the ball, which is the $6 billion market, the $3 billion market with our prostate cancer and breast cancer products and got to get those trials filled and get them done on time and the whole bit. And so for Tadfin to add a little extra cash, you know, to the pile of cash that we're accumulating so that we can keep this moving, I think it's attractive. We're basically, you know, we're almost there.

And and not use on marketing and selling dollars to do that as a company and let our partners do that.

And I can tell you we are in active partner discussions around tap and internationally and nationally and and will be great for us because again, we've got to keep our eye on the ball, which is the $6 billion market 3 billion dollar market, our prostate cancer and breast cancer products and got to get those trials filled and get it done on time and the whole bit and so from a tad from.

And to add a little extra cash.

To the pile of cash that we're accumulating so that we can keep this moving I think it's attractive and we're basically we're almost there and we also heard from.

The FDA that they're going to wave the fee on the PDUFA fee I think is the technical term for it so the so the Anda and good were small company. So we're not doing is we're not getting and spend that filing fee for this product and so it's it's it's upside for us.

Mitchell S. Steiner: And we also heard from, you know, the FDA that they're going to waive the fee, you know, the PDUFA fee, I think is the technical term for it. So the NDA, because we're a small company. So we're not going to even pay that filing fee for this product.

Great. Thanks, so much per year for the first quarter much. Thank.

Mitchell S. Steiner: So it's, you know, it's upside for us. Great, thanks so much for the further coverage, Mitchell. Thank you. The next question comes from Kumar Raja of Brooklyn Capital Markets. Please go ahead.

Thank you.

And next question comes from Kumar Raja Brookline capital markets. Please go ahead.

Congratulations on the in life and thing on thanks for taking my quick and.

Kumar Raja: Congratulations on the in-licensing and thanks for taking my questions. For the Enobasm phase 3 trial, are you planning to go forward with the 9 mg dose or the 18 mg dose? What can you share with regard to the safety and efficacy profile for both those doses?

On a broader you know about them create threed cry and are you planning to go forward with the nine milligram, both on 18 million on both.

And what can you share with regard to the fifth behind it because the profile part both both growth and.

And also for what needs to be done before you can start the clear crude price do you have enough drug supply.

Mitchell S. Steiner: And also, what needs to be done before you can start the phase 3 trial, do you have enough drug supply, and how easy or difficult is it to manufacture this drug? Thank you for both the questions. This refers to the new acquisition in Ovisarum. The Phase II study had 9mg and 18mg doses.

On how easy on difficulties that good amount of parts of the drug.

Good. Thank you for both the questions and this has this refers to the new acquisition and overtime on the.

Phase two study had nine milligram and 80 milligram doses today the presentation on what happened at nine nine a no tomorrow tomorrow's to presentation on that part of it so stay tuned and so I can't give you.

Mitchell S. Steiner: Today the presentation will happen at 9a – no, tomorrow. Tomorrow is the presentation on that part of it, so stay tuned. So I can't give you the actual details, but I can give you some general comments. After being in 25 trials, this is a very well-tolerated drug. Not even for a cancer drug, just as a drug in general. Even if it was a quality-of-life drug, it's amazingly well-tolerated. So we're going to announce the safety of this product there. Things that you would worry about with an agent of this sort would be hematocrit increases, and liver toxicity. You'd be worried about virilization in women, and we just don't see that. We'll share with you the exact safety profile in the future right after that presentation. So that spotlight presentation in San Antonio will have that information, and then we'll put it out subsequently so everybody can get access to it if they're not getting into the program. So with that said, it's very well-tolerated.

I can't give you the actual details, but I can give you some general comments general comments after being in 2025 trials now this is a very well tolerated drug.

Naved their cancer, just as a drug and general even if it was.

The quality of life drug I mean, and Nick it's it's amazingly well tolerated and and so were going and announced the safety there and things that you worry about within and agent. This on we'd be on him adequate increases liver toxicity.

Worried about.

Realisation and women and we just don't see that came from.

And so so it will.

We'll we'll we'll give you the we'll we'll share with you the exact.

Yes.

Safety profile in the future right after that presentations of the presentation on what that spotlight presentation, the San Antonio and have that information and then we'll put it out subsequently so everybody can get access to it if they're not getting into the into the into the program.

So with that said, it's very well tolerated now with that said the nine milligram and 18 milligram, you'll see the efficacy and again I don't want to I want to share much more on that except to say that like the phase.

Mitchell S. Steiner: Now, with that said, the 9mg and the 18mg, you'll see the efficacy. And again, I don't want to share much more than that, except to say that, like the first Phase II that was done in 22 patients, it showed good activity, and you'll see that. But we are going to go with the 9mg, and you'll see the reason why after the presentation. And that's where we met with the FDA, and the FDA agreed to the 9mg. So this drug definitely has activity in a heavily pre-treated patient population. When I say heavily pre-treated, not only multiple lines of endocrine therapy but also chemotherapy.

Like the first phase two that was done and 22 patients.

It's good activity and youre going to see that and.

But we are going to go with the nine milligram and you'll see the reason why.

After the presentation, and and Thats, where we met with the FDA and the FDA agreed to the nine milligram. So drug it definitely has activity and heavily pretreated patient population and but.

And I say heavily peach pretreated, not only and multiple lines of and Ocwen therapy, but also chemotherapy and so these are patients that are not the patients who are going to be in our phase three in which it would not have had chemotherapy and there will be even more likely to respond.

Mitchell S. Steiner: So these are patients that are not the patients that are going to be in our Phase III, in which we would not have had chemotherapy, and they'll be even more likely to respond to Inovasar. As for what we're waiting for, we had to meet with the FDA, and we got that out of the way. And the next thing is, you're absolutely right, we do have to have the to-be-marketed drug product, and so we're doing that now. It's not hard to make, but you have to go through the process where you want to bridge from the new to-be-marketed form to the form that was used in the other 25 trials. And so it's not complicated; it just takes time.

Two and nobody star and.

As it relates to what are we waiting for we had to we had and meet with the FDA.

And and we got that out of the way that and and the next thing is you're absolutely right. Now we do have to have the to be marketed to on a product and on and so we're doing that now it's not hard to make its.

But you have to go through the process, where you want to bridge.

From the new too big to be marketed form into the form that was used and the other 25 trials and and so it's not complicated just takes time and so would all that's happening as we speak right now and so we are on target to start.

Kumar Raja: And so all that's happening as we speak right now. And so we are on target to start in the first half, hopefully by early summer, we'll get started with the actual phase three part of it. And so it'll take us about a quarter, a quarter and a half to do the GMP stuff.

And the first half.

Yes.

Hopefully by early summer, we'll get started with the actual face the actual phase III part of it and so it'll take us it takes about a quarter quarter and a half to do the GMP stuff.

Operator: Okay, thank you so much. Thank you. The next question comes from Peter McMullen of McMullen Consulting. Please go ahead. Congratulations, Mitch. Thank you, Peter. We talk about maximizing assets, and if you were to sell off the FC2, for example, how would you propose to maximize the tax losses, which are considerable?

Okay and just on my.

Thank you.

The next question comes from Peter Mcmillan of Macmall and consulting. Please go ahead.

[noise] Congratulations mentioned and.

Thank you Peter.

We talk about maximizing assets and if you were to sell off the.

FC too for example.

How would you propose to maximize the tax losses, which are considerable.

Great guys Lords and Thats great question, So I'm going let Michelle and answer that question and then on.

Peter McMullen: Great question, yeah that's a great question, so I'm going to let Michele answer that question, and Michele, would you like to take that one on? Sure. You know, Peter, we would be selling the company in the UK, which holds the $63 million in NOL. And so we would take that into consideration when we look at the value that we're looking for if we were to sell the FC2 business. That's a good thought. And what about the U.S. side?

Michelle would you like to take that went on.

Sure.

You know and Peter we would we would be selling the and and.

The company in the UK, which holds the $63 million and nonetheless.

And so we would take that into consideration when we look at the value and.

And that we're looking for if we were to sell the FC too busy.

Uh huh.

Good day.

And what about the U.S. side.

The U.S. side.

Mitchell S. Steiner: The U.S. side, you know, if we were to sell the FC2 business, it's just assets in the U.S. All the NOLs would be retained by Veru. Okay, thank you. Ladies and gentlemen, this concludes our question and answer session. I would like to turn the conference back over to Dr. Mitchell Steiner for any closing remarks. Thank you, operators. Again, I appreciate everybody joining us on today's call, and I look forward to updating all of you on our progress and our next investors call. Have a Merry Christmas and a Happy New Year, and hopefully, 2021 will look a lot different than 2020.

If we were to sell that seek to business its just assets and the U.S. and all the and I will also be retained by there and.

Great. Thank you.

Ladies and gentlemen, this concludes our question and answer session I would like to turn the conference back over it and Dr. Mitchell Steiner for any closing remarks.

Thank you operator.

Again, I appreciate everybody joining us on today's call and I look forward to updating all of you on our progress on our next investors call have a Merry Christmas happy new year, and and hopefully 2021 look a lot different and 2020.

Thank you.

Michele Greco: Thank you. The digital replay of the conference will be available beginning approximately noon Eastern time today, December 9, by dialing 1-877-344-7529 in the US and 1-412-317-0088 internationally. You will be prompted to enter the replay access code, which will be 1-0149-625. Please record your name and company when joining. The conference is now concluded. Thank you for attending today's discussion. You may now disconnect.

A digital replay of the conference will be available beginning approximately noon eastern time today December nine by dialing 187734475 to nine and the U.S. and one for one Q3, one seven.

0088 internationally you.

You will be prompted to enter the replay access code, which will be one year on line.

Sure and nine six to five please record your name and company when joining the conference is now concluded. Thank you for attending today's discussion you may now disconnect.