Veru Inc. (VERU) CEO Mitchell Steiner on Q1 2019 Results - Earnings Call Transcript

May 16, 2019 1:47 AM ETVeru Inc. (VERU)
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Veru Inc. (NASDAQ:VERU) Q1 2019 Earnings Conference Call May 15, 2019 8:00 AM ET

Company Participants

Mitchell Steiner - Chairman, Chief Executive Officer and President

Michele Greco - Chief Financial Officer and Chief Administrative Officer

Phil Greenberg - Executive Vice President, Legal

Conference Call Participants

Kumar Raja - Brookline Capital

Leland Gershell - Oppenheimer

Yi Chen - H.C. Wainwright

Peter McMullin - Tiger Management

Operator

Good morning, ladies and gentlemen and welcome to Veru Inc.’s Investor Conference Call. [Operator Instructions] Please note that this event is being recorded. 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.

Mitchell Steiner

Thank you, operator, and good morning. This is Dr. Mitchell Steiner, Chairman, President and CEO of Veru; and joining me are Michele Greco, Chief Financial Officer and Chief Administrative Officer; and Phil Greenberg, Executive Vice President, Legal.

Thank you for joining our call. Veru is a urology and oncology biopharmaceutical company focusing on prostate cancer and prostate cancer supportive care medicines. 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 second fiscal quarter 2019. Our strategy is to be the prostate cancer company. We are dedicated to the development and commercialization of products to address unmet medical needs of prostate cancer treatment and supportive care. The markets for prostate cancer treatment and prostate cancer supportive care are well established as multibillion-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 are enrolling an open-label Phase 1b/2 clinical trial for VERU-111, a novel, proprietary, first-in-class, oral selective antitubulin agent in metastatic castration-resistant prostate cancer patients that have also become resistant to novel androgen blocking agents, enzalutamide or abiraterone but prior to IV chemotherapy also referred to as a pre-chemotherapy state. In other words, the open-label Phase 2 trial will target those patients whose prostate cancer has progressed but before they go on to IV 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. In the Phase 1b study, we are determining the maximally tolerated dose, so we can then select a treatment dose that will be evaluated in the Phase 2. We find the maximally tolerated dose by treating 3 patients with an oral daily does of VERU-111 for 7 days followed by 2 weeks off drug, which represents 1 cycle. We will treat for at least 3 cycles and for the patients that are responding to treatment, we’ll continue this treatment until there is evidence of prostate cancer progression. This will allow us to assess the durability of the anticancer response. We are evaluating escalating doses and cohort to 3 patients with 4.5, 9, 18, 27, 36 and 45 milligrams doses of VERU-111.

We are also assessing at least two dosing schedules. At this time, we can comment on some promising early clinical observations. As for safety, VERU-111 appears to be well tolerated. No reported complaints of neurotoxicity and no evidence of neutropenia or liver enzyme changes. We are also encouraged as we are seeing in some men whose PSAs were rising prior to enrollment into the Phase 1b, PSA stabilizations and reductions, even at the lowest doses that being tested, which is a promising early indication of efficacy. We will continue to report safety and efficacy clinical data from the Phase 1b, which we expect to be completed by the summer. After we have selected a dose in the Phase 1b, we expect the Phase 2 study will commence by early fall. There are currently no FDA approved drugs for this indication.

According to our QBF, abiraterone enzalutamide for advanced prostate cancer had over $6 billion in 2018 global annual revenue. Interestingly, in men with castration-resistant prostate cancer who take these drugs, 12% to 25% will continue to have cancer progression and 75% to 85% of men will have an initial tumor response and then have cancer progression within 9 to 15 months. Men who fail these novel androgen blocking agents is the exact population that VERU-111 is targeting, which we estimate represents a $4.5 billion annual global market.

Our next clinical product candidate is zuclomiphene, a novel, proprietary, oral, non-steroidal, estrogen-receptor agonist being evaluated to treat hot flashes, the most common side effect in men on androgen deprivation therapy for advanced prostate cancer. We are enrolling approximately 100 men in a multi-center double-blind placebo dose finding Phase 2 clinical study. Enrollment is progressing in approximately 17 clinical sites in United States, and we anticipate top line results this summer of 2019. Based on the current blinded, aggregate, preliminary clinical data from our placebo-controlled trial, we can make the following general clinical observations. Some men are experiencing reductions in hot flashes. And as for safety, zuclomiphene appears to be well tolerated.

Based on an independent market analysis sponsored by the company, which included interviews with payers covering 259 million U.S. lives, urologists and medical oncologist, the market research estimates that the U.S. potential sales for zuclomiphene citrate will be over $600 million annually with a 25% market penetration. This independently confirms that zuclomiphene for the indication of treatment of hot flashes to men on the androgen deprivation therapy for advanced prostate cancer is a major market opportunity. Currently, there are no FDA-approved drugs for this indication. We will continue to seek new drugs to add to our portfolio of products for prostate cancer treatment and prostate cancer supportive care.

Veru’s ability to advance the clinical development of our proprietary prostate cancer drugs that address unmet medical needs in large markets is being substantially supported by investments from 2 commercial sources of revenue. As you can see from the earnings release, in Q2 fiscal year 2019, we have again experienced significant growth in revenues and gross profits from our commercial products, the FC2 female internal condom as well as PREBOOST now being marketed as Roman Swipes, which is a 4% benzocaine wipe for premature ejaculation. In the commercial segment of our business, which is FC2 and the Roman Swipes and drug commercialization costs, our gross profit in Q2 fiscal year 2019 was $4.6 million compared to $1.2 million in Q2 fiscal year 2018, which is up 285%. In fact, gross profit for year-to-date 2019 in 2 quarters was $9.3 million compared to all of fiscal year 2018 of $8.8 million. Because of this continued revenue growth and the use of other existing capital sources, we have been able to fund the development of our prostate cancer clinical programs and our urology specialty pharmaceuticals for the past 6 months with an approximate $3 million loss from operations.

Michele will cover these financial results highlights in a few moments. It’s important to note the intent to continue this revenue growth trajectory as we have completed a successful bioavailability and bio-equivalency clinical trial for the company’s proprietary Tadalafil/finasteride combination tablet for the treatment of symptoms of BPH. As I mentioned before, we have trademarked the commercial name of TADFIN and have filed patent applications that have issued will have an expiry of 2040. We expect this to be the company’s first pharmaceutical urology asset to move into commercialization. We are in the process of making FDA and commercial batches of the drug, and we plan to submit the new drug application later this year to early 2020 with an approval and launch expected in 2020. We believe that TADFIN will be an attractive product for BPH. BPH treatments have an established multibillion-dollar global market. If approved, TADFIN will be the first commercially available combination of an erectile dysfunction and BPH medicine, Tadalafil, known as Cialis and finasteride [indiscernible] process – prostate also known as Proscar.

In the U.S., we intend to launch TADFIN to telemedicine channels. We are also in discussions with potential commercial partners outside the U.S., having TADFIN revenues next calendar year from U.S. sales and potential partnerships with upfront payments and royalties from outside the U.S. should add substantial near-term revenues with high gross margins to the existing and growing revenues from FC2 and PREBOOST Roman Swipe products.

I will now turn the call over to Michele Greco, CFO, CAO to discuss the financial highlights. Michele?

Michele Greco

Thank you, Dr. Steiner. Let’s start with our second quarter results for the 3 months ended March 31, 2019. FC2 unit sales totaled $9.8 million, up 137% over the prior year second quarter of $4.1 million. Net revenues were up 171% to $7 million from $2.6 million in the prior year second quarter. The company reported FC2 sales growth in both its prescription business and its public sector business. Net revenues from the U.S. prescription business was up 753% to $2.6 million from $300,000 in the prior year second quarter. Net revenues for the public sector business was up 88% to $4.2 million from $2.3 million in the prior year second quarter.

Gross profit was up 285% to $4.6 million from $1.2 million in the prior year second quarter. Gross margin increased to 66% from 47% in the prior year second quarter. The increase in gross margin is driven primarily by the increase in the U.S. prescription business. These financial results do not reflect the new tender orders that will be coming from South Africa. We previously announced that we won 75% of the South Africa tender, representing up to 120 million units over 3 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 a 3-year period.

We expect these new orders from South Africa to commence shipping during the third quarter of this fiscal year. Operating expenses for the quarter increased by $800,000 to $6.7 million compared to the prior year second quarter of $5.9 million. The increase is primarily driven by the increase in research and development cost of $800,000. During the quarter, we incurred $1.9 million of interest expense and change in fair value of the derivative liabilities related to the synthetic royalty financing compared to $372,000 incurred in the prior year second quarter. We entered the synthetic royalty financing during March of 2018. For the quarter, we recorded a tax expense of $25,000 compared to a tax benefit of $1.3 million in the prior year second quarter. The effective tax rate for this quarter of 0.6% is due to recording a valuation allowance against the net operating loss generated for the quarter in the United States. The bottom line results for the second quarter of fiscal 2019 was a net loss of $4 million or $0.06 per diluted common share compared to a net loss of $3.8 million or $0.07 per diluted common share in the prior year second quarter.

Turning to the results for the 6 months ended March 31, 2019, for the first 6 months of fiscal 2019, the FC2 unit sales totaled $17.2 million compared to 8.5 million units in the prior year period, an increase of 101%. Net revenues were up 159% to $13.3 million from $5.2 million in the prior year period. The company reported growth in FC2 sales in both its U.S. prescription and public sector businesses and in PREBOOST. Net revenue from the U.S. prescription business was up 1,000% to $5 million from $458,000 in the prior year period. And just to note, all of fiscal year 2018 saw U.S. prescription revenue of $2.4 million. Net revenue for the public sector business was up 73% to $8.1 million from $4.7 million in the prior year period. Net revenue for PREBOOST Roman Swipes was $180,000 compared to $4,600 in the prior year period, an increase of 3,800%.

Gross profit was up 268% to $9.3 million from $2.5 million in the prior year period. Gross margin increased to 69% from 49% in the prior year period. The increase in gross margin is driven primarily by the increase in the U.S. prescription business. Operating expenses decreased by $2.3 million to $12.4 million compared to the prior year period of $14.6 million. Included in the prior year operating expenses is the $3.76 million related to the settlement agreement we entered with our Brazilian distributor, Semina, during December of 2017. Excluding the settlement agreement, the increase in operating expenses of $1.5 million is primarily driven by the increase in research and development cost of $1.2 million. During the period, we incurred $2.9 million of interest expense and change in the fair value of the derivatives liabilities related to the Synthetic Royalty Financing compared to $372,000 in the prior year period.

For the 6 months, we recorded a tax expense of $118,000 compared to tax benefit of $4.5 million in the prior year period. The effective tax rate for the 6 months of 1.9% is due to recording of valuation allowance against the net operating loss generated for the 6 months in United States. The company has net operating loss carry-forwards for U.S. federal tax purposes of $33.2 million, with $14.4 million expiring in years through 2037 and $18.8 million which can be carried forward indefinitely. And our U.K. subsidiary has net operating loss carry-forwards of $62.3 million, which do not expire. The bottom line results for the first 6 months of fiscal 2019 was a net loss of $6.2 million or $0.10 per diluted common share compared to a net loss of $8.1 million or $0.15 per diluted common share in the prior period. The reduction in the net loss of $1.9 million is due primarily the increase in our net revenues offset by the interest expense.

Now looking at the balance sheet, as of March 31, 2019, our cash balance was $5.9 million, and our accounts receivable balance was $4 million. Our net working capital was $2.9 million at March 31 compared to a negative $2.4 million at September 30, 2018. During the 6 months ended March 31, 2019, we used cash of $4 million in operations, and we received net proceeds from financing activities of $6.1 million, of which $9.1 million relates to the public offering of the company’s common stock, offset by installment payments on the synthetic royalty agreement of $3.2 million. We continue to make significant progress on our clinical programs and are optimistic about the continuing increase in the U.S. prescription business for FC2, the increasing global public sector volume, as well as the increasing sales of Roman Swipes to Roman Health Ventures.

Now, I would like to turn the call back to Dr. Steiner.

Mitchell Steiner

Thank you, Michele. I am happy that we have had another strong financial quarter, which has allowed us to significantly advance our clinical programs during the quarter without the need for new financing. In fact, we now have had three strong quarters showing revenue growth in the commercialization of our products. Furthermore, as we have completed at least one month into Q3 fiscal year 2019, the revenues continue to be strong for the fiscal year third quarter as well. It should be noted that we are expecting the first South African tender orders to occur in Q3 fiscal year 2019.

I would like to repeat that because of higher revenues and gross profit, we have improved the operating loss of $4.7 million in Q2 fiscal year 2018 to $2.1 million in Q2 fiscal year 2019, and from $12.1 million fiscal year-to-date 2018 to $3.1 million fiscal year-to-date 2019. With the improving performance of the commercial products and strengthening of the balance sheet, we believe that we will be able to substantially pay for the continued clinical development of our prostate cancer drug product candidates as well as to submit NDAs and if approved, commercially launch TADFIN, which provide even more revenue, adding to the already growing revenues from the female health division and from PREBOOST Roman Swipes.

I will now provide financial guidance for the full year fiscal year 2019. We expect net revenues will grow to $29 million to $32 million for the first full year fiscal year 2019, which represents a 95% increase or with the full year fiscal year 2018. And we expect gross margin will be approximately 66% in fiscal year 2019 compared to 55% in fiscal year 2018. We will not provide guidance on operating margin at this time, and do not expect to update the guidance for the full fiscal year 2019 before releasing earnings for the next fiscal quarter.

Based on the current cash on hand and the expected cash and current sales forecast, along with existing sources of capital, the company does not anticipate the need for a new equity financing until at least fiscal year 2021. In this window of time, we expect to report open-label efficacy and safety clinical results from the Phase 1b and the Phase 2 clinical trials with VERU-111, our oral tubulin inhibitor, for metastatic castration and novel androgen blocking agent resistant prostate cancer as well as start a Phase 3 study. Report clinical results for the Phase 2 clinical trial, evaluating zuclomiphene for the treatment of hot flashes caused by androgen deprivation therapy by summer of 2019 and to have started a Phase 3 study. Submit the NDA for TADFIN and expect approval and launch in 2020, have secured partnerships for our drug partner products, identified or developed additional drugs for prostate cancer treatment and prostate cancer supportive care. We are committed to driving shareholder value by becoming the prostate cancer company and by providing a continuum of care for prostate cancer patients.

With that, I’ll now open the call for questions. Operator?

Question-and-Answer Session

Operator

[Operator Instructions] The first question comes from Kumar Raja of Brookline Capital. Please go ahead.

Kumar Raja

Good morning. Thank you for taking my questions. So with regard to VERU-111, what further can you share in terms of the doses that are being tested and in patients whom you are seeing reductions in the PSA level, what are the expectation in terms of whether this would be sustainable? And based on the early indications, what are your thoughts on the – you were expecting to dose 26 patients in the Phase 2, do you think this would be sufficient to provide indications for the Phase 3 trial design?

Mitchell Steiner

Okay. I got your first two questions. Give me that third one again. So of the 26 patients.....

Kumar Raja

Yes. So you are planning to dose 26 patients, so based on the early data, do you guys think that needs to be increased or decreased or you think that would be sufficient to design the Phase 3 trial, yes?

Mitchell Steiner

Yes, yes. I think so I will answer the third question first. And the answer is we believe the 26 patients will be sufficient. First question had to do with pretty much where are we now currently in the clinical trial. Let me just work backwards. We believe I gave you approximately 6 different escalating treatment groups. And so by summer, we will have all 6 completed. And the way that works is that the patient is dosed for 7 days and 2 weeks off and we make a safety assessment after the first cycle. So we don’t wait for three cycles before we move to the next one. So that kind of gives you a feel for the ends up being about, and we’re really filling this trial pretty quickly. I mean the interestingly, we’re finding the clinical sites, fighting over for these fighting over those 3 spots to get their patients in there, which is kind of interesting. And again, it shows you this is an unmet medical need. So, with that, as a background, the limiting factor is not patients. Limiting factor is just purely time that we have to treat the patient one week on, 2 weeks off and then make a determination. So, if you look at it that way, and we’re going to be done by the summer, we’re pretty much in the middle of this trial, as we speak. As it relates to durability of the PSA response or PSA stabilizations, really hard to say much at this point and so, what I would say is give us a little bit more time, and I’ll be able to answer that. And as I mentioned on the third question, we believe 26 patients will be more than enough to give us an understanding of the percent of patients that will have a PSA reduction, what is the actual PSA 50 reduction and then finally, what is the durability of response.

Kumar Raja

And the expectation is that we will have data presentation at ESMO?

Mitchell Steiner

When is ESMO?

Kumar Raja

It’s end, of September.

Mitchell Steiner

Yes. We could by end of September, we should be able to have Phase 1B data. And so yes, that would be a good thing to target. And also, the other thing that we target is some of the fall meetings. So, for example, the Society of Urologic oncology, SUO, will also be sort of late fall as well. But truth of the matter is that’s when scientific part we can start to show some data. But if we have data this summer that looks exciting, we’ll find a way to get the information out.

Kumar Raja

Maybe I can sneak a question on zuclomiphene. So obviously, you guys are expecting a 22% placebo effect. How much variability is there in the placebo effect? Is this 22% the higher level or and how should we include it?

Mitchell Steiner

Yes. Since we don’t know who’s treated and who’s a placebo, I can tell you from the literature that there’s several studies, and one, quite frankly, that we were involved with a selective estrogen receptor module in the former company and then there’s the gabapentin study that was done by the Prinze and there was another study that was done with Matthew Smith’s and basically 22% seems to be that magic number for the placebo effect. The reason that’s important is because women, the placebo effect for hot flashes is close to the 40% to 50% and for men, it’s closer to 20%. 20% seems to be the magic number.

Kumar Raja

Okay great thanks.

Mitchell Steiner

Thank you.

Operator

The next question comes from Leland Gershell of Oppenheimer. Please go ahead.

Leland Gershell

Good morning. Congratulations on all the progress commercially and developmentally. Just have one question. Most my questions were asked and answered. Just do you have any update on the status of the patent application for TADFIN?

Mitchell Steiner

As you know, patent applications take a while to get decisions made, so we filed the patent application several months ago. And we feel pretty good based on the fact it’s a new formulation. We had unintended positive effects that could translate to a safety benefit that we think the chances are pretty good we’re going to get that patent. And but it’s really kind of early to say in terms of decisions. I mean I will tell you the zuclomiphene patent, which is issued in the U.S. that was having been involved with over 400 or 500 patents, and I’m not exaggerating, that when we got like in 18 months or something like that and issued. That’s unheard of. Usually it’s years. So, with that said, the expiry date is based on your 20 years from filing, and so that’s why we said, we believe that, that patent, if issued, the expiry date will be 2040.

Leland Gershell

Okay [indiscernible] thanks very much.

Mitchell Steiner

Thank you, Leland.

Operator

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

Yi Chen

Alright my first question is when you start recognizing the sales from orders from South Africa, is it only limited to the third quarter or you will have recurring revenue in the fourth quarter as well?

Mitchell Steiner

No. This is all we’re trying to say is that we had originally guided that this year that we were expecting for the full year that South Africa would be ordering. The truth of the matter is we spent 6 months packaging, they wanted some new packaging and all the other stuff. So, we took care of all of that. So, the good news is, we haven’t lost any orders. They’re going to continue they’re going to happen and continue. So, the way I look at it is, starting in Q3 fiscal year 2019, we’ll start getting the first orders and then that’s like a 3-year annuity at that point. So, we’re expecting to see money coming in for the next 3 years. So no, this is definitely recurring.

Yi Chen

Got it. Second question, I noticed that in the second quarter, the operating expenses is was higher than the first quarter. How should we expect the operating expenses to trend during the rest of fiscal 2019?

Mitchell Steiner

So, as I mentioned in my comments that we’re not going to try to guide on operating margin just because you’re hitting a key point. We’re using our money for what? To invest in clinical trials. And the clinical trials, the way that works is, you put money aside to pay for the clinical trial, sometimes those events happen, sometimes those events get delayed and so it’s not an exact science. And so, the operating margin will fluctuate based on what bills come in and what bills don’t come in. What we can say for the overall year that we’re going to be fine. That we’re not going to need to, as I mentioned, in my comments, new equity financing to cover all of the expenses for drug development at least until 2021. The reason we don’t go beyond that is because we’ve got to get that the point and then wherever we guide but with revenue coming in, it’s allowing us to invest in these programs.

Yi Chen

Okay. Will the 10-Q be filed today?

Mitchell Steiner

Yes.

Yi Chen

Thank you.

Mitchell Steiner

Thank you.

Operator

The next question comes from Peter McMullin of Tiger Management. Please go ahead.

Peter McMullin

I think my question would be more commercially. As things progress, you must be attracting some attention and have there been inquiries as somebody that might like to codevelop or put some money in? And therefore, delay the need for equity. How do you feel about the options there for the future?

Mitchell Steiner

Yes. So, let’s break it up into 2 pieces. The first piece is the commercial side and the other piece is the drug development side. On the drug development side, particularly TADFIN because we’re filing the NDA, we have had a very, very active partnership discussions, particularly Europe and South America. And we are I mentioned in my comments that we believe we could be able to secure partnerships that will provide upfront and royalties for TADFIN, which is the closest one in the drug development pipeline. So that’s exciting, okay? As it relates to zuclomiphene and VERU-111, zuclomiphene, as you know, is the hot flash product. We are also in discussions with potential European partners, which could provide upfront money and offload some expense in the Phase 3 and ultimately, we’ll have a royalty stream and milestones. And so those kinds of discussions are going on. So, I do expect, as we get clinical data this summer, there will be a lot of activity there. As it relates to VERU-111 interestingly, as you know, that’s the big one and the large pharmaceutical companies that you would expect want to reach out to us and talk to us about it, particularly those that have the big drugs that we’re solving the problem and patients develop resistance. Yes, we’re talking to them too and hopefully that eventually that will bear fruit in the long run.

As it relates to the commercial products, which is FC2 and PREBOOST, well, PREBOOST, Get Roman, which is a premier men’s health telemedicine group signed an exclusive agreement with the us. It’s a 3-year multicontract so that really beared fruit. And I mean at one point, I think we sold like $11,000 worth of PREBOOST over a year using traditional marketing and sales. And with Get Roman, which is a telemedicine-based men’s health Internet group, I mean we’re qualifying a second plant. So that’s really exciting for us because that was unfound newly found revenue. As it relates to FC2, oh my gosh. We tried 6 different channels to get FC2 sold and I can tell you that in the U.S., what has really been incredibly helpful is this new wave of telemedicine and telemedicine is very, very young. It’s basically 2 years and in that 2-year period, it has taken us very, very quickly to a point that we’re now using this money to invest and not have to go and, as you said, get alluded because we’re using this money. And we are continually signing up additional telemedicine groups.

And for people who are not aware of telemedicine, telemedicine is basically a online source where people want to get a discrete product like a men’s health product or a women’s health product. And they want to avoid the doctor and going to the doctor’s office and standing in the pharmacy and being embarrassed or whatever. And instead they can have these products discreetly sent to their home, and it’s really, really working. And so, telemedicine is here to stay. And so part of what you’re trying to do strategically is continuing to add additional telemedicine groups. And I’m happy to report that, that is also happening. So, there’s a lot of activity, Peter, both on the commercial side to expand that and also on the drug development side as we start getting paid and as we start moving along, we’re going to begin to attract potential partners. The main goal right now is to see what we can do with our own resources. And so here we are now with this model 2 years later, 2.5 years later and the model works. At the beginning, everybody said it’s too complicated. You’re not going to be able to do it. The answer is yes, we’ve done we were able to do it now, and we’re feeling pretty good about the future to look, I’m a big shareholder, and I want to make sure as much as possible we don’t dilute.

Peter McMullin

Congratulations on great progress.

Mitchell Steiner

Thank you.

Operator

And we have a follow up from Kumar Raja from Brookline Capital.

Kumar Raja

Mitch, I just wanted to get update with regard to the Tamsulosin extended release. What’s happening with regards to the bioequivalence studies there?

Mitchell Steiner

Great, great question. As you can see from our presentations this morning, the call we’ve got a lot going on. The goal in the for our company is to be the prostate cancer company. So, the first focus is to make sure we move our prostate cancer products, which we have been very good in this short period of time getting them into meaningful clinical trials, the clinical data coming out this year. So that was goal #1. Number two is to be able to provide resources to pay for the prostate cancer programs through 2 mechanisms – 2 sources of revenue. One was the female health division, which is, you can see now is bearing fruit, particularly because of the U.S. prescription business and because of the outstanding work done by Denise van Dijk, who is the President of the Public sector side and she’s done a wonderful job getting South Africa and other countries, including UNFPA to step up.

So those resources have helped us invest, okay? On the urology specialty pharmaceutical side, a couple of positive developments happened, one was PREBOOST. All of a sudden now we’re signing multiyear contract with a telemedicine company that can provide revenue to come in from that product. And the second product is TADFIN, which hit bioequivalence, it hit bioavailability and we are filing the MDA later this year, beginning of next year with a approval and launch expected in 2020. So tamsulosin is we’re still working on it. But in terms of all the stuff that’s going on, our bandwidth is such that we’re going to keep moving that along as another it’s an asset, it’s one of our, asset. Solifenacin’s another one of our assets. We’re very, very fortunate that we have all of these assets, and I’ll only make one last comment and that is we are very, very interested in from a business development standpoint and also from a standpoint of becoming the prostate cancer company, we really, really, really are focusing on additional products, whether we develop them internally, or whether we bring them in externally to grow our prostate cancer portfolio. So, the real value of our company, ultimately, ultimately, ultimately be around how successful we are transforming this company into a prostate cancer company.

Kumar Raja

Okay thanks.

Mitchell Steiner

Thank you.

Operator

The next question is a follow up from Leland Gershell of Oppenheimer. Please go ahead.

Leland Gershell

Hi Mitch, I do have one follow up. Even as you define yourselves as a prostate cancer company and with 111 clearly showing continued indication of robustness for that type of malignancy, given the mechanism of the drug, want to ask about other sensors that may be away from a uro-oncology that you may be considering for testing. Thank you.

Mitchell Steiner

Yes, great question. As you know, the other thing is, in addition to being a prostate cancer company, we have to be incredibly opportunistic when we have a potential for a multibillion-dollar product. And so yes, the beauty of VERU-111 is that in prostate cancer, the 2 drugs that have really, really shown promise, put immunotherapy aside, is going to be hormone therapy, such as androgen deprivation therapy so castration and second is the antitubulins, which IV taxanes is an example. So that’s why we went into prostate cancer. But it turns out there are so many cancer types that are sensitive to antitubulins that if we had an oral agent, particularly an oral agent that works in taxane-resistant tumors that we have a real opportunity to expand beyond prostate into other cancer types. And so, you’re absolutely right.

So, we do have evidence and we have presented at ASCO, not this year but last year, evidence in ovarian cancer, pancreatic cancer, triple negative breast cancer. We publish on melanoma, lung cancer, so you’re absolutely right, we would be it would not it would be in the best interest of the company that if we enter into the summer with PSA responses, durable responses, safety where there is no neutropenia and that continues the whole true and no narrow toxicity, which are the major side effects of taxanes, then we it would make sense for us to expand into a series of small Phase 2 studies to begin to show the true value of VERU-111, particularly for a partner. So, if we do end up partnering the opportunity, then you can see how we could partner the opportunity where we can focus these in the clinical development or stay in our wheelhouse, which is understanding prostate cancer. But we could use a large pharmaceutical company that can take on the development of the rest of the portfolio and other tumor types.

Leland Gershell

Great thanks that’s very helpful.

Mitchell Steiner

Thank you.

Operator

[Operator Instructions] 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.

Mitchell Steiner

Thank you, operator. I really appreciate you joining us on today’s call. I look forward to updating all of you on our progress in our next investors call. Thank you.

Operator

The digital replay of the conference will be available, beginning approximately noon Eastern Time today, May 15, by dialing 1877-344-7529 in the U.S. and 1412-317-0088 internationally. You’ll be prompted to enter the replay access code, which will be 10130716. Please record your name and company when joining. The conference has now concluded. Thank you for attending today’s discussion. You may now disconnect.

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