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Date

May 14, 2026

Call participants

  • Chief Executive Officer — Michael E. McFadden
  • Chief Financial Officer — Henry Du
  • Chief Commercial Officer — Lauren D'Angelo

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Takeaways

  • Revenue -- $3.5 million, up 40% sequentially from Q4 2025, driven entirely by ZUNVEYL sales as reported by both Michael E. McFadden and Henry Du.
  • Prescription bottles dispensed -- 6,050 bottles in the quarter, a 23% increase over 4,140 bottles in Q4 2025, with March setting a new monthly high and April trending higher.
  • Prescriber base -- 1,060 health care professionals wrote at least one ZUNVEYL prescription, reflecting a 23% sequential increase, and 28% of those called on wrote prescriptions.
  • Nursing home penetration -- 914 nursing homes dispensed ZUNVEYL, up 25% quarter over quarter, representing 36% of targeted facilities, with an 81% repeat order rate at the facility level.
  • Customer-facing team -- 60-person field force fully staffed, enabling a 93% quarter-over-quarter increase in “call down” prescribers to 3,760, and broader territory coverage.
  • Product pricing -- 6% price increase for ZUNVEYL to $869.36 per bottle implemented during the quarter.
  • Payer access progress -- Medicare D contracts secured with two major PBMs covering 45 million lives; 16% downstream formulary implementation achieved, both with no prior authorization, and an 89% approval rate when company supports prior auth submissions.
  • Clinical studies -- Three real-world studies (BEACON, CONVERGE, RESOLVE) advancing, with BEACON enrollment completing this quarter and top-line data accelerated to early Q3; CONVERGE and RESOLVE initiate this quarter with data expected in 2026.
  • Patent developments -- Two new U.S. patents granted, extending ZUNVEYL protection through 2045 for Alzheimer’s and traumatic brain injury applications.
  • Operating expenses -- $11.6 million this quarter, up from $10.7 million in Q4 2025 and $6.3 million in Q1 2025, reflecting expansion of sales, marketing, and clinical investments.
  • Net loss -- $6.5 million, or $0.30 per share, compared to $1.7 million, or $0.11 per share in Q1 2025; cash and equivalents at $54.2 million, and debt-free status maintained.
  • Expense guidance -- 2026 operating expense guidance reaffirmed at $54 million to $58 million; Q2 spending expected to increase modestly relative to Q1.
  • Sublingual formulation -- Comparative pharmacokinetic study of new formulation versus tablet to initiate this quarter; positive PK data could expedite clinic advancement.
  • Board and management -- Bethany Censenig appointed as independent board member, bringing additional financial governance and strategic experience.
  • Ex-US partnership -- CMS advancing regulatory submissions in multiple Asian countries, with two product approvals anticipated in 2026.

Summary

Alpha Cognition (ACOG 4.54%) delivered significant sequential revenue growth and expanded its commercial footprint for ZUNVEYL, now marking the company's fourth quarter since launch. Commercial metrics showed accelerating adoption across prescribers and long-term care facilities, supported by a fully staffed field team and evidence-building clinical initiatives. Management confirmed that BEACON study enrollment will finish ahead of schedule, targeting early Q3 for top-line results, while patent extensions secure commercial exclusivity through 2045. Financial strategy remains focused on scaling, with ramped investment in commercial and clinical infrastructure and a debt-free cash position of $54.2 million. Strategic clarity continues as the company reiterated its 2026 operating expense guidance and maintained its target to achieve operating profitability in 2027.

  • Management's statement that "April is stronger than March" indicates a sustained upward trend into the subsequent quarter, suggesting ongoing demand momentum.
  • Company emphasized that 75% of active prescribers issued repeat prescriptions, and 81% of nursing home facilities placed repeat orders, highlighting depth of market adoption.
  • Commercial analytics, AI-enabled targeting tools, and peer-to-peer education initiatives are emphasized as core tactics for optimizing field team productivity and accelerating prescriber conversion.
  • Management asserted all investments are "core to advancing ZUNVEYL's long term trajectory," reinforcing the disciplined approach to scaling.

Industry glossary

  • PBM (Pharmacy Benefit Manager): Third-party administrators that manage prescription drug benefits and negotiate contracts with health plans, pharmacies, and drug manufacturers to control costs and access, cited as key partners for ZUNVEYL’s payer access.
  • Polypharmacy: The use of multiple medications by a patient, particularly prevalent in long-term care and elderly populations, addressed in the CONVERGE clinical study.
  • PK (Pharmacokinetic): Study of how a drug is absorbed, distributed, metabolized, and excreted in the body, relevant to the pending sublingual ZUNVEYL formulation study.

Full Conference Call Transcript

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.