ACOG
Alpha CognitionFDocument history
Earnings documents stored for ACOG.
Investor releaseQuarter not tagged2026-05-15Alpha Cognition Inc. Common Stock Q1 2026 Earnings Call Summary
Moby
Alpha Cognition Inc. Common Stock Q1 2026 Earnings Call Summary
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved 40% sequential revenue growth driven by increased prescriber adoption and deepening penetration within the long-term care segment. Expanded the customer-facing field team to 60 representatives to drive broader market reach and improve conversion efficiency. Attributed commercial momentum to a 'depth over breadth' strategy, where 75% of active writers have placed repeat prescriptions. Strengthened the intellectual property portfolio with two new patents extending ZUNVEYL protection through 2045, including a strategic entry point into the $14 billion Traumatic Brain Injury (TBI) market. Invested intentionally in real-world evidence studies to address the primary friction point of payer access by demonstrating clinical value in actual treatment settings. Leveraged AI-enabled commercial analytics to optimize territory execution and identify high-value prescriber opportunities. Reiterated target to achieve operating profitability in 2027, supported by disciplined scaling of commercial infrastructure. Accelerated timelines for the BEACON study, with top-line data now expected no later than early Q3 2026 to support payer and provider confidence. Anticipates two strategic product approvals in Asia during 2026 through the ongoing partnership with CMS Pharma. Plans to advance a sublingual formulation to the clinic following a comparative pharmacokinetic study expected to yield data in Q3 2026. Maintains full-year 2026 operating expense guidance of $54 million to $58 million, with a modest spending increase expected in Q2 as clinical trials ramp. Implemented a 6% price increase for ZUNVEYL to $869.36, reflecting management's confidence in the product's value proposition and underlying demand. Identified payer access as the most significant near-term friction point, with downstream implementation currently at approximately 16% of the total contracted book of business. Reported a net loss of $6.5 million for Q1 2026, which management characterizes as a deliberate investment phase to scale market reach and clinical evidence. Noted that while Medicare D contracts are in place with two major PBMs, broader implementation remains a 'waiting and seeing game' typical of new therapy access curves. One stock. Nvidia-leve...
Investor releaseQuarter not tagged2026-05-15Alpha Cognition (ACOG) Q1 2026 Earnings Transcript
Motley Fool
Alpha Cognition (ACOG) Q1 2026 Earnings Transcript
Image source: The Motley Fool. May 14, 2026 Chief Executive Officer — Michael E. McFadden Chief Financial Officer — Henry Du Chief Commercial Officer — Lauren D'Angelo Need a quote from a Motley Fool analyst? Email [email protected] Michael E. McFadden: Thank you, Henry. Good afternoon, everyone, and welcome to today's call. The 2026 represents our fourth full quarter of commercialization for ZUNVEYL. The first new oral Alzheimer's treatment approved in more than 15 years, and the quarter was a strong 1. We delivered 40% quarter over quarter revenue growth, acceleration in prescriber adoption, advanced strategic priorities across our clinical programs, We strengthened our intellectual property portfolio and the company further built out our organization as we enter the expansion phase for ZUNVEYL. We continue to execute with discipline and confidence, and I believe this quarter that ZUNVEYL's commercial victory is tracking well with our internal expectations. In Q1 2026, we generated net total revenues of $3.5 million a 40% sequential increase over Q4 2025. While we are very pleased with ZUNVEYL's trajectory, we are still at only the start of ZUNVEYL's commercial phase. The company remains optimistic and believe we will continue to see signs of sustained product performance and adoption within the long term care segment. Looking at Q1, we saw growth in the quarter with March delivering our strongest month of demand sales, and April is stronger than March. Overall, we believe we are on track with our 2026 strategic priorities and we continue to expect to achieve operating profitability in 2027. On the adoption side, our prescription KPIs remain strong. Our bottles dispensed grew 23% over Q4. Our HCP writers grew 23% over year end 2025. And we are on track to achieve our 2026 goal of approximately 2,000 prescribers. Our call down prescribers expanded 93% quarter over quarter, and our nursing homes with ZUNVEYL prescriptions grew 25%. Additionally, the commercial team built out a 60 person customer facing team in the quarter. We saw an added experience marketing and payer engagement capabilities to the team. And last month, we strengthened our board of directors with the addition of a new independent board member, Bethany Censenig. We look to her experience to help build out AlphaCognition strategy, and for her to provide financial governance for the company. Turning...
Investor releaseQuarter not tagged2026-05-15Alpha Cognition Q1 Earnings Call Highlights
MarketBeat
Alpha Cognition Q1 Earnings Call Highlights
Interested in Alpha Cognition Inc.? Here are five stocks we like better. ZUNVEYL sales and adoption continued to accelerate in Q1 2026, with net product revenue rising to $3.5 million from $2.5 million in Q4 2025 and bottles dispensed up 23% sequentially. Alpha Cognition said March was its strongest month since launch and April was even stronger. Commercial metrics improved across prescribers, long-term care, and repeat use, including 1,060 active healthcare provider writers, 914 long-term care homes with prescriptions, and high repeat rates in both channels. The company says it is on track toward its 2026 goal of about 2,000 prescribers. Spending is rising as Alpha Cognition invests in commercialization and studies, with Q1 operating expenses of $11.6 million and a full-year 2026 expense guide of $54 million to $58 million. The company ended the quarter with $54.2 million in cash and still expects to reach operating profitability in 2027. Alpha Cognition (NASDAQ:ACOG) reported 40% sequential revenue growth in the first quarter of 2026, as executives said commercial adoption of its Alzheimer’s treatment ZUNVEYL continued to build across prescribers and long-term care facilities. Chief Executive Officer Michael McFadden said the quarter marked the company’s fourth full quarter of commercialization for ZUNVEYL, which he described as “the first new oral Alzheimer’s treatment approved in more than 15 years.” Alpha Cognition generated net product revenue of $3.5 million in the quarter, up from $2.5 million in the fourth quarter of 2025. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? “While we are very pleased with ZUNVEYL’s trajectory, we’re still at only the start of ZUNVEYL’s commercial phase,” McFadden said. He added that March delivered the company’s strongest month of demand sales and that April was stronger than March. Chief Operating Officer Lauren D’Angelo said the company saw “meaningful execution across prescriber adoption, nursing home penetration, and payer engagement” during the quarter. → Micron Investors Face a High-Stakes Moment After the Latest Rally According to D’Angelo, Alpha Cognition’s commercial team reached approximately 7,900 healthcare providers and called on 3,762 prescribers, a 93% increase from the prior quarter. Healthcare provider writers, defined as prescribers who have written at least one ZUNVEYL prescri...
Investor releaseQuarter not tagged2026-05-15Alpha Cognition Inc. Reports First Quarter 2026 Financial Results and Provides Operational Update
Business Wire
Alpha Cognition Inc. Reports First Quarter 2026 Financial Results and Provides Operational Update
ZUNVEYL generated net product revenue of $3.5 million in Q1 2026, a 40% quarter-over-quarter increase Cumulative net product revenue totaled $10.3 million through first four full quarters of launch Q1 2026 bottles dispensed increased 23% quarter-over-quarter to 6,054, with March representing the strongest month of demand since launch Approximately 75% of prescribers and 81% of facilities demonstrated repeat utilization, reinforcing durable adoption trends Real-world clinical studies active, with BEACON enrolling ahead of schedule Cash and cash equivalents totaled $54 million as of March 31, 2026, supporting the Company’s continued target of operating profitability in 2027 Company to host conference call and webcast today, May 14, at 4:30 p.m. ET VANCOUVER, British Columbia & GRAPEVINE, Texas, May 14, 2026--(BUSINESS WIRE)--Alpha Cognition Inc. (ACOG: NASDAQ) ("Alpha Cognition", "ACI", or the "Company"), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. "The first quarter of 2026 marked our fourth full quarter of commercial operations for ZUNVEYL, the first new oral Alzheimer’s treatment approved in more than 15 years. We delivered 40% sequential revenue growth from Q4 to Q1, supported by clear quarter-over-quarter acceleration in prescriber adoption. March was our strongest demand month since launch, with approximately 75% of active prescribers generating repeat prescriptions and consistent utilization across both prescribers and facilities. These trends demonstrate not only expanding adoption but increasing depth of use across our commercial base," said Michael McFadden, Chief Executive Officer of Alpha Cognition. "Our clinical programs are also advancing, with BEACON enrollment substantially complete, and topline data now anticipated in early Q3, ahead of schedule. CONVERGE is underway, and by the end of 2026 we expect to have two real-world evidence datasets to support payer coverage expansion and further reinforce prescriber confidence. With our full field team now in action, we are focused on driving productivity across territories while remaining firmly on track to achieve profitability in 2027," concluded Mr. McFadden. ZUNVEYL Commercial Performance Net ZUNVEYL Revenue: Generated approximate...
TranscriptFY2026 Q12026-05-14FY2026 Q1 earnings call transcript
Earnings source - 55 paragraphs
FY2026 Q1 earnings call transcript
As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Henry Du, Interim CFO. You may begin.
Thanks, Kate. Good afternoon, everyone, thank you for joining us today for Alpha Cognition's Q1 2026 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 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.alphacognition.com. During the course of this call, management may make certain forward-looking statements regarding future events and the company's future performance. These forward-looking statements reflect Alpha Cognition's current perspective on existing trends and information. Any such forward-looking statements are not guarantees of future performance and involve 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 statements.
For the benefit of those of you who may be listening to the replay, this call is being held and recorded on May 14, 2026. Since then, the 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. Alpha Cognition declines any obligation to update these forward-looking statements except as required by applicable securities laws. I'll now turn the call over to Michael. Michael?
Thank you, Henry Du. Good afternoon, everyone, and welcome to today's call. The of 2026 represents our fourth full quarter of commercialization for ZUNVEYL, the first new oral Alzheimer's treatment approved in more than 15 years, and the quarter was a strong one. We delivered 40% quarter-over-quarter revenue growth, acceleration in prescriber adoption, advanced strategic priorities across our clinical programs. We strengthened our intellectual property portfolio, and the company further built out our organization as we enter the expansion phase for ZUNVEYL. We continue to execute with discipline and confidence, and I believe this quarter demonstrates that ZUNVEYL's commercial trajectory is tracking well with our internal expectations. In Q1 2026, we generated net total product revenues of $3.5 million, a 40% sequential increase over Q4 2025. While we are very pleased with ZUNVEYL's trajectory, we're still at only the start of ZUNVEYL's commercial phase.
The company remains optimistic and believe we will continue to see signs of sustained product performance and adoption within the long-term care segment. Looking at Q1, we saw growth in the quarter with March delivering our strongest month of demand sales and April is stronger than March. Overall, we believe we're on track with our 2026 strategic priorities, we continue to expect to achieve operating profitability in 2027. On the adoption side, our prescription KPIs remain strong. Our bottles dispensed grew 23% over Q4. Our HCP writers grew 23% over year-end 2025, we're on track to achieve our 2026 goal of approximately 2,000 prescribers. Our call-on prescribers expanded 93% quarter-over-quarter, our nursing homes with ZUNVEYL prescriptions grew 25%. Additionally, the commercial team built out a 60-person customer-facing team in the quarter.
We saw and added experienced marketing and payer engagement capabilities to the team. Last month, we strengthened our board of directors with the addition of a new independent board member, Bethany Sensenig. We look to her experience to help build out Alpha Cognition's strategy and for her to provide financial governance for the company. Turning to our clinical programs, we have three active real-world studies underway, which we believe will strengthen ZUNVEYL's positioning with payer and healthcare providers. BEACON, our real-world effectiveness study evaluating ZUNVEYL in long-term care residents with Alzheimer's disease, will complete enrollment this quarter. The company will report top-line data from BEACON no later than early Q3, an acceleration from our prior expectation of late Q4.
CONVERGE, our retrospective data analysis evaluating tolerability, dosing, polypharmacy, and adverse events in long-term care, initiates in Q2 as planned, and we expect top-line data from this trial in Q3 of 2026. We expect both BEACON and CONVERGE to provide the company numerous publication opportunities over the coming year. RESOLVE, our Phase IV outpatient study, will also initiate this quarter. This study will provide additional data regarding tolerability and efficacy in treating behaviors associated with Alzheimer's disease in the outpatient setting. On the intellectual property front, the U.S. Patent Office issued two patents to provide additional protection for ZUNVEYL. A new patent covering dosage regimens for benzgalantamine was given in February, and a second covering the use of benzgalantamine for treating traumatic brain injury was issued in March.
Both patents extend protection of the product through 2045, and the TBI market, by the way, represents an addressable opportunity for the company estimated at approximately $14 billion. Regarding our sublingual formulation program, we will initiate a comparative pharmacokinetic study versus our tablet this quarter. The PK data, should it show equivalence, could be sufficient to advance the sublingual formulation to the clinic. With respect to our ex-U.S. partnership, CMS Pharma continues to advance the regulatory process across multiple countries in Asia, and we anticipate two strategic product approvals in 2026. From a financial perspective, the company's operating spend of approximately $12 million reflects a deliberate investment in our commercial capabilities and in studies that support our positioning with healthcare providers and payers. I want to be direct about the way we're thinking about our investment phase.
Our net loss this quarter reflects the company scaling our efforts intentionally. We're deploying capital against our highest return opportunities in the business, including expanding prescriber reach, building real-world evidence to support ZUNVEYL, and unlocking additional payer access. These are investments that will drive the company to achieve operating profitability in 2027 and beyond. We continue to remain on track with these targets. Henry will now review the financials in detail. Lauren will provide a comprehensive commercial update after Henry concludes his comments. Henry?
Thank you, Michael. Good afternoon, everyone. As I review our first quarter of 2026 results, please refer to today's press release and 10-K, 10-Q filed this afternoon. For the Q1 of 2026, we generated total net product revenues of $3.5 million from ZUNVEYL. This compares to Q4 2025 net product revenues of $2.5 million, representing 40% sequential growth quarter-over-quarter. On a year-over-year basis, Q1 net product revenues were $347,000, representing only the final two weeks of March 2025 following our commercial launch, plus $2.6 million in licensing revenue from our CMS agreement. The trajectory from that initial quarter to $3.5 million in Q1 2026 illustrates the significant commercial progress ZUNVEYL has made in just one year of commercialization.
Total operating expenses, including cost of revenues for Q1 2026, were approximately $11.6 million, reflecting our continued commercial infrastructure investment, taking into account a fully staffed 60-person customer-facing sales team, expanded payer engagement capabilities, marketing resources, and the initiation of our RESOLVE clinical study. For context, Q4 2025 total operating expenses were $10.7 million and $6.3 million in Q1 of last year. The step up from the aforementioned periods to Q1 2026 reflects the intentional investment decisions Michael described. Scaling field force, expanding market reach, and initiating studies that would generate the real-world data needed to accelerate payer coverage and prescriber adoption. For Q1 2026, we reported a net loss of approximately $6.5 million of $0.30 basic loss per share.
This compares to a net loss of $1.7 million or $0.11 per share in Q1 2025. The year-over-year increase reflects the investments made in our commercial infrastructure, payer engagement, and clinical programs, all of which are core to advancing ZUNVEYL's long-term trajectory. Our core operating efficiency is also improving, and we view our current investment level as appropriate for this phase of growth. As of March 31, 2026, the company had approximately $54.2 million in cash and cash equivalents compared to $66 million at December 31, 2025. The company maintains a debt-free balance sheet. We continue to believe our current capital position is sufficient to fund operations, sustain ZUNVEYL's commercialization, and advance our clinical programs, as well as reaching operating profitability in 2027.
While we are not providing revenue guidance at this time, we are reiterating our full year 2026 operating expense guidance of approximately $54 million-$58 million. This is unchanged from our prior guidance. We expect Q2 spending to increase modestly relative to Q1 as RESOLVE ramps and our peer-to-peer education programs accelerate. The overall 2026 spending profile remains in line with our plan. We believe this reflects investments needed to support our commercial operations, 3 real-world clinical studies, payer engagement programs, and advancement of our sublingual formulation. With that, I will now turn the call over to Lauren to discuss commercial progress. Lauren?
Thank you, Henry. I'm pleased to provide a detailed update on our Q1 2026 commercial performance. This was a quarter of meaningful execution across prescriber adoption, nursing home penetration, and payer engagement. The data tell a compelling story of durable, accelerating commercial traction. Let me start with our adoption metrics. In Q1, the commercial team reached approximately 7,900 total healthcare providers and called on approximately 3,762 prescribers, a 93% increase over the prior quarter. This reflects the expanded reach of our now fully staffed 60-person customer-facing field team. HCP writers categorized as prescribers who have written at least one ZUNVEYL prescription grew 23% quarter-over-quarter to 1,060.
This represents approximately a 28% conversion rate from prescribers called on, a strong indicator of early commercial efficiency. We entered 2026 with a goal of reaching approximately 2,000 prescribers, and our Q1 growth puts us on a strong trajectory for us to reach this goal. 795 of our 1,060 active writers, or approximately 75%, have placed repeat prescriptions. Importantly, this implies not just adoption, but sustained utilization, with each writer averaging approximately five to six prescriptions in the quarter. Homes with ZUNVEYL prescriptions grew 25% quarter-over-quarter to 914. This represents approximately 36% penetration of the facilities we called on, with each active home averaging over six prescriptions in the quarter. 736 have placed repeat orders, an 81% repeat rate at the facility level.
This is what durable adoption looks like. We called on 2,502 unique nursing homes in Q1, 26% more than in Q4, and we brought 110 new homes on board in March alone, our highest single month new account total since launch. Q1 monthly trajectory is notable because it captures how our commercial momentum built through the quarter. In March, we delivered 2,321 bottles, our highest demand month since launch. This represents a roughly 29% increase over February and establishes a clear exit velocity as we enter Q2. Total bottles dispensed in Q1 were 6,054, a 23% increase over Q4's 4,941 bottles. Across both prescribers and facilities, we are seeing consistent patterns of depth, not just breadth of adoption.
Conversion rates, repeat utilization, and prescriptions per account all point to a product that is not only being tried, but actively integrated into clinical practice. We believe our ongoing real-world evidence programs will further reinforce these adoption trends over time. BEACON, CONVERGE, and RESOLVE are designed to generate clinically relevant data in the settings where Alzheimer's patients are actually treated, including long-term care and outpatient practice. Importantly, we expect these studies to provide meaningful promotional value for our commercial organization by supporting peer-to-peer education, strengthening payer discussions, and increasing physician confidence around tolerability, polypharmacy management, behavioral outcomes, and caregiver burden. We believe these datasets will become increasingly important tools as we continue expanding market access and prescriber utilization. During the quarter, we also implemented a 6% price increase for ZUNVEYL to $869.36.
We believe our ability to take pricing reflects growing confidence in the product's value proposition, strong underlying demand trends, and the continued depth of adoption we are seeing both prescribers and facilities. Payer access remains both our most significant near-term friction point and our most significant near-term opportunity. We view this as a timing dynamic rather than a demand constraint, given the strength of our underlying prescription growth and repeat utilization trends. Our team continued active engagement with national and regional plans throughout Q1. To provide context on where we stand, we have Medicare Part D contracts in place with 2 major PBMs representing approximately 45 million covered lives. Both contracts carry no prior authorization requirements for ZUNVEYL. This positions us favorably from a policy standpoint once implementation expands across downstream plans. Implementation across downstream plans clients is currently at approximately 16% of the total contracted book of business.
When our reimbursement team helps support the prior authorization submission process, our approval rate is approximately 89%. The path to broader implementation is a waiting-and-seeing game typical of an access curve. As is common with newly launched therapies, plans are monitoring early utilization trends before fully activating formulary access across their networks. We expect contracts to begin gaining meaningful traction in Q2 and Q3, and we are working to accelerate this through our real-world evidence program and our expanded payer engagement team. We are seeing small pockets of improvement across specific plans and regions, and our focus now is on scaling those early wins into broader system-wide adoption across large national plans. Our full sales team of 60 customer-facing representatives and management is now in place and productive. With the team fully deployed, we are now focused on driving productivity and conversion efficiency across territories.
We are also leveraging AI-enabled commercial analytics and targeting tools to help optimize territory execution, identify high-value prescriber opportunities, and improve the efficiency of our field engagement efforts. We believe these capabilities will allow us to scale our commercial organization thoughtfully while maximizing return on investment. In Q1, we completed our speaker training for 48 key opinion leaders and have begun rolling out our peer-to-peer educational program, an important tool for converting curious prescribers to confident ZUNVEYL writers. We presented new clinical data at the American Association for Geriatric Psychiatry conference in April, and we are presenting at the Neuroscience Education Institute Spring Congress in May. These engagements are key components of our strategy to reinforce clinical confidence and expand awareness among high-value prescribers.
These conference appearances, combined with our digital educational programs and virtual webinar series, represent a comprehensive multi-channel approach to building scientific credibility and prescriber confidence for ZUNVEYL. In summary, Q1 2026 was a quarter of deliberate, well-executed commercial progress. We are seeing strong underlying demand, high repeat utilization, and increasing depth of adoption across both prescribers and facilities. We are growing our prescriber base, deepening facility penetration, building a compelling evidence base, and making steady progress on payer access. As access expands, we believe these fundamentals position us well for continued acceleration. I'll now hand it back to Michael for closing remarks.
Thank you, Lauren. Let me briefly summarize what I believe are the key takeaways for the company for Q1 2026. First, ZUNVEYL's growing. We delivered 40% sequential growth in revenues from Q4 to Q1, and our highest bottle count since launch was in March. We continue to grow, and our commercial trajectory is accelerating. Secondly, our clinical programs are advancing ahead of schedule. BEACON will complete enrollment this quarter. We expect top-line data reported no later than early Q3. RESOLVE and CONVERGE will initiate this quarter. By the end of 2026, we'll have 2 real-world evidence datasets in hand, a powerful foundation for our payer coverage expansion and also to build prescriber confidence. Third, we're scaling with discipline. Our Q1 operating spend of approximately $12 million reflects intentional investment in the resources needed to win in our market, and we're building very deliberately.
Full year 2026 expects guidance of $54 million-$58 million is unchanged. We remain on track for operating profitability in 2027. Fourth, our organization's stronger than ever. Our full field team is in place. We've added meaningful payer and marketing talent. We've strengthened our board. We're building this company to win. We're excited about the balance of 2026, our pipeline of near-term catalysts, BEACON data, CONVERGE data, both in Q3, sublingual PK data in Q3, continued ex-U.S. milestones that will advance and ongoing payer progress. All of these things give us encouraging signs that our platform we built for ZUNVEYL will continue to reap rewards. Operator, with that comment, we'll now take questions.
Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. 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. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Thank you. Our first question comes from the line of Ram Selvaraju with H.C. Wainwright. Please go ahead.
I thank you for taking my question. This is Jan, sitting in for Ram. I have a few questions. The first is, would you be able to tell me if there have been any notable changes in prior authorizations or step edit requirements over the past several months?
Sure. Thanks for the question. I would say that there has not been a noticeable change in terms of an increase or decrease in the number of prior authorizations since launch, really. What we have seen a change in is our approval rate. When our reimbursement team is able to support the prior authorization with the additional resources and just experience over the past year, we know what it takes to get a prior authorization approved. You will see that we say 89%, but sometimes higher from an approval rate for those prior authorizations. No, we haven't seen any really hard restrictions put in place in terms of step edits or prior authorizations. I would say it's pretty consistent over the last three quarters.
Got it. For my next question, I was wondering if you'd be able to tell me, are there any anticipated to be key feasibility milestones that would be reached in the development of the film formulation over the remainder of 2026?
Yes. That's a great question. We are advancing with a PK study comparing our sublingual formulation to our tablet formulation. Should that data show equivalence, we will submit an IND to FDA for that sublingual program, which we believe, if approved, would move us to clinic, and we anticipate delivering that IND the latter part of the year.
Thank you. I have one more if there's time. What will be the cadence of data release from the ongoing and planned clinical studies of ZUNVEYL in the post-approval context?
Another good question. We are completing enrollment with BEACON much earlier than we anticipated. We anticipated enrollment and top-line data reported the latter part of Q4. We're completing enrollment this quarter. We have to analyze the data and review our tables, and we anticipate that we'll be able to release top-line data for BEACON no later than early Q3. Well ahead of expectations. Significance of the study is that this is one of the only datasets in long-term care, the segment that we participate in, that will be published and will be executed from a study standpoint. The data should give us insights in ZUNVEYL efficacy for both cognition and behavioral response.
It'll give us data on tolerability for ZUNVEYL, and it'll also give us data on polypharmacy, the use, increase, or decrease of other agents when ZUNVEYL is utilized in therapy. It's a goldmine of data, and I anticipate there'll be a lot of publication opportunities from BEACON. CONVERGE initiates this quarter. It's a retrospective data analysis, so the work will be done rather efficiently, and we anticipate top-line data from CONVERGE will occur in Q3 of 2026. We'll have our first segment of that data complete in Q3, and there'll be additional segments that will follow. All of those datasets will be publishable, and we'll be submitting for publication with both CONVERGE and BEACON. RESOLVE initiates in Q2. We don't expect that RESOLVE will complete in 2026. It'll complete in Q2 of 2027.
Got it. Thank you so much.
Our next question comes from the line of Chase Knickerbocker with Craig-Hallum Capital Group. Please go ahead.
Good afternoon. Thanks for taking the questions. Maybe just two from me. I'll ask them both upfront. You spoke to March acceleration. Helpful to understand the cadence through the quarter. Can you just maybe speak to what extent you've seen that acceleration, you know, that trend continue into April? You know, kind of what you kinda see as driving it in March and again, you know, what you're seeing in April. Are you seeing your kinda lower tenure reps starting to be more productive, et cetera? Just second, you know, your kinda customer metrics are growing at a similar kinda rate as volume if we look sequentially. How should we kinda think about the deepening of prescribing patterns?
Do you have any cohorts that are, you know, mature enough over the course of the last couple quarters that you can kinda see how that trend develops as far as, you know, a prescriber that's been writing for two or three quarters and how the deepening of their prescribing patterns occurs over time? Thanks.
Sure. Two really good questions. I'll start with the first one. Yes, March was our biggest month since launch. We saw the highest number of bottles dispensed, and we are seeing that continued acceleration into April. You know, I think when we look at these key foundational factors that we put into place, we completed, you know, the increase in our sales force, our customer-facing sales force. That really completed, you know, in the early part of this quarter. We've put our speakers in place, our speaker program execution. We've made some adjustments in our payer team and our marketing team to bring on just more power as we approach the market. With each passing day, we are seeing continued acceleration, and we expect that acceleration to continue in a very positive, you know, momentum.
As for the way that we're segmenting the market, you're absolutely right. We've talked a lot about that over the past year. You know, typically, a provider will try the product. You know, it's a very vulnerable population in the long-term care community, they'll try a couple of patients. They wait a month, two, sometimes three months to see how the drug performs, then they'll add additional patients onto ZUNVEYL. At this point, we are very in tune with that adoption pattern, how fast it takes a physician to move from one tier, you know, to the loyalist tier, if you wanna call them that. What we're seeing is very, very positive.
All the entire commercial team is focused on these segment of physicians who have tried, they've got a few patients on, and we can move them further to the right, and that's exactly how we're approaching the market. We definitely understand the pattern. We continue to see more and more physicians move into that loyalist bucket, and we'll continue to execute our tactics with a focus on that type of segmentation. I don't know if that answers your question, but that's kinda how we are actually focusing our tactics and our activity.
It does. Thank you. Very helpful. Thanks for taking the questions.
Your next question comes from the line of Dave Storms with Stonegate. Please go ahead.
Evening, thank you for taking my questions. Lauren, I wanted to start maybe with the AI analytics comment that you made.
Sure.
Give us that maybe a little more color about how far along this is and maybe any early results here?
Sure. No, absolutely. Our team, you know, Michael and I, from the very beginning, have really tried to be out in the forefront as it relates to AI capabilities, it's not that hard to implement AI tools in today's environment. We have actually started applying AI tools across the board, not just commercial, but really across the entire company. Most of our team members are using AI on a daily basis. As it relates to our commercial opportunity, how we're approaching the market, how we're segmenting the market, that's really where we're leveraging the AI tools.
As you can imagine, we have a ton of data, you know, that is constantly coming in on a daily basis, and we're able to leverage those tools to really decipher the key information that we need to turn around and approach the market, you know, with a very specific tactic. We've used it across the board from a targeting perspective. We've used it across the board for a segmenting perspective. We're using it daily just to be more efficient from an administrative perspective across the team. We really are at the point. We're not all the way where we're, I would say, we're 100% AI, but we have definitely probably adopted AI, and we're using it to be more efficient, more targeted, make sure we're calling on the right customers, making sure that we're delivering the right message to the right customer.
I think we are actually pretty far above most companies in our AI, you know, technical capabilities.
Understood. Thank you. Maybe just a quick modeling question as well. The R&D call-out that it's gonna be a little bit higher in Q2, should we expect this to kind of ramp with the studies throughout the year? Are there any variables that would make this a little more bumpy?
Yeah, I think it'll depend on enrollment with Resolve. Resolve is the majority of our R&D spend in 2026. We're initiating first patient in Q2. We should see some acceleration in Q3, Q4. One would think that would be later, David, but we have a lot of sites that will be un-enrolling in Q3, so it will depend on how fast they begin to enroll patients. It could be a little bit of bump, there could be a little bumpiness in Q3, Q4.
That's perfect. Maybe one more for me, Michael. You mentioned in your prepared remarks, that you have a new TBI patent. Recognizing that this is a long-term project for you guys, is there just maybe any more information you can give us here about kind of what the outlook is for this channel?
No, it's extremely exciting opportunity for the company. $14 billion market opportunity. Affects patients from teenage years all the way to 65. That's where the majority of the patients reside, across all patient age ranges. No approved product to treat TBI, and there's nothing really off-label that's used that works to treat the cognitive impairment that occurs in about one-half of concussion or TBI patients. We're really excited about our early phase data. We'll roll that out this year. The fact that our drug demonstrated significant cognitive effects, neurogenesis, a decrease in inflammation, mobility improvements, et cetera. That data is very good pre-clinical data. You know, we'll see if it translates into the clinic, we're most excited about advancing that program.
From a clinical next steps, we plan to use our sublingual formulation for TBI. We have met with the agency on pre-IND program, we will run a tox study, a 12-week tox study this year. We believe that is all the pre-clinical work needed for that program to advance an IND, which would move us to the clinic.
That's perfect. Thank you very much.
This now concludes our question and answer session. I would like to turn the floor back over to Michael McFadden for closing comments.
Thank you, operator. Thanks for everyone for joining us this afternoon. We feel like the company is executing, both with our KPIs, our clinical study expertise to support our payers and healthcare professionals, and we encourage everybody to continue to watch the company as it continues to execute in Q2. If those attending this call or reading the transcript have questions, feel free to reach out to our IR group, and we're happy to answer follow-up questions that result following this call. Thank you for attending.
Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines, and have a wonderful day.
Investor releaseQuarter not tagged2026-05-07Alpha Cognition Inc. (ACOG) Expected to Beat Earnings Estimates: What to Know Ahead of Q1 Release
Zacks
Alpha Cognition Inc. (ACOG) Expected to Beat Earnings Estimates: What to Know Ahead of Q1 Release
Alpha Cognition Inc. (ACOG) is expected to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended March 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on May 14. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.41 per share in its upcoming report, which represents a year-over-year change of -105%. Revenues are expected to be $3.39 million, up 15.7% from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive...
Investor releaseQuarter not tagged2026-04-29Alpha Cognition (Nasdaq: ACOG) to Report First Quarter 2026 Financial Results and Provide Business Update on Thursday, May 14, 2026
Business Wire
Alpha Cognition (Nasdaq: ACOG) to Report First Quarter 2026 Financial Results and Provide Business Update on Thursday, May 14, 2026
Management to host conference call on Thursday, May 14, 2026 at 4:30pm ET VANCOUVER, B.C. & DALLAS, April 28, 2026--(BUSINESS WIRE)--Alpha Cognition Inc. (Nasdaq: ACOG), a biopharmaceutical company dedicated to advancing treatments for neurodegenerative diseases, today announced that it will report its first quarter 2026 financial results and provide a business update on Thursday, May 14, 2026, at 4:30 p.m. ET, after market close. The company will issue a press release detailing its first quarter financial results and business highlights on that date. The financial results and accompanying materials will be available in the News section of the Alpha Cognition website at www.alphacognition.com/investors/news/. Following the release, management will host a conference call to review financial and operating results. Conference Call Information: To participate in the conference call, please use the dial-in information below: Participant Listening: 1-877-407-9039 or 1-201-689-8470 or https://callme.viavid.com/viavid/?callme=true&passcode=13752398&h=true&info=company&r=true&B=6 Participants can use guest dial-in #s above and be answered by an operator, or click the Call me™ link for instant telephone access to the event. Call me™ link will be made active 15 minutes prior to scheduled start time. The live audio webcast will be accessible here: https://viavid.webcasts.com/starthere.jsp?ei=1761279&tp_key=1a22b7db8e A replay of the earnings call is available after the conference call has ended. Replay Dial-In: 1-844-512-2921 or 1-412-317-6671 Access ID: 13760339 Replay Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1761279&tp_key=1a22b7db8e About Alpha Cognition Inc. Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease and Cognitive Impairment with mild Traumatic Brain Injury ("mTBI"), for which there are currently no approved treatment options. ZUNVEYL® is a patented drug approved as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer’s disease, with expected minimal gastrointestinal side effects. ZUNVEYL’s active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cogn...
Investor releaseQuarter not tagged2026-04-01Alpha Cognition (ACOG) Q4 2025 Earnings Transcript
Motley Fool
Alpha Cognition (ACOG) Q4 2025 Earnings Transcript
Image source: The Motley Fool. Thursday, March 26, 2026 at 12 a.m. ET Chief Executive Officer — Michael McFadden Chief Operating Officer — Lauren D’Angelo Chief Financial Officer — Henry Du Need a quote from a Motley Fool analyst? Email [email protected] Henry Du: Thank you, Sherry. Good afternoon, and thank you, everyone, for joining us today for Alpha Cognition's Fourth Quarter and Full Year Fiscal 2025 Results Call. Today, after the close of market, the company issued a press release announcing our financial results. Joining me on the call today are Alpha Cognition's Chief Executive Officer, Michael 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.alphacognition.com. During the course of this call, management may make certain forward-looking statements regarding future events and the company's future performance. These forward-looking statements reflect Alpha Cognition's current perspective on existing trends and information. Any such forward-looking statements are not guarantees of future performance and involve 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 statements. Please review the note regarding forward-looking statements in our earnings press release was disseminated prior to this call for more information on forward-looking statements. Please also note that the company's actual consolidated financial results remain subject to completion of our annual audit procedures. Our actual audited consolidated financial results are expected to be reported in connection with the filing of our annual report which is expected to be filed on or about March 31, 2026. Our actual consolidated financial results may differ from the results discussed on this call, including as a result of audit adjustments and other developments that may arise between now and when the financials are finalized and filed. The results discussed on this call should not be viewed as a substitute for audited consolidated financial statements and related notes. Accordingly, you should not place undue reliance on the results discussed in this call, which have been prepared by and is a responsibility of our management. For the benefit of those of you w...
Investor releaseQuarter not tagged2026-03-27Alpha Cognition Inc. Common Stock Q4 2025 Earnings Call Summary
Moby
Alpha Cognition Inc. Common Stock Q4 2025 Earnings Call Summary
Performance in Q4 was driven by a 62% quarter-over-quarter growth in ZUNVEYL demand, with December marking the strongest month since launch at 1,859 bottles dispensed. Management attributes accelerating adoption to a 'predictable adoption curve' where providers initially trial the drug on 1-2 patients before expanding use after observing behavioral and tolerability outcomes. Strategic focus has shifted toward the $2 billion long-term care market, specifically targeting medical directors and psychiatry consultants who prioritize symptom and behavioral management. The company successfully secured a second national PBM contract, now covering two of the top four PBMs, which management views as a critical foundation for downstream plan access. Operational expansion included fully filling the sales force and increasing the field reimbursement team to address payer friction points and facilitate patient initiation. Management highlighted a significant lack of recent acetylcholinesterase education in the market, positioning ZUNVEYL's dual mechanism of action as a key differentiator for behavioral symptoms. The $40 million capital raise in Q3 2025 is being deployed to expand commercial reach and fund real-world studies intended to strengthen the value proposition for payers. Management is targeting operational profitability in 2027, supported by a current cash runway that extends well into that year. Payer access is expected to see early traction in Q2 2026 with 'broad implementation' of downstream plans anticipated in Q3 2026. The company expects to report top-line data from the CONVERGE polypharmacy study in Q3 2026 and the BEACON tolerability and efficacy study in Q4 2026. Strategic product approvals in two Asian countries via partner CMS Pharma are anticipated in 2026, alongside a contingent business development milestone payment from the Chinese government. Clinical development for the sublingual formulation is slated to advance toward a Type C FDA meeting in late summer 2026, with a potential clinic entry in early 2027. Reported GI adverse events remain in the low single digits, which management notes is significantly lower than the 'triple digits' typically expected at this stage of a launch. Operating expenses for 2026 are projected between $54 million and $58 million, reflecting increased investment in clinical studies and sales infrastructure. Payer coverag...
Investor releaseQuarter not tagged2026-03-27Alpha Cognition Inc. Reports Fiscal 2025 Financial Results and Provides Operational Update
Business Wire
Alpha Cognition Inc. Reports Fiscal 2025 Financial Results and Provides Operational Update
Alpha Cognition generated fourth quarter 2025 ZUNVEYL net product revenue of $2.5 million, contributing to full year 2025 total revenue of $10.2 million Fourth quarter bottles dispensed increased 62% quarter-over-quarter to 4,941, with December representing the strongest month since launch Executed second national PBM contract and initiating three studies to further support ZUNVEYL’s positioning in long-term care Alzheimer’s patients Cash and cash equivalents totaled $66 million at year-end 2025, supporting the company’s continued target of operating profitability in 2027 Company to host conference call and webcast today, March 26, at 4:30 p.m. ET VANCOUVER, British Columbia & GRAPEVINE, Texas, March 26, 2026--(BUSINESS WIRE)--Alpha Cognition Inc. (ACOG: NASDAQ) ("Alpha Cognition", "ACI", or the "Company"), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. "2025 was a year of strong commercial execution for Alpha Cognition as we continued to build momentum for ZUNVEYL – the first new oral Alzheimer’s treatment approved in more than 15 years. In the fourth quarter, we saw strong growth in demand, with December representing our strongest month since launch. We’re encouraged by the increasing rates of repeat ordering, indicating ZUNVEYL is moving beyond initial trial and becoming increasingly integrated into routine management in long-term care," said Michael McFadden, Chief Executive Officer of Alpha Cognition. "Importantly, we also executed a second national PBM contract, bringing us to two of the four major PBMs relevant to long-term care. Combined with the consistent clinical feedback we’re hearing on ZUNVEYL’s tolerability and behavioral profile, we believe we are well positioned to continue driving adoption as payer pull-through improves in 2026. We enter the year well-capitalized and focused on expanding our commercial footprint, deepening prescriber engagement, and advancing toward operational profitability in 2027." ZUNVEYL Commercial Performance Net ZUNVEYL Revenue: Generated approximately $2.5 million in net product revenue in the fourth quarter of 2025. Launch-to-date net product revenue through year-end 2025 was approximately $6.8 million. Total revenues for the year 202...
Investor releaseQuarter not tagged2026-03-27Alpha Cognition Q4 Earnings Call Highlights
MarketBeat
Alpha Cognition Q4 Earnings Call Highlights
Alpha Cognition reported Q4 total revenue of $2.8M (including $2.5M in net ZUNVEYL sales) with 4,941 bottles dispensed in Q4 and management highlighting strong adoption in long-term care—bottles dispensed grew 62% QoQ and 82% of homes ordering in Q4 were repeat customers. The company signed a second national PBM contract (now agreements with two of four major PBMs) and expects "downstream pull-through" to start showing early traction in Q2 2026 with broader plan-level implementation in Q3 2026. Alpha Cognition ended 2025 with about $66 million in cash and no debt, sees that funding as runway "well into 2027," expects 2026 operating expenses of $54–58M, and is targeting operating profitability in 2027. Interested in Alpha Cognition Inc.? Here are five stocks we like better. Alpha Cognition (NASDAQ:ACOG) executives told investors the company is seeing continued sales growth and what it described as accelerating, durable adoption following the commercial launch of ZUNVEYL, an oral treatment approved for mild to moderate Alzheimer’s disease. Management emphasized early demand indicators in the long-term care channel, progress on payer access through additional pharmacy benefit manager (PBM) contracting, and a slate of real-world studies planned for 2026 to support positioning with providers and payers. Chief Executive Officer Michael McFadden said the fourth quarter represented the company’s “third full quarter” after the commercial launch of ZUNVEYL and reiterated the company’s belief that the product has a meaningful opportunity in long-term care, where symptom management, tolerability, and behavioral management can drive treatment decisions. → Microsoft’s Next AI Leg: Can MSFT Still Outperform From Here? For the fourth quarter, the company reported total revenue of $2.8 million, including $2.5 million in net product revenue from ZUNVEYL. For the full year, Alpha Cognition reported total revenue of $10.2 million, including $6.8 million in net product sales. Management highlighted several launch and adoption indicators during the quarter: 4,941 bottles of ZUNVEYL dispensed in Q4, including 1,859 bottles in December, which executives said was the strongest month since launch. The field team reached almost 2,000 nursing homes during the quarter, bringing the launch-to-date total to nearly 4,000 unique facilities (Lauren D’Angelo later specified 3,856 unique homes...
TranscriptFY2025 Q42026-03-26FY2025 Q4 earnings call transcript
Earnings source - 29 paragraphs
FY2025 Q4 earnings call transcript
Greetings. Welcome to Alpha Cognition Fourth Quarter and Full Year 2025 Earnings Call. [Operator Instructions] Please note this conference is being recorded. I will now turn the conference over to Henry Du, Interim CFO. Thank you. You may begin.
Thank you, Sherry. Good afternoon, and thank you, everyone, for joining us today for Alpha Cognition's Fourth Quarter and Full Year Fiscal 2025 Results Call. Today, after the close of market, the company issued a press release announcing our financial results. Joining me on the call today are Alpha Cognition's Chief Executive Officer, Michael 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.alphacognition.com. During the course of this call, management may make certain forward-looking statements regarding future events and the company's future performance. These forward-looking statements reflect Alpha Cognition's current perspective on existing trends and information. Any such forward-looking statements are not guarantees of future performance and involve 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 statements. Please review the note regarding forward-looking statements in our earnings press release was disseminated prior to this call for more information on forward-looking statements. Please also note that the company's actual consolidated financial results remain subject to completion of our annual audit procedures. Our actual audited consolidated financial results are expected to be reported in connection with the filing of our annual report which is expected to be filed on or about March 31, 2026. Our actual consolidated financial results may differ from the results discussed on this call, including as a result of audit adjustments and other developments that may arise between now and when the financials are finalized and filed. The results discussed on this call should not be viewed as a substitute for audited consolidated financial statements and related notes. Accordingly, you should not place undue reliance on the results discussed in this call, which have been prepared by and is a responsibility of our management. For the benefit of those of you who may be listening to the replay, this call is being held and recorded on March 26, 2026. Since then, the 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. Alpha Cognition declines any obligation to update these forward-looking statements, except as required by applicable securities laws. I'll now turn the call over to Michael.
Thank you, Henry, and good afternoon, everyone. Thanks for taking time to join us on today's call. This quarter marks our third full quarter following the commercial launch of ZUNVEYL for the treatment of mild to moderate Alzheimer's disease. As a reminder, ZUNVEYL is the first new oral Alzheimer's treatment approved in more than 15 years, and we believe it has a meaningful opportunity in long-term care where symptom management, tolerability and behavioral management are central to care decisions. To sum up our results, the commercial launch progress and what we're focused on in 2026, the fourth quarter and fiscal year was characterized by the following: continued sales growth and ongoing demand expansion of ZUNVEYL, further traction in long-term care, including expanding both breadth and depth of prescribing in the $2 billion high-volume long-term care market; progress on payer access, including a second signed contract with a national PBM, which now gets us contracted with 2 out of the top 4 PBMs nationwide. The company raised $40 million in Q3, which enabled us to appropriately expand our commercial reach and payer engagement strategies. And importantly, we maintained a strong financial foundation, which we believe keeps the company well funded with a clear path toward operational profitability in 2027. In addition to the solid commercial and operational progress the company has made, we announced 3 real-world studies that are or will be initiated in 2026. These studies will provide further evidence to strengthen ZUNVEYL's positioning with payers and provide additional evidence for health care providers who need a therapy that's well tolerated and demonstrates behavioral and cognitive efficacy for their patients. Lauren, our COO, will come on later and talk a bit more about how our commercial strategy is progressing as well as comment on the payers who obviously pay an integral part of our market penetration strategy. Before I discuss our leading indicators in demand and adoption, let me briefly speak to revenues. For the fourth quarter, we generated total revenues of $2.8 million, including net product revenues of $2.5 million from ZUNVEYL. Launch to date through year-end 2025, Alpha Cognition has generated total revenues of $10.2 million. We view these results as an early important foundation for the company. At the same time, we recognize that in the initial phase of launch, reported revenue can be influenced by the pace of payer coverage and the national ramp in prescribing behavior, and they may not fully reflect long-term potential of the product. That's why our emphasis remains on the leading indicators that tell us whether ZUNVEYL is building a durable, scalable trajectory in the long-term care setting. Today, what we're most focused on is the underlying demand indicators and durability of adoption, particularly repeat ordering behavior, increased provider confidence and expanding payer access, which we believe are the most reliable predictors of sustained performance and future growth. In terms of demand indicators in Q4, we dispensed 4,941 bottles of ZUNVEYL, including 1,859 bottles in December alone, our strongest month since launch. And our sales team reached almost 2,000 nursing homes during the quarter, bringing our launch to date to nearly 4,000 unique facilities. We're also encouraged by what we're seeing in terms of depth of prescribing. Prescribing doctors increased 50% versus Q3 and cumulative homes with prescriptions increased 69% in Q4, which is an early indicator of expanding adoption across our commercial footprint. Taking a step back, we believe the adoption curve is doing what we would expect in long term. The providers start cautiously, they treat a small number of patients. They observe the tolerability and the clinical outcomes for these patients, and then they move toward broader use. Speaking of payers, payer access remains a major friction point with prescription approvals, but it also presents a major opportunity for the company. The team is working with payers to demonstrate compelling data that we believe will improve coverage for ZUNVEYL in the coming quarters. I'm pleased to announce that we executed a second national PBM contract during the quarter in addition to the first PBM contract previously announced. That means we now have agreements with 2 of the 4 major PBMs that are relevant to our long-term care business. Our execution now shifts to downstream pull-through, ensuring that contracted coverage translates into practical access at the plan level with fewer or no restrictions and a smoother prior authorization process. We believe progress here can be a meaningful accelerant to new starts and sustained growth. Lauren will speak more on this in detail, including timing expectations for early traction and broad implementation. Regarding clinical performance, ZUNVEYL appears to be performing consistently with few adverse events reported. Reported GI adverse events continue to be in the low single digits. Spontaneous adverse event reporting is still limited to 2 GI adverse events at the end of the quarter, and we would have expected reports in the triple digits at this point during the launch. Regarding medical progress, the company completed the year with 15 abstracts and posters submitted and presented at medical meetings and conferences. We believe these data set a good baseline for acetylcholinesterase education to the market, which has been severely lacking in the last decade. The medical team now turns its attention this year to ZUNVEYL data focused on adverse events, behavioral response and MOA or method of action, all of which we believe differentiates ZUNVEYL from other drugs in the class. The company announced 3 studies in the last quarter, 2 in long-term care, one called BEACON and the second CONVERGE and one in the outpatient setting, that study is named RESOLVE. We believe the long-term care data will be differentiating with our customers as there are very few studies completed in long-term care. BEACON will provide ZUNVEYL data focused on tolerability, cognitive and behavioral efficacy. We initiated this study in February, and we're very pleased already with the quality and quantity of researchers who are participating in the study. We expect top line data in Q4 of 2026. CONVERGE will initiate in April. And with the construct of that study, top line data will be reported quickly in Q3 of 2026. And RESOLVE will initiate in Q2 in the outpatient setting. We believe data from RESOLVE will be promotional for the commercial team, and it could be label enabling for the company. Regarding R&D, the company continues to make progress with the sublingual formulation, and we will initiate a comparative PK study versus our tablet and intranasal formulations in Q2 of this year. The company believes the local toxicity study and an equivalent PK data set will be sufficient to advance the product to the clinic. From a business development perspective, our partner in Asia, CMS Pharma, continues to work through the regulatory process with multiple countries in Asia. We anticipate 2 strategic product approvals in 2026, which could provide incremental long-term growth opportunities for the company. The company still awaits approval of a business development milestone payment, which is contingent on a regulatory approval with the Chinese government. We anticipate this payment will materialize in 2026, although we cannot say when. We believe it's not a question of approval, but of timing. We are working constructively with -- on this process with the Chinese regulatory authorities. The company continues to capitalize on emerging opportunities in the long-term care market. Chief among these is optimally positioned ZUNVEYL, which has clinically meaningful benefits, both cognitively and behaviorally to treat symptoms associated with Alzheimer's. As noted, the company raised $40 million in Q3, and we immediately put the capital to work. We've increased our field team reach with long-term care medical directors and consultant psychiatry community. We also initiated marketing resources that will better position ZUNVEYL as a treatment of choice for symptom management of Alzheimer's disease. Our sales force increases and the improved marketing efforts will position the company to take advantage of these opportunities in the coming quarter. With this investment, combined with the early demand indicators we're seeing, we believe the company is well funded to execute our commercial strategy, and we're focused on driving toward operating profitability in 2027. Lauren will discuss more on our commercialization process momentarily, but first, Henry will speak to the financials for the company. I'll now turn it over to Henry.
Thanks, Michael, and good afternoon, everyone. As I review our fourth quarter and full year 2025 results, please refer to today's press release or our Form 8-K filing. I'll begin with a review of our financial results for the fourth quarter and full year 2025, followed by an update on our balance sheet and expectations for 2026. Overall, the year reflected continued commercial progress for ZUNVEYL, supported by growing prescriber adoption and investments in our commercial infrastructure. Starting with revenue. For the fourth quarter, we generated total revenue of $2.8 million, driven primarily by $2.5 million in net product sales from ZUNVEYL, our lead commercial product. We also recognized $259,000 in licensing revenue from our collaboration with CMS Pharma. For the full year, total revenue was $10.2 million, including $6.8 million in net product sales from ZUNVEYL. These results reflect steady growth in adoption, and we continue to receive positive feedback from prescribers and caregivers regarding the impact ZUNVEYL is having on patients. Turning to operating expenses. Total operating expenses for the fourth quarter were $10.7 million, which included $258,000 in cost of goods sold and cost of revenues and $10.4 million in SG&A and R&D expenses. This compares to $2.7 million in operating expenses in the fourth quarter of 2024. For the full year of 2025, total operating expenses were $32.9 million, which included $1.9 million in cost of goods sold and cost of revenues compared with $12 million in 2024. The year-over-year increase primarily reflects higher SG&A expenses associated with the expanding commercialization organization, including personnel costs as we continue building our sales team and supporting the launch and commercialization of ZUNVEYL. As a result, we reported an operating loss of $7.9 million for the quarter compared to $2.7 million in the fourth quarter of last year. For the full year, operating loss was $22.7 million compared to $12 million in 2024. Moving on to net loss. For the fourth quarter of 2025, we reported a net loss of $6.9 million or $0.30 per share compared with a net loss of $5.8 million or $0.52 per share in the same period last year. For the full year 2025, net loss was $20.7 million or $1.17 per share compared with $14.8 million or $2.04 per share in 2024. These results include a gain from change in fair value of warrant liabilities of $441,000 in the fourth quarter and $88,000 for the full year compared to losses of $3.3 million and $3.2 million, respectively, for the same period last year. Turning to the balance sheet. We continue to maintain a strong financial position and remain debt-free. As of December 31, 2025, we had approximately $66 million in unrestricted cash and cash equivalents, including roughly $38 million in net proceeds raised in October 2025 through our equity offering and over-allotment exercise. Based on our current operating plan, we believe this capital provides operational runway well into 2027, supporting both our commercial initiatives and ongoing development activities. Regarding expectations for 2026, as in prior periods, we are not providing formal revenue guidance. However, we expect continued sequential growth in ZUNVEYL sales through 2026 as physician awareness increases and payer access continues to expand. Finally, from an expense perspective, we currently expect full year 2026 operating expenses to be in the range of $54 million to $58 million. The increase primarily reflects planned clinical studies intended to generate additional efficacy data for ZUNVEYL as well as continued investment in sales and marketing initiatives to further educate prescribers on the benefits of our drug. With that, I'll turn the call over to Lauren. Lauren?
Thanks, Henry. The fourth quarter marked what we believe is an important inflection point in the U.S. launch of ZUNVEYL in long-term care. What we are seeing now is not just continued growth, it is accelerating durable adoption. In Q4, total demand measured as bottles dispensed reached 4,941 bottles, representing 62% quarter-over-quarter growth. Just as importantly, demand strengthened through the quarter with 1,859 bottles dispensed in December, our strongest month since launch. That December performance gives us meaningful momentum as we enter 2026. While Ex-factory shipments can fluctuate as wholesalers manage inventory, what matters most at this stage is underlying patient demand, which continues to build consistently and sequentially. Adoption is compounding. The most encouraging signal we're seeing is repeat behavior. In Q4, we engaged 1,986 homes, bringing total REITs launched to date to 3,856 unique homes. 729 homes placed orders and 82%, over 600 of those were repeat orders. That level of repeat order activity this early in launch tells us ZUNVEYL is moving beyond initial trial use and becoming embedded in facility treatment protocols. We also added nearly 100 new ordering homes in the final month of the quarter, demonstrating that new adoption continues even as existing homes expand utilization. On the prescriber side, we recorded 3,681 total HCP calls, including nearly 2,000 prescriber calls. Approximately 865 prescribers wrote orders in Q4 and 69%, roughly 600 prescribers were repeat writers. That repeat rate is critical. What we consistently observe is a predictable adoption curve. Providers start cautiously. They treat 1 or 2 patients they observed behavioral improvement and strong tolerability and then prescribing expands. We are in that expansion phase. Behavioral differentiation is also driving acceleration. Our behavioral positioning continues to resonate strongly. Physicians are increasingly comfortable titrating patients to the 10-milligram therapeutic dose, and that comfort is building faster than we expected. That reflects growing confidence in ZUNVEYL's tolerability profile and limited GI adverse events. In long-term care, behavior drives resource utilization, caregiver burden and facility stability. When providers see meaningful improvement in that domain, adoption accelerates, and we are hearing that consistently across regions. Payer unlock is the next catalyst for us. While demand is accelerating, payer coverage is still in the early stages of pull-through. As we expand unrestricted coverage and streamline prior authorizations, we expect reduced friction and patient initiation and increased velocity of new starts. Importantly, demand growth today is occurring despite limited unrestricted access. As coverage broadens, we believe it will act as a force multiplier. Importantly, and as shared during our last call, we expected to sign a second national PBM contract by year-end 2025, and I'm pleased to report that we achieved that milestone. We now have 2 of the 4 major PBMs under contract, and we are intensely focused on downstream plan execution. We expect to begin seeing early traction in Q2 with broader implementation in Q3. Another key catalyst for 2026 is the activation of peer-to-peer education. In January, we completed national speaker training for 48 key opinion leaders across long-term care and psychiatry. These key opinion leaders will now begin leading structured educational programs across the country. Up until this point, adoption has largely been driven by our field team. As peer-to-peer education expands, we expect increased physician pull-through, broader clinical validation and an acceleration in prescriber confidence, particularly among our later adapters. In long-term care, education from trusted peers carry significant weight. We believe this initiative will amplify awareness, reinforce ZUNVEYL's behavioral differentiation and support continued acceleration throughout 2026. Let me share why we are so excited about 2026. When we take a step back, we see strong sequential demand acceleration, high repeat ordering rates, growing prescriber confidence, expansion of ordering homes, increasing comfort with therapeutic dose titration, expanding payer access, activation of national peer-to-peer education and upcoming real-world data milestones. We are no longer proving product market fit. We are now focused on scaling it. As we move into 2026, our focus is straightforward: expand penetration per home, deepen prescriber relationships, accelerate payer pull-through and execute with discipline. Based on the trajectory exiting Q4, we believe ZUNVEYL is well positioned for continued acceleration. And with that, I'll turn it over to Michael.
Thank you, Lauren. The team is focused on executing these quality calls with high-value medical directors and psychiatry consultants. We're meeting with health plans to pull through our PBM contracts, and we're working to manage efficiently the reimbursement process with our customers. Our relationship with CMS Pharma continues to grow. We're working through the regulatory process with our partner to gain approvals for ZUNVEYL in 2 countries this year. This last quarter, our leadership team has met with over 40 prescribers. The clinical outcomes they're seeing with ZUNVEYL are robust. The tolerability they see in patients is very good. They see improvements in cognition and improvements or complete amelioration of behaviors, and they report that commonly to us during these meetings. This gives us confidence that when we reduce the friction points with payers, our demand will grow. More importantly, we believe the company is well funded to execute, and we are focused on driving toward operational profitability in 2027, while building a durable commercial franchise around ZUNVEYL. We'll now take questions. Operator?
[Operator Instructions] Our first question is from Ram Selvaraju with H.C. Wainwright.
Congratulations on all this recent progress. I wanted to, first of all, start with some commercial aspects. I was wondering if you could give us some additional color regarding your anticipated timing for conversion of the additional payers that you haven't already converted as well as when you anticipate potentially promoting into the neurologist prescriber base relative to the long-term care facilities and those specialist prescribers?
Sure. Thanks, Ram, for the question. First, so timing conversion for the payers. So as we've shared with you all, we're really excited that we signed 2 of the big 4. So that represents a significant percentage of our overall business. And if you look at both of those PBMs, right now in one of the PBMs, we have about 16% open business. So we're still working really, really hard to pull through the rest of the regional plans on that PBM. And then we just signed that second PBM at the end of last year. So we're working through now the downstream accounts. The biggest downstream accounts are really who were targeted. And the plan -- we're having great conversations with those regional payers. Our thoughts around when we're going to start to see adoption for those regional plans, we expect that we're going to see some acceleration in Q2. So a small amount of those plans will likely pick us up in Q2 with broad implementation in Q3 is where we expect to see significant pickup from the downstream. Now as far as promoting into the neurologist or the specialty space, our plan has always been that as we get closer to breakeven, profitability in 2027, that's when we would look to expand into neurology.
Okay. And then with respect to the clinical development plans, I wanted to drill down specifically on 2 of these initiatives, one of which is obviously a current clinical program for ZUNVEYL. I was wondering specifically if you could give us some additional color on the key -- what you hope to be the key aspirational takeaways, if I can put it that way, from the CONVERGE study, in particular, as this pertains to polypharmacy because clearly, this study will provide a lot of important information, but we wanted to just kind of get a sense of assuming that you get the information that you expect this study to deliver, how that is going to play into your long-term promotional strategy for ZUNVEYL? And to what extent this study is likely to be a fulcrum with prescribers?
That's a great question. So CONVERGE is a data analysis of the long-term care market, and we plan to evaluate polypharmacy in 3 ways. In the long-term care market for the Alzheimer's patient, polypharmacy is very common for patients with sleep disturbance that occurs with the other agents in the class, patients with GI disturbance that is very commonly seen with other agents in the class and to control behaviors, which other agents in the class have a modest or no effect on being able to control. We anticipate with the advent or utilization of ZUNVEYL that we've seen in these homes that we'll see a reduction in that polypharmacy, but the data will tell that story, and that will be one of the #1 things that the study will look at. It will also look at things like adherence, tolerability dosing and consistency across ZUNVEYL and other agents in the class. So we'll have a plethora of data looking at all of those areas. We think that will be really key for providers and also decision-makers into determining positioning for ZUNVEYL with health plans and determining how they want to use ZUNVEYL in the long-term care marketplace.
Okay. Great. And then just lastly on the preclinical sublingual formulation. Three quick questions here. Firstly, I was wondering if you could comment on any additional precision with which you expect this to enter the clinic in 2026 and what the prerequisite steps might be for that milestone to be reached. Secondly, I was wondering if you could maybe just sketch out for us what you expect the clinical development time line and paradigm to look like for the sublingual formulation. I presume that it would also fall under the 505(b)(2) pathway, but perhaps you could give us some additional color regarding how you expect it to move towards potential market entry. And of course, if you could give us some sense of timing with which it might reach the market? And also if you have thoughts at this early stage regarding assuming success in clinical development, how this sublingual formulation would play alongside ZUNVEYL, how this might broaden your overall reach into the Alzheimer's community? And also if there are any technical plans envisaged with respect to looking at the feasibility of formulating not only ZUNVEYL sublingually, but also potentially generating combination therapies. So this would essentially involve sublingual delivery of both benzgalantamine and potentially other anti-Alzheimer's medications in the same sublingual formulation.
A lot to unpack there. Let me start with the position in the market with the sublingual. Why are we investigating and trying to advance the sublingual. In the long-term care marketplace, it's estimated that up to 20% of patients have dysphagia or aphasia. That's an inability or difficulty in swallowing a tablet or capsule formulation of any medication. Currently, these patients with Alzheimer's who have this difficulty either use a patch or if there's a capsule or a tablet, it's crushed or opened and put into a feeding tube or mixed with apple sauce and it's administered to the patient. As you can imagine, that's very challenging and difficult. The sublingual, we believe, will displace a very difficult-to-use patch and displace a very challenging administration in apple sauce or in a tube by simply putting this under the tongue, it dissolves within seconds. So it's easy to administer provided that the data allows us to move forward with the compound. Let me talk about the things that we're looking at and the milestones that we need to undertake in conquer to move this to the clinic. First, we are going to initiate a PK comparative study with our sublingual versus our tablet and our intranasal formulation. If that PK data shows parity, we will use that as the basis to enter the clinic with FDA. Now we'll need to complete a Type C meeting, which would happen in the late summer with FDA. And post a positive Type C meeting, we would be advancing the sublingual formulation to the clinic likely in the very first part of 2027. This will all be dependent upon the data from the agency, but we believe that's all that's needed. We've completed all other data that we believe we need to complete to move the product to the clinic. If we're able to move to the clinic, we would take a modified 505(b)(2) path. Our current thinking is we would complete a 505(b)(2) study. And then we would follow that with a tolerability study with the sublingual that could be label-enabling for that asset to allow us to utilize that data for both promotion and the label for the sublingual. That is to be determined on how long that study needs to be. That will be part of our Type C meeting conversation with FDA. We also plan to use the sublingual formulation to advance our program for cognitive impairment with mild traumatic brain injury. It's an easy to take formulation that would be administered easily for that patient population. So we have a dual use for that asset and dual programs that we will utilize the asset for.
And one clarification -- sorry, go ahead.
Regarding combo therapy, combo therapy will follow both of those programs. Those programs are #1 and #2 on the company's priority for medical development at this time.
Okay. Just one commercial clarification. I assume that if the sublingual formulation reaches the market specifically in order to address dysphasia or aphasia in Alzheimer's patients that you would anticipate being able to leverage it using your existing sales and marketing infrastructure and you would not, at that time, need to bring on additional sales firepower. Is that an accurate assumption?
Yes, you're correct that there's 100% synergy with the sublingual and our existing sales infrastructure.
Our next question is from Dave Storms with Stonegate Capital.
I actually kind of wanted to follow up there with the sales rep expansion. Just maybe what are you seeing here? Is it complete? Are there still territories to fill? And then I guess a follow-up to that would be, as the sales team continues to grow, when should we maybe expect some sort of inflection here, if any? Just trying to think about ramp times and the like.
Sure, sure. No, thanks for the question, Dave. So over the past quarter, the team has been focused on increasing the sales force to ensure that we have greater reach and frequency on our customer base. I'm pleased to announce that our increase is fully filled. So I know you asked how many territories do we have left to fill. We moved very quickly. That's the beauty of having a very experienced long-term care leadership team. I think we've talked about that a lot on previous calls. So we were able to expand our sales force as of January. And really, we had almost 98% full and then we've recently added a couple more reps in March to complete our full sales force expansion. So that's one key mechanism that we believe is going to accelerate the business significantly. There's also a couple of other things that we've done with the sales force. So we've really honed in on behaviors and going deeper with psychiatry. That was a big reason or factor on why we did expand the sales force because we found that our drug, the feedback we're getting on our drug and the behavioral symptoms is far better than we expected, and we knew that we need to expand to the psychiatry customer within the long-term care setting. And so we've done that. We're putting these new reps, the expanded reps out there delivering that message. And then on top of that sales force, right, because we know payer is a friction point for us, we've increased our reimbursement team. And that will allow, as the team has expanded, we put additional sales reps on the ground. We now have additional field reimbursement team who can help pull their demand through from a payer perspective. So that's been a key mechanism for us as well. And then, of course, with the expanded sales force, I know you asked a question about sales force, but it kind of -- it is a domino effect on all the other mechanisms that we put into place to fully support that expansion is this training of the 48 thought leaders so that with the additional sales force, they'll be able to leverage the KOLs and get out there and support the peer-to-peer education. So we really believe that really those 4 key areas are the mechanisms they're going to help us accelerate. And we believe that when it does, it's going to be very meaningful.
That's great color. I appreciate that. Can I just circle back maybe on to something you mentioned in your answer about expanding to psychiatry customers. Now that ZUNVEYL has been in the market and you're starting to get the market reception of it, I guess how else is that marketing changing? Is the psychiatry -- yes, go ahead.
Sure. Yes. When we originally launch the product, and I think even for several years leading up to the launch, right, when we were planning the positioning of ZUNVEYL, it was all about the tolerability, right? The no GI, we know that's a significant issue with the acetylcholinesterase inhibitors. And so that's really where we leaned into. Then we -- at the same time when we launched, we talked about the dual mechanism of action, and that's how it differentiates us from the other acetylcholinesterase in the class. So that was really our core positioning when we launched ZUNVEYL. But very quickly, and I think you guys will remember from the last couple of calls, the feedback we were hearing from customers around how this drug was working on behaviors really was just overwhelming. And behaviors, what we learned is really what drives adoption in the nursing home because the behaviors are what the physicians are obviously very concerned about when you've got this frail population living in a nursing home. So we've shifted our positioning. We still hone in on strong tolerability. I mean, to date, we still only have 2 spontaneous reports of GI. We've been out there for almost a year now. I mean that's pretty incredible if you think about it. Not to say that it's not happening in other places, we just haven't heard about it. But we've really shifted more to this behavioral messaging the dual mechanism of action supports that behavioral messaging, and it's widened our prescriber base because the psychiatrists in a nursing home treat those behaviors. So I would say we're still positioning on GI and tolerability, but it's really those 2 things, behaviors and tolerability. And that's really the small shift. But we made that shift pretty quickly a couple of quarters ago because we just kept hearing great stories from physicians. What I can say, David, is going all the way back to our first call, the first month we launched and the stories we were hearing, we hear those stories on a routine basis. I just talked to a customer yesterday. This is probably our most successful story yet, where there was a patient who was living in a nursing home, terrible behaviors, very agitated, there's a lot of these patients, but throwing things at the staff, that patient is going home after being on 3 months of ZUNVEYL. I mean you can't get a better success story than that. So we're really leaning into those providers who have tried it, they love it. You see that through the repeat ordering. We're leveraging that experience. We're now taking that experience through peer-to-peer education so that other providers who haven't adopted the drug will hear those stories. And then, of course, we're leaning into the product profile, which is behaviors and tolerability. So I hope that's helpful.
That's super helpful. And I mean, I know it's anecdotal, but that is a great story. One more, if I could. Michael, just because I really appreciate your answer around the CONVERGE study. If I could compare it maybe the same phrasing for the BEACON trial. Maybe just any thoughts on what aspirational outlook is like for BEACON and maybe compare it to CONVERGE?
Yes. So BEACON is a different study in that it will look at ZUNVEYL tolerability, ZUNVEYL efficacy in treating cognition, ZUNVEYL efficacy in treating behavioral symptomatology. And so we hope with -- at the end of that study, aspirationally, we hope that the study demonstrates strong cognitive effect, strong behavioral symptomatology amelioration or improvement, along with great tolerability for ZUNVEYL. That would be the hope. We'll see what the data tells us. But it's a very important study for us because in the long-term care market or long-term care segment of the Alzheimer's market, there are very few completed studies. There's very few observational Phase IV and almost no Phase III studies to evaluate drug performance evaluate drug tolerability. And so this will be one of the first studies that provides a very good data set and 200 patients in the nursing home market. And we plan to use that data not only with our providers, the physicians who treat but the nursing homes who administer care for the patients and just as importantly, the payers who are making coverage decisions on behalf of ZUNVEYL. So we think that study is going to be very meaningful for the company.
That's great. And just a point of clarification. You mentioned in your prepared remarks that we should expect those results in Q4 of this year?
Yes. For BEACON in Q4 of 2026. And for CONVERGE, we'll have top line data in Q3 of 2026.
We have reached the end of our question-and-answer session. I would like to turn the conference back over to management for closing remarks.
Okay. Thanks, everybody, for attending the call today. I think you've heard our focus for 2026. I'll just reiterate, we plan to continue to focus on sales execution. We plan to focus on payer coverage and improvement in ZUNVEYL coverage with our payers. While doing that, we'll work diligently to complete our studies on time and with high quality and advance our R&D pipeline. And along with all of that, as we have done, to date, we'll manage our expenses appropriately to move to operating profitability in 2027. So you can look forward for updates on all of those items as you follow the company through the course of 2026. Thanks for attending.
Thank you. This will conclude today's conference. You may disconnect at this time, and thank you for your participation.

