Aytu BioPharma, Inc.
Q4 2018 Earnings Call Transcript

Published: 7 Sep 2018

[Operator:]

Good afternoon, everyone. Thank you for joining us for the Aytu BioScience Fourth Quarter and Fiscal 2018 Year End Business Update Call. With me this afternoon are Aytu's Chief Executive Officer, Josh Disbrow; Chief Financial Officer, Dave Green; and Chief Operating Officer, Jarrett Disbrow. Aytu BioScience 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, an archived webcast replay will be available on the company's Investor page, under Corporate Presentations and Media at aytubio.com, following the conclusion of this conference call. Finally, I would also like to call you 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, belief, 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, September 6, 2018 these statements are not guarantees of future performance. Time sensitive information may no longer be accurate at the time of after the time around [ph] 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.

[Josh Disbrow:]

Thank you, Jeremy. Good afternoon and thank you for joining us for today's call. I'm pleased to be speaking with you this afternoon and I'm excited to share that this was a transformational quarter for the company. It was transformational both in how we're approaching and growing our Natesto business and then that we brought in another FDA approved product opportunity in ZolpiMist that doubles our total addressable market. With respect to Natesto, this quarter, we made a substantial pivot that we kicked off just before our last call and I'm happy to share that the strategic changes we've made around Natesto are already paying off. And these changes are paying off quite a bit earlier than we expected. Further, ZolpiMist has already launched through our sales force and it's making early revenue contributions ahead of schedule and ahead of our internal forecast. Before handing it over to Dave to cover the financials, I'll first share some highlights around our quarterly performance. I'll focus on Natesto's significantly strengthened performance and growth trajectory over the last three months, since making a strategic shift. And I'll also comment on the exciting clinical development we've undertaken with Natesto to improve the product profile even further. Finally, I'll report on the progress of the ZolpiMist launch, based on the early feedback from our sales force after what was an earlier than expected field launch. In short, this was a very good quarter for Natesto. Natesto revenues hit an all-time high and increased 178% sequentially from Q3 to Q4, a rather remarkable revenue jump. This increase is due to the company continuing to drive prescription sales, while dramatically reducing coupon utilization and stopping free vouchers. It is also attributable to the ramping up of the various reimbursement support services we rolled out last quarter that have now begun to take hold. We've continued to refine our reimbursement support offering over the last two to three months, and as evidenced by the significant growth from quarter-to-quarter, things are working well. So, for Natesto, revenue is up 178% quarter-to-quarter, coupon use is way down and vouchers have been turned off entirely. We're expecting growth going forward. Looking at the fiscal year as a whole, we increased Natesto total Rx’s 220% year-over-year and increased Natesto specific revenues 183%. Additionally, refill prescriptions are up 14% over just Q3 and an impressive 242% over fiscal 2017. Further, the company decreased its net loss from 22.5 million to 10.2 million, so, we're pleased with how we came out of the year and the momentum we've carried into this new fiscal year. I'm pleased to say also that Natesto sales are tracking higher this quarter, our first fiscal quarter than last quarter. And ZolpiMist is already contributing in Q1, ahead of schedule to put us on a continuing growth trajectory. As we began Q4, we knew we had a lot of work to do to move our business beyond the promotional stage of offering discounted voucher Natesto prescriptions. We did this to get Natesto's name into the market, knowing that we would pivot and we pivoted very effectively this past quarter. We sought to reduce our coupon rate and get away from vouchering and we did that without sacrificing very much in terms of sales volume. From Q3 to Q4, Natesto coupon used as a percentage of TRx’s decreased from an average couponing rate of 63% to a much lower rate of 28% in Q4. Yet, unit volume only dropped by about 13% in Q4. That unit sales figure takes into account the stripping away of the free vouchers and cutting coupons by more than half. This relative volume stability shows us that we have a product in Natesto, in which physicians believe and that they're willing to write the product because of the clinical value it offers. This shift has in turn helped to drive Natesto revenue to an all-time high and take our cumulative Natesto prescribers to now over 2,000 and over 1,400 prescribers in fiscal 2018 alone. Additionally, our reimbursement support services have begun to yield good results with approval rates for Natesto in the 60% range and even higher among some large national plants. Scripts are going through at better rates than before and this is evidenced that our support programs are working as we planned. So, with these performance highlights serving as a backdrop in what was a very good quarter and a good start to our fiscal 2019, I'll hand it over to Dave to cover our financials. Dave?

[Dave Green:]

Thanks, Josh and thank you to everyone joining today. Let me start by saying the Natesto performance I previewed last quarter that’s net revenue per script continued to build each month during our fourth quarter. As Josh mentioned, with a drastic reduction of coupons and the full elimination of free vouchers at the end of Q3, we substantially improved net revenue per script during Q4. As a result, net revenue and its growth is expected to correlate much more closely with TRx and Rx growth as we report our results in the upcoming quarters of 2019. For our Q4 2018 results, total net revenue is up 52% sequentially to 925,000 and was led by Natesto's strong performance. For the fiscal year ended June 30, 2018, net revenue was $3.66 million, representing 14% growth over 2017. For some additional context on the growth rate, during this fourth quarter, we realized no material revenue from the products that were discontinued in fiscal year 2017 and these products represented approximately $640,000 of revenue in the first three quarters of this year. Adjusting out revenue from discontinued products for both 2017 and 2018, year-over-year revenue growth would be 104%. Total operating expenses, excluding COGS for the quarter were $4.5 billion, a decrease of 19%, compared to Q4 2017 and a sequential decrease of 36% from Q3 of this year. For 2018, operating expenses were $21.3 million, a decline of 3% over the full year 2017 operating expense of $21.9 million. Pre-tax loss for 2018 was $10.2 million, compared to a loss of $22.5 million for 2017. And considering the bottom line performance, it should be noted that we have significant GAAP required non-cash income and expense items throughout our income statement and these impacts pre-tax income. We also recognized below the line net other income of $9.5 million in 2018 and net other expenses, totaling $2.4 million in 2017. Now turning to cash. Cash used from operating activities was $4.5 million for the quarter and $15.9 million for 2018. If we were to adjust out the Q4 one-time launch cost for ZolpiMist, our cash use from operating activities would be approximately $4.25 million. On the balance sheet, we ended the year with a $7.1 million cash balance and total assets of $21 million, compared to $15 million in total assets one year earlier. Total equity was $13.4 million as of June 30, 2018, compared to $4 million at June 30, 2017. In summary, we’re pleased with the 2018 results in the state of our stronger balance sheet, and we’re especially encouraged by the Q4 performance reported today, which reflects the strategic shift we made in our business model at the beginning of this final quarter of 2018. And finally, on August 10, we completed a 1-for-20 reverse stock split and our stock listing is in compliance with NASDAQ's continued listing standards. Let me now turn the call back over to Josh for some additional comments.

[Josh Disbrow:]

Thank you, Dave. So, before I open it up to Q&A, I will speak to our plans going forward as we've moved now into fiscal 2019. There are three primary elements of our growth plan that I'll highlight. First, we'll continue to build on a Natesto sales momentum. We expect to do this by continually evaluating our support programs and enhancing where needed. And we'll continue to sharpen the sales all through constantly improving our targeting and our execution. We'll also do this by increasing experienced levels at the representative level and by continuing to develop the clinical data that demonstrates Natesto's product benefits. On the support program front, we've just launched an enhancement called Natesto Direct, whereby for eligible commercially insured patients, we're offering home delivery along with the reimbursement services that have already been in place. We believe that this combination of payer related assistance and high touch customer support will help further drive prescription rates and increase patient adherence. On the sales execution side, we'll continually upgrade our team and we've done so over the last seven quarters. We've also ensured that we're in the right sales territories with messages that resonate and indeed they resonate very well and the team is enthusiastic about all the recent upgrade that has created this momentum. As evidence of the continuing momentum, we increased Natesto utilization to an all-time high and demonstrate a 220% prescription growth from 2017 to fiscal 2018. As the second element of our near-term growth plan, we just launched ZolpiMist, and this new opportunity adds another product in a $1.8 billion category. ZolpiMist offers a unique mode of delivery and distinct advantages over the incumbent product Ambien and the early feedback has been good. We launched ZolpiMist less than a month ago, which is ahead of our originally planned timing. As a result, we're realizing early revenues ahead of schedule. As a secondary product to Natesto, we're launching ZolpiMist to a large subset of overlapping testosterone and sleep aid prescribers. And sharing with these physicians, the benefits of two uniquely delivered products. ZolpiMist is a unique product offering past patients a fast onset of action through its oral spray delivery. In clinical data demonstrated patient achieving high levels of zolpidem quickly, so ZolpiMist might be a preferred quicker method to getting to sleep over the standard tablet regimen. This product fits well within our current sales infrastructure. And again, is an effective complement to Natesto in the overlapping target offices on which we call. Finally, and to complement our near-term commercial plans, we're executing very well on the Natesto clinical development front. Importantly this quarter, we ramped up our collaboration with the University of Miami's urology department, that is leading the Natesto Spermatogenesis Study. With more than 20 patients now enrolled in this study and led by Dr. Ranjith Ramasamy, we're expecting an interim readout of this data soon. If positive, these data could position Natesto, the only TRT that doesn't demonstrate a significant impact on sperm production. This is an important study strategically as the results have clear potential benefits to the brand. Among others, these benefits include the potential to extend our patent runway and the potential to position Natesto exclusively for the roughly 20% of the market of Low T men who wish to preserve their fertility. 20% of $1.8 billion market or $360 million is a sizable addressable market and one that Natesto could exclusively serve at these data bear-out over time. We expect an interim look at the data in the fall and we're optimistic based on some preliminary data. A final readout is expected next summer. To close out our prepared remarks, it's important to note, also that things continue to progress well with our male infertility device MiOXSYS, key thought leaders and institutions around the world continue to be highly engaged with the product. And with recent European guidelines specifically citing oxidative stress as a corporate in male infertility, we believe the market will increasingly accept and integrate this noble testing method. MiOXSYS is now CE marked and approved now in Canada, Australia and recently, Mexico and with over 48 million couples affected worldwide, the infertility market is large and the male infertility market in particular, remains largely unsatisfied. We expect to continue to expand MiOXSYS awareness and use overseas, while we work through the potential approval process here in the U.S. and I'll be happy to share more if that is formalized. So overall, we're very pleased with the quarter and the year as a whole, we're particularly excited about the commercial pivot we've made with Natesto in the early dividend that has paid. Further, we've doubled our total addressable market to nearly $4 billion and now with two products in the sales force's bag and those products growing, we look forward to what’s ahead. So, with that, let me open up the call to questions. Jeremy, please open up the lines.

[Operator:]

[Operator Instructions] Our first question comes from the line of Joshua Horowitz from Palm Global Fund. Please proceed with your question.

[Joshua Horowitz:]

Hi, thank you. Great job guys on a solid quarter. A few quick ones I guess. How big do you think ZolpiMist can be revenue wise?

[Josh Disbrow:]

So, we don't – we haven't and really don't guide specifically in terms of what we think the near-term opportunity, but what I'll say Josh is, we think it's a very sizable opportunity. Again, it's a $1.8 billion market if you look at total wholesale sales, so that's WACC sales. If you look at just the zolpidem tartrate molecule, so the Ambien in combination with Ambien generics, extended release, immediate release and so forth, that's about 30 million prescriptions annually. And so, if you looked at it and just said if just theoretically if you got just 1% of that market of 30 million, you'd be talking 300,000 prescriptions. 300,000 prescriptions times the selling price of our product is $329 for the 30 doses. That's a 98 to call a $100 million in gross sales, we applied some discount to that, so you cut it in half, maybe you take it down to a 40% deduction, that's a $60 million opportunity with the percent. So again, not guiding to that specifically, but it's a very large market and the opportunity could be quite substantial.

[Joshua Horowitz:]

Generally speaking, what are your growth expectations for the company for Q1?

[Josh Disbrow:]

Well, what I can say without giving you real specifics is we're ahead of last quarter's pace, in terms of our revenue, in terms of sort of the revenue per prescription that Dave alluded to, we're on a pace that supersedes where we were. We obviously have a third of the quarter remaining and as Dave also pointed out, we tend to do better as the quarter builds. First month tends to be good, second is better and third has historically been even better than that. So, if that holds, I think we're looking forward to seeing a nice growth number beyond what we posted here in Q4.

[Joshua Horowitz:]

Terrific. Thank you very much for taking my questions.

[Josh Disbrow:]

Thank you.

[Operator:]

[Operator Instructions] Our next question comes from the line of Anthony Vendetti from the Maxim Group. Please proceed with your question.

[Anthony Vendetti:]

Thanks. Josh, I was just wondering if you can go into little more details on the commercialization strategy for ZolpiMist, I mean it looks like it's a big opportunity if it's complementary to what you currently have with Natesto. But it looks like it would be a potentially different call point for the physician.

[Josh Disbrow:]

Yes, good question. Thanks for that Anthony. Good to have you on the call. So, we obviously have a very, very finite understanding of our business down in the territory, when we look at the Natesto prescribers and the prescriptions and we look at the call deck if you will, the day-to-day call efforts that our sales force is making, over half the time they're calling on primary care physicians. So, internists primary care, family practice, PA's, so they spend a lot of time essentially 50% plus of the time in these PCP offices. PCPs are the highest prescribers of sleep aids, while they're also very, very prolific writers of testosterone therapy. So, there is a very natural overlap there. We've got a fixed cost in our sales infrastructure, that's essentially been fixed for the last several quarters, very predictable. So, we're in a situation where we've got an opportunity and we've got time in these offices. So, what we have instructed them as a secondary priority to Natesto is, when they're having launches or they are having appointments with these physicians, after they've had their discussions around Natesto to be able to engage in a very quick, very simple discussion around a faster acting zolpidem tartrate formulation. So, it's a good overlap, it's not any incremental cost in terms of having to expand the sales structure, and ultimately from what we've seen already, it's hand in glove in these offices and it's off to a good start.

[Operator:]

Anthony, do you have any further questions?

[Anthony Vendetti:]

Yes, just a quick follow-up. Can you – Josh just describe the pros and cons of ZolpiMist versus Ambien?

[Josh Disbrow:]

Yes, happy to. So, Ambien is obviously been widely prescribed for years, is still to this day sold by Sanofi although it's largely genericized. So, there is a couple of inherent challenges with respect to tablets. The most notable is the fact that patients over time report sort of lack of consistency in terms of time of onset to sleep. Sleep onset is the single biggest complaint, so that's an issue. Patients that have been taking it for some period of time report tolerance or perceived tolerance and ultimately a high variability in terms of how long it takes them to get to sleep. So, that's a negative in many patients and so you've got a oral spray formulations in ZolpiMist that by virtue of the fact that it absorbs directly into the mucosa, you've got a much more consistent, much more rapid onset of action. And in fact, when you look at the clinical study report presented to the FDA, 19% of patients at 15 minutes are essentially at the sleepiness level if you will, if you look at zolpidem blood levels, compare that to 63%. So, more than a threefold increase in terms of the percentage of patients getting sleepy on the spray version. So, that's probably the biggest difference, if you will, laying them side-by-side. Some patients also report a hangover with Ambien in the morning likely due to just metabolism to the liver by virtue of the fact that an oral spray doesn't metabolize to the liver primary as a first pass. There is at least a theoretical advantage that it may clear more quickly. So, those are a couple of things to give you a sense for how it may compare favorably to Ambien.

[Anthony Vendetti:]

Okay, great. Thank you.

[Josh Disbrow:]

Thank you.

[Operator:]

Our next question comes from the line of Carl Byrnes from Northland Securities. Please proceed with your question.

[Carl Byrnes:]

Great. Thank you. First, congratulations. Just – with this spermatogenesis study around the corner, do you see it playing a role in your gross net discounting with Natesto going forward or what's your viewpoint on that if at all?

[Josh Disbrow:]

Thank you, Carl. Good to hear from you. Potentially, really, we look at the strategic implications if you will of this data or these data are fairly far reaching. One, obviously, I spoke to the fact in my prepared remarks that we might expect and it'd be reasonable to expect increased patent runway and that would be obviously be a substantial boon to the brand. With data that is unique as this maybe in such a distinct clinical differentiator in this lack of effect, I think there is a scenario where you could take that information to payers to potentially enable better access and maybe enable preferred access in some settings. That's not suggesting we would get that, obviously, we need to see the data as a first step and then advance it to a final form. But, I would say, we would be comfortable taking that in front of payers to see if there is a way to leverage that with respect to getting some preferential status. So, that might in turn result in improved access at pharmacies, improved access just in general and a larger market obviously that might just open this up for some. When you start talking about fertility, payers often have to stop look and listen, it's a high needs environment, it's not – and that's a relatively sensitive patient in terms of their willingness to go to [indiscernible] for the prescription. So, I think there is a scenario where it could economically improve the profile of the product beyond just the natural clinical profile.

[Carl Byrnes:]

Great, and congratulations again. Thank you.

[Josh Disbrow:]

Thanks. Appreciate it.

[Operator:]

[Operator Instructions] Ladies and gentlemen, we have reached the end of the question-and-answer session. And I would like to turn the call back to management for closing remarks.

[Josh Disbrow:]

Thank you, Jeremy, and thanks to everyone who joined us for today's call. Again, we believe it was a very good quarter for the company and we're pleased with the momentum that we've created, particularly here as of late. We look forward to sharing an additional update with you all next quarter. So, stay tuned for that. Thanks very much again and have a good evening.

[Operator:]

This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation.