管理層發言
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.
Thank you.
You may begin.
Thank you, Sachi. Good afternoon, everyone, and thank you for joining us today for AlphaCognition'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 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?
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 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 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 topline 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 presentations as they are accepted and confirmed. We expect CONVERGE topline data in Q3. We believe this will provide the company two 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.
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 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 and 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?
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 $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 one ZUNVEYL prescription) grew 27% quarter-over-quarter to 1.35 thousand and cumulative life-to-date writers reached 1.91 thousand. 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 1.02 thousand Q2 writers, approximately 76% placed repeat prescriptions, and productivity per writer continued to climb, rising to approximately 6 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 1.09 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 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. 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 DONA and MPA, 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. 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.
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 1.3 thousand HCP writers, over 1 thousand repeat writers, a thousand nursing homes with prescriptions, and almost 900 homes with repeat prescriptions. Repeat utilization remains one 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 opportunities in the business, and our evidence generation continues to advance. The company's enrolling RESOLVE and CONVERGE are underway, and BEACON was completed ahead of schedule. The company will have publications from that study to present to the medical community this fall. So we are excited about the balance of 2026. The foundation we built for ZUNVEYL is strengthening and our commercial indicators are moving in the right direction. We remain focused on disciplined execution. With that, operator, we will now take questions.
分析師問答
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. One moment please while we pull for questions. First question is from Raghuram Selvaraju from H.C. Wainwright. Please go ahead.
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 who have written prescriptions in multiple months, can you give us additional granularity on that specific element of prescribing behavior, particularly what may be converting the 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. Secondly, could you give us a sense of when you might expand sales and marketing outreach beyond long-term care into the specialist neurologist population? And lastly, with respect to formulary access, could you elaborate further on when you anticipate that emerging as a tailwind above and beyond the pull-through demand that you are seeing? Thank you.
Thanks, Raghuram. Those are very solid questions. I will start with your first one around our repeat prescriber rate and what is driving the repeat group to continue writing ZUNVEYL. I think it really comes down to their experience with the drug. You start by calling 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 one or two patients, and then they start repeating once they have experienced positive effects from ZUNVEYL. What we are seeing are significant repeat rates — 76% of providers are writing again — that is some of the highest I have seen in my experience. Based on feedback we have gotten from our customers, it is really three things. First, they want to make sure this drug is tolerable because prior experience with older generics did not have great tolerability. Once they see that ZUNVEYL is very tolerable, they then look at efficacy and see meaningful cognitive effects, which is the core foundation for why they use these drugs in the first place. And then, as we have talked about, they are seeing significant benefits across behavior. Those are the three factors 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 the neurology space, we are really focused right now on maximizing the long-term care opportunity. We obviously believe there is tremendous upside 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 is the payer lens. 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. So it is really operating profitability and payer coverage that would determine when we expand into neurology. On payer, we are actively engaged with all of the key payers that matter to the long-term care business. We are having consistent conversations and are focused on increasing demand so that we increase the likelihood of gaining formulary coverage. What we are seeing across the board, specific to ZUNVEYL and the broader Medicare Part D space, is the impact of the Inflation Reduction Act. That is having a significant impact on the plans and the additional cost they have to pick up. So we must continue driving demand. We are hopeful that we will see movement in the second half of the year. It is not a matter of if, but when, because payers recognize the demand and the growth that we are driving, and we will continue to have those conversations to start obtaining formulary coverage.
And then just very quickly, could you provide 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 toward when the study would be completed, but when would data be available? And then if you could also comment on the size of the market opportunity you expect to be addressable with the sublingual formulation and whether you would consider instituting revenue guidance for 2027 along with possibly instituting an expense guidance range for that year.
A lot to unpack there. First, CONVERGE: we anticipate topline data for CONVERGE in Q3 of 2026. The significance of CONVERGE is the quantitative retrospective data analysis on the long-term care Alzheimer's market. It will provide data on persistence, adherence, polypharmacy with all drugs, as well as a number of other elements like ADL improvement, tolerability, and patient profiling for each of the drugs. That data will result in multiple publications; they likely will not be public until 2027 as we will begin preparing manuscripts and submitting those for publication thereafter. We also believe that with CONVERGE quantitative data and BEACON qualitative data, there is an opportunity to analyze that data pharmacoeconomically which will provide additional information useful for payers and decision makers who have a financial interest in how Alzheimer's drugs are used. RESOLVE is underway and recruiting to our expectations. We anticipate that study will complete in Q2 of next year, and we expect to have data in the summer or fall depending on the timing in Q2. From a sublingual perspective, we are excited about the opportunity. We believe the sublingual opportunity represents about 10 to 20 percent of patients with Alzheimer's disease. Data indicate that about 10 to 20 percent of patients have either aphasia or dysphagia, meaning they cannot swallow or have difficulty swallowing. Treatment choices for those patients are currently very limited. A sublingual formulation has the opportunity to take significant share from existing therapies and from patches that are often used, which are difficult and challenging to administer. We have a gating item for the sublingual product: we are running a peak-to-trough PK study this quarter. We anticipate that data will be available in Q3 and that will determine the timeline for the clinical program for sublingual. Regarding 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.
The next question is from David Storms from Stonegate. Please go ahead.
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 that could have impacted sales? And also, if 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.
Both are really good questions. As it relates to material stocking: no, we did not have a significant increase in stocking. Our pharmacies 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 reimbursement, right now we are holding strong at about 74%. If we do not see significant formulary additions 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 gross-to-net by the end of the year.
The next question is from Chase Nickerbacher from Craig-Hallum Capital Group. Please go ahead.
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 speak a bit to what you have seen from a demand perspective so far in the third quarter? And to what extent are plan pull-through and payer dynamics playing a role here versus is it just commercial execution from your team?
Q2 results and demand were increasing month over month, and June was our strongest demand month as of Q2. I can tell you momentum has continued into Q3. We have had no formulary wins and our 16% contracted open book of business is consistent since last quarter. So we believe the strong demand 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, and we believe that is really what is driving the demand. Any formulary wins that come in the future are upside for us because we already have strong growth.
Then lastly, could you 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?
We are still tracking adherence rates because long-term care is a little different in how you look at the data, so it's hard to give a precise average time on drug or an exact six- or 12-month retention number today. What we do see is patients generally stay on drug longer in the long-term care facility versus a retail segment because they are being cared for daily. I hesitate to give a specific number because we are still working through that adherence rate, but Q2 was driven by significant new growth as well as refills from previous quarters. Hopefully in the future I will be able to give a more accurate number around adherence.
The next question is from David Storms from Stonegate. Please go ahead. David Storms, your line is open.
Hi. Can you hear me?
Yes. We can hear you, David.
Hi. Apologies for that. Two quick questions. First, can you comment on specific geographies or types of prescribers or 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? How refractory are the patients that you are putting on the drug in terms of number of therapies they have already been on?
As it relates to growth across the nation for Q2, we have seen growth in every region. The largest volume is coming from key markets that have the largest opportunity, but overall we are seeing significant growth across the country and there is not one specific area outperforming far above others. With our 60-person sales team, every region is gaining traction. Regarding the feedback on why physicians switch patients to ZUNVEYL: there are several reasons. We see many new patients who have not been on a drug in a while because they had previously failed donepezil or one or two generics and had no other tolerable alternative. Physicians are reenergized to try something else for these patients because they could not tolerate earlier drugs. We also see a significant amount of switching due to tolerability issues with other therapies, including insomnia and GI issues, and because physicians are seeing behavioral improvements with patients on ZUNVEYL. Therefore, some patients are switched from other drugs to ZUNVEYL based on observed behavioral benefit. So both tolerability and behavioral benefits are primary drivers for switching. Those patients that are being switched often have tried prior therapies; we see a mix, but many are switching due to tolerability or lack of behavioral benefit on prior treatments.
The next question is from David Storms from Stonegate. Please go ahead.
Afternoon. Thank you for taking my questions. Just wanted to start with 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 are more focused on the white space?
That is a great question. One of the challenges with long-term care data is we call them ghost writers. So even though it might show in the data that a prescriber has only written one prescription, they often have written more and the order was entered under another doctor. We do not have many physicians who tried once and dropped off entirely. We have segmented the market and our prescribers into tiers: a first tier, a second tier where they have written several scripts but are not writing for the full share of patients yet, and a third tier. The good news is in Q2 every tier improved. Previously, early physicians who had only tried one or two needed two to three months to get experience with the drug. We are now seeing that wave of physicians move into significant repeat writing. It's a continual cycle where we call on tier three, they get two to three months' experience, and then they move into the next tier. Across all tiers we have seen significant improvement and we expect that trend to continue.
And then maybe one more modeling question. With SG&A expense guidance decreasing, is there any more you could give us on how sticky that might be and how much could be applied into 2027? Any more color would be helpful.
Yes, I can comment on that. We anticipate some consistency into 2027, but we have not finalized our 2027 numbers. We have a number of studies ongoing this year which increase expenditures and those will be concluding in Q2 of next year. Our commercial efforts and opportunities may offset some of that into 2027. Please bear with the company as we finalize our 2027 budget and spending plan; we will provide that data, but it will be in a similar range for next year.
The next question is from William Wood from B. Riley Securities. Please go ahead.
Hi, thanks for taking our questions. A couple for us. For patients who come off the drug, what is the main driver for patients not continuing persistence? Is it adverse events or lack of efficacy? Alternatively, what is driving the prescriber to stop prescribing it? And in terms of long-term care home base, it looks like you have continued expansion. But I'm curious in terms of the percentage of total base you have built into. I know it is early, but curious how much potential expansion you have left in that top-line opportunity.
Those are great questions. We talk to customers daily and follow patients that discontinue ZUNVEYL. While discontinuations do happen, within our data we have not seen patients come off due to tolerability or lack of efficacy; the feedback has been overwhelmingly positive. The downside of long-term care is that patients are very frail, so you will see deaths, patients leaving the facility, hospitalizations after falls, etc., which appear as discontinuances in the data but are not true therapy failures. We typically recapture those patients when they return to the home. Also, if there is a formulary change or a prior authorization issue, our reimbursement team follows up to ensure the patient gets back on the drug. Those are the main reasons you might see a patient come off ZUNVEYL. Regarding opportunity and market penetration, we see significant opportunity in long-term care. If you look at the highest volume Alzheimer's patients across the country and split these into homes, there are about 5,000 homes that are tier-one targets which provide significant opportunity for ZUNVEYL, and about 3,000 top-tier physicians. Right now we have about 1,000 writers, so not only do we need to increase depth with existing providers, but we also have many more prescribers to activate. From our perspective, there is a lot of upside opportunity.
One last question: In terms of the patients who are switching or starting drug, are you getting more patients that are refractory to other drugs or more switchers actively looking for a drug — in other words, pulling from non-drug users or drug users?
We are seeing about a 50/50 mix. In long-term care many patients who appear treatment-naive in current data may have tried therapies previously but are off treatment now; they look treatment-naive but likely tried something earlier. We are also seeing significant switches where patients already on other therapies experience tolerability issues or behavioral concerns. That switch group is one of our highest contributors because ZUNVEYL's profile addresses tolerability and behavioral impact. So roughly half of our business comes from patients previously treated (but not on treatment currently) and half comes from direct switches from generic acetylcholinesterase inhibitors due to tolerability or behavioral issues.
There are no further questions at this time. I would like to turn the floor back over to Michael E. McFadden for closing comments.
Thanks, everybody, for attending the call and to those who are listening. We are excited about the quarter. We had a strong quarter highlighted by our growth in bottles, prescribers, adoption, our progress in payer and evidence generation, and our focus on high-target opportunities for the company that we believe will continue to drive growth in quarters to come. Thank you for listening to the call. If you are interested in speaking with the company further, you can reach out to our IR on our website. Thank you so much.
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.