Niagen Bioscience - Q2 2024

Executive Summary

• Q2 2024 revenue was $22.7M, up 12% year-over-year; gross margin was 60.2% and net loss was approximately breakeven ($15K), with positive Adjusted EBITDA of $1.6M.
• Management lowered FY2024 revenue growth guidance to 10–15% (from “>16%” previously) and reduced FY2024 G&A outlook to down $1.5M YoY (from up $1.5–$2.5M), citing later-than-expected NIAGEN+ IV commercialization; gross margin “slight improvement” and S&M stable % of sales maintained.
• Launch of NIAGEN+ IV and injectables is a near-term catalyst; supply constraints drove October scaling, with clinic injectables expected in 2–3 months and potential at-home injectables by year-end or Q1 2025.
• Strategic science/regulatory progress: FDA Orphan Drug and Rare Pediatric Disease designations for nicotinamide riboside chloride (NRC) in AT; new peer-reviewed publications in PAD and brain NAD+ elevate the medium-term narrative.
• Note: management commentary on e-commerce mix (57% current vs 64% prior year) conflicted with the investor presentation (64% Q2’24 vs 57% Q2’23); figures in the presentation and press release indicate 64% e-commerce in Q2’24.

What Went Well and What Went Wrong

What Went Well

• Revenue growth and profit trajectory: Total net sales rose 12% YoY to $22.7M; Adjusted EBITDA improved to $1.6M from $0.2M in Q2’23; operating loss narrowed to $0.3M.
• Product and science milestones: Unveiled NIAGEN+ (IV and injectable), launched NIAGEN+ NAD+ Test Kits; FDA orphan/rare pediatric designations for NRC in AT; new clinical publications (Nature Communications PAD trial; UPenn brain NAD+ study) bolster legitimacy.
• Management quote: “We are thrilled to finally unveil our new product line, Niagen+, … the first company to offer NR in both oral and intravenous forms” — Rob Fried, CEO.

What Went Wrong

• Guidance reset: FY2024 revenue growth lowered to 10–15% due to delays in NIAGEN+ IV commercialization; G&A outlook pivoted from an increase to a $1.5M YoY decrease given timing shifts.
• Margin pressure: Gross margin fell 60 bps YoY to 60.2% on business mix; S&M rose to 30.6% of sales as brand investments increased without last year’s one-time Amazon event tailwind.
• Working capital drag: Operating cash flow was roughly breakeven for 1H’24 vs $6.1M inflow prior year, driven by higher trade receivables (+$4.2M) and lower accounts payable (-$2.5M).

Transcript

Operator (participant)

Ladies and gentlemen, thank you for standing by, and welcome to ChromaDex Corporation's Second Quarter of 2024 Earnings Conference call. My name is Dustin, and I will be the conference operator today. This time, all participants are in a listen-only mode, and as a reminder, this conference call is being recorded. This afternoon, ChromaDex issued a news release announcing the company's financial results for the second quarter of 2024. If you have not reviewed this information, both are available within the investor relations section of ChromaDex's website at www.chromadex.com. I would now like to turn the conference call over to Ben Shamsian, Vice President of Lytham Partners. Please go ahead, Mr. Shamsian.

Ben Shamsian (VP of Investor Relations)

Thank you, and good afternoon, and welcome to ChromaDex Corporation's second quarter of 2024 results investor call. With us today are ChromaDex's Chief Executive Officer, Rob Fried; Interim Chief Financial Officer, James Lee; Senior Vice President of Scientific and Regulatory Affairs, Dr. Andrew Shao; and Vice President of Finance, Wesley Yu. Dr. Shao and Mr. Yu will join the call for Q&A. Today's conference call may include forward-looking statements, including statements related to ChromaDex'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 ChromaDex'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 ChromaDex's quarterly report on Form 10-Q most recently filed with the SEC, including results of operations, financial condition, 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 and are available on the company's website, present reconciliations to the appropriate GAAP measures. Finally, the conference call is being recorded via webcast. The webcast will be available at the investor relations section of our website at www.chromadex.com. With that, it's now my pleasure to turn the call over to our Chief Executive Officer, Rob Fried.

Rob Fried (CEO)

Thank you, Ben. Good afternoon, everyone, and thank you for joining us today on our investor call. For the second quarter, we delivered another solid performance with $22.7 million in revenue, a 12% increase year over year, and an unexpected virtual break-even net income, $15,000 net loss. We achieved $1.6 million in positive adjusted EBITDA, marking our fifth consecutive quarter of positive adjusted EBITDA. This reflects our steadfast focus on maintaining fiscal discipline across the company while still supporting upcoming launches and key initiatives. In the second quarter, we generated total positive cash flows and ended the quarter with $27.9 million in cash and no debt. As most of you know, ChromaDex is the gold standard in the NAD space, and we are at the forefront of improving the health of all individuals.

After significant time and investment in research and development, I am excited that our Niagen Plus product line launch is finally here. In June, we first introduced the Niagen Plus product line featuring pharmaceutical-grade Niagen. U.S. FDA-registered 503(b) outsourcing facilities will compound and distribute pharmaceutical-grade Niagen, which will be available in intravenous (IV) and injectable forms exclusively at clinics with prescription. Starting this month, Niagen IV and injections will debut at select IV clinics through Wells Pharmacy Network, including Cenegenics, Drip Hydration, REVIV, Next Health, Restore Hyper Wellness, and many others. This innovation not only opens significant growth opportunities for the company in a global market valued at over $2 billion, but also represents a major advancement in NAD+ IV therapy, offering a superior tolerability, 75% shorter infusion time, and a faster elevation of NAD blood levels post-infusion.

Over the last few years, we have seen the increasing popularity of NAD IV therapy among celebrities, athletes, and influencers who seek to biohack the aging process. We know that users of traditional NAD IV therapies have reported very uncomfortable experiences and shared that it takes hours to administer. This is not the case with Niagen IV. We believe that Niagen IV will provide a superior experience for all consumers, and we are excited to bring the best NAD-boosting ingredient to IV therapies. We also announced the launch of the Niagen Plus NAD Test Kit, available exclusively to healthcare practitioners to provide a reliable method for measuring patient blood NAD levels. The Niagen NAD Test Kit allows healthcare practitioners a tool to provide patients with personalized and effective protocols by more accurately tracking NAD changes over time.

ChromaDex is the only company to offer our patented NR in both oral and injectable sterile formulations. We are indeed holding true to our commitment to developing new products and mechanisms to benefit the way humans age. This is beyond traditional dietary supplementation. The team at ChromaDex is passionate about this constant stream of innovations, and there is more to come. I am very proud of everyone here for their diligence and thoroughness throughout the development process to ensure the proper safety, efficacy, and compliance has been established. As I have said previously, the mission at ChromaDex is to improve health span to as many lives as possible. In a past earnings call, I referenced the clinical study that investigated the safety benefits of long-term NAD supplementations in individuals with Ataxia telangiectasia, a rare genetic neurodegenerative disorder.

AT is a rare progressive disease where children suffer from adverse effects of premature aging and face limited life expectancy. The results of the study were published in October 2023 and confirmed that long-term supplementation of NR was safe and well tolerated and improved motor coordination, eye movement in AT patients of various ages. In June, we announced the U.S. FDA-granted orphan drug designation and rare pediatric disease for NR as a candidate for treatment of AT. We plan to file an investigative new drug application with the FDA in anticipation of conducting human clinical trials guided by Dr. Wilhelm Bohr, Professor at the University of Copenhagen, and scientific advisor to ChromaDex. We eagerly anticipate the results from future research and how NR can bring therapeutic benefits to individuals suffering from AT.

With regard to our Parkinson's initiative, just last week, a new patent was granted in Europe for the use of nicotinamide riboside in the treatment of Parkinson's disease. This is a very exciting step forward. We look forward to the results of the phase III NOPARC study, which is nearing completion. We anticipate the study to be complete sometime in the first half of next year. The NOPARC study aims to examine the therapeutic potential of NR in patients with Parkinson's disease, all of whom take either a placebo or a gram a day for a year of nicotinamide riboside. Since our last quarterly update, there have been a few key clinical publications that I'd like to highlight. In June, results of a pivotal phase II trial were published in the journal Nature Communications. The study, led by Dr.

Mary McDermott at Northwestern University revealed that six months of NR supplementation at 1,000 milligrams per day significantly improved the six-minute walk distance and treadmill walking time in people with peripheral artery disease, or PAD. This compared to a placebo. PAD is a condition characterized by plaque buildup in peripheral arteries that restricts blood flow. It affects 200 million people worldwide. In July, a peer-reviewed clinical study was published demonstrating that a single dose of NR supplementation affects NAD levels in the brain. The study out of the University of Pennsylvania examined the effect of supplementing 900 milligrams of NR offered to them as True Niagen in healthy adults and found that within four hours, brain NAD levels increased significantly by about 16% compared to baseline.

This study is the first to demonstrate an increase in brain NAD levels after just a single dose of True Niagen, and the results are consistent with previously published clinical evidence demonstrating supplemental NR increases brain NAD levels. These recent findings are quite compelling as the brain relies heavily on NAD to support its extensive metabolic functioning. These publications add to our understanding of the many profound benefits NR supplementation can provide to all individuals. I'd now like to give a brief update on the current core business. At $13 million for the second quarter, e-commerce continues to be our largest and most consistent source of revenue, remaining stable year-over-year. Several factors play into our current position in e-commerce. First, as you all know, last year we invested in a brand campaign through Amazon's homepage takeover.

This drove a significant increase in new-to-brand purchases for the first quarter of 2023. Subsequently, in the second quarter of 2023, our team reduced top-of-the-funnel spending but redirected our efforts to retargeting consumers exposed to the homepage takeover event. In contrast, during the first two quarters of 2024, our marketing team focused on different initiatives, moving away from heavy promotional periods and instead utilizing influencer marketing, refreshed content, and social media presence to drive acquisitions and brand awareness. Absent a large-scale event like last year, we are seeing positive signs from our marketing efforts, including increases in subscriptions on Amazon and on our own website. Total Niagen-related sales on Amazon marketplaces have grown significantly year-over-year, reflecting increased consumer awareness that Niagen is the gold standard in NAD-boosting supplementation.

True Niagen as a brand continues to grow on Amazon, and the presence of our other Niagen partners, including Life Extension, Neurohacker, and Nestlé's brand Solgar, has furthered the recognition of Niagen's benefits without requiring significant marketing expenditure from us. Unfortunately, other brands have emerged on Amazon promoting NAD-boosting products that do not live up to their claims. It is troubling that such misinformation and misleading practices continue to persist, but it only strengthens our resolve to emphasize Niagen's superior quality. As the popularity and awareness of NAD continues to grow, we will remain vigilant in our actions against infringers and against brands that continue to be disingenuous to consumers. We are dedicated to ensuring that Niagen remains recognized as the premier choice in the NAD-boosting industry through our continued focus on product excellence and consumer education.

Watsons remains a valued strategic partner, providing steady recurring revenue with occasional quarterly fluctuations. We continue to explore new opportunities with Watsons to enhance brand awareness. One such initiative is the development of a sample-sized package of 10 300-milligram doses of True Niagen. This smaller offering is intended for use in gift-with-purchase promotions or as a standalone product to attract new customers. Additionally, we are collaborating with Watsons on further marketing initiatives planned later this year and perhaps new product offerings as well. Nestlé Health Science has made excellent progress in integrating Niagen into their brands. Earlier this year, Pure Encapsulations reformulated two of their existing SKUs to replace NMN with Niagen. Last month, Pure Encapsulations launched a new multi-ingredient product featuring Niagen called NR Longevity. We are quite proud to collaborate with Nestlé, working together to deliver products that enhance cellular health and support health span.

As many of you know, Brianna Gerber stepped down as CFO in July. Brianna was an important business partner to me and to the rest of the organization. Her leadership contributed to our progress toward cash flow break-even and better. As she moves on to a new opportunity, we'd like to thank her for her contribution to ChromaDex, and we wish her the best of luck. While we search for a new CFO, we have promoted James Lee to the position of interim CFO. James has been with ChromaDex over 15 years and has over 20 years of public accounting experience at ChromaDex and Samsung Electronics. I have immense trust in James's capability and expertise, and I am confident in his leadership during this transition. In the past quarter, we have made significant announcements around our upcoming launches and around NR Science.

As the commercialization of the Niagen IV took longer than we had originally anticipated, this may have implications on our overall growth plans for the balance of 2024. Over the last few years, we've put tremendous time and effort in applying for the patents around Niagen IV to secure pharmaceutical-grade Niagen, to obtain 503(b) approval with the FDA, and to conduct third-party independent studies to assess safety and efficacy. Accordingly, while we are still driving toward higher growth, we are introducing a range that contemplates the later launch of Niagen IV and contemplates factors not within our control that may impact our top-line expectations. James will review the updated 2024 outlook in greater detail shortly, but we look to finish the rest of 2024 by building momentum toward stronger growth in 2025 while still maintaining positive cash flow through continued fiscal discipline.

In summary, this quarter marks an important point for ChromaDex. The debut of Niagen Plus will be transformative for ChromaDex as the NAD company. At the same time, we are continuing to focus on optimizing our e-commerce marketing strategy and our business partnerships to gather momentum to end the year in a strong position, and we are eagerly anticipating our progress on Parkinson's and on ataxia. I would now like to hand the call over to James to run through the quarter's financials and then on to Q&A and closing remarks. James?

James Lee (Principal Accounting Officer and CFO)

Thank you, Rob. It's a pleasure to address our investors, partners, and team members today. I am honored to step in as interim CFO, and I'm committed to upholding the operational efficiency and financial discipline that have been central to ChromaDex's success these past few years.

The progress we've made on key initiatives is promising, and I'm excited about the opportunities ahead. As Rob said, we're diligently searching for a permanent CFO who will guide us through the next phase of our journey. In the meantime, I'm dedicated to leading the company through this transition and continuing to drive our strategic and financial goals forward. Moving to the key highlights of our second quarter performance, ChromaDex delivered total net sales of $22.7 million, solid gross margins of 60.2%, a reduction in overall operating expenses of $0.7 million, and a near break-even net loss of $15,000. Additionally, we had near break-even operating cash flows and a positive $1.6 million of Adjusted EBITDA, a non-GAAP metric. Our performance this quarter demonstrates our continued financial discipline across the organization while making meaningful progress with key initiatives such as Niagen Plus.

With that, let's turn to the second quarter financials in more detail. As noted, total net sales in the second quarter of 2024 reached $22.7 million, reflecting a 12% increase compared to the second quarter of 2023. This growth was primarily driven by a 10% increase in True Niagen sales, with steady e-commerce performance year over year, and a 44% increase in combined Watsons and other B2B sales, partly due to timing of sales. As a quick reminder, in mid-March of the previous year, we invested in a brand-building event with the Amazon homepage takeover, which drove higher e-commerce sales during the second quarter of 2023. Even without a similar initiative this year, we maintained robust e-commerce performance. Regarding Watsons and other B2B sales, the timing of sales can vary for our partners on a quarterly basis.

Nonetheless, we continue to see steady recurring demand from existing partners and have realized some modest upside. Additionally, total ingredient sales grew $0.6 million, partly driven by timing of sales from our partners. Gross margins remain strong at 60.2%, slightly down compared to 60.8% in the second quarter of 2023. This modest decline is mainly due to changes in our business mix, with e-commerce sales constituting 57% of our total net sales in the current quarter, compared to 64% in the prior year. Even with this shift, our margins continue to reflect strong operational efficiency and cost management. Selling and marketing expense as a percentage of net sales rose to 30.6%, compared to 29.6% in the second quarter of 2023.

As discussed earlier, our investment in a major brand-building event in the first quarter of the prior year allowed us to retarget consumers effectively and achieve overall efficiencies in the second quarter of last year. This year, without a comparable campaign, we increased our marketing investments but still managed to drive similar efficiencies, demonstrating our commitment to strategic growth and our ability to adapt our marketing approach to continue delivering strong results. Research and development expenses remain stable year-over-year as we continue to focus on advancing innovations and developing new NAD precursors. General and administrative expense decreased by $1.6 million compared to the previous year. This reduction was largely due to lower costs in executive and administrative headcount, benefits, severance and restructuring, and royalty and commissions expenses.

For the second quarter of 2024, our operating loss was $0.3 million versus a $2.3 million loss in the second quarter of 2023, an improvement of $2.1 million, driven by higher net sales and lower operating expense. The net loss attributable to common stockholders for the second quarter of 2024 was near break-even or a loss of $0.00 per share, compared to a net loss of $2.2 million and a loss of $0.03 per share for the second quarter of 2023. Moving to the balance sheet and cash flow, our balance sheet remained strong. We ended the quarter with $27.9 million in cash and no debt. For the six months ended June 30, 2024, net cash provided by operations was near break-even at $31,000, compared to a $6.1 million cash inflow in the same period last year.

The difference year over year was largely driven by changes in working capital, with a relatively greater increase in trade receivables of $4.2 million and a greater reduction in accounts payable of $2.5 million. As it relates to our 2024 full-year P&L outlook, detailed information on key financial metrics can be found in our earnings press release and accompanying slide presentation. As mentioned in the prior earnings call, our top-line outlook included revenues from new product launches. Due to the longer-than-expected commercialization process of Niagen Plus, stemming from the necessary steps to ensure thorough diligence, we have revisited our outlook. While we continue to aim for higher growth, we now anticipate a 10%-15% year-over-year growth, driven by our global e-commerce business, new and existing partnerships, and the launch of Niagen IV.

Our revised top-line expectations account for the extended commercialization timeline of Niagen Plus and other factors beyond our control. We also revised our general and administrative expense outlook, which is now down approximately $1.5 million, a reduction from the previous increase of $1.5 million-$2.5 million. Initially, we provided the guidance that G&A was going to increase year-over-year due to investments in infrastructure to support our growth trajectory and new market launches. Even with the later launch date of Niagen IV, we have shifted the timing for some of those initiatives into 2025. Beyond these adjustments, our key metrics remain consistent with last quarter's outlook. We expect strong and steady gross margins, with a slight improvement over the prior year's 60.8%. We plan to make greater investments in sales and marketing expense while maintaining similar efficiencies and increase research and development investments to support our strategic initiatives.

In summary, we delivered a solid financial performance in the second quarter, both at the top and bottom lines. We advanced crucial aspects of our strategic plan, including the introduction of Niagen Plus, which opens up exciting new market opportunities. While unlocking the full revenue potential of the Niagen Plus launch may take time, we're seeing encouraging responses from our partners, and we're proud of the progress we have made. We will remain disciplined in managing the business at cash flow break-even or better, while scaling our revenues and making key investments for growth. Our core business remains strong, with continued positive operating cash flows and a healthy balance sheet. All of the achievements this quarter are a testament to the team here at ChromaDex. Their dedication and hard work in bringing these initiatives to fruition have been instrumental in driving us forward.

As we continue to pursue our goals together, I am committed to maintaining the operational efficiency and financial discipline that have been key to our success. Operator, we're now ready to take questions.

Operator (participant)

Thank you. As a reminder, if you'd like to ask a question, please press star and the number one on your telephone keypad. We will pause for just a moment to compile our roster. With that, we will begin the question-and-answer session. Your first question comes from the line of Mitch Pinheiro from Sturdivant & Co. The line is open.

Mitch Pinheiro (SVP and Director of Fundamental Equity Research)

Yep. Hey, good afternoon.

Rob Fried (CEO)

Hi, Mitch.

Mitch Pinheiro (SVP and Director of Fundamental Equity Research)

Hey, Rob and company, congratulations on all the sort of new products and initiatives that you've launched recently. I would just like to take a look at if you could provide a little more color around the Niagen Plus. How many clinics are we talking about right here, initial shipments?

Just looking at the advantages that your product has over the current product set, why wouldn't you expect adoption to be faster? Who wants 3-hour infusion times with pain? I mean, why wouldn't you be able to capture 50 share right out of the gate? What are the obstacles that I'm missing on that?

Rob Fried (CEO)

Thanks, Mitch. That's a very good question. We do think we'll get more than 50% share. Head-to-head, the product is so significantly better than NADIV. The reason why it's so much better than NADIV is the same reason why it's so much better than NMN. Neither NAD nor NMN, when consumed, easily are taken up in the cells. Neither one of them. NAD is a very large molecule, and it is a nucleotide. It has a phosphate on the perimeter. The same with NMN. It has a phosphate.

It's that phosphate that blocks entry into the cell. In the case of NAD, they have the double whammy. They have the phosphate, and it's an extra-large molecule. That's the reason why when people sit down to ingest NAD via infusion, it takes so long, and there's so much nausea and stress and sweating, because it's unable to get into the cell. So what happens with both NAD and NMN is it tries, creates friction, and we believe inflammation, but eventually breaks up into smaller molecules. One of the molecules it breaks up into is nicotinamide riboside, Niagen. Once that NR molecule is floating through the bloodstream, it quite easily upregulates into the cell. So that's why the test results are exactly what we expected.

If you do an IV infusion of Niagen, it cleanly goes right up into the cell with no side effects and has a dramatically increased level of NAD after. That's why NR is better than NMN. That's why it's better than NAD. This is a difficult message to communicate, but that's our quest. We've got the superior product. Explaining it to people is challenging. We know that once we explain the science to the clinics, they all know what the experience is with NAD. They say, "Wow, you have something that only takes minutes instead of hours. It doesn't have side effects. When can I get it?" So we know that the thing sells. They all want it. The problem has been the supply. Like everything that we do, Mitch, we do it very, very much by the book.

It puts us at a disadvantage from some players who like to steal patents or make false claims or put things in bottles that are inaccurate. As you know, there have been 2 studies out there that showed that a very low percentage of the NMN bottles that are sold out there actually have any NMN, let alone accurately labeled. But we went through the process. We've worked on this thing for almost 4 years. We got the FDA to put it on the 503(b) list as an improved ingredient, and we applied for it. We have patents pending on this process, delivery of NR and NAD precursors via this mechanism. But most importantly, it had to be pharmaceutical-grade material. It's going right into the bloodstream. And that has been a very long process.

It's a completely different supply chain than the one we're using on the food-grade material we sell as a dietary supplement. It's a different supply chain. It's different partners. Every step of the way has to be FDA approved. It's triple sterilized, triple validated, purified. The thing is perfect. In fact, our partner, Wells Pharmacy Network, our compound pharmacy, said it tests better than any ingredient they've ever tested before. That's how painstaking we are and how slow it is. In August, we have a limited amount of ingredient. We only have a few kilos. Those kilos have already been sold. In October, we're going to get a much larger batch. So that's the reason. It's not demand. It's not that they don't get it, and it's not that they don't want it. It's just been very, very challenging to do things the right way.

It's why it's taken us so long. We anticipated initially that we were going to have the product available at the beginning of this year, not October. That's really the main reason why we had built it into the forecast for the year. That's why we are slightly lowering our forecast for the year, because we just don't know what's going to happen in October, November, and December when we finally have the ingredient. So just to be safe, we created that slightly lower expectation. I know I answered a bunch of questions in one, but I knew those other questions were coming from you anyway, Mitch. Yeah, no, that was very helpful. Let me ask you this. You're getting a larger batch in October. I mean, when do you think you'll be at the point where you're fulfilling orders real-time as opposed to batching?

Mitch Pinheiro (SVP and Director of Fundamental Equity Research)

October.

Rob Fried (CEO)

Could you hear me, Mitch? I'm sorry. No? Lost the connection, I think. Hello? Yeah. Can you hear me? This is Rob. Dustin. Dustin. Dustin, are you still with us?

Operator (participant)

Yes, sir. I was about to announce our second question if Mr. Pinheiro would not respond after that answer.

Rob Fried (CEO)

What? Mitch, are you still on?

Operator (participant)

I have returned him to the queue. And I apologize. Our second question comes from Bill Dezellem from Tieton Capital Management. The line's open.

Rob Fried (CEO)

Hi, Bill.

Bill Dezellem (Co-Founder, President, and Chief Investment Officer)

Hello, Rob. I could hear your answer. And hopefully, Mitch will come back in. Those were good questions. So continuing on with that line of questioning, I think that you answered the question that Mitch kind of started with, which was, what's the biggest hurdle to Niagen's adoption? And I believe you basically said availability of product.

So if once you have full availability, then what do you see as the biggest hurdle to Niagen IV being adopted?

Rob Fried (CEO)

That's an interesting question because the demand is already there. I mean, there is an NAD IV business out there already. We think we have the opportunity to expand that market dramatically because it is a fairly expensive consumer product. I think that's one answer. That's one limiting factor. But also because NAD IV is such an unpleasant experience, it's limited the broad adoption. We think Niagen IV and Niagen shots, Niagen injection, have the opportunity to dramatically expand the market. So I think the challenge there would be just communicating that it's out there.

Bill Dezellem (Co-Founder, President, and Chief Investment Officer)

All right. Thank you. And which I guess means that it's the clinics that ultimately will be doing the marketing to their local constituents.

Rob Fried (CEO)

Well, we will be doing some marketing, but our customer is the pharmacy. The pharmacy sells to the clinics, and the clinics sell to the consumer. But we will be doing broad marketing of Niagen IV at both the clinic level and the consumer level.

Bill Dezellem (Co-Founder, President, and Chief Investment Officer)

Okay. Thank you, Rob. And then maybe I should be asking this question slightly different than I was thinking, but I was going to ask what percentage of the IV therapy market do the partners that you've identified, do they represent? And when I say partners, in my mind, I was thinking clinics, but maybe the correct way to characterize it is pharmacies. So maybe you could help me ask the question the right way and then answer it. I guess you get to do both sides of this.

Rob Fried (CEO)

Well, there are many 503(b) and 503(a) compound pharmacies out there. The 503(b) pharmacy business generally exists because of special situations where there's a unique critical need for an ingredient that may not have a specific drug approval for an indication but is approved by the FDA to be offered through this channel, through this means. Or if there's an example like Ozempic, for example, where the supply is not meeting the demand.

So many of these 503(b) companies are actually selling these GLP-1 products because the demand is so great that and other peptides, because the demand is so great that the drug companies can't make it in time to meet that demand. So NAD, as a percentage of that market, is really kind of a small percentage of that overall market. We think at the clinic level, at the consumer level, the NADIV market in the U.S. is somewhere between $100 million-$150 million total.

So you split that with the pharmacy, then you split it again with the ingredient supplier, which in this case would be ChromaDex. So that's how big we think that market is today. But we think we have an opportunity to expand that market because the product is so much superior to what's out there presently.

Bill Dezellem (Co-Founder, President, and Chief Investment Officer)

And Rob, the clinics that you're in partnership with, what percentage of that $150 million at retail do they represent?

Rob Fried (CEO)

More than 50%. The other 50% would be physicians that administer NAD either via an injection or an IV in the actual physician's office. But the clinics are the majority of that business.

Bill Dezellem (Co-Founder, President, and Chief Investment Officer)

Great. Thank you. That is helpful. A couple of other questions before I hop off, if I may. The first one is relative to AT. How is this process that you're going forward with AT different than the process that you had several years ago with Cockayne syndrome?

Rob Fried (CEO)

That's a good question. The Cockayne studies that were done were just mouse studies. Have you contemplated, and actually, Andrew's on the call. I'll give you a quick answer, and then I'll let Andrew chime in if you'd like, Andrew. The Cockayne studies, which is comparable in a way, it's also an orphan disease that's accelerated aging disease. And it was Wilhelm Bohr, who's on our SAB and at the time was at the NIH, who oversaw those Cockayne studies while at the NIH. And he, again, is overseeing these ataxia studies presently. We never did Cockayne studies that reached the human level. They never got to the clinical level, whereas ataxia did.

We had that study published in October of last year, which I think is a phase two human clinical study on ataxia. So we thought that there's a therapeutic benefit to both, but we thought ataxia was further along. Andrew, is there anything else you want to add to that?

Andrew Shao (SVP of Global Regulatory and Scientific Affairs)

Sure. Sure, Rob. I'll just add a little bit. Great question, Bill. The overall regulatory process is the same. And as Rob mentioned, Cockayne syndrome had never been explored in a human clinical study setting, whereas ataxia, as you've heard from Rob's comments earlier, has been studied in a couple of trials most recently, a two-year trial in a group of patients. So it's just further along as far as its investigation in humans. But the regulatory process going through FDA's Office of Orphan Disease and so forth is the same.

Bill Dezellem (Co-Founder, President, and Chief Investment Officer)

And then the, I guess, business logic for going down the path with AT with human studies first versus Cockayne syndrome, was that a decision that ChromaDex made, or was that really tied to those who were doing the studies, the researchers, and you all really did not have a role in that?

Rob Fried (CEO)

I'm sorry. Could you ask that one more time?

Bill Dezellem (Co-Founder, President, and Chief Investment Officer)

Yeah. Did ChromaDex make the decision to go down the AT path in terms of the human trials and to not go down the? Yes. Okay. And why AT instead of Cockayne syndrome?

Rob Fried (CEO)

Well, you know the way our CERP program works is usually companies come to us, and somebody came to us on both Cockayne syndrome and ataxia telangiectasia, then we just thought ataxia telangiectasia was easier to get approval on, easier to get done, easier to get financed.

Bill Dezellem (Co-Founder, President, and Chief Investment Officer)

Great. Okay. That's helpful. And then one additional question, please. The B2B sales being up 44%, congratulations. Does that represent a sell-through level, or is that business still really dictated by lumpy orders depending on your consumers' needs? I don't have a lot of clarity if they're just ordering on a consistent basis now or more batch orders.

Rob Fried (CEO)

So there's an interesting development that we alluded to in our talks. And that is that one of our ingredient customers this year began aggressively marketing a combination product of Niagen plus another ingredient on Amazon and marketing it very heavily and doing extremely well on Amazon. So we're in this interesting position where we sort of compete with our customer. So his sales have been extremely strong on Amazon and on his website. So he's been purchasing a lot of ingredient. And we think that's a really good thing. And it's obviously good for our top line and bottom line.

But maybe had he not done that, our top line would be significantly higher if you follow what I'm saying. But we think on balance, it's good for the health of Niagen overall and our company overall. And they're very effective marketers, and they advance the word on NAD and Niagen in particular. So because of that, that's why ingredient sales have gone up so significantly and why we expect them to continue to, at least for the rest of the year.

Bill Dezellem (Co-Founder, President, and Chief Investment Officer)

Great. That's an excellent problem to have. Thank you for all the time.

Operator (participant)

Thank you. Our next question comes from the line of Ram Selvaraju from H.C. Wainwright. The line is open. Hey, everyone.

Mitchell Kapoor (Analyst)

This is Mitchell on for Ron. Thanks for taking our questions. A few from us. I wanted to know how you'll go about setting the pricing for Niagen IV and what impact you expect the rollout to have on overall gross margins. If you could just provide a little more color. I know you touched briefly on your expectations for margins changing. And then separately, how long do you expect it to take for NR to replace NMN in ex-US markets, and in particular in China? Thank you.

Rob Fried (CEO)

So the way we priced it is we worked backward. We saw what the pricing was or is for NAD IV. We priced ours slightly higher than that and then worked our way back to the split with the clinics and with the compound pharmacies. The margins are higher than our corporate margins, so it should have a positive impact on our gross margins. As you know, NMN is illegal in the United States.

The FDA has ruled on that numerous times. All reputable companies have ceased selling NMN in the U.S., but there is a proliferation of it, of increase, many, many companies coming out there, building a website, selling NMN, taking advantage of awareness level that was mostly generated by a few podcasts and by a Harvard professor. Since that has happened, and one of the things that we've shown, and there are two studies to show it, is that the vast majority of these NMN bottles are mislabeled, and many have endotoxins present, meaning a real health issue. The endotoxin presence comes as a result of poor manufacturing processes. You have to realize that if the FDA makes a decision that NMN cannot be sold, the companies that decide to keep selling it are the same companies that probably don't care much about from where they get it.

The companies that are making it are also companies that have decided to keep making it despite the FDA's decision. And that's why you're seeing the presence of endotoxins in many of these NMN products. It's a function of poor manufacturing processes. That type of approach has been very prevalent in China as well: mislabeling, presence of endotoxins, false claims, and then, of course, the FDA's decision on NMN. So the Chinese government has decided that NMN is no longer legally sellable as a cross-border product in China. So NMN sales in Asia and China have dropped dramatically in the last year, very, very, very dramatically. It has not yet benefited us, and our partner, Sinopharm, believes that the reason it hasn't yet benefited us is because the average consumer seems to confuse True Niagen with NMN. They don't yet understand that we are different.

But they are persistent about continuing to get that message across. The Chinese government has not issued anything negative on True Niagen, nor will they, because they're aware of the studies we've done and the way we go about doing our business. But it has not yet translated into a convergence of sales from NMN to Niagen or to True Niagen. We have added one or two additional partners. iHerb is a partner that we added that's selling True Niagen globally and soon will be selling in China. And they are doing well and growing. So we hope that between H&H, Sinopharm, iHerb, and maybe one or two others, we'll start to see an increase in cross-border sales into China.

Mitchell Kapoor (Analyst)

Great. Thank you so much.

Rob Fried (CEO)

Sure.

Operator (participant)

Thank you. Again, if you'd like to ask a question, please press star one on your telephone keypad. Our next question comes from the line of Sean McGowan from Roth MKM. The line's open.

Sean McGowan (Managing Director and Senior Research Analyst)

Thank you, Rob, James, and others. I have a couple of questions too. So regarding the shift in the timing, let's say, of the rollout of Niagen Plus, if we had a certain expectation for where you would be by, let's say, the middle of next year, would this delay have an impact on that, or is it you can catch up pretty quickly, so you'll be basically where you expect it to be by th

Rob Fried (CEO)

e middle of next year? And I would ask the same question regarding the spending associated with that. Yes. I think it will not have an impact on where we expect to be in the middle of next year on either spending or on revenue.

Sean McGowan (Managing Director and Senior Research Analyst)

Okay. That's very helpful. When you say I think you said earlier that you would expect at some point you didn't say when, but we get greater than 50% share of that market, and then you shared what the current market is, but said you expect to expand it. So do you think that there's a lot of growth in the existing market, or are you basically going to be providing all of that growth?

Rob Fried (CEO)

It's a new business for us. Many of us know what it's like to start a new business and get into a new business, and it's just the unknowable. You just don't know. So we want to be conservative about this. We just don't know what problems will emerge, but we've been at this for a long time. The early indications are, I would say, extremely positive. We've given Niagen IV to many people at this point.

Dozens of people have tried it, not just in the test, but at the clinics and various influencers and celebrities, and they've all validated what the tests show and what we believe. So we're confident based on what we know, but until we're actually up and running and in the business and steady, we don't know what we don't know. So we're being conservative with our projections. We're hopeful that it'll expand the market. It seems very intuitive and logical that it might, since it's a better product than what's on the market. It doesn't have the same side effects and is much quicker and elevates NAD higher. And you have all these clinics that know how to communicate it and have communicated it, so it does seem intuitive that it would expand the market, but we're not jumping to that conclusion yet.

Sean McGowan (Managing Director and Senior Research Analyst)

Well, I guess the corollary to what I'm asking is, are you expecting if you weren't entering the market, would you expect the existing market to exhibit strong growth, or is it kind of flattened out and you're just going to take all the incremental sales?

Rob Fried (CEO)

The existing NAD.

Sean McGowan (Managing Director and Senior Research Analyst)

You're going to expect the existing market. Yeah, the existing NAD market. What's already out there before you enter the market? Is that a double-digit, triple-digit growth rate?

Rob Fried (CEO)

Yeah. So the existing NAD market, and I know you know this and I've said it before, and everybody does know, but I feel like it needs to be emphasized. We don't sell NAD. We sell Niagen NR, which is a precursor to NAD. But what it ultimately does is it elevates NAD. But if you just simply do NAD through infusion or oral, it just doesn't work. And Niagen IV does work.

The existing NAD IV and injection market has not actually been growing. It's been at this range of between $100 million and $150 million for two years or three years now. The reason why it hasn't been growing is, A, it's expensive, but most importantly, because it's a very unpleasant experience. So we hope that it will grow now that we're introducing Niagen IV into the space, but it's mostly been targeting a very influential group: the influencers, the biohackers, the celebrities, and the athletes. But it hasn't been a market that's been growing. The one thing I will say is, right now, we're offering it as an infusion. Soon, we will be offering it also as an injection. And then we will be offering it as an at-home injection.

One market that has grown very substantially in the last couple of years is the GLP-1 market, where people inject these GLP-1 peptides at home. That market has become extremely popular, and it's our belief that people who want to stay thin also want to stay young. We think that there is the potential for Niagen IV to gain popularity in that community of people who are already injecting themselves with Ozempic-type peptide products. We think that has the potential to take off and become very popular once we offer these injection products, especially the at-home injection products. Another one final point is that one of the side effects to Ozempic is low energy. As you know, elevating NAD with Niagen increases mitochondrial biogenesis and mitochondrial output. It increases cellular energy. So we think it also could be a complementary product in that regard.

But again, we're being conservative with our projections. We just think that we're hopeful about that. We see the opportunity.

Sean McGowan (Managing Director and Senior Research Analyst)

That's very helpful. Thanks for addressing that. And my last question is regarding the reduction in spending. Would you characterize that delta from your previous guidance on where that spending would be? Is that delta entirely due to the timing of Niagen Plus, or were there reductions related to other reasons?

James Lee (Principal Accounting Officer and CFO)

Hi. This is James. Yeah. We believe that most of the reduction is due to the shift in timing of the launches of the Niagen Plus. As explained before, we have forecasted quite a bit of investment in the overall infrastructure related to Niagen Plus, including spend in regulatory, legal, and other G&A activities to support the launch. So yeah, we would characterize it that most of it is related to the shift in timing of Niagen Plus.

Sean McGowan (Managing Director and Senior Research Analyst)

Okay. Thank you very much. Appreciate it.

Rob Fried (CEO)

Thanks, Sean.

James Lee (Principal Accounting Officer and CFO)

Thanks.

Operator (participant)

I think we're all waiting to see if Mitch.

Mitch Pinheiro (SVP and Director of Fundamental Equity Research)

And Mitch, you're back. I apologize. Let me put him back again. Dustin?

Operator (participant)

Hello, Mr. McGowan. I apologize. You're back on the line.

Rob Fried (CEO)

Mr. McGowan.

Sean McGowan (Managing Director and Senior Research Analyst)

Well, I'll defer the floor. I'll yield the floor to Mitch if he's interested.

Ben Shamsian (VP of Investor Relations)

Okay. All right. Dustin, I think we wanted to reconnect with Mitch, not Sean. Mitch.

Operator (participant)

Understood. Just a minute, please. Sure. Also, we have another question here. The next question is coming back from the line of Bill Dezellem from Tieton Capital Management. Your line is once again open, sir.

Bill Dezellem (Co-Founder, President, and Chief Investment Officer)

Thank you. I fear it's a great disappointment to hear that it's me instead of Mitch, but.

Rob Fried (CEO)

Never. Not at all.

Bill Dezellem (Co-Founder, President, and Chief Investment Officer)

Thank you. So you had mentioned in the Chinese market that the NMN players are significantly reduced and that Sinopharm is optimistic. I know that this has been a really long process, but does any of this somehow favor your Green Hat approval and change the outlook or opportunity for that?

Rob Fried (CEO)

It's a very important question, but sadly, no. We're really having a difficult time getting to the Blue Hat approval process. There has not been an ingredient approved by the China FDA in many years that's not from China. And we don't have an outlook on when we will be getting Blue Hat approval.

Bill Dezellem (Co-Founder, President, and Chief Investment Officer)

Great. Thank you.

Operator (participant)

Thank you. And our next question comes from the line of J.P. Mark from Farmhouse Equity Research. The line is open.

JP Mark (Founder and Senior Analyst)

Hi, Rob. Thanks for taking my call. Very quickly, just a quick question about the injectables. Do you know approximately when you think you're going to be launching that product, when that might be available?

Rob Fried (CEO)

We will have an injectable product that's available at the clinics in just 2 or 3 months. When we have one that's an at-home product, I'm just giving you a loose estimate. I'm going to say by the end of the year, but it might be the first quarter of next year.

JP Mark (Founder and Senior Analyst)

Okay. Sounds great. Thank you. Appreciate it.

Rob Fried (CEO)

Sure.

Operator (participant)

Thank you. Seeing as, oh, I apologize. The next question here comes from Howard Horberg from Horberg Enterprises. The line is open, sir.

Howard Horberg (Business Professional and Sole Manager)

Hey, Rob. This is a quick question. I know it's a refocus on the Niagen drip, but with regards to Parkinson's, can you tell me what the addressable market would be there if and when we get favorable results in 2025? So there's approximately 10 million diagnosed Parkinson's patients globally, and there is no drug approved for that. There's approximately 1 million in the United States.

The majority of them are outside of the United States. The study that's being done on Parkinson's, as you know, is in Norway. It's being conducted by Dr. Tzoulis, who is a world-renowned Parkinson's expert, and it's being funded by the Norwegian government, and hoped to be the last patient in that study was enrolled on May 1st. So it's a four-year study, and that patient will be completed on May 1st of next year. Then, months after that, hopefully, they will tabulate the data. Hopefully, at that point, we'll see it, and it will be positive. Then it will take some months after that when they write up the manuscript and have it published.

But if we don't look at it as a drug approval, if we just simply look at it as a dietary supplement opportunity in the United States, the way we see it is that we now have a pharmaceutical-grade pipeline because of IV. If we released a pharmaceutical-grade product on the market comparable to the one done in the study, and the study itself is positive, we think a good percentage of those global Parkinson's patients will seek out a safe, tested dietary supplement from a very reputable, trustworthy company that conducted the study. We think the addressable market there, if there's 10 million people globally, what percentage do you think would be interested in that dietary supplement if the study results are good? This is putting drug approval completely to the side. Just as a dietary supplement, if it's 5%, it's 500,000 people.

We all know people with Parkinson's, it's quite debilitating and heartbreaking. We understand that Parkinson's is a mitochondrial disorder, and we understand how Niagen and NAD help mitochondrial health, so we are optimistic. The phase one clinicals have been published, which were mostly about safety, but the secondary endpoints were positive. We are cautiously optimistic. It's a blinded study. We have no idea, obviously, if it's going to work or if it's not going to work, but we think that if it does work, there's a very, very dramatic, significant opportunity for us, even if we do not pursue drug approval, just as an opportunity to sell True Niagen pharma grade. I think you could do the math and realize that the numbers are quite large.

Yeah, I appreciate your asking that question because if you take a step back and look at the ChromaDex business plan, we are very focused on making sure that we are cash flow positive and that we are responsible in managing our base business, but we are pursuing several initiatives, catalysts, if you will, all of which have the potential to be fairly significant, but you never know. The IV is one. Parkinson's is one. Ataxia is another. If any of those hit well, it has a dramatic impact on the company. So what we are doing is just making sure that we're running a safe, stable, well-managed business that plays by the rules with excellent players, that does things the right way, develops its intellectual property, and grows.

Yes, it would be nice if we were growing slightly greater, and perhaps we could, and perhaps we will, but we are still growing, managing our cash flow, and managing the business while we take these very, very dramatic shots on goal, any one of which has significant upside potential. Thank you for the question. Thank you.

Operator (participant)

Thank you. That concludes our question-and-answer session. I'll now turn the call back over to Ben Shamsian for closing remarks. Sir, please go ahead.

Ben Shamsian (VP of Investor Relations)

Thank you, Operator. 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 us today and for your continued support of ChromaDex.