VERU (2020 - Q3)

Good morning, ladies and gentlemen. Welcome to Veru Inc.'s Investors Conference Call. All participants will be in listen-only mode. [Operator Instructions] After this today'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. Go ahead. Sam Fisc

Good morning. The statements made in 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 businesses. Our actual results and future developments could differ materially from the results or developments 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, risks related to the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and company operations, risks related to competition, government contracting risks, and other risks detailed in the Company's press releases, shareholder communications, 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. 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. With me on this morning's call are Michele Greco, CFO and CAO; Phil Greenberg, Executive Vice President, Legal; and Sam Fisch, Director of Investor Relations. Thank you for joining our call. Veru is an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer. Before I provide the update on the clinical development of our drug pipeline and the commercialization of our products, as well as provide financial highlights for the third quarter fiscal year 2020, it is important to reflect on the great progress we have made transforming our company into an oncology biopharmaceutical company that's supported in part by a growing revenue cash generating sexual health business. Not only are we planning for 2021 two Phase 3 registration trials; one for VERU-111, our novel oral tubulin targeting agent to treat metastatic castrate resistant prostate cancer, and the other for VERU-100, our three-month GnRH antagonist long-acting depot to treat hormone sensitive advanced prostate cancer, but also we expect to continue to grow our base sexual health business. In fact, we've had 10 quarters of continued significant growth for FC2 and PREBOOST, known by the brand name Roman Swipes, and we plan to submit an NDA for TADFIN, the combination of Tadalafil and Finasteride for BPH, late this year to continue to profits for even more revenue. The model is working. The transformation is near complete. Now, let's focus on the significant progress we have made on the advancement of our drug pipeline. VERU-111 is a novel oral first-in-class tubulin targeting agent that cross links and disrupts alpha and beta tubulin subunits of microtubules. VERU-111 is in its clinical development to treat metastatic castration, a novel androgen receptor targeting, which is Enzalutamide and Abiraterone resistant prostate cancer, but prior to IV chemotherapy; a growing unmet medical need in advanced prostate cancer. The Phase 1b clinical study enrolled 39 subjects from seven clinical sites in the United States. A standard 3x3 design was used to establish the maximum tolerated dose to select a recommended clinical dose of Phase 2 study, and to assess preliminary evidence of anti-tumor activity. The maximum tolerated dose of VERU-111 was determined to be 72 milligrams as three of 11 of these men had reversible grade 3 diarrhea. No grade 3 diarrhea was observed with doses of 63 milligrams or less per day. At doses of VERU-111 of 63 milligrams or lower per day, the most common adverse events were mild-to-moderate nausea, vomiting, diarrhea, and fatigue. There were no reports of neurotoxicity and no neutropenia observed at 63 milligrams and lower with continuous oral 21-day daily dosing cycle. We have seen evidence of anti-tumor efficacy with PSA declines and objective tumor responses. Ten men or 25% of the study subjects received at least four 21-day cycles of oral VERU-111. The study is ongoing as subjects are still on study without tumor progression. The median duration of treatment without progress so far is 10.5 months with a range of 5.5 to 16 months. To better understand the clinical relevance of these preliminary findings, it is important to note that all patients with metastatic castrate resistant prostate cancer at the time of enrollment into the Phase 1b had evidence of disease progression with at least one of the novel androgen receptor targeted agents, Abiraterone and Enzalutamide, that 44% of the subjects in the Phase 1b has failed both Enzalutamide and Abiraterone, and contemporary studies recently reported in the scientific literature for this similar population of men, the median observed time to cancer progression, while being treated with an alternative antigen-blocking targeting agent was approximately 3.6 months and even less like 2.5 months for men that have failed both the androgen receptor targeting agents, Abiraterone and Enzalutamide. We are also near completion in the enrollment of our approximately 40 men in the open-label Phase 2 portion of the clinical trial in 14 U.S. centers. The patient population for this portion of the trial is men with metastatic castration novel entry blocking agent resistant prostate cancer, and prior to any IV chemotherapy, and we're using the recommended dose and schedule selected from the Phase 1b, which is the 63 milligram oral daily dosing for continuous 21 days per cycle. Like the Phase 1b, we have already observed significant PSA declines in the Phase 2 clinical study. We have the clinical safety and antitumor efficacy data necessary from the Phase 1b clinical study to move forward to select the patient population, VERU-111 dose and schedule for the Phase 3 registration trial. By late fall, we will have additional clinical data on the 63 milligram oral daily for 21 continuous days per cycle in almost all of the Phase 2 subjects. Recently, we have received positive FDA input, agreement, and regulatory clarity for our proposed Phase 3 registration trial program. The Phase 3 trial was designed to be an open-label, single pivotal randomized clinical study to evaluate the efficacy and safety of VERU-111 versus an alternative androgen receptor targeting agent in men with metastatic castration resistant prostate cancer, who have developed cancer progression, while receiving one androgen receptor targeting agent. The primary endpoint will be radiographic progression free survival. By having radiographic progression free survival is the primary endpoint. The sample size of the Phase 3 study could be potentially between 200 and 300 men, which is substantially smaller size study, clinical study that might otherwise have been required, if the primary endpoint was overall survival. We plan to submit the final Phase 3 clinical registration study protocol to FDA in the fourth quarter of calendar year 2020. We anticipate starting the global Phase 3 pivotal registration clinical study in the first quarter of calendar year 2021. We also plan to meet with the European Medicines Agency to obtain their input as well. This pre-chemotherapy space in men who have metastatic castration and androgen receptor targeting agent resistant prostate cancer is currently one of the fastest-growing unmet medical needs segments in advanced prostate cancer. There are currently no FDA approved drugs for this indication. According to IQVIA, oral drugs Abiraterone and Enzalutamide to advanced prostate cancer over $6 billion in 2018 global annual sales, and $3.1 billion in the U.S. Men who have failed these novel androgen receptor targeted agents of the same patients with VERU-111 is currently targeting, which we estimate represents about $5 billion annual global market. In summary, the objective with respect to the clinical development of VERU-111, which has a unique drug mechanism of action, as it does not target the androgen receptor, is to position VERU-111 as the next go-to drug in men who have metastatic castrate resistant prostate cancer and who have developed prostate cancer progression, while being treated with an androgen receptor targeting agent like Abiraterone or Enzalutamide but prior to using IV chemotherapy, an advantage of VERU-111 an oral medication with a favorable safety profile is that it can also be prescribed not only by the medical oncologist but also the urologists. The results from the VERU-111 clinical program firmly positions Veru as an oncology focused biopharmaceutical company, the results from the Phase 1b 2 two clinical study, VERU-111 have been accepted for oral presentation at the prestigious European Society for Medical Oncology, ESMO Virtual Congress in 2020, to be held September 19, to the 21. Mark Markowski, MD PHD, Assistant Professor of Oncology at the Johns Hopkins Sidney Kimmel comprehensive cancer center will be the presenter. Next, I will update you on VERU-100, our proprietary peptide drug candidate for the treatment of hormone sensitive advanced prostate cancer and established multibillion dollar global market. Target product profile for VERU-100 is commercially and scientifically compelling is having a number of anticipated advantages over currently available androgen deprivation therapies. VERU-100 is a long-acting gonadotropin-releasing hormone antagonist, also known as GnRH antagonist. This formulation was designed to be administered as a small volume subcutaneous three-month depot injection without a loading dose, as a GnRH antagonist it is intended to immediately suppressed testosterone with no testosterone surge upon initial and repeated administration, and no testosterone micro increases, which may adversely affect patient outcomes a problem which potentially occurs with the approved LHRH agonist drugs like Lupron, Zoladex, and Eligard. As previously mentioned, we received agreement from FDA that development program for VERU-100 may follow an expedited pathway based on this FDA input, the company plans to commence a single open-label multi-center dose finding Phase 2 clinical trial in approximately 35 men, followed by a single open-label multi-center Phase 3 registration clinical trial in only approximately 100 men. Veru has made great progress and scaling up the GMP manufacturing of the drug product for the clinical trials of VERU-100, the company intends to submit an investigational new drug application by the end of 2020. So that we can commence the open-label Phase 2 clinical study by Q4 calendar year 2020. The Phase 3 registration study is expected to start in the second-half of calendar year 2021. Androgen deprivation therapy is a $2.8 billion global market that appears to be moving towards supporting GnRH antagonists over LHRH agonists like Lupron, Leuprolide, and Eligard, Zoladex, the LHRH agonist is a class have a blackbox warning for an increased risk of cardiovascular events including heart attacks and stroke. The GnRH antagonist class does not have the same black box warning. Recently, a randomized Phase 3 study in 930 men that compared and LHRH agonists to GnRH antagonists confirmed that the incidence of cardiovascular events was significantly low in men receiving GnRH antagonists. Based on the study published by Dr. Neal Shore and his colleagues in the New England Journal of Medicine in 2020, the incidence of adverse cardiovascular events was 54% lower when antagonists versus an agonist. Furthermore, in men who have a history of adverse cardiovascular events, the incidence of new adverse cardiovascular events was 80% lower with an antagonist versus an agonist. Therefore it appears that GnRH antagonist may become the drug of choice if ADT because of their better safety profile. Currently, there are no GnRH antagonist injectable treatments commercially approved for beyond one month making VERU-100 if approved the only commercially available long acting GnRH antagonist treatment depot. Our next product candidate is Zuclomiphene, novel proprietary oral non-steroidal estrogen receptor agonist being evaluated to treatment of hot flashes, the most common side effect in men with androgen deprivation therapy for advanced prostate cancer and a major reason why men want to stop androgen deprivation therapy. The next step is to have an end of Phase 2 meeting with FDA for the Zuclomiphene and to obtain agreement on the Phase 3 clinical program design that will be acceptable for approval. We will provide details of design and the timing of the study after we have met with the FDA. Although Veru is focused on prostate cancer and oncology due to the urgency of the current global pandemic, the fact that no effective therapies have been found and that VERU-111 has the potential to treat both the SARS-CoV 2 infection and the associated reactive severe lung inflammation and COVID-19 patients at high risk for acute respiratory distress syndrome. The company is evaluating VERU-111 18 milligrams for this COVID-19 indication. Drugs that target microtubules have broad anti-viral activity by disrupting the intracellular transport of viruses such as SARS-CoV-2 along the microtubules. Microtubule trafficking is critical for viruses to cause infection, and furthermore, microtubule depolymerisation agents that target alpha and beta tubulin subunits of microtubules like colchicine have had evidence of strong anti-inflammatory effects, including the potential to treat the cytokine release syndrome, also known as the cytokine storm, induced by the SARS-CoV-2 viral infection that seems to be associated with the high COVID-19 mortality rates. In fact, we recently reported the results of an in vitro study conducted by a team of researchers at the University of Tennessee Health Science Center to determine if VERU-111 can suppress toxic shock levels of these key cytokines of the cytokine storm. The effects of VERU-111 on cytokine production was assessed by stimulating isolated mouse spleen cells with an endotoxin that causes shock and this is called lipopolysaccharide, we just call the LPS. The cells was stimulated with LPS for one hour and then incubated overnight with VERU-111 to mimic the clinical cytokine release clinical situation and the cytokine level was then analyzed, and a concentration that represents blood levels of VERU-111 observed in clinically dosed patients, VERU-111 at 40 nanomolar significantly reduce at a p-value less than 0.001, the production of key cytokines known to be involved with the COVID-19 cytokine storm. TNF alpha was minus 31%, IL-1 alpha was minus 123%, IL-1 beta was minus 97%, IL-6 was minus 85%, and IL-8 homologue was minus 96%. This reduction was similar to or greater than depending on the specific cytokine to what's been observed with dexamethasone at 10 nanomolar, which is a steroid and a known inhibitor of toxic shock cytokine production. Suppression of these key cytokines may be an effective way to prevent clinical deterioration of patients with COVID-19 to ARDS. Veru is currently enrolling at a double-blind randomized 1:1 placebo-controlled Phase 2 clinical trial evaluating daily oral doses of Veru-111 18 milligrams versus placebo for 21 days in 40 hospitalized patients, who have tested positive for SARS-CoV-2 virus and who are at high risk to ARDS. The primary efficacy endpoint will be the proportion of patients that are alive without respiratory failure at day 22, secondary endpoints with this trial include the measured improvements in the WHO disease severity scale, which is an 8 point ordinal scale, which compares COVID-19 disease symptoms and signs, including hospitalization to progression of pulmonary symptoms to mechanical ventilation as well as death. Based on VERU-111 having antiviral activity and also confirmed in this in vitro study that VERU-111 may have ability to suppress key cytokines in the COVID-19 patients were even more hopeful that in the Phase 2 study with COVID-19 patients at high risk ARDS that VERU-111 will improve patient outcomes. As an aside, this current cytokine study also further supports the use of VERU-111 in prostate cancer as cytokines IL-6, IL-1 and IL-8 appeared to play key roles in the promotion of prostate cancer progression, metastasis and drug resistance as well. The ability of VERU-111 to suppress these cytokines may benefit men who have metastatic castrate resistant prostate cancer, which is the primary indication that VERU-111 is being developed for. There's really no downside to conducting this small study, especially if we can get non-dilutive funding for future clinical testing and VERU-111 shows efficacy for this indication, the upside will be substantial patients. Veru's ability to advance the clinical development of our proprietary prostate cancer drugs that address unmet medical needs and large markets is being substantially supported by the sexual health business, which currently is comprised of two commercial sources of revenue, the FC2 female internal condom as well as PREBOOST/Roman Swipes, which is a 4% Benzocaine wipes for premature ejaculation. The company also expects a third source of revenues from TADFIN for which an NDA is expected to be submitted in late 2020 or early 2021, and this will provide additional resources to support the company's clinical development programs. As you can see from the earnings release in Q3 fiscal year 2020 and year-to-date fiscal year 2020, we continue to have significant growth in revenue from these commercial products. Although Ms. Greco will cover the detailed financial results highlights in a few moments, I would like to make a few comments. We again have the pleasure of reporting robust growth in fiscal year 2020 and expect further increases in FC2 sales in both U.S. prescription sales and public sector for the rest of the year. Focusing now on Veru's commercial segments, which is the sexual health business currently comprising of FC2 and PREBOOST/Roman Swipes and drug commercialization costs, the company's net revenues increased again in fiscal year-to-date 2020 it was $30.8 million compared to fiscal year-to-date 2019 of only $23.1 million, representing an increase of 33%. Our income from operations for this segment of the business was $17.6 million for fiscal year-to-date 2020, up from $11.4 million in fiscal year-to-date 2019, an increase of 54%. In fact, to give you a sense of our growth trajectory for all of fiscal year 2019, we sold 159,000 units of FC2 into the U.S. prescription market, while we sold just in the first three quarters of fiscal year 2020, 234,000 units of FC2 into the U.S. prescription market. As you can see, our base commercial business is doing very well and as a standalone business would be quite valuable as we're experiencing significant growing revenue and income from operations, it should also be noted that we do not have a sales force and minimally spend on marketing and selling these products. This continued revenue growth and profit and positive cash flow from base commercial business has allowed us to substantially invest in the development of our prostate cancer clinical programs, which enhances the value of Veru for our shareholders. We intend to continue this revenue growth trajectory with not only the current growth of revenues from FC2 and PREBOOST, but also from the revenues that we expect to generate from the commercialization of the company's proprietary to Tadalafil/Finasteride combination capsule for the treatment of symptoms of BPH called TADFIN. We're collecting 12 months stability data on TADFIN manufacturing batches and expect to submit the NDA by the end of 2020, early 2021. In the U.S., we're exploring the eventual commercial launch of TADFIN through telemedicine channels. As you have seen, we've had great success with our other products using this sales channel. We expect TADFIN to add substantial near-term revenues with high gross margins, the existing and growing revenues from FC2 in PREBOOST/Roman swipes. I will now turn the call over to Michele Greco, CFO and CAO, to discuss the financial highlights. Michele?

Thank you. Dr. Steiner. As Dr. Steiner indicated, we're off to a great first three quarters of fiscal year 2020. Let's start with the highlights of our third quarter results for the three months ended June 30, 2020. Overall, net revenues were up 6% to $10.3 million from $9.7 million in the prior year third quarter due to the growth in our U.S. FC2 prescription business. The company reported significant FC2 sales growth in its prescription business with net revenues up 23% to $5.4 million from $4.4 million in the prior year third quarter. While, overall FC2 unit sales declined slightly by 3% to 10.5 million units from 10.9 million units in the prior year third quarter. We are pleased with the overall net revenue increase despite the slight decline in overall FC2 units sold. Net revenues for the public health sector business was $4.3 million compared to $4.9 million in the prior year third quarter. Gross profit was $6.5 million or 63% of net revenues, compared to $6.6 million or 68% of net revenue in the prior year third quarter. The decrease in gross profit and gross margin is driven primarily by increased cost of sales recognized during the third quarter, due to the temporary shutdown of the company's manufacturing facility in Malaysia as a result of the COVID-19 pandemic. Additionally, we have seen an increase in labor and equipment maintenance cost as we have ramped up production in huge demand. We are pleased to report that our FC2 Malaysian manufacturing facility is back up and running with volumes consistent with volumes prior to COVID-19 pandemic Malaysian government ordered shutdown. These financial results for the third quarter reflect shipments of $3.6 million units under the new tender orders from South Africa. We previously announced that we want 75% of the South African tender, representing up to $120 million units over three years for the total tender. This translates to approximately $30 million units per year for our company and potentially $10.4 million in revenue per year for a total of approximately $30 million over three years. We started shipping these orders from South Africa, during the third quarter of fiscal year 2019 and today in excess of 10 million 80,000 units. We continue shipping South Africa orders during the current fiscal fourth quarter. Operating expenses for the quarter decreased by $501,000 to $7.9 billion compared to the prior year third quarter of $8.4 million primarily due to the decrease in research and development costs, which will show you the timing the drug development activities. Additionally, the company received a potentially forgivable loan approximately $540,000 under the paycheck protection program at the CARES Act forgivable loans was treated like a government grant and recognizes reduction in operating expenses during the quarter. As a result, we recorded the reduction, design general administrative expenses of approximately $420,000 and a reduction to payroll related research and development costs of approximately $120,000. Non-operating expenses were $1.4 compared to $933,000 in the prior year third quarter and primarily consisted of interest expense and change in fair value of the derivative liability related to the synthetic royalty financing. We entered the synthetic royalty financing during March 2018. For the quarter, we recorded tax expense of $241,000, compared to the minimum tax benefit in the prior year third quarter. The effective tax rate of this quarter is 8.6% and for the prior year quarters basically zero, due to recording evaluation allowance against the net operating loss generated for the quarter in the U.S., which is a majority of the CK drugs for the period. The bottom-line results for the third quarter of fiscal 2020 was a net loss of $3 million, or $0.05 per diluted common share compared to a net loss of $2.8 million or $0.04 per diluted common share in the prior year third quarter. Turning to the results of the nine months ended June 30, 2020. For the first nine months of fiscal 2020, net revenues were up 34% to $30.8 million from $23.1 million in the prior year period. As a reminder, total net revenues for all of fiscal year 2019 were $31.8 million. Overall, FC2 unit sales totaled $27.5 million compared to $28.1 million units in the prior period. Net revenue from the U.S. prescription business was up 95% to $18.4 million from $9.4 million in the prior year period. It's also worth noting that all of fiscal year 2019 U.S. prescription revenues were $14.1 million. Net revenue for the public health sector business was $11.2 million compared to $13 million in the prior year period. Net revenue for previous Roman Swipes increased to $1.2 million from $623,000 in the prior year period. Gross profit was up 34% to $21.2 million from $15.8 million in the prior year period. Gross margin was flat at 69% due to an increase in the cost of sales resulting from increased labor transportation and equipment maintenance costs and increased costs incurred during the temporary manufacturing shutdown in Malaysia, as result of the COVID-19 pandemic, which offset the increase in the U.S. prescription business. Operating expenses increased to $24.7 million compared to the prior year period of $20.8 million, primarily due to the increase in Research and Development costs. Non-operating expenses were $3.6 million compared to $3.9 million in the prior year period, which primarily consisted of interest expense and changing the fair value of the derivatives liabilities related to the synthetic royalty financing. For the nine months, we recorded a tax expense of $30,000 compared to $117,000, the prior year period. The effective tax rate for both nine month periods is close to 1%. It is due to recording evaluation allowance against the net operating loss generated during those nine month period in the U.S., which represents the majority of the pre-tax loss for the period. The company has net operating loss carry-forwards for U.S. federal tax purposes of $42.6 million with $14.4 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 $61.7 million, which do not expire. The bottom-line results for the first nine months of fiscal 2020 was a net loss of $7.1 million or $0.11 per diluted common share compared to a net loss of $9 million or $0.14 per diluted common share in the prior period. Looking at the balance sheet, as of June 30, 2020, our cash balance was $50.4 million and our accounts receivable balance was $4.1 million. Our net working capital was $9.5 million at June 30, 2020 compared to $2.8 million at September 30, 2019. During the nine months ended June 30, 2020, we used cash of $1.6 million in operations, and we received net proceeds from financing activities of $10.8 million primarily due to $13.4 million that relates to the sale of shares under the 2020 purchase agreement, and the 2017 purchase agreement with Aspire Capital. Overall, we're delighted to see the continued increases in sales in the U.S. FC2 prescription business and the increasing sales and previous Roman Swipes to Roman Health Ventures and look forward to increasing FC2 sales in the global public health sector business in the fourth quarter. These revenue sources continue to be important sources of funds we used to invest in our promising pharmaceutical clinical development programs, as we continue to transform our company into an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer. Now I'll turn the call back to Dr. Steiner.

Thank you, Michele. We have enjoyed yet another strong financial quarter, which has allowed us to significantly advance our clinical programs. In fact, we now are into our third year of growth in our fifth FC2 U.S. prescription business. Looking forward to the rest of fiscal year 2020, we expect our revenues to continue to be strong and growing towards a record year. With the improving performance of the sexual health business, we believe that we'll be able to substantially invest in the continuous clinical development of our prostate cancer drug candidates, as well as submit the NDA and if approved commercially launched apps in which we put, which will provide even more revenue adding to the already growing revenue from FC2 and PREBOOST Roman Swipes. We anticipate a steady flow of important positive news for Veru over the next few months to one year, the VERU-111, an oral tubulin targeting agent. We will report open-label efficacy and safety clinical results for the Phase 2 clinical trials of VERU-111 in patients with metastatic castration and androgen receptor targeting agent resistant prostate cancer. We plan to submit the Phase 3 pivotal registration trial protocol in calendar year Q4 2020, and start the Phase 3 registration and clinical trial in calendar year of Q1 2021. With VERU-100, our novel peptide GnRH antagonist 3-month depot formulation, we will complete GMP manufacturing of the clinical supply of VERU-100, submit the IND and initiate a Phase 2 clinical trial and by the second-half of calendar year 2021, we will initiate a Phase 3 pivotal registration clinical trial. For Zuclomiphene, our oral estrogen receptor agonist will have a face-to-face end of Phase 2 meeting with FDA. We plan to complete the Phase 2 clinical program for COVID-19 subjects with high risk to ARGS, submit the NDA for TADFIN. We plan to continue to demonstrate robust growing revenues for commercial products FC2 and PREBOOST/Roman Swipes. We will also have secured partnerships with some of our drug products. We have substantially transformed our company into an oncology biopharmaceutical company supported in part by growing revenue, cash generating sexual health business. The model is working, the transformation is near complete. With that, I now will open the call to questions. Operator?

Ladies and gentlemen, at this time, we will begin our question-and-answer session. [Operator Instructions] Our first question is from Brandon Folkes from Cantor Fitzgerald. Go ahead.

Hi. Good morning, Mitch and team, and thanks for taking my questions, and congratulations on all the progress during the quarter. Firstly, on 111 when we see the Phase 1b data presented in September, will there be any new data, and if so, what do you think are going to be the most pertinent parts of the data received from that 1b, given that we're seeing some of it later in the year? And then secondly, as a follow-on, on 111, and I think as we've spoken in the past, you talked about having a very good indication of what you believe the FDA wants to see from a Phase 3 protocol, and it sounds like that been further concerned with the dialog, but maybe just as the Phase 2 progresses, do you envision any amendments to the Phase 3 protocol, and what are some of the factors there that you are watching in the Phase 2 that could still meaningfully have stick the Phase 3 protocol? Thank you.

Good, okay. So, really the first question is basically you're going to be presenting data at ESMO in the fall, is there anything new that you're going to be presenting? And the answer is yes. What we've presented today, which is sort of highlights of what we had in the study, and so, you'll see more details. Now, interestingly, which is kind of unusual for Phase 1b 2, we were selected for a oral presentation. So, unlike a poster where we can just lay everything out, the oral presentation is going to be limited, that it will be highlighted. So, Dr. Mark Markowski is going to go through additional efficacy and additional safety data that that has not been presented before, and so, I think that's going to be important to look at, and so, as I said, you'll see some more safety and you'll see why we're excited about the safety, and remember safety is critical if a urologist is going to give the medicine over medical oncologist, and if it's an IV product, it's a no-go for urologist, of course, but this is oral, and I think you'll find it interesting, and then I think there'll be some additional tumor pictures that you'll be able to see tumors that have shrunk, and so you can see further evidence of objective tumor responses, and that's about as much as I can say without giving you more data. As it relates to the second question, which is -- and we're excited about it, okay, and that's and that's the reason we went to the FDA and that's why we accelerated our discussions with the FDA because we were able to pick a dose based on safety and efficacy, and we know our patient population, and so, that's a reason why we went forward to the FDA. We picked the doses 63 milligrams per oral daily dosing for 21 days continuously, and we have enough patients in the Phase 1b to give us a very good indication of the efficacy and safety around that dose. The Phase 2 program is just going to be further confirmation of the safety and the efficacy around the 63 milligram dose, and that's how I would view that study. The difference between the two is the other one, we're doing three plus three design and this one, everybody's synchronized, starting at the 63 and not having other doses and so we're going to see what happens with just 63, and I can tell you at this point now, I'm not expecting anything in that study to change to change what we've presented to FDA, and mainly because most of the stuff that we spoke to the FDA about was around a clinical trial design. So, progression-free radiographic progression free survival, which was an important endpoint to get, that's not going to change, and that's going to dictate what size study, the patient population well that's not going to change because the patient population of patients who have metastatic castration resistant prostate cancer that have progressed on at least one androgen receptor, one androgen receptor targeting agents, that won't change, and so, really, it's going to be and that's the reason why we, as I said, that's the reason why I went to the FDA sooner rather than later. So the Phase 2, if the Phase 1b is still going on, we got patients 16 months and 12 months and they're going to continue. Another way, look, at a year and a half to two years is what is happening with the 1b potentially, the same thing is going to happen with the Phase 2. So that's the reason why we don't want to wait another two years is you're not going to gain any additional information for patients that traditionally, if they were on one antigen blocking agents and they failed, and they go to an alternative one, you're looking at progression free survival of about 3.7 months, and if they had both Abiraterone and Enzalutamide failed, it's more like two and a half months, and here we are with a 25% of our patient population in a Phase 1b it's certainly beyond that. So that's why I think what you're going to see is the Phase 3 is going to be final protocol will be submitted in October, irrespective of the Phase 2 and the study will start at the beginning of the calendar year 2021, and the Phase 1b and the Phase 2 again, still be going on in the background, because we're expecting patients to continue to respond to the medicine for a long period of time. So I'm not expecting any amendments or anything of that sort. I think once we get some of the non-clinical and some of the other stuff pull together, that's all October's when we're going to put the final protocol in, and then of course, we'll report back after the FDA has had a chance to review the final protocol to see what tweaks we need to make.

Great, thanks very much, Mitch. It's very comprehensive, like putting the data into templates, and maybe just one more if I could sneak in, I will hop back in the queue; on the COVID program, if you tell from the Phase 2, do you think there's a chance of getting emergency use authorization for that product?

We had that debate internally, and it'd be to be fully transparent. We have that debate internally. Some of the folks at Veru feel that it's possible. I don't I think we're going to have to do more work, and so, I'm thinking we're going to get non-dilutive funding, and we'll do a Phase 3 study and we'll see but a lot of it depends on and what are the outcomes and how dramatic they are, and if they're dramatic, then your chances are that you may be able to move forward. If there needs to be confirmed, then you'll do the Phase 3, so it's really hard to say, but I wouldn't rule out emergency use, I just think it's more likely that we'll move to a Phase 3. I wanted to be clear that if we do move to a Phase 3, that that will be with non-diluted dollars. We've to get funding support for that. My guess is given the current environment and if our data supports going to Phase 3, we should be successful in getting that non-dilutive money.

Great, thank you very much.

Thank you.

Our next question is from Leland Gershell from Oppenheimer. Go ahead.

Hey, good morning, Mitch. Thanks for taking my questions. Congrats on all the progress. Once asked, you've been having great success with commercial business, growing revenue, obviously great margins, but you will be facing, increased expenses with the Phase 3 and prostate cancer, probably one of the more expensive if not most expensive trials you're going to take. So just want to ask in terms of how we could think about modeling, would you expect that the commercial would be sufficient to fund the bandwidth to other operations as we think about potential capital financing that may occur perhaps in 2021? And then I have a follow-up. Thanks.

Yes. So, let's make some assumptions first. The first assumption is that if the commercial business continues to grow at this rate and that we're not using any money for marketing and selling for the most part and that all that gross profit and the more we make and the fixed costs are going to take less of that, right, but on a percentage basis. So every additional dollar that we get is pretty much going to drug development, and FC2 and PREBOOST, I'm telling you 2021 looks very, very good, and so, again, continue to grow, and so, if we're in the order of, as we reported three quarters in, and we're $30.8 million in revenue, and it looks like we're going to finish this year off as a record year, and next year is supposed to be another record year. How does that magnitude of money match up with what we would potentially have to spend in a Phase 3 program? So we have two Phase 3 programs that we're facing for next year. One is the big one, bigger one, I should say, which is going to be between 200 and 300 patients, and from a money standpoint, that's probably in the order of about $20 million to $25 million, and then we have 100 patients study, which is going to be the GnRH antagonist, and that one is more like the 100 patients in testosterone's endpoint and all that expensive work with CT scans and all of that. We don't have to do that, and so, that study would be more in the range of about $10 million or something like that. But that's not going to start to the second-half of next year. So if we're start looking into money, if you're between $25 million to $35 million in money that you need over the next 18 months, it's not a far stretch that our commercial business can help pay for a substantial amount of that, and so, it puts us in a very, very good position to be opportunistic, and if people begin to realize the full value of the underlying sexual health business, which on its own clearly has more value in that we're trading at today with that kind of cash and it's continuing to grow in spite of COVID. That base business alone means that if anybody invests in our company, they're getting the drugs for free, and so, my thinking is that we will be opportunistic as it makes sense but if not we are generating enough revenue and cash coming from the sexual health business that over 18 months. We would be able to self-fund a substantial portion of it.

Okay. That's helpful, and then in that same vein, given the success you've had with the sexual health business, I know you'll have TADFIN coming down the pike and that'll be a meaningful increment to that. Would you -- or are you considering adding yet other products to the commercial business just given how you don't need to really worry about sales force costs and things like that. You can kind of plug into the telemedicine channel and benefit from additional revenue. How should we think about those kinds of thoughts?

Yes. So let's take a step back. We started working in telemedicine two-and-a-half years ago, is that right? Two-and-a-half years, something like that, and the reason I say that is everybody is comfortable with telemedicine post-COVID and -- because COVID has forced everybody as a disruptor to start looking at telemedicine as an alternative to visiting doctors, and now people are not even -- doctors not only -- family not allowed to come in when the patient comes to see a doctor. Do you think they're going to let a sales rep in? So, the world has changed, right, and so, I feel sorry for the companies that are launching products in this current environment. Now, we chose telemedicine, and the reason we did that is because it turns out that the new generation are very comfortable using their cellphones or their smartphones to order anything from bottled water they want that evening at their home to prescription products, where they don't want to wait, to get the prescription they don't want to wait to stand in line at the pharmacy, they don't want to wait for the pharmacy to get it. They just push a button and they get it, and female contraception took the lead, and we're able to attract folks to their website through their marketing dollars, and now all of these women that were in colleges were sent home, and so, instead of going to the infirmary to pick up their birth control, they now have to find alternative sources and guess what, they end up getting online and they're starting to move towards a telemedicine platforms, and just like you -- the first day that you went to Amazon and bought something, you said, boy, this is pretty cool. So you're not just going to buy that one product. You start to add other products, and so, the telemedicine folks are beginning to realize they need to offer a portfolio of products, and so, yes, I think what you're going to see in telemedicine, they're going to continue to grow and that the model is going to change. As it relates to us, we're kind of doing that right. We started out with a female condom business. We put that into telemedicine. Then we did PREBOOST, put that into telemedicine and took it. When we removed it from a sales force that was your traditional marketing and selling, got rid of that sales force, whether it was a license that we no longer had, we got rid of or it was internal group of people that we know that we had to let go as we structured it into a different model. And so, TADFIN seems to fit that model as well because it is a BPH product that has other benefits, but BPH is a men's health, sexual health issue, and yes, we're in talks with telemedicine groups to help us launch that, and the power of telemedicine is that once the FDA makes the -- assuming we get an approval, you push a button and you've got all these patients in your universe that -- for the telemedicine universe that you can bring in and begin to consult and then provide a prescription, and it's just amazingly efficient. So would we continue to grow the sexual health business with other products? The answer is yes. Why would we not even though our focus is prostate cancer and that kind of stuff, and then we're going to continue to be focused in prostate cancer, that's our core business. We will be opportunistic, particularly when it doesn't mean it costs our shareholders anything. If it's a matter of taking advantage of our contacts and growing the business and we can do a deal where the other party makes money, we make money, but we're not spending money, and one plus one equals five in the core sexual health business, do that all day long, and that's kind of what we're seeing now. I mean, look, we hit a critical mass in which we're actually being called by these telemedicine groups to see if we have products for him. So, this is a very interesting time and we're trying to adapt to it, and I think we've done a good job taking at least two products now and soon a third product and showing that this is real and we do this pre-COVID, and now I think COVID-19 going forward is disrupted the whole field that we're kind of in the right place for that.

Great, that's really helpful. Thanks for taking the questions and we look forward to the data at ESMO.

Thank you. Appreciate it.

[Operator Instructions] Our next question is from Yi Chen from H.C. Wainwright. Go ahead.

Hi, good morning. Thank you for taking my question. The U.S. prescription sales of FC2 at $5.4 million in fiscal third quarter seems to be lower than $7.0 million in the fiscal second quarter and $6.1 million in the fiscal first quarter. So could you give us some additional color on the dynamics of the U.S. prescription market? And whether there's any seasonal trend or whether it is affected by COVID-19 at all? Thank you.

Yes. Good question. So the question is, it looks like this quarter, there's a little dip in the U.S. prescription sales, even though over the fiscal year, it's clearly we're way ahead. As I mentioned before, 159,000 prescriptions were written last -- 159,000 12 pack units were dispensed in fiscal year 2019, and in just this first three quarters where 200 -- whatever the number is, 239,000, whatever the number is, so it's big, and so, that means this next quarter if it's an even quarter, it's going to be a record year. So that I want to make it very clear that the U.S. prescription business is robust and it is growing. What you are seeing is that the purchase orders that we get from the telemedicine groups don't necessarily fall with the quarters, and so, some of that -- I think you are seeing some of that dislocation, and COVID-19 -- I would argue that COVID-19 helped us with that dislocation rather than not. Meaning that if there was some inventory, the inventory was quickly used up because of the fact that women at home now using the Internet and what we have heard uniformly from the FC2 telemedicine providers or as you say the customers is that COVID-19 did indeed increase their business, and so, I don't think COVID-19 is going away. So, I think our next year is going to look robust as well, but I think some of that dislocation again we have the purchase orders come in, but I will let -- Michele, do you want to add a little color to that?

Sure. The other item that we did see was customers working and building inventory, and so, they were -- and figuring out how much inventory they wanted to keep on hand versus how quickly they place orders and turn it around and have a sell through, and so, we did experience some of that, and as Mitch said, our customers will put in a three-month purchase order, and then, pull down from that as they see fit, and that just doesn't coincide all the time with what we are seeing as we cut off our quarters.

Okay, thank you.

Thank you.

Our next question is from Kumar Raja from Brookline Capital Markets. Go ahead.

Hi, thanks for taking my questions. With regards to the prostate cancer trial, what is your expectation of timing of meeting with the EMA? And how do you think the expectations of EMA would be different compared to the FDA? And do you think you can incorporate the requirements of both the agencies in the single Phase 3 trial you are planning?

Yes. Good question. So, the EMA for everybody is European Medicines Agency, and we are going to be running a global Phase 3 and the intent is that this global Phase 3 which served the registration both in the U.S. and with EMA, and so, with that said, we have to -- you got to pick and choose, and so, the first step is to get FDA input. The FDA and EMA have tried very hard to harmonize their advice globally, but just to be safe, we want to make sure that they agree, and I will tell you that based on some of the other prostate cancer studies that have been done and have met with the EMA that what the FDA is allowing us to do is not specific to us. It seems to be what the FDA has settled in terms of endpoints in this space. So, we are going to meet with EMA probably late this year. We are just starting the [request and part of that] [ph] was we just met with the agency in July. So, this is what you would do, and so, now we are going to submit to EMA and get their advice, but the goal would be that when we start our study in first quarter of calendar year 20 - 21 that would have input from both agencies, and that would serve as a single Phase 3.

And with regards to VERU-100, what remains to be done before you can go ahead and file IND?

So, all we are waiting for that is the -- all the non-clinical is done. Everything is done. Only thing that we are waiting on is GMP manufacturing. As you know when a GMP manufacture a peptide, it's little different. It takes a little bit more time, and you have got other issues all worked out, and so, what we are doing now is just waiting for the final batch to be manufactured so that we can forward, and you can't really file an IND until you have that CMC information, and so, the CMC information as soon as it's available, then we will file in the IND, and as you know, 30 days after that you can start the trial. So, literally just waiting for the last parts of the manufacturing to do be done under GMP, and then we will start the Phase 2, you know, not right at the end of the year, right at the beginning of the year, and that will be a small study, single injection, and that will guide us in what we need to do for the Phase 3. So, we are close.

Thank you.

All right.

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

I appreciate you joining us on today's call, and I look forward to updating all of you about our progress in our next investors call. Thank you for joining us.

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