Aytu BioPharma, Inc.
Q2 2019 Earnings Call Transcript

Published: 7 Feb 2019

[Operator:]

Good afternoon, everyone. Thank you for joining us for the Aytu BioScience Second Quarter Fiscal 2019 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 morning 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 replay access code 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 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, 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, February 7, 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.

[Josh Disbrow:]

Thank you, Jen. Good afternoon and thank you for joining today's call. I'll begin by touching on our financial results at a high level, recap our quarterly highlights and then provide a deeper discussion around the performance of each product in our portfolio. After that I'll turn it over to Dave to review the financials in greater detail and then I'll conclude with some closing remarks and include an update on the Natesto Spermatogenesis Study, following that we'll open it up for Q&A. Starting with the financial results, the quarter ending December 31, 2018, was our third consecutive quarter of significant revenue growth following the strategic shift we implemented back in early calendar 2018. We posted all time high revenue of 1.8 million, which represents 71% growth over the same quarter last year and 25% sequential growth for the quarter ending September 30. This strong sequential and year-over-year growth keeps the company on a rapid growth trajectory as we continue to grow in Natesto scripts and revenue and integrate our two new products ZolpiMist and Tuzistra XR into its commercial mix. Moving into the quarterly highlights, this quarter was active and we achieved quite a lot. I thank our entire team for their hard work, great output and excellent operating results. Along with the strong revenue growth for Natesto, this quarter we expanded our commercial portfolio by launching ZolpiMist into its first full quarter and license to Tuzistra XR a novel cough suppressant competing in a $3 billion prescription market. As part of the Tuzistra XR licensing agreement, we also licensed a complimentary cough suppressant that is going to the FDA regulatory process and could be approved in the relative near term. So along with Tuzistra XR, we acquired a small pipeline if you will and we're excited about this potential addition to the product mix. Additionally this quarter, we transformed the company from a capitalization standpoint and are bringing on two additional board members to bolster the company's leadership team. In November, we closed an oversubscribed $15 million equity offering and followed that with a $5 million strategic investment from Armistice Capital. We then announced the planned addition of Steve Boyd, the Armistice Capital Founder and Principal and the appointment of Ketan Mehta, the Founder and CEO of Tris Pharma to our Board of Directors. We're pleased to have attracted such high caliber individuals at this important time in the company's short history. Along with this bolstering of the balance sheet and board, we continue to execute well on our operational plan this quarter and growing the Natesto prescriptions while substantially improving the product's gross to net. Natesto prescriptions have continued to grow and our refill RX to new RX rate continues to decline. With that we posted all time high weekly RXs in the month of December. Now, turning to specifics on the performance of each product in our portfolio, some of you likely recall that we made a strategic shift this time last year, just about four quarters ago, specifically for our naval testosterone product, Natesto. We sought to increase revenue from Natesto as we built on the early prescribing that was largely vouchered or deeply discounted. After almost a year into the shift in eliminating those vouchers, we're happy to say that the plan has paid off. Natesto prescriptions and revenues have risen steadily. Further and fuller implementation of Natesto Direct, our Patient Support Services Program, Natesto refills have dramatically increased from Q1 to Q2. This increase demonstrates the impact of a high touch, high engagement patient service model. The Natesto Direct model is helping us get more prescriptions in participating patients hands and providing a simple method of improving patient compliance with Natesto and yielding a much higher rate of refills. Total Natesto prescriptions increased 27% sequentially this quarter, and again we achieved all-time weekly highs in December. We expect to continue to drive patients through Natesto Direct through which we maintain our highest refill rate, our highest gross to net and higher patient retention that is achieved through the retail channels. Natesto Direct has performed well, yet it still continues to improve and become more efficient as we move along. To give you a sense for the substantial improvement in our Natesto performance, consider that paid prescriptions have increased 111% from last January to December, while at the same time increasing revenue per prescription by a factor of four. Additionally, looking at the number of physicians participating in the Natesto Direct program, we've seen an 86% increase over just a three month period. We're pleased with the momentum that we built with Natesto. I'll move over now to ZolpiMist, now that it's been in the fold for its first full quarter. Upon acquiring ZolpiMist, we adjusted the wholesale price to market levels and we manage various aspects of the supply chain and the wholesaler channel and began some early initial field promotion. Now in Q3, our current quarter, we expect to have meaningful revenue going forward with regular prescribing in pharmacy script filling. With ZolpiMist the message of oral spray convenience and rapid absorption into the bloodstream resonates with physicians. This makes for a solid secondary detail to our Natesto details given the simplicity of the oral sleep spray delivery message. Natesto was the primary revenue contributor for this quarter, so with our new products coming online now the opportunity to grow revenues through multiple products contributing is exciting. Moving over to Tuzistra XR, in Q2 we acquired the exclusive license to Tuzistra XR and got commercial efforts underway. This quarter, in the first couple of weeks in January, we launched Tuzistra XR through our field sales force is doing quite well. In the early going through just four weeks of full sales force promotion we've seen rapid script growth. We'll be finalizing January script numbers and we expect to report on that as soon as we have the final script data. It's early and the magnitude of the flu and cough season is still uncertain. However, we're quite pleased with the early script ramp for Tuzistra XR. As a reminder Tuzistra XR is the only 12 hour coding based cough suppressant suspension and competes in a $3 billion dollar prescription category. All other coding suspensions are dosed every four to six hours. So this extended release, 12 hour formulation offers a distinct advantage for cough patients trying to get to the long day and sleep through the night. From a sales force execution standpoint Tuzistra XR is a good fit. It's a good overlapping product placed to Natesto as approximately half of the Natesto prescriptions come from outside of urology and endocrinology and they're mostly primary care physicians. Thus, while we're in those primary care offices, we can leverage our sales forces efforts with the multi-product details to drive multiple revenue lines for the company across Natesto, Tuzistra XR and ZolpiMist. The addition of ZolpiMist and Tuzistra XR have broadened our portfolio nicely and provide great leverage with our nationwide sales force. A strong differentiated product portfolio is what we think will drive the most value which will growth. So we're looking forward to the new products contributing alongside Natesto. Outside the US, MiOXSYS our diagnostic platform for male infertility continues to make very good progress. MiOXSYS is getting more and more established in andrology laboratories and urology practices around the world. Further, MiOXSYS continues to gain support from some of the most reputable fertility thought leaders in the world, with numerous papers and presentations by these thought leaders demonstrating that. Instrument placements have grown and we're now in over 30 countries around the world. This business within a business continues to show progress as the team continues with commercial development of launching MiOXSYS. As a reminder, MiOXSYS is the company's in house develop diagnostic platform and is the only rapid method of assessing seminal oxidative stress in the assessment of male infertility. So before handing it over to Dave, let me just say that the commercial and operating results were strong. It was a good quarter for us and we're proud of the results. With that I'll hand it over to Dave to provide a deeper review of the financials.

[Dave Green:]

Thank you, Josh. And thank you all for joining us today. Today I'll review our financial results for the second quarter of our 2019 fiscal year that ended 12/31 2018. This morning we filed Form 10-Q with the SEC for the three and six month periods ended 12/31, '18. That filing contains our full second quarter report. We also issued a press release this morning with a summary of the Q2 results. The press release including Q2 financial statements and the 10-Q report can be found on our website www.aytubio.com. Today, I'm happy to announce a second consecutive quarter of record revenue for Aytu and the third consecutive quarter of strong sequential revenue growth. Our Q2 record revenue was $1.8 million, which is 25% higher than our prior record last quarter of $1.4 million and 71% higher than the same quarter last year. And again, Natesto was the biggest contributor. Also our year-to-date revenue of $3.2 million is 52% greater than revenue for the same period last year. In addition to revenue growth, we also reported record gross profit of approximately $1.3 million for Q2, which is nearly double the gross profit reported for Q2 last year. Operating expenses excluding cost of goods sold for Q2 were $5.8 million and higher than Q1 by approximately $1.4 million. I'll note that approximately $760,000 of the 5.8 million Q2 operating expense were non-cash items, and two thirds of the Q2 operating expense increase over Q1 was due to a normalized level of FDA fees this quarter compared to Q1, which was artificially low due to a large FDA refund received in Q1. During Q2, we recognize normalized 2019 FDA program fees for Natesto and Tuzistra. During Q1 we recognized FDA program fees only for the Natesto, but we also recognized FDA fee refunds, which lowered our overall regulatory expense for Q1 to a negative expense amounts. That Q1 benefit artificially inflated the delta between the two quarter's expense recognition. The remaining operating expense increase from Q1 is largely attributable to onetime acquisition and launch cost related to Tuzistra XR. To add more context to the operating expense spend, let's look at the year-to-date OpEx and adjusted out non-cash items and COGS which naturally grow with revenue. Year-to-date 2019 operating expenses without COGS and $936,000 of non-cash expense was $8.86 million. Op expense for the same period of 2018 with the same two adjustments was $8.5 million. From this vantage point the progress we have made is clear. We grew revenue by 71% or $1.1 million, while cash OpEx increased only modestly by $375,000. And further if one time launch costs are also excluded our year-to-date OpEx is lower this year compared with last year. This demonstrates our focus on top line revenue expansion while maintaining an efficient operating structure that supports our growth. Our year-to-date bottom line net loss was $8.1 million, compared to a loss of $7.9 million for the same period last year. Turning to the cash flow statement in the 10-Q, net cash used in operating activities for the first half of fiscal year 2019 was approximately $300,000 lower than the same period of fiscal year 2018. Turning to the balance sheet, during the second quarter we strengthened the balance sheet substantially. As Josh mentioned, we added $15 million of new equity in a public offering and raised an additional $5 million of debt in the form of a three year note for a total $20 million of new capital. We ended the quarter with a cash balance of $17.9 million and total assets of $42.3 billion, compared to 7.1 million of cash and 21 million of assets as of our fiscal year end 6/30, 2018 and that was just six months ago. So in summary, for the second quarter, we continue to show strong top line revenue growth. We acquired and launched our third product Tuzistra XR. We integrated ZolpiMist list into the portfolio and substantially increased the strength of the balance sheet. And with that, I'll turn the call back over to Josh.

[Josh Disbrow:]

Thank you, Dave. So to revisit some of what Dave said, this quarter was an important one from the financing perspective. We closed a successful oversubscribed $15.2 million registered deal. In this race, we brought in a mix of investors with a large healthcare focused institutional fund leading the race. After the race and specifically to support the Tuzistra XR licensing deal, Armistice Capital infused another $5 million note. We appreciate Armistice's support in securing Tuzistra XR and helping the company continue to expand. We're now very well positioned with a healthy balance sheet. Subsequent to the Q2 quarter end and in fact just this week, we had a positive development related to this note. Armistice's approach was about retiring the $5 million note in exchange for equity and given the terms for the company of retiring debt in exchange for equity price near market, we accepted this exchange. This keeps the company debt free and enables Armistice to increase their equity investment in this growth opportunity. We formally agreed to this transaction yesterday. So upon shareholder approval at our upcoming annual meeting, we expect to officially convert the debt, a new combination of common stock, preferred stock and warrants. All the equity that will be issued will be unregistered and restricted. So we expect Armistice to be a substantial and supportive shareholder moving forward. To that end, this quarter, we announced that to new board members would be appointed, Ketan Mehta and Armistice Founder Steve Boyd. Ketan has already joined the board and we expect to formally appoint Steve soon. Both men had a great deal to our board and both their experience in healthcare as well as their experience with capital markets and scaling businesses. Steve's commanded at the healthcare capital market space is unparalleled as the Founder of Armistice Capital and Ketan's launching and scaling of a world class specialty pharmaceutical company and Tris Pharma has been remarkable. We're happy to have both of these men joining the team. On the clinical development front it was an exciting quarter for the company. The ongoing Natesto Spermatogenesis Study at an early interim read out and data were presented by the study's PI, Dr. Ranjith Ramasamy. The results he presented are excellent and we and the investigators are encouraged by the interim results. I'll remind you about the study and also remind listeners that we expect to study to be completed this summer with results to be presented and published thereafter. The Natesto Spermatogenesis Study is a single center perspective study evaluating testosterone levels, gonadotropin levels and semen parameters in hypogonadal men between 18 and 55 years of age that are treated with Natesto testosterone nasal gel. All men receive treatment with Natesto over six months. This is the first such study utilizing testosterone replacement therapy that evaluates the preservation of gonadotrophins and fertility while restoring serum testosterone levels. So now a recap of the results, as of the interim read out, 39 patients had been enrolled in the study and 14 Natesto treated patients had been evaluated at their three months treatment time point reflecting one complete sperm cycle. Nine Natesto treated patients had been evaluated at their six month treatment time point reflecting two complete sperm cycles. In the take home from the interim work is quite simply that across the cohort of patients treated for the three and six months, all patients achieved normal testosterone levels with Natesto, but most importantly across all three measured semen or sperm parameters, sperm concentration, sperm motility and total modal sperm count, all three parameters remain normal after treatment with Natesto. For the first time a testosterone replacement therapy has shown minimal or no impact on sperm production and semen parameters. This is exciting and we're looking forward to the readout of the final results. If the results continue as we've seen thus far, the implications are far reaching. This would be the first product for low T to potentially preserve fertility and therefore be an exclusive TRT option for the 2 million or so hypogonadal men who wish to keep their fertility options open. Dr. Ramasamy calls these results potentially paradigm shifting. So we'll be excited to see if indeed the trends hold in this first of its kind interventional studies in low T. So to recap, the quarter, Q2 was an excellent quarter, during which we showed strong revenue and RX growth. We launched ZolpiMist into its first full quarter of promotion, we acquired Tuzistra XR and a pipeline asset and we secured significant capital to put $18 million on the balance sheet as of December 31. Also, we announced two board additions in Ketan and the planned addition of Steve. Finally, we got an early glimpse of very promising clinical data surrounding Natesto in what could change the treatment paradigm and low T. This next quarter, we expect to continue our growth and are already off to a good start, Tuzistra XR is up and running and we also expect a meaningful revenue contribution from ZolpiMist and MiOXSYS this quarter while Natesto continues to grow. Quite simply going forward, we expect continued growth. We're a growth company as evidenced by three consecutive high growth quarters and we believe we can continue to grow through our continued commercial execution. So with our prepared remarks now concluded, I'll ask our operator Jen to open the lines for questions.

[Operator:]

Thank you. The floor is now open for questions. [Operator Instructions] And our first question comes from Jeffrey Cohen from Ladenburg Thalmann. Please state your question.

[Jeffrey Cohen:]

Good morning, Josh, Dave and Jarrett, can you hear me okay?

[Josh Disbrow:]

Very fine Jeff. Good morning.

[Jeffrey Cohen:]

Awesome, so could you tell us a little bit more about the other filing for the other cough suppressant that you mentioned, composition and maybe some timelines or parameters that we may hear more about it?

[Josh Disbrow:]

Yeah, good question. We haven't disclosed very much about Tuzistra [indiscernible] private company. And there was a previous licensing arrangement that that's put us in a bit of a position to be a little bit cautious about it. But the bottom line is that it is a complimentary antitussive. So it's similar and obviously the call point is going to be virtually identical. It's a similar type of product, but the ingredient mix is a bit different. And it is with the FDA. So it has been submitted to the FDA. And really all we've said generally speaking, is that obviously that entails a relatively near term review. We're not putting a specific timeline on it, but it is it is in front of the FDA. So you can surmise that it's a relative near term opportunity for us. We wouldn't expect it this cough and cold season potentially in the coming one this fall or perhaps the one following that so I would say in the relative near term,

[Jeffrey Cohen:]

Okay. And as far as severity would it be less than or greater than Tuzistra?

[Josh Disbrow:]

I'm sorry, say that again.

[Jeffrey Cohen:]

As far as severity of cough and cold, where would it be on the treatment paradigm, would it be for more severe cases or less severe cases?

[Josh Disbrow:]

It'd be for slightly more severe cases, but not markedly so. It would be - it's an extra ingredient on top of the coding, so wouldn't necessarily move too far up the treatment channel, but a complimentary patient, it's just - it takes care of an extra symptom.

[Jeffrey Cohen:]

Okay, got it. And then a little more color on the deck conversion, we'll see some news on that in the short term, you mean coming days or weeks and what you expect that goes to equity or it goes to other instruments, will be pure equity?

[Josh Disbrow:]

It is pure equity and so we have disclosed the details in the queue. And ultimately Armistice Capital agreed, essentially to a near market conversion from debt into equity. So it was a three year 8% note that was payable by the company any time. But Armistice approached us relatively recently, negotiated it back and forth, conferred with the board and other advisors and ultimately really aftermarket day before yesterday, really yesterday agreed to essentially take it and convert it. So we believe favorable terms for the company and it is relatively well detailed in the queue as a subsequent event.

[Jeffrey Cohen:]

Got it, okay, that's great news and then one for Dave if I may. Dave, it looks like the OpEx is demonstrating greater leverage than we have previously expected as far as the top line relative to the OpEx. Do you expect that to continue or it seems like it was one time in nature to some degree from Q2 because it comps off to Q1.

[Dave Green:]

So it's a good observation, Jeff and yes, we do expect to continue to use the operating leverage that we've got. Our cost structure is essentially in place, the comp point for the new product is - the comp point we've been after the entire time. So there's really no need to add commercial infrastructure which is our biggest cost in the operating expenses, feeding the sales force and the whole commercial team. So we expect revenue to continue to grow and we expect to hold the operating expense roughly where it is today.

[Jeffrey Cohen:]

Okay, got it. And then one more if I may for Josh or Dave or Jarrett, any chat about the M&A front and your current appetite versus your previous appetite, now with the four products all tucked in and getting commercial.

[Josh Disbrow:]

Yeah, good question, Jeff. We obviously feel good about the portfolio we have now. We've got three solid differentiated products, all serving large markets, all unique in their delivery and ultimately the patient stay. They treat we've got this antitussive product off in the wings that came in with the Tuzistra deal. I would say we're in a very good spot and not –certainly not in need of anything. That having been said, we'll remain open and certainly will take inbound calls we are not actively looking to go and dramatically broaden the portfolio. Again, we feel like we've got a product mix that makes sense and can be efficiently leveraged to the sales force. But we return phone calls and certainly people know that we're acquisitive, inquisitive and ultimately have conversations, but we buy right, we don't overpay for these assets. We tend to do deals that are mutually beneficial such that there are relatively low up front, relatively low startup costs and really more backend reward for both parties and that's what we've done really with the last several deals and expect to do going forward. So if it is something we could do without shedding much off the balance sheet, it's something we would entertain, but there's nothing imminent and we're happy with the portfolio we have in place today.

[Jeffrey Cohen:]

Okay, got it. Thanks again, nice quarter.

[Josh Disbrow:]

Thank you, Jeff.

[Operator:]

Thank you. Our next question comes from Carl Byrnes from Northland. Please state your question.

[Carl Byrnes:]

Great thanks so much. Congratulations on the quarter. I've got a couple questions, actually a few - three or four. First, with the complimentary comps suppress, would you expect that to also be scheduled three similar to Tuzistra?

[Josh Disbrow:]

We would expect it to be a C3, yeah. We're not looking actively to go up the chain in terms of opioids, so we've heard loud and clear doctors have a preference C3s over C2s, lot of reasons for that safety obviously chief among those. So yeah, that's about as far as I think we prefer to go in terms of describing what the anti-tested is. But yeah, we would expect that it will be a C3.

[Carl Byrnes:]

Great, and with respect to cash burns, can you give us any guidance on what that might look like for the second half of the year considering ZolpiMist and the Tuzistra launches? And then also just coupling with Tuzistra launch, given that where your - and flu season and expecting is a strong flu season, any promotions or couponing that you're going to use or expect us to jump start to Tuzistra launch?

[Josh Disbrow:]

Yeah, I'll take that one first and then touch on the burden. Dave can pig you back. We're doing as we've done in the past and other companies do in the early stage of the Tuzistra XR launch and it is going quite well. We'll do the regulatory coupon. We also are pursuing third party payers, the predecessor company that had licensed it the US had some favorable coverage and so we'll look to parlay that coverage into some of our own contracts and actively pursuing that. Have a team in place to do that do that already. So we expect to do couponing in the near term, certainly to this first season, just to get the word out to ensure good, broad acceptance and continued awareness. So that's how we'd approach that. In terms of cash burn, Carl, we expect to grow revenue, and really that's going to be the driver of the decrease in our cash burn as we go forward. We've continued to say we expect to be a high growth company for the coming quarters and potentially even beyond that. And with that, obviously, we would expect the operating base, operating expense base to stay relatively static. As Dave said, it's relatively fixed and so while there may be sort of one timers here or there, the various things that may be done quarter-to-quarter on the whole, I think if you look at six months over six months, and ultimately year-over-year, we do expect to report lower cash use as we go forward., I don't know if you would add anything to that Dave.

[Dave Green:]

Yeah, that's very much the story. It's a simple formula, we're growing the top line, we're holding the cost structure as it is, there's no real need to build out anything further. As Josh mentioned, with an acquisition there's costs that pop up that are one time only that we'll see this quarter, we'll probably see a couple more next quarter, but nothing that really shakes the foundation that we have or changes the overall nature of our cost structure. So expect the burn to decline going forward and really proportionally too as we grow the top line that will really dictate the decline in burn and our gross profit is very much stabilized and so we expect cash use to go down as we move forward quarter-by-quarter, here.

[Carl Byrnes:]

Great, thanks and just one final question, Josh, again you commented on this Spermatogenesis trial expecting to be completed in summer, would you also expect to have top line results shortly thereafter, obviously that was indicate top line read out prior to the end of the fiscal year is that consistent?

[Josh Disbrow:]

Potentially we - I'll remind you in the color that this is an investigator initiated trial and so the University of Miami and Dr. Ramasamy will really control the timing and the format by which the results are released. We want to be respectful of that. This is obviously something he's been working very hard at for quite a long time. And so while we do expect to have at least internally a glimpse, the timing on when exactly when that would be made public will be dependent upon their publication and presentation plans. Our hope would be that we would be in a position to release at least top line results shortly after they are read out. But again, we're going to be respectful of their desire to get it into obviously a high impact journal and potentially present this at a reputable scientific conference. So I guess a little bit more to be determined on that.

[Carl Byrnes:]

That's great, congratulations again, thanks.

[Josh Disbrow:]

Thank you.

[Operator:]

Thank you. And there are no more questions at this time. I'll now turn the call back over to Josh Disbrow.

[Josh Disbrow:]

Great, thank you, Jen. So that concludes obviously the quarterly call. We thank you for joining. We thank you for your questions. With the Q&A now complete, let me just say thanks again for joining. Look forward to sharing more as we move forward and report out on this quarter's results here shortly, so thanks again. Have a good day.

[Operator:]

Thank you. This does conclude today's teleconference. We thank you for your participation. You may now disconnect your lines at this time and have a great day.