Alpha Cognition - Earnings Call - Q4 2024

Transcript

Speaker 4

Greetings and welcome to the Alpha Cognition Earnings 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 then zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Henry Du, Interim CFO. Thank you. You may now begin.

Speaker 3

Thank you, Drew. Good afternoon, everyone, and thank you for joining us today for Alpha Cognition's fourth quarter and full year 2024 financial results conference call. Today, after the close of 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 March 31, 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.

Speaker 1

Thank you, Henry. Good afternoon, everyone. Thanks for taking time to join us on today's call. This is an exciting milestone for our company as it marks our first earnings report following the commercial launch of Zunveyl for the treatment of mild to moderate Alzheimer's disease. The fourth quarter of 2024 was characterized by a successful capital raise, a cross-list from the Canadian Securities Exchange to NASDAQ, commercial manufacturing progress, and preparation for our commercial launch of Zunveyl. In November, the company executed a cross-list from the Canadian Securities Exchange to NASDAQ and raised $52 million in gross proceeds during this process. The company was able to attract an excellent group of investors who recognize the Alzheimer's market represents a large but dissatisfied market primed for disruption.

We believe the capital raised is sufficient for the company to move to break-even status in year three of launch, provided we execute and achieve our internal revenue forecasts for years one through three, and we manage our expenses judiciously. During the quarter, the company made substantial progress on commercial manufacturing, initiating the commercial batches for the 5 and 10 milligram strengths, which have been followed by the 15 milligram strength in January to complete our initial commercial supply for the market. CMC stability test results demonstrate a stable compound extending our API life to five years and finished goods to two years, which we feel is more than sufficient for commercialization activities. Finished product for all strengths is available for pharmacies to order. As a reminder, this is a retail pharmacy distribution model, meaning patients can obtain product with a prescription at any retail pharmacy provider.

Long-term care pharmacies can order the product direct or through their wholesaler and all have access to Zunveyl as we have this call. From a pipeline perspective, the company reclaimed two programs from Alpha Seven Therapeutics, a preclinical program for cognitive impairment with mild traumatic brain injury and an early-stage program for acute pancreatitis. These programs will strengthen the company's pipeline and allow more flexibility and speed in completing the preclinical work for both programs. We have initiated work to reformulate our sublingual formulation of Alpha 1062. This work will initiate in early Q2 to improve taste and disintegration of the formulation. We anticipate the work will be completed in the fourth quarter of 2025. The significance of this formulation is that it can be used for patients with Alzheimer's who have dysphagia or aphasia, which are difficulty or inability to swallow tablets or capsules.

Estimates are that 20% of the Alzheimer's patient population may suffer from this malady, and currently, they have the option of a patch formulation or they must grind a tablet or mix the contents of a capsule in applesauce or something similar in order to take their medication. We believe if ultimately approved, the sublingual formulation can displace the current options available for these patients. Additionally, the company's bomb blast preclinical study with Alpha 1062 will conclude in late Q2 with results released in Q3. Now, this was a two-part study funded with a Department of Defense grant. The first part of the study concluded in Q4, and it demonstrated that Alpha 1062 administration reduced levels of neuroinflammation and neuropathology that occurs after bomb blast trauma.

In the quarter, the company added to its IP portfolio, securing a new composition of matter patent in the US covering tablet formulation of benzgalantamine. This patent extends Zunveyl protection in the US market through 2044. We have this patent under review in multiple other territories outside the US and expect approvals throughout the world during the next 18 to 24 months. We've also made significant progress with our first ex-US partner, CMS Pharmaceuticals, who is representing Zunveyl R&D and distribution in China and greater Asian territories. We expect to hear from Chinese regulatory authorities on the regulatory path in Q3 and expect our first territory distribution initiation to occur the second half of 2025. Although expected revenues will be modest, the initiation of commercialization activities will allow CMS and Alpha Cognition to learn from these activities ahead of potential product approval in China.

I'll ask Lauren to discuss commercialization progress momentarily, but I'll turn the call over to Henry to speak to the financials of the company. Henry?

Speaker 3

Thank you, Michael. Good afternoon, everyone. As I review our fourth quarter and full year 2024 results, please refer to today's press release and 10-K that were filed earlier today. Starting with our operating loss, for the fourth quarter of 2024, we reported an operating loss of $2.5 million, which represents a slight increase of 5% compared to $2.4 million in the same quarter last year. This increase was primarily driven by higher general and administrative expenses, which rose by 50%, mainly related to costs associated with our US equity offering. For the full year 2024, our operating loss was $11.9 million versus $9.9 million in 2023. This was largely attributed to an increase in general and administrative expenses reflecting consulting fees related to financing transactions, strategic initiatives, professional services, and other operational support.

Moving on to net loss, for the fourth quarter of 2024, we reported a net loss of $5.7 million or $0.51 per share, essentially unchanged compared to a net loss of $5.7 million or $1.33 per share in the same quarter last year. This was driven by favorable changes in the fair value of derivative liabilities, partially offset by increased interest expenses and a loss from foreign exchange fluctuations. For the full year 2024, our net loss was $14.6 million or $2.02 per share compared to $13.8 million or $3.84 per share in 2023. This increase reflects higher operating expenses and interest expense, partially offset by favorable changes in the fair value of derivative liabilities and increased grant income and interest income. As of December 31, 2024, the company—apologies.

As of December 31, 2024, the company had approximately $48.6 million in cash compared to $1.4 million as of December 31, 2023. This increase was primarily due to cash generated from the fourth quarter capital raise. The company has a strong balance sheet with sufficient liquidity to launch Zunveyl into the long-term care segment of the market. Now turning to guidance, the company will not provide revenue guidance for 2025, but can provide expense guidance for the year. For the full year 2025, the company expects operating expenses to range from $38 million-$42 million. In summary, while we faced increased costs in 2024, these investments were essential to positioning Alpha Cognition for future growth and success. We remain focused on executing our strategic priorities and delivering value to our stakeholders. With that, I will now turn the call over to Lauren to discuss commercial progress.

Speaker 5

Thanks, Henry. The first quarter of 2025 has been transformational for Alpha Cognition. The launch of Zunveyl in the US long-term care market represents a significant milestone, and I'm pleased to report that our commercial execution has been strong. During the first quarter, our commercial team completed meetings with the large payers and updated our previous market research on pricing. The feedback from payers was consistent with previous research, indicating a need for new therapies and a price range consistent with the branded product on the market. The team is actively engaging with key payers to submit Medicare bids for the 2026 year. We announced wholesale acquisition price in January of $749 per month. We believe this is a competitive price that balances product differentiation with pricing of other branded products in the market.

Regarding the commercial team, during the quarter, we hired our commercial leaders who bring significant experience to the company. This exceptional team brings a combined 330 years' commercial experience, 150 years in long-term care, and 140 product launches. Additionally, we hired our four sales leaders with significant CNS and LTC experience and then concluded the hiring of our field sales team in mid-Q1. The caliber of talent we've assembled with this sales force truly is exceptional. Collectively, our sales force has an average of 16 years' industry sales experience and 10 years' long-term care. We officially launched the product on March 19th of this year. With less than two weeks on the market, we are pleased with the positive feedback we are hearing from prescribers and expect that to translate to a strong initial demand for the product.

Customers have proactively expressed interest in Zunveyl, and we are working through their initial pharmacy orders and formulary process to gain access to Zunveyl. We expect this to continue over the next several weeks, leading to a positive early uptake. With market access, we've made significant progress in engaging with key payers to secure coverage, ensuring that Zunveyl is accessible to patients who need it most. Our experienced regional sales leaders, supported by an experienced high-performing sales force, are successfully engaging with healthcare providers across the key long-term care networks. From a marketing perspective, our targeted campaigns and physician education initiatives are driving strong brand awareness and interest. Our commercial infrastructure has been optimized for scale, ensuring that we can continue to meet growing demand. As we move into Q2 and beyond, we remain focused on driving continued market penetration, expanding payer coverage, and further strengthening our commercial execution.

We are confident in our ability to sustain this momentum and to deliver value to both patients and shareholders. Thank you to our incredible commercial team for their dedication and to our investors for their continued support. With that, I'll turn it over to Michael.

Speaker 1

Thank you, Lauren. In summary, the team is executing with commercialization efforts with the full team hired on schedule and on budget. Our commercial supply manufactured in our supply chain field on schedule and on budget, and an ex-US partnership activity that's off to a great start. The company believes we have a disruptive opportunity with Zunveyl, and we'll focus the next quarters on our selling efforts, on financial discipline, and on ex-US operational execution. Operator will now take questions.

Speaker 4

Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star, then one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star, then two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Thank you. Your first question comes from Michael Freeman with Raymond James. Please go ahead.

Speaker 0

Hi, good afternoon, Michael, Lauren, Henry. Congratulations on closing out this big year and on your inaugural quarterly call. My first question is on coverage. I appreciate how intentional and organized you guys are with ensuring market access. I wonder, given these initial conversations, how you would see the timelines for first commercial agreements being concluded, and will you be—do you expect to be announcing these publicly?

Speaker 5

Sure. I'll take that. Thank you for the question. We are actively, as I shared, engaging with those key plans. The nice thing about the long-term care space is there are five plans that represent greater than 75% of the patients. The feedback right now has been very, very positive. We're just completing our clinical presentations. As you probably know, CMS or Medicare runs on an annual—they're about 12-18 months behind. We're looking at coverage for next year. When I say coverage, I mean actually on one of their tiers. Right now, we are eligible to be covered by CMS and Medicare. It's just with prior authorization or a medical necessity form. We are looking to see if there will be any potential early ads this year, but right now, we plan to announce specific contracts starting early next year.

Just to highlight again, with long-term care, because many of these patients are dual eligibles, you actually do not need coverage to get Zunveyl to the patient. Right now, actually, especially as of April 1, CMS will cover our drug with a medical necessity or a prior authorization. In the meantime, we are obviously working with these plans to try to get better coverage and contracts in place by early January 1 of next year. That is the typical Medicare process.

Speaker 0

All right. Thank you, Lauren. Thanks for that color. I wonder if, I guess, among your sales leaders and your on-the-ground sales force, I wonder if you could share some early feedback you've got from physicians in long-term care and how might that feedback inform how you're thinking about the launch?

Speaker 5

Oh, absolutely. I am thrilled to answer. We've actually had overwhelming feedback from the physicians that we've gotten to in the past. I know it's just a couple of weeks on the market. We've actually been holding national webinars where we've had quite a few, more than I've seen in my career or in my launches this early on with physicians, big prescribers dialing into the national webinars to hear about our product. Of course, I'm talking to my sales leaders daily. The feedback is very strong. I think once the team is able to get through the Zunveyl story, we really do bring a differentiated product to the market.

When we start talking about Zunveyl's technology, the way that we minimize absorption in the gut, potentially leading to less GI, we talk about the insomnia attribute, the physicians are literally saying, "You're going to sell a ton of this." We are feeling very good about the feedback. I think what we are focused on right now is just getting to as many prescribers as we can as we get out there and we execute. Overall, I think we are feeling very good about how the message is resonating with physicians.

Speaker 0

All right. That's fabulous. Thank you. Maybe I'll shoehorn one last question. You recently had a very successful equity financing. I wonder, with the cash position you currently have, how much runway do you expect that this will provide you, especially given the OpEx guidance you just provided?

Speaker 1

Yeah. Thank you, Michael, for the question. We anticipate that our spend on a year-to-year basis will be in the $38 million-$42 million range that Henry outlined. While we're not providing revenue guidance, we anticipate with what I'll call a hockey stick uptick by this product or adoption by this product that we would be cash flow break-even in year three of launch. We believe the cash that we have currently is sufficient for us to move to break-even status in the long-term care segment of the business. The caveat is if the company chooses to expand in neurology or if the company has excellent feedback from the FDA that allows us to move into clinical programs for some of our pipeline assets, we would need to raise more capital.

For long-term care commercialization efforts, the cash that we have currently is sufficient to move the company to break-even.

Speaker 0

Fantastic. Thanks very much for answering my questions, and I'll pass the line now.

Speaker 1

Thank you, Michael.

Speaker 4

The next question comes from Dave Storms with Stonegate. Please go ahead with your question.

Speaker 2

Hello, everyone, and thank you for taking my questions. Just wanted to start with your exciting partnership and wanted to see if there are any other geographies that you're looking at for maybe future partnerships, thinking either in Asia or in the, excuse me, the Greater Asia region or in Europe.

Speaker 1

Yeah. Thank you, David, for the call. The CMS partnership, one, we're very pleased with that. They have a great history of excellent partnerships with US pharmaceutical companies and other companies around the world, and they've shown significant prowess in being able to commercialize those assets in China. They also have rights to a number of Asian or Greater Asian territories, excluding Japan. Some of the smaller Asian countries, CMS will launch Zunveyl in those countries as they obtain approval. Additionally, we do believe that we can execute another partnership with another territory around the globe. We're in multiple conversations now, and we believe one of those territories will emerge with a second deal for Alpha Cognition in 2025. The Alzheimer's market is significant in almost every territory around the world, and we believe this is a product that can be partnered in different territories around the globe.

Speaker 2

Understood. Very helpful. Thank you. Just one more for me. You mentioned the cash flow break-even target being year three. Can you maybe go into a little more detail on what the major variables are to reaching that break-even? Is it primarily just revenue-based, or are there other levers that can be pulled there?

Speaker 1

Two primary levers. One is we have to execute on our selling efforts in the long-term care marketplace. I've shared previously that we anticipate a hockey stick uptick for this type of product, meaning that doctors in 2025 will try the product. They'll gain experience with the product. They'll use more of the product if they have good experience. As their comfort level increases with Zunveyl, they'll figure out a way to normalize the product into how they treat their patients with mild to moderate Alzheimer's disease. We have to execute on that side of the equation with our sales team, educating doctors, educating staff, making sure they understand the benefits that Zunveyl can add to their treatment of mild to moderate Alzheimer's patients. On the expense side, we have to be diligent in managing our expenses as the company has been to date.

We have to remain diligent as we launch and commercialize the asset. We watch the expense line very carefully with this company. We'll have to continue to do that as we expand our footprint into long-term care and look for efficiencies in how we work and how we execute our commercial plan. Those are the two primary drivers that we have to measure. If we execute according to our internal plans, we should be in a very good place in year three for this company.

Speaker 2

Understood. Thank you for taking my questions. Congrats on the launch and good luck in Q1.

Speaker 1

Thank you, David.

Speaker 4

Ladies and gentlemen, this now concludes our question-and-answer session. I would like to turn the floor back over to management for closing remarks.

Speaker 1

Thank you, Drew. Thank you, everyone, for your interest in listening to the Alpha Cognition Q4 earnings call. We remain optimistic about our commercialization opportunity with Zunveyl, what we believe is a disruptive treatment for the treatment of mild to moderate Alzheimer's disease. The company has executed according to our plan in 2024 and in early 2025. We remain focused on selling efforts, on financial discipline, and in optimizing our ex-US operational execution with our partner CMS Pharmaceuticals. Thank you for attending the call. We look forward to future communications with you as the company progresses. Thank you.

Speaker 4

Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines and have a wonderful day.