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Aytu BioPharma, Inc. (AYTU)

Q4 2021 Earnings Call· Mon, Sep 27, 2021

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Transcript

Operator

Operator

Good afternoon and thank you for joining us for the Aytu Biopharma Fourth Quarter and Full-Year Fiscal 2021 Financial Results Call. With me this afternoon are Aytu's Chairman and Chief Executive Officer, Josh Disbrow; and Chief Financial Officer, Richard Eisenstadt. Aytu Biopharma issued a press release earlier today with the details of the company's operational and financial results for the fiscal fourth quarter and full-year 2021. 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 Biopharma. Although management believes these statements are reasonable based on estimates, assumptions and projections as of today, September 27, 2021, 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 obligations to update or revise any of these forward-looking statements. I would now like to turn the call over to Aytu's CEO, Josh Disbrow. Sir, the floor is yours.

Josh Disbrow

Management

Thank you, Taryn. Good afternoon everyone and thanks for joining us today. Over the past year and a half we embarked on a transformational journey to become a premier pediatric focused, specialty pharmaceutical company. We successfully executed on several key milestones which I look forward to discussing in more detail on this call. We are excited about how Aytu Biopharma is positioned today, as we implement our growth plans and seek to drive future value with our growing prescription portfolios, our resized and integrated commercial infrastructure, our growing consumer health subsidiary, and an exciting late-stage therapeutics pipeline. We have the products, the people, and the pipeline in place and we're prepared to execute. We are now operating as a fully integrated company following our merger with Neos Therapeutics which closed just five months ago, as well as an additional three transactions, including the purchase of our pipeline asset, AR101 from Rumpus Therapeutics. Through both these strategic acquisitions and organic product growth, we have posted 138% year-over-year revenue growth and we're now on a $90 million pro forma revenue run rate. Rich will discuss the financials in more detail shortly, but I wanted to quickly touch on revenues and our cash position before turning to a review of our commercial business and product pipeline. This quarter we posted revenue of $23.5 million, an all-time high for Aytu, up from $13.5 million last quarter and $14.9 million in the same quarter of last year. Included with this revenue number, our consumer health division posted another all-time high revenue quarter of $8.9 million. Our revenue growth was primarily driven by the addition of the Neos Rx portfolio and the growth of our consumer health segment through our e-commerce and direct-to-consumer channels and new product introductions. We ended the quarter with approximately $50 million…

Richard Eisenstadt

Management

Yes, thank you Josh and thanks everybody for joining us tonight. Net revenue for the full fiscal year ended June 30, 2021was $65.6 million compared to $27.6 million reported for the year ended June 30, 2020. Net revenue for the fourth quarter was at an all-time high of $23.5 million compared to $13.5 million reported last quarter and $14.9 million in the same quarter last year. Net revenue from the consumer health division as Josh mentioned was an all-time high of $8.9 million, up from $6.9 million in the same quarter last year. Consumer health growth was driven by multiple product launches and growth of the e-commerce channel. Net revenue from prescription division was $14.6 million as compared to $7.9 million in the same quarter last year. The fourth quarter was the first quarter that results reflected a full three months of revenue from the products we acquired in the Neos acquisition, including $10.6 million of ADHD net revenue. Gross margin for the three months ended June 30, 2021 was $11.3 million versus $10 million in the same quarter one year ago. Gross margin was negatively impacted by $2.1 million increase in cost of goods sold for the ADHD products resulting from the full absorption of increased inventory cost at fair value at the Neos therapeutics acquisition date resulting in zero margin for those products in the fourth quarter of fiscal 2021. Our reported gross margin percentage for the quarter of 48%would have been a pro forma 57% if the ADHD products had been costed out of manufacturing cost. The write up in inventory values will not affect the financial statements in future periods. Research and development expense was $4.8 million for the three months ended June 30, 2021, approximately $1.5 million -- versus $1.5 million from one year ago.…

Josh Disbrow

Management

Thank you, Rich. As you can see, we've made significant headway toward value creation as a newly transformed pediatric focused specialty pharmaceutical company. Going forward we are committed to focusing on our integrated and streamlined core Rx business supported by our consumer health business and building our pipeline led by AR101 and Healight. Performance across our core Rx products been solid. Adzenys has grown 25% year-over-year, Contempla has grown 18% year-over-year and the ADHD market continued to grow even through the COVID pandemic, demonstrating the strength of this market. Our prescription multivitamin line has experienced tremendous growth these last five quarters posting nearly 50% TRx growth year-over-year. This growth and the growth of our core brands can largely be attributed to our consistent field efforts, market growth, as well as the growing strength of our pharmacy network in patient access program Aytu RxConnect. We expect to continue to expand RxConnect to maximize Rx portfolio pharmacy pull through and grow these core products. We also anticipate multiple new product launches in the consumer health segment in the first half calendar 2022 and to drive organic product growth through the e-commerce and direct-to-consumer channels. As we continue on our trajectory we expect to continue to identify and potentially bring in accretive complementary products to add into RxConnect while also considering late-stage pipeline opportunities and further develop our pipeline. For AR101 we are seeking Orphan Drug Designation and IND acceptance from the FDA and we expect to get PREVEnt trial started in the first half of calendar year 2022. For Healight, we expect to initiate or study in Spain shortly with topline data in the first half also of calendar ‘22. We look forward to updating you on our progress. I'll now turn it back over to the operator Taryn for Q&A. Taryn?

Operator

Operator

Thank you. The floor is now open for questions. [Operator Instructions] We'll take our first question from Jennifer Kim with Cantor Fitzgerald. Please go ahead.

Jennifer Kim

Analyst

Hi, thanks so much for taking my questions. I've a couple here. Maybe to start off on the ADHD revenues for the quarter, I think you said that this quarter it was around $10.6 million. Is there any colour you can give so far on back-to-school season trends you’ve in the coming quarter and how you think...?

Josh Disbrow

Management

I'm sorry Jennifer, we lost you...

Jennifer Kim

Analyst

Oh, can you hear me?

Josh Disbrow

Management

We lost just the back half of the question. You got cut off after back-to-school and any colour and then you kind of faded out.

Jennifer Kim

Analyst

Oh yes, any colour you can give on the back-to-school season trends so far? And I have a couple more questions, but I'll wait until -- after your respond.

Josh Disbrow

Management

I'm happy to take that and Richard if you want to jump in, I can say we're certainly, we're trending according to our plan, generally speaking, certainly understanding that the market really starts to pick back up about this time of the year. So certainly, the market is beginning to move in the direction you'd expect and we're happy with the progress. We don't guide to any specific numbers and other than to say we’re on generally speaking where we expected to be. Obviously, revenues are ultimately what really matters and that continues to be monitored on a week-by-week, day-by-day and certainly quarter-by-quarter basis. And what I mean by that is our gross to nets continue to fluctuate. They do certainly have some pressure. That having been said, we’re working every day to make sure that we can buoy those gross to nets to improve the revenue for prescription, but all in all we're happy with the script trends in the market and with our brands. Rich, anything you'd add to that?

Richard Eisenstadt

Management

Yes, the only thing I'll add, Jennifer is probably ADHD is seasonal, and the worst month of the year is generally July. So, your quarter-over-quarter, it's even though we're seeing a really nice rebound with the back-to-school, it tends not to when compared to the previous quarter, it's not necessarily a step up from that previous quarter.

Jennifer Kim

Analyst

Okay, that's helpful. And then on the non-ADHD Rx portfolio, I think you said so, so it was 400k came from the COVID test kits and is the run rate for those Rx products, are we sort of, taking out that 400k? Is that sort of the base we should be going off of?

Josh Disbrow

Management

Yes, go ahead Rich. Go ahead.

Richard Eisenstadt

Management

Yes, go on, Josh.

Josh Disbrow

Management

I think generally, again we don't guide from a revenue perspective, but obviously, we took out the Natesto revenue, we took out MiOXSYS and now then you can essentially consider as you said, test kits to be removed. So really, focus on the other prescription products with an eye towards Poly-Vi-Flor and Karbinal, Tri-Vi-Flor and to some degree test Tuzistra. And so generally speaking, it's probably a decent base to work off of understanding that those products just got added into the RxConnect platform and so we do expect growth from this baseline.

Richard Eisenstadt

Management

Yes, the one thing I'll add Jennifer is the $750,000 quarterly we get from the test, it doesn't show in the revenue line, it's below the line. So, we continue -- that drops straight to the bottom line, but it doesn't show up on the revenue line. So that's one of the reasons we adjusted our guidance to our actual annualized run rate.

Jennifer Kim

Analyst

Okay, and then I have a two parter, I think you talked about the normalized cash burn, what is your normalized cash burn again, barring the onetime adjustments we've seen? And then do you have an idea on when you would expect it to get to that normalized cash burn?

Richard Eisenstadt

Management

Yes, so in the quarter our normalized cash burn was $3.2 million. So again, that was backing out the deal costs associated with Neos and the Rumpus acquisitions Jennifer. So we backed out the deal fees, and there was some lagging severance and all the deal costs associated with the Neos deal which was at the end of March that leaked over into our quarter reflective of cash flow. I think this current quarter, so the third calendar quarter, first fiscal quarter of 2022 should be a pretty normalized quarter as far as all the operating results as far as cash and expenses as well, so there's nothing unusual that we're forecasting in there.

Jennifer Kim

Analyst

Okay, great. And then my last question, sorry. With your current cash runway, I think you said that you have sufficient cash to get to operating breakeven. Could you remind us of what, I guess what goes into those numbers and what your assumptions are in terms of getting to breakeven?

Richard Eisenstadt

Management

Yes, so we don't guide as far as when we're expecting breakeven, Jennifer, but the operating line is just the operating expenses. So, it's the gross margin minus the G&A, R&D and sales and marketing costs. So, we don't go below the line on that into the debt expense. Of course, I think that we do have a debt payment that is due in May 2022. We've been exploring opportunities to refinance that and there has been a lot of interest and we don't have anything to announce today regarding that.

Jennifer Kim

Analyst

Okay. That's super helpful. That's it from me guys. Thanks again.

Josh Disbrow

Management

Thank you, Jennifer.

Operator

Operator

We'll take our next question from Vernon Bernardino with H.C. Wainwright. Please go ahead.

Vernon Bernardino

Analyst · H.C. Wainwright. Please go ahead.

Hi, guys. Congrats on the progress and especially the nice results in the pediatric portfolio. Regarding the pediatric portfolio, just wondering, the products are doing well, ADHD. What can you say as far as what's driving the growth in the market or is it what you were thinking of specifically in your comments is just your product portfolios growth in the ADHD market?

Josh Disbrow

Management

Yes, thank you Vernon. I'll start this and then Rich can fill in. Generally speaking, you know, we are seeing growth across the portfolio, as I mentioned, and it's largely a consequence of sales force efforts out in the field, the market growth, particularly with respect to the ADHD market, which has really shown nice rebound. And while the pediatric segment has been slower to recover, both the pediatric and the adult segment are showing nice growth and bounce from COVID era level, so that's certainly helped driving things. And then what I'm most excited about as I know, Rich is RxConnect as we get these products fully integrated onto the RxConnect platform that's helping to drive significant prescription volume. And we've got lot of plans with respect to how to further improve RxConnect, how to get additional pharmacies on board and how to make sure that we're maximizing pull through across the portfolio to maximize obviously not just revenue per prescription, but refills and ultimately continuing just to pull more of that through, so it's a great tool for the team. Certainly the sales force is excited to have it expanded to now have the entire portfolio in tow. And so I think really those, those are the key factors that are driving the most growth. And all of these markets, particularly the ADHD market really set up for continuing growth. As the world starts to normalize, adults getting back to work, kids getting back into the classroom, we expect to see that market continue to grow. And there's the remains of significant unmet needs, these products, Adzenys and Cotempla are the only orally disintegrating tablets, certainly have found a nice position in the marketplace. So as the market grows, we certainly think we'll continue to be able to maintain and potentially grow share and grow those products. So, I think that's what's really driving most of the growth.

Vernon Bernardino

Analyst · H.C. Wainwright. Please go ahead.

Would you say then RxConnect is the biggest driver or is it a mix of that and products differentiation?

Josh Disbrow

Management

I'd give it sort of top billing for both really sales force execution and driving through prescriptions, at the end of the day physician demand is what will drive a lot of this. But you really can't have one without the other. You've got to have the hand in glove of physician demand coupled with good pharmacy access and so I think they both work well together. And now that we've got the sales team right sized it's a good size sales force with 40 folks on the CNS side and 10 that are very focused and very directed on the pediatric side. They're in the right places where they need to be. We've really gotten ourselves geographically in the right spots, and I think are working now to optimize the mix of prescriptions with respect to what flows into RxConnect and ultimately to enable the greatest pull through there. So I'd say it's a combination of those two key factors and presuming the market continues to grow at the rate that it will, that will just, I think, serve as a baseline buoy to continue to bring sales up as we move forward.

Vernon Bernardino

Analyst · H.C. Wainwright. Please go ahead.

And as a follow up, I was wondering if you could tell me what kind of expectation do you have as far as the timeline for completion of the Healight study in Spain?

Josh Disbrow

Management

Yes, we haven't given specific timeline on that other than to say we expect to read out the results in the first calendar half of 2022 Vernon. So are working feverishly to get that study set up and underway and certainly expect to be in a position to share that news as it's up and running and as patients get enrolled. But generally speaking, what we've said is first half of calendar 2022.

Vernon Bernardino

Analyst · H.C. Wainwright. Please go ahead.

Okay, thanks. I'll follow up another time with gross margin questions, I'm probably too involved here. Thank you for taking my questions.

Richard Eisenstadt

Management

Thanks, Vernon.

Josh Disbrow

Management

Thanks very much.

Operator

Operator

That's all the questions we have at this time.

Josh Disbrow

Management

Great, thanks very much. Thank you, Taryn. Thanks to everyone for joining us today. So that will conclude our call. We look forward to providing our Q1 fiscal 2022 update coming up here in November. Thanks very much.

Operator

Operator

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