Alpha Cognition (ACOG) Q3 2026 Earnings Call Transcript

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DATE

Wednesday, Nov. 11, 2026

CALL PARTICIPANTS

• Interim Chief Financial Officer and Vice President of Accounting and Finance - Henry Du
• Chief Executive Officer - Michael E. McFadden
• Chief Operating Officer - Lauren D'Angelo

TAKEAWAYS

• Net Product Revenue -- $7.8 million, representing 30% sequential growth and 230% growth year over year driven by accelerating volume for ZUNVEYL.
• Filled Prescriptions -- 11,000, reflecting a 40% sequential increase as physician experience with the therapy developed over time.
• Net Revenue Per Prescription -- $650, remaining stable compared to the prior quarter while volume drove total revenue growth.
• HCP Writers -- 1,150, growing 23% sequentially as the company surpassed its original full-year goal of 2,000 cumulative writers a quarter early.
• Facility Adoption -- 1,400 homes with active prescriptions, an increase of 29% quarter over quarter with 80% of those facilities placing repeat orders.
• Prescriber Productivity -- 7 prescriptions per writer, up from six in the previous quarter, indicating deepening utilization among existing healthcare providers.
• Operating Expense Guidance -- $50 million to $54 million for the full year 2026, which the company reiterated following $37.5 million in spending through nine months.
• GAAP Gross Product Margin -- 94%, consistent with the second quarter of 2026 performance.
• Operating Loss -- $6.4 million, showing sequential improvement as revenue growth outpaced the company's relatively flat operating spend.
• Net Loss -- $7.6 million or $0.35 per share, including a $1.2 million noncash charge related to the change in fair value of warrant liabilities.
• Cash Position -- $37.8 million as of Sept. 30, 2026, supported by $1.4 million in proceeds from warrant and stock option exercises.
• Payer Access -- 70% of long-term care lives have access with a $0 copay, even as broader contracted formulary access remained unchanged during the quarter.
• Prior Authorization Approval Rate -- 95%, where the internal reimbursement team supported the process for healthcare providers.
• CONVERGE Study Data -- 80% of residents reached a therapeutic dose within 180 days, a rate management described as statistically superior to other drugs in its class.
• Polypharmacy Impact -- ZUNVEYL residents discontinued two medication classes on average, while those on generic inhibitors added two classes to manage side effects or behaviors.
• Clinical Enrollment -- 57 patients enrolled in the RESOLVE interventional study, with top-line data expected in the second half of 2027.
• Intellectual Property -- Patent protection extended through 2045 following the publication of proprietary manufacturing processes for benzglantamine.
• SG&A Expenses -- $12.4 million for the third quarter, compared to $1.3 million in research and development spending.

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RISKS

• McFadden stated, "the data was inconclusive from this study," regarding a pharmacokinetic study for the sublingual ZUNVEYL format, necessitating an additional study to be initiated in January 2027.

SUMMARY

Alpha Cognition Inc. (NASDAQ:ACOG) reported accelerating commercial momentum for ZUNVEYL during the third quarter of 2026, achieving record levels of net product revenue and prescription volume. Management emphasized that growth was supported by improved commercial productivity and deepening adoption among existing healthcare providers and long-term care facilities. The company maintained its target of achieving operating profitability in 2027 by combining revenue expansion with disciplined operating spend, which remained relatively flat on a sequential basis. Furthermore, management indicated that newly released real-world evidence from the CONVERGE study would serve as a key differentiator in ongoing discussions with payers and medical professionals regarding the therapy's tolerability and impact on polypharmacy.

• Prescriber conversion rates improved significantly, with D'Angelo noting that more than half of targeted prescribers called on wrote ZUNVEYL during the quarter compared with approximately 35% in the second quarter.
• Management reported that 78% of current prescribers placed repeat orders, demonstrating established prescribing behavior within the core customer base.
• The company is leveraging real-world evidence to address common practitioner questions, with D'Angelo stating, "The CONVERGE data provide real-world evidence addressing that question and give our commercial team additional evidence to support conversations with health care professionals."
• Regulatory efforts continue in Asia, with management awaiting responses from Chinese authorities following multiple rounds of inquiries regarding the product's approval.
• The company remains debt-free and focuses on long-term care maximization before considering a potential expansion into outpatient territories or larger salesforce investments.
• McFadden indicated that the polypharmacy data, showing a reduction in concomitant medication use, would be used with payers to enhance formulary discussions and economic modeling.

INDUSTRY GLOSSARY

• ZUNVEYL: An oral tablet formulation approved for the treatment of Alzheimer's disease.
• CONVERGE: A retrospective real-world evidence program analyzing longitudinal long-term care data for Alzheimer's patients.
• Acetylcholinesterase Inhibitor: A class of medications that work by slowing the breakdown of a key neurotransmitter involved in memory and judgment.
• Polypharmacy: The simultaneous use of multiple medications by a single patient, often leading to increased side effects and costs in elderly populations.
• Prior Authorization (PA): A management process used by insurance companies that requires healthcare providers to obtain approval before a specific medication is covered.
• BEACON: A program involving the analysis of multiple clinical abstracts related to cognition, tolerability, and treatment patterns.
• RESOLVE: An ongoing interventional study focused on assessing the tolerability and behavioral impacts of ZUNVEYL in outpatient settings.
• Pharmacokinetic (PK) Study: A clinical study that measures how a drug moves through the body, including absorption, distribution, metabolism, and excretion.
• Benzglantamine: The proprietary compound used in ZUNVEYL for treating neurodegenerative diseases.

Full Conference Call Transcript

Operator: Greetings, and welcome to the AlphaCognition Third Quarter 26 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance, As a reminder, this conference is being recorded. it is now my pleasure to introduce Henry Du, interim CFO and VP of accounting and finance. Henry, please go ahead.

Henry Du: Thank you, Joe. Good afternoon, everyone, and thank you for joining us today for AlphaCognition's Third Quarter 26 Financial Results Conference Call. Today, after the close of market, the company issued a press release announcing these results. On the call with me today are Alpha Cognition's chief executive officer, Michael E. McFadden and chief operating officer, Lauren D'Angelo. Today's call is being made available via the Investors section of the company's website at www.opacognition.com. During the course of this call, management may make certain forward-looking statements regarding the future events and the company's future performance. These forward-looking statements reflect AlphaCognition's current perspective on existing trends and information.

Any such forward-looking statements are not guarantees of future performance and about risks and uncertainties. Including those noted in the risk factors section of the company's latest SEC filings. Actual results may differ materially from those projected in these forward-looking For the benefit of those of you who may be listening to the replay, this call is being held and recorded on 11/11/2026. Since then, company may have made additional announcements related to the topics discussed. Please reference the company's most recent press releases and current filings with the SEC. AlphaCognition declines any obligation to update these forward-looking statements except as required by applicable securities laws. I will now turn the call over to Michael. Michael?

Michael E. McFadden: Thank you, Henry. Good afternoon, everyone. Welcome to today's call. The third quarter of 26 was our strongest quarter since the launch of ZUNVEYL. The first new oral Alzheimer's treatment approved in more than a decade. We delivered accelerating demand and record prescriber and facility adoption while holding our operating spend essentially flat with the second quarter. This growth, in combination with disciplined operating spend, aligns with our goal of achieving operating profitability in 2027. During this call, we will emphasize 4 primary things. ZUNVEYL's growth is accelerating. Growth achieved on better targeted calls financial stewardship, remains on track for operating profitability in 2027, and will highlight real-world evidence for ZENVEL as it continues to strengthen positioning and differentiation.

In Q3, we generated net product revenues of $7.8 million representing 30% sequential growth over Q2 26. Fill prescriptions for the quarter were up 31% quarter over quarter. More than 30,000 prescriptions have been filled for ZUNVEYL across 6 quarters of commercialization. We are pleased by the growth underlying these numbers with HCP riders, cumulative riders since launch, and homes with ZunVeyl prescriptions. All reaching or exceeding our expectations for the quarter. Lauren will provide more color on the KPIs and our commercial progress in a moment, but I will share that management is pleased with our KPI attainment at this point in the year. Turning to our clinical and medical programs.

We are continuing to read out real-world data in the setting where these patients are actually treated. We believe the data the company is generating will help us in discussions with our long term care practitioners, and with payers. Let me start with Converge. On October 1, we announced first results for from Converge, a retrospective real-world evidence program using longitudinal long-term care data. I want to highlight 2 things. The first was titration data. Among residents who were new to acetylcholinesterase inhibitor therapy or switch from a competitor, 80% of ZUNVEYLe residents reached a therapeutic dose within 180 days. This is statistically superior to all other drugs in the therapeutic class.

For 3 decades, the single biggest practice failure of this drug class in nursing homes has been that patients never get to an effective dose because they cannot tolerate the older medications. So I am very pleased with what this data represents about the potential for ZUNVEYL to make a difference. The second is polypharmacy. ZUNVEYL residents on average discontinued 2 medication classes producing a net decrease across all 8 medication classes evaluated. This included antipsychotics, other psychotropics, gastrointestinal medications, and sleep medications. Residents on generic acetylcholinesterase inhibitors did the opposite. They added 2 more medication classes, then they discontinued with net increases across the same 8 medication classes just listed.

Now in a setting where polypharmacy drives cost, staff burden, CMS quality measures, we believe this data will resonate with both our nursing home providers, the nursing homes themselves and their staff, and with payers and Converge remains ongoing. We expect additional dataset updates in January, and also in March, which should expand the number of ZUNVEYL residents available for analysis and we expect to publish data from CONVERGE starting in the first half of 27. Turning to BEACON. We have completed and presented 11 abstracts at medical meetings. The analysis spanned cognition, activities of daily living, neuropsychiatric symptoms, tolerability, treatment patterns, and psychotropic medication utilization.

And this data is now available for medical professionals on the AlphaCognition website under the medical affairs tab. Resolve our interventional study in patients with behavioral symptoms, continues to enroll, with over 57 patients enrolled. We continue to anticipate study completion in the second half of 27, and we will provide top line data when that study completes. And on the development side, we are continuing to do work with our sublingual program. Our PK study concluded in early October and the data was inconclusive from this study. The company believes we can resolve this with an additional study, which we are initiating in early January.

And our partner, CMS Pharma, we continue to work through the regulatory processes in Asia, where we anticipate approvals in 2 countries in the near term. We responded to the Chinese regulatory authorities on their questions and inquiries about the program, and we await any additional questions they may have. On the intellectual property front, in October, we announced that the US Patent and Trademark Office published our patent application covering proprietary manufacturing processes for benzglantamine. Additionally, we had the benzglantamine polymorph patent approved in Hong Kong and Russia during the quarter. This further strengthens patent protection for benzglantamine in the U.S. market and around the world. And the company anticipates additional patent approvals in the coming weeks and quarters.

With that, I will turn the call over to Lauren to discuss our commercial progress. Lauren?

Lauren D'Angelo: Thank you, Michael. This was our strongest quarter since launch. With continued demand growth and meaningful improvement in commercial productivity. Q3 generated $7.8 million in net product sales, up 30% sequentially, driven by over 11,000 filled prescriptions, an increase of 40% quarter over quarter. Net revenue per prescription remained essentially stable at $650 per bottle, demonstrating that growth was driven by prescription volume rather than price. Just as importantly, we are becoming more productive in how we generate that demand. During Q3, our commercial team made over 7000 calls and reached roughly 3400 targeted prescribers. We continue to refine both who we call on and the frequency of engagement, and we are seeing the impact of that increased focus.

The number of HCP writers grew 23% sequentially to 1150 with cumulative writers reaching 2440. More than half of the prescribers we called on wrote ZUNVEYL during Q3 compared with approximately 35% in Q2. At 2440 cumulative writers launched to date, we have already surpassed our original full year goal of approximately 2,000 prescribers with 1 quarter remaining and remain on track to exceed our revised goal of 2500. Importantly, we are not simply adding writers. We are seeing greater depth within our existing prescriber base. 78% of prescribers placed repeat prescriptions while productivity increased to approximately 7 prescriptions per writer, up from approximately 6 in Q2.

We are seeing similar momentum at the facility level, We called on approximately 2800 nursing homes during the quarter, and the number of homes with the ZUNVEYL prescription grew 29% sequentially to 1400 with 80% of those homes placing repeat orders. Cumulatively, we have now reached 1900 ordering homes with 81% placing repeat orders. Expansion continued through quarter end, including 103 new ordering homes in September alone. We are pleased that a significant and growing part of our business now comes from the psychiatry channel, including psychiatrists, nurse practitioners, and physician assistants practicing in long-term care. Turning to payer access, we continue to see encouraging progress.

Where our reimbursement team supports the prior authorization process, 95% of prescriptions are approved and 70% of long-term care lives have access to ZUNVEYL with a $0 copay. What is particularly encouraging to us is that we achieved strong sequential prescription growth in Q3 without a meaningful change in formulary access. As broader contracted access is implemented downstream, we believe payer access can become an additional driver of growth. As Michael discussed, our real-world evidence program is also beginning to support our commercial efforts in a very practical way. 1 of the most common questions our representatives have heard since launch is whether frail long-term care residents can successfully be titrated to an effective dose.

The CONVERGE data provide real-world evidence addressing that question and give our commercial team additional evidence to support conversations with health care professionals. So stepping back, Q3 demonstrated progress across the key areas we have been focused on, accelerating demand, improving commercial productivity, expanding and deepening our prescriber base, increasing facility penetration, and advancing payer access. We exceeded our original. Full-year prescriber goal a quarter early and remain on pace to exceed our home goal. With increasing depth among existing prescribers and facilities, continued customer expansion, and further payer access ahead of us, we believe ZUNVEYL enters the fourth quarter from a position of increasing commercial strength.

I will now turn it over to Henry to discuss the financials in greater detail. Henry?

Henry Du: Thank you, Lauren. Good afternoon again, everyone. For the third quarter of 26, ZUNVEYL generated $7.8 million in net product revenues. Compared with $6 million in the second quarter. Representing 30% sequential growth. On a year over year basis, this compares with $2.3 million in net product revenues in the third quarter of 25. Growth of more than 230%. GAAP gross product margin was 94% for the third quarter, consistent with the prior quarter. Other operating expenses for the third quarter were $13.7 million compared with $12.9 million in the second quarter and $5.6 million in the third quarter of 25. That is roughly $12.4 million of SG&A and $1.3 million of R&D expense.

The important point is that our spend was relatively flat sequentially while revenue grew at 30%. We reported an operating loss of $6.4 million for the quarter, an improvement from the second quarter and a direct result of revenue growth outpacing spend. Net loss for the third quarter was $7.6 million or $0.35 per share. Compared with a net loss of $8.2 million or $0.38 per share in the second quarter. The difference between our operating loss and our net loss reflects approximately $1.2 million of nonoperating items primarily a noncash charge related to the change in fair value of warrant liabilities. As of 9/30/2026, the company had $37.8 million in cash and cash equivalents.

Compared to $41.4 million at 6/30/2026. The company remains debt free. Cash declined only approximately $3.6 million in the quarter, which includes approximately $1.4 million of proceeds from warrant and stock option exercises. On a sequential basis, these numbers reflect both revenue growth and expense discipline. We are reiterating the full year 2026 operating expense guidance we gave last quarter. Through the first 3 quarters, we have spent approximately $37.5 million which keeps us comfortably within the range of $50 million to $54 million for the full year.

We are not providing revenue guidance at this time, As we indicated last quarter, we expect to provide guidance for 2027 expense guidance of 2027 either late in the fourth quarter or at the very beginning of 2027. I will now hand it back to Michael for closing remarks.

Michael E. McFadden: Thank you, Henry. Let me briefly summarize what I believe are key takeaways from this quarter. First, ZUNVEYL's growth is accelerating. Number 2, we are achieving growth on better targeted calls and operational efficiency. 3, we are demonstrating operating leverage, we remain on track for operating profitability in 2027. And fourth, the company remains excited about the real-world evidence we are building. This data is both compelling and highly differentiating for our customer base and for the payers. With that, operator, let's open up the floor for questions.

Operator: Thank you. Ladies and gentlemen, if you would like to ask a question, please press 1. And a confirmation tone will indicate your line is in the question queue. You may press 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. And our first question comes from the line of Nav Raman with Maxim Group. Please proceed.

Nav Raman: Hi, everyone. Congrats on all the progress. It looks like ZUNVEYL is doing great. So based on that and all the progress you have seen, I guess, what are your thoughts about expanding the Salesforce or the territories you promoted in? I guess, what sales milestones or what metrics would you have to see internally to consider expanding the promotional effort? Thanks.

Lauren D'Angelo: Sure. So currently, we believe that our current commercial infrastructure is appropriately sized for where we are today. Now as our business grows, we will continue to evaluate our field force capacity and the product, we will invest where we believe we can generate an attractive return. But the couple of the key indicators that we have talked about in previous quarters and remain consistent today is 1, formulary coverage. When we look to expand outside of long term care, we think it is really that we have formulary coverage for those outpatient patients. And we are also focused on just maximizing long-term care. Currently, we believe we have significant opportunity to maximize where we are.

We believe that our current broad adoption right now with our 2500 writers is, you know, evidence of broad adoption, but there is a significant opportunity for us to increase the depth and the consistency of these current prescribers before we would actually expand into either additional prescribers or go outside of long-term care.

Nav Raman: Got it. That was helpful. Thanks for taking my question.

Operator: The next question comes from the line of Ryan Deschner with Raymond James. Please proceed. Please proceed.

Ryan Deschner: Thanks for the question, and congratulations on the growth this quarter. What main initiatives or dynamics do you attribute the better than expected prescriber growth to? And what do you attribute the increase in prescriber conversion of 50% versus what we have seen in the second quarter? And how do you see this kind of evolving going forward? And I have a follow-up.

Lauren D'Angelo: Sure. So, you know, it is very similar to what we have shared in the past in terms of the adoption rate of an Alzheimer's therapy, especially with long term care providers. This is a frail patient population. You know, they are they are a little slower to adopt than, let's say, the retail setting, for an Alzheimer's therapy. So what we believe is really contributing to the growth is experience. So physicians need experience with the product. Patients need to be able to move through that access and fulfillment process with a new therapy. And then, of course, prescribing behavior develops over time.

So when we look at our prescribers today and why we are seeing a significant increase, it is really about giving them the time to get the experience with our drug. The drug is working. it is working far better than we thought it would. We are seeing a significant impact, not just with tolerability, but obviously with the behaviors that are associated with Alzheimer's disease. So as physicians get experience, they are writing more. And you see that in the metric where, you know, last quarter, they wrote about 6 prescriptions. We have increased that to 7. They are just getting more comfortable with the drug, and then they are adding it to additional patients.

So we believe experience with ZUNVEYL will continue to contribute to that growth. Thank you.

Ryan Deschner: And then can you give us a little more color on the inconclusive PK study for the sublingual ZUNVEYL format? And also, what other items need to be completed before IND submission there? Thanks.

Michael E. McFadden: Yes. So we saw a signal with PK data specifically AUC that was inconsistent with previous datasets that we have concluded. We have concluded 4 datasets with both ZUNVEYL, the Doctor tablet, which was included in this study. As well as sublingual and intranasal. The data was inconsistent with previous data that we have seen. And so we feel like that could be either a analysis issue from the CRO or it could be a species issue with the species that was included in the study. So we are going to initiate an a additional study in the first quarter of next year that we think will resolve those issues and allow the company to move forward.

We believe this is the only study left to advance that product with a meeting with the agency, which would move us to the clinic, and we believe the. No other data is needed at this time. Thank you very much.

Operator: The next question comes from the line of Chase Knickerbocker with Craig Hallum Capital Group. Please proceed. It appears Chase is disconnected. So the next question will come from the line of Raghuram Selvaraju with H. C. Wainwright. Please proceed.

Raghuram Selvaraju: Thanks so much for taking our questions, and congratulations on all the progress made this quarter. Firstly, I was wondering if you could give us any additional visibility on what recent formulary or contracting wins have occurred since the second quarter and what you anticipate potentially being likely to achieve on the access front between now and the end of this year. And looking ahead to 2027, what the core objectives are for the company on that front as you look to accelerate the pace of market uptake for ZUNVEYL?

Lauren D'Angelo: Sure. So payer coverage has remained unchanged. Since the previous quarters. Obviously, we had hoped that, you know, that we would see some adoption. But we do ask absolutely believe that broader coverage is achievable. So what we are finding obviously, we know market access is a process, particularly for a new product. And timing is varying considerably by plan. So what we are doing, our focus is we are continuing to engage payers and we do believe that our growing physician experience, the increase of volume, the patient utilization, and, of course, the accumulating real-world experience and evidence that we are generating will support those discussions.

Right now, we do not expect any, you know, formulary win in the next couple of months through the remainder of the year, but we are very, you know, focused as we always have been with the specific plans that we are engaging with. And we do hope to see some traction early next year.

Raghuram Selvaraju: And then with respect to the repeat prescribers and the productivity on a prescription per prescriber basis, are you expecting there to be significant increases in those statistics over the course of the coming quarters. Do you think, for example, you know, now that you are in the high 70s with respect to repeat prescribers that, you know, this has more or less reached a steady state? And the principal drivers of growth are more going to come from expansion and access, expansion in number of facilities, and expansion in the number of new to brand prescribers.

Lauren D'Angelo: You know, that is something that we are focused on every single day. We absolutely believe that there is a significant opportunity to increase the depth and consistency of prescribing among existing writers. So while we are. We do plan, obviously, to continue to add new writers, we add a significant amount every single month. Really, the more significant opportunity for us right now is to increase that depth and that consistency. So we do expect repeat rates to go up across the board with our providers and our customers, and we are seeing that on a month by month, quarter by quarter basis.

So it really is expansion of the writers but also, more importantly, going deeper with our existing writers is where we are focused today. Now, of course, formulary coverage oh, sorry. Go ahead. No. No. Go ahead, please. Yeah. So formulary coverage is, of course, incremental you know, upside for the company. We are very pleased with the amount of progress we have made and the goals we have been able to hit. with a lack of formulary coverage. So we actually see formulary coverage providing significant upside, for the company.

Raghuram Selvaraju: And then with respect to the real-world evidence and phase 4, data that you already have and that you expect to generate in the near term, how do you expect that to feed into the ongoing promotional messaging And what impact does your market research indicate this might have, particularly the data demonstrating the ease with which ZUNVEYL residents reach therapeutic dose and the degree to which patients on ZUNVEYL can drop use of certain concomitant medications.

Lauren D'Angelo: So what we have seen so far, it is very early. We just, announced that data. So we are actually working on that promotional messaging so far. But market research, you know, says that those are key indicators. 1 of the biggest issues with this class is that a majority of these patients who are on a generic acetylcholinesterase inhibitor are not able to get to the therapeutic dose due to the tolerability issues. That really was, you know, obviously with the foundation of launching ZUNVEYL, in the first place. So that message highly resonates in market research with our customers as does the polypharmacy message.

Those were our 2, most important factors, and that is why we released that data, and we got that data the earliest. Now as we get resolved in some of the other evidence we are generating, we are generating this data over time. You know, all of the information that we are putting in front of customers in terms of what we are looking at is highly compelling. From a adoption perspective. But I do wanna highlight that what we have today, our current story for ZUNVEYL and the experience that they are actually getting with our drug, is just as good.

That we are looking at all of this real-world data as incremental to what we already have and what we have launched with. From a promotional message perspective.

Michael E. McFadden: And, Raghuram, I will just add that all of the all of the polypharmacy data, dosing data, pharmacoeconomic data that we have and has not been published but is to come plus additional pharmacoeconomic analysis will be used with payers. To enhance those discussions and, will be included in dossier formulary kits, et cetera, with other decision makers throughout the stakeholder segment that we call on.

Raghuram Selvaraju: Can you just provide 1 quick point of clarification regarding the process patent that you announced the publication of? I believe it was last month. Can you just give us a sense of what degree of protection that is likely to afford and to what extent that might represent a meaningful and potentially unique challenge for potential generic competitors to try to overcome. And assuming it is issued, what do you expect the potential expiration date time frame to be without factoring in Hatch Waxman extensions or patent term adjustments? Thank you.

Michael E. McFadden: I will start with the last question first. That patent would give us patent protection through 2045 in the U.S. We believe it is incremental to the additional patents that we have that cover the product, which include polymorph, which is a patent, composition of matter, method of use patents, and then we have some additional Orange Book patents that have been filed and accepted and approved by USPTO. So we are building a really nice patent shield around the product to protect it in all ways. The manufacturing product is really interesting. in that the claims made provide protection on how the product is manufactured.

So when you are manufacturing a prodrug, there are specific processes that 1 needs to use. We have identified those that are novel. It had unexpected findings to provide us that patent, so we believe it is protective of the product in addition to the other patents that we already have approved. Thank you.

Operator: The next question comes from the line of Chase Knickerbocker with Craig Hallum Capital Group. Please proceed.

Chase Knickerbocker: Good afternoon. Thanks for taking the questions. Sorry about the technical difficulties there. Congrats on the great quarter. Maybe just on formulary coverage. As we await kind of pull-through there, just trying to get a sense for how frequent the friction point is there with the prior auth. Is there a revenue level that you kind of see in an account you start to have that friction as a result of that prior auth? I guess a better way to ask it is just have you seen any of your high volume accounts get to levels where volumes start to kind of level off? You know, specifically due to that friction from the prior auth?

Lauren D'Angelo: We are not there yet. I think we still have, you know, significant opportunity, with the ZUNVEYL in terms of driving demand and driving volume. You know, there used to be a certain point friction point, that would happen, but we are we are certainly not there yet. Now, as you know, as we have talked about in the past, you know, our payer coverage is Med D, and there are 4 plans that matter. We are obviously driving as much volume as we can on all 4 of these plans, to put friction honestly on the payer so that, you know, they will continue to engage and obviously work with us for formulary coverage.

But right now, we are not at a point where it is starting to level off. Now what I will say is the prior authorizations are real. The great news is that our team continues to get better and better at supporting that prior authorization process. And when our team does touch prior authorization, we get 95% approval. So, you know, most of our writers, you know, we especially our high volume writers are very used to this, and they know how to work the prior authorization process, and they are working with our team to make sure that ZUNVEYL is approved through the prior authorization process.

But I wish I could give you a specific, but unfortunately, we are not there yet where we have hit a certain milestone.

Chase Knickerbocker: That makes sense. Understood. Maybe kind of a lead into the next 1 there. What percentage of those prior auths are you handling right now of your overall demand? And how can you expand that further, you know, given a 95% success rate? And then second to that, do you see higher scripts per writer in those accounts where you are handling that prior auth?

Lauren D'Angelo: So yes and yes. So we are absolutely focused on increasing the number of prior auth obviously, that our team touches. that is a number 1 focus for us. We also have, you know, some other avenues where, the provider is very They have a system set up within their own practice within their facility. Where they can process those PAs. What we have done is we have gotten really productive in our targeting. So we are very focused on those physicians who will work with our team, and we are very focused on those pharmacies will work with our team to ensure that our effort is actually gonna result in a prior authorization approval.

So that is exactly what we are doing, and we are continuing to see, you know, increased support from our team month by month, and you see it growing. it is also obviously getting our representatives, to pull through that process as well. So, yes, we are focused on increasing as many prescriptions as we can with our team. Now to give you an exact number, it is pretty hard to be able to tell you, but it is significant. In terms of what our team is touching.

Chase Knickerbocker: Got it. And you kinda have the capacity there to do, you know, even more?

Lauren D'Angelo: Absolutely. We have, our team has gotten so efficient with processing these PAs. They are really, really good. And we are actually--you know, they are also working with offices. Now offices are actually. has gotten really good at doing the prior authorizations on their own as well. So it is a partnership between us and our customers. And we are continuing to do that.

Chase Knickerbocker: Great. Thanks a lot.

Lauren D'Angelo: Sure.

Operator: The next question comes from the line of William Wood with B. Riley Securities. Please proceed.

William Wood: Hi. Thanks for taking my questions and congrats on the quarter. Just given that we are already a little over a month into the fourth quarter, could you provide any color on how you are seeing new patient enrollment and script growth through the beginning of the quarter and maybe how that might set up going into year end? And then also, what are your expectations for gross to net through the end of the year? And then as we get into 2027, once PBM rebates under the Part D contract are paid, should we expect a change in gross to net, maybe also a change in price? Then I have a follow-up.

Lauren D'Angelo: Okay. So I will address. We expect the GTN to stay about the same. As you know, as more patients get through the end of the year, with the IRA, you might see a little bit more patients come into what used to called the doughnut hole. But, no, we do expect a pretty consistent, GTN through the remaining court remaining Q4. We do not plan to take any, you know, price as well. So our price will stay the same through the end of the quarter. Did I answer both of your questions?

William Wood: I know you had a 3-part question. Did I answer--is there 1 more question in there? 7 should we expect a change in early 27 and or price or gross to net And then what you are seeing potentially in terms of scripts new patient enrollment, given that we are about a month and a half or month into the fourth quarter?

Lauren D'Angelo: Sure. So our growth continues. I know we do not provide guidance in terms of revenue or prescriptions, but, our growth is continuing into the fourth quarter. that is about all I will say on that matter. And then moving into next year, we do not expect. At this point, we have not made any decisions as it relates to price, but we do expect the. Unless we see a formulary, obviously, then we expect the GTN to stay the same or consistent.

William Wood: Okay. Thank you. And then in terms of. You have obviously shown data, very nice data from CONVERGE and Beacon so far with Resolve coming up next year. I am curious, a, on the 2 trials that have already read out, you know, how has that moved the needle both on prescribers as well as payers? And then in terms of resolve, this looks to be an open-label study with no comparator, either placebo or, say, just donepezole. So I am just curious on the exact takeaway that we will be able to gain from this in terms of improvements on behavior or cognition even tolerability? Within this trial. Thanks.

Michael E. McFadden: Yeah. I will start with RESOLVE. So for RESOLVE, our primary is tolerability. The importance of that is that trial is geared toward the outpatient patient with mild to moderate Alzheimer's disease. The data will be useful for physicians who treat those patients out in an outpatient setting. To assess what tolerability they might see when ZUNVEYL is initiated. As a secondary, we have, the MPI, the neuropsychiatric behavioral management by drug. And so we will be assessing that for that trial. If that trial demonstrates some effect or signal, that would be advantageous for the company. And we will we will know more from it when that trial reads out. Regarding BEACON and CONVERGE, so BEACON is read out.

We published data We are starting to see some impact on that. But as you know, it takes multiple calls. And multiple touch points with the stakeholders within the segment that we call on for that to really build traction. And then with the payers, we have initiated some messaging with Beacon and We just released, the CONVERGE data and are just starting to have discussions with payers on the CONVERGE data set. Of note, the CONVERGE dataset is really significant because it involves over 6400 patients, so really big patient numbers. it is retrospective, longitudinal look at what happens when all drugs in the class are used.

So very, very important to build modeling that the payers look at and value. When they are making a formulary assessment. And it also is important for their formulary assessment. And also is really, to assess some of the cost measures that payers evaluate when they are managing or looking at therapeutic class. Of this class, it is really unique in the fact that polypharmacy is rampant. In the Alzheimer's category. it is rampant from a side effect management standpoint with GI meds, sleep meds, and other medicines that are used to try to keep patients on these medication class. And it is also rampant because 90% of patients suffer from neuropsychiatric behaviors.

And when they suffer from neuropsychiatric behaviors, if they are on a drug that is not ameliorating or lessening those behaviors, they are always put on at least 1 and often multiple agents to manage the psychiatric behaviors. So to see data that reduces those meds with ZUNVEYL while at the same time patients that are using other meds show increase, we think, is going to be very persuasive data for payers. And certainly, it is going to be equally persuasive to the psychiatrists who consult for treatment of these behaviors.

William Wood: Got it. Very helpful. Thank you.

Operator: The next question comes from the line of Dave Storms with Stonegate. Please proceed.

Dave Storms: Good evening, and thank you for taking my questions. Lauren, I wanted to ask a question around, the prescriber profile. You know, you obviously mentioned that it is up to averaging 7 prescriptions, up from 6 last quarter. But what does the high volume prescriber profile look like? Is this, you know, a product of them just being with the customer. With the product longer, seeing more patients? Is there a time frame where that starts to level out? Anything there would be helpful.

Lauren D'Angelo: Oh, no. Absolutely. So, you know, it is hard to pinpoint an exact profile for you. But what I can tell you is some of our earlier adopters and our high volume, writers, 1, they manage a lot of homes. Right? They are not a single home doctor. They see a lot of patients. So, that. that is 1 of the number indicators in terms of our highest-volume writers. Number 2 is they write a lot of donepezil. So, you know, obviously, when you are doing a targeting exercise and you are going up to your high volume writers, we have been able to see that the quicker adopters of ZUNVEYL are those donepezil writers.

Now, obviously, you will say, okay. it is the market leader that makes sense. But there is a specific prescription profile on those physicians who see a number of patients and writing a ton of donepezil because we get a significant amount of switches. From donepezil. Those are the providers that need a treatment choice for these patients, and they have had nothing else, so they use So, really, for us, the high volume profile is high, obviously, high volume of patients and high donepezil use. And that typically. We see conversion pretty quickly, when we target that specific profile.

Dave Storms: Understood. that is very helpful. Thank you. And then, Henry, I wanted to ask a question. Around the expense run rate. You know, full year guidance implies roughly $14 million in the fourth quarter, give or take. Just curious how much of that spending do you think is associated with CONVERGE and resolve? I know you are not providing, you know, 2027 guidance yet, but just trying to back into what maybe could be coming out in the first half of 27 and then maybe what gets added you know, from the PK study. Just trying to work the puts and takes there.

Henry Du: Sorry. Can you repeat the last part of your question? I think I did not catch that last part.

Dave Storms: Sorry. Just trying to work through maybe some of the puts and takes that we might see in the early part of 27 for the expense, if that $14 million that is implied in 4Q is a reasonable run rate or if a lot of that $14 million is tied to a CONVERGE and resolve that might drop off. In the first half of 27.

Henry Du: So the. That run rate is you know, is consistent with what our expectations are for Q4. And the expenses for CONVERGE should, you know, kind of taper off a bit, but there would still be some expenses related to But for the most part, the cash flow would be related to commercialization. And just general operating expenses.

Dave Storms: Understood. I appreciate that. And then if I could just sneak 1 more in, Michael, I know earlier this year, you know, we have talked about regulatory approvals in Asia. Just maybe any high level updates there, anything we should keep an eye out for? In the near future?

Michael E. McFadden: Yeah. We submitted for 3 country approvals, products undergoing regulatory review. In those 3 countries. 1 of the most significant being China. We have completed multiple rounds of questions from the regulatory authorities in China, and now we are waiting their responses or further questions they may have on the responses that have been submitted. So no substantive data to tell on any of those. it is in the hands of regulatory authorities, and we are awaiting either their responses with more questions or approvals of the product.

Dave Storms: Understood. Appreciate the update. Thank you for taking my questions, and good luck in the next quarter.

Operator: Thank you. There are This concludes the question-and-answer session. And I would like to turn the call back to Michael E. McFadden for closing remarks.

Michael E. McFadden: Yes. Thank you, Joe. Thanks, everybody, for attending the call today. We believe you can hear that our commercial progress is accelerating. Our product data is strengthening. Our position, ZUNVEYL's position, relative to the competition. We feel like the team has continued to execute with discipline and focus. So I wanna thank you for attending the call today, for our investors, for supporting the company. And we will talk to you next quarter. Thank you.

Operator: This concludes today's conference. You may disconnect your lines at this time. And we thank you for your participation.

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