Alpha Cognition - Earnings Call - Q3 2025

Transcript

Operator (participant)

Greetings. Welcome to Alpha Cognition's Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Henry Du, Interim CFO. Thank you. You may begin.

Henry Du (VP for Finance and Accounting and Interim CFO)

Thank you, Vaughn. Good afternoon, everyone, and thank you for joining us today for Alpha Cognition's Third Quarter Financial Results Conference Call. Today, after the close of the market, 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 investor 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 November 13, 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.

Michael McFadden (CEO and Director)

Thank you, Henry. Good afternoon, everyone, and thanks for taking the time to join us on today's call. This call marks our second quarter, of earnings, following the commercial launch of ZUNVEYL, for the treatment of mild to moderate Alzheimer's disease. The third quarter, of 2025, was characterized by sales growth, of ZUNVEYL, continued engagement in the long-term care segment, of the market, additional pricing action on ZUNVEYL, progress with our business development partner, CMS Pharma, and additional publications that highlight ZUNVEYL data, and the Alzheimer's market opportunity. Post-close of the quarter, the company raised additional capital that strengthened its balance sheet and will allow the company to invest in a significant growth opportunity, that has emerged with symptom management of Alzheimer's disease. The capital will be used to accelerate growth and invest in sales, marketing, and research for ZUNVEYL, in treating behavioral symptoms, that often emerge with Alzheimer's.

During the quarter, the company made substantial progress on our commercial launch. The sales and marketing team, has made contacts with over 1,850 prescribers, in the long-term care market, and we saw prescriptions written, in over 500 nursing homes. Launched to date, we've seen duplicative prescriptions written in 70%, of these nursing homes, which is a strong indicator of product trial. We expect new and duplicative home numbers to rise significantly in the coming quarters. Regarding clinical performance, ZUNVEYL, appears to be performing well with anecdotal reports of cognition improvement, behavioral reduction or amelioration, and continued limited reports of adverse events. Reported GI adverse events, continue to be in the low single digits, indicative of a well-tolerated medication. One of the company's focuses in 2025, has been to share medical information that provides rationale for ZUNVEYL, treatment of Alzheimer's.

This quarter, the medical team, had seven abstracts, accepted for publication, with three, poster presentations made to long-term care pharmacy at ASCP. This is the Association of Consultant Pharmacists, in October. Two poster presentations were made to psychiatrist,s and neuroscientists, at the Neuroscience Education Institute, last week, and two poster presentations will be made to Alzheimer's researchers, as clinical trials for Alzheimer's disease, or CTAD, in December. Our medical team continues to publish compelling data in the Alzheimer's segment, regarding cognition and behavioral symptoms. Regarding research and development, the company will initiate two studies in long-term care setting, one in Q4, of 2025, and one in Q1,of 2026. The two studies, which we call CONVERGE and BEACON, will assess ZUNVEYL cognitive benefits, tolerability, effects on sleep and behaviors, and utilization parameters, like polypharmacy. These studies will provide critical data for ZUNVEYL, and the patient population for our commercialization focus.

We anticipate CONVERGE, will complete in Q3, of 2026, and BEACON, will complete in Q4, 2026. Both of these studies are lower-cost studies, which are accounted for, in our current spend guidance for this year and in 2026. The company will also initiate a prospective registry trial, in Q1, of 2026, called RESOLVE. That will provide valuable data on ZUNVEYL efficacy, in treating behaviors that occur with Alzheimer's disease. The trial will also assess ZUNVEYL's tolerability, and caregiver burden. These are important measures all providers consider when choosing a treatment, and we think the data will be instrumental for ZUNVEYL, positioning with physicians and payers. More information will be communicated about the registry trial in Q1. From a business development perspective, our partner CMS Pharma, filed in China, for approval, and the file was accepted for review.

We anticipate the 18-month review process, will apply to our application, and the approval could occur at the end of 2026. We also 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 existing formulations and will use this data as a basis for submission of an IND, in Q3, of 2026. The company continues to manage our 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. Lauren will discuss our commercialization process momentarily, but first, Henry, will speak to the financials for the company. Henry?

Henry Du (VP for Finance and Accounting and Interim CFO)

Thank you, Michael. Good afternoon, everyone, and thanks for joining us today. As I review our third quarter 2025 results, please refer to today's press release and Form 10-Q. Let's start with the numbers. For the quarter, we generated total revenue of $2.8 million, driven by $2.3 million in net product sales from our lead commercial product, ZUNVEYL, and $507,000 in licensing revenue from our collaboration with CMS Pharma. These results show encouragingly early traction and lay a solid foundation for scalable growth in the quarters ahead. Our total operating expenses were $8.2 million, including $633,000 of cost of goods sold and cost of revenues, and $7.5 million in operating expenses, compared to $2.5 million of operating expenses in Q3 of last year. The increase mainly reflects higher SG&A costs as we ramped up our commercial launch activities for ZUNVEYL and expanded our operations to support growth.

That resulted in an operating loss of $5.3 million versus $2.5 million in the same period of 2024. Turning to net income performance, we reported a net loss of $1.3 million, or $0.08 basic loss per share, and $0.30 diluted loss per share, compared with a net loss of $1.9 million, or $0.31 per share, basic and diluted, last year. The improvement reflects a $3.7 million non-cash gain from changes in the fair value of derivative liabilities, along with $378,000 in interest income for the quarter. Now moving on to the balance sheet, where we remain well-capitalized. As of September 30, we held $35.4 million in unrestricted cash and cash equivalents, which does not include approximately $38 million in net proceeds raised in October through our equity offering and overall alignment exercise.

Combined, these resources provide a strong balance sheet and an operational runway that extends well into 2027, giving us the flexibility to execute on our commercial and corporate priorities with confidence. Lastly, a brief update on guidance. Looking ahead, while we're not providing formal revenue guidance today, we expect continued sequential growth in ZUNVEYL's sales as awareness and payer access expand through 2026. From an expense perspective, we now expect full-year 2025 operating expenses to be in the range of $28-$30 million. That's a reduction from prior guidance, reflecting our ongoing focus on cost discipline, operational efficiency, and prudent resource allocation. Areas of concentration were contract negotiations, reassessment of marketing spend, and delaying the hiring of certain positions that we believe would be more cost-effective to outsource in the near term.

Overall, the third quarter was a period of continued momentum, highlighted by steady revenue growth from ZUNVEYL and a solid financial position. We're encouraged by our early market progress, and as we look forward to the remainder of the year, our team remains focused on discipline execution, sustainable growth, and creating long-term value for our shareholders. Thank you. I will now turn the call over to Lauren to discuss commercial progress. Lauren?

Lauren D'Angelo (COO)

Thanks, Henry. The third quarter, reflected continued strong momentum in the U.S. rollout of ZUNVEYL , within the long-term care market. Following a successful launch earlier this year, Q3 results, showed sustained acceleration in demand and prescriber adoption, reinforcing ZUNVEYL's, growing role in Alzheimer's disease management. We delivered another quarter, of robust growth. Ex-factory purchases rose 44%, versus Q2, increasing from 2,640 to 3,808 bottles. The company believes this does reflect increased levels of inventory, for multiple wholesalers, and may have some impact on Q4, purchases. Demand sales, bottles dispensed grew even faster, up 102%, from quarter two. Importantly, we are seeing double-digit growth month over month since June. Growth was broad-based across all regions, reflecting deeper facility engagement and rising prescriber confidence. Fulfillment rates remain high, and patient titration, and persistence continue to meet expectations. Our commercial footprint continues to expand rapidly.

We engaged 2,038 homes in Q3, bringing our total reach launched to date to 2,942 unique homes. Of these, 605 homes have ordered ZUNVEYL, with 70% of those homes repeat ordering and 15% new orders in September. Additionally, we saw a 50/50 split between 5 mg and 10 mg orders in Q3, which demonstrates the strong tolerability profile of our drug as patients are consistently able to reach the therapeutic dose, an outcome that has not been possible with current treatment options. Our field team directly engaged with 1,850 prescribers in Q3, bringing total launch-to-date engagements to 2,630. 576 prescribers wrote orders in Q3, a 55% increase from Q2, with 62% of them writing multiple orders, a strong signal of growing confidence and clinical fit. These metrics highlight deepening engagement and sustained momentum across our prescriber base. Market access, continues to advance as planned.

Following our National Health Plan agreement, earlier this year, we focused on operationalizing coverage and expanding regional payer discussions. 2027 Medicare, Part D, submissions remain on track. For the planned contract, previously announced, the company has seen 15%, of business cover ZUNVEYL, with no restriction. We have no additional visibility for this PBM, regarding when other plans may make a formulary decision for ZUNVEYL. The company anticipates a second PBM payer contract, to execute by the end of 2025 and anticipates that it will take two quarters, to realize unrestricted coverage from that business. We also executed a strategic WAC adjustment, to $820.15 per month, aligning pricing with ZUNVEYL's, differentiated value and CNS benchmarks. Payer feedback confirms the price remains competitive within long-term care formularies. Our field and operations teams remain fully deployed and highly effective.

With an average of 16 years of industry experience, including 10 years, in long-term care, our reps are driving meaningful clinical education, and adoption across this complex channel. We have maintained strong product availability and fulfillment rates. Operational learnings, from payer interactions are streamlining prior authorization process, improving speed to therapy and patient access. We have expanded our reimbursement team to better support homes in processing prior authorizations, enabling closer alignment with customers and allowing us to anticipate and address challenges more quickly. The organization continues to execute with financial discipline, ensuring every pricing, promotional, and resource decision supports long-term value creation. Our marketing remains focused on HCP education, and brand reinforcement. Digital and in-person initiatives, continue to emphasize ZUNVEYL's, differentiated clinical profile, particularly its label-consistent benefits across multiple behavioral domains, measured by the Neu,ropsychiatric Inventory.

Feedback on our refined clinical messaging and titration support toolkit has been highly positive, reinforcing prescriber confidence and proper initiation. As we enter Q4, and prepare for 2026, our priorities remain clear and consistent: expand ZUNVEYL's presence, across additional long-term care homes, deepen relationships with high-potential prescribers, optimize payer access and approval timelines, and sustain disciplined execution across all functions. ZUNVEYL's accelerating adoption, durable demand growth, and expanding payer access underscore our strong commercial foundation and exceptional team execution. We remain confident in our ability to drive continued growth and broaden access for patients and caregivers in the quarters ahead. With that, I'll turn it over to Michael.

Michael McFadden (CEO and Director)

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

Operator (participant)

Thank you. At this time, we will now be conducting the question-and-answer session for selected analysts. To place your question in the queue, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the queue. You may press star two if you would like to remove your question from the queue. For any participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. We'll give a brief moment to poll for questions. Our first question comes from Ram Selvaraju, from HC Wainwright. You may proceed with your question.

Hi. How's it going? This is Eduardo, on for Ram. Thanks for all the color on the commercial development. It was tough to catch all the information. I was hoping to go back to what's the current status of contracting discussions and how many GPOs, have reached agreement to cover ZUNVEYL. You mentioned the second one, so I assume there's one, maybe the second one on the way by the end of the year, just to add a little more color there.

Lauren D'Angelo (COO)

Sure. No, absolutely. We are highly, highly focused on all of the plans that matter in the long-term care setting. I think I've shared in past calls there's four key Medicare plans, PBMs, that we are hyper-targeting. We have one of those under contract, as I mentioned in my last call, and we are now working the downstream accounts to ensure that they pick up coverage for ZUNVEYL. We expect we are in very close finalization with another contract, another one of those big PBMs. We expect to have that complete by the end of the quarter. As we look into Q1 and Q2, we are already focusing on those downstream accounts, having those regional payer calls to make sure they pull through the contract and cover ZUNVEYL. When we look across these four plans, they are an equal split.

I mean, you can assume each plan covers about 25%, of lives for long-term care. We feel really good about where we're at right now, so close to just launching. We've got one. Now we have to pull that through. We hope to have another by the end of this quarter, and then we'll pull that through, obviously, in Q1 and Q2 ,of next year. Of course, we're still staying in tight negotiations with the other two.

Got it. Thanks so much for the update.

Very helpful.

Yeah, that was really helpful. You mentioned 15% coverage, one five, without restriction right now?

Yeah. So what we have visibility to, so when you think about the plan that we signed last quarter, what happens is it takes six to nine months, for the downstream plans to adopt the contract. What we know is about 15%, of those have adopted, they are processing claims for ZUNVEYL, without any restriction. We do not have visibility into the other plans yet, and we will start to see more of that over the next couple of quarters.

Got it. Thanks so much. To get a little bit details on the, you mentioned the number of unique prescribers for ZUNVEYL, and the change there, and how many of them, the breakdown between repeat and new prescribers.

Sure. Total launch to date, actually, in Q3, we had 576 prescribers, and of those, 62%, wrote multiple orders. If you look launch to date, when we look at the homes, because the orders are coming out of the homes, we see 605, homes have ordered ZUNVEYL. 70%, of those homes have repeat orders, but then 15%, more are new homes that are prescribing in September, at the final month of the quarter. We are seeing a lot of repeat ordering. We are hearing about a lot of repeat ordering. Basically, the general consensus feedback from physicians is once they try, they start off slow, they try the product, you have to give it a little bit of time. This is a frail elderly population. Once they start seeing results in one or two patients, they start writing quite a bit more.

It's kind of getting through that initial prescribing, trying the product, then they'll try a few more, and then it kind of starts to compound. We're seeing quite a bit of repeat orders. I think importantly, Ram, what I mentioned when I was going over my section, not only are they writing quite a bit, but they're writing month over month. We're seeing double-digit growth, and they're getting to the 10 mg dose. That's so key because if you look at the last three decades, of these products, most of these patients are on a subtherapeutic dose. They're able to titrate the patient. We've got half of our prescriptions on the 10 mg dose. That's something we haven't seen in this market, and it's because the drug is working as it's intended.

Great. Thanks for all the color. If I could have one more, when do you expect to start? This is related to galantamine, royalty revenue, from China.

Michael McFadden (CEO and Director)

Yeah. Probably not until 2027, from mainland China, but we should have some smaller Asian countries, obtain approval in 2026. From those countries, we would be launching immediately upon approval so the company would realize revenue in the quarter launch from each of those countries.

Got it. Thanks so much for taking the questions.

Operator (participant)

Our next question comes from Boris Peaker, with Titan Partners. You may proceed with your question.

Boris Peaker (Managing Director and Senior Research Analyst)

Great. First, I just want to say congratulations on the excellent sales growth here. Maybe kind of speaking of that, could you comment on what are the key marketing messages that are maybe resonating with prescribers, and what is the most common pushback that you get?

Lauren D'Angelo (COO)

That's a great question. I will say that depending upon the stakeholder type, we have several different customers within the home that we're calling on. Certain key messages really resonate with that specific customer. I would say overall, we are hearing a lot of positive impact on ZUNVEYL's impact, on behaviors. As we've shared in quarters past, we have adjusted our messaging. We heard early on that prescribers were seeing a significant impact on patients who are having behaviors that are also obviously mild to moderate Alzheimer's, patients. We've started really messaging that. We have label-consistent data on ZUNVEYL, that shows a significant benefit in behaviors. That's probably one of the most impactful messages that we're delivering. I think many providers are very interested in the no impact on sleep. That's a significant key message for us.

We knew that going into the launch because if you look at donepezil, which of course is the market leader, it's highly associated with insomnia, sleep disorders, nightmares. That one is very much resonating because we're seeing a lot of our business coming from switches, and a lot of that has to do with the no insomnia. I would say those are our top two messages. Overall, I think the package of benefits that ZUNVEYL, brings to the table is really valuable to all of these customers with this specific patient population.

Boris Peaker (Managing Director and Senior Research Analyst)

Rdight. In terms of pushback?

Lauren D'Angelo (COO)

Yeah. No. The pushback as it relates, I would not say we are getting any pushback from ZUNVEYL, messaging per se. I think obviously one of our main pushbacks, is working through the payer obstacles, helping the prescriber and the homes process the prior authorizations when they are required. From a messaging drug-working experience for ZUNVEYL, that is doing far better than we expected. I think our biggest pushback is how can we help support them in the prior authorization process so that the drug can get approved? That is why we have really put an emphasis on growing our reimbursement support team. We have learned a ton in a very short amount of time how to ensure we can provide that support, and that is really where we are focused. We have increased that team. We are aligning with providers.

We are providing support so that they know how to complete the prior authorizations appropriately so that the drug gets approved. What I can say on that is if the PA, is filled out appropriately, very, very high percentage of approvals. That is really where our team is focused right now.

Boris Peaker (Managing Director and Senior Research Analyst)

Got it. My last question maybe on the WAC adjustment, you were talking about. Can you please explain exactly? Maybe I missed the details of that and kind of what the impact is on the gross to net from that and kind of your revenue per patient.

Lauren D'Angelo (COO)

Sure. We took a price increase because what we were seeing is that when you look across the long-term care market, you look at CNS products, and payers reinforce that the product got the value that we could take that price increase. We have had no pushback with the price increase. As it relates to gross to net, we are still keeping our percentages very high. As we shared, we have one contract. We have only seen about 15%, offer with no restrictions. We still have very, very high GTN, at this point. Michael, I do not know if you want to comment on that.

Michael McFadden (CEO and Director)

Yeah. I'll add it. I assume a plus nine short term on 9%, on the impact of that price and its steady state. We still anticipate we'll have a $500-$550 net price , on ZUNVEYL.

Boris Peaker (Managing Director and Senior Research Analyst)

Yeah. In terms of percentages, GTN, should be in the mid to

upper 20% discount, just from a percentage standpoint.

Great. Thank you very much for taking my questions.

Operator (participant)

Our next question comes from David Storms, with Stonegate. You may proceed with your question.

David Storms (Director)

Good evening, and thank you for taking my questions. I was hoping we could go back. You mentioned earlier that you're getting about 50%, to the 10 mg dosage. Could you spend a little more time talking to maybe the difference in demand among the dosages and how that changes as prescribers get more comfortable with the product?

Lauren D'Angelo (COO)

Sure. When we launched the product, obviously a significant amount were right off the bat the 25, because you have to get them through the four- to eight-week titration period, especially in this frail population. Most providers, they start low and go slow is kind of the motto within the nursing home. We actually expected the ratio to shift more to the 50 mg over time. We thought we would see more of that shift happening in Q4 and Q1, of next year. We figured it would take a lot longer to get providers comfortable to titrate them to the 10 mg, because of the population. For decades, they have not been able to push the dose in the treatment options that were available.

We were pleased to see what's happening is because we've seen such a low AEs, as providers have tried the product, they are definitely getting more comfortable titrating quickly, which is why we're seeing a 50/50 ratio, in Q3, which is happening much faster than we expected. I don't know if that answers your question in terms of what we expected and prescriber confidence, but I think what we're seeing is physicians are trying it, obviously, at the starting dose. And once they get a few patients titrated to 10s, they're definitely getting more comfortable, you know what I mean, titrating other patients that they start a little bit quicker. Maybe not waiting eight weeks, they're waiting four weeks. We're definitely seeing a faster acceleration to the 10s, which just speaks to the product's tolerability.

David Storms (Director)

Understood. That is exactly what I was looking for. Thank you for that, Laura.

Lauren D'Angelo (COO)

Sure.

David Storms (Director)

Just one more for me. Maybe how does the sales cycle look? You've been in the market for a couple of quarters now. Is the sales cycle shortening? Is maybe the prescriber interaction to order ratio, number of interactions declining to orders? Maybe any anecdotes of prescribers that have already been made aware of ZUNVEYL, before the initial call? Anything like that?

Lauren D'Angelo (COO)

Sure. Right now, what we're seeing is we're definitely, the way that it works with the launch, especially in long-term care, is all providers are going to start slow. Even a provider that might have been a part of the studies, they will start with a couple of patients, see how it works, and then they're going to obviously titrate, see how it works, and then they're going to start expanding the patients that could potentially be a candidate for ZUNVEYL. We've seen that. Now, what we are seeing is physicians who are starting to write a lot more, they accelerate quicker. It is pretty much a slow start for everybody, just given the vulnerable patient population and the fact they've been let down for decades in this class of drugs. Once they get started, you start to see them increase their patient base more rapidly.

Our focus right now from a sales perspective, because our homes are, as I shared kind of during the call, many of them are repeat ordering. Seventy percent, of our homes have repeat orders. That is a really high target or a really high metric, for a launch brand in just two quarters. We absolutely are seeing that for those providers who have tried it, they have given it time, there is a quicker sales call, obviously, for them to try it again and use it in more patients. Typically, that HCP naive patient, who has not tried it, you are looking at a couple of months before you can get them to try it. Obviously, they are going to wait. They are going to titrate. It takes a little bit before they are comfortable.

David Storms (Director)

Understood. Thank you for the call.

Lauren D'Angelo (COO)

Sure.

Operator (participant)

Ladies and gentlemen, this now concludes our question and answer session and does conclude today's teleconference as well. We thank you for your participation. Please disconnect your lines and have a wonderful day.