Q1 2026 AYTU BioPharma Inc Earnings Call
Speaker #1: Greetings. Welcome to the AYTU BIOPHARMA fiscal 2026 this time, all participants are in a listen-only mode. A Q1 earnings call. At formal presentation. If anyone should require operator press star zero on your telephone keypad.
Speaker #1: Please note this conference is being recorded. I will now turn the conference over to your host, assistance during the conference, please Robert Blum, with Investor Relations.
Speaker #1: You may begin.
Speaker #2: everyone. As the operator indicated Thank you very much. And good afternoon, All right. during today's call, we will be discussing AYTU BIOPHARMA's fiscal 2026 first quarter operational and financial results.
Speaker #2: For the period 2025, joining us on today's call is AYTU's Chief Executive Officer, Joshua Disbrow, Chief Financial Officer. At the conclusion of today's prepared remarks, we'll open the call for a question-and-answer session.
Speaker #2: I'd like to remind everyone that today's replay of today's call will be available by call is being recorded. A using the telephone numbers and conference ID provided in the press release issued and Ryan Selhorn, the company's utilizing the link on the company's website under events and presentations.
Speaker #2: Finally, customary safe harbor disclosure information. The conference call today will regarding forward-looking contain certain forward-looking statements including statements regarding the goals, strategies, beliefs, expectations, and future potential operating results of AYTU BIOPHARMA.
Speaker #2: Although management believes these statements are assumptions and projections as of today, these statements are not guarantees of Time-sensitive information may no longer be accurate at future performance.
Speaker #2: the time of any telephonic or webcast materially as a result of replay. Actual results may differ risks, uncertainties, and other to the factors set forth in factors including but not limited the company's filings with the reasonable based on estimates SEC.
Speaker #2: obligation to update or revise any of these forward-looking statements. With that said, let me turn the call over AYTU undertakes no Josh, please proceed.
Speaker #3: Everyone, I'm excited to be speaking with you on the heels of a very positive and highly productive first quarter. Let's jump into the high-level highlights. Thank you, Robert, and welcome.
Speaker #3: First off, net revenue for the quarter was $13.9 million. This was above our expectations as our ADHD portfolio has really continued to perform well.
Speaker #3: First off, net revenue for the quarter was $13.9 million. This was above our expectations as our ADHD portfolio has really continued
Speaker #3: perhaps had expected a pullback in revenue was essentially up 10% ADHD sales, due to the threat of a generic launch and our shifting focus to Officer of AYTU BIOPHARMA.
Speaker #3: ex you a launch preparations, we are actually experiencing net revenue growth. This is quite impressive and really the added stickiness and positive economic benefits that are inherent in our reinforces our long-held belief on remind you approximately 85% of our branded ADHD prescriptions are dispensed.
Speaker #3: I'll dive into this more in a moment. But occur by the end of calendar first, and perhaps even more important, is that the '25.
Speaker #3: to ensure success, including With significant advancements being made KOL engagement, Salesforce training, product positioning, messaging, ex you a launch remains on track to payer assessments, and integration, within RxConnect.
Speaker #3: We continue to believe ex you a is a game-changing opportunity for AYTU, and the past few months have Let's dive into our AYTU, excuse me, let's dive into our ex you a launch campaign development, and pricing, execution initiatives in more detail.
Speaker #3: really reinforced that belief. manufacturing, labeling, third-party logistics provider with the initial serialization, and shipment to the company's First off, we're finalizing product December of '25.
Speaker #3: shipments on track for delivery in launch and it remains on In many ways, track. training and have our formal launch meeting scheduled to We are nearing completion of Salesforce That said, leading up to the launch meeting, our reps are and will continue to be in the field talking with and preparing physicians and setting up appointments, etc., with the full Salesforce take place in January of '26.
Speaker #3: Launching product stocking, following launch stocking and the launch positioning, preparation of the promotional campaign, and meeting. The product, inclusive of promotional materials, refinement of physician messaging, is nearing completion.
Speaker #3: We are development of patient support materials is also implementing a comprehensive promotional program whereby we're establishing a clear positioning for ex you a based on its attributes, the competitive landscape, and ultimately where we believe we can win with the product.
Speaker #3: We have completed refinement of the sales territory alignments with physician targeting also essentially complete. We are maintaining a Salesforce of approximately 40 people, the same as what we have had historically with ADHD, but have altered some territories to ensure maximum reach while also aligning with where market access is expected to be strongest and prescribing potential is expected to be the highest.
Speaker #3: Nearly universal coverage is a condition that is federally mandated. Remember, for class whereby MDD prescriptions must be covered. This government segment represents approximately 30% to 40% of MDD covered lives, depending on the geography.
Speaker #3: So with 40, the 30 to 40% of the antidepressant category covered by virtue of this protected status, we are aligning sales territories appropriately to ensure optimal patient access with respect to both government and commercial payers.
Speaker #3: Further to that point, we've also established product pricing that is in line with or at a treatments. We are also finalizing integration of ex you a into our AYTU RxConnect patient access platform.
Speaker #3: premium to other unique psychiatric We expect to drive distribution through and dispensing from our RxConnect network pharmacies as we do now with our ADHD portfolio.
Speaker #3: This will enable us to gain strong insights on reimbursement and coverage rates to help guide selective and smart payer contracting, which we will consider as the underway.
Speaker #3: prescribers of ex you a as it relates to help ensure minimal friction with new coverage and the typical barriers they face when prescribing new ramp-up in our key opinion leader engagement.
Speaker #3: brands. And the final key launch activity has been the Employing RxConnect will also Ex you a has a long history of peer-reviewed publications, and that was added to recently by product launch gets yet another peer-reviewed article discussing Jepperone and the class of 5-HT1 agonists.
Speaker #3: Further, we recently attended our first medical Institute Fall Conference in Colorado Springs. The response to ex you a was vice president of scientific affairs, Dr. Gerwin Westfield, we will continue to be proactive in our conference, the Neuroscience Education broader education of ex you a to the medical community and engagement with the scientific tremendous.
Speaker #3: community. successful in getting the ex you a method of use Led by our senior patent for ex you a's extended Finally, as most of you likely saw, we were to September of 2030.
Speaker #3: The patent extension further expands upon the new chemical entity exclusivity period. Beyond the 2030 date, we are engaged in discussions to expand upon the existing potential lifecycle management approaches which might extend exclusivity beyond 2030.
Speaker #3: This is all to say, we are laser-focused on the successful commercial launch of ex you a as we focus on positively impacting the lives of estimated 21 million Americans with major depressive disorder.
Speaker #3: Our entire team is beyond thrilled as we collectively believe ex you a is quite simply transformational for AYTU. Turning back quickly to the ADHD portfolio, as most of you know, there has been a long since negotiated paragraph four settlement agreement with TEVA whereby they were allowed to enter the market with a generic to Adzenis back on September the 1st.
Speaker #3: 13th, more than two months after they were As we eligible to have entered, they have yet to launch. We talked about this during our last earnings call, but to quickly impact to our ADHD franchise, even if TEVA does enter, will not be as significant as you might see with other sit here today on November products sold via traditional retail are multifold, but include one, the fact that again, distribution.
Speaker #3: prescriptions run through our RxConnect platform, not through regular way retail approximately 85% of our ADHD like CVS or Walgreens. generics might try to compete on pricing and spread.
Speaker #3: This system is quite unique and The reasons for this Two, switching. Opportunities have existed for many years to prescribe and fill highly genericized market with minimal dramatically alters the normal way in which share of the market for multiple XR, yet we've held a consistent years.
Speaker #3: Third, the gross to below what industry observers might expect when generics typically enter the market. Price erosion has already largely occurred by nets on our ADHD portfolio are already virtue of the fact that we discount alternatives like generic Adderall significantly to overcome patient pricing objections in a highly genericized market.
Speaker #3: This is to say that the substitution impact and transition to a the ADHD category is already a generic price market and subsequently to a generic price is not nearly as high as you might see in other situations.
Speaker #3: fourth, we launched our own authorized generic of Adzenis on September the 2nd. This AG will serve as an important offensive tool in what we believe will help us maintain a material share of And the Adzenis market irrespective of a potential generic entry by having a truly equivalent version of a product available that is sold as a generic.
Speaker #3: And importantly, our AG is already off to a very good start representing a significant share of the prescriptions after just two months on the market.
Speaker #3: We know it's still early, but we'll continue to believe that anyone's projections of a worst-case scenario for broader impact or ADHD franchise are unlikely, but clearly we will continue to monitor things.
Speaker #3: One more quick note before I turn it over to Ryan to review the financials in more detail. As some of you may have seen, on October 31st, the FDA put out a communication regarding their position on fluoride-containing drugs and some potential regulatory action.
Speaker #3: This has been anticipated for some time, and we've communicated this to you during past calls. We continue to monitor the situation, but note importantly that AYTU has not received any direct communication from the agency seeking action on our fluoride products.
Speaker #3: Even in the event FDA ultimately pursues any action, it's important to note that this is a very small portion today of our overall business.
Speaker #3: During the quarter, fluoride products amounted to only about 300,000 dollars in revenue. And importantly, our infant drops product line represents only approximately 1.4 million dollars when looking at the trailing 12-month period ending September 30th.
Speaker #3: So any potential impact will not have a sizable impact on our financials given that any agency action would likely center only on the fluoride liquid drops for the youngest patients.
Speaker #3: Also importantly, following the FDA's October 31st communications on fluoride supplementation, the American Dental Association issued yet another press release that clearly supports supplementation and the association doubled down on continuing their recommendation to continue with fluoride supplementation in areas where fluoridated water either doesn't exist or has inadequate levels of fluoride.
Speaker #3: Again, we'll continue to monitor the situation. With that, let me turn the call over to Ryan to go into more detail on the financials. I'll then make a few closing comments and look to address any questions you might have.
Speaker #3: Ryan?
Speaker #2: Thank
Speaker #2: you, Josh. Let's jump right into it. Let's start on the revenue line. Net revenue for the quarter was 13.9 million, compared to 16.6 million for the prior year.
Speaker #2: As mentioned in the press release, the year-ago quarter included a one-time benefit due to an accrued rebate liability settlement related to the ADHD portfolio of 3.3 million, which resulted in an increase in the Q1 fiscal 2025 net revenue of 3.3 million.
Speaker #2: We highlighted this item last year as well. Excluding the rebate on an apples-to-apples basis, net revenue would have actually increased 5% compared to the year-ago quarter.
Speaker #2: Breaking net revenue down, the ADHD portfolio net revenue was 13.2 million, compared to 15.3 million in the prior year period. Excluding the rebate, the year-ago quarter would have been 11.9 million, highlighting net revenue increasing for our ADHD portfolio of about 10% on an equivalent basis.
Speaker #2: The increase is attributable partially to product price increases during the past year and improved gross-to-nets, offset by a decrease in total prescriptions.
Speaker #2: The pediatric portfolio was 0.7 million for the first quarter compared to 1.3 million last year. The change in net revenue is attributable to manufacturing delays with one of our suppliers, which we are in the process of being resolved, as well as multivitamin product returns and a broader de-emphasis in marketing toward the pediatric portfolio in anticipation of the recent actions by the administration and the FDA.
Speaker #2: Gross margin was 66% during the quarter, compared to 72% last year. Again, the rebate here flowed entirely through the gross profit line as well, so on an equivalent basis, gross margin during the year-ago period would have been 65%.
Speaker #2: So we actually saw gross margin improvement from the year-ago period when excluding the rebate. Turning to OPEX, operating expenses excluding amortization of intangible assets and restructuring costs was 10.2 million in the first quarter compared to 11.2 million in the prior year period.
Speaker #2: This $10.2 million figure also includes about $100,000 in depreciation and stock compensation, so the cash OPEX number is about $10.1 million. The decrease is primarily a result of continued cost reduction efforts and improved operational efficiencies as part of the company's overall strategic realignment, offset by increased exo launch investments.
Speaker #2: When you look at the modeling of expenses going forward, we anticipate that our baseline total operating expense level, inclusive of amortization and depreciation, will remain at about that 10 million dollar per quarter.
Speaker #2: Then, added to that, we will have an incremental investment of about 10 million dollars on the launch of exo this fiscal year. So all in, that is about a 50 million dollar OPEX number for the fiscal 2026.
Speaker #2: Importantly, of the 10 million dollars of exo investment this year, about 6 million dollars of that is sort of one-time items such as training development, commercial and medical affairs consultants, and campaign and marketing materials development.
Speaker #2: The bulk of this spend will be in our December and March ending quarters from a one-time perspective. Going forward, we will certainly adjust our spend as the ramp of exo continues, but think of our exiting the fiscal year at about 11.4 million dollar quarterly normalized run rate with about half a million of that in non-cash expenses.
Speaker #2: Assuming gross margins in this mid to high 60% range, that puts our break-even at about 17.3 million of net revenue per quarter all in, including exo spends.
Speaker #2: Cash break-even would be 16.6 million per quarter. For the quarter, we reported a net income of 2 million dollars or 21 cents net income per share basic, compared to net income of 1.5 million or 24 cents net income per share basic in the prior year period.
Speaker #2: The fiscal 2026 and fiscal 2025 first quarter results were impacted by derivative warrant liability gains of 3.8 million and 2.9 million respectively, primarily due to a change in the company's stock price, and as mentioned earlier, the prior year first quarter benefited by 3.3 million due to the rebate liability adjustment, which directly increased net income.
Speaker #2: I'll touch on the warrant liability in a moment, but this is largely due to the pre-funded warrants issued in the exo transaction. Finally, adjusted EBITDA was a negative 0.6 million for the first quarter of fiscal 2026 compared to a positive 1.9 million in the year-ago period.
Speaker #2: The change primarily relates to the benefit we received in the year-ago period from the rebate, as well as Exo launch investments, which took place in the first quarter of this year.
Speaker #2: Now turning to the balance sheet. Cash and cash equivalents were 32.6 million at September 30th, 2025. This compares to 31 million at June 30th of 2025.
Speaker #2: A couple of other small notes on the balance sheet. We continued to pay down some higher interest liabilities during the quarter, namely the TRIST fixed payment arrangement.
Speaker #2: You will see that the other current liabilities line went from 3.4 million in June to 0.2 million this quarter. This has resulted in a substantial decrease in interest expense from 1 million dollars in the prior year quarter to half a million dollars in the current year quarter.
Speaker #2: While we don't anticipate half a million of savings each quarter, we should see continued savings throughout the fiscal 2026. The rest of the balance sheet is pretty much in line with where the quarter where it was last quarter.
Speaker #2: Circling back to my comment on the derivative warrant liability gain, as you may recall, the financing transaction we completed in connection with the exo acquisition was basically a straight common stock deal, but it did have pre-funded warrants issued due to ownership percentage blockers.
Speaker #2: This does cause gyrations to the income statement based on the movement of our stock price, which creates gains or losses to the derivative warrant liabilities line each quarter.
Speaker #2: On the balance sheet, those warrants are treated as liability until they are converted to common shares, at which time they will move to additional paid-in capital.
Speaker #2: During the quarter, there were 935,000 pre-funded warrants exercised, which effectively added 2.1 million dollars to AYTU. As we sit today, there are 10.2 million common shares outstanding, plus an additional 9.4 million pre-funded warrants outstanding, which effectively puts us at a 19.6 million shares outstanding.
Speaker #2: Before I turn it back over to Josh to reconfirm what we communicated last September, late September, during our call at year-end, let me spend a few minutes walking through some of the assumptions we have on exo for the remainder of the year.
Speaker #2: To be clear, there have been no changes to what we mentioned during the last call. I simply want to make sure anyone that missed it has the information handy.
Speaker #2: So, as discussed, we plan to launch exo in the fourth quarter of calendar 2025, which is our second fiscal quarter of 2026, or the December 2025 ending quarter.
Speaker #2: This will be the initial product load-in. We would not expect there to be any significant revenue to report during the second fiscal quarter. The launch will continue into the March 2026 quarter, where we expect to see some initial ramp in revenue, but the real story is expected to occur during the June 2026 quarter and beyond.
Speaker #2: From a gross margin perspective, as a reminder, we have a 28% royalty on exo in addition to a true-up on cost of goods sold.
Speaker #2: Think of it as, in essence, as a 31% cost of goods sold or 69% gross contribution margin. We do anticipate some fixed expenses to be incurred in cost of goods sold following the launch.
Speaker #2: However, the upfront fee, post-launch fee, and any milestone payments will be reported as an intangible asset and amortized to the operating expenses starting once we launch the product.
Speaker #2: As I noted earlier, from an OPEX perspective, we expect to invest approximately 10 million dollars in the initial launch of exo here in fiscal 2026.
Speaker #2: This was well defined in the plan heading into the product acquisition and financing that we conducted, and we expect this puts us in a good cash position as Exo begins to ramp as we exit fiscal 2026.
Speaker #2: As always, happy to go over any details during Q&A. With that, Josh, let me turn it back over to you. Thanks, Ryan. I want to make sure we leave time for questions, so let me wrap up here quickly, and then I'll turn it over for questions.
Speaker #2: Simply put, we were on the cusp of bringing to market what we believe is a game-changing opportunity for major depressive disorder. Every physician survey conducted, whether by us or independently, has shown almost universally that once available, physicians have patients for whom they will prescribe exo due to its effectiveness in treating the symptoms of depression, without inducing critical side effects such as sexual dysfunction and weight gain.
Speaker #2: As I've said in the past, nowhere in the package insert are the words "sexual dysfunction" mentioned. A claim virtually no other MDD pharmaceutical treatment can make.
Speaker #2: We think this is critical. Further, exo is a weight-neutral and doesn't increase anxiety to additional product features we in our survey prescribers view as extremely valuable and also distinct from many other treatment options.
Speaker #2: And while we think the peak sales for this product are extremely high, the reality is that even if this doesn't a fraction of what many of the competing products in the market do, or if we receive just a fraction of the scripts written that are ADHD drugs have, this is a huge opportunity for AYTU and for our shareholders.
Speaker #2: The coming months are very exciting for AYTU. We're laser-focused on the launch and success of exo and look forward to getting this into the hands of physicians in the months to come.
Speaker #2: As always, I want to thank everyone participating on today's call. We'll now be happy to answer any questions. Operator?
Speaker #3: Certainly. At this time, we will be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad.
Speaker #3: A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue.
Speaker #3: For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. One moment, please, while we poll for questions.
Speaker #3: Your first question for today is from Thomas Flatten with Lake Street Capital.
Speaker #4: Hey, good afternoon, guys. Congrats on the quarter. Josh, I was wondering if you could comment on how significant or maybe how many territories were affected by the realignment and then part two of that question is how are you thinking about the incentive comp plan post exo launch?
Speaker #2: Yeah, good questions. Thank you, just writing those down. Thanks for those questions, Thomas. How many territories affected? You know, in whole or in part, off the top of my head, it's probably no more than about a third of the territories that have been maybe altered or reshaped.
Speaker #2: We have gone denser in some areas where we fully expect substantially better coverage than we have for ADHD meds and actually really favorable coverage.
Speaker #2: So I think of it as probably about a third in one way, shape, or form. Some were modestly affected, a few zip codes here or there, others were more materially affected.
Speaker #2: But yeah, probably in that range. In terms of IC, very rich IC plan still being finalized, but we will certainly incentivize very, very heavily around exo activating new psychiatrists, getting new offices set up, and then obviously rewarding for going deeper within those prescribers as well.
Speaker #2: So incentivized to get them turned on and initially utilizing exo and then obviously incentives to get repeat prescribing as they identify more and more patients.
Speaker #2: So we will be hyper-focused as we've said in the past, this will be a strict psychiatry play. So we'll be in offices that are housing psychiatrists and psychiatry nurse practitioners and PAs, and that's really where the density of the prescribing for the brands in this category happens.
Speaker #2: So that's the right place to be.
Speaker #4: And then if I may, one more. What have you been doing pre-launch with respect to payer engagement? Is that something you've been doing? And what expectations do you have for coverage improving beyond the kind of protected Medicare component of it?
Speaker #2: Yeah, good question. So for us, first, second, and third, around anything related to particularly commercial payers for us is wait and see. We're not going to proactively contract so as to jeopardize best price that will have afforded to us on the government side.
Speaker #2: As you know, with the mandate to cover antidepressants, we'll have we think a pretty wide open field, particularly in at least a handful of states.
Speaker #2: And we'll be able to have access, open access with the standard 23.1% rebate to the Medicaid plans in particular. So as we think about that and we think about the portion of the business that that is likely to represent, call that 30 to 40% depending on the geography, we want to be very judicious in how we think about contracting on the commercial side.
Speaker #2: So as not to reset that best price. So that is all to say we have done assessments. We do have had some light engagement with commercial payers.
Speaker #2: We are reluctant to do anything at the outset until we get a sense for exactly what coverage rate looks like, exactly what the lay of the land is, and we'll have that access through RxConnect.
Speaker #2: And so that having been said, if you look at precedent products, a good one of which is Alvelity, marketed by Axone Therapeutics, as you know, that product enjoys 100% coverage on the government side and last we checked in the range of 70% coverage on the commercial side.
Speaker #2: And that's with what we perceive to be very limited direct contracting, perhaps with one PBM. And so using that as a bit of a guidepost, we will be very judicious.
Speaker #2: But we would still, out of the gate, expect enormously better coverage for exo than we have for our ADHD meds. And of course, just higher price points in general when you look at net pricing by virtue of the coverage on both the commercial and the government side.
Speaker #2: So hopefully that answers your question, but we are not one to go out and announce a bunch of deals with payers that frankly may not be worth the paper they're written on.
Speaker #2: We'd rather take it one step at a time, utilize the RxConnect mechanisms to optimize reimbursement on the pharmacy front while obviously minimizing the copay and the hassle on the patient front.
Speaker #2: So that's how we'll approach it. Not to say we'll never contract. We'll certainly look at it, but we'll be very judicious. But I want to make sure we approach it in the right way.
Speaker #4: That's great. I appreciate it. Thanks,
Speaker #4: guys. Thank
Speaker #2: you. Your next question for
Speaker #3: today is from Nas Rahman with Maxim Group.
Speaker #5: Hi, everyone. Congrats on the progress. And thanks for taking my questions. I understand you haven't initiated the full launch yet, but thus far, how much of your target prescriber market have you reached out to?
Speaker #5: And what kind of feedback have you gotten from that prescriber market thus far?
Speaker #2: Yeah, good question. I would say probably second question first, which is nearly universally positive when you look at the doctors that are that we're most actively engaged with.
Speaker #2: The sweet spot for us in terms of targets is psychiatrists in our footprint that are already comfortable with our products and with RxConnect. And when you overlay sort of those three criteria, you get an overwhelmingly positive response.
Speaker #2: In terms of the percentage of the market that we've reached out to, still relatively small by virtue of the fact that we're trying to be hyper-focused in the areas where we know we can be successful.
Speaker #2: Again, these are physician customers that are already fans of ours. They already prescribe at Zenith, at Cotempla in many cases, to the tunes of hundreds of prescriptions a week or, sorry, a month or a quarter.
Speaker #2: And thousands over the course of a year. And so that's really where we want to start. And we think by really kind of tripling down and not trying to spread ourselves all over and try to beat all things to all people, let's be very focused and very concentrated with who we think will be the most likely to prescribe.
Speaker #2: And these are doctors, again, in our geographies, like our products, utilize our pharmacy partners. They also prescribe the newer products like Alvelity and Trintellix and Spravato.
Speaker #2: And so you put all those things together and we think that's going to lead to a relative highly accelerated launch. And then we'll expand out from there.
Speaker #5: Thanks. That was helpful. And based on the feedback you have gotten thus far from the limited positions, have you been able to build out what a target patient profile might look like and what kind of patients that these positions might initially treat or attempt to treat with exo?
Speaker #2: We have, and this is part of our communications and part of our materials, but it's a younger patient in the prime of their life seeking to improve their life.
Speaker #2: And by virtue of that, minimize the side effects they may be experiencing on current medication. So we would rightly be targeting patients that have been on a therapy or two or three and remain dissatisfied largely due to the side effects they're experiencing with respect to sexual dysfunction, and weight gain, and before they would go to another therapy that maybe has less incidence of sexual side effects, we would insert ourselves in there and say, for that younger patient, when I say younger, 18 to 50, I just turned 50, so I'd like to think of myself as still in that demographic.
Speaker #2: Those are patients ideally suited to be switched from an SSRI or an SNRI that, again, might be working to some degree, but is leaving them dissatisfied from a side effect perspective.
Speaker #2: So that's the type of profile that we'll be starting with. Again, we want to be very specific. We don't want to go in and ask a physician for all of his or her patients.
Speaker #2: That's not realistic. It's not going to be really allowable by virtue of just the market dynamics and just the standardization of care, given that 99 times out of 100 patients will start on an SSRI or SNRI, and the payers, by the way, will require that.
Speaker #2: And so we'll be looking for that switch after that. And honestly, even if we get the switch after that switch or after the switch after that, that's a huge funnel of patients to be starting with, even if we're talking third, fourth, fifth, sixth, or even later line.
Speaker #2: So just such a big market opportunity with 340-plus million prescriptions annually. And at the price point that we would anticipate netting, that's a huge opportunity for us, even if it's used much later
Speaker #2: line. Got it.
Speaker #5: Thanks for taking my
Speaker #5: questions. Thank
Speaker #3: Once again, if you. you would like to ask a question, please press star one. Your next question is from Ed Wu with Ascendant
Speaker #3: Capital. Yeah, congratulations on all the
Speaker #6: progress. My question specifically is on your supply chain. How quickly and flexible are you to ramp up if demand is greater than you expect?
Speaker #6: And at what is your leverage opportunity margin opportunity to get if you do get to a certain scale in terms of your margin expansion?
Speaker #2: I'll take the first one, Ed, and hand the second one to Ryan in terms of margin expansion. I would say generally speaking, we have manufacturer, but there is enough flexibility.
Speaker #2: supply produced outsized forecast, even versus what we have as for, I would say, an a base case. So we could have enough produced in sitting in bulk, not yet packaged, but We are working through a contract sitting in bulk that's multiples higher than our first 24-month forecast.
Speaker #2: And our first 24-month forecast, I wouldn't call conservative. So we have adequate supply to scale as needed. There's also accelerate production of sort of a API already in hand to enable us to second run.
Speaker #2: So to ramp. Again, by multiples in the event that we need to. And in terms plenty of product to get us started, plenty of product of opportunities for margin expansion, maybe Ryan, you can just share generally how the margin works and kind of the sales level at which we would potentially start to see a reduction in royalty.
Speaker #6: Yep, absolutely. So as I mentioned, we have a 28% royalty. So that's not obviously related to the manufacturing of the down to 24% once we hit about product.
Speaker #6: 1.3 billion in aggregate sales. The actual cost of the product is only the net But that will drop about we're projecting about 2% of revenue.
Speaker #6: units, For so it's pretty small to begin batches, there's a little bit of efficiency, but it's not an expensive with. produce in the If we were to size up the
Speaker #1: guys good luck. Thank
Speaker #3: We have reached
Speaker #3: We have reached the end of the question and answer session, and I will now turn the call over to management for closing
Speaker #2: progress we're making as we are on excitement around this opportunity to help you. these many millions of patients Thanks very much, everyone, for fighting major depressive disorders.
Speaker #2: So with that, thanks again for joining. And we'll look forward to updating you after our second quarter wraps up on our quarterly call in February.
Speaker #2: Thanks very much. And have a good day.
Speaker #2: evening.