Good afternoon, and thank you for joining us for Aytu BioScience Fourth Quarter and Fiscal 2020 Business Update Call. With me this afternoon are Aytu's Chairman and Chief Executive Officer, Josh Disbrow; and Chief Financial Officer, Dave Green. Aytu BioScience issued a press release earlier this afternoon with details of the company's operational and financial results for the fiscal second quarter. A copy of the press release is available on the news page of the company's website at aytubio.com. I'd like to remind everybody that today's call is being recorded. A replay of today's call will be available by using the telephone numbers and the conference ID provided in the earnings press release. In addition, a webcast will be available live and archived Aytu's website within the Investors section under Events and Presentations at aytubio.com. Finally, I would also like to call your attention to the customary safe harbor disclosure regarding forward-looking information. The conference call today will contain certain forward-looking statements, including statements regarding the goals, strategies, beliefs, expectations and future potential operating results of Aytu BioScience. Although management believes these statements are reasonable based on estimates, assumptions and projections as of today, October 6, 2020, these statements are not guarantees of future performance. Time-sensitive information may no longer be accurate at the time of any telephonic or webcast replay. Actual results may differ materially as a result of risks, uncertainties and other factors, including, but not limited to, the factors set forth in the company's filings with the SEC. Aytu undertakes no obligation to update or revise any of these forward-looking statements. I would now like to turn the call over to Aytu's CEO, Josh Disbrow.

Thank you, Sherry. Good afternoon, everyone. Thanks for joining today's call for the fourth quarter and fiscal year ended June 30, 2020. This last quarter of our fiscal 2020 was particularly notable for the company as we posted by far, our highest revenue quarter in history with $14.9 million. This quarter's revenue was 2x higher than all of fiscal '19's revenue combined. So the plan that started last summer to transition the company to a fully integrated Rx and Consumer Health specialty pharmaceutical company is taking form. Before getting into today's prepared comments, let me first acknowledge that we are filing a few days beyond the originally planned filing date for this 10-K, but it has been for good reason. Putting together 2 public companies, along with a significant asset purchase from Cerecor and bringing on a new COVID-19 rapid test product line was an extremely heavy lift, but I think you'll see with our results, that the effort has been more than worth it, and these transactions are paying off. The June quarter was the company's first full quarter of integrating the Aytu heritage and Cerecor Rx businesses, along with the recently acquired Innovus Consumer Health business. The integration of these 3 businesses has gone well. Not only did we post all-time high in revenue, this quarter, we also reported an adjusted EBITDA loss of just $1.7 million, as we grew revenues and rationalized overlapping areas and removed redundant expenses. Also, we ended the year with over $40 million -- $48 million in cash, restricted cash, cash equivalents so we believe we have adequate cash to operate going forward and reach profitability at current spending levels. Importantly, last quarter, we sold our first COVID-19 rapid tests, having received test kit inventory just prior to the beginning of the June…

Thank you, Josh, and thank you all for joining us. Today, I'll review our financial results for our fourth quarter and the fiscal year ended June 30, 2020. I'll begin today with an observation that despite the disruption our country has endured in the wake of the COVID-19 pandemic, Aytu has been focused on integrating the operations of 3 businesses and executing on new growth opportunities. In the past 2 quarters, we also quickly adapted our business processes and shifted staffing to enable the acquisition and distribution of test kits, advance the development of our promising Healight technology and launched new products this quarter from our Consumer Health platform. In terms of our business organization, following the Cerecor and Innovus transactions, we refer to the Innovus business as our Consumer Health segment. The Rx segment includes our primary care portfolio, the pediatric portfolio acquired from Cerecor and our medical devices and diagnostics. And now for our financial results. This has been our most productive period for Aytu and our results prove it out. Net revenue for the full fiscal year ended June 30, 2020, was $27.6 million compared to $7.3 million reported for the year ended June 30, 2019. Net revenue for Q4 was an all-time high of $14.9 million, which is nearly 2x the $8.2 million reported last quarter and close to 9x, the $1.7 million reported for the year ago fourth quarter. The substantial Q4 revenue growth was due to the inclusion for the first time, full quarters of revenue from both the Pediatric Portfolio and Innovus. As a reminder, both transactions were announced and closed during fiscal year 2020. With these transformational transactions now integrated, we are clearly a different company today. For the 2020 fiscal year, gross profit was $20.1 million, representing a 72.7% gross profit…

Thanks, Dave. So as you just heard from Dave, our performance was strong in Q4 and for fiscal 2020. It was indeed our best quarter and best year yet. And the pieces from the 2 acquisitions these last few quarters have come together. We have more work to do to continue to optimize efficiencies, but we're clearly headed in the right direction with a dramatically reduced adjusted EBITDA and record revenue. Both of our revenue streams from the Consumer Health and Rx segments performed well, contributing to the strong Consumer Health results was organic growth within the core Consumer Health product lines of diabetes supportive care, sexual wellness and urinary and bladder health. Additionally, the e-commerce business for Consumer Health was stronger. Furthermore, our newly launched Consumer Health product, Regoxidine and over-the-counter minoxidil foam for hair growth is on track to contribute revenue in excess of 7 figures in its first 12 months from launch. That makes it a solid new contributor to our Consumer Health segment's growth. On the Rx side, revenue was $7.9 million, a significant increase compared to Q3's $4.7 million. Contributing to Rx revenue was solid contribution from the Pediatric franchise, the former Cerecor business. Additional value was created with Natesto, gaining preferred status on Express Scripts national formulary and the Natesto spermatogenesis study results published in the Journal of Urology. We expect both of these developments to drive Natesto prescription growth in the coming quarters. Rx growth was fueled by a relatively balanced contribution across our key products and improved sales execution. Despite the impact COVID has had on sales reps accessing physician offices, Q4 represented a record revenue quarter for the Rx business and showed significant growth over previous quarters. This is a testament to our ongoing execution and the clinical value of our…

[Operator Instructions] Our first question is from Jeffrey Cohen with Ladenburg Thalmann.

So I'll keep it to a few questions. So I just wanted to confirm. So the antibody and antigen tests are and will be falling under the Rx portfolio, correct?

Correct.

Okay. Got it. And could you talk about the R&D expenditure for the quarter? Was that primarily or majority based from Healight, the $1.5 million?

Jeff, yes, it was almost all Healight. We had a little bit in our test kits, about $1.3 million was Healight. As I guess one thing you should note about that is it's -- none of it's -- we're not able to capitalize it. So these are -- these all have to be run through the P&L.

Got it. And it looks like there will be expected enrollment of 5 patients at Cedars-Sinai. Would you expect that to read out in the coming weeks or further along?

So that's part of my commentary around just how we'll update the public in general. We obviously want to give deference to our partners and the short answer is, it's not a long period of time to expect to have those results available. And we would expect to roll right into a larger multi-center study here in the relative near term, but not putting a specific time frame on it other than it's not going to take too terribly long to enroll a small number of patients like that.

Okay. Got it. Was there any antigen test kit revenue from Q4?

No. We have not sold antigen tests in Q4.

Got it. And could you talk about, Dave, what was the cash used for the fourth quarter? I did catch the EBITDA loss, but I didn't catch the cash use for the quarter.

Yes. So Jeff, the cash uses, it's a little bit more complex this quarter. We did have some debt pay downs, the $15 million piece from Deerfield and then another couple of million that we inherited some from Innovus and then some liability paydown from the Cerecor transaction. So those together are about $17 million. And then the -- basically, the EBITDA loss, adjusted EBITDA loss of $1.7 million, if you add the 2 actual cash cost that we factor out of adjusted EBITDA, they were transaction costs and the Healight investment. You could add those to the $1.7 billion. And then on the balance sheet, and this is all operations. On the balance sheet, we did have some inventory stocking in the fourth quarter to the tune of about a net of $3.5 million. So -- and which is heavier than normal, but with putting the 2 companies together and making sure we've got the right products stocked up to sell. There were some transition lump sum inventory purchases in the fourth quarter. So that's about how the operating cash outflow works out.

Okay. Got it. The $2 million payment under the CVR was as a result of Cerecor hitting milestones on the revenue front, is that correct?

So they did earn the milestone. It was paid in equity. And…

The Innovus milestone, yes.

Yes. Yes. Sorry, the Innovus milestone. Yes, they did -- that was achieved, yes.

Okay. Got it. I misspoke, it was Innovus. And then lastly, any commentary on the BD front as far as any specific areas of focus or specific areas of holes in your portfolio that you determined might be beneficial?

The short answer is nothing to share specifically, Jeff, other than we continue to apply the same filters of products that fit, generally speaking, within the core areas on both the consumer and the Rx side. And it's going to be an ongoing part of how we grow going forward. We obviously have a good growing core business, but we'll continue to look at other things and be opportunistic. So looking both Rx and Consumer things that potentially have some area of overlap Rx products that could potentially be sold through the consumer platform and vice versa. So -- but nothing specific to share at the moment.

Our next question is from Vernon Bernardino with H.C. Wainwright.

Congrats on the strong results. Looking forward to the next fiscal year. I just had a few questions as far as Healight was concerned. Obviously, Healight is a different product from the rest of the portfolio. What are your preparations that you're undertaking to perhaps position the product as far as education is concerned upon its launches and approved products?

Yes. Good question. So obviously, Healight is to some degree, a moonshot. It's a big opportunity and one that, frankly, you could build an entire company around. And so a fair amount of work has already been done at this early stage from a commercial development standpoint. So as I mentioned in my prepared remarks, we've already engaged with commercial or prospective commercial partners. To evaluate the opportunity. We've formed a scientific advisory board already. So some experts from around the world in infectious disease and pulmonary and critical care medicine. So that's well underway. We've begun to obviously scale the relatively small-scale but scale manufacturing from a pilot standpoint, identify suppliers. So we have request for proposal out and already bids back in so we can obviously assess what our costs are going to be. And then obviously, have begun to engage thought leaders from around the world, just in general. So a fair amount has been done already. And obviously, now that we are underway with the clinical study and soon to be, we think, underway with a larger scale study and then continuing discussions from a regulatory standpoint, we'll then start to build out the commercial development. So we obviously still need to understand everything that we have here with respect to the clinical profile of the product, but we're optimistic that it's going to prove out to be a product that has good clinical promise. And obviously, we'll build out a commercial plan and infrastructure accordingly.

Now regarding the work that had already been done, how are clinicians viewing the product? Do they see it as something they could readily just add to -- and I imagine it'd be infectious, those who are specialized infectious disease treatment. And infections in general that this is something they could just add to the armamentarium they have in their clinical side or can these be stand-alone things, for example, that even our primary care physicians be able to add on someday?

Yes. So a lot of potential in that -- and how I'll answer this, but -- and obviously, a lot sort of within that question. So the short answer is, we view this as a relatively straightforward and very cost-effective add-on for a patient that's intubated already in the ICU and very costly to the system. So if you think about the daily cost of an ICU patients, it's tremendous. And so the ability to add something as cost-effective as Healight on to improve outcomes, minimally reduce viral and bacterial load and potentially improve outcomes to the point of minimizing number of days within the ICU and getting patients to discharge faster. The value proposition there has the potential to be enormous. So just on the basis of simply adding it on to what is already a very expensive very resource-intensive patient is exciting. And then you think about build out applications in the outpatient setting and while this isn't anything that we have put sort of clinical protocols around and specific planning around. We have -- I keep -- I'll remind you, we have licensed global rights to not just esophageal and tracheal applications but also nasopharyngeal applications. So you think about patients that may present very early with a severe infection like COVID-19, the ability to potentially treat those patients with something other than something going down a breathing tube. Something going through the nasopharynx. That's very exciting to think about because that's a huge number of patients. And as you think about broad applications again and beyond the critical illness like COVID, which obviously the application for a patient presenting with a severe respiratory illness in the emergency room, that's a significant number of patients. By definition, many more patients are in the ER than end up in the ICU. So the funnel, so to speak, is much larger there. But then it gets even larger when you think about patients that have chronic infections, chronic rhinosinusitis, chronic bacterial infections, chronic bronchitis, and these are patients that have been through the gamut with respect to how they've been treated in the number of antibiotic courses that they've already been exposed to. So I get very excited when I think about the build-out applications beyond that. So it's very, very broad. But we're taking it one step at a time. We think there's a near-term opportunity to gain proof-of-concept here in the intubated inpatient setting and obviously expand out from there as appropriate. So a lot of potential to say the least.

That's very helpful. Second question I have is regarding COVID testing. Just wondering if you could make a general comment as to how you're seeing these days as far as the distribution, if you're able to -- in direction that antigen and antibody testing is going.

I would say, in general, it continues to all be about turnaround times and decentralization. So there continues to be bottlenecks. We hear about it daily in the national and local news and right here in our own communities. So we see what we have with 2 rapid tests that can be deployed from virtually anywhere as very important in the fight. We don't see testing and the need for testing going away anytime soon. And right when it looks like we've got areas under control. We see areas spike back up and obviously, the need for testing to continue. And I think there's going to continue to be a balance between the need for diagnostic tests like the antigen test and PCR testing as well as surveillance serology testing as we have, obviously, with the antibody test. So there'll continue to be a role for both, even on the other side of a vaccine. We obviously don't expect broad distribution of the vaccine in the immediate term. In fact, that's very recent news over the last couple of days with the FDA stepping in and very clearly establishing that the rigor for approval is higher than potentially previously thought. So that's going to delay the time of having a vaccine out there. And even then, we know that it's going to take a while to get broad distribution. So there's going to be a continuing need for diagnosis, and there's going to be a continued need for surveillance. So but again, it's going to come down to turnaround time and rapid near-term -- near patient side of testing.

Thank you, we have reached the end of our question-and-answer session. I would like to turn the conference back over to management for closing remarks.

Thanks very much. Thanks for the questions, and thanks to everyone for joining today's call. We appreciate your interest and continued support of Aytu, and we look forward to speaking with you again on our Q1 fiscal '21 call coming up in November. Thanks again. Have a good evening.

Thank you. This does conclude today's conference. You may disconnect your lines at this time, and have a wonderful evening.