Veru Inc. (VERU) Q4 2019 Earnings Report, Transcript and Summary

Good morning, ladies and gentlemen, and welcome to Veru Inc.'s Investor Conference Call. All participants will be in a listen-only mode. [Operator Instructions] 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.

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 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. Please go ahead.

Thank you, Sam, and good morning. Also joining me today 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 developing novel medicines for the management of prostate cancer, as well as other cancer types. Today, we will update you on the clinical development of our drug pipeline and the commercialization of our products, as well as provide financial highlights for the fourth fiscal quarter and year-end fiscal year 2019. We are delivering on our strategy to be the prostate cancer company. We are dedicated to the development and commercialization of products to address unmet medical needs for prostate cancer treatment and supportive care. We will remain opportunistic as our cancer drug product candidates have shown efficacy against other cancer types in animal models and they ultimately show efficacy in man as well. The markets for prostate cancer treatment and prostate cancer supportive care are well established as multi-billion dollar markets. And given our core expertise and the number and type of drugs in our pipeline, we are uniquely positioned to understand, develop and commercialize medicines for these unmet medical needs of prostate cancer patients. Here is a brief update on the advancement of the prostate cancer drug pipeline. We have made significant progress with our open-label Phase 1b/2 clinical trial, the VERU-111, a novel proprietary first-in-class oral selective antitubulin agent for metastatic castration-resistant prostate cancer patients, who have also become resistant to novel androgen blocking agents enzalutamide or abiraterone, but prior to IV chemotherapy, also referred to as a pre-chemotherapy stage or chemotherapy naive. In other words, the open-label Phase 1b/2 trial is targeting those patients whose prostate cancer is progressing that is spreading, but before they are offered IV Cabazitaxel taxane chemotherapy. This pre-chemotherapy space in men who have failed a novel androgen blocking agent is currently the fastest growing unmet medical need segment in advanced prostate cancer. We have reached a point in our Phase 1b/2 clinical study that our clinical results have become relevant to our decisions going forward for the clinical development of VERU-111 and positions Veru solidly as an oncology biopharmaceutical company. Accordingly, I will share some of the pertinent details while the full results will be released formally in an upcoming scientific meeting. As a relevant benchmark, a New England Journal of Medicine article was recently published in October of 2019 by Dr. de Wit et al on the use of cabazitaxel in men with metastatic castration-resistant prostate cancer who were previously treated with docetaxel, but who had cancer progression while receiving an androgen blocking agent to either abiraterone or enzalutamide. These men are at a similar stage of treatment as the men, we are currently enrolling in our Phase 1b portion of the Phase 1b/2 study. Interestingly, imaging-based progression-free survival is the primary endpoint, which was defined as the time from randomization until objective tumor progression, progression of bone metastasis or death. A total of 255 men underwent randomization to either IV cabazitaxel or another androgen blocking agent which studies results noted that the imaging-based progression-free survival with the additional androgen blocking agent was a median of 3.7 months with a range of 2.8 months to 5.1 months. And for cabazitaxel, it was a median of eight months with a range of 5.7 months to 9.2 months. Veru did not run a head-to-head study with cabazitaxel versus VERU-111. So any comparison has limitations, but nonetheless the intent is to use this valuable information to put into perspective our current ongoing results when compared to a recently reported contemporary study. Now, let's turn our attention to our Phase 1b/2 clinical study. In the Phase 1b/2 study, the objective is to determine the maximum tolerated dose of VERU-111 by finding the dose limiting toxicity that indicates that higher doses are not tolerated by the patients. By the studies design, the maximum tolerated dose is determined by treating three patients at a time with an oral daily dose VERU-111 for seven days followed by two weeks off drug which treatment schedule represents one cycle. For patients that tolerate treatment, we increased the schedule to two weeks on drugs, and one week off, and then three weeks continuously on drug, until there is evidence of prostate cancer progression. This will allow us to assess the durability of the anticancer response. We have treated 33 men to-date. The escalating doses of VERU-111 tested so far are 4.5 milligrams, 9 milligrams, 18 milligrams, 27 milligrams, 36 milligrams, 45 milligrams, 54 milligrams, 63 milligrams, 72 milligrams and 81 milligrams. As for safety, VERU-111 appears to be generally well tolerated. There are no reports of neutropenia, which is the dose limiting toxicity of an IV taxane. There have been no reported complaints of neurotoxicity, a side effect that also commonly occur with IV taxanes. There have been a few isolated mild liver enzyme changes that in some instances resolved while on drug. There have been reports of side effects consistent with VERU-111 or other antitubulin cytotoxic effects such as mild to moderate diarrhea, nausea, vomiting and fatigue. We have not yet reached a dose limiting toxicity with VERU-111 in order to determine a maximum tolerated dose. We know that with oral dosing VERU-111, it's getting absorbed into the bloodstream, which means we have bioavailability, with VERU-111 concentration going up with increasing drug doses. In fact, we have achieved VERU-111 blood concentrations in humans that match the efficacy concentrations we measured in the pre-clinical animal studies, where prostate cancer tumor shrunk. Furthermore, we are achieving drug concentrations at VERU-111 in a range of those of docetaxel and cabazitaxel approved doses without the safety observations that are typically observed with these drugs. Although this is a safety study, we do see significant anti-tumor activity. As a reminder, in the DeWitt study published in New England Journal of Medicine, adding another androgen blocking agent resulted in imaging based progression free survival median of 3.7 months and treatment with IV cabazitaxel resulted in imaging-based free progression medium of eight months. In our Phase 1b, we have 20 men in the study that have the potential to be treated for 4.5 months, which means they are in that lower dosing range because they were in the studies earlier. And even without having determined in optimal dose or a dose schedule yet, there were four men who are still ongoing in the trial with no tumor progression at 9.75 months, 8.4 months, 8.4 months, 5.6 months. All of these men have experienced PSA reductions from base of peak values. Another six men have progressed at 4.2 months. The patient still in the trial at 9.75 months has had a PSA reduction of 63% and had two of his cancerous lymph nodes shrink as measured by CT scan. Another patient on the study with stable disease stopped losing weight, reported that his fatigue resolved and had a PSA reduction. It appears, looking at the Dewitt study that VERU-111 is an active compound similarly to cabazitaxel but better than adding another androgen blocking agent. And that is also well tolerated with a wide safety margin. Wide safety margin means that we are seeing anti-cancer activity at doses where we are not seeing drug toxicity. Again, we will present the full clinical results in an upcoming major scientific meeting. As we have not yet reached dose limiting toxicity, we will continue to test higher doses of VERU-111 until we reach a maximum tolerated dose in the current Phase 1b/2 study. Nonetheless, given the current efficacy and safety profile, early in 2020, we plan to expand the clinical program of VERU-111 to a study of three additional tumor types or indications where we've had demonstrated anti-cancer activity in pre-clinical animal studies. The planned new cancer types are metastatic pancreatic cancer, metastatic breast cancer and post-chemotherapy metastatic castration and taxane-resistant metastatic prostate cancer, metastatic breast cancer and metastatic pancreatic cancer. We plan to report top line clinical results with the Phase 2 clinical trial evaluating zuclomiphene for the treatment of hot flashes caused by androgen deprivation therapy, submit the NDA for TADFIN, complete GMP manufacturing of clinical supply for VERU-100, submit the IND and complete the Phase 2 clinical trial. The secured partnerships with some of the other drug products and continues to demonstrate robust growing revenues from our commercial products PREBOOST/Roman Swipes and FC2. We are committed to driving shareholder value by becoming the prostate cancer and providing a continuum-of-care for prostate cancer patients. With that, I'll now open the call to questions. Operator?

[Operator Instructions] The first question today comes from Brandon Folkes of Cantor Fitzgerald. Please go ahead.

Hi, thanks for taking my questions and congratulations on all the progress during the quarter and year. Firstly, can you provide some color around the cohorts at the form [ph] that you called out as nine months to eight months and the five to six months? Any color on what dosing cohorts those gentlemen received? And then, following on from that, can you just elaborate a bit more in terms of if you are seeing a dose response regarding efficacy? Thank you.

Yes, it's a good question. So really, the question is, can you give more color to those four patients? And, I will -- because of the way the trial is designed, the safety part, they come in at whatever dose they are supposed to come in; so there is 4.5, if it's 9 or it's 18; that's the first dose those three patients would receive for seven days. And then they go to 14 days with that dose, and then they will continue with that dose, and if they are still stable then we keep going up. And so, yes, what we are seeing is as the schedule goes up; now as you go from 7 days to 21 days continuously on each day, and you grow up on the dose. You're seeing that correlates with the PSA response for example, because they're already stable. And so unlike a Phase 2 study where you just say, okay, this is the schedule I'm going to pick, it's going to be continuous, and this is the dose I'm going to pick and you run everybody that way. That's the only way you're going to be able to get core [ph] percentage of 20 patients for example that responded to that dose of schedule. But I could say in general, what's interesting is that these 20 patients are really the first 20 patients in the study, we're 33 right now -- and so, that's what makes it so encouraging; and the study, again, is not designed to be an efficacy study but yet -- you know, when you see a lymph node shrink, you get pretty excited about that.

Great, thanks. And just one follow-up, if I may. How are you thinking about dose selection for the three Phase 2 trials you talked about initiating in early 2020? Thank you.

So it's a great question, again. So, here is our dilemma. The dilemma is that we have not reached dose limiting toxicity. And so -- but we're seeing anticancer activity. So another way of saying that is, there appears to be a wide margin of safety so that -- so that you can push the drug levels up, and you're not seeing the neutropenia, you're not seeing the neurotoxicity; we're seeing little nausea, vomiting and that kind of stuff. And so the idea is, we're going to pick a dose in the upper range of what we've already tested because we're seeing activity, and we're going to move it into the Phase 2; and if need be, we can always continue to increase the dose in that Phase 2 as long as the patient is tolerating it. So rather than just sit here and wait until we get to a point where we actually have a dose-limiting toxicity; if it's got a wide margin, there is a situation then and we talked about this internally, that -- it may not make sense to be at that high, high range anyway. I mean, if you're seeing activity at a much lower range and that's why you move forward. So, it will become clear as we go forward. So we're going to pick a dose at somewhere in the middle, and then we're going to -- almost certainly, it feels like the schedule should be something like continuous but it gives us the ability to go back to 14 days, one week off, if we need to, or just drop the dose that we need to. And we're picking the tumor types where we have seen in our preclinical animal models, the concentrations that we're achieving now in these men, we've achieved; and for example, triple-negative breast cancer which was recently published, pancreatic cancer, that's also published. And also, interestingly, in the post chemotherapy space because -- and I'll make this very clear, because of VERU-111 is not a substrate for P-glycoprotein, so which is an MDR. So one of the main mechanisms by which taxanes become resistant is that the cell has these pumps called P-glycoprotein, and it pumps out the chemotherapy, so the cell doesn't get killed by the chemotherapy. So docetaxel fits right into that pump and gets pumped out; cabazitaxel, which is used after docetaxel, fits into the pump but not as well, and so you see activity. VERU-111 doesn't fit in the pump it all. And so, when you look at the animal models in breast cancer, and pancreatic cancer, and lung cancer, prostate cancer; when we treat a cell that's become resistant to a taxane, it dies just like a cell that's never seen a taxane. And so that's a real -- that's -- that could be a really cool way to get to market. So each one of these cancer types that we picked, we have -- as I said, we have preclinical data and we have good scientific rationale for why those should be the next ones that we should go for. And they are small, so you don't need big studies in hundreds; these are Phase 2s that will inform you for the Phase 3. And so that's the other advantage of doing a few of these Phase 2s. And again, if we can show in addition to prostate cancer and stay with prostate cancer, that's a wheelhouse [ph], but also showing the other tumor types; that will tremendously increase the value of the asset. And as you know, oral targeted therapies is where the world is moving right now, and our biggest concern was what was going to happen if you feed this sort of patient orally; was it going to be able to get into the bloodstream -- it gets into the bloodstream, the biggest issue with taxanes, it doesn't get into the bloodstream. And then the second thing, the biggest issue is; are you going to be able to give it and not have so much toxicity that you can't achieve the same levels as you can with IV, and we're not seeing that. So this is all very positive.

Great, thank you very much. And congratulations on all the progress, again.

Thank you.

The next question today comes from Yi Chen of H.C. Wainwright. Please go ahead.

Good morning. This is [indiscernible]. Just a few questions from me. I'm wondering how many tablets patients have to take on VERU-111 at the 81 milligram dose?

It's a good question. But as you know, we haven't done the full formulation; so there is no reason why once we have to do the formulation that we believe will be the dose that will go forward and we have one tablet a day or one capsule a day. So what we've done to make the trial easier as we made 9 milligram tablets, excuse me, capsules; and so you get 9 times 9 in that situation, but we can make -- we can make -- there is no limitation here, the bioavailability is very good. And so, whatever the to-be-marketed form will be, it will be a single pill, and given once a day. And also, the idea would be that we would also have a pill that would have a lower dose so the patient needs to have a dose reduction they will be happy to. And then, this is a key point; these are patients that don't -- do not need to be pre-medicated like the IV taxanes -- IV taxanes because of the hypersensitivity reactions that they get because of the solvents they used to try to make taxanes soluble in IV form, they had to be pre-medicated with anti-histamines and prednisone, and all this other stuff. We don't have to do any of that, we have not seen one hypersensitivity reaction in the 33 patients nor that we expected. And, so really the number of pills a patient will have to take will be one a day, and -- and that's as you know, that's much better than what -- with some of these androgen blocking agents and others. Now we have to take multiple pills a day, but you also have to take prednisone. So clinical trials, we're using 9-milligram capsules as we go up in the safety in the 3-plus-3 design, but there is nothing about the drug that will stop us from just providing a single pill a day.

Okay, that's good to know. I have a follow-up just based on sort of the last question as well, just sort of a clarifying point. I'm wondering if you're going to use that same dosing scheme for all three Phase 2 trials? I'm sorry, both…

Yes.

I think breast cancer and the prostate cancer. And then, just on this current trial, it seems that you're not going to be enrolling anymore patients to reach that maximum tolerated dose. So, it doesn't seem like the start of the Phase 2 trials are going to be affected; is that correct?

You're good upto that point. So the answer is yes, we are going to continue dosing to try to get the maximally tolerated dose. And because we haven't reached it, and so we'd like to be put a bow on that. But because we're seeing anti-cancer activity that looks very, very good at the lower doses, you know, we don't have to wait. So as you know, most cancer trials have a way to get to maximally tolerated dose but we're usually getting a maximally tolerated dose at the same time we're seeing the efficacy because as you know, at the end of the day it's a poison, and you push the poison to the point that you kill more cancerous cells than normal cells, in our situation, it seems to be a wide window. So in that situation -- so we do see that we're going to try our best to get to a dose limiting toxicity, and at some point we're going to -- we're going to -- I think it will be GI because the GI tract has turnover of cells and all that stuff, and so -- we would do that, then you can back-off and then pick the dose below that. But because -- again, because it's a wide margin, it's going to give us tremendous flexibility in the Phase 2; so we'll get started and with the dose change it could. But the good news is, it will in the sense that you're going to try to get more efficacy out of it, not less. And, so I think we're in a unique situation but -- but you know, we have not hit a dose limiting toxicity and yet we've reached a point where it makes good sense at the concentrations that we're achieving in these patients based on the preclinical models with there. And not only that, we're at the top range of those concentrations where we saw dramatic tumor responses in the preclinical model; so it doesn't make sense to keep pushing up from an efficacy standpoint.

Right, I appreciate that clarity. And just a final, just house-keeping item. I'm just wondering if you can elaborate on some of the total operating expenses, you expect for 2020?

Michele?

Yes. We're going to continue to see the R&D expenses continue to increase. If you look at this year, we'll be reporting the -- issuing the 10-K here, shortly today. And as I indicated, what our R&D expenses were going to -- I can just go over that again. In 2018 you saw $10.8 million, and then 2019 you saw $13.7 million. And the rest of the SG&A is relatively flat year-to-year, and we will stay at that level; and the emphasis is going to be in our spends going into drug development.

Excellent. Thank you for taking the questions, and congrats on a great year.

Thank you. Appreciate it.

The next question comes from Kumar Raja of Brookline Capital. Please go ahead.

Thanks for taking my questions and congratulations on all the progress. On the prostate cancer trials, maybe we can touch a little bit on the patients who are progressing -- who are not progressing -- who are progressing. So these patients are the more -- do they have like a more aggressive cancer? And they are not able to reach efficacious dose, that's what is happening with these patients? Maybe you can elaborate a little bit on that.

So I want to make sure I understand the question. So the question is for the patients that are not responding; are they having a more aggressive disease. That's the question?

Yes.

Okay. Yes, yes. So, as you know, in clinical trials even the best medicine; so for example, I'm going to answer in two ways. I'm going to tell you a little bit about the other medicines and their rates, and then I'll come back to this one. So even in the other medicines like abiraterone and post-chemo, if you go back and look at the PSA response in the New England Journal of Medicine paper, it was about 28%. If you look at enzalutamide in the same space, about 50%, which is another way of saying that anywhere between 72% and 50% of men are just going to march right through it no matter how great the drug is. And that's because prostate cancer is heterogeneous, there is all kinds of different kinds of mutations and so on. And so -- and that's in the Phase 3 setting where you've optimized everything. Cabazitaxel and Docetaxel, the same thing; it's in the range of 30% to 45%, 50%. So clearly, there are different kinds of prostate cancer. Our situation, we cannot comment and reason we can't comment is because think with me for a moment, we're taking patients that have failed abiraterone and enzalutamide and ADT and we starting slow. So we're giving them a low dose and we're giving them a low dose at a small period of time. 7 days and then 14 days off, then they go 14 days, and then one week off and they go 21 days continuous. So every time you make that change it's another three weeks, another three weeks, another three weeks, and another three weeks. So there is no question. There are many patients in our study that are being under dosed and under scheduled as we try to understand the safety and so that's why you can't take a Phase 1B and say I had 10 patients in 75% responded because of the heterogeneity of the dosing and the schedule. So we're hoping that once we find the right dose and the right schedule, and the fact that we're seeing this kind of activity at the inconsistent dose, in consistent schedule certainly tells us that will be similar if not hopefully better than what's currently available.

And in terms of pancreatic cancer and breast cancer, at what doses to see response in the animal models and how does it..

Good question. So in the question basically is if you look at the human equivalent dose in the animal model and you're trying to make it point back to the human. So the human equivalent dose in animal models with, first of all in the animal model, whether it was breast cancer, pancreatic cancer or post chemotherapy taxane and quite frankly, and the other ones even lung cancer is all kind of the same and that is you start seeing activity about and this is in the mouse, which is 5 mix per gig and then you see great activity at 10 megs per gig, 12.5 megs per gig, 15 megs per gig and 20 megs per gig. And but time you hit 12 to 15 is one of, was the equivalent dose in the human study. So the equivalent dose is anywhere between 63 milligrams and 72 milligrams gets us in that sweet spot and we're beyond that, we're at 81 right now. So that's why we're saying, look, guys. We're reaching concentrate and we've measured the blood levels post-trial and so we know that it's getting in and we know we're seeing those concentrations and so we're feel. So if you're doing that then it turns out funny we're more like to rat in the mouse in terms of the way we handle the drug. And so the human equivalent dose to get to those concentrations where we saw efficacy in the animal models is we're in that sweet spot. With that said, we're not seeing the dose limiting toxicity. We're not seeing neutropenia. We're not seeing neurotoxicity, which are classic side effects of taxanes and as you know the dose-limiting toxicity of docetaxel and cabazitaxel which are very, very active in prostate cancer is neutropenia. And so we feel comfortable taking the dose that we're currently giving in our study and using it in those other tumor types, because it is amazingly consistent across tumor types the response to the same concentration of the drug.

Okay. And in terms of the zuclomiphene once we have the Phase II data, how long will it be before we can start the Phase III trial. And in terms of the Phase III, you think you will have similarly two doses there and what is the expectation in terms of number of patients?

It's a great question. So a lot of it depends on when we see the data. What we see in the data. Whether we go with one dose or more than one dose, we hope that the Phase III will be just one dose versus treatment. About I mean, keep up the flexibility and as the plan is if we are able to determine the minimally effective dose and we're able to determine the effective dose with the top line data, as you know it's top line then we get the full dataset hopefully January and February but beginning of January anytime from now into the beginning of January, we hope to get the topline data. Than the plan would be to have an end of Phase II with FDA and by the time you get you in the Phase II meeting with FDA and get everything ready for the Phase III, the goal we have the Phase III start in sort of the May, June timeframe.

And maybe a final question on the female condoms, what's happening in terms of this contracting in South Africa and Brazil? And how should we think about revenues for fiscal 2020?

So what I'm going to do is, I'm going to tell you what I think about Brazil and South Africa and then I'll have Michele comment on what he's thinking in terms of the numbers. As it relates to Brazil we ended up getting more orders than expected from Brazil and part of that is because the people are voting in Brazil. The women are voting, they like our product better than they like the competitor's product. And as a result, they keep ordering. And so Brazil has been very interesting in that regard, Michel can kind of guide you on the numbers. So we've ended up with more orders than expected from Brazil and we actually expect that to continue to increase. In terms of South Africa, they were slow to get started and now they're starting to get started. And interestingly, as you know, they had a three-year contract for 120 million units of which we picked up about 75% and now because it is so slow. It looks like this is just leasing based on hearsay right now. That they're probably going to go to a five year contract instead of just three. So it's be now at 120 over 5 or will be more condoms, but the same players will be able to get more over, more time this has happened many times with South Africa. So what I'm saying is not unusual. And so from that standpoint all of a sudden now our numbers in that is reflecting this in Q4, all the additional orders because as you know we can't recognize those orders until we ship it. And so they're sitting, they're ready to ship, they've been order and so you'll see it in our Q1 fiscal year 2020 numbers but South Africa is started kicking in and Michelle, you want to comment?

No, what Mitch said is correct. We shipped a significant amount of what we want under the Brazil tender by September 30. However, they have also gone above what their original tender order was, that's going to be shipped here in Q2 of this fiscal year. And South Africa was slow, lot of these countries test product on their own and they were testing our product and as Mitch said we couldn't ship it, we couldn’t recognize it by September 30. So we're starting to see the sales pickup in Q1 here and you'll see that once we report those results and then we'll go into Q2 and Q3 and we are getting a lot of indications that the three year will turn into a five year especially how slow it was upfront to start to whole process.

Okay, great, thank you so much.

Thank you for your questions.

[Operator Instructions]. The next question comes from Alexandra [ph] Hauler of Oppenheimer. Please go ahead.

Good morning. This is Alex [ph]. Congrats on a great quarter and data. My question actually been answered but already, but now that you have some additional data for VERU-111. Can you walk us through your thoughts and provide any additional color on the trial design for the next studies?

I mean the next Phase 2?

Yes. And that products [ph] history, you have thoughts on that.

Yes. So for the phase I'll just tell you what we're thinking at this point, nothing is etched in stone. And the Phase 2 the idea would be that we would have approximately 20 patients of each tumor type. We open label and since these patients, just like the prostate cancer patients. We have now which, let me just emphasize the Phase 1B/2 that we're doing now. These are patients who have actively progressing disease coming into the study. So that means they failed abiraterone and enzalutamide and ADT and the PSA is going up and they have tissue evidence whether it's bone scan or CT scan that the tumor is progressing. So when we say stable disease they came in progressing. Similarly, we believe in the Phase II for the other three cancer types again prostate cancer that's resistant the taxane and abiraterone and enzalutamide as well as breast cancer and pancreatic cancer they will be progressing. So we'll be very similar and so the trial design will be the same. We're going to pick continuous because continuous looks like the best way in the tolerating. Continuous means the drug will be given every day and the patient will take one pill once a day and every day and what we'll do is, if it's a Phase II and you can play with dose finding if you like. And if they're tolerating it and the responding, then we'll keep escalating because we haven't reached MTD. So that's quite kind of what I'm thinking for the Phase II. As it relates to the Phase III for the prostate cancer drug, I mean for the prostate cancer indication. In that situation you now were looking at a patient population that has failed abiraterone or enzalutamide following failing ADT. So they are castration-resistant and androgen blocking agent resistant. So for example, they failed abiraterone then the understanding would be that you would -- it's almost like the study that I just mentioned from the way it similar design. We will take patients and with that situation and you would randomize to either or VERU-111at the right dose and schedule that we would have picked from the Phase 1b/2. Randomize against whatever the androgen blocking agent they did not have. So they start out with abiraterone and they feel that. They can be randomized to either enzalutamide or our drug and if they failed enzalutamide they can be randomized to abiraterone or our drug. And so this way we'll be adding the alternative engine blocking agent versus our drug. So this is all pre-chemo. So this is because we are new chemical entity, we're not a taxane, we buying to the alpha beta antitubulin -- alpha and beta tubulin subunits so we're very, very different. And so this is not really a taxane to taxane, as you know some companies are developing an oral taxane because they recognize that oral is the way to go, but in that situation when you look at the blood it's a taxane, and that taxane is going to have to be compared to the IV taxanes, the fact that we're not a taxane when new chemical entity allows us to be in that pre-chemo space. Does that help?

Yes, it does. Thank you so much.

The next question today comes from Peter McMullin [ph], a Private Investor. Please go ahead.

Good morning, Dr. Steiner.

Hi, Peter.

We are two months plus into the first quarter. Obviously, we've got some color from Michele but any more color on how the quarter is going, getting that cash flow from two commercial products is important to financing the rest. And I just wonder if you could give us a little more color on what's going on in Q1?

So what I said in my comments was that every quarter for the last eight quarters, we've been growing and I expect this quarter to be exactly the same growing. And so that's remarkable. So we're on the streak. So our ninth quarter is going to look like it's a strong growth and it's coming from our products. It's coming from getting additional contracts. Again, let me make a comment. This is so important, we are not spending any money on marketing and selling. We are basically whole selling to Get Roman and for the premature ejaculation product, for the FC2 in the US. It's all and we don't spend any money on marketing and selling, we are providing product to telemedicine in the retail pharmacies and the internet pharmacies. And so it's really a different model. So with that, it allows us actually to have a better prediction for how we're going to do. And I don't come and show you, look we got $50 million in revenue and I spent $20 million to get it. I'm telling you. I’m giving you an example for pre-boost. I don't know 0.1 FTEs is being spent on managing that product and that's growing. We did a multi-year contract with Get Roman. So I think the model is allowing us to use that gross profit, which as you can see has more operating margin to use that to pay for our products and we just have to make a decision, decision was not to be a commercial enterprise. This decision was how do you take your resources and invest it in this much bigger market. We can always decide down the road once we hit approval or pre-approval. What we want to do, but at this point now. This was the most efficient way to keep the company from having to have to raise money constantly to keep up with all these clinical programs. We have not raised money and as I mentioned, we would look good until the end of 2021 and then we'll reassess them because money is coming in.

That's brilliant, you did make one comment about potential partners down the road would these be something like Europe or any…

Yes, yes.

What are the products that you do a deal where you got some progress payments, royalties whatever?

Yes. So the one that's that -- yes, so we are actively pursuing partnerships. The one that we're most active with is TADFIN, we've spent the last few years or so doing that and so we're -- we are mature along in terms of some of the discussions that we've had in Europe and South America are the two areas primarily. Zuclomiphene will be the next one that we would look for a partner, we just want to wait till we have the data and that one's easy because in Europe we can get -- again, that will be primarily Europe or Asia. VERU-111, we have not -- we've informed large pharma and our feeling is, especially now is the right decision to sit tight until we get more and more data because we'll be much more attractive. And so from that standpoint that could be a very different kind of relationship, that could be a U.S. and ex-U.S. relationship. But primarily, we're looking for Europe and Asia but TADFIN will be Europe and South America.

Thank you very much.

Thank you.

The next question today comes from James Rowe of Rowe and Company. Please go ahead.

Yes. Mitch, congratulations. Can you take the VERU-111, the VERU-100 -- I might have mispronounced zuclomiphene. And what's the sort of timeframe from here to assuming things that go the way you expect to be able to get to market with the each of these three products?

It's a good question. I actually have a little cheat sheet which I don't have in front of me, but what we've been saying is, I can just work it out in my mind. So basically you're looking at TADFIN or I could give you that one -- that we could launch beginning of 2021. The zuclomiphene, the Phase 3s would go through 2020 and 2021, and therefore that looks like it's going to be a filing in 2022 with a 2023 launch, that's what I'm saying -- we're pulling it out right now, hold on one second. Give me just few seconds and I'll pull it up here for you, so this way I give you the right information. Hold on for one moment, please. Here we go. I got it, okay. So, we're looking -- I'll just give you the bottom-line. For VERU-100, we're looking at 2023. For zuclomiphene, 2022, 2023; and VERU-111, I can't tell you now because it's moving quickly. Originally, we were thinking it would be at 2022 NDA but that could change but call it 2022, 2023. So as you can see, this investment is allowing us to have three shots on goal, three large shots on goal to have a significant revenue producing opportunity between 2022 and 2023. And so VERU-111 is a $4.5 billion market. Zuclomiphene is $600 million to $800 million; sales to us at peak, with a 25% to 28% market penetration. And VERU-100, we have 28% of global share, that's about $700 million. And so, these are big markets and that's why we're just so glad that we can use our own resources to continue to move these things along and not dilute our shareholders.

Great. Thank you.

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, operator. I appreciate everybody joining us on today's call, and I look forward to updating all of you on our progress at our next investors call. Have happy holidays and Happy New Year. Thank you.

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