Good morning, everyone. Thank you for joining us for the Aytu BioScience’s Year-End and Fourth Quarter Business Update Call for the Year-Ended June 30, 2019. With me this afternoon are Aytu’s Chairman and Chief Executive Officer, Josh Disbrow; and Chief Financial Officer, Dave Green. Aytu BioSciences issued a press release earlier this afternoon with details of the company’s operational and financial results. 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 everyone that today’s call is being recorded. A replay of today’s call will be available by using the telephone numbers and conference ID provided in the earnings press release. In addition, a webcast will be accessible live and archived on – I’m sorry, Aytu BioSciences website within the Investors section under Events & Presentations at aytubio.com. Finally, I’d 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 BioSciences. Although management believes these statements are reasonable based on estimates, assumptions and projections as of today, September 26, 2019, 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’d now like to turn the call over to Aytu’s CEO, Josh Disbrow. Sir, please go ahead.

Thank you, Tom. Good morning, and thanks for joining us for today’s fiscal 2019 full-year operational and financial highlights call. We’re glad to be with you this afternoon. Today’s call will primarily focus on 2019’s key accomplishments, our growth plans as we enter our fiscal 2020 and the recently announced acquisition of Innovus Pharmaceuticals, which we’re extremely excited about. Starting with the company’s key accomplishments. Fiscal 2019 was an exceptional year of growth, doubling revenue and going from two commercial products in fiscal 2018 to now four with the licensing of ZolpiMist and Tuzistra XR were both huge developments for the company in 2019. It was also a pivotal year from a Capital Markets perspective having completed two financings bringing in over $20 million, led by healthcare institutional investor, Armistice Capital. Following that, we were successful in attracting two reputable Wall Street healthcare analysts from Ladenburg Thalmann and Northland Securities. Finally, this past year, we added two exceptional board members and Steve Boyd and Ketan Mehta. Steve is a highly respected investor and Founder of healthcare institutional investor, Armistice Capital; and Ketan is a Pharmaceutical Entrepreneur and President of specialty pharmaceutical company, Tris Pharma. We’re pleased to have both gentlemen on the Board, and we couldn’t be more pleased with the progress we made in 2019. Now a specific regard to our financial and operational performance. I’m pleased to reiterate that revenues increased 100% this year to $7.3 million, up from $3.7 million that prior year. And this performance was largely driven by Natesto and MiOXSYS, which both saw strong year-over-year growth. Diving a little deeper on both products performance, Natesto total prescriptions grew 33% for the year, and this prescription growth was accompanied by growth of the prescriber base to almost 2,800 riders nationwide. Additionally, the product refill rate…

Thank you, Josh, and thank you all for joining us this afternoon. Today, I review our financial results for the fiscal year ended June 30, 2019, which was the strongest year for the company since inception. First, a couple of housekeeping notes. Our Form 10-K covering the 12-month periods ended June 30, 2019 and June 30, 2018 will be filed with the SEC later today. That report contains our full annual report. We also issued a press release earlier this afternoon with a summary of the 2019 results. The press release, which includes summary financial statements can be found in the investors section of our website, www.aytubio.com and now our 2019 financial results. As Josh mentioned, revenue for 2019 was $7.32 million, which represents a doubling of 2018 revenue. The 100% revenue growth was led by Natesto surging 97% year-over-year. Next in line our medical device, MiOXSYS, grew 89% year-over-year, with strong performances in both Europe and Japan. And finally, both products launched in 2019 Tuzistra and ZolpiMist contributed to our 2019 top line growth. While Q4 revenue was generally in line with expectations, we did come in at the lower-end of the range of our range for Q4, due to the seasonal drop off of Tuzistra and a one-time accrual related to the new revenue recognition standard ASC 606, which we adopted this year. That said, Natesto’s RXs were up and the business is strong. Gross profit for 2019 was $5.1 million, compared to $1.6 million in 2018. That’s a more than 3x increase on higher revenue and a stronger gross profit margin. Operating expenses, excluding COGS were approximately $22 million in 2019, compared to $21.3 million in 2018. Factoring out non-cash items, operating expenses were $18.7 million in 2019, compared to $17 million in 2018. The increase was…

Thanks, Dave. As I alluded to in my opening remarks, we’re very proud of our fiscal 2019 performance, but believe that our current year fiscal 2020 would be even stronger and you might say transformational. We think this for a number of reasons, which includes some announcements that were made in our current fiscal first quarter ending September 30, 2019. First, on September 4, we announced the co-promotion agreement for Tuzistra XR with privately-held specialty pharmaceutical company, Poly Pharmaceuticals. This commercial collaboration will nearly double the Tuzistra XR Salesforce to approximately 60 representatives across the United States. Poly’s geographic footprint covers approximately 750,000 antitussive prescriptions annually, accounting for approximately $128 million in annual revenue. Poly Salesforce started physician and pharmacy promotion to Tuzistra XR on September 3, and expects to promote to approximately 5,000 subscribers to the 2019-2020 cough and allergy season. We’re excited about the new relationship and excited about having Poly on Board. Since Poly’s founding in 1980, the company has been mostly focused on the antitussive and allergy markets. So they’re an ideal partner for us as we launch into our first full season of promotion with Tuzistra XR. While only a few weeks into promotion and squarely ahead of the cough season setting in, we’re encouraged by the early physician customer feedback. Secondly, in fiscal Q1 2020, we also announced that Natesto Spermatogenesis Study results have been accepted for presentation as a Late-Breaking Abstract at the American Society for Reproductive Medicine, ASRM Annual Meeting. The Natesto Spermatogenesis Study results have been submitted in abstract form to ASRM and the complete results will remain in Embargo until the date of the presentation, which is October 16, 2019. We’ve talked about Natesto Spermatogenesis Study in this planned data release for several months and the readout is now just…

Thank you, sir. The floor is now open for your questions. [Operator Instructions] We’ll take our first question from Jeffrey Cohen with Ladenburg Thalmann.

Hi, Josh and Dave, how are you?

Hi, Jeff.

Hey, Jeff.

So a few questions. I’ll just roll through in a specific order. So you called it MiOXSYS strength for the quarter in particular. Could you give us any additional color as far as what geographic areas were strong there?

Yes, we can. As Dave just mentioned his comments. Japan and Europe are both quite strong for us. We’re building a nice base of installed instruments in both areas. We’ve got an excellent partner in both areas, in fact, has multiple partners potentially in the works in the Asia Pacific region. So both both Asia and Europe are quite strong.

Okay, got it. Dave, a couple of questions on the financial side, two in particular. One, could you talk about – or what was the actual Q4 accrual size? And the second one is, could you speak to the amortization in the fourth quarter seemed a little heavier versus what we had expected?

Yes, So Jeff, the amortization is really due to product acquisitions and they were probably a partial quarter that you’ve seen in the past. We now have kind of a full-year and full accounting of the accruals. On the rev reg side, that accrual is kind of a little deep and in the weeds for discussion today. But I would say that the quarter would have shown better on the top line, much further in line with past experience without the 606 adjustments that we made at the end of the year. This was our first year. We had just implemented ASC 606. So as the year progressed and we collected more data and got more experience with the new pronouncement, it just created a need for an adjustment at the end of the year. And it’s – I would say that it’s a one-time, so it’s not something that really needs to be analyzed and considered for moving forward. It’s a one-time. It’s behind us and it’s – won’t affect future quarters.

Okay, got it. And then, finally, Josh, could you talk a little bit about more about the upcoming ASRM conference and the Embargo on the Abstract with the publication and podium. Could you hypothesize with us when we might see a publication afterwards prior to the full presentation?

Yes. So, as I mentioned, Jeff, ASRM is coming up and it’s been accepted for – the abstract has been accepted for Late-Breaking Abstract the afternoon is October the 16. And so we would expect to be in a position to release that shortly thereafter. In terms of publication planning, there is a rather extensive publication plan in the context of obviously the main set of data and then subsets, because this is an investigator initiated study, and because there’s sort of an impact around the Embargo status, we can’t speak to specifics other than to say, there obviously are efforts underway being led by Dr. Ramasamy and his team to get the product – to get the publication out relatively quickly. I will say the Abstract will publish in abstract form in fertility sterility as is typical with any in the presentations or abstracts presented at ASRM. So that will be the first publication that the abstract will be formally put out, and then TBD, but as soon as practical with respect to a full peer-reviewed publication and the expectations are high in terms of the impact of the journals. So, look, yes, look forward to that.

Okay. That does it for me. Thanks for taking the questions.

Thanks, Jeff.

Thank you, Jeff.

We’ll take our next question from Carl Byrnes with Northland Capital.

Hey, good afternoon, Josh and Dave. A couple of questions here. Just a follow-up on the [indiscernible] readout at the ASRM that’s coming up. What’s your expectations in terms of using the data? We – do you see this as a supplemental clinical data in PI, or would you take it to potentially a supplemental NDA filing? And how do you see this just affecting marketing over the course of the next, let’s call it, 12 to 24 months? And then I have a couple more follow-up questions. Thanks.

Thanks. Thanks for that, Carl. And so this will be a great opportunity for us to engage with our partners at Acerus, who are obviously going to get much more intimately involved with the U.S. business. But suffice it to say, we’re excited about collectively the prospect of what the data readout might mean. Obviously, we’re not tipping our hands specifically as to what the data will be. But assuming that the data readout is positive, there’s certainly a fairly broad implications. There are opportunities to engage with the FDA. And again, we’ll sit down with our partners at Acerus and really evaluate what makes the most sense in terms of potential label changes and the specific pathway by which we follow. So more to follow on that, but I think there’s good optimism. There’s also a fairly substantial implication around intellectual property. So, more to follow on that. But with respect to really how the product is protected the portfolio surrounding Natesto, this could become a relatively important piece of that and again, in partnership with our partner that Acerus will evaluate the best ways to really pursue and exploit the the additional patent protection. So the specifics around whether it’s an sNDA filing or some other sort of supplemental submission to the FDA, obviously, we got to see the data first, get feedback and collaborate. And obviously, our plan would be to as assertively, but compliant as possible to showcase the data to clinicians. And I will say, even with the really relatively limited data sets that are out there today, there’s quite a bit of interest around it, particularly in the reproductive medicine arena. So we’re excited about getting it out there on a more fulsome basis. So we’re excited about the prospects, again, with the hope that the data readout is positive on the 16th of October.

Great. Understood. Thanks so much. And just [Technical Difficulty] with respect to Natesto, is there any details that you can give us with respect to cover lives on formulary, where they are now versus where they were year-end last year, you obviously given the announcements of recent time?

Yes. So we’ve announced here in the last couple of months the addition of Natesto to formularies representing in excess of 36 million lives. I will say, it’s actually significantly more than that and we’ve opened up multiple more lives. So what we’ve done is signed the first two commercial contracts with payers this year. We previously had not had the product contracted. So we’ve dramatically broadened the coverage again to well in excess of 36 million lives. For confidentiality reasons, we can’t speak to the exact number of lives, because it frankly tips the hand of which PBM we may be referring to. So suffice it to say, we’ve landed contracts with very influential Pharmacy Benefit Manager and thing this will go a long way to broadening the uptake. This – both contracts affect patients nationwide, quite literally in every key area, key MSA. There are lives impacted by this positive decision. So looking forward to, again, working with our partners at Acerus, as they get underway with their commercial footprint here of really driving home the importance of picking up such a substantial plan. So excited about it.

Great. And then switching gears a little bit with respect to cash, $11 million in cash and change at the end of the fiscal year, the burn in terms of cash used was up $13.8 million. What’s your expectations looking at closing in your fiscal second quarter the Innovus for your cash, I think, over the next 12 to, let’s say, 18 months? And I guess, maybe another way to look at it, how long – how much cash do you think you have in terms of us sustaining operations, if you can quote on – if you can comment on that at all? Thanks.

Yes, Carl. So what I would say is that, we have been reducing the burn. We reduced it by a little over $2 million this past fiscal year. With the addition of Innovus as close as they are to cash flow break-even, we think that putting out to public company costs, the duplicative costs in that regard and some of the other, say, synergistic costs that we can remove, when we combine the two entities will – is expected to wipe out pretty much of the losses – the cash losses at Innovus. And on top of that, that company is growing. We’re growing nicely with some of the initiatives that we have put into place that Josh covered, like the Acerus situation and some of the new co-promotion partners, which really have no cash cost to us, but do have – expected to have a significant impact on lifting the top line. We do expect that $11.3 million we have on the balance sheet as of June 30 to stress even quite a bit longer than we have in the past. So, don’t have a specific forecast for you. But we do believe that the burn will be reduced as we move forward more rapidly than we have over the past 12 months.

Great. Thanks so much. Thank you. At this time, I’d like to turn the call back over to Josh Disbrow. Please go ahead, sir.

Great. Thank you, Tom. Well, thanks to everyone for joining us on today’s calls. Again, we are very pleased with how fiscal 2019 win. We’re extremely optimistic about all that we have planned for 2020. So with that, I’ll just say thanks again for joining. Thanks for your interest, and we’ll look forward to updating you following our fiscal 2020 first quarter’s results. So with that, I wish you a good afternoon and a pleasant evening and thanks again for joining.