Alpha Cognition Inc. Common Stock (ACOG) Q2 2025 Earnings Report, Transcript and Summary

Greetings, and welcome to the Alpha Cognition Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Henry Du, Interim Chief Financial Officer, Vice President of Accounting and Finance. Thank you. You may begin.

Thank you, Sachi. Good afternoon, everyone, and thank you for joining us today for Alpha Cognition's Second Quarter 2025 Financial Results Conference Call. This morning, the company issued a press release announcing these results. On the call with me today 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, the management may make certain forward-looking statements regarding future events and the company's future performance. These forward-looking statements reflect Alpha Cognition's current perspective on existing trends and information. Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the Risk Factors section of the company's latest SEC filings. Actual results may differ materially from those projected in these forward-looking statements. For the benefit of those of you who may be listening to the replay, this call is being held and recorded on August 14, 2025. Since then, the company may have made additional announcements related to the topics discussed. Please reference the company's most recent press releases and current filings with the SEC. Alpha Cognition declines any obligation to update these forward-looking statements, except as required by applicable securities laws. I'll now turn the call over to Michael.

Thank you, Henry. Good afternoon, everyone. Thanks for taking the time to join us on today's call. Today marks an exciting milestone for our company as it marks our first quarter of earnings following the commercial launch of ZUNVEYL for the treatment of mild to moderate Alzheimer's disease. The second quarter of 2025 was characterized by a successful commercial launch of ZUNVEYL, engagement in the Long Term Care segment of our market, advances with payers, progress with our business development partner and the initiation of publications highlighting ZUNVEYL data and the market opportunity before us. During the quarter, the company made substantial progress on our commercial launch. The sales and marketing team made contacts with over 3,700 HCPs in the long-term care market. We saw prescriptions written in over 300 nursing homes. We saw duplicative prescriptions written in 65 of these nursing home -- 65% of these nursing homes, which we believe is a strong indicator of product trial. We expect new and duplicative home numbers to rise significantly in the coming quarters. Regarding medical progress, ZUNVEYL appears to be performing well with anecdotal reports of cognitive improvement, behavioral reduction and continued limited reports of adverse events. Our medical team has 5 abstracts that have been accepted for publication with three presentations made at AAIC in July. Additionally, we anticipate 7 additional abstracts to be submitted for publication or presentation at future medical meetings in the Long Term Care segment. Regarding an update on research and development, we continue to advance our sublingual formulation and anticipate formulation and [ tasting ] work to be completed in Q1 of 2026. The company plans to run a comparative PK study versus our tablet and intranasal formulations, and we will use this data as a basis for submission of an IND in the first half of 2026. The significance of this formulation is it can be used for patients with Alzheimer's who have dysphasia or aphasia, which is difficulty swallowing or the inability to swallow tablets or capsules. Our estimates are that 20% of Alzheimer's patient population suffer from this ] malady, and they currently have the option of a patch formulation or their caregiver must grind a tablet or mix capsule contents and apple sauce or something similar to deliver their medicine. We believe if ultimately approved, the sublingual formulation will displace the current options for majority of patients. Further in research and development, the company's Bomb Blast preclinical study with ALPHA-1062 concluded in late Q2. This was a two-part study funded with the Department of Defense grant and in collaboration with the U.S. Department of Veterans Affairs and the Seattle Institute of Biomedical and Clinical Research. The conclusions of Part 1 of the study demonstrated that ALPHA-1062 administration reduced levels of neuroinflammation and neuropathology that occur after a blast trauma. The second part of this study concluded that ALPHA-1062 administration reduced brain levels of three toxic forms of the protein Tau. One of the forms, pTau 217 has been suggested to identify patients at greater risk of long-term cognitive decline. An additional form, pTau 231, is elevated in early Alzheimer's disease and in TBI. These toxic forms of Tau suggest a potential role for ALPHA-1062 in the treatment of TBI. Additional benefits were shown that ALPHA-1062 reduced numbers of myeloid cells, which play a critical role in neuroinflammation and tissue repair as well as the number of astrocytes, which regulate neurotransmitters like glutamate and GABA, which support neuronal health. These changes are consistent with reduced neuroinflammation following ALPHA-1062 administration. Regarding business development, the company made significant progress with our first ex U.S. partner, CMS Pharmaceuticals, who's representing ZUNVEYL R&D and distribution in China and Greater Asia. The company heard from Chinese regulatory authorities they've accepted ZUNVEYL application for review, which represents a milestone for CMS and the Alpha Cognition teams. Additionally, our partner is on track to file in four additional countries by the end of 2025, which keeps us on track to generate ex U.S. revenues in the latter part of 2026. The company continues to manage expenses judiciously while preparing to capitalize on emerging opportunities in the Long Term Care market. Chief among these is optimally positioning ZUNVEYL, which has clinically meaningful benefits across both cognitive and behavioral symptoms associated with Alzheimer's disease. These effects are consistent with the product label as multiple studies have shown ZUNVEYL to improve behavioral symptoms frequently observed in patients with mild to moderate Alzheimer's disease. I'll ask Lauren to discuss our commercial progress momentarily, but first, I'll turn the call over to Henry to speak to the financials for the company.

Thank you, Michael. As I review our second quarter 2025 results, please refer to today's press release and 10-Q that were filed earlier this afternoon. Starting with our operating results. For the second quarter of 2025, we generated total revenue of $1.7 million. This consisted of $1.6 million in net product sales from our lead commercial product, ZUNVEYL, which launched at the end of Q1, an additional $81,000 in licensing revenue from our strategic collaboration with CMS. Since launch, we have reported approximately $2 million in net product revenues for ZUNVEYL. These results underscore initial traction in our commercialization efforts and lay the foundation for scalable growth in the quarters to come. Total costs and expenses for the quarter were $7.4 million. This comprised of $539,000 in first year cost of revenues and operating expenses of $6.9 million versus $2.4 million in Q2 2024. The change was largely attributed to initial year sales and an increase in selling, general and administrative expenses as we invested in our commercial launch activities for ZUNVEYL and related operational expansion. Correspondingly, our operating loss was $5.7 million versus $2.4 million during the same period in 2024. Turning to net income performance. For the second quarter of 2025, we reported a net loss of $10.5 million or $0.65 per share compared to a net loss of $2.1 million or $0.35 per share in the same quarter last year. The difference primarily reflects a $5.2 million noncash loss from changes in fair value of warrant liabilities. Now moving on to the balance sheet, where we remain well capitalized. As of June 30, 2025, the company had approximately $39.4 million in unrestricted cash and cash equivalents, supplemented by $425,000 of interest income earned during the quarter. Lastly, a brief update on guidance. While we are still not providing revenue projections at this time we anticipate our full year 2025 operating expense to be in the range of $34 million to $38 million. This reduction from previous guidance primarily reflects the successful execution of cost optimization initiatives, disciplined expense management and a more efficient allocation of resources across the organization. We believe this range appropriately reflects the level of investment required to advance our commercial efforts and support key corporate initiatives throughout the year. In summary, the second quarter of 2025 was a period of continued momentum, highlighted by the incremental revenue growth from ZUNVEYL and a solid liquidity position. These outcomes demonstrate prudent financial execution and encouraging early signs of market uptake. As we look ahead, our team remains committed to executing against our strategic goals and creating long-term value for all our stakeholders. I will now turn the call over to Lauren to discuss commercial progress. Lauren D’Angelo: Thanks, Henry. The second quarter of 2025 marked a significant acceleration in our commercial rollout of ZUNVEYL in the U.S. long-term care market. Following our late Q1 launch, we are seeing strong early indicators, including positive market signals, meaningful early adoption and encouraging engagement from both prescribers and LTC facilities. By the end of Q2, ZUNVEYL had been ordered in over 300 long-term care homes across our priority regions. Notably, 65% of those facilities have already placed repeat orders, a strong early indicator of both clinical confidence and operational fit within the LTC setting. Prescriber feedback remains very strong. The majority of new patient starts are progressing through the titration period as expected. We are closely tracking patient persistence and initial data trends are encouraging. While increased demand created new payer-related hurdles, particularly around prior authorizations, these challenges have not dampened prescription volume, though they have slowed the approval process. I am pleased to report, though, that 90% of ZUNVEYL orders have been filled. Our team is actively adapting to the nuances of each health plan and PBM, and we expect the approval process timeline to compress with continued learning. Our sales team made substantial progress in expanding clinical reach during Q2. As of quarter end, our field force had directly engaged with 1,564 unique prescribers and reached 1,969 homes. Additionally, virtual education programs have been well attended, helping to drive ongoing brand awareness and clinical confidence. To-date, approximately 370 HCPs have written at least one ZUNVEYL prescription during Q2 and 56% of those writers have written more than one order, a strong early indicator of initial interest across our target prescriber base. Looking at the 1,969 homes reached, 330 of those homes are productive with 65% of ordering homes having repeat orders, reflecting strong engagement. Additionally, 28% ordered for the first time in June. Our disciplined market access strategy continues to progress. As of July 1, we are pleased to report the signing with a large national health plan, one of the largest pharmacy benefit managers in the U.S. This agreement opens the door to potential access for approximately 17 million Medicare Part D lives. While access across downstream clients may vary, this milestone significantly strengthens our position within long-term care. Additional discussions with regional payers and LTC-focused plans are currently underway. Our 2026 Medicare Part D bid submissions remain on track. We remain committed to broadening access while maintaining pricing discipline. Our wholesale acquisition cost of $749 a month continues to be viewed as competitive and aligned with branded CNS therapies. Our commercial organization continues to perform at a high level. All four regional sales leaders and our full field team are now fully deployed. Their deep CNS and long-term care experience is driving effective engagements across the complex and highly regulated channel. With an average of 16 years of industry sales experience, including 10 years in LTC, our team is demonstrating a strong competitive advantage. Operationally, we've maintained high fulfillment rates across our distribution network, ensuring reliable product availability as demand scales. Q2 marketing efforts were highly targeted with a focus on HCP education and brand visibility. Our digital and in-person initiatives were carefully crafted to reflect the unique decision-making structure within LTC settings. Early feedback on messaging and materials has been very positive. Importantly, based on direct provider feedback, we have refined our messaging to highlight ZUNVEYL's label-consistent benefits across multiple behavioral domains measured by the Neuropsychiatric Inventory or the NPI. These refinements ensure our communications remain clinically grounded, regulatory aligned and relevant to prescribers managing a broad spectrum of behavioral symptoms in Alzheimer's disease. NPI was a key secondary endpoint in galantamine's registrational trial and the findings provide strong support for ZUNVEYL's impact on neuropsychiatric features commonly seen in long-term care populations. We also introduced a clinical titration support toolkit to aid HCPs during initiation. This resource has been well-received and is reinforcing clinical confidence. Looking ahead, as we enter the second half of 2025, our commercial focus remains on expanding ZUNVEYL's presence across additional long-term care homes, growing our base of repeat prescribers, deepening engagement with high potential HCPs and advancing payer access initiatives in preparation for 2026. We are encouraged by our early results and confident in our ability to sustain momentum in the quarters ahead. Thank you to our commercial team for their outstanding execution and to our investors for your continued support. With that, I'll turn it over to Michael.

Thank you, Lauren. In summary, the team is focused on execution. We're focused on executing more calls with high-value HCP targets, managing current restrictions with health plans and pulling through the contracts with others, increasing prescriptions by home and by prescriber to take advantage of the opportunity we see for ZUNVEYL in the long-term care market. Our business development team has worked with our partner in Asia to file ZUNVEYL ahead of schedule to deliver what we believe will be 2026 approvals that will add additional revenues for the company. The company continues to believe we have a disruptive opportunity with ZUNVEYL, and we'll focus the next quarters on our selling efforts and continued financial discipline. With that, we'll take questions. Sachi?

[Operator Instructions] The first question is from Ram Selvaraju from H.C. Wainwright.

Congratulations on all the progress so far. First, a couple of questions for Lauren. I was wondering if you could characterize for us the typical profile of what you expect to be a repeat prescriber of ZUNVEYL. If there's anything particularly distinguishable about such physicians. And also, if you could perhaps comment on what you expect the state of contracting to be by the end of this year, how many additional contracts you expect to have in place, whether that is likely to be primarily at the GPO level and what the scale of those contracts is likely to be based on the discussions you're currently having? Lauren D’Angelo: Sure. No, those are great questions, Ram. Thank you so much for the questions. As far as what the typical profile looks like for a repeat prescriber, the good news is most of -- so we've got targets that we set at quarterly business reviews, and our sales representatives are really targeted in on those specific targets. And what we have seen to-date with consistent messaging, with consistent frequency visits calling on these facilities, most of them are repeat customers. So I wouldn't say there's a particular specific type of profile that's repeat because we've already honed in on those really high-volume nursing home facilities. that have a high number of Alzheimer's patients. And then now with our additional behavioral messaging, it broadens the opportunity even further for potential patients for ZUNVEYL. So I hope that answers your question. It's really about us [ staying ] super diligent and focused on our key targets that we've identified during our quarterly business reviews and executing to that plan. And those customers, based on all of the feedback to-date that we've received with their experience on ZUNVEYL, we expect repeat customers. As it relates to additional contracts for the remainder of the year, as you can probably hear in my tone, we are very excited that we already have a very large plan that we have contracted with. This is very rare when you just launch a couple of months within the first quarter to get a signed contract. I'm happy to report that we are in deep discussions with a couple more plans. I do expect to have at least one more large national plans contracted by the end of the year. And hopefully, as the team stays diligent on our market access strategy, we could potentially announce additional plans. But I feel confident that we will have another large plan by the end of the year.

And then just a couple more, maybe both Lauren and Michael, you can address these. Firstly, with respect to the evolving picture on the prior authorization front, maybe you can give us a little bit more color on that precisely what in addition is being asked or put in place in terms of previous treatment history, prior experience with cholinesterase inhibitors that is different from what we saw at the previous earnings report as well as with respect to -- as we look ahead to how the company is going to be prioritizing capital allocation, maybe this question is a little bit more for Michael and maybe also Henry. How are you thinking about the timeline for ongoing and future R&D activities, particularly clinical development as things scale on the revenue side? Lauren D’Angelo: Sure. So I'll take the prior authorization question, and then I'll pass it over to Michael. So when we came out of the gates in April, as you'll probably remember, I reported to the team here that we were seeing very little prior authorizations. And of those prior authorizations, we were seeing a very simple checklist and they were getting approved. What we found as we moved into May and June with increased demand, we came out pretty strong. The plans did take notice. And so we did see the prior authorizations increase amongst -- across the board among all of the prescriptions that were written. Also in the long-term care setting, there's a concept called transitional fill. So when a patient is put on a new treatment, many of these patients will get a 14-day or 28-day transitional fill without a prior authorization, and then they'll get -- the prior authorization will kick in. So we saw a lot of that coming into April, which is why we saw such little prior authorizations. Now as what the team is doing, and I'd say we are adjusting on demand daily, we're having calls to see which plans are giving us more trouble. I will say that the prior authorization checklist or what's required is very similar to what we are seeing from just a smaller number in April. So have they failed and tried a generic and then is there a reason why they can't use a generic? So the prior authorizations, the ones that the team is getting to and supporting the pharmacies on guidance on how to fill out these prior authorizations, we're able to provide support, they are all getting through. So we are getting much better with monitoring the prior authorizations. We now know what to expect. Our reimbursement specialists are in contact with all -- a lot of key pharmacies. They have a relationship ongoing, and therefore, we're able to provide best case scenarios, what has worked in the past. So it's still a simple PA. There's just more of them. So we're not seeing the PAs not get approved. I think as I mentioned, 90% of orders are getting filled. It's just delaying the time to fulfillment. So we're seeing -- we could see up to a 3-week delay before that PA actually gets through just because the volume is increasing. I hope that answers your question, Ram.

No, that's very.

I'm sorry, do you have a follow-up, Ram, on that before I answer the clinical question?

Just in that context, I was wondering if you would care to share at this point in time what the monthly net revenue run rate looks like here in the third quarter.

We anticipate a range of $575 million to $625 million, depending on the execution of that contract. So I think that's a good net number for everybody to model. And regarding the clinical funding for advancement with our sublingual formulation and advancement on the TBI front, we have built into the expense guidance that Henry provided the dollars required to advance those programs to IND. So we're in good shape. The formulation work that we're doing is tedious complex work, but it's low-cost work. And we've already captured the work necessary on the TBI front as well for next steps for that program.

The next question is from [ Boris Peaker from Titan Partners ].

Great. My first question is, can you comment maybe anything particularly special about the initial adopters from the patient's perspective? Do they have GI symptoms or are these patients just starting cholinesterase inhibitors or are they may be switching from Aricept? Just kind of help us understand kind of low-hanging fruit from the patient side. Lauren D’Angelo: Sure. So what we're seeing as it relates to which patient type physicians are using ZUNVEYL on, I would say about half of them are patients who are a donepezil patient, and we are seeing those patients being switched from donepezil to ZUNVEYL. That also helps obviously with the prior authorization because right there, you've got a recent activity that they were already on a generic. But we are also seeing a large bolus of patients who have been treated in the past, but in most cases, they weren't able to tolerate the treatment medication. As you guys know, that's why ZUNVEYL is here. And so they may have been off treatment for a little bit, but they're on nothing. And so they will initiate therapy with ZUNVEYL. I would say those are our two most common types of patients. However, recently, with the launch of our behavioral messaging, we have really, really solid data that is consistent with label, regulatory aligned that we are able to use with ZUNVEYL on these behavioral symptoms associated with Alzheimer's disease. I would say moving into the quarter that we're in now, we're seeing a little broadening there where physicians are now identifying patients who have - or have Alzheimer's, whether they're on an acetylcholinesterase inhibitor or they're not, and they see an opportunity for ZUNVEYL to help with some of those behaviors. So I think we're moving into a third patient type as we move forward with our new messaging on behaviors.

Great. My next question is on gross to net discounting. Can you maybe comment on where it stands now and how you think that's going to evolve maybe over the next 6 to 12 months?

Yeah. We're approximately $600 now. We think over the coming quarters, not months, but quarters, it will be in the $575 to $625 range, depending on the mix of patients per health plan. So I think those are good numbers to model.

Great. And my last question is, when should we be expecting that second $3 million tranche from CMS?

We expect it at the last quarter of this year based on current progress with CMS.

The next question is from Dave Storms from Stonegate.

I just want to start, you've mentioned in the past that you're expecting a hockey stick shaped revenue curve. I guess, do you see anything changing there? Does maybe Asia run a little ahead of schedule, deepen this curve, move it so left a little bit? Anything there?

I think currently, our expectations remain the same. We're seeing exactly what we thought we would see in the Long Term Care segment. The physicians are trying the -- our drug unveil in a few patients. They're monitoring those patients. They're going through the titration process. We anticipate in this quarter, they're going to try a second tranche of patients and go through the same process. After they try that second tranche of patients, we anticipate physicians gain comfort if they continue to see good results with ZUNVEYL, then they're thinking about the patient type and broadening their use of the drug, either in protocol or in how they're using it in the nursing homes. Regarding the remainder of the business, I think for the next two to three quarters, we don't see ex U.S. revenues changing substantially that hockey stick. I think those will become meaningful in late 2026 or early 2027.

That's perfect. And then maybe more of a modeling question also kind of looking into 2026, your guidance for operating expenses anticipates a ramp-up through the second half of the year. Should we expect that ramp to continue into 2026 for operating expenses or do you anticipate that will maybe level out over the next couple of quarters here?

I think it levels out. I think that $34 million to $38 million range is going to be pretty consistent over the next three to four quarters.

This concludes the question-and-answer session. I would like to turn the floor back over to Michael McFadden, Chief Executive Officer, for closing comments.

Thank you, operator. Thank you, everyone, for attending the call today. I'll reinforce, we're excited about the initial quarter of launch for ZUNVEYL. We're focused on execution in this quarter and coming quarters to build our base of prescribers to build the base of nursing homes where ZUNVEYL can be used and then to optimize our messaging with on-label promotion. We'll continue to be judicious with our expenses. And we hope that these efforts reward our shareholders, and I appreciate you taking time to be on our call today.

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