Veru Inc.
Q1 2018 Earnings Call Transcript

Published: 14 Feb 2018

[Operator:]

Good morning, ladies and gentlemen, and welcome to Veru Inc.’s Investors Conference Call. All participants will be in 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. 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 CEO and President. Please go ahead.

[Dr. Mitchell Steiner:]

Thank you, operator, and good morning. This is Dr. Mitchell Steiner, President and CEO of Veru Inc. And joining me are Michele Greco, CFO and CAO; and Kevin Gilbert, Senior Vice President, Corporate Development and Legal. Today, we will provide an update on the clinical development of our drug pipeline; commercialization of our products, as well as provide financial highlights for the first fiscal quarter 2018. We are making good progress as Veru transitions to a urology and oncology biopharmaceutical company. Our strategy for revenue growth is to have several near-term and mid-term drugs under clinical development progressing at the same time to ensure that in the near-term we file several NDAs and commercial multiple drugs in urology and oncology. Over the next 18 months, we expect to file three NDAs for four drugs. First, we have the proprietary new slow release granule formulation of Tamsulosin in two drug products, Tamsulosin DRS, extended release granules for oral suspension and Tamsulosin XR capsules. These two new drug formulations address two important clinical challenges that are found in current branded and generic FLOMAX formulations. First, FLOMAX is only available in a capsule form. And according to FDA package insert, FLOMAX capsules should not be crushed, chewed or opened, because it may lead to serious side effects of low blood pressure and dizziness. The new slow release granule formulation, Tamsulosin DRS, may be given to the 60% of men in long-term care and 15% of men in the community who have difficulty or cannot swallow pills and cannot take FLOMAX, as instructed by FDA. A second clinical challenge with FLOMAX is that it has a food effect, meaning that a greater amount of Tamsulosin drug gets rapidly absorbed, resulting in higher drug blood levels when given on an empty stomach, and must be given 30 minutes after a meal. The new slow release granule formulation does not appear to have the food effect, based on the bioequivalent studies we have conducted. Because of this advantage for drug administration and compliance, we plan to offer these proprietary slow release granules in a capsule form, as Tamsulosin XR capsules. Tamsulosin XR capsules will allow us to expand to the broader multi-billion dollar urology and primary care BPH markets including those men who can actually swallow tables or capsules. We expect final bioequivalence clinical data and filling an NDA in 2018 for Tamsulosin DRS 0.4 milligrams, which is the Tamsulosin HCL extended release oral suspension and Tamsulosin XR 0.4 milligram capsules, for the treatment of symptoms of an enlarged prostrate causing difficulty in urination, also known as benign prostatic hyperplasia or BPH. This launch is planned for 2019. Our second urology drug is a proprietary Solifenacin DRG delayed release granule formulation of Solifenacin, the active ingredient in VESIcare, a popular drug for the treatment of overactive bladder, which is urgency, urge incontinence and frequency in both and women. Similarly, as instructed for FLOMAX, the FDA package insert states that Solifenacin tablets must be swallowed whole. There are no granular formulations available for this class of drugs, the class is called the selective M3 muscarinic receptor antagonists for men or for women who have the common condition of overactive bladder and who have difficulties or cannot swallow tablets. Our proprietary Solifenacin DRG formulation utilizes the same delivery technology platform as our Tamsulosin DRS slow release granule formulation. The overactive bladder market is also a multi-billion opportunity. Prevalence of overactive bladder is between 16% and 23% in the United States and increases with age. According to a recent study conducted by the Department of Health and Human Resources, 37% of short-term and 70% of long-term nursing home residents did not have complete bladder control. Consequently, the initial target population will be men and women in long-term care facilities with overactive bladder symptoms who have difficulty or cannot swallow tablets. We expect to utilize the same sales channels that would be already in place for Tamsulosin DRS. We expect for Solifenacin DRG, a slow release granules for the treatment overactive bladder in men and women final bioequivalence clinical data in 2018 and filling an NDA in 2019. Our third urology drug is a new proprietary Tadalafil 5 milligrams, Finasteride 5 milligrams combination capsule formulation, this proprietary combination formulation contains the active ingredients of CIALIS, which is Tadalafil 5 milligrams approved for the treatment of BPH and erectile dysfunction and Proscar, which is Finasteride 5 milligrams, which is approved for actually shrinking the enlarged prostate to treat BPH. The Tadalafil/Finasteride combination in capsule formulation will allow us to offer a portfolio of BPH drugs that have different mechanisms to treat different symptoms and signs of BPH. For example, Tamsulosin treats urinary symptoms of BPH quickly in men with smaller prostate, whereas Tadalafil/Finasteride combination capsule formulation quickly treats urinary symptoms of BPH, while it also shrinks the size and prevents the progressive growth of the prostate in men who have actually present with an enlarged prostate. We anticipate a Tadalafil/Finasteride combination capsule formulation for the treatment of lower urinary symptoms because of an enlarged prostate, the final bioequivalence clinical data in 2018 and filing an NDA in 2019. We are well-positioned to take advantage of the multi-billion dollar BPH and overactive bladder opportunities. These four products, Tamsulosin DRS granules, Tamsulosin XR capsules; Solifenacin DRG granules, and the Tadalafil/Finasteride combination capsules will allow us to file NDAs, as well as launch and partner when appropriate, multiple urology drugs over the next two and a half years. The next wave of urology and oncology pharmaceuticals will include VERU-944, which is cis-clomiphene citrate for the treatment of hot flashes in men who are on hormone therapy to treat advanced prostate cancer. In May of 2017, FDA agreed that VERU-944 may advance into Phase 2 dose-finding clinical study. We will file the IND and initiate the Phase 2 clinical trial in early 2018 with the clinical data expected in early 2019. It should be noted that the U.S. patent for VERU-944 was recently issued and will expire in 2035. We’re also developing VERU-111, a novel oral anti-tubulin therapy that targets alpha & beta tubulin subunits of microtubules for the treatment of metastatic prostate, breast, ovarian, endometrial and other advanced cancers. We are completing the required preclinical studies and will be ready to begin the clinical trials by the second half of 2018. We will include in the trials initially men with metastatic castration-resistant prostate cancer who have failed current hormonal therapies in a Phase 1/2 open label clinical trial, which means we will start to see the clinical data in the latter part of 2018. In the Phase 2 portion of the clinical study, we will target men with metastatic castration-resistant prostate cancer who have become resistant to, who have failed, ZYTIGA, which is abiraterone, or XTANDI, which is enzalutamide. These are prostate cancer hormone drugs that are generating several billion dollars in annual revenue today and unfortunately men [ph] will break through. In addition, VERU-111 can be developed as an oral therapy for other tumor types that are currently being treated by intravenously given anti-tubulin chemotherapies, which is also a large market opportunity, well over $5 billion of annual revenues today. Scientific pre-clinical data for VERU-111 was recently presented at the American Society of Clinical Oncology GU meeting in San Francisco and has been accepted for future presentations at the European Association of Urology in Copenhagen, Denmark, in March of 2018 and the American Urologic Association meetings in San Francisco, in May of 2018. We have a full and advancing pipeline of drugs. We’ll also continue to be opportunistic by both internally developing and/or finding new pharmaceutical products to license in urology and oncology. We have accomplished a lot this year by obtaining regulatory clarity and advancing the clinical development of our pipeline of drugs. We were able to do this with our existing resources and without undertaking a separate debt or equity financing. We paid for these activities this past year in part by the revenue produced from our commercial products, the FC2 female condom business from The Female Health Company division and PREBOOST. The Female Health Company division has revenue from both the global public health sector and the U.S. market. In the global public health sector, FC2 is the world’s leading female condom. With growing international competition, now more than ever, we need to protect our brand, beat our competition and aggressively grow our product revenues in the global public sector, the channel where FC2 is purchased in bulk quantities by governments and non-governmental donor agencies for public health distribution. This first quarter felt the impact of two of our largest customers, Brazil and South Africa, who did not place orders due to their normal procurement cycles. We believe fiscal year 2018 should be better as Brazil is awarding a 50 million unit tender for this year and South Africa is expected to award this year a 40 million unit tender per year for three years, totaling 120 million units. We’re confident that we will get some orders from one of both of these tenders in 2018, 2019 and beyond. In the U.S. market, FC2 is uniquely positioned as the only FDA-approved female condom to prevent both unwanted pregnancies and sexual transmission of STIs, including HIV/AIDS and the Zika virus. Our challenge was to create the distribution and marketing to service U.S. market. As I reported last month, we’re seeing traction with new revenue in these new areas of market access. FC2 is reimbursable with a prescription by both public and private payers under the Affordable Care Act and under the laws of numerous states prior to the Affordable Care Act. We now have the pharmacy distribution, market access and reimbursement infrastructure in place, so FC2 is available and reimbursable in over 98% of retail pharmacies across the country. We have a small sales force of about 12 people that market to OB-GYN and primary care physicians. We have eliminated the middlemen FC2 distributors and we will now sell directly to departments of health and community organizations with better margins. We have signed a master service agreement to sell directly to 340b covered entities, which is approximately 56,000 entities such as HIV and STD clinics. We have partnered with the HeyDoctor telemedicine application, so that an FC2 prescription could be obtained by the patient via an Apple, an Android smartphone via this app where the prescription could be sent to their local pharmacy or ship to their home by a specialty pharmacy. We have an uninsured or underinsured assistance program, where the individual can purchase FC2 at a discount from our website. And finally, we have an active colleges and universities program that continues to grow. As I mentioned, we’re finally seeing new revenue being generated and growing in the U.S. market. Historically, the average annual U.S. revenues for FC2 over the past three years have been about $1.9 million a year. I’m pleased to report because of these new marketing and selling efforts in just the past four months, the past four months, the revenues for FC2 in the U.S. were $1.5 million. Because of this progress, we’re exploring in the near-term the possibility to expand our marketing and sales efforts of 12 people to a hybrid independent contracted sales force of up to 4,200 people who are seasoned independent contractors with the established relationships in primary care and OB-GYN offices. As this is a contracted sales force, our Company should incur no additional expenses. The ramp up to this number of sales people will be compensated by commission on FC2 sales alone. Our other revenue opportunity is PREBOOST, 4% benzocaine wipes for the prevention of premature ejaculation. We launched PREBOOST via digital and social media marketing and we also entered into a co-promotion of distribution agreement with Timm Medical Technologies, a specialty urology sales organization. I will now turn the call over to Michele Greco, CFO, to discuss the financial highlights. Michele?

[Michele Greco:]

Thank you, Dr. Steiner. This quarter, we experienced the decline in the public sector volumes. This decline is primarily driven by the timing of public sector tenders and orders from two main customers, Brazil and South Africa, and is also in part impacted by the U.S. political and geopolitical donor uncertainty resulting in a downturn in our order frequency and in the order size from some customers such as UNFPA and USAID. For the first quarter of fiscal 2018, the FC2 unit sales totaled 4.4 million compared to 6.4 million units in the prior year first quarter. Net revenues for the first quarter totaled $2.6 million compared to $3.2 million in the prior year quarter. Gross margin was 51% for both quarters. Operating expenses increased by $5.2 million to $8.8 million compared to the prior year quarter. Included in operating expenses is $3.8 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 is primarily driven by the increased research and development costs of $1.9 million. For the quarter, we recorded a tax benefit of $3.2 million, compared to tax benefit of $530,000 in the prior year quarter. The bottom line results for the first quarter of fiscal 2018 was a net loss of $4.3 million or $0.08 per diluted common share compared to a net loss of $1.4 million or $0.04 per diluted common share in the prior period. Looking at the balance sheet. As of December 31, 2017, our cash balance was $3.6 million and our accounts receivable balance was $3 million. Our net working capital was $4 million at December 31, 2017 compared to $4.8 million at December 31, 2016. During the quarter, we generated $300,000 from operating activities, compared with $1.2 million in the prior period. We continue to make significant progress on our clinical programs. We are very optimistic about the U.S. market, for FC2 and expect the global public sector to return closer to historical volume. Now, I’d like to turn the call back to Dr. Steiner

[Dr. Mitchell Steiner:]

Thank you, Michele. We have established the foundation to make Veru a leading urology and oncology biopharmaceutical company. We have several near-term and mid-term products progressing at the same time to have multiple shots to have drugs filed and launched in urology and oncology. We aspire to file at least one NDA each year for the next five years. This will provide the engine for growth as we continue to develop and commercialize existing drugs in our portfolio. We are excited about VERU-111 as a noble targeted oral therapy for multiple types of cancer and look forward to starting the clinical trial this year and sharing the preclinical data at multiple scientific meetings. We will continue to seek non-dilutive ways to finance clinical development and commercialization in part through PREBOOST and FC2 sales. We will drive shareholder value through a lower cost and expedited clinical development for large market opportunities in urology and oncology. We are committed to becoming a leading urology and oncology biopharmaceutical company. With that, I’ll now open the call to questions. Operator?

[Operator:]

Ladies and gentlemen, at this time, we will begin the question-and-answer session. [Operator Instructions] And our first question will come from Yi Chen of H. C. Wainwright. Please go ahead.

[Yi Chen:]

Thank you for taking my question. My first question is, could you be able to tell us some -- some color on the design of the coming Phase 2 trial of VERU-111?

[Dr. Mitchell Steiner:]

You mean the Phase 1/2 trial of VERU-111?.

[Yi Chen:]

Sorry. Yes, Phase 1/2 trial for 111.

[Dr. Mitchell Steiner:]

Yes, I’d be happy to. So, VERU-111, we are in discussions with Johns Hopkins right now, and working with them to design the protocol. We chose them because, if you look at the literature on castration-resistant prostate cancer, one of the sub-types that’s most important is AR-V7, which is a splice variant that really does not see any benefit from the hormonal drugs and this marches right through. So, it’s a sub-type of cancer that these men have that of resistant from the beginning, quite frankly to secondary hormone therapy. So, the folks at Hopkins that actually identified and have written most widely on this sub class of cancer, prostate cancer are helping us. Okay? Now, with that said, we’re going to be broad, we’re going to go after men in a Phase 1/2 setting, first safety, where we do almost a 3 plus 3 design to make sure that as we escalate the oral doses of this medicine that it's safe. And then, the second part we’ll be looking for efficacy. And because the way that these men present with progressive prostate cancer is by an elevated PSA. Then, PSA is a perfect biomarker for us to determine whether the patient is going to respond to the medicine. And typically, we look at PSA response of greater than 50% reduction in PSA at 90 days or 12 weeks. And so, the design we’ll be looking at PSA responses, and of course, we’ll be looking at metastatic disease and all the other end points that you would expect for prostate cancer. So, the design is roughly -- we’re still working out the exact numbers, but somewhere between 16 to 24 patients in the initial safety portion, but we’ll be collecting efficacy data at the same time. So, if all goes well, then in summer time, we will actually start to study and so that -- and it will be Hopkins and other big centers like Hopkins and then we would expect in the late fall to winter to start seeing some of the data. And so, we're excited about it because at the ASCO meetings, we got a lot of interest, at GU ASCO from medical oncologists that were just saying, look, we had an oral agent that was an anti-tubulin, this would be very, very big because as you know, the hormonal therapies, secondary hormonal therapies, enzalutamide and also which is XTANDI and ZYTIGA which is abiraterone or oral agents. And so, this would be the ability to let urologists continue to manage their patients. And medical oncologists will like this because the patient can take the medicine at home and you can do things like take the medicine on a daily basis instead of coming in and getting an IV and sitting in an IV chair for eight hours. So, there's a lot of benefits. And of course, they can be claim that any cancer that has sensitivity, the taxanes, like breast, endometrial, pancreatic, head and neck, lung, I can go on and on that this agent could have activity. So, we're likely going to have a lot of fun with this, but we're going to start out by making sure that in our wheelhouse which is prostate cancer that with an endpoint PSA that people feel comfortable, if you see a reduction that that's going to -- that would be clinically meaningful from the standpoint of activity against metastatic disease and death from prostate cancer, overall survival. So, that's a design of VERU-111 Phase1/2. The idea is -- just to add, the idea is that we call it Phase 1/2 is because we're going to ride ahead of time in a protocol that after we're done with the safety portion, then, we’ll expand into a cohort of patients. So, basically the Phase 2 portion would continue without stopping enrollment. So that allows us to be much more expeditious in getting to efficacy data in the Phase 2 setting.

[Yi Chen:]

Thank you. My next question is, will Tamsulosin DRS be marketed by separate sales team that is currently focused on FC2? Thank you.

[Dr. Mitchell Steiner:]

Good question. So, the answer is -- the first question is, what is our strategy? So, the strategy at this point is to focus on long-term care. Long-term care is basically nursing homes, both short-term and long-term nursing home care, but it also means home health. Because it turns out, a lot of the older folks choosing to be taken care at home. And so, it's much bigger than what you and I are thinking about, just having a hospital facility. With that said, we do know that about three GPOs manage about 80% to 90% of these nursing home formularies. And so, think of the long-term care business is almost like the hospital based business. In the hospital based business, you can typically cover the entire United States between 12 and 18 account managers or salespeople. And so, it's not a big sales force. So, the idea is that the infrastructure that we have built to support FC2 as a prescription product, much of that infrastructure can also be used to help us support the launch of Tamsulosin DRS in long-term care. And part of the reason why we're moving to a contract sales force, where we don't have to pay them their salaries and bonuses, it’s all done by commission. So, there is no additional fixed cost for us it to allow us to take our 12 sales people that we have now and begin to cultivate them to help us with the Tamsulosin launch. And so, you don’t need a big number. And interestingly, Solifenacin DRS, which is the slow release granules with the overactive bladder drug would also go into that same channel. And so, you would be able to have these 18 account representatives that we would have in our Company going into long-term care, have two products in their bag, if you will, as they go and talk to long-term care facilities. As it relates to urology and primary care markets, which a large, our initial approach would be to see we can find a partner and co-promote that into those areas. We just have to see where our cash position is at the time and what is the best way to gain as much market share as possible. And initially, we’ll be focusing on long-term care and no additional headcount because we can use our existing headcount.

[Operator:]

[Operator Instructions] Our next question comes from Peter McMullen, [ph] a Private Investor. Please go ahead.

[Unidentified Analyst:]

Hello, Dr. Steiner, how are you?

[Dr. Mitchell Steiner:]

Hey, Peter. Good to her your voice.

[Unidentified Analyst:]

Yes. I got just a couple of questions here. First of all, on the write-down, it took -- does that mean Brazil doesn’t owe you the money or it will be just later than coming, can you just describe that little bit? And I guess, the second thing was the ambitious plans, just how you are going to finance the growth?

[Dr. Mitchell Steiner:]

Yes. So, the first part is, just to give you a little color, when we started the -- when Aspen Park Pharmaceuticals was acquired by The Female Health Company approximately 16 months ago, we were looking at accounts receivables in Brazil of approximately $13 million to $14 million. Brazil then said to us that they planned to pay us half of that in calendar year 2017, and Brazil paid about half of that in calendar year 2017. Then, as you saw the political landscape became pretty unstable in Brazil, Temer was being vote of confidence and they found a corruption tape and the whole world was upside down. All the plans, formidable plans that Temer had, started to fall. And as you know with the Brazil politics, when a leader falls, then everybody doesn’t stay behind him. As a result, we started getting signals from Brazil that yes, we are going to pay because Brazil has never defaulted, but it may be delayed. And so, in our world, that delay is money. And so, is there a way for us to do something about it? So, our feeling was instead of leaving us a Brazilian overhang for accounts receivables, is there a way that we could settle, and so we settled and we settled. So, literally right now, as far as the accounts receivables are concerned, we’re settled. And when we go into the new tender, we’re going to be very, very aggressive to make sure that we’re not putt in this position again and the way that we handle with our distributor in Brazil and the way that distributor in Brazil is going to try to work with the government. 50 million units over a year coming from Brazil was a big deal for us. And so, again, Brazil ended up paying, but we got to figure out how we can get that money sooner rather than later. So, that’s kind of the story behind Brazil. And part of the reason why it looks like we have a bigger loss this quarter is because we had to take -- what's the word I’m looking for, we had to record that settlement in the way that it’s reflected. But really, it’s good for us because we end up getting the money now. Michele, do you want to add anything to that or…?

[Michele Greco:]

Sure. So, in the P&L, we took the loss of $3.8 million right before the end of the calendar year December 31st. They owed us the remaining $3.8 million, they paid $2.2 million and the remaining balance of $1.6 million is going to be collected before the end of this month and then we’ll be all settled with Brazil.

[Dr. Mitchell Steiner:]

The second question has to do with how you -- gosh, guys, how you’re going to finance all this. Okay? And I can remember over a year ago when we started outlining this ambitious program, everybody said, my gosh, these guys are going to have to go out and raise lots and lots of money, and that was the mood out there in the investment community. We are now 16 months later, and we have not raised a red cent. And so, that’s not true. What we’ve been able to do is two things. One is, we have a product portfolio that does not require a lot of investment because we are doing-- three of our products have bioequivalence studies alone, and those are typically 36 patients, a non-expensive study. But the thing that’s important is that we can file NDAs and these are going after big markets. So, we went after products that we didn’t have to put big amounts of capital in to begin with. As you know that pathway is called the 505(b)(2) pathway where the FDA lets you reference a lot of the current existing information. So, for example, the Tamsulosin, for Solifenacin, for Tadalafil, CIALIS, we do not have to prove clinical efficacy or safety. It’s purely blood levels. Okay? With 944, which is a Phase 2 study, and I think I have said publicly that study is about a 120 patients; we have $4 million study over 18 months, not a big number. We do have to show efficacy and safety. And for VERU-111, which is the cancer product, that’s a Phase 1/2, that’s going to be a handful of patients. And any signal that we see there is going to change the enterprise value of our Company. So, we are being incredibly aggressive in taking advantage of the asset -- the revenue producing asset that we have now, because that revenue producing asset has been the reason why we have not had to go the marketplace. And so, one of the biggest concerns was that we were out of phase with the two big customers, Brazil and South Africa, out of phase with their procurement cycles, meaning that we’ve seen this two of the times over the last 10 years, when they both don’t order that year, you get a bad year. Well, we had a bad year. Now that both coming back, so, we expect that’s going to be reflected in our numbers. Second issue with the female condom was that it was kind of a lumpy business, because of the fact that we didn’t -- and it wasn’t growing because it was done by four or five customers, non-governmental agencies and government customers. And so, any of them order, didn’t order was quite lumpy, but no one got worried because it always sort of caught up. So, we were taking a different initiative and that was is there a way to get rid of that lumpiness by -- revenue lumpiness, by investing and showing that in the U.S. we can have significant growth. And unless you caught on my comments, in the last three years, even though I am not trying to -- and we’re not providing any guidance, I am just giving you a sort of snapshot of where we are. You’ll see that the U.S. market, the U.S. revenue for the last years, last three years historically in the U.S. has been about $1.9 million in the entire year in revenue dollars. And we are seeing $1.5 million in revenue just the past four months of this year, the last four months being the fiscal year. And so, we are like really excited that this is finally telling us that that could be pretty high value money for us to help us invest in our programs. And it’s also showing that with just it's having launched the U.S. sales force in April, here we are now less than a year later and we are starting to see some positive trends. So, this is good for us. This is the reason why I said that we are hoping to finance through non-dilutive dollars being internally generated, we are very sensitive to shareholders and we want to make sure we finance this thing appropriately and that the stock price has to go higher, so that we feel comfortable if we do something with equity. Right now, we are trying to focus on non-equity type financing.

[Unidentified Analyst:]

As this happens, don’t you have kind of a standby financing mechanism in place?

[Dr. Mitchell Steiner:]

Yes, we do. And those, we haven’t touched it, and that’s -- we have Aspire Capital agreement of $15 million, basically it’s a put. And it's valuable to us, because it just means that we're being fiscally responsible in a sense that when we authorize new shares, second, we put a shelf up; I’ve touched it, but we put a shelf up; and finally, we put a mechanism in place that we can allow us to continue to finance internally, knowing that we're good in the future, if we need to be. And that can be opportunistic for us, because that's going to be an efficient way to do something if we need to. But, yes, so that's in place to another lever. So, our thinking is, let's focus on using our own resources coming from our own products and putting the mechanisms in place, by which to make it look strong going forward that we're able to finance without necessarily having to push those buttons, right now.

[Operator:]

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.

[Dr. Mitchell Steiner:]

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

[Operator:]

The digital replay of the conference will be available beginning approximately noon Eastern Time today, February 14th, by dialing 1-877-344-7529 in the U.S. and 1-412-317-0088, internationally. You’ll be prompted to enter the replay access code, which is 10116643. Please record your name and company when joining. The conference has now concluded. Thank you for attending today’s discussion. You may now disconnect your lines.