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ACOG

Alpha CognitionD
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-14
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Earnings documents stored for ACOG.

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Investor releaseQuarter not tagged2026-08-14

Alpha Cognition Inc. Common Stock Q2 2026 Earnings Call Summary

Moby
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. Delivered 71% sequential net product revenue growth in Q2 2026, reaching approximately $6 million, driven by a 37% increase in bottle demand. Achieved high repeat utilization rates, with 76% of prescribers and 81% of nursing homes placing repeat orders, signaling ZUNVEYL's transition into routine clinical practice. Attributed strong demand to clinical pull rather than formulary tailwinds, as the company saw significant growth despite static payer access levels. Focused commercial efforts on the long-term care (LTC) segment, utilizing a right-sized 60-person field force to target high-volume facilities and prescribers. Advanced the 'evidence generation' strategy to differentiate ZUNVEYL, highlighting improvements in cognition, neuropsychiatric symptoms, and polypharmacy reduction from the BEACON study. Maintained a high GAAP gross product margin of approximately 94%, reflecting efficient manufacturing and supply chain economics. Simplified the capital structure and improved future cash flows by completing the early settlement of the Galantos Pharma royalty obligation. Reiterated the target to achieve operating profitability in 2027, supported by disciplined capital deployment toward high-return commercial and clinical opportunities. Lowered full-year 2026 operating expense guidance to a range of $50 million to $54 million, down from the previous $54 million to $58 million range. Anticipates top-line data from the CONVERGE retrospective study in Q3 2026, which will be used to strengthen pharmacoeconomic arguments for payers. Expects the RESOLVE study to complete in Q2 2027, providing further clinical validation to support long-term prescriber confidence. Plans to evaluate expansion into the neurology specialist and retail markets only after achieving operating profitability and securing broader payer coverage to avoid high abandonment rates. Identified the Inflation Reduction Act (IRA) as a significant headwind for Medicare Part D plans, which has slowed the pace of broad formulary activation. Acknowledged that payer access expansion is tracking slower than previously projected, characterizing it as a timing dynamic rather than a demand constraint. Noted that while patient churn exists in LTC, it is primarily…Read full document

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. Delivered 71% sequential net product revenue growth in Q2 2026, reaching approximately $6 million, driven by a 37% increase in bottle demand. Achieved high repeat utilization rates, with 76% of prescribers and 81% of nursing homes placing repeat orders, signaling ZUNVEYL's transition into routine clinical practice. Attributed strong demand to clinical pull rather than formulary tailwinds, as the company saw significant growth despite static payer access levels. Focused commercial efforts on the long-term care (LTC) segment, utilizing a right-sized 60-person field force to target high-volume facilities and prescribers. Advanced the 'evidence generation' strategy to differentiate ZUNVEYL, highlighting improvements in cognition, neuropsychiatric symptoms, and polypharmacy reduction from the BEACON study. Maintained a high GAAP gross product margin of approximately 94%, reflecting efficient manufacturing and supply chain economics. Simplified the capital structure and improved future cash flows by completing the early settlement of the Galantos Pharma royalty obligation. Reiterated the target to achieve operating profitability in 2027, supported by disciplined capital deployment toward high-return commercial and clinical opportunities. Lowered full-year 2026 operating expense guidance to a range of $50 million to $54 million, down from the previous $54 million to $58 million range. Anticipates top-line data from the CONVERGE retrospective study in Q3 2026, which will be used to strengthen pharmacoeconomic arguments for payers. Expects the RESOLVE study to complete in Q2 2027, providing further clinical validation to support long-term prescriber confidence. Plans to evaluate expansion into the neurology specialist and retail markets only after achieving operating profitability and securing broader payer coverage to avoid high abandonment rates. Identified the Inflation Reduction Act (IRA) as a significant headwind for Medicare Part D plans, which has slowed the pace of broad formulary activation. Acknowledged that payer access expansion is tracking slower than previously projected, characterizing it as a timing dynamic rather than a demand constraint. Noted that while patient churn exists in LTC, it is primarily driven by patient frailty, hospitalizations, or deaths rather than drug tolerability or efficacy issues. Highlighted a gating PK study for the sublingual formulation in Q3 2026, which will determine the development timeline for this 10-20% market opportunity. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management noted that repeat rates are driven by physicians observing ZUNVEYL's superior tolerability compared to legacy generics, followed by improvements in cognition and behavioral symptoms. The typical adoption cycle involves a 2-to-3-month monitoring period for initial patients before a provider moves into significant repeat writing. Management clarified that while they are in active conversations with all key payers, the IRA has increased costs for plans, leading to more cautious formulary additions. They remain optimistic for second-half 2026 progress, viewing current demand growth as a lever to force payer conversion. The sublingual product targets the 10-20% of Alzheimer's patients with dysphagia (difficulty swallowing) who currently have limited treatment options. Management views this as a significant opportunity to take share from existing patches, which are often difficult for caregivers to administer. Business is split roughly 50/50 between direct switches from generic inhibitors and patients who were previously off-treatment due to past failures with other drugs. ZUNVEYL is being positioned as a 're-energizing' option for physicians to treat patients who could not tolerate previous therapies.

Investor releaseQuarter not tagged2026-08-14

Alpha Cognition (ACOG) Q2 2026 Earnings Call Transcript

Motley Fool
Image source: The Motley Fool. Thursday, Aug. 13, 2026 at 4:30 p.m. ET Interim CFO, VP Accounting and Finance - Henry Du Chief Executive Officer - Michael E. McFadden Chief Operating Officer - Lauren D'Angelo Operator: Greetings, and welcome to the AlphaCognition Earnings Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Henry Du, interim CFO, VP Accounting and Finance. Henry Du: Thank you. Operator: You may begin. Henry Du: Thank you, Sachi. Good afternoon, everyone, and thank you for joining us today for AlphaCognition's Second Quarter 26 Financial Results Conference Call. Today, after the close of market, the company issued a press release announcing these results. On the call with me are AlphaCognition Chief Executive Officer, Michael E. McFadden, and chief operating officer, Lauren D'Angelo. Today's call is being made available via the Investors section of the company's website at www.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 AlphaCognition'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 August 13, 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. AlphaCognition declines any obligation to update these forward looking statements except as required by applicable securities laws. I will now turn the call over to Michael. Michael? Michael E. McFadden: Thank you, Henry. Good afternoon, everyone. Welcome to today's call. The second quarter of 2026 represents another important quarter of commercialization for ZUNVEYL. The first new oral Alzheimer's treatment approved i…Read full document

Image source: The Motley Fool. Thursday, Aug. 13, 2026 at 4:30 p.m. ET Interim CFO, VP Accounting and Finance - Henry Du Chief Executive Officer - Michael E. McFadden Chief Operating Officer - Lauren D'Angelo Operator: Greetings, and welcome to the AlphaCognition Earnings Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Henry Du, interim CFO, VP Accounting and Finance. Henry Du: Thank you. Operator: You may begin. Henry Du: Thank you, Sachi. Good afternoon, everyone, and thank you for joining us today for AlphaCognition's Second Quarter 26 Financial Results Conference Call. Today, after the close of market, the company issued a press release announcing these results. On the call with me are AlphaCognition Chief Executive Officer, Michael E. McFadden, and chief operating officer, Lauren D'Angelo. Today's call is being made available via the Investors section of the company's website at www.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 AlphaCognition'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 August 13, 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. AlphaCognition declines any obligation to update these forward looking statements except as required by applicable securities laws. I will now turn the call over to Michael. Michael? Michael E. McFadden: Thank you, Henry. Good afternoon, everyone. Welcome to today's call. The second quarter of 2026 represents another important quarter of commercialization for ZUNVEYL. The first new oral Alzheimer's treatment approved in more than 15 years. It was a strong quarter of execution, with clear sequential growth in ZUNVEYL demand, expansion and prescriber adoption, increased nursing home penetration, and continued progress with evidence generation to clinically support 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 expectations as we continue to scale the brand and the long term care segment. In Q2, we generated approximately 6 million in net product revenues, representing approximately 71% quarter-over-quarter growth versus Q1 2026. While we are pleased with ZUNVEYL's trajectory, we are still in the early phases of the product's commercial phase, and remain optimistic that we will continue to see signs of sustained product performance and adoption in the long term care setting. Looking at the quarter, monthly prescription volume strengthened consistently, with high single digit sequential growth each month, All KPIs were positive, including prescriber number increases, nursing home prescriptions, and repeat prescriptions. Overall, we believe we are on track with our 2026 strategic priorities as we continue to drive prescription growth and build a durable path toward operating profitability in 2027. Turning to our clinical and medical programs, we continue to advance our evidence generation priorities in which we believe will strengthen ZUNVEYL's positioning with both payers and health care providers over the long term. During the second quarter, the company reported positive top line results from the BEACON study, We initiated CONVERGE, a retrospective data review in long term care, and we initiated RESOLVE, with sites selected, sites activated, and initial patient enrollment underway. Of note, the BEACON study demonstrated that following initiation of ZUNVEYL, providers observed improvements in cognition. Improvements in neuropsychiatric symptoms, and improvements in activities of daily living along with reductions in polypharmacy. These are all meaningful outcomes for long term care practitioners treating patients. With mild to moderate Alzheimer's disease. Based on these positive findings, our medical team has submitted the data for presentation at several upcoming medical meetings. We look forward to announcing additional, as presentations are accepted. and confirmed. We expect CONVERGE top-line data in Q3. We believe this will provide the company 2 nursing home datasets that can be utilized to inform stakeholders of the changes in cognition, neuropsychiatric behaviors, and ADLs they might expect to see when utilizing ZUNVEYL in the nursing home setting. Henry will provide financials in detail in a moment, and Lauren will provide a more comprehensive commercial update thereafter. But first, let me make a few high level remarks on our financial position. Our operating spend of 13.5 million this quarter continues to reflect a deliberate investment in our commercial capabilities, and in studies that support our positioning with health care providers and payers. As I said last quarter, I want to be direct about the way we are thinking about this investment. Our net product loss this quarter reflects the company's intentional scaling. We are 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, and we continue to remain on track with these targets. I will now turn it over to Henry. Henry Du: Thank you, Michael. Good afternoon again, everyone. As I review our second quarter 2026 financial results, please also refer to the press release and 10-Q to be filed this afternoon. For the second quarter of 2026, ZUNVEYL generated approximately $6 million in net product revenue compared with approximately $3.5 million in the first quarter. Representing approximately a 71% sequential growth quarter-over-quarter. Total revenue for the quarter was 6.1 million compared to $1.7 million in the prior year period driven primarily by ZUNVEYL product sales. From a margin perspective, GAAP gross product margin was approximately 94% for the second quarter. Based on net product sales of $6 million and cost of product sales of approximately $400 thousand. Regarding spending, total operating expenses for the second quarter were 13.5 million including $11.5 million of SG&A and $2 million of R&D expense. SG&A reflects continued investment behind the commercial infrastructure payer engagement, marketing resources, and public company operations. while R&D reflects continued investment in evidence generation, and development programs required to build ZUNVEYL for the long term. Net loss for the second quarter was $8.8 million or $0.40 per share, compared with a net loss of $13.2 million or $0.82 per share in the prior year period. As of June 30, 2026, the company had $41.4 million in cash and cash equivalents. And 57.9 million in total current assets. Total current liabilities were 6.4 million resulting in working capital of approximately 51.5 million. During the quarter, we also completed the early settlement of our Galantos Pharma royalty obligation. This transaction simplifies our capital structure eliminates future royalty burden on the product economics, and increases our long term long term participation in the value created by ZUNVEYL. We believe this is a prudent use of capital a strategic step that improves the future cash flows and strengthens the economics of the franchise as the brand continues to grow. We continue to believe our current capital position together with expected future sales of ZUNVEYL and potential milestones and royalties, can support our plan towards operating profitability in 2027. Lastly, based on the strong commercial performance of ZUNVEYL and our continued focus on operating discipline, we are lowering our full year 2026 operating expense guidance from our previous range of 54 million to $58 million. To a new range of $50 million to $54 million. While we remain committed to deploying capital to support the growth of ZUNVEYL, in advancing key evidence generation initiatives, we will identify opportunities to operate more efficiently across the organization. This revised outlook reflects our confidence in our ability to balance growth investments with prudent expense management. With that, I will now turn the call over to Lauren to discuss commercial progress. Lauren? Lauren D'Angelo: Thank you, Henry. I am pleased to provide a detailed update on our Q2 2026 commercial performance. Building on the momentum we described last quarter, Q2 was a period of meaningful execution across prescriber adoption nursing home penetration, and payer engagement. And the data tell a compelling story of durable and accelerating commercial traction. Let me start with the headline. Q2 demand generated $6 million in net product sales, representing 71% sequential growth over Q1. That result was driven by approximately 8.29 thousand bottles up roughly 37% quarter-over-quarter. Turning to adoption. In Q2, the commercial team reached 8.19 thousand total customers and called on 3.9 thousand prescribers, reflecting the reach of our now right-sized, approximately 60-person productive field organization and the continued refinement of our targeting approach. HCP writers, prescribers who wrote at least 1 ZUNVEYL prescription grew 27% quarter-over-quarter to 1.35 thousand and cumulative life-to-date riders reaching 1.91 thousand. This keeps us firmly on track to meet or surpass our 2026 goal of approximately 2,000 cumulative riders. As I have said in the past, depth matters as much as breadth. Of our 1.02 thousand Q2 riders, approximately 76% placed repeat prescriptions, and productivity per rider continued to climb, rising to approximately 6 prescriptions per rider. Evidence that adoption is deepening, not just widening. That sustained repeat behavior is 1 of the strongest signals that ZUNVEYL is moving from initial trial into routine clinical practice. We see the same pattern at the facility level. Homes with ZUNVEYL prescriptions grew 20% quarter-over-quarter to 1.09 thousand including 346 new homes added during the quarter. Of homes with prescriptions, roughly 81% placed repeat orders consistent with the durable facility level adoption we described in Q1. The monthly trajectory shows how momentum built through the quarter each month delivering sequential growth with June, our strongest demand month to date. That exit velocity establishes clear momentum as we move into Q3. Payer access remains our most significant near term opportunity and candidly, our most significant near term friction point. Implementation across the downstream plan clients in Q2 was roughly consistent with Q1. We wanna be very direct about that. The broad formulary activation we anticipated has not yet materialized at scale, and access expansion is tracking slower than the access curve we outlined last quarter. Critically, we view this as a timing dynamic, not a demand constraint. The clearest evidence is that our Q2 demand grew approximately 37% in bottles and 71% in net sales even without any expansion in payer access. Underlying prescription growth and an 81% facility repeat rate are being driven by genuine clinical pull, not by a formulary tailwind. That means payer conversion remains almost entirely ahead of us as upside. Reinforcing that access work is our real world evidence program. Beacon, Converge, and Resolve. We expect these studies to deliver meaningful promotional value supporting peer to peer education, strengthening payer discussions, and building physician confidence around tolerability, polypharmacy management, and caregiver burden. That evidence base is already fueling our education efforts. Since March, we have conducted more than 240 peer to peer programs reaching 1.06 thousand attendees and 325 prescribers. We also maintained a strong scientific presence at key congresses, including the DONA and MPA. Reinforcing ZUNVEYL's credibility among high value prescribers. In summary, Q2 26 reflected strong commercial execution with growing demand improving conversion, high repeat utilization, broader prescriber adoption, and deeper facility penetration. While payer access has not yet expanded, the strength of demand underscores the clinical pull behind ZUNVEYL and the opportunity ahead. As access improves, we believe we are well positioned for continued acceleration I will now hand it back to Michael for closing remarks. Michael E. McFadden: Thank you, Lauren. Let me briefly summarize what I believe are the key takeaways from the quarter. First, ZUNVEYL's growing. We delivered approximately 71% sequential growth from Q1 to Q2, and monthly prescriptions increased from April through June. The commercial trajectory is accelerating. Secondly, adoption's deepening. We had over 1.3 thousand HCP riders, over 1 thousand repeat riders, a thousand nursing homes with prescriptions, and almost 900 homes with repeat prescriptions. Repeat utilization remains 1 of the most important indicators of good product adoption. And third, we are executing on our commercial and company strategy with discipline. Our commercial organization is in place, Our focus is on deploying capital against high return in the business. And our evidence generation continues to advance. The company's enrolling resolve converges underway, and Beacon was completed ahead of schedule. And the company will have publications from that study to present to the medical community this fall. So we are excited about the balance of the 26 year. The foundation we built for Zumbel is strengthening Our commercial indicators are moving in the right direction. We remain focused on disciplined execution. With that, operator, we will now take questions. Operator: Thank you. We will now be conducting a question-and-answer session. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Moment please while we pull for questions. First question is from Raghuram Selvaraju from H.C. Wainwright. Please go ahead. Ram Selvaraju: Thanks so much for taking our questions, and congratulations on a very solid quarter. I was wondering if you could comment on the following 3 aspects. At this point in the launch. Firstly, when you look at the repeat prescribers and the percentage of repeat prescribers, that you have seen write prescriptions in multiple months. Can you give us an additional granularity on that specific element prescribing behavior, particularly what it may be that converts the repeat prescriber into not only writing more than 1 script, but sticking with the product over a lengthy period of time. And if at this point, we have enough data to indicate, you know, what the characteristics of that group of prescribers are. Secondly, I was wondering if you could give us a sense of at this point in time, given where you are with the launch, when you believe you might expand sales and marketing outreach beyond long term care, into the specialist neurologist population. And then lastly, with respect to formulary access, I was wondering if you could elaborate a little bit further on when you anticipate that emerging as a tailwind above and beyond the pull through demand that you are seeing? Thank you. Michael E. McFadden: Thanks, Raghuram. Very solid. Good 3 there. I will start with your first 1 around our repeat prescriber rate, what we are seeing in terms of what is causing that repeat group, to continue writing ZUNVEYL. I think it really comes down to, their experience with the drug. We have talked previously on many quarters that, you know, you start out with Brett, You call on a significant amount of physicians. Once you convince them to try the drug, it takes 2 to 3 months for them to really get that experience to monitor the 1 or 2 patients, And then, of course, you know, they will start repeating once they have experienced positive effects from ZUNVEYL. What we are seeing is these are significant repeat rates. 76% of providers are writing again. that is some of the highest I have seen, in my experience. And we believe based on all of the feedback we have gotten from our customers, is that it is really 3 things. First, they wanna make sure this drug is tolerable because, obviously, they are experience with the generics in the decades past has not been, great as it relates to tolerability. Once they see that ZUNVEYL is a very tolerable drug, they are then looking, obviously, at the efficacy, and they see significant cognition that core foundation of why they use these drugs in the first place, And then as we have talked about in the past, they are seeing significant benefit across the behavior So those are really the 3 things. Those are the 3 factors that are causing these physicians to write again, and that feedback is consistent across the board. As it relates to when we will step outside of long-term care and potentially go into retail or that neurology space, We are really focused right now on maximizing the long term care opportunity. We obviously believe there is tremendous upside and opportunity in the long term care space. And as we get to operating profitability next year, that is when we would look to, you know, start evaluating whether it is time to go into the neurology space. Another key aspect of that expansion into neurology is the payer lens, which obviously goes to your next question. You do not wanna launch into retail without solid formulary coverage because you will see significant abandonment rates in the retail setting, you know, when the co pay is too high. So it is really operating profitability and payer coverage that would determine at what point in time we will expand into neurology. And then finally, your question around payer. You know, we are, again, actively engaged with all of the key payers that really matter to the long term care business. We are having consistent conversations We are focused on increasing our demand so that, you know, we increase the likelihood that we can gain formulary coverage. What we are seeing across the board, just specifically to ZUNVEYL, really across the industry and the Medicare Part D space, is the impact of the inflation reduction act. That is having a significant impact on the plan and the additional cost that they have to pick up. So that is why, you know, we have got to continue driving demand. We are hopeful that we will see something as we have always communicated, you know, the second half of the year But it is not a matter of if. it is a matter of when because the payers definitely recognize the demand and the growth that we are driving, and we will continue, to have those conversations to make sure that obviously, we start to obtain formulary coverage. Ram Selvaraju: And then just very quickly, I was wondering if you could maybe provide us with your sense of when CONVERGE data becomes available to what extent that constitutes a potential game changer in trending the curve upwards as well as when you anticipate being able to provide data from, the RESOLVE study I know you have guided towards, you know, when the study would be completed, but when data would be available. And then if you could also comment on the size of the market opportunity that you expect to be addressable with the sublingual formulation and whether you would consider the possibility of instituting a revenue guidance range for 2027 along with possibly also instituting, an expense guidance range for that year. Michael E. McFadden: A lot to unpack there. First, I will start with Converge. So we anticipate top line data for Converge. in Q3 of 2026. The significance of CONVERGE is the quantitative retrospective data analysis on the entire Alzheimer's market. And it will provide data on persistence adherence, polypharmacy with all drugs, as well as a number of other elements like ADL improvement, tolerability, types of patients that are being profiled for each of the drugs, etcetera. That data will result in multiple publications They likely will not be public until 2027. We will begin writing, data post study and then submitting those for publication thereafter. We also believe that with CONVERGE, quantitative data, and Beacon qualitative data, that there is an opportunity to analyze that data pharmacoeconomically which will provide additional information that we believe will be useful for payers. And decision makers that have a financial interest in how Alzheimer's drugs are used. RESOLVE, studies underway. it is recruiting to our expectations. We anticipate that study will complete. In Q2 of next year. We will have data in the summer, fall. Depending on when in Q2 the data of resolve is provided. From a sublingual perspective, we are really excited about the sublingual opportunity. We believe that the opportunity represents about 10 to 20 percent of patients with Alzheimer's disease. The data indicates that about 10 to 20 percent of patients with Alzheimer's have either aphasia or dysphasia, meaning they cannot swallow or have difficulty swallowing. And the treatment choices for those patients currently are very limited. So we believe a sublingual has the opportunity to take significant share from existing therapies and from a patch that is often used, on the torso or the arm of these patients. Which is quite difficult and challenging to administer and for the patients to utilize that drug. We have a gating item for the sublingual product. We are running a peak compared to PK study this quarter. We anticipate that data will be available in Q3, and that will determine timeline for clinical program for sublingual. And then for revenue guidance, currently, we have not commented on when we will provide revenue guidance. We will provide expense guidance for 2027. And we will likely do that at the very beginning of 2027 or the latter part of Q4. Thank you very much. Operator: The next question is from David Storms from Stonegate. Please go ahead. Nav Raman: Congrats on the quarter and the progress, and thanks for taking my questions. I just have 2 quick questions. In the quarter, did you have or see any outsized stocking or material stocking in the quarter that could have impacted sales? And also, if the, if you hear reimbursement and coverage is going slower than anticipated, what do you expect your gross to net to be by the end of the year or through the year? Thanks. Lauren D'Angelo: Yeah. Both really good questions. So as it relates to material stock? No. We did not have a significant increase in stocking. Our pharmacy and our wholesalers are now at a point where they are purchasing on demand. So what you see this quarter is pure demand growth. And we feel very strongly about that because we can follow the trends in the data. As it relates to our reimbursement, obviously, right now, we are holding strong at about 74%. So, obviously, you know, if we do not see any significant formulary ads by the end of the year, we would stay pretty consistent. We will pick up some of the IRA penalty, but it will stay within a pretty similar GTN by the end of the year. Thanks for taking my questions. Sure. Operator: The next question is from Chase Nickerbacher from Craig Hallum Capital Group. Please go ahead. Jake: Good afternoon, everyone. Thanks for taking the questions. This is Jake on for Chase. We have seen another nice month in scripts in July. Could you maybe just speak a bit to what you have seen from a demand perspective so far in the third quarter? And what level is plan pull through and payer dynamics playing a role here versus is it just commercial execution from your team? Lauren D'Angelo: Sure. So Q2, results and demand were increasing month on month. And June was our strongest demand as of Q2. What I can tell you, I know we do not provide guidance, is that momentum has continued. In my opinion, it is all, we have had no formulary wins. Our 16% contracted open book of business is consistent. Since last quarter. So we believe that the strong demand in Q2 is pure commercial execution. We have gotten a lot smarter with targeting the right customers. We are now at the ideal 60 person customer-facing salesforce. So we believe that is really what is driving the demand. that is why we like to say that any formulary wins that will come in the future, it is all upside for us because we have got strong growth, and we continue to have strong growth. in Q3. Thanks for that color, Lauren. Jake: Then lastly, could you just speak to how adherence is trending now that we are more than a year into launch? How have you seen this change over time, and what do you calculate patient retention is at 6 or 12 months, however you want to present it? Lauren D'Angelo: Sure. So we are still tracking adherence rates because long term care is a little bit different how you look at the data. So, you know, it is hard for me to give you a number in terms of the average time on drug. You know, how much is new business versus, refill business. But what we do see is patients do stay on drug longer in the long term care facility, you know, versus a retail segment, obviously, because they are, you know, they are being cared for every day. I hate to give you a number because we are still working through that adherence rate. But what I can tell you is Q2 was driven by significant new growth as well as those refill from previous quarters. But I hopefully, in the future, I will be able to give you a more accurate number around adherence. Yeah. That would be very helpful. Thank you for taking the questions. Sure. Operator: The next question is from David Storms from Stonegate. Please go ahead. David Storms, your line is open. Ryan Deshner: Hi. Michael E. McFadden: Can you hear me? Yes. We can hear you, David. Ryan Deshner: Hi. Apologies for that. 2 quick questions for me, The first, can you comment on specific geographies or types of prescribers or really any other attributes where you are seeing the most growth this quarter? and going into next quarter? And then as you are collecting feedback from prescribers, who switch patients over to ZUNVEYL, what have the primary drivers for switching over been as of recent? And how refractory are the patients that you are putting on the drug in terms of number of therapies that they have already been on. How is that looking so far? Thanks. Lauren D'Angelo: Sure. So as it relates to the growth across the nation for Q2, we have seen growth across every region. Where we are seeing, obviously, the largest volume is coming from those key markets that have the largest opportunity. But overall, I am pleased to say that across the country, we are seeing pretty significant growth, and there is not 1 specific area that is doing far better. than, let's say, another area of the country. I think we are finally getting to a point with our 60 person sales team, you know, where we are gaining momentum. Every region is gaining traction, so that is really exciting. Your second question around what the feedback has been and what is causing that reason for shifting. So there is several reasons. You know, I think and we are talking to customers every day, and the feedback continues to overwhelm us. With the positive impact that ZUNVEYL is having on patients. But we see a lot of news new patients who have not been on a drug in a while because they had already failed donepezil. They already failed maybe 1 or 2 generics, and there is been no other alternative for them. So the physician is reenergized to try something else for these patients because they were not able to tolerate some of these drugs previously. We also see a significant amount of switching. And I think some of that is due to tolerability. it is due to, you know, which obviously includes insomnia on some of the other drugs. It could be the GI issues on some of the other drugs. But also the behavioral impact. So I think physicians have started to get experience with ZUNVEYL. They are seeing a positive impact across behaviors. And so patients that are on another drug, they have seen behavioral impact with patients already on ZUNVEYL, so it is causing them to switch those patients over to ZUNVEYL just from their pure experience. With other patients. I do not know if that answers your question, but those 2 areas are probably the biggest reasons for switch. Or to try ZUNVEYL. that is very helpful. Thanks so much. Operator: The next question is from David Storms from Stonegate. Please go ahead. Dave Storms: Afternoon. Thank you for taking my questions. Just wanted to start with maybe some of the prescribers that have only been 1-time prescribers thus far. Do you feel the need to maybe go back and retrace your steps there, or is there still so much runway in front of you that you are more focused on the white space there? Lauren D'Angelo: that is a great question. So 1 of the challenges with long-term care data is we call them ghostwriters. So even though it might show in the data that they have only written 1 prescription, they have actually written more. The order was just entered under another doctor. So that is we do not have a lot of physicians who have tried 1 and dropped off, and they are not using the drug anymore. What I can tell you, though, that I think ties to your question is that we have segmented the market, and we have obviously our physicians and our writers into our first tier. Or second tier where they have written several scripts, but they are maybe not writing it for 30% of patients. And then we have got a third tier And the good news in what we are seeing in Q2 is that every single tier is improving. So if you will remember in previous quarters, we talked a lot about those early physicians who have only tried 1 or 2, they need 2 to 3 months to get experience with the drug. We are seeing that wave of physicians now moving into significant repeat writing. And so it is kind of a constant cycle where we will continue to call on a tier 3. They are getting that 2 to 3 months experience with the drug, they will move into the next tier. And so in every single tier, we have seen significant improvement. it is just time and experience with ZUNVEYL. And we expect that trend will continue. that is really great color. I appreciate that. Dave Storms: And then maybe, just 1 more modeling question. With the SG&A expense guidance decreasing, is there any more you could give us there -- just maybe how sticky that might be, how much that could be applied. Into 2027, just maybe any more color there would be helpful. Michael E. McFadden: Yeah. I can comment on that? We anticipate some consistency, David. Into 2027, but we have not finalized our 2027 numbers. We have a number of studies ongoing this year, which increase expenditures Those will be concluding in Q2 of next year. But our commercial efforts and opportunities, you know, may offset that into 2027. So I ask you to bear with the company as we finalize our 2027 budget and spending plan, and we will provide that data. But it will be in a similar range. For next year. Perfect. Okay. Thank you for taking my questions. Operator: The next question is from William Wood from B. Riley Securities. William Wood: Hi, thanks for taking our questions. So just a couple from us. So I was curious in terms of the patients that do not-- or come off the drug, And so on that churn where they do not continue persistence, what is the main driver for the patient to either to get off drug? Is it adverse events or just lack of efficacy? Or, you know, alternatively, what is what is driving the prescriber to stop prescribing it? And then also in terms of long-term care home base, it looks like you have got a continued very nice expansion there. But I was curious in terms of percentage of total base that you have been potentially building into. I know it is still early times, but just curious how much of an expansion you have sort of room to grow on that sort of top line full expansion there. Thank you. Lauren D'Angelo: Sure. Sure. Both of those are really great questions. So I can tell you that, you know, we are talking to customers daily. We are getting significant feedback. And we are following those patients that discontinue ZUNVEYL. What I can tell you, it does not mean that it is not happening. I am not speaking to the universe, but we have not had or heard a patient's especially within our data, that are coming off due to tolerability or lack of efficacy. We have actually heard the very opposite. This drug works, and this drug works really well. And I think it is the feedback has been overwhelmingly positive. Of course, the downside of long term care is these patients are very frail. And so you will see deaths for patients. You will also see patients who leave the long term care facility, and they have a fall. So they get put into the hospital. So you might have some breakage. We will recapture those patients when they come back into the home, but the time that it looks like a discontinuance in the data when they are actually checking into the hospital. So those are really probably the 2 biggest factors And then, of course, if there is a formulary change or we need-- the prior authorization was not completed, then our reimbursement team will follow-up and ensure that patient gets put back on the drug. So those would be the main reasons why you would see a patient come off ZUNVEYL. To your question about opportunity and our base from my perspective and the company's perspective, we have significant opportunity in long term care. If you look at the just the highest volume Alzheimer patients across the country, and you split these out into homes, there is about 5 thousand homes, right, that are at your tier 1 targets. That provide significant opportunity, for ZUNVEYL. And then, of course, there is about 3 thousand top-tier physicians. So right now, we have got about a thousand writing. You So not only do we need to increase the depth of those providers, but we also have significant more prescribers that we need to activate. on ZUNVEYL. So from our perspective, tons of upside opportunity from a market opportunity. Got it. William Wood: And 1 last 1, if I may. In terms of just the patients who are switching or are starting drug, do you find that you are getting more patients that are refractory to other drugs or more switchers that are actively looking for a drug, so sort of pulling from a non-drug user or a drug user. Yeah. Lauren D'Angelo: We are seeing about 50/50. So if you look at the data, of course, in long term care, you know, there is many, many patients who have already tried these drugs. You know, these drugs have been out for decades. there is nothing available to them, so they have been off drugs for some time. So they look like a treatment-naive But they have actually tried something previously likely. So we are actually we are getting many call them treatment naive, but patients who were not on drugs, but we are also seeing a significant amount of switches. So those patients who are already either already still on it today, they are having tolerability issues, they are experiencing significant insomnia, Many of them already have behavioral issues. Those patients-- that patient profile right there is probably our highest switch because that is obviously, you know, with ZUNVEYL being core foundation and impacting all of those areas in a positive way, it is a pretty easy switch for a physician. So I would say about half of our business is coming from patients who have probably tried and failed. They are no longer on treatment right now. But the doctor has been put on ZUNVEYL. Or they are being directly switched from a generic acetylcholinesterase inhibitor. Due to those issues that I described. Got it. Very helpful. Thank you for taking our questions, and congrats on the quarter. Thanks. Operator: There are no further questions at this time. I would like to turn the floor back over to Michael E. McFadden for closing comments. Michael E. McFadden: Thanks, everybody, for attending the call and those who are listening to the call. We are excited about the quarter. Feel like we had a strong quarter. Highlighted by our growth, both in bottles, prescribers, adoption, our progress in payer and evidence generation, and the focus on high target opportunities for the company that we believe will continue the growth in quarters to come. Thank you for listening to the call. If you have interest in speaking with the company further, you can reach out to our IR on our website. Thank you so much. Operator: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation. Before you buy stock in Alpha Cognition, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Alpha Cognition wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $400,209!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,375,393!* Now, it’s worth noting Stock Advisor’s total average return is 964% — a market-crushing outperformance compared to 215% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 13, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Alpha Cognition (ACOG) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Investor releaseQuarter not tagged2026-08-13

Alpha Cognition Q2 Earnings Call Highlights

MarketBeat
Interested in Alpha Cognition Inc.? Here are five stocks we like better. ZUNVEYL demand accelerated: Second-quarter product revenue rose 71% sequentially to approximately $6 million, supported by a 37% increase in bottles sold, broader prescriber adoption and a 20% rise in nursing-home facilities ordering the drug. Payer access remains the main growth constraint: The company’s contracted open-book coverage stayed at 16%, limiting broader expansion into retail and neurology channels, although repeat orders and underlying demand remained strong. Evidence programs and finances progressed: Alpha Cognition reported positive top-line BEACON findings, advanced CONVERGE and RESOLVE, held $41.4 million in cash, and lowered 2026 operating-expense guidance to $50 million-$54 million while maintaining a 2027 operating-profitability target. Alpha Cognition (NASDAQ:ACOG) reported second-quarter 2026 net product revenue of approximately $6 million from its Alzheimer’s treatment ZUNVEYL, up about 71% sequentially from $3.5 million in the first quarter, as the company cited growing prescriber adoption and deeper use in long-term care facilities. Total revenue was $6.1 million, compared with $1.7 million in the prior-year period. GAAP gross product margin was approximately 94%, with cost of product sales totaling roughly $0.4 million. The company recorded a net loss of $8.8 million, or $0.40 per share, improving from a loss of $13.2 million, or $0.82 per share, a year earlier. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be “It was a strong quarter of execution with clear sequential growth in ZUNVEYL demand, expansion in prescriber adoption, increased nursing home penetration, and continued progress with evidence generation,” Chief Executive Officer Michael McFadden said on the company’s Aug. 13 earnings call. Chief Operating Officer Lauren D’Angelo said second-quarter demand included approximately 8,294 bottles of ZUNVEYL, a 37% increase from the prior quarter. The company reached 8,194 total customers and called on 3,905 prescribers through its approximately 60-person field organization. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand Healthcare provider writers—prescribers issuing at least one ZUNVEYL prescription—increased 27% from the first quarter to 1,347. Cumulative life-to-date writers reached 1,908, nearing the company’s a…Read full document

Interested in Alpha Cognition Inc.? Here are five stocks we like better. ZUNVEYL demand accelerated: Second-quarter product revenue rose 71% sequentially to approximately $6 million, supported by a 37% increase in bottles sold, broader prescriber adoption and a 20% rise in nursing-home facilities ordering the drug. Payer access remains the main growth constraint: The company’s contracted open-book coverage stayed at 16%, limiting broader expansion into retail and neurology channels, although repeat orders and underlying demand remained strong. Evidence programs and finances progressed: Alpha Cognition reported positive top-line BEACON findings, advanced CONVERGE and RESOLVE, held $41.4 million in cash, and lowered 2026 operating-expense guidance to $50 million-$54 million while maintaining a 2027 operating-profitability target. Alpha Cognition (NASDAQ:ACOG) reported second-quarter 2026 net product revenue of approximately $6 million from its Alzheimer’s treatment ZUNVEYL, up about 71% sequentially from $3.5 million in the first quarter, as the company cited growing prescriber adoption and deeper use in long-term care facilities. Total revenue was $6.1 million, compared with $1.7 million in the prior-year period. GAAP gross product margin was approximately 94%, with cost of product sales totaling roughly $0.4 million. The company recorded a net loss of $8.8 million, or $0.40 per share, improving from a loss of $13.2 million, or $0.82 per share, a year earlier. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be “It was a strong quarter of execution with clear sequential growth in ZUNVEYL demand, expansion in prescriber adoption, increased nursing home penetration, and continued progress with evidence generation,” Chief Executive Officer Michael McFadden said on the company’s Aug. 13 earnings call. Chief Operating Officer Lauren D’Angelo said second-quarter demand included approximately 8,294 bottles of ZUNVEYL, a 37% increase from the prior quarter. The company reached 8,194 total customers and called on 3,905 prescribers through its approximately 60-person field organization. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand Healthcare provider writers—prescribers issuing at least one ZUNVEYL prescription—increased 27% from the first quarter to 1,347. Cumulative life-to-date writers reached 1,908, nearing the company’s approximately 2,000-writer goal for 2026. Among 1,024 second-quarter writers, approximately 76% placed repeat prescriptions, while prescriptions per writer rose to about six, according to D’Angelo. Nursing homes with ZUNVEYL prescriptions increased 20% sequentially to 1,095, including 346 facilities added during the quarter. About 81% of facilities that ordered the drug placed repeat orders. → On Holding's Price Stumble May Be an Opening for a Company Built to Run D’Angelo said demand increased each month during the quarter, with June representing the strongest month to date. She added that momentum continued into the third quarter, though the company does not provide revenue guidance. Management said growth was not driven by material inventory stocking at wholesalers or pharmacies. “What you see this quarter is pure demand growth,” D’Angelo said, adding that pharmacies and wholesalers are now generally buying on demand. While ZUNVEYL demand grew, the company said broad formulary activation among downstream payer clients did not materialize at the pace management previously expected. D’Angelo described payer access as the company’s most significant near-term opportunity and friction point. Alpha Cognition said its contracted open book of business remained at 16%, unchanged from the prior quarter. D’Angelo said the lack of formulary expansion did not appear to constrain underlying demand, given the rise in bottle sales and high facility repeat-order rate. The company expects payer coverage to be an important factor in any eventual expansion beyond long-term care into retail and neurology settings. D’Angelo said the company is focused on maximizing the long-term care opportunity until it reaches operating profitability, which management continues to target for 2027. Management also cited the impact of the Inflation Reduction Act on Medicare Part D plans and said this has contributed to the current payer-access environment. The company said it remains hopeful for coverage progress in the second half of 2026 but did not provide a specific timing forecast. Alpha Cognition reported positive top-line findings from its BEACON study during the quarter. McFadden said providers observed improvements in cognition, neuropsychiatric symptoms and activities of daily living after ZUNVEYL initiation, along with reductions in polypharmacy. The company has submitted the data for presentation at medical meetings and expects publications from the study to be presented this fall. The company also initiated CONVERGE, a retrospective long-term-care data review, and began patient enrollment in RESOLVE. CONVERGE top-line data are expected during the third quarter of 2026, according to McFadden. He said the study is expected to provide quantitative information on persistence, adherence, polypharmacy, activities of daily living, tolerability and patient profiles across Alzheimer’s treatments. RESOLVE is recruiting in line with expectations and is expected to complete in the second quarter of 2027, with data anticipated during the summer or fall of that year, McFadden said. Alpha Cognition is also conducting a comparative pharmacokinetic study for a sublingual formulation during the current quarter. McFadden said results are expected in the third quarter and will determine the timing of the formulation’s clinical program. The company estimates that 10% to 20% of Alzheimer’s patients have swallowing difficulties that could make a sublingual treatment relevant. Second-quarter operating expenses totaled $13.5 million, including $11.5 million in selling, general and administrative expenses and $2 million in research and development. The company said spending reflected investments in commercial infrastructure, payer engagement, marketing and evidence-generation programs. As of June 30, Alpha Cognition had $41.4 million in cash and cash equivalents, $57.9 million in total current assets and $6.4 million in current liabilities, resulting in working capital of approximately $51.5 million. During the quarter, the company completed an early settlement of Organtus’ former royalty obligation. Chief Financial Officer Henry Du said the transaction eliminates future royalty burdens and is intended to improve the franchise’s future cash flows and economics as ZUNVEYL sales grow. Alpha Cognition lowered its full-year 2026 operating expense guidance to a range of $50 million to $54 million, from a prior range of $54 million to $58 million. Du said the revision reflects opportunities to operate more efficiently while continuing to support ZUNVEYL’s commercial growth and evidence-generation initiatives. Alpha Cognition, Inc is a clinical stage biopharmaceutical company that develops treatments for underserved neurodegenerative diseases such as Alzheimer's Dementia and Amyotrophic Lateral Sclerosis. The company was founded in 2000 and is headquartered in Vancouver, Canada. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Alpha Cognition Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Investor releaseQuarter not tagged2026-08-13

Alpha Cognition Inc. Reports Second Quarter 2026 Financial Results and Provides Operational Update

Business Wire
ZUNVEYL® net product revenue increased approximately 71% quarter-over-quarter to $6.0 million in the second quarter of 2026. Bottles dispensed increased approximately 37% quarter-over-quarter to 8,294, with monthly demand reaching 2,997 in June. Quarterly prescribers increased approximately 26% to 1,347 and repeat prescribers increased approximately 29% to 1,024, with approximately 76% prescribing in multiple months. Cash and cash equivalents totaled $41.4 million as of June 30, 2026, supporting the Company’s continued target of operating profitability in 2027 Company to host conference call and webcast today, August 13, at 4:30 p.m. ET. VANCOUVER, British Columbia & DALLAS, August 13, 2026--(BUSINESS WIRE)--Alpha Cognition Inc. (NASDAQ: ACOG) ("Alpha Cognition", "ACI", or the "Company"), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, today reported financial results for the second quarter ended June 30, 2026, and provided a business update. "We are pleased with the continued commercial adoption of ZUNVEYL during the second quarter," said Michael McFadden, Chief Executive Officer of Alpha Cognition. "Our commercial team continues to execute effectively, expanding the prescriber base while driving deeper utilization within existing accounts. We are particularly encouraged by the growth in repeat prescribers, long-term care facility adoption and monthly prescription demand, which we believe reflects increasing clinical confidence in ZUNVEYL. Its differentiated profile and growing real-world utilization provide a strong foundation for continued growth." Mr. McFadden continued, "As we move through the second half of 2026 and into 2027, we will remain focused on further strengthening commercial execution, supporting appropriate patient access and maintaining disciplined capital allocation." ZUNVEYL Commercial Performance Net ZUNVEYL Revenue: Revenue increased to approximately $6.0 million in the second quarter of 2026, representing approximately 71% growth compared to first quarter 2026 revenue of $3.5 million. Bottles Dispensed: Dispensed 8,294 bottles during Q2 2026, compared with 6,054 in Q1 2026, representing approximately 37% quarter-over-quarter growth. Monthly prescription demand grew throughout the quarter to 2,997 in June, reflecting consistent commercial momentum. Expanding Prescriber Base: Q2 202…Read full document

ZUNVEYL® net product revenue increased approximately 71% quarter-over-quarter to $6.0 million in the second quarter of 2026. Bottles dispensed increased approximately 37% quarter-over-quarter to 8,294, with monthly demand reaching 2,997 in June. Quarterly prescribers increased approximately 26% to 1,347 and repeat prescribers increased approximately 29% to 1,024, with approximately 76% prescribing in multiple months. Cash and cash equivalents totaled $41.4 million as of June 30, 2026, supporting the Company’s continued target of operating profitability in 2027 Company to host conference call and webcast today, August 13, at 4:30 p.m. ET. VANCOUVER, British Columbia & DALLAS, August 13, 2026--(BUSINESS WIRE)--Alpha Cognition Inc. (NASDAQ: ACOG) ("Alpha Cognition", "ACI", or the "Company"), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, today reported financial results for the second quarter ended June 30, 2026, and provided a business update. "We are pleased with the continued commercial adoption of ZUNVEYL during the second quarter," said Michael McFadden, Chief Executive Officer of Alpha Cognition. "Our commercial team continues to execute effectively, expanding the prescriber base while driving deeper utilization within existing accounts. We are particularly encouraged by the growth in repeat prescribers, long-term care facility adoption and monthly prescription demand, which we believe reflects increasing clinical confidence in ZUNVEYL. Its differentiated profile and growing real-world utilization provide a strong foundation for continued growth." Mr. McFadden continued, "As we move through the second half of 2026 and into 2027, we will remain focused on further strengthening commercial execution, supporting appropriate patient access and maintaining disciplined capital allocation." ZUNVEYL Commercial Performance Net ZUNVEYL Revenue: Revenue increased to approximately $6.0 million in the second quarter of 2026, representing approximately 71% growth compared to first quarter 2026 revenue of $3.5 million. Bottles Dispensed: Dispensed 8,294 bottles during Q2 2026, compared with 6,054 in Q1 2026, representing approximately 37% quarter-over-quarter growth. Monthly prescription demand grew throughout the quarter to 2,997 in June, reflecting consistent commercial momentum. Expanding Prescriber Base: Q2 2026 prescribing healthcare professionals increased to 1,347, compared with 1,060 in Q1 2026, representing approximately 26% sequential growth. Cumulative prescribing healthcare professionals reached 1,908 launch-to-date, compared with 1,484 at March 31, 2026, reflecting continued expansion of the Company’s prescriber base. Repeat Prescribers: Repeat prescribers increased to 1,024, compared with 795 in Q1 2026, representing 29% sequential growth. Approximately 76% of all Q2 prescribers generated prescriptions in multiple months during the quarter, demonstrating growing prescribing consistency and continued utilization across the prescriber base. Commercial Reach: Long-term care facility penetration continued to expand, with 1,095 facilities generating prescriptions during Q2 2026. Recent and Upcoming Business, Clinical, and Operational Highlights Reported positive topline results from BEACON, a real-world effectiveness study evaluating provider-reported cognitive, behavioral, functional, and tolerability outcomes among long-term care residents with mild to moderate Alzheimer’s disease ("AD") who were receiving ZUNVEYL. Initiated CONVERGE, a 400-patient retrospective data analysis evaluating tolerability, dosing, polypharmacy, and adverse events in long-term care, in April 2026 as planned. This study is designed to provide insights into real-world use in complex patient populations, including polypharmacy, which is a key consideration for both prescribers and payers. The Company continues to expect topline data for CONVERGE in Q3 2026. Initiated RESOLVE, a Phase 4 interventional trial in AD patients with behaviors that will evaluate ZUNVEYL’s effect on tolerability, cognitive and behavioral outcomes, and caregiver burden, with sites selected, activated, and initial patient enrollment underway. The study is expected to be completed in Q2 2027 and expands the Company’s evidence base into the outpatient setting, representing a significant long-term commercial opportunity. Continued to advance the sublingual development program toward the clinic in 2027. The Company believes this formulation, if approved, would provide a disruptive treatment option for AD patients with dysphagia or severe swallowing difficulties who currently have limited treatment options for medication treatment Second Quarter 2026 Financial Results Revenues: Revenue for the second quarter of 2026 was approximately $6.0 million, compared to $3.5 million for the first quarter of 2026 primarily due to an increase in sales volume. Cost of Product Sales: Cost of ZUNVEYL Product Sales, including amortization of intangible assets, for the second quarter of 2026 was approximately $352 thousand, compared to $111 thousand for the same period last year. Gross margin increased slightly to 94% for the second quarter of 2026 compared to 93% in the same quarter last year. Research and Development (R&D): R&D expenses for the second quarter were approximately $2.0 million compared to $406 thousand in the comparable period in 2025, reflecting continued advancement of the BEACON study, and RESOLVE clinical trial, which initiated during the first quarter and is actively enrolling. Sales, General & Administrative (SG&A): SG&A expenses for the three months ended June 30, 2026 were approximately $11.5 million compared to $9.5 million for the same period in 2025, primarily driven by commercial activities supporting the launch and expansion of ZUNVEYL, partially offset by cost-containment initiatives and operational efficiencies. Operating Loss: Total operating expenses for Q2 2026 were approximately $13.5 million, resulting in an operating loss of approximately $7.8 million. This was compared to total operating expenses of $9.9 million and a net loss of $8.4 million for the same period last year. The increase in operating expenses reflects deliberate investment in commercial infrastructure, payer engagement, and clinical programs. These investments are aligned with driving long-term revenue growth and market expansion. The Company is reducing it’s full-year 2026 R&D and SG&A expense guidance to $50–$54 million. Net Loss: Net loss for the second quarter of 2026 was approximately $8.8 million, or $(0.40) per share, compared with $13.2 million, or $(0.82) per share, in the comparable prior-year period. Cash Position: Cash, cash equivalents and short-term investments totaled approximately $41.4 million as of June 30, 2026. The Company continues to manage expenditures prudently and believes its current resources support execution of its strategic commercial and development priorities. Conference Call Information Alpha Cognition will host a conference call and webcast today, August 13 at 4:30 p.m. Eastern Time. To access the live conference call by phone, dial 877-407-9039 or 201-689-8470. The live audio webcast will be accessible at https://viavid.webcasts.com/starthere.jsp?ei=1767388&tp_key=54be15fdaf. A replay of the call will be available three hours following the call via the Events section of the Alpha Cognition website. 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 cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia, and as an intranasal formulation for Cognitive Impairment with mTBI. INDICATION AND USAGE ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or to any inactive ingredients in ZUNVEYL. Serious skin reactions have occurred. WARNINGS AND PRECAUTIONS Serious Skin Reactions: Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine (the active metabolite of ZUNVEYL tablets). If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed, and alternative therapy should be considered. Anesthesia: See Drug Interactions Section Cardiovascular Conditions: Cholinesterase inhibitors, including ZUNVEYL, have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. Bradycardia and all types of heart block have been reported in patients taking cholinesterase inhibitors, both with and without known underlying cardiac conduction abnormalities. Therefore, all patients should be considered at risk for adverse effects on cardiac conduction. Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope. Gastrointestinal Conditions: Cholinesterase inhibitors, including ZUNVEYL, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. Galantamine has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. Monitor the patient's weight during therapy with ZUNVEYL Genitourinary Conditions: Although this was not observed in clinical trials with galantamine, cholinesterase inhibitors, including ZUNVEYL, may cause bladder outflow obstruction. Neurological Conditions: Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. Seizure activity may also be a manifestation of Alzheimer's disease. Patients with Alzheimer's disease should be monitored closely for seizures while taking ZUNVEYL. Pulmonary Conditions: Cholinesterase inhibitors, including ZUNVEYL, should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease. Monitor for respiratory adverse reactions. ADVERSE REACTIONS The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. DRUG INTERACTIONS Use with Anticholinergics: Galantamine has the potential to interfere with the activity of anticholinergic medications. Use with Cholinomimetics and Other Cholinesterase Inhibitors: A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol. USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data may cause fetal harm. Hepatic Impairment: In patients with moderate hepatic impairment, a decrease in clearance of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with severe hepatic impairment is not recommended. Renal Impairment: In patients with a creatinine clearance of 9 to 59 mL/min, an increase in exposure of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with creatinine clearance less than 9 mL/min is not recommended. These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit www.fda.gov/MedWatch or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information. Forward-looking Statements This news release contains forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding the commercial performance, growth prospects and market adoption of ZUNVEYL®; prescription demand, bottles dispensed, prescriber adoption and repeat prescribing trends; long-term care facility penetration; payer access and reimbursement; implementation and expansion of Medicare Part D and pharmacy benefit manager ("PBM") contracts; the Company's expectations regarding future revenues, operating expenses, capital allocation, liquidity, cash runway and potential operating profitability; the timing, conduct, completion and results of the Company's clinical, observational and real-world evidence studies, including CONVERGE, RESOLVE and BEACON; advancement of the Company's sublingual development program and other product candidates; and the potential benefits, characteristics, commercial opportunity and future development of ZUNVEYL and the Company's development programs. Forward-looking statements are often identified by words such as "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "target," "seek," "continue," "ongoing," and similar expressions, or the negative of such terms, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on management's current expectations, assumptions and beliefs and are subject to a number of known and unknown risks, uncertainties and other factors that could cause actual results, performance or achievements to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others: risks related to the commercial adoption and market acceptance of ZUNVEYL; prescription demand; prescriber behavior and repeat prescribing patterns; long-term care facility adoption; patient access; payer coverage; formulary positioning; reimbursement levels; PBM and Medicare Part D implementation; utilization management restrictions; pricing pressure; gross-to-net deductions, including rebates, chargebacks, discounts, returns and patient assistance programs; the accuracy, completeness, timing and potential revision of third-party prescription and commercial data; the Company's ability to achieve revenue growth, manage operating expenses, maintain adequate liquidity, obtain additional financing if needed, and achieve its expected financial and operational objectives, including any target of future operating profitability; risks related to commercial manufacturing, supply chain operations, inventory management, distribution, marketing and sales execution; risks related to the safety, efficacy, tolerability and real-world clinical performance of ZUNVEYL; ongoing regulatory oversight, pharmacovigilance obligations and product labeling requirements; risks related to the initiation, enrollment, conduct, timing, completion, results and interpretation of clinical trials, chart review studies and real-world evidence programs; risks relating to the development, regulatory review and potential approval of new formulations and product candidates; intellectual property protection and enforcement; and other risks described from time to time in the Company's filings with the U.S. Securities and Exchange Commission and Canadian securities regulatory authorities. Additional information regarding these and other risks and uncertainties is contained in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K filed with the SEC on March 31, 2026, and in the Company's subsequent filings with the SEC, as well as the Company's filings available under its profile on SEDAR+. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this news release. Except as required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Note regarding Key Performance Indicators As the company began commercial sales of ZUNVEYL in 2025, management has identified several key performance indicators that it utilizes to assess the progress of commercialization and sale of ZUNVEYL and the success of its operations period over period. These key performance indicators include bottles dispensed, number of prescribers, homes and unique facilities engaged. These indicators are defined below along with management’s reasons for focusing on these indicators. "Bottles dispensed" refers to the number of 30-day prescriptions of ZUNVEYL filled during a given period. This data is sourced from third-party providers. Reported figures reflect the bottles recorded as dispensed within that period based on management’s review of the data. Because the data may be updated over time, actual totals may vary slightly. Management considers bottles dispensed a key performance metric because it closely reflects real-world product usage and is a meaningful indicator of ZUNVEYL’s commercial performance and the Company’s operational progress. "Prescribers" refers to the number of healthcare providers actively writing prescriptions for ZUNVEYL at the end of a reported period. This data is sourced from third-party providers and is evaluated on a weekly basis. The reported number reflects prescriber activity at a specific point in time and may not represent the total number of prescribers throughout the entire period. Management considers prescribers a key metric because it indicates the level of commercial adoption of ZUNVEYL among healthcare providers and helps assess the potential for future growth in bottles dispensed. "Homes" refers to the number of long-term care facilities where medical staff have prescribed ZUNVEYL to patients residing in those facilities. "Unique facilities engaged" refers to the number of long-term care facilities with which the Company’s sales team has had discussions regarding prescribing ZUNVEYL. This data is sourced from third-party providers. Reported figures may vary from actual totals as data is updated over time. Management considers homes and unique facilities engaged to be key performance metrics, as they reflect the effectiveness of the Company’s sales efforts in reaching potential prescribers and expanding coverage within the long-term care market. View source version on businesswire.com: https://www.businesswire.com/news/home/20260813925169/en/ Contacts For further information: Investor Relations LifeSci Advisors, PJ [email protected]

TranscriptFY2026 Q22026-08-13

FY2026 Q2 earnings call transcript

Earnings source - 78 paragraphs
Operator

As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Henry Du, Interim CFO, VP Accounting and Finance. Thank you. You may begin.

Henry Du

Thank you, Sachi. Good afternoon, everyone, and thank you for joining us today for Alpha Cognition's second quarter 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 are Alpha Cognition 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.

Henry Du

For the benefit of those of you who may be listening to the replay, this call is being held and recorded on August 13, 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 will now turn the call over to Michael. Michael?

Michael McFadden

Thank you, Henry. Good afternoon, everyone. Welcome to today's call. The second quarter of 2026 represents another important quarter of commercialization for ZUNVEYL, the first new oral Alzheimer's treatment approved in more than 15 years. It was a strong quarter of execution with clear sequential growth in ZUNVEYL demand, expansion in prescriber adoption, increased nursing home penetration, and continued progress with evidence generation to clinically support 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 expectations as we continue to scale the brand in the long-term care segment. In Q2, we generated approximately $6 million in net product revenues, representing approximately 71% quarter-over-quarter growth versus Q1 2026.

Michael McFadden

While we are pleased with ZUNVEYL's trajectory, we are still in the early phases of the product's commercial phase and remain optimistic that we will continue to see signs of sustained product performance and adoption in the long-term care setting. Looking at the quarter, monthly prescription volumes strengthened consistently with high single-digit sequential growth each month. All KPIs were positive, including prescriber number increases, nursing home prescriptions, and repeat prescriptions. Overall, we believe we are on track with our 2026 strategic priorities as we continue to drive prescription growth and build a durable path toward operating profitability in 2027. Turning to our clinical and medical programs, we continued to advance our evidence generation priorities in Q2, which we believe will strengthen ZUNVEYL's positioning with both payers and healthcare providers over the long term. During the second quarter, the company reported positive top-line results from the BEACON study.

Michael McFadden

We initiated CONVERGE, a retrospective data review in long-term care, and we initiated RESOLVE with sites selected, sites activated, and initial patient enrollment underway. Of note, the BEACON study demonstrated that following initiation of ZUNVEYL, providers observed improvements in cognition, improvements in neuropsychiatric symptoms, and improvements in ADLs, along with reductions in polypharmacy. These are all meaningful outcomes for long-term care practitioners treating patients with mild to moderate Alzheimer's disease. Based on these positive findings, our medical team has submitted the data for presentation at several upcoming medical meetings. We look forward to announcing additional details as presentations are accepted and confirmed. We expect CONVERGE top-line data in Q3.

Michael McFadden

We believe this will provide the company two nursing home data sets that can be utilized to inform stakeholders of the changes in cognition, neuropsychiatric behaviors, and ADLs they might expect to see when utilizing ZUNVEYL in the nursing home setting. Henry will provide financials in detail in a moment, and Lauren will provide a more comprehensive commercial update thereafter. But first, let me make a few high-level remarks on our financial position. Our operating spend of $13.5 million this quarter continues to reflect a deliberate investment in our commercial capabilities and in studies that support our positioning with healthcare providers and payers. As I said last quarter, I want to be direct about the way we are thinking about this investment. Our net product loss this quarter reflects the company's intentional scaling.

Michael McFadden

We are 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, and we continue to remain on track with these targets. I will now turn it over to Henry.

Henry Du

Thank you, Michael. Good afternoon again, everyone. As I review our second quarter 2026 financial results, please also refer to today's press release and 10-Q to be filed this afternoon. For the second quarter of 2026, ZUNVEYL generated approximately $6 million in net product revenue, compared with approximately $3.5 million in the first quarter, representing approximately a 71% sequential growth quarter-over-quarter. Total revenue for the quarter was $6.1 million, compared to $1.7 million in the prior year period, driven primarily by ZUNVEYL product sales. From a margin perspective, GAAP gross product margin was approximately 94% for the second quarter, based on net product sales of $6 million and cost of product sales of approximately $0.4 million. Regarding spending, total operating expenses for the second quarter were $13.5 million, including $11.5 million of SG&A and $2 million of R&D expense.

Henry Du

SG&A reflects continued investment behind the commercial infrastructure, payer engagement, marketing resources, and public company operations. R&D reflects continued investment in evidence generation and development programs required to build ZUNVEYL for the long term. Net loss for the second quarter was $8.8 million, or $0.40 per share, compared with a net loss of $13.2 million or $0.82 per share in the prior year period. As of June 30, 2026, the company had $41.4 million in cash and cash equivalents and $57.9 million in total current assets. Total current liabilities were $6.4 million, resulting in working capital of approximately $51.5 million. During the quarter, we also completed the early settlement of Galantos Pharma royalty obligation. This transaction simplifies our capital structure, eliminates future royalty burdens on the product economics, and increases our long-term participation in the value created by ZUNVEYL.

Henry Du

We believe this was a prudent use of capital and a strategic step that improves the future cash flows and strengthens the economics of the franchise as the brand continues to grow. We continue to believe our current capital position, together with expected future sales of ZUNVEYL and potential milestones and royalties, can support our plan towards operating profitability in 2027. Lastly, based on the strong commercial performance of ZUNVEYL and our continued focus on operating discipline, we are lowering our full-year 2026 operating expense guidance from our previous range of $54 million-$58 million to a new range of $50 million-$54 million. While we remain committed to supporting the growth of ZUNVEYL and advancing key evidence generation initiatives, we have identified opportunities to operate more efficiently across the organization. This revised outlook reflects our confidence in our ability to balance growth investments with prudent expense management.

Henry Du

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

Lauren D'Angelo

Thank you, Henry. I am pleased to provide a detailed update on our Q2 2026 commercial performance. Building on the momentum we described last quarter, Q2 was a period of meaningful execution across prescriber adoption, nursing home penetration, and payer engagement. The data tell a compelling story of durable and accelerating commercial traction. Let me start with the headline. Q2 demand generated approximately $6 million in net product sales, representing 71% sequential growth over Q1. That result was driven by approximately 8,294 bottles, up roughly 37% quarter-over-quarter. Turning to adoption. In Q2, the commercial team reached 8,194 total customers and called on 3,905 prescribers, reflecting the reach of our now right-sized, approximately 60-person productive field organization and the continued refinement of our targeting approach. HCP writers, prescribers who wrote at least one ZUNVEYL prescription, grew 27% quarter-over-quarter to 1,347, and cumulative life-to-date writers reaching 1,908.

Lauren D'Angelo

This keeps us firmly on track to meet or surpass our 2026 goal of approximately 2,000 cumulative writers. As I have said in the past, depth matters as much as breadth. Of our 1,024 Q2 writers, approximately 76% placed repeat prescriptions, and productivity per writer continued to climb, rising to approximately six prescriptions per writer. Evidence that adoption is deepening, not just widening. That sustained repeat behavior is one of the strongest signals that ZUNVEYL is moving from initial trial into routine clinical practice. We see the same pattern at the facility level. Homes with ZUNVEYL prescriptions grew 20% quarter-over-quarter to 1,095, including 346 new homes added during the quarter. Of homes with prescriptions, roughly 81% placed repeat orders, consistent with the durable facility-level adoption we described in Q1.

Lauren D'Angelo

The monthly trajectory shows how momentum built through the quarter, each month delivering sequential growth, with June our strongest demand month-to-date. That exit velocity establishes clear momentum as we move into Q3. Payer access remains our most significant near-term opportunity and candidly, our most significant near-term friction point. Implementation across the downstream plan clients in Q2 was roughly consistent with Q1. We want to be very direct about that. The broad formulary activation we anticipated has not yet materialized at scale, and access expansion is tracking slower than the access curve we outlined last quarter. Critically, we view this as a timing dynamic, not a demand constraint. The clearest evidence is that our Q2 demand grew approximately 37% in bottles and 71% in net sales, even without any expansion in payer access.

Lauren D'Angelo

Underlying prescription growth and an 81% facility repeat rate are being driven by genuine clinical pull, not by a formulary tailwind. That means payer conversion remains almost entirely ahead of us as upside. Reinforcing that access work is our real-world evidence program, BEACON, CONVERGE, and RESOLVE. We expect these studies to deliver meaningful promotional value, supporting peer-to-peer education, strengthening payer discussions, and building physician confidence around tolerability, polypharmacy management, and caregiver burden. That evidence base is already fueling our education efforts. Since March, we have conducted more than 240 peer-to-peer programs, reaching 1,058 attendees and 325 prescribers. We also maintained a strong scientific presence at key congresses, including NADONA and NPA, reinforcing ZUNVEYL's credibility among high-value prescribers. In summary, Q2 2026 reflected strong commercial execution with growing demand, improving conversion, high repeat utilization, broader prescriber adoption, and deeper facility penetration.

Lauren D'Angelo

While payer access has not yet expanded, the strength of demand underscores the clinical pull behind ZUNVEYL and the opportunity ahead. As access improves, we believe we are well-positioned for continued acceleration. I will now hand it back to Michael for closing remarks.

Michael McFadden

Thank you, Lauren. Let me briefly summarize what I believe are the key takeaways from the quarter. First, ZUNVEYL is growing. We delivered approximately 71% sequential growth from Q1 to Q2, and monthly prescriptions increased from April through June. The commercial trajectory is accelerating. Secondly, adoption is deepening. We had over 1,300 HCP writers, over 1,000 repeat writers, 1,000 nursing homes with prescriptions, and almost 900 homes with repeat prescriptions. Repeat utilization remains one of the most important indicators of good product adoption. Third, we are executing on our commercial and company strategy with discipline. Our commercial organization is in place. Our focus is on deploying capital against high-return opportunities in the business, and our evidence generation continues to advance. The company is enrolling RESOLVE, CONVERGE is underway, and BEACON was completed ahead of schedule.

Michael McFadden

The company will have publications from that study to present to the medical community this fall. So we are excited about the balance of the 2026 year. The foundation we built for ZUNVEYL is strengthening. Our commercial indicators are moving in the right direction. We remain focused on disciplined execution. With that, operator, we will now take questions.

Operator

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. One moment, please, while we poll for questions. The first question is from Ram Selvaraju from H.C. Wainwright. Please go ahead.

Ram Selvaraju

Thanks so much for taking our questions, and congratulations on a very solid quarter. I was wondering if you could comment on the following three aspects at this point in the launch. Firstly, when you look at the repeat prescribers and the percentage of repeat prescribers that you have seen write prescriptions in multiple months, can you give us an additional granularity on that specific element of prescribing behavior? Particularly, what it may be that converts a repeat prescriber into not only writing more than one script, but sticking with the product over a lengthy period of time, and if at this point we have enough data to indicate what the characteristics of that group of prescribers are.

Ram Selvaraju

Secondly, I was wondering if you could give us a sense of, at this point in time, given where you are with the launch, when you believe you might expand sales and marketing outreach beyond long-term care into the specialist neurologist population. Lastly, with respect to formulary access, I was wondering if you could elaborate a little bit further on when you anticipate that emerging as a tailwind above and beyond the pull-through demand that you're seeing? Thank you.

Lauren D'Angelo

Thanks, Ram. Very solid, good three questions there. I'll start with your first one around our repeat prescriber rate, what we're seeing in terms of what's causing that repeat group to continue writing ZUNVEYL. I think it really comes down to their experience with the drug. We've talked previously on many quarters that you start out with breadth. You call on a significant amount of physicians. Once you convince them to try the drug, it takes two to three months for them to really get that experience to monitor the one or two patients. Then, of course, they'll start repeating once they've experienced positive effects from ZUNVEYL. What we're seeing is these are significant repeat rates. 76% of providers are writing again. That's some of the highest I've seen in my experience.

Lauren D'Angelo

We believe, based on all of the feedback we've gotten from our customers, is that it's really three things. First, they want to make sure this drug is tolerable, because obviously their experience with the generics in the decades past has not been great as it relates to tolerability. Once they see that ZUNVEYL is a very tolerable drug, they're then looking obviously at the efficacy, and they see significant cognition, that core foundation of why they use these drugs in the first place. Then, as we've talked about in the past, they're seeing significant benefit across the behavior. So those are really the three things. Those are the three factors that are causing these physicians to write again, and that feedback is consistent across the board.

Lauren D'Angelo

As it relates to when we will step outside of long-term care and potentially go into retail or that neurology space, we are really focused right now on maximizing the long-term care opportunity. We obviously believe there is tremendous upside and opportunity in the long-term care space. As we get to operating profitability next year, that is when we would look to start evaluating whether it is time to go into the neurology space. Another key aspect of that expansion into neurology is the payer lens, which obviously goes to your next question. You do not want to launch into retail without solid formulary coverage because you will see significant abandonment rates in the retail setting, when the copay is too high. It is really operating profitability and payer coverage that would determine at what point in time we will expand into neurology. Then finally, your question around payer.

Lauren D'Angelo

We are, again, actively engaged with all of the key payers that really matter to the long-term care business. We are having consistent conversations. We are focused on increasing our demand so that we increase the likelihood that we can gain formulary coverage. What we are seeing across the board, not just specifically to ZUNVEYL, but really across the industry and the Medicare Part D space, is the impact of the Inflation Reduction Act. That is having a significant impact on the plan and the additional cost that they have to pick up. So that is why we have got to continue driving demand. We are hopeful that we will see something, as we have always communicated, the second half of the year.

Lauren D'Angelo

But it is not a matter of if, it is a matter of when, because the payers definitely recognize the demand and the growth that we are driving, and we will continue to have those conversations to make sure that obviously we start to obtain formulary coverage.

Ram Selvaraju

Just very quickly, I was wondering if you could maybe provide us with your sense of when CONVERGE data becomes available, to what extent that constitutes a potential game changer in bending the curve upwards, as well as when you anticipate being able to provide data from the RESOLVE study. I know you have guided towards when the study would be completed, but when data would be available. Then if you could also comment on the size of the market opportunity that you expect to be addressable with the sublingual formulation and whether you would consider the possibility of instituting a revenue guidance range for 2027, along with possibly also instituting an expense guidance range for that year.

Michael McFadden

A lot to unpack there. First, I'll start with CONVERGE. We anticipate top-line data for CONVERGE in Q3 of 2026. The significance of CONVERGE, it's a quantitative retrospective data analysis on the entire Alzheimer's market, and it will provide data on persistence, adherence, polypharmacy with all drugs, as well as a number of other elements like ADL improvement, tolerability, types of patients that are being profiled for each of the drugs, et cetera. That data will result in multiple publications. They likely will not be public until 2027. We'll begin writing data post-study and then submitting those for publication thereafter. We also believe that with CONVERGE quantitative data and BEACON qualitative data, there's an opportunity to analyze that data pharmaco-economically, which will provide additional information that we believe will be useful for payers and decision-makers that have a financial interest in how Alzheimer's drugs are used.

Michael McFadden

RESOLVE study's underway. It's recruiting to our expectations. We anticipate that study will complete in Q2 of next year. We'll have data in the summer, fall, depending on when in Q2 the data of RESOLVE is provided. From a sublingual perspective, we're really excited about the sublingual opportunity. We believe that the opportunity represents about 10%-20% of patients with Alzheimer's disease. The data indicates that about 10%-20% of patients with Alzheimer's have either aphagia or dysphagia, meaning they cannot swallow or have difficulty swallowing, and the treatment choices for those patients currently are very limited. So, we believe the sublingual has the opportunity to take significant share from existing therapies and from a patch that's often used on the torso or the arm of these patients, which is quite difficult and challenging to administer and for the patients to utilize that drug.

Michael McFadden

We have a gating item for the sublingual product. We're running a comparative PK study this quarter. We anticipate that data will be available in Q3, and that will determine timeline for clinical program for sublingual. Then for revenue guidance, currently, we haven't commented on when we'll provide revenue guidance. We will provide expense guidance for 2027, and we'll likely do that the very beginning of 2027 or the latter part of Q4.

Ram Selvaraju

Thank you very much.

Operator

The next question is from Nav Rahman from Maxim Group. Please go ahead.

Nav Rahman

Hi, everyone. Congrats on the quarter and the progress, and thanks for taking my questions. I just have two quick questions. In the quarter, did you have or see any outsized stocking or material stocking in the quarter that could have impacted sales? Also, if the current reimbursement and coverage is going slower than anticipated, what do you expect your gross nets to be by the end of the year or through the year? Thanks.

Lauren D'Angelo

Yeah, both really good questions. As it relates to material stocking, no, we did not have a significant increase in stocking. Our pharmacy and our wholesalers are now at a point where they're pretty much purchasing on demand. What you see this quarter is pure demand growth, and we feel very strongly about that because we can follow the trends and the data. As it relates to our reimbursement, obviously, right now, we're holding strong at about 74%. Obviously, if we do not see any significant formulary adds by the end of the year, we would stay pretty consistent. We'll pick up some of the IRA penalty, but it will stay within a pretty similar GTN by the end of the year.

Nav Rahman

Thanks. Thanks for taking my questions.

Lauren D'Angelo

Sure.

Operator

The next question is from Chase Knickerbocker from Craig-Hallum Capital Group. Please go ahead.

Speaker 6

Good afternoon, everyone. Thanks for taking the questions. This is Jake on for Chase. We have seen another nice month in scripts in July. Could you maybe just speak a bit to what you have seen from a demand perspective so far in the third quarter?

Lauren D'Angelo

Sure.

Speaker 6

What level is plan pull-through and payer dynamics play a role here versus is it just commercial execution from your team?

Lauren D'Angelo

Sure. So Q2 results and demand were increasing month-on-month, and June was our strongest demand as of Q2. What I can tell you, I know we do not provide guidance, is that momentum has continued. It is all, in my opinion, we have had no formulary wins, our 16% contracted open book of business is consistent since last quarter. So we believe that the strong demand in Q2 is pure commercial execution. We have gotten a lot smarter with targeting the right customers. We are now at the ideal 60-person customer-facing sales force. So we believe that is really what is driving the demand. That is why we like to say that any formulary wins that will come in the future, it is all upside for us because we have got strong growth and we continue to have strong growth in Q3.

Speaker 6

Thanks for that color, Lauren.

Lauren D'Angelo

Sure.

Speaker 6

Lastly, could you just speak to how adherence is trending now that we are more than a year into launch? How have you seen this change over time, and what do you calculate patient retention is at six or 12 months? However, you want to present it.

Lauren D'Angelo

Sure. We are still tracking adherence rates, because long-term care is a little bit different, how you look at the data. It is hard for me to give you a number in terms of the average time on drugs. How much is new business versus refill business. But what we do see is patients do stay on drug longer in the long-term care facility versus a retail segment, obviously, because they are being cared for every day. I would hate to give you a number because we are still working through that adherence rate. But what I can tell you is Q2 was driven by significant new growth as well as those refills from previous quarters. Hopefully, in the future, I will be able to give you a more accurate number around adherence.

Speaker 6

Yeah, that would be very helpful. Thank you for taking the questions.

Lauren D'Angelo

Sure.

Operator

The next question is from Ryan Deschner from Raymond James. Please go ahead. Ryan Deschner, your line is open.

Ryan Deschner

Hi, can you hear me?

Michael McFadden

Yes, we can hear you, Ryan.

Ryan Deschner

Hi. Apologies for that. Two quick questions. For me, the first, can you comment on specific geographies or types of prescribers or really any other attributes where you're seeing the most growth this quarter and going into next quarter? Then, as you're collecting feedback from prescribers who switch patients over to ZUNVEYL, what have the primary drivers for switching over been as of recent, and how refractory are the patients that you're putting on drug in terms of number of therapies that they've already been on? How has that looking so far? Thanks.

Lauren D'Angelo

Sure. As it relates to the growth across the nation for Q2, we have seen growth across every region. We are seeing, obviously, the largest volume is coming from those key markets that have the largest opportunity. Overall, I am pleased to say that across the country, we are seeing pretty significant growth, and there is not one specific area that is doing far better than, let us say, another area of the country. I think we are finally getting to a point with our 60-person sales team where we are gaining momentum. Every region is gaining traction, so that is really exciting.

Lauren D'Angelo

Your second question around what has the feedback been and what is causing that reason for shifting. There are several reasons. I think, and we are talking to customers every day, and the feedback continues to overwhelm us with the positive impact that ZUNVEYL is having on patients.

Lauren D'Angelo

We see a lot of new patients who have not been on drug in a while because they had already failed donepezil. They already failed maybe one or two generics, and there has been no other alternative for them. The physician is re-energized to try something else for these patients because they were not able to tolerate some of these drugs previously. We also see a significant amount of switching, and I think some of that is due to tolerability. It is due to, which obviously is insomnia on some of the other drugs. It could be the GI issues on some of the other drugs. Also the behavioral impact. I think physicians have started to get experience with ZUNVEYL. They are seeing a positive impact across behaviors.

Lauren D'Angelo

Patients that are on another drug, they have seen behavioral impact with patients already on ZUNVEYL, so it is causing them to switch those patients over to ZUNVEYL just from their pure experience with other patients. I do not know if that answers your question, but those two areas are probably the biggest reasons for switch or to try ZUNVEYL.

Ryan Deschner

That is very helpful. Thanks so much.

Operator

The next question is from Dave Storms from Stonegate. Please go ahead.

Dave Storms

Afternoon. Thank you for taking my questions. Just wanted to start with maybe some of the prescribers that have only been one-time prescribers thus far. Do you feel the need to maybe go back and retrace your steps there, or is there still so much runway in front of you that you're more focused on the white space there?

Lauren D'Angelo

That's a great question. One of the challenges with long-term care data is we call them ghostwriters. Even though it might show in the data that they've only written one prescription, they've actually written more. The order was just entered under another doctor. We don't have a lot of physicians who have tried one and dropped off and they're not using the drug anymore. What I can tell you, though, that I think ties to your question is that we have segmented the market, and we have obviously bucketed our physicians and our writers into our first tier, our second tier, where they've written several scripts, but they're maybe not writing it for 30% of patients. Then we've got a third tier. The good news in what we're seeing in Q2 is that every single tier is improving.

Lauren D'Angelo

If you'll remember in previous quarters, we talked a lot about those early physicians who have only tried one or two. They need two to three months to get experience with the drug. We're seeing that wave of physicians now move into significant repeat writing. It's kind of a constant cycle where we'll continue to call on a tier 3. They're getting that two to three-month experience with the drug. They will move into the next tier. In every single tier, we've seen significant improvement. It's just time and experience with ZUNVEYL, and we expect that that trend will continue.

Dave Storms

That is really great color. I appreciate that. Then maybe just one more modeling question. With the SG&A expense guidance decreasing, is there any more you could give us there? Just maybe how sticky that might be, how much of it could be applied into 2027? Just maybe any more color there would be helpful.

Michael McFadden

Yeah, I can comment on that. We anticipate some consistency, Dave, into 2027, but we haven't finalized our 2027 numbers. We have a number of studies ongoing this year which increase expenditures. Those will be concluding in Q2 of next year. Our commercial efforts and opportunities may offset that into 2027. So, I ask you to bear with the company as we finalize our 2027 budget and spending plan, and we'll provide those datas, but it will be in a similar range for next year.

Dave Storms

Perfect. Okay. Thank you for taking my questions.

Operator

The next question is from William Wood from B. Riley Securities. Please go ahead.

William Wood

Hi, thanks for taking our questions. Just a couple from us. I was curious in terms of the patients that don't or come off drug. On that churn where they don't continue persistence, what is the main driver for the patient to either to get off drug? Is it adverse events or just lack of efficacy? Alternatively, what's driving the prescriber to stop prescribing it? Also, in terms of long-term home care base, it looks like you've got a continued very nice expansion there. I was curious in terms of percentage of total base that you can potentially building into. I know it's still early times, but just curious how much of an expansion you have sort of room to grow on that sort of top line full expansion there? Thank you.

Lauren D'Angelo

Sure. Both of those are really great questions. I can tell you that we're talking to customers daily. We're getting significant feedback, and we are following those patients that discontinue ZUNVEYL. What I can tell you, it doesn't mean that it's not happening. I'm not speaking to the universe. But we have not had or heard of patients, especially within our data, that are coming off due to tolerability or lack of efficacy. We've actually heard the very opposite. This drug works, and this drug works really well, and I think the feedback has been overwhelmingly positive. Of course, the downside of long-term care is these patients are very frail and you will see death for patients. You'll also see patients who leave the long-term care facility, and they have a fall, so they get put into the hospital. You might have some break.

Lauren D'Angelo

We will recapture those patients when they come back into the home, but the time that they, it looks like a discontinue in the data when they're actually checking, going into the hospital. Those are really probably the two biggest factors. Then, of course, if there's a formulary change or the prior authorization wasn't completed, then our reimbursement team will follow up and ensure that that patient gets put back on drugs. Those would be the main reasons why you would see a patient come off ZUNVEYL. To your question about opportunity and our base, from my perspective and the company's perspective, we have significant opportunity in long-term care. If you look at just the highest volume Alzheimer patients across the country, and you split these out into homes, there's about 5,000 homes that are at your tier 1 targets that provide significant opportunity for ZUNVEYL.

Lauren D'Angelo

Then, of course, there's about 3,000 top tier physicians. Right now, we've got about 1,000 writing. Not only do we need to increase the depth of those providers, but we also have significantly more prescribers that we need to activate on ZUNVEYL. From our perspective, tons of upside opportunity from a market opportunity.

William Wood

Got it. One last one, if I may. In terms of just the patients who are switching, or are starting drug, do you find that you are getting more patients that are refractory to other drugs or more switchers that are actively looking for a drug? So, sort of pulling from a non-drug user or a drug user? It is a minor difference there.

Lauren D'Angelo

Yeah. We are seeing about 50/50. If you look at the data, of course, in long-term care, there are many patients who have already tried these drugs. These drugs have been out for decades. There is nothing available to them. So, they have been off drugs for some time. So they look like a treatment naive, but they have actually tried something previously, likely. So we are getting many, we will call them treatment naive, but patients who were not on drugs, but we are also seeing a significant amount of switches.

Lauren D'Angelo

So those patients who are either already still on it today, they are having tolerability issues, they are experiencing significant insomnia. Many of them already have behavioral issues. That patient profile right there is probably our highest switch because that is obviously, with ZUNVEYL being core foundation and impacting all of those areas in a positive way, it is a pretty easy switch for a physician.

Lauren D'Angelo

I would say about half of our business is coming from patients who have probably tried and failed. They are no longer on treatment right now, but the doctor is then adding ZUNVEYL, or they are being directly switched from a generic acetylcholinesterase inhibitor due to those issues that I described.

William Wood

Got it. Very helpful. Thank you for taking our questions and congrats on the quarter.

Lauren D'Angelo

Thanks.

Operator

There are no further questions at this time. I'd like to turn the floor back over to Michael McFadden for closing comments.

Michael McFadden

Thanks everybody for attending the call and those who are listening to the call. We're excited about the quarter. Feel like we had a strong quarter highlighted by our growth, both in bottles, prescribers, adoption, our progress in payer and evidence generation, and the focus on high target opportunities for the company that we believe will continue the growth in quarters to come. Thank you for listening to the call. If you have interest in speaking with the company further, you can reach out to our IR on website. Thank you so much.

Operator

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Investor releaseQuarter not tagged2026-08-12

Liquidia Corporation (LQDA) Q2 Earnings and Revenues Beat Estimates

Zacks
Liquidia Corporation (LQDA) came out with quarterly earnings of $0.74 per share, beating the Zacks Consensus Estimate of $0.7 per share. This compares to a loss of $0.49 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +5.71%. A quarter ago, it was expected that this company would post earnings of $0.34 per share when it actually produced earnings of $0.52, delivering a surprise of +52.94%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Liquidia Corporation, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $171.68 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 3.89%. This compares to year-ago revenues of $8.84 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Liquidia Corporation shares have added about 155.3% since the beginning of the year versus the S&P 500's gain of 12.9%. While Liquidia Corporation has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Liquidia Corporation was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #1 (Strong Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see th…Read full document

Liquidia Corporation (LQDA) came out with quarterly earnings of $0.74 per share, beating the Zacks Consensus Estimate of $0.7 per share. This compares to a loss of $0.49 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +5.71%. A quarter ago, it was expected that this company would post earnings of $0.34 per share when it actually produced earnings of $0.52, delivering a surprise of +52.94%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Liquidia Corporation, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $171.68 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 3.89%. This compares to year-ago revenues of $8.84 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Liquidia Corporation shares have added about 155.3% since the beginning of the year versus the S&P 500's gain of 12.9%. While Liquidia Corporation has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Liquidia Corporation was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #1 (Strong Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.74 on $163.09 million in revenues for the coming quarter and $3.02 on $658.24 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 38% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Alpha Cognition Inc. (ACOG), another stock in the same industry, has yet to report results for the quarter ended June 2026. The results are expected to be released on August 13. This company is expected to post quarterly loss of $0.39 per share in its upcoming report, which represents a year-over-year change of +40%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Alpha Cognition Inc.'s revenues are expected to be $4.32 million, up 160.2% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Liquidia Corporation (LQDA) : Free Stock Analysis Report Alpha Cognition Inc. (ACOG) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-06

Halozyme Therapeutics (HALO) Q2 Earnings and Revenues Surpass Estimates

Zacks
Halozyme Therapeutics (HALO) came out with quarterly earnings of $2.28 per share, beating the Zacks Consensus Estimate of $1.82 per share. This compares to earnings of $1.54 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +25.28%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $1.54 per share when it actually produced earnings of $1.6, delivering a surprise of +3.9%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Halozyme Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $481 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 17.44%. This compares to year-ago revenues of $325.72 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Halozyme Therapeutics shares have added about 24.2% since the beginning of the year versus the S&P 500's gain of 12.8%. While Halozyme Therapeutics has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Halozyme Therapeutics was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the nea…Read full document

Halozyme Therapeutics (HALO) came out with quarterly earnings of $2.28 per share, beating the Zacks Consensus Estimate of $1.82 per share. This compares to earnings of $1.54 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +25.28%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $1.54 per share when it actually produced earnings of $1.6, delivering a surprise of +3.9%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Halozyme Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $481 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 17.44%. This compares to year-ago revenues of $325.72 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Halozyme Therapeutics shares have added about 24.2% since the beginning of the year versus the S&P 500's gain of 12.8%. While Halozyme Therapeutics has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Halozyme Therapeutics was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $2.05 on $455.73 million in revenues for the coming quarter and $7.96 on $1.77 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Alpha Cognition Inc. (ACOG), is yet to report results for the quarter ended June 2026. The results are expected to be released on August 13. This company is expected to post quarterly loss of $0.39 per share in its upcoming report, which represents a year-over-year change of +40%. The consensus EPS estimate for the quarter has been revised 11.5% lower over the last 30 days to the current level. Alpha Cognition Inc.'s revenues are expected to be $4.32 million, up 160.2% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Halozyme Therapeutics, Inc. (HALO) : Free Stock Analysis Report Alpha Cognition Inc. (ACOG) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-06

Alpha Cognition Inc. (ACOG) Expected to Beat Earnings Estimates: What to Know Ahead of Q2 Release

Zacks
Alpha Cognition Inc. (ACOG) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 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 August 13. 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 $0.39 per share in its upcoming report, which represents a year-over-year change of +40%. Revenues are expected to be $4.32 million, up 160.2% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 11.49% lower over the last 30 days to the current level. 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 the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. 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 fo…Read full document

Alpha Cognition Inc. (ACOG) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 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 August 13. 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 $0.39 per share in its upcoming report, which represents a year-over-year change of +40%. Revenues are expected to be $4.32 million, up 160.2% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 11.49% lower over the last 30 days to the current level. 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 the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. 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 Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Alpha Cognition Inc., the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +6.90%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination indicates that Alpha Cognition Inc. will most likely beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Alpha Cognition Inc. would post a loss of$0.41 per share when it actually produced a loss of -$0.37, delivering a surprise of +9.76%. Over the last four quarters, the company has beaten consensus EPS estimates two times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Alpha Cognition Inc. appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Another stock from the Zacks Medical - Biomedical and Genetics industry, Axsome Therapeutics (AXSM), is soon expected to post loss of $0.99 per share for the quarter ended June 2026. This estimate indicates a year-over-year change of -7.6%. Revenues for the quarter are expected to be $224.52 million, up 49.6% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Axsome has been revised 14.8% down to the current level. Nevertheless, the company now has an Earnings ESP of +12.69%, reflecting a higher Most Accurate Estimate. When combined with a Zacks Rank of #4 (Sell), this Earnings ESP makes it difficult to conclusively predict that Axsome will beat the consensus EPS estimate. Over the last four quarters, the company surpassed EPS estimates just once. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Alpha Cognition Inc. (ACOG) : Free Stock Analysis Report Axsome Therapeutics, Inc. (AXSM) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-03

Alpha Cognition to Report Second Quarter 2026 Financial Results and Provide Business Update

Business Wire
VANCOUVER, British Columbia & DALLAS, August 03, 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 second quarter 2026 financial results and provide a business update on Thursday, August 13, 2026, at 4:30 p.m. ET, after market close. The company will issue a press release detailing its second 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. Following the release, management will host a conference call to review financial and operating results. Details for the conference call can be found below: Please call the conference telephone number or log on to the web access link five minutes prior to the start time. A replay of the call will be available three hours following the call via the Events section of the Alpha Cognition website. 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"), an indication 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 cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia, and as an intranasal formulation for Cognitive Impairment with mTBI. Forward-looking Statements This press release contains forward-looking statements within the meaning of applicable U.S. and Canadian securities laws. Forward-looking statements are not historical facts and include, but are not limited to, statements regarding the timing of the Company's financial results announcement and conference call, the Company's commercialization activities, business strategy, market opportunities, product developme…Read full document

VANCOUVER, British Columbia & DALLAS, August 03, 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 second quarter 2026 financial results and provide a business update on Thursday, August 13, 2026, at 4:30 p.m. ET, after market close. The company will issue a press release detailing its second 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. Following the release, management will host a conference call to review financial and operating results. Details for the conference call can be found below: Please call the conference telephone number or log on to the web access link five minutes prior to the start time. A replay of the call will be available three hours following the call via the Events section of the Alpha Cognition website. 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"), an indication 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 cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia, and as an intranasal formulation for Cognitive Impairment with mTBI. Forward-looking Statements This press release contains forward-looking statements within the meaning of applicable U.S. and Canadian securities laws. Forward-looking statements are not historical facts and include, but are not limited to, statements regarding the timing of the Company's financial results announcement and conference call, the Company's commercialization activities, business strategy, market opportunities, product development plans, clinical development programs, regulatory activities and future operating performance. Forward-looking statements may be identified by words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would," and similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are based on management's current expectations, assumptions and beliefs and involve known and unknown risks, uncertainties and other factors that could cause actual results, events or developments to differ materially from those expressed or implied by such forward-looking statements. Although the Company believes it has a reasonable basis for these forward-looking statements, it can give no assurance that such expectations will prove to be correct. Actual results may differ materially from those expressed or implied by these forward-looking statements. Risks and uncertainties that could cause actual results to differ materially include, without limitation, risks related to the commercialization, market acceptance, reimbursement, pricing, distribution and sale of ZUNVEYL®, the Company's ability to maintain and protect its intellectual property, regulatory oversight and product safety matters, manufacturing and supply chain activities, the availability of adequate reimbursement coverage, competition from existing and future therapies, product liability exposure, the outcome of research and development activities, the results of clinical trials, the Company's ability to obtain additional regulatory approvals, and general economic, market and business conditions. Additional information regarding these and other risks and uncertainties is contained in the Company's filings with the U.S. Securities and Exchange Commission ("SEC"), including the risk factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2025, subsequent Quarterly Reports on Form 10-Q, and other filings made with the SEC, as well as the Company's filings with Canadian securities regulatory authorities, each of which is available on the applicable regulatory websites. The forward-looking statements contained in this press release are made as of the date hereof, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260803960737/en/ Contacts LifeSci Advisors, PJ [email protected]

Investor releaseQuarter not tagged2026-06-09

Alpha Cognition Reports Positive Top-Line Results from BEACON Real-World Study of ZUNVEYL® in Alzheimer’s Disease

Business Wire
In a retrospective observational study based on provider assessments and chart review: Providers reported cognitive improvement in 92% of patients following initiation of ZUNVEYL Providers reported improvement in neuropsychiatric symptoms in 93% of patients after initiation of ZUNVEYL Providers reported delayed initiation or discontinuation of concomitant psychotropic medications in 80% of patients receiving ZUNVEYL Providers reported favorable changes in activities of daily living (ADLs) in 71% of patients following initiation of ZUNVEYL Providers reported improvements across sleep-related outcomes in 72% of patients following initiation of ZUNVEYL Providers reported favorable gastrointestinal (GI) tolerability and overall treatment experience in patients receiving ZUNVEYL VANCOUVER, British Columbia & GRAPEVINE, Texas, June 09, 2026--(BUSINESS WIRE)--Alpha Cognition Inc. (NASDAQ: ACOG) ("Alpha Cognition", "ACI", or the "Company"), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, today announced the top-line results from its BEACON real-world study evaluating provider-reported cognitive, behavioral, functional, and tolerability outcomes among long-term care residents with mild to moderate Alzheimer’s disease who were receiving ZUNVEYL. The BEACON study evaluated provider-reported outcomes from 21 investigators treating 162 long-term care patients with mild to moderate Alzheimer’s disease who received ZUNVEYL for 3 to 12 months following prior acetylcholinesterase inhibitor (AChEI) treatment or after discontinuation of available AChEI therapies presumably due to limited efficacy or tolerability. "We believe that long-term care patients with Alzheimer’s disease remain underrepresented in traditional clinical datasets despite representing a significant and clinically complex treatment population," said Michael McFadden, Chief Executive Officer of Alpha Cognition. "BEACON provides valuable real-world insights into the treatment experience of long-term care patients with Alzheimer’s disease receiving ZUNVEYL." "The importance of the BEACON study lies in its focus on the patients we care for every day in long-term care facilities—individuals with Alzheimer's disease whose cognitive decline is often accompanied by neuropsychiatric symptoms, functional impairment, and substantial medication burden," said Erik C…Read full document

In a retrospective observational study based on provider assessments and chart review: Providers reported cognitive improvement in 92% of patients following initiation of ZUNVEYL Providers reported improvement in neuropsychiatric symptoms in 93% of patients after initiation of ZUNVEYL Providers reported delayed initiation or discontinuation of concomitant psychotropic medications in 80% of patients receiving ZUNVEYL Providers reported favorable changes in activities of daily living (ADLs) in 71% of patients following initiation of ZUNVEYL Providers reported improvements across sleep-related outcomes in 72% of patients following initiation of ZUNVEYL Providers reported favorable gastrointestinal (GI) tolerability and overall treatment experience in patients receiving ZUNVEYL VANCOUVER, British Columbia & GRAPEVINE, Texas, June 09, 2026--(BUSINESS WIRE)--Alpha Cognition Inc. (NASDAQ: ACOG) ("Alpha Cognition", "ACI", or the "Company"), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, today announced the top-line results from its BEACON real-world study evaluating provider-reported cognitive, behavioral, functional, and tolerability outcomes among long-term care residents with mild to moderate Alzheimer’s disease who were receiving ZUNVEYL. The BEACON study evaluated provider-reported outcomes from 21 investigators treating 162 long-term care patients with mild to moderate Alzheimer’s disease who received ZUNVEYL for 3 to 12 months following prior acetylcholinesterase inhibitor (AChEI) treatment or after discontinuation of available AChEI therapies presumably due to limited efficacy or tolerability. "We believe that long-term care patients with Alzheimer’s disease remain underrepresented in traditional clinical datasets despite representing a significant and clinically complex treatment population," said Michael McFadden, Chief Executive Officer of Alpha Cognition. "BEACON provides valuable real-world insights into the treatment experience of long-term care patients with Alzheimer’s disease receiving ZUNVEYL." "The importance of the BEACON study lies in its focus on the patients we care for every day in long-term care facilities—individuals with Alzheimer's disease whose cognitive decline is often accompanied by neuropsychiatric symptoms, functional impairment, and substantial medication burden," said Erik Cabrera, MD, Board-Certified Psychiatrist and Long-Term Care Practitioner. "The provider-reported observations from BEACON provide descriptive real-world information regarding treatment experiences among long-term care patients receiving ZUNVEYL. While the study was not designed to establish causality, these findings may help inform clinical discussions and future research in this challenging patient population." Because BEACON was a retrospective observational study without a randomized control group, the reported observations cannot establish causality and should not be interpreted as evidence that ZUNVEYL caused the reported outcomes. Key Findings 98% of providers reported a favorable overall treatment experience among patients receiving ZUNVEYL Cognitive and Functional Reports Providers reported cognitive improvement in 92% of patients following ZUNVEYL treatment Providers reported improvement in activities of daily living (ADLs) in 71% of patients following treatment with ZUNVEYL Neuropsychiatric and Behavioral Reports Providers reported improvement in neuropsychiatric symptoms in 93% of patients following ZUNVEYL administration These observations were provider-reported and do not establish that ZUNVEYL improves agitation, aggression, anxiety, sleep disturbances, or other neuropsychiatric symptoms Reduction in Medication Burden Providers reported delaying initiation or discontinuing concomitant psychotropic medications in 80% of patients; the study was not designed to determine whether these changes were attributable to ZUNVEYL. Antipsychotics and anxiolytics were the medication classes most frequently reported as delayed or discontinued during the observation period Tolerability Reports Providers reported improvement in sleep-related issues in 72% of affected patients after transitioning to ZUNVEYL. These observations were based on provider assessments and do not establish an effect of ZUNVEYL on sleep-related outcomes. When taking ZUNVEYL, providers reported favorable gastrointestinal tolerability observations in 89% of patients with a history of GI side effects while receiving prior acetylcholinesterase inhibitors. About the BEACON Study BEACON was a Phase IV, retrospective, observational real-world effectiveness and tolerability study designed to capture provider assessments and chart review observations in long-term care clinical practice settings. Providers participating in the BEACON study reported observations related to cognition, neuropsychiatric symptoms, medication utilization, and tolerability, which may contribute to understanding treatment experiences in complex elderly patients receiving routine clinical care. As a retrospective observational study, BEACON was not designed to establish causality, and findings reflect provider-reported clinical experience in real-world long-term care practice settings. The findings reported in the BEACON study are subject to limitations inherent in observational research, including potential bias, confounding factors, variability in clinical practice, and the absence of randomization or a control group. As a result, provider-reported observations regarding cognition, neuropsychiatric symptoms, functional outcomes, medication utilization, tolerability, and other clinical measures may not be attributable to ZUNVEYL and may not be predictive of future clinical outcomes. There can be no assurance that the observations reported in the BEACON study will be confirmed in prospective, controlled clinical trials, will be replicated in broader patient populations, or will support future regulatory, medical, reimbursement, commercial, or clinical conclusions regarding ZUNVEYL. About ZUNVEYL (benzgalantamine) ZUNVEYL was designed with a differentiated metabolic profile that results in reduced gastrointestinal exposure to galantamine relative to conventional oral galantamine formulations. The clinical significance of this pharmacokinetic difference has not been established beyond findings described in the approved prescribing information. 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 acetylcholinesterase inhibitor approved for the treatment of mild-to-moderate Alzheimer's disease in adults. ZUNVEYL’s active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, including the alpha-7 subtype, which has been studied in preclinical and clinical research. Benzgalantamine is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia, and as a sublingual formulation for Cognitive Impairment with mTBI. INDICATION AND USAGE ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or to any inactive ingredients in ZUNVEYL. Serious skin reactions have occurred. WARNINGS AND PRECAUTIONS Serious Skin Reactions: Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine (the active metabolite of ZUNVEYL tablets). If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed, and alternative therapy should be considered. Anesthesia: See Drug Interactions Section Cardiovascular Conditions: Cholinesterase inhibitors, including ZUNVEYL, have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. Bradycardia and all types of heart block have been reported in patients taking cholinesterase inhibitors, both with and without known underlying cardiac conduction abnormalities. Therefore, all patients should be considered at risk for adverse effects on cardiac conduction. Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope. Gastrointestinal Conditions: Cholinesterase inhibitors, including ZUNVEYL, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. Galantamine has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. Monitor the patient's weight during therapy with ZUNVEYL Genitourinary Conditions: Although this was not observed in clinical trials with galantamine, cholinesterase inhibitors, including ZUNVEYL, may cause bladder outflow obstruction. Neurological Conditions: Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. Seizure activity may also be a manifestation of Alzheimer's disease. Patients with Alzheimer's disease should be monitored closely for seizures while taking ZUNVEYL. Pulmonary Conditions: Cholinesterase inhibitors, including ZUNVEYL, should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease. Monitor for respiratory adverse reactions. ADVERSE REACTIONS The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. DRUG INTERACTIONS Use with Anticholinergics: Galantamine has the potential to interfere with the activity of anticholinergic medications. Use with Cholinomimetics and Other Cholinesterase Inhibitors: A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol. USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data may cause fetal harm. Hepatic Impairment: In patients with moderate hepatic impairment, a decrease in clearance of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with severe hepatic impairment is not recommended. Renal Impairment: In patients with a creatinine clearance of 9 to 59 mL/min, an increase in exposure of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with creatinine clearance less than 9 mL/min is not recommended. These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit www.fda.gov/MedWatch or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information. Forward-looking Statements This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company’s current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These statements include but are not limited to statements regarding the impact of provider-reported observations from the BEACON study on future care decision including the possibility to support simplified treatment management in complex elderly patients. In some cases, you can identify forward‐looking statements by the words "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "objective," "anticipate," "believe," "estimate," "predict," "project," "potential," "target," "seek," "contemplate," "continue" and "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company’s intellectual property in relation to ZUNVEYL, risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company’s filings with Canadian securities regulatory authorities and available at www.sedar.com and the Company’s filings with the United States Securities and Exchange Commission (the "SEC"), including those risk factors under the heading "Risk Factors" in the Company’s most recent Annual Report on Form 10-K filed with the SEC on March 31, 2026 and the Company’s other filings with the SEC available at www.sec.gov. These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260609909539/en/ Contacts For further information:Investor RelationsLifeSci Advisors, PJ [email protected]

Investor releaseQuarter not tagged2026-05-15

Alpha Cognition Inc. Common Stock Q1 2026 Earnings Call Summary

Moby
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…Read full document

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-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management noted no significant changes in the volume of prior authorizations but highlighted an improved approval rate of approximately 89% when supported by their internal reimbursement team. Confirmed that no new hard restrictions or step edits have been implemented by payers over the last three quarters. The company is conducting a PK study to show equivalence to the tablet; if successful, they will submit an IND to the FDA in the latter part of 2026. The sublingual formulation is also intended for use in the Traumatic Brain Injury (TBI) program. BEACON data (early Q3) will provide rare long-term care insights on cognition, behavior, and polypharmacy. CONVERGE, a retrospective analysis, is expected to deliver top-line data in Q3 2026, while the RESOLVE outpatient study will continue into Q2 2027. Management confirmed that the momentum from March—the strongest month since launch—has continued into April. Growth is being driven by the now fully-staffed sales force and the rollout of peer-to-peer educational programs for key opinion leaders.

Investor releaseQuarter not tagged2026-05-15

Alpha Cognition (ACOG) Q1 2026 Earnings Transcript

Motley Fool
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…Read full document

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 to our clinical programs. We have 3 active real world studies underway, which we believe will strengthen ZUNVEYL's positioning with payer and health care providers. Beacon, our real world effective 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 third quarter, an acceleration from our prior expectation of late Q4. CONVERGE, a 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 2026. We expect both BEACON and CONVERGE to provide the company numerous publication opportunities over the coming year. Resolve our Phase 4 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 US Patent Office issued 2 patents to provide additional protection for ZUNVEYL. A new patent covering dosage regimens for benzhydrogalantamine was given in February and a second covering the use of benzhydrogalantamine 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 for the company estimated at approximately $14 billion. Regarding our sublingual formulation program, 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 US partnership, CMS continues to advance the regulatory process across multiple countries in Asia, and we anticipate 2 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 health care providers and payers. I want to be direct about the way we are thinking about our investment phase. Our net loss this quarter reflects the company's scaling our efforts and we are 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, and we continue to remain on track with these targets. Henry will now review the financials in detail, and Lauren will provide a comprehensive commercial update after Henry concludes his comments. Henry? Henry Du: Thank you, Michael. Good afternoon, everyone. As I review our 2026 results, please refer to today's press release, and 10-K's 10 Q filed this afternoon. For Q1 2026, we generated total net product revenues of $3.5 million in 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 thousand. Representing only the final 2 weeks of March 2025 following our commercial launch. Plus, $600 thousand in licensing revenue from our CMS agreement. The trajectory from that initial quarter to $3.5 million in Q1 26 illustrates the significant commercial progress ZUNVEYL has made in just 1 year of commercialization. Total operating expenses including cost of revenues, for Q1 26 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 initiation of a RESOLVE clinical study. For context, Q4 25 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 26 reflects the intentional investment decisions that Michael described. So scaling field force spending on market reach, and initiating studies that would generate the real world data needed to accelerate payer coverage and prescriber adoption. For Q1 26, we reported a net loss of approximately $6.5 million or $0.30 basic loss per share. This compares to a net loss of $1.7 million or $0.11 per share in Q1 25. The year over year increase reflects 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 03/31/2026, company had approximately $54.2 million in cash and cash equivalents. Compared to $66 million at 12/31/2025. The company maintains a debt free balance sheet We continue to believe our current capital position is sufficient to fund operations sustains ZUNVEYL 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 to $58 million This is unchanged from our prior guidance. We expect Q2 spending to increase modestly relative to Q1. As Resolve ramps in our peer-to-peer education programs accelerate. But 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 single formulation. With that, will now turn the call over to Lauren to discuss commercial progress. Lauren? Lauren D'Angelo: Thank you, Henry. I am pleased to provide a detailed update on our Q1 26 commercial performance. This was a quarter of meaningful execution across prescriber adoption, nursing home penetration, and payer engagement. And 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 7.9 thousand total health care providers and called on approximately 3.76 thousand 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 prescriber who had written at least 1 ZUNVEYL prescription grew 23% quarter over quarter to 1.06 thousand. 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 thousand active writers or approximately 75% have put in repeat prescriptions. Importantly, this implies not just adoption, but sustained utilization with each rider averaging approximately 5 to 6 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 6 prescriptions in the quarter. 736 have placed repeat orders, and an 81% repeat rate at the facility level. This is what durable adoption looks like. We called on 2.5 thousand unique nursing homes in Q1, 26 percent 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 2.32 thousand 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 6.05 thousand a 23% increase over Q4's 4.14 thousand 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. Importantly, we view this as a time 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 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 plan 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, a bit of an access curve. As is common with newly launched therapies, plans are monitoring early utilization trends before fully activating formulary access across their network. We expect contracts to begin gaining meaningful traction in Q2 and Q3, and we are working to accelerate this through a 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 adoption across large national plans. Our full sales team of 60 customer facing representatives 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 of Geriatric Psychiatrists 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 multichannel approach to building scientific credibility and prescriber confidence for ZUNVEYL. In summary, Q1 26 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 will now hand it back to Michael for closing remarks. Michael E. McFadden: Thank you, Lauren. Let me briefly summarize what I believe are the key takeaways for the company for Q1 26. 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. And by year-end 2026, we will have 2 real world evidence data sets in hand, a powerful foundation for our payer coverage expansion, and also to build prescriber confidence. Third, we are scaling with discipline. Our Q1 operating spend of approximately $12 million reflects intentional investment and the resources needed to win in our market and we are building very deliberately. Full-year 2026 expense guidance of $54 million to $58 million is unchanged. And we remain on track for operating profitability in 2027. And fourth, our organization's stronger than ever. Our full field team is in place. We have added meaningful payer and marketing talent. We have strengthened our board. We are building this company to win. So we are 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 US milestones that will advance an ongoing payer progress, All of these things give us encouraging signs that our--we built for ZUNVEYL will continue to reap rewards. 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As of 2026-08-22 • Updated weeklySource: Earnings sourceIngestion runbook