Aytu BioPharma, Inc.
Q2 2020 Earnings Call Transcript

Published: 14 Feb 2020

[Operator:]

Good afternoon and thank you for joining us for the Aytu BioScience Second Quarter Fiscal 2020 Business Update Call for the Quarter Ended December 31, 2019. 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 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 Aytu's 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 BioScience.Although management believes these statements are reasonable based on estimates, assumptions and projections as of today, February 13, 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'd now like to turn the call over to Aytu's CEO, Josh Disbrow. Sir, the floor is yours.

[Josh Disbrow:]

Thank you, Cynthia. Good afternoon, and thanks for joining our second quarter fiscal 2020 operational update call. This was perhaps our busiest and most productive quarter on record, during which we accomplished a tremendous amount to move forward with our corporate transformation. Also this quarter, we posted the highest revenue in our history, more than doubling our revenue sequentially to $3.2 million for the quarter. Additionally, we completed the Cerecor commercial portfolio asset purchase, and we filed the S-4 proxy statement for the Innovus Pharmaceuticals merger.We also kicked off two co-promotes on top of the Tuzistra co-promote that was announced shortly before the quarter began. Finally, just today, we received the required votes to approve the Innovus acquisition, and we now expect to close that acquisition very soon. With that acquisition soon to be complete, that takes our revenues to over $40 million on a pro forma basis, with planned revenue growth ahead on both the Rx and consumer health business.Without question, this has been the most productive and transformative period in our company's history, but we're still just getting started. As a final part of my introductory comments, I'll also share that the company has engaged a healthcare-focused investment bank to assist in securing non-dilutive financing. Further, on the equity side, we've received a funding commitment from a health care institutional fund with whom we're having active discussions.Now turning to the specifics around our performance. Again, I'm proud to say that we posted our highest revenue in the company's history with $3.2 million, 121% over last quarter and up 77% over the same quarter last year. Importantly, this revenue increase includes only two months of revenue from the recently acquired Cerecor commercial portfolio, given the time of that closing.Thus, in Q2, we had not yet realized the full benefit of the expanded portfolio. And of course, these numbers in no way account for any Innovus revenues, which we would begin recognizing as soon as we close that transaction. Starting with this current quarter, we'll begin to realize the benefit of booking a full quarter of revenue for the entire expanded Rx portfolio.From there, as we get products and people integrated, we expect growth of the Rx portfolio and are excited about sharing our Q3 revenue numbers. Across the product portfolio, we saw strong performance with several highlights to note. For the six-month period ending 12/31, ZolpiMist TRxs are up 38% from the preceding six-month period. And considering that the co-promotion agreement with Validus Pharmaceuticals just got underway in October, we're encouraged to see this uptick prior to their sales team starting to make a meaningful impact.Tuzistra prescriptions are up 75% when comparing December's Rxs to December of last year. The cough and cold season is more significant than last year, and our newly launched co-promotion with Poly Pharmaceuticals is beginning to yield promising early results. We're excited to be in our first full cough season of promotion with Tuzistra, and things are going well.Karbinal, our newly acquired liquid extended-release antihistamine also had an outstanding Q2. Karbinal Rxs grew 59% over the preceding quarter and 90% over the same quarter last year. With respect to Natesto, it was a successful quarter on multiple fronts. First, as we continue to transition physicians and patients to the new Natesto at home program, we're seeing good uptake through that program.Natesto at home refills have doubled since September and are up fourfold from the preceding quarter. We view the Natesto at home prescriptions as the most valuable prescriptions given that these scripts generate a higher refill rate when compared to retail Rxs, and we're seeing a nice uptick in refills through the program.Second, as it relates to Natesto, our revised partnership with Acerus got underway at the end of Q2. Acerus has launched their U.S. specialty force – sales force footprint and expects to expand their team in the coming quarters and will call on urologists and endocrinologists. Recall that the revised contract calls for their fielding of a 20-person specialty team, so this will substantially expand our Natesto promotional footprint.Importantly, just this week, Acerus announced an equity infusion of $18 million to accelerate the growth of Natesto in the U.S. We're excited about having this partnership now fully funded by them and fully operational. We congratulate Acerus for closing this financing and for launching their U.S. team.Earlier, I alluded to our co-promotions on both Tuzistra and ZolpiMist, and they're now underway with early signs of solid contribution from each co-promote partner. Poly's 30 reps are essentially doubling our promotional footprint with Tuzistra, and their contribution in the first few months of their promotion is noteworthy.Validus, again, our co-promotion partner selling ZolpiMist in psychiatry, has their team fielded, and the early returns are also promising. Psychiatrists represent 10% of sleep aid prescribing, so we expect a nice bump from this additional share of voice on ZolpiMist. Both partnerships are proving fruitful, yet we're just a few months in.I'll continue with my prepared comments following Dave’s commentary on our financial performance. So now I'll hand it over to Dave to cover the financials.

[Dave Green:]

Thank you, Josh, and thank you all for joining us. Today, I'll review our financial results for the second quarter of our 2020 fiscal year that ended December 31, 2019. Top line net revenue for Q2 was $3.2 million compared to $1.8 million in Q2 2019 and $1.4 million last quarter. The $3.2 million of net revenue represents a record high for Aytu and growth rates of 77% year-over-year and 121% sequentially.Year-to-date, 2020 net revenue was $4.6 million compared to $3.2 million for the same six-month period last year, a 44% year-over-year increase. Q2 net revenue benefited from two months of sales contribution from the product portfolio we acquired from Cerecor in November of 2019.Gross profit for Q2 2020 was $2.6 million compared to $1.3 million in Q2 2019 and approximately $1.1 million last quarter. Gross profit margin was approximately 81%, a substantial improvement over the 71% gross profit margin reported in Q2 of last year. Operating expenses, excluding cost of goods sold, were $7.5 million for Q2 this year, which was approximately $1.7 million greater than total operating expenses realized in Q2 last year, and $1.7 million greater than the operating expenses last quarter.The increase is due to both absorbing and integrating the former Cerecor commercial team and related transaction costs of approximately $1.2 million, offset by a reduction in force we completed in October, altogether representing a net cost of approximately $2.25 million. Therefore, on an adjusted basis, operating expenses were approximately $550,000 lower this quarter than both last quarter and the year ago quarter on an apples-for-apples basis.The operating loss for the quarter was $5 million compared to $4.7 million in Q1 2020 and $4.6 million in Q2 last year. By adjusting $1.2 million of transaction costs out of operating expense, the operating loss for the quarter would have been $3.8 million, smaller than both last quarter and the second quarter of last fiscal year.EBITDA loss was $3.8 million for Q2 of 2020 compared with $3.9 million last quarter and $3.8 million for Q2 last year. Again, removing the $1.2 million of transaction costs, our EBITDA loss would have been $2.6 million, again, lower than both last quarter and the year ago quarter. Our net loss was $0.2 million for Q2 2020 compared to $4.7 million in the year ago quarter and $4.9 million last quarter.The substantially lower net loss was largely driven by a $5.2 million noncash gain resulting from benefits arising from the restated agreement with Acerus for approximately $2.5 million in scheduled milestone payments, and an additional $35 million in potential future milestones were eliminated. EPS for Q2 were a loss of $0.01 per share compared to a loss of $0.72 per share in the year ago quarter and a loss of $0.32 per share last quarter.Turning to the balance sheet. Our total assets as of 12/31 were $74.5 million, more than double the $34.7 million reported at our last fiscal year-end in June 2019. The substantial increase is largely due to the recognition of the fair value of the acquired assets, including the associated goodwill. Other key items driven by the asset purchase include a higher AR balance, which reflects increased sales, and some changes to the administrative processes related to AR collections.Inventory and prepaid asset balances each increased due to the asset purchase, and a new asset, other current asset, was recognized for amounts owed to the company by third-parties for certain reimbursable operating costs. Our Q2 ending cash balance totaled $5.5 million. On the liability side, our accounts payable increased by approximately $7.3 million as a result of assuming $4.1 million of liabilities related to the asset acquisition, increased operating expense associated with absorbing the former Cerecor commercial team and transaction costs.Accrued liabilities increased approximately $1 million due primarily to the assumption of new royalty and other product-related fees tied to the asset purchase. Our long-term liabilities now include fixed payment obligations in the stated amount of approximately $26 million, which were assumed with the asset purchase. One portion of the fixed payment obligations matures in January of 2021, requiring a payment of approximately $15 million.So in summary, we have a much larger balance sheet as a result of the asset purchase and have assumed certain fixed liabilities and other obligations. Looking ahead, we expect top line growth to continue with the addition of the acquired product portfolio and the burn rate to decline as revenue grows and we shed overlapping costs that resulted from the asset purchase over the next two to three quarters.And with that, I’ll turn the call back over to Josh.

[Josh Disbrow:]

Thank you, Dave. Again, it was an extremely busy and transformational quarter, particularly on the corporate and also on the scientific development front. Natesto had a breakout quarter with respect to its clinical story. On October 17, the company announced positive results from the Natesto’s Spermatogenesis Study, which were presented at the Annual Meeting of the American Society for Reproductive Medicine. Dr. Ranjith Ramasamy, the study’s principal investigator and Director of Reproductive Urology at the University of Miami, presented that over the course of a six-month treatment period with Natesto, hypogonadal men increased their serum testosterone levels while maintaining normal sperm concentration, sperm motility and total motile sperm count.This data readout convincingly separates Natesto from other low T treatments in that men maintain their fertility while taking Natesto, something no other testosterone-replacement therapy has demonstrated. We’re excited about getting these data into the scientific domain, and following that, we’ll look to begin discussions on potential label modification for Natesto. We’ll work in concert with our partners at Acerus to move that initiative forward.Now on to our corporate transformation. In Q2, again, we closed that Cerecor asset purchase of the commercial Rx portfolio. This commercial portfolio generated $12.7 million in revenue for the 12 months ended 12/31 and consists of five novel and differentiated therapeutics.Following the asset purchase, we moved immediately to bring over much of the former Cerecor commercial group and their leader, Matt Phillips. In conjunction with that move, we rationalized multiple low-performing or overlapping legacy sales territories and kept the highest performers across both legacy organizations.With the acquisition of the commercial portfolio, we’ve increased Rx portfolio revenues to $20 million on an annual basis, and we believe more growth is in store. The sales teams have come together as one, as we’ve just concluded our first national sales meeting a few weeks ago. At that meeting, we conducted extensive cross-training on Natesto, such that all former Cerecor reps are now out there promoting Natesto alongside the Aytu legacy reps. We’ll continue to evaluate and implement cross-selling opportunities across the product line and put the best resources to work to grow our portfolio.Now on to the most recent component of our transformation, the pending acquisition of Innovus. Just this morning, both companies held their special shareholder meetings, during which the merger was approved. With this approval, we expect to close the transaction in short order. This acquisition will complete the Aytu transformation and would take annual revenues to over $40 million across both business segments.The plan is now to integrate the elements that make sense, eliminate the unnecessary or redundant expenses and functions and grow both the Rx and consumer health products. By growing the top line across both portfolios, we expect to substantially accelerate our path to breakeven and to increase shareholder value. So today is an exciting day for the company, and we’re ready to get to work growing the newly transformed Aytu BioScience once we close the Innovus transaction.An important aspect of gaining this new revenue scale is that we believe we are well positioned now to secure non-dilutive financing, enough to pay off the previously described Deerfield note and to provide working capital for the combined entity. We’re engaged with a healthcare-focused investment bank to help secure this financing, and the process is underway. We also have secured funding commitments on the equity side to complement that debt as needed.So in closing, Q2 was a productive, transformative quarter. We’re poised now to operate the newly expanded Rx business, and upon closing, the combined Rx and consumer healthcare business. We will integrate the best from each, and we’re actively rationalizing the redundant and unnecessary expenses. All of this expense savings, we expect, will be rationalized over several quarters. We now have products and the infrastructure and the people in place and have a clear line of sight to profitability.So with our prepared comments complete, we’ll take some time and open it up for questions. Cynthia, please prepare the lines.

[Operator:]

Thank you. The floor is now open for questions. [Operator Instructions] Our first question comes from Carl Byrnes of Northland Securities. Please state your question.

[Carl Byrnes:]

Great. Congratulations. My first question is, obviously, with the favorable vote today and your comment that you anticipate closing the Innovus transaction imminently, would you – is it safe to assume that, that might be in the next week, two weeks? What sort of brackets can you put around that? And then an additional question relating to cash burn. What would you anticipate going forward in the next six months and 12 months relative to your cash needs? Thanks.

[Josh Disbrow:]

Hi, Carl. Thanks for your question. So yes, we would suggest that it’s certainly within the next week or so. We’re very close, and so we’ll update everyone accordingly, but feel very comfortable with where we are with respect to the transactional process. Obviously, final details to be sort of ticked and tied, but we’re in very good spot to get the Innovus acquisition closed in very short order.With respect to cash need, as I said, we’re – and as David said, where we cut the burn and when you look at it on a true apples-to-apples basis, as Dave very well described, so we’re very comfortable that the burn will continue to come down, particularly as we get on the other side of these deal costs. As I also mentioned, we – so we do have a clear line of sight to profitability, not guiding specifically to when that will be, but increasingly clear view of really when that is.And importantly, I think it’s good for people to know that we have engaged an investment bank on the debt side and begun that process. Again, given this revenue scale, particularly when we get to the other side of the Innovus merger, obviously, that provides a really nice basis for lenders to come in. And suffice it to say, we’re pleased with the interactions we’re having.So that’s what I would say with respect to cash and cash needs. We’ll, obviously, make an attempt and feel good about the non-dilutive aspect of that and would only bring in equity sort of as needed, and obviously, it would be kind of a complement to any debt that come in.

[Carl Byrnes:]

Great, thank you.

[Josh Disbrow:]

Thank you.

[Operator:]

Our next question comes from Jeffrey Cohen of Ladenburg Thalmann. Please state your question.

[Jeffrey Cohen:]

Hi, it’s Jeff Cohen. How are you? Couple of quick questions. Could you talk about the feedback as far as what we know thus far as far as Acerus in the co-promote?

[Josh Disbrow:]

Yes. Good question, Jeff. I’ll, obviously, rely on our partners to the north there at Acerus to give specifics on their next earnings call and as they have the opportunity to engage with investors. But what I’ll say is they’ve obviously started the process and are now fully underway. As we previously announced, we enabled them to get started earlier with an initial subset of representatives that had been selling Natesto that are now really working exclusively for Acerus and will be transitioned over to them. They’re in some nice territories, some productive, very large territories in the Northeast.So that’s where, obviously, the footprint started. They just announced very recently, just this week, that they have secured a significant amount of funding in the form of $18 million in equity that will obviously kick them into high gear with respect to building out the footprint. So they haven’t given specifics publicly, so I’d like to not speak about the exact planned time line other than to say it is now in full gear, full sprint, if you will, and certainly ready to scale. So I think that’s probably sufficient so as not to tread on anything that they want to be kept privately, just on the basis of what they’ll share with investors.

[Jeffrey Cohen:]

Okay. Got it. And could you talk about some of the key territories which you’re targeting by your co-promotions for Tuzistra and ZolpiMist?

[Josh Disbrow:]

ZolpiMist, again, it’s psychiatry. And in terms of key territories, it’s really – it’s less than – a little less than a dozen key geographies in terms of where they cover. So it’s the large metropolitan areas, primarily in the Northeast, Mid-Atlantic, Southeast over to Texas. So fairly substantial areas from DFW sort of eastward and upward. With respect to Poly Pharmaceuticals, Poly’s footprint is largely in the Southeastern U.S.So really starting in Tennessee and kind of moving southward, and then westward to Texas. Got a very large footprint in Texas, Louisiana and Mississippi. So they’re in what I often refer to as the cough, cold belt. Very entrenched in those markets and very, very extensive experience in calling on high prescribers of antitussives and antihistamines. So they are in some areas where we are. And so we have very diligently carved out targets that are exclusive to Poly, and we’ve retained, obviously, high prescribers as well.And so we’ve sort of partitioned off various offices, such that those are off limits to one party or the other. So we’re not tripping over each other, and we’re truly maximizing the footprint. So – and again, we’re more than doubling – essentially doubling the footprint from our organic or in-house reps to what they have, and they’ve got about 30 reps to our 30-ish or so. So yes, that’s their geographies.

[Jeffrey Cohen:]

Okay. Perfect. And then one more, if I may. Dave, any look into as far as once everything gets tucked in on Innovus on ramifications to your gross margins, I mean you’ve got pretty healthy gross margins out. Do you expect a little bump more north or south or kind of where we’re expecting?

[Dave Green:]

Well, we got a nice bump this quarter, which is reflective of the Cerecor assets coming on. Innovus gross profit margins are probably not quite as strong as what we realized in the Rx business. So the blend of those will still – will probably be in the range of where we’ve been in the 75% – 70%, 75% range. We hit 80% or a little north of that this quarter, which was nice. But Innovus brings quite a bit of revenue. A little bit lower gross profit margin, but altogether blended, we shouldn’t be too much different from where we’ve been in the past.

[Jeffrey Cohen:]

Okay. Got it. That’s it for me. Good news. Thanks, again.

[Dave Green:]

Thank you.

[Josh Disbrow:]

Thank you, Jeff.

[Operator:]

And gentlemen, there appear to be no further questions at this time. Mr. Disbrow, I will turn the conference back over to you for any closing comments.

[Josh Disbrow:]

Thank you, Cynthia. Thanks, again, for the questions, and thanks to everyone for joining our call today. We appreciate your interest. We’re excited about the future with the company and where we’re moving forward. Look forward to sharing more on our next quarterly call. So with that, I’ll say thanks again, and have a good evening.

[Operator:]

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