Niagen Bioscience, Inc. (NAGE) Earnings Call Transcript & Summary

May 7, 2025

NASDAQ US Consumer Staples Personal Care Products earnings 46 min

Earnings Call Speaker Segments

Operator

operator
#1

Ladies and gentlemen, thank you for standing by, and welcome to Niagen Bioscience, Inc.'s First Quarter of 2025 Earnings Conference Call. My name is Kayla, and I will be the conference operator today. [Operator Instructions] And as a reminder, this conference call is being recorded. This afternoon, Niagen Bioscience issued a news release announcing the company's financial results for the first quarter of 2025. If you have not reviewed this information, both are available within the Investor Relations section of Niagen Bioscience's website at www.niagenbioscience.com. I would now like to turn the conference call over to Wesley Yu, Vice President of Finance. Please go ahead, Mr. Yu.

Wesley Yu

executive
#2

Thank you. Good afternoon, and welcome to Niagen Bioscience's First Quarter of 2025 Conference Call. With us today are Niagen Bioscience's Chief Executive Officer, Rob Fried; Chief Financial Officer, Ozan Pamir; and Senior Vice President of Scientific and Regulatory Affairs, Dr. Andrew Shao. Dr. Shao will join the call for Q&A. Today's conference call may include forward-looking statements, including statements related to the company's research and development and clinical trial plans and the timing and results of such trials, the timing of future regulatory filings, the expansion of the sale of Niagen products and ingredients in new markets, business development opportunities, future financial results, cash needs, operating performance, investor interest and business prospects and opportunities as well as anticipated results of operations. Forward-looking statements represent only the company's estimates on the date of this conference call and are not intended to give any assurance as to actual future results. Because forward-looking statements relate to matters that have not yet occurred. These statements are inherently subject to risks and uncertainties. Many factors could cause Niagen Bioscience's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These risk factors include those contained in Niagen Bioscience's quarterly report on Form 10-Q most recently filed with the SEC, including results of operations, financial conditions, cash flows as well as global market and economic conditions on our business. Please note that the company assumes no obligation to update any forward-looking statements after the date of this conference call to conform with the forward-looking statements actual results or to changes in its expectations. In addition, certain financial information presented in this call references non-GAAP financial measures. The company's earnings presentation and earnings press release, which were issued this afternoon are available on the company's website present reconciliations to the appropriate GAAP measures. Finally, this conference call is being recorded via webcast. The webcast will be available at the Investor Relations section of our website at www.niagenbioscience.com. With that, it's now my pleasure to turn the call over to our Chief Executive Officer, Rob Fried.

Robert Fried

executive
#3

Thank you, Wesley, and good afternoon, everyone, and thank you for joining us on our first ever investor call as Niagen Bioscience, formerly known as ChromaDex. I am pleased to announce that we had an excellent start to 2025. In the first quarter, we delivered $30.5 million in revenue, a 38% year-over-year increase, and we delivered net income of $5.1 million. We generated $7.9 million of cash from operations. We ended the quarter with $55.6 million in cash and no debt. In this first quarter, our e-commerce continued to be a main driver of our topline growth with net sales of $16.8 million, a 31% increase year-over-year. Our food grade and pharmaceutical grade Niagen ingredient business grew to $8 million, a 95% increase year-over-year. Our Niagen+ product remains a key focus area for the company. Niagen+ refers to intravenous and injection Niagen. This is available now at almost 600 clinics nationwide. In the last 2 months, we partnered with clinics at different events and conferences, including SoCal Wellness Summit, Biohackers World to offer Niagen+ to influencers and consumers. The feedback has been extremely positive, many commenting on a much faster infusion time than NAD IV with minimal side effects in many stages that they feel rested and revitalized following the infusion. We will continue to work closely with clinics to promote Niagen+ as the superior experience and solution to boosting NAD levels. The pharmaceutical application of NR continues to be an important strategic initiative for the company. As it relates to the Phase III NO-PARK study investigating the use of NR and the treatment of Parkinson's disease, we continue to be in consistent dialogue with the researchers and still expect that the study will be completed by June. Once the study is completed, we will not be able to see the results for a few months, but we look forward to sharing more updates as we know them. We continue to have ongoing dialogue with the FDA about NR for the treatment of Ataxia Telangiectasia, AT. We hope to have an update for you later this year. As per our intellectual property, we made a very important announcement in March that a new composition of matter patent was granted, broadening our patent portfolio and expanding protection for all salt forms of nicotinamide riboside. There is no form of NR that does not infringe upon 1 or 2 of the patents controlled by Niagen Bioscience. As most of you know, demand for products to boost NAD levels is surging. More consumers are understanding that Niagen is the trusted and most effective solution. While the NAD market continues to grow significantly, there continues to be a misconception that supplementing with NAD itself, either through oral supplementation or intravenous is an effective way to elevate cell and tissue NAD levels. The proven fact is that NAD cannot bypass cell membranes and must be broken down into NAD precursors like NR to enter cells and increase NAV levels. NAD supplementation and IV continues to be mentioned in more press and on social media despite not being an effective method to boost NAD levels. Furthermore, companies continue to take advantage of this trend in market pure NAD substance on Amazon and other marketplaces. Taking NAD as a molecule in oral form does not elevate NAD, there are no studies to date that show that it does, you need a precursor. As the global leader in NAD science and commerce, we hold the responsibility to embody integrity and precision science to promote healthy aging. However, the same cannot be said from many of the other sellers of NAD supplements. Our ongoing market surveillance program shows that 3/4 of the higher selling NAD supplements on Amazon failed to meet their label claims, 3/4. We continue to call upon like minded industry stakeholders in holding companies and brands accountable by the products they market and sell to consumers. With regard to NMN, the FDA ruled that NMN is not a lawful dietary ingredient under the Federal Food, Drug, and Cosmetic Act. We recognize that the agency has been sued for this decision, but we reaffirm our position in support of the FDA and believe it will uphold this decision. As we continue to see NMN products find their way on the market, we urge the FDA to maintain and enforce its ruling to protect consumers to ensure that only compliance, properly regulated ingredients are marketed as dietary supplements. The fact is, if you're interested in an NAD product, and that product does not say Niagen, I would recommend you stay away. As I mentioned before, this is the first call as Niagen Bioscience versus ChromaDex. The evolution from ChromaDex into Niagen Bioscience signifies more than just a company name. It is an alignment of our brand with our mission. Niagen Bioscience aims to reinforce Niagen, the forefront of NAD boosting solutions making the main Niagen synonymous with healthy aging. We will continue to uphold these core values, scientific rigor, transparency, authenticity, innovation and integrity. We are here to show you our shareholders, our customers and all our stakeholders. But thanks to Niagen, there is a better way to age. And I would now like to hand the call over to Ozan to run through the quarter's financials and then on to Q&A and closing remarks. Ozan?

Ozan Pamir

executive
#4

Thank you, Rob. And thank you to our investors, partners and team members for joining us today. As Rob highlighted, Niagen Bioscience had a strong start to the year, delivering record revenues and achieving net income for the third consecutive quarter. While it's still early in the year, we are committed to demonstrating operational discipline and focus on executing our key initiatives to drive these results. Now I'll go over our first quarter financial performance. In the first quarter of 2025, we delivered strong results with total net sales of $30.5 million, a 38% increase or $8.3 million from the same period last year. Our Tru Niagen business driven primarily by e-commerce grew 31%, adding $4.2 million, while our Niagen ingredient business nearly doubled, up 95% and contributed $4.1 million. Within the ingredients business, we delivered $2.9 million in higher food grade Niagen sales and $1 million in pharma grade Niagen sales. Gross margin improved to 63.4% in the first quarter, up 270 basis points compared to 60.7% a year ago. This improvement was driven by changes in our product and business mix, including the benefit of higher e-commerce sales and continued sales of pharmaceutical grade Niagen as well as supply chain cost savings. As we continue to scale, we remain focused on further optimizing our supply chain and operations to drive sustained value creation and long-term profitability. Speaking of our supply chain, last month, we issued a press release stating that our operations remain unaffected by the newly imposed tariffs. I want to take this opportunity to reaffirm that our ability to deliver Niagen products to our customers, both domestically and internationally, remains intact following recent trade policy changes. As a reminder, we've established a primarily U.S.-based supply chain. And as a result, we do not currently anticipate any disruption to our cost structure or pricing. However, we are actively monitoring the evolving international trade policies and will continue to manage our operations with discipline and agility to mitigate any potential impact. Selling and marketing expense as a percentage of net sales improved to 26.6% compared to 30.4% in the first quarter of 2024. This improvement reflects our continued focus on scaling sales efficiently through a measured and high-return investments. Research and development expense was $800,000 lower year-over-year. The driver for this was the increased investment in the prior year R&D to support the successful launch of Niagen+ product line. General and administrative expenses decreased by $200,000 compared to previous year. In Q1, we recovered $1.3 million of credit losses related to our legal settlement with Elysium, representing the second and final payment associated with the bad debt written off in 2019. And this was partially offset by increased investments in infrastructure to support the scaling of our business. For the first quarter of 2025, our net income was $5.1 million or earnings of $0.07 per share, a significant improvement compared to a net loss of $0.5 million and a loss of $0.01 per share for the first quarter of 2024. Turning to the balance sheet and cash flow. We ended the quarter with $55.6 million in cash and no debt, maintaining significant liquidity and financial flexibility. During this period, net cash provided by operations was $7.9 million compared to $300,000 in the same period last year. The year-over-year improvement was largely driven by a $5.6 million improvement in net income, along with favorable changes in working capital, including relatively stronger collections on trade receivables and an increase in accounts payable compared to the prior year period. These were partially offset by a decrease in credit loss expense due to the recovery of previously written-off amounts and higher investment in inventory to support the scaling of our operations. As it relates to our 2025 full year P&L outlook, detailed information on key financial metrics can be found in our earnings press release and the accompanying slide presentation. Building on our strong start to the year, we are raising our full year topline growth outlook from approximately 18% to a range of 20% to 25% year-over-year. This reflects our confidence in the sustained momentum across both our e-commerce and Niagen ingredients businesses as the NAD market expands. We expect e-commerce to remain a steady growth engine, while sales to our major partners may fluctuate quarter-to-quarter, we remain confident in the strength of our full year trajectory. We're also updating our outlook for general and administrative expenses. We now expect an increase of approximately $7 million to $8 million compared to our previous estimate of $5 million to $6 million year-over-year. This increase in outlook is primarily driven by an increase in share-based compensation related to performance stock grant tying management performance directly to long-term value creation for the company. While this grant will result in an increase in G&A expense, it is a strong reflection of the alignment between leadership and shareholder interests. Beyond these adjustments, all of the key metrics remain consistent with the outlook I shared last quarter, we continue to expect steady gross margins and sustained profitability. Looking beyond operational efficiencies and the expanding NAD market, we have a clear and compelling path forward to sustain our momentum and profitability. Our strong performance in the first quarter positions us well for the year ahead, and we're encouraged by the positive market trends and opportunities emerging across our business. I remain inspired by the resilience and dedication of the Niagen Bioscience team, and I'm confident that our continued focus on execution will lead to further success. I look forward to sharing more positive results in the future. Operator, we are now ready to take questions.

Operator

operator
#5

[Operator Instructions] Our first question comes from the line of Ram Selvaraju with H.C. Wainwright.

Raghuram Selvaraju

analyst
#6

Congratulations on the outstanding performance to kick off the year. I wonder would it be possible for you folks to give us some sense of what you see as emerging tailwinds for adoption of the Niagen IV product lineup. And in particular, if you could comment on the possibility of compounding clinics and pharmacies becoming more interested in dispensing Niagen IV.

Robert Fried

executive
#7

Thank you for the question, Ram. We put an announcement out earlier this week that we were up to 600 clinics. We continue to see fairly dramatic interest from clinics and now physicians in offering Niagen IV. We've been holding many events where we host celebrities and influencers, especially those that have tried or are interested in NAD IV and the head-to-head comparison is really no comparison. Niagen IV elevates NAD levels much higher and it doesn't have those same uncomfortable side effects that NAD IV have, but also it takes minutes as opposed to hours. And the reason for that is quite simple. The NAD molecule is very large and it's a nucleotide and there's a phosphate on the perimeter. So it endeavors to get into the cell but fails, it needs to break down in the bloodstream into smaller molecules, the best of which is actually nicotinamide riboside, which then freely flows up into the cell and then converts into NAD once it's in the cell. So it's just simply a serial product. We also detecting the data from the studies that there is inflammation associated with NAD. So as more and more people experience it, they're getting the benefits of elevated NAD, but they're having a much more pleasant experience. So we're seeing many clinics contact us. But as we've discussed in the past, we had some supply chain challenges. It's a pharma-grade product, it's not food grade like the dietary supplement that we sell. It's pharmaceutical grade, which is an entirely different supply chain, much more challenging supply chain, one that is heavily regulated and has to make sure that it's completely pure, no particulate matter. And it's taken us a while to learn that process. But we now have and our supply is secure and there is a very long, what they call BUD shelf life so that the clinics feel comfortable of purchasing it. So our expectation is in the next few quarters, we'll start to see a fairly dramatic increase in the sales of pharma-grade Niagen to the clinics and the physicians.

Raghuram Selvaraju

analyst
#8

Great. And then with respect to the e-commerce business, I was wondering if there are some new promotional strategies that you expect to employ in order to push more volume via the e-commerce channel? And if so, what some of these strategies might be? And if you're thinking about the possibility, you mentioned influencers before, is there any potential applicability of the use of influencer campaign in the course of 2025 to further accelerate growth through the e-commerce channel?

Robert Fried

executive
#9

Well, as you've seen in the last few quarters, we have done a good job of dramatically increasing our overall e-commerce growth. You recall, 1.5 years ago, the growth rate was much lower in our -- this quarter, we're over 30%. But we are, as a company, extremely focused on profitability and efficiency, return on advertising spend, long-term value. So we're unlikely to do some aggressive cost inefficient influencer deal that won't have a measurable, reliable return on investment. But if one comes along that we like, we are quick to do it. There are many celebrities that have tried Niagen IV and are excited by it and have expressed interest. But making a deal like that is challenging because we want to deliver a profit to our investors and expect to continue to do so. There are influencer strategies with lesser-known celebrities, particularly in the health care space that we continue to align with and make deals with. We have not been terribly aggressive on TikTok with influencers. We expect to increase our presence there in the near term, and we think that, that will be helpful. But as more and more people experience the Niagen IV and the Niagen injections and more and more people become interested in NAD and more and more articles come out, we're seeing general increased interest in Niagen in all forms. The more people research, the more they realize. But the only safe, legal, well-tested, reliable, consistent brand in the entire NAD space is the Niagen brand. So we do expect to continue to grow in the e-commerce space. We do expect to use more influencers and word-of-mouth and event-oriented campaigns in the future, but nothing overly dramatic is on the immediate horizon.

Operator

operator
#10

And your next question comes from the line of Jeff Cohen with Ladenburg Thalmann.

Destiny Buch

analyst
#11

This is Destiny on for Jeff. I appreciate you taking our question. I'm curious when you look at the market for Niagen+, how many clinics do you think are a good fit for this product? And then how should we think about the onboarding of new clinics, if you will, going through the remainder of 2025 because it's been very impressive from the time of launch to now. And I'm curious if we should continue to expect that trend?

Robert Fried

executive
#12

Destiny, thank you for that question. We hope to be in 1,000 clinics by the end of the year. We feel that we are on pace for that, but it's difficult to do. We think there are upwards of 2,000 to 3,000 clinics that are the potential addressable market. And then there are numerous physicians that also offer IV or injections directly without using a clinic. So we think that the overall addressable market for administration of IV and injection is significantly larger than the 600 where we are present today.

Destiny Buch

analyst
#13

Got it, okay. To that same extent, I'm wondering if you're seeing any ordering patterns from these initial clinics that you can talk about? And how that may change now that you have a longer or more extended BUD.

Robert Fried

executive
#14

So as you know, Destiny, we did this. Before we launched this, we did many things aside from getting on the list with the FDA, which took a long time and also making pharmaceutical grade material, which took a long time. We also patented the process and have applied for that patent which is pending, but also conducted a study showing the safety of Niagen IV and also comparing it to NAD IV. Once we completed all of that, we had to build the commercial distribution pipeline, which is quite different than the Tru Niagen dietary supplement pipeline. And we launched it initially in August and we quickly ran out of supply, and it took several months for us to replenish that supply, but we're now in shape to do that. But we don't have a great deal of anecdotal data on how the consumers are using it or how they are benefiting it. We do surveys. We have some preliminary information. There are some patterns that we're seeing. For example, one thing that keeps popping up is this thing that the clinics are calling the Niagen Glow. It seems as though people that go in and get the Niagen IV notice almost immediately a certain skin glow. Another thing that we have noticed right away is improved sleep right away and people who go in and get the Niagen IV seem to notice a difference in sleep right away. But these are just anecdotal pieces of information. We're conducting many studies, and we're planning many studies to show the therapeutic and prophylactic benefits of Niagen injection and IV versus all the studies that we've conducted with Tru Niagen as a dietary supplement.

Destiny Buch

analyst
#15

That makes sense. I'm hoping that you have a hash tag that says Niagen Glow because that's excellent, on your circle, of course. And then if I can squeeze one more in. Can you just expand a little bit on the ingredients revenue? I'm just kind of curious, I know it could be kind of unpredictable, maybe a little bit lumpy, and this is the first quarter. So I'm not sure if there were larger orders that may sustain your partners throughout the remainder of the year? I'm just trying to get a better feel.

Ozan Pamir

executive
#16

Yes. Hi, Destiny, thank you for this question. Yes, we had $7 million of food grade ingredient sales in the quarter, as you know. As I kind of alluded to earlier in my speech, it can be lumpy orders. We expect the trend to continue, but it's a little hard to predict each quarter. So you're right in that assessment that we can expect some fluctuation. On the pharma grade ingredient side, that's a Niagen+ line, we expect an upward trend.

Operator

operator
#17

And your next question comes from the line of Mitch Pinheiro with Sturdivant & Co.

Mitchell Pinheiro

analyst
#18

So just one follow-up question on the Niagen+ is, are you seeing -- you mentioned physicians' offices or another location where you could get the IV, what kind of physicians are they? And like how are you doing in the health care practitioner market, which seems to be where -- well, a lot of people do their own research on supplements. Oftentimes, your physician is obviously the most credible source of sort of therapy. So where do you see that health care practitioner market going and I'll leave at that.

Robert Fried

executive
#19

Yes. We think that the health care practitioner market is very important for us as a company. As we've often said, if one were to do a business school case study on Niagen Bioscience, the case study would be, how do you sell a dietary supplement that works like a drug? This is not an ingredient that you pee out. This has a meaningful benefit, and we have proven that it's safe yet the regulations are very clear that one cannot imply a claim on any disease state. You can only make structure function claims in the dietary supplement space. And for a company like ours that now has 38 peer-reviewed high-impact factor clinical human studies, randomized, controlled and another 40 in process. This is very, very rare and very, very uncommon. Most dietary supplement companies more or less will sell anything as long as the FDA or the FTC don't get on their case but not us. It's a meaningful ingredient, we saw a meaningful product. If you take it, there will be a therapeutic benefit. If you take it long enough and you measure it, you'll notice the benefit. And we consider that to be an extraordinary unique differential advantage for our company, but also a disadvantage because we're competing with many companies who really don't care. They'll say anything, they'll do anything, they'll make it anywhere, there's no quality controls like the ones that we put in here, they're really not trustworthy brands and trustworthy companies, but not Niagen. We are almost obsessive with being conservative with our claims and with the highest, purest quality that can be offered, we make it here in the United States. So that means health care practitioners are extra important for us because these are theoretically, theoretically, the people who do their research and do their work and they investigate which are the brands that can be trusted and which are the ingredients that have research behind it. What are the C of As, is it Certificates of Authenticity. Is it what they say it is. And they are the ones that can influence the consumers the most. We think that, that is the best way for us to market the product. We think the answer to the question, how do you sell a dietary supplement that works like a drug, as you don't, you let others do it for you? And we think health care practitioners are central to that strategy.

Mitchell Pinheiro

analyst
#20

Okay. And then my other question was on your marketing spend. So you're going to -- you're ramping up marketing spend a little bit. And it certainly seems in a disciplined way. And your last -- the first quarter, your marketing efficiency looks pretty good. Is this new spending going to be at that efficiency level? Or is it some experimental marketing spend that you're not exactly sure of the returns. How do you view the increase this year in your marketing spend?

Robert Fried

executive
#21

We intend to maintain in this area of marketing as a percentage of revenue, and there will be experimental marketing but nothing overly dramatic.

Mitchell Pinheiro

analyst
#22

And will it be spread out? Is the cadence of the marketing spend this year relatively even for the remaining 3 quarters? Or is there going to be a higher spending in any one quarter?

Ozan Pamir

executive
#23

Yes. We expect the spend to be evenly distributed throughout the year. And just to note, as you said, I just want to reiterate, even though dollar amount went up, our -- as a percentage of net sales, our marketing spend has gone down significantly this quarter.

Operator

operator
#24

And your next question comes from the line of Sean McGowan with ROTH Capital Partners.

Sean McGowan

analyst
#25

A couple of questions. So can you update us on the kind of status of the injectable side of Niagen+. What do you expect for that as a rollout? Let's start with that.

Robert Fried

executive
#26

It is being offered in many clinics presently, it's a lower dose. We are developing right now an at-home version of it that people can take at home. We hope to have an at-home version of Niagen injectable on the market by the end of the year. We don't know if it will be the pen version like you see with GLP-1, but there'll be a syringe version with a vial that people can purchase and self-inject at home.

Sean McGowan

analyst
#27

Any sense of when that might be kind of widely available?

Robert Fried

executive
#28

We think the syringe version will be available certainly by the fourth quarter, maybe sooner. And we think if there is a pen version, we're exploring it right now, it won't be available before the first quarter of next year.

Sean McGowan

analyst
#29

Okay, that's helpful. It's a risk of maybe putting the cart before the horse here, but in terms of this Parkinson's study, trying to anticipate in advance the timing of when there might be some commentary on this. Is the timing of when you would be able to comment on this in any way a function of whether the news is kind of good or bad like are people going to be looking into the time that it takes to make a comment and inferring from that, whether it's positive or negative?

Robert Fried

executive
#30

No, you can't interpret whether the news is good or not good by the timing of our announcement. And the reason for that is the study will be completed, but this is a very long, very large study. So it will take several months the researchers to compile the data and analyze the data and then share the data. But after that, they will want to get the study published, and they will write up a manuscript and submit it to several journals for peer review. And they won't want to risk getting accepted in these journals by the data being leaked. So it will be a while. It could be a year or more, after June before it is publicly available. It is possible that it is sooner than that. But we don't intend to rush it, it's a great study. We have very high hopes, but of course, we have no idea. It's double blinded. Neither the participants nor the researchers have any idea about who took what and what the efficacy and the results were. So the reason we're hopeful is because we understand the mechanisms of action of Parkinson's and it's -- how it relates to mitochondrial malfunctions, and that's really where we are most effective, but also there were studies that were already published that were smaller Phase I studies that indicated a benefit. So we are hopeful, but we really have no idea.

Sean McGowan

analyst
#31

Okay. That's very helpful. Ozan, if I can just ask you to clarify one thing on the G&A, not only in the number in the quarter, but on your commentary. Was there anything besides the reversal of that kind of bad debt reserve in the first quarter of this year that you would consider kind of an unusual or unrepeatable benefit? Or if we just make the adjustment and assume that, that's just the starting point?

Ozan Pamir

executive
#32

Yes, that would be the only one. The only -- the difference between Q1 and the rest of the quarters is the -- I think we talked about it a little bit earlier to stock-based compensation. We didn't have full order impact of that in Q1 since the grant was done a little bit later in the quarter. So I would on a go-forward basis, there will be an impact there. But in terms of onetime events, the reversal, the bad debt, $1.3 million is the only item.

Sean McGowan

analyst
#33

Does all of the stock-based comp taken in that line?

Ozan Pamir

executive
#34

Sorry, say again.

Sean McGowan

analyst
#35

Is all of stock-based compensation reflected in that G&A line? Or is it...

Ozan Pamir

executive
#36

I believe so, yes. It is shown in the 10-Q as spread out.

Operator

operator
#37

And your next question comes from the line of Matt Dhane with Tieton Capital Management.

Matthew Dhane

analyst
#38

Great. Thank you. I wanted to ask, are you able to meet all demand for the Niagen IV product today? Yes, I just was curious about that.

Robert Fried

executive
#39

Yes.

Matthew Dhane

analyst
#40

Okay. Are you holding back additional clinics from signing up though or being a persistent until you have the full Niagen IV product availability in the -- I guess, the supply ramped up?

Robert Fried

executive
#41

No.

Matthew Dhane

analyst
#42

Okay. And then I also did want to touch on what is happening around your discussions with the FDA around the AT and Niagen. You said that there should be some maybe potentially some developments later this year. Just curious what's going on behind the scenes? Is there active discussions today with the FDA? Are you having discussions with potential partners? Just was hoping to get a little bit more color there, that would be great.

Robert Fried

executive
#43

It's a good question. We are having active discussions with the FDA. We submitted a pre-IND to them in October. They gave us their comments in December, we responded to them. They got back to us a few weeks ago. There is some discussion about the endpoints, the number of studies, but it is definitely progressing. And no, we have not had any active discussions with third-party partners. We want to take it further along before we do that.

Matthew Dhane

analyst
#44

Okay, okay. And so now the FDA has got back to you with their comments. And so basically, you're understanding what the next steps are, and then you'll just continue down the path back and forth with the FDA until you're to that point to do the filing here later this year, then it sounds like?

Robert Fried

executive
#45

Correct.

Operator

operator
#46

And your next question comes from the line of Susan Anderson with Canaccord Genuity.

Susan Anderson

analyst
#47

Nice job on the quarter. I guess maybe just to ask about the various Tru Niagen formulations. I guess, you started doing the Stick Packs. I think you have an Immune product now. I guess I'm just curious how those are performing. Are they helping to add to growth at all? And then are you planning for any more product rollout for the rest of the year?

Robert Fried

executive
#48

Those are good questions, and welcome, Susan. They are selling, it's not -- it doesn't yet have a meaningful impact on overall sales. Most of our sales are still the various Tru Niagen SKUs and the ingredient business. But both Stick Packs and Immune are growing, and we intend to invest more in our marketing efforts in both of those products because we see increasing demand in both. We may be doing some alterations in the Immune formulation based on consumer feedback. But we expect both Stick Packs and Immune to grow more as the year progresses. Yes, there is another formulation that we call Tru Niagen Beauty. It was a formulation that we created a few years ago, specifically for Watsons, Hong Kong at their request. We're making a few alterations to that formula as well and intend to launch it here in the U.S., perhaps as early as this year.

Susan Anderson

analyst
#49

Okay. Great. And will that be launched on your own website or another website?

Robert Fried

executive
#50

It will be launched on our website and other websites.

Susan Anderson

analyst
#51

Okay, great. And then maybe I could just follow up on the Niagen injectables. Maybe a question, you talked about the at-home potentially rolling out in the fourth quarter. I guess I'm curious do you already have plans on kind of what channels will that be rolling out the clinics? Will it be rolling out other even DTC kind of clinic providers where consumers could even order them online? Or how should we think about that?

Robert Fried

executive
#52

Yes. We expect that consumers will be able to order them online. And it might be through some of these telehealth companies that presently are selling GLP-1 at-home products. We don't have any deals like that to announce presently, and it will likely also be available on other platforms like Google shop, for example. But one thing to point out that's important to remember is we sell Niagen to the compound pharmacy. The compound pharmacy then sells to those telehealth companies and clinics. So we are not the direct seller to those customers, we are more marketers. Of course, we're very, very involved in that process, and we develop very close relationships with these clinics and telehealth companies. Indeed, in most cases, we actually bring them to the pharmacy. But it's an important distinction to understand in the supply chain.

Operator

operator
#53

And your next question comes from the line of JP Mark with Farmhouse Equity Research.

Jan Mark

analyst
#54

Hey, Rob, I just wanted to say my questions have been asked and answered. I just wanted to send along my congratulations on a great quarter.

Robert Fried

executive
#55

Thank you very much.

Operator

operator
#56

And there are no further questions at this time. Wesley Yu, I turn the call back over to you.

Wesley Yu

executive
#57

Thank you, Kayla. There will be a replay of this call beginning at 7:30 p.m. Eastern Time today. The replay number is 1 (800) 770-2030 and the replay ID is 858-4242. Thank you, everyone, for joining today and for your continued support of Niagen Bioscience.

Operator

operator
#58

This concludes today's conference call. You may now disconnect.

This call discussed

For developers and AI pipelines

Programmatic access to Niagen Bioscience, Inc. earnings transcripts and 32,000+ others is available through the EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments, full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.