Charlotte's Web Holdings Inc

TSX:CWEB

Earnings Call Transcript

[Operator]

Good morning, ladies and gentlemen, and welcome to the Charlotte's Web Holdings Inc. second quarter conference call. [Operator Instructions] This call is being recorded on Thursday, August 12, 2021.I would now like to turn the conference over to Cory Pala, Director of Investor Relations. Please go ahead.

[Cory Pala, Director of Investor Relations]

Thank you, Jessica, and good morning, everyone. Thank you for joining us for our 2021 second quarter earnings conference call for Charlotte's Web Holdings, Inc. My name is Cory Pala, Director of Investor Relations, and leading the call this morning is Charlotte's Web's CEO, Deanie Elsner, along with incoming CFO, Wes Booysen. Wes, replaces former CFO, Russ Hammer, who has recently retired.Our earnings press release, financial statements for the second quarter, along with our MD&A can all be found in the Investor Relations section of our website and filed on sedar.com.On today's call, Deanie, will share some high-level comments on the quarter with an update on the business and some color around recent correspondence with the FDA, and Wes will highlight our financials. We will take questions from our analysts at the end of our prepared remarks.A replay of this call will be available through the next week, accessible for the details provided in our earnings release. A webcast replay of this call will also be available for an extended period of time, accessible through the IR section on our website at charlottesweb.com.A reminder to our listeners that certain statements made on this call, including some answers, we may provide certain questions may include content that is forward-looking in nature, and therefore, subject to risks and uncertainties and other factors, which could cause actual future results or company performance to differ materially from implied expectations. Such risks surrounding forward-looking statements are all outlined in detail within the company's regulatory filings on sedar.com.In addition, during this call, we will refer to supplemental non-IFRS accounting measures, including adjusted EBITDA, which do not have any standardized meaning prescribed by IFRS. Adjusted EBITDA is therefore defined in our press release as well as in MD&A as filed on SEDAR.With that, I will now hand over the call to Charlotte's Web Chief Executive Officer, Deanie Elsner.

[Adrienne D. Elsner, President, CEO & Director]

Thanks, Cory. Good morning from Denver, Colorado, and thank you for joining our call. With me this morning is Wes Booysen, our new CFO. Wes brings a significant amount of M&A and international experience to Charlotte's Web. He was appointed CFO following Russ Hammer's decision to retire. I want to thank Russ for helping to build the infrastructure, team and processes, especially during the difficult times in the pandemic. We wish him well on his much deserved retirement.To set the context for Q2, I want to provide a little bit of perspective. 2021 year-to-date has been characterized by advancements within the CBD category with notable progress made behind 3 key themes: first, a recovery in brick-and-mortar retail traffic; second, continued competitive consolidation within the CBD category; and third, legislative progress on the regulatory front for CBD.First, brick-and-mortar retail began to recover in Q2 with category sales improving across most channels. According to the Brightfield Group, consumer data between Q1 and Q2 reflects a shift of about 4 to 5 percentage points from online to brick-and-mortar channels. Channels with the greatest net benefit were CBD retail dispensaries, natural food and vitamin shops and pharmacies.Second, the competitive consolidation within the CBD category continued and accelerated in Q2. According to the Brightfield Group, the CBD category competitive set is down about 1/3 from its peak a year ago.SPINS data supports the accelerating contraction in the natural channel in Q2 with a 15% reduction in competitive brands, which is an acceleration versus a 7% reduction noted in Q1. We expect this trend to continue with a core group of brands emerging.Finally, on the regulatory front, we've seen progress legislatively with several recent developments advanced to establish a legal pathway for dietary supplements containing CBD and other hemp-derived products.First, the House of Representatives, Bill 841, was reintroduced by Representative Schrader and Griffith in Q1, which would legislate hemp and its derivative products as dietary supplements. H.R. 841 continues to gain additional cosponsors on a bipartisan basis with a hearing on the bill planned by the Committee of Jurisdiction in the back half of this year.In May, Senators Merkley, Paul and Wyden introduced a bill to the Senate, Senate Bill 1698, named the Hemp Access and Consumer Safety Act. It contains additional language to allow CBD in food and beverage. This was followed by the Booker, Schumer, Wyden's, Cannabis Reform Bill, which is called the Cannabis Administration and Opportunity Act, which also includes a legal pathway for CBD and dietary supplements.At the end of July, the House of Representatives approved an amendment in the 2022 Appropriations Package. That encourages regulation allowing CBD as a dietary supplement and food ingredients. This, along with the 3 bills shows the intent of Congress, through bipartisan support, in both the House and the Senate to establish a legislative framework within which the FDA would regulate hemp and its derivatives.A legislative approach to enable a framework within which the FDA can regulate full spectrum hemp extracts as a dietary supplement has become important and necessary. I will comment on this further at the end of today's call.Now shifting to our second quarter results. Net revenue increased 11.4% versus a year ago to $24.2 million. It was driven by our B2B business, which increased 37.7% versus a year ago as consumers began returning to brick-and-mortar retail shopping and the addition of the Abacus acquisition to our portfolio.Despite consumers transitioning back to retail, our DTC eCommerce held on to the gains made at the beginning of the pandemic a year ago and even increased slightly, up 1% in Q2 versus a year ago. In Q2, DTC represented 65% of our total revenue and B2B represented 35%. This is a 4-point increase for B2B from 31% in Q1 of this year and is consistent with the Brightfield estimate.For the second quarter, DTC net revenue -- for the second quarter of 2021, DTC net revenue was up 1% to $15.7 million. In terms of DTC KPIs, overall traffic was down almost 25% versus a year ago, reflecting the return to retail. Other KPIs delivered strong results versus a year ago.Conversion was up 27%. Subscriptions were up 43%, and our subscriber user base grew more than 50% versus a year ago. These loyal consumers drive a significantly higher Life Time value for Charlotte's Web and demonstrate a strong consumer engagement with our brand, which our DTC channel will capitalize on going forward.Within our B2B segment, net revenue increased 37.7% versus year ago in Q2. Net revenue gains were realized in our largest and most established channels. Natural was up 9%. Healthcare practitioners were up 159%. In addition, we established distribution in emerging new channels. Alternative retail was up 59%, and pet was up 67%.In our established channels, we are leveraging the acquisition of the Abacus business by unlocking incremental distribution with legacy Charlotte's Web doors for newly acquired Abacus products as well as accessing legacy Abacus distribution for Charlotte's Web products. We're taking advantage of this cross-selling benefit across all of our channels.In addition, we're beginning to expand into -- distribution into new retailers and new channels. In Q2, for the first time, Charlotte's Web is expanding into the fitness segment directly through a multi-year exclusive agreement with Life Time, a national, healthy lifestyle brand now offering Charlotte's Web and CBDMEDIC branded hemp products at 140 of the Life Time clubs.In total, we expanded our retail distribution over 500 new doors in Q2, including new doors in the pet channel and our alternate retail channels. This strong performance has translated into market share gains.Food/drug/mass market share increased 6 points to 25%, driven by distribution gains and double-digit velocity increases year-over-year. The natural channel market share was 14.5%, up 0.5 share point versus a year ago, driven by double-digit increases in unit velocities.On a gross revenue basis, both our ingestible and topical segments grew in Q2 versus a year ago. Total ingestibles gross revenue increased by 1% versus a year ago, led by gummies, up 65%, offset by capsules down 1% and tinctures, down 21%. Our gummies business is the largest in the category and demonstrates our ability to successfully transform our portfolio to meet the needs of an evolving consumer.Total Q2 topical gross revenues increased 202% versus a year ago, primarily due to the acquisition of Abacus in June of 2020. Topicals contributed 20% of total gross revenue and versus contributing just 8% a year ago and contributing 18% in Q1 of 2021. Looking forward, we expect this trend to continue as topical sales become an even bigger part of our portfolio.I will now pass the call over to Wes for an overview of our financial performance. Wes?

[Wessel Booysen, Chief Financial Officer]

Good morning, everyone. Thank you again for joining us. Deanie already provided some color on Q2 revenue. So I won't repeat it. But what I would add is that the 11.4% revenue growth doesn't fully reflect the increase in unit volume due to the contribution coming through B2B sales.B2B is wholesale pricing, which generates lower revenue per unit. So demand for growth from Charlotte's Web's products is higher than our revenue may suggest this quarter due to channel mix. This is very encouraging and reflected in the market share gains we made this quarter.Turning to Q2 gross margin and profit. In terms of gross profit for the quarter, year-over-year increases in both revenue and gross margin resulted in a 38% increase in gross profit for a total gross profit of $15.8 million compared to $11.5 million in Q2 last year. Blended gross margin came in at 65.5% for the quarter, a significant 12.6 point increase from 52.9% reported in Q2 2020.For greater transparency, the Q2 2020 gross margin of 52.9% included inventory provisions of $2.5 million for discontinued products. Prior to this adjustment, Q2 2020 gross margin was 64.6%.For modeling purposes, we expect second half consolidated gross margin in the mid-60s range based on sales mix and increasing into 2022 from production and fulfillment cost improvements as our new facility becomes fully operational. We expect improved manufacturing efficiencies as volumes ramp up, and this is very encouraging.Now turning to operating expenses. Total OpEx for the second quarter was $25 million, down 15.2% from $29.5 million a year ago. Q2 last year included approximately $5.2 million of onetime expenses related to the Abacus acquisition and legal fees. Excluding these items, for better comparison, Q2 2021 net OpEx increased modestly by approximately 3%.Our OpEx level also reflects the success of our expense reduction program that we implemented in Q3 2020 to reduce our OpEx by 10% from the Q3 2020 peak to bring our costs more in line with pandemic impacted revenue levels. We have been ahead of that plan with our OpEx run rate down 11.7% in Q2 from our Q3 2020 run rate.We recorded a net loss of $5.4 million for the quarter compared to a net loss of $14.4 million a year ago. This is a 63% improvement, reducing our loss by $9 million. On an adjusted EBITDA basis, we recorded a loss of $3.9 million, a 31.1% year-over-year improvement versus Q2 2020 adjusted EBITDA loss of $5.7 million. We are modeling smaller losses through the remainder of 2021 as we head towards adjusted EBITDA breakeven at the end of this year and into 2022.So to summarize the P&L, we delivered higher revenue, increased our gross margin and reduced OpEx, which improved our adjusted EBITDA and reduced our net losses. This is what we want to see, continued directional improvements across the board.Moving on to CapEx. Our CapEx spend during the second quarter was approximately $1.6 million, primarily related to completing the final phase of our R&D, production and distribution facility. As this facility becomes fully operational this year, we will be able to reduce some production costs and improve margins.Total CapEx in the first half of 2021 was $3.3 million, and we expect CapEx investment for the full year to be between $7 million and $9 million. We look forward to hosting an Investor Day to showcase the capabilities and efficiencies of our new R&D, production and distribution facility in the near future.Turning to liquidity. Use of cash during the second quarter included $6.5 million in operations compared to $7.9 million in Q2 of last year. Total cash used for the first half of this year was $25.7 million. For context, approximately 2/3 of cash used during this period was nonrecurring. Cash at the end of Q2 was $27.1 million, which excludes our short term IRS tax receivable of $10.9 million.With reduced losses through the remainder of 2021 and as we head towards adjusted EBITDA breakeven at the end of this year and into 2022, we believe that we are sufficiently capitalized to deliver on our plan. We also maintained 0 debt and an unused line of credit extendable to $20 million.Turning to guidance. I'm comfortable that we will continue our quarterly revenue and market share growth. But having been with the company a short time, I'm going to hold off on providing specific revenue guidance for the year. In summary, I expect the positive revenue and margin trends evident in the second quarter to continue.I will now turn the call back over to Deanie for her closing remarks.

[Adrienne D. Elsner, President, CEO & Director]

Thanks, Wes. I conclude today's prepared remarks with some additional color around our recent formal correspondence with the FDA as well as providing an update on other international regulatory progress.Since passing the 2018 Farm Bill, there's been significant attention on the FDA to resolve a regulatory pathway for full spectrum hemp extract with naturally occurring CBD. The FDA has indicated publicly it wants to ensure consumer access to safe CBD containing products. They have had several public meetings on this topic, and they opened a docket over 2 years ago to obtain information from stakeholders on these products. In addition preparing and then withdrawing a formal draft enforcement discretion policy.During this period of time, the CBD category has grown to become $3 billion to $4 billion in annual sales with thousands of brands entering, but it remains unregulated. After 2.5 years, it has become increasingly more apparent that in the FDA's own words, potential legislation might be appropriate to enable a framework for under which the FDA can regulate full spectrum hemp extracts as dietary supplements.During the second quarter of 2021, we put this thesis to test by formally submitting a new dietary ingredient notification to the FDA for our full spectrum hemp extract as they have been recommending. The FDA responded with an objection letter to our NDI notification. Their response, substantially based on their drug preclusion provision, reveals that legislation is required to enable the FDA to establish a regulatory oversight for full spectrum hemp extracts as dietary supplements.Both the House and the Senate have introduced bills that would recognize hemp CBD as a dietary supplement, and we are encouraged by this progress. Our experience with the FDA shows that this legislation is a critical step in securing a regulatory environment to protect consumers and to establish guidance for manufacturers. It is our intent to stay at the forefront of this issue by working to establish a safe and transparent legal framework to regulate this category.We believe that given our vertically integrated supply chain and our leadership in this category, we are uniquely positioned to work with Congress and with the FDA to establish a regulatory framework for the benefit of the hemp wellness industry.And, finally, we've been previously discussed in our intent to extend our footprint, making moves to expand geographically within the sector, which I'll follow-up on now for you.Internationally, we're focused on the U.K., the EU, Canada and Israel through valuable strategic partnerships rooted in R&D, quality, manufacturing and distribution. In the U.K. and the EU, we are diligently working with the evolving regulatory statutes and have successfully submitted our U.K. and EU novel foods applications. We have successfully passed the first leg of the regulatory process in the EU and currently await validations by the U.K. regulatory body. In addition, we're working with several distribution partners to establish our territorial reach as regulations mature.In April of 2021, we secured Health Canada Approval to bring proprietary Charlotte's Web CBD genetics to Canada having been accepted to the list of approved cultivars. We now have successfully planted our first international hemp crop of our proprietary patented hemp cultivars in the agriculturally rich Okanagan Valley in British Columbia, Canada.We believe that our proven full spectrum products, coupled with our leading brand trust, will be a highly advantaged in the Canadian market. We already have a large waiting list of consumers in Canada where we have never actively marketed our products. We are employing an asset-light model approach to the Canadian market, developing our Canadian supply chain and expect product to be commercialized in Q1 of 2022.And in Israel, we've continued to develop our exclusive partnership with Canndoc, a division of InterCure and await reclassification of CBD as a dietary supplement following the establishment of the new Israeli government. Our recent bill to legalized recreational cannabis did not pass. However, we currently expect that separately, hemp could be declassified through the Ministry of Health by the end of this year.In the interim, we are exploring pathways to market through food/drug and mass as well as pharmacy dispensaries through the Israeli medical cannabis program. We currently expect to have products selling in Israel by the front half of 2022. In the territories where medical cannabis is federally permissible, including Canada and Israel. We are investigating both CBD hemp as well as cannabis wellness opportunities through asset-light partnerships to leverage our brand and genetics.With that, I will wrap up and ask the operator to open the call to questions.

[Operator]

[Operator Instructions] Your first question comes from Gerald Pascarelli of Cowen.

[Gerald John Pascarelli, Vice President]

So can we just start on the top line? Obviously, it looks like, at least in B2B, that trends did improve over duration of the quarter. As we're like halfway through 3Q now, can you offer any kind of color on how your top line is running either from a total company perspective or by e-comm and B2B, just to give us some color on how trends are faring given what are going to be a little bit tough -- what are going to be tougher comps as we get into the back half of the year? Any color you could provide there would be helpful.

[Adrienne D. Elsner, President, CEO & Director]

Yes, absolutely, Gerald. It's a great question. I think from a company standpoint, Charlotte's Web is uniquely advantaged in the category, because we're the only company that has products in every segment in CBD, and we're the only company that participates in every channel of those segments are being sold in. So the benefit of our portfolio is that we can pivot and shift with where the consumer is going and certainly, that's the case this year.Through the first half of this year, our net revenue is up in total about 11% year-to-date. And that is in large part because of our B2B business. As mentioned, Q2 B2B is up about 38%. That's coming through our big established channels like medical, natural, and we're seeing a really nice uptick in our new alternate channels, and so I'm actually pretty bullish on our B2B business in the back half of the year as we look at where the consumer is, we have access to those channels, and we have products they want. And so I would expect B2B to continue on the trajectory it's on.In terms of DTC, our front half has been a little challenged from a traffic standpoint, and I think that is a return to retail, and we're seeing that across the board. However, we're now working diligently to reach out to new consumers in our DTC model. And again, we've got one of the most developed DTC models in the industry and so, we're going after new consumers and new ways of selling. And we'll be piloting or expanding a pilot of that very shortly in the next month. And so I'm actually excited to see an acceleration of DTC in the back half of the year.On total, I would expect to be outperforming the category in terms of total growth for the company. And the exact number is going to depend on how the channel opportunities develop. In terms of new products, we launched in the first half of the year, THC-free products, which we feel really good about. In the back half of the year, you're going to see us expand our gummy portfolio and gummies right now represent just shy of about 30% of our business. And so we think we've got all the pieces working. We've got the segments where the consumers are shopping. We have access with the products, and we're bullish about the top line for the rest of the year.

[Gerald John Pascarelli, Vice President]

My next question is just on gross margin. It definitely came in higher than I was expecting. And I'm trying to reconcile the 65.5%, like understanding that there was an inventory provision, which was impacting the year-over-year. Like when you look at your -- when I look at your sales mix, the negative mix associated with such faster B2B growth, and it doesn't look -- sound like there was any pricing taken. Just like, I think sequentially, the margin expanded like over 700 basis points. So maybe just any additional color that you can provide on the strong margin?And then Wes, maybe based on your commentary on the production and fulfillment center, is that coming online? Is that still scheduled to come online in the back half of this year? Or is that getting pushed out now through this year and maybe into the first half of next year? Just -- that's like a clarification question.

[Adrienne D. Elsner, President, CEO & Director]

I'll provide a little bit of context and then flip the question over to Wes. We have been transparent about our desire to work hard on our gross margin. We've put a lot of initiatives in place to reduce our costs. And one of the big reasons for doing the manufacturing and distribution stand up was to ensure we had the opportunity to control our costs in a much more aggressive way and so what you're seeing in our gross margins in Q2, we believe, is the baseline of what we will be going forward with opportunity to improve, and so that's the whole business model that we've built is that. I'll let Wes speak to the specifics of what to expect.

[Wessel Booysen, Chief Financial Officer]

A couple of things. Maybe let me provide some more color and help you unpack that number. If you look at the 12.6 point increase in gross margin. So last year, 52.9% to 65.5% for this Q2 of this year. That included an inventory provision, as you rightfully said, of $2.5 million for expiring product. And so prior to this adjustment, Q2 2020 gross margin was 64.8%. Maybe something else, it would be helpful as well. Gerald as, historically, we've guided our gross margin in the 60% to 65% range, obviously, depending on the product and channel mix. And so we are modeling now for the second half of this year consolidated gross margin in the mid-60s range.And you're absolutely right. It's based on some of the supply chain savings, and yes, we do anticipate the new facility coming -- becoming fully operational later this year and those improved manufacturing efficiencies will see as volumes ramp up.

[Operator]

Our next question comes from Scott Fortune with ROTH Capital Markets.

[Scott Thomas Fortune, MD & Senior Research Analyst]

Deanie, you want to talk about kind of a new product innovation. You're seeing the THC-free being rolled out there. But it seems on your call, you called out the -- really the mix of gummies really increasing while the tinctures have come off. Is that a continuing kind of shift, you think, for the consumers that you're targeting more gummies versus the tincture? And how does that relate to kind of the margin profile as you see going forward and expectations of these new products moving forward here?

[Adrienne D. Elsner, President, CEO & Director]

Yes, it's a great question. So a big part of how we run our new innovation is to identify the consumers we're targeting and adjust products and develop products that specifically meet the needs that they're looking for. And so for us, we launched gummies in August of 2019, because we saw the opportunity in the dietary supplement space and new within CBD hemp extracts, that was going to be something that was going to translate over, and so we were the first to do that in the category.Today, our gummies are the biggest segment in the category. Fun fact is, in the natural channel, our sleep gummies are the most popular sleep product -- not sleep hemp product, but sleep product available in the natural channel. So we know we're producing good products, and we know we're producing products in a format that consumers prefer. Our key will now be to figure out who are the consumers going forward and how does our product portfolio from a format standpoint adjust to meet their needs.As we look at gummies, we saw an acceleration of gummies in our portfolio all through 2020 and through Q1 of 2021. In Q2 2021, the gummy growth has begun to slow a little bit. I know 65% growth doesn't sound like slowing. But when you're comparing it to triple-digit from the previous year, we see it stabilizing a little bit more and our tincture decline stabilizing. And so Scott, I don't have the exact answer for you in terms of how these segments ultimately pan out. What I do have is a set of capabilities and infrastructure that enables us to adjust in a really agile way to meet the needs of the consumer regardless of where she's going.I believe dietary supplements will be defined by gummies, and I believe this category, gummies will remain a very big segment in the category, and we're certainly doing our part to expand our portfolio in the back half of this year with a couple of new offers across our channels. So we're bullish on gummies.As you can expect, when you launch a new product, building the infrastructure in-house financially is not as feasible and so our gummies have been a product mix dilutive from a gross margin standpoint in the early days because of our dependency on a [ common ] manufacturing network, but we have gotten more aggressive about getting our gummy COGS improved and have plans to see a really nice ramp-up in that into 2022, hopefully before the end of 2021, but that is coming around the corner, and we're really quite excited about what that will be in our portfolio going forward.

[Scott Thomas Fortune, MD & Senior Research Analyst]

I appreciate the color on that. And then I just want to focus on the international, kind of up on Canada, the opportunity there as more competitors look to get to U.S., there seems to be less competition up there. You mentioned the opportunity, but can you highlight, is it going to be a full, broad portfolio that you can offer in the Canadian market right away? Or how are you kind of looking at that as you roll out on the international side of things with your product mix?

[Adrienne D. Elsner, President, CEO & Director]

Yes, Canada for us is both an opportunistic move, because the hemp CBD category is relatively underdeveloped. Although, it's a very strong cannabis THC market, a lot of the CBD product that exists in the Canadian market is actually derived from the cannabis plant. The THC plant, coming in with a CBD specific genetic is really quite advantage and when you combine that with our patented cultivars and genetics, we think that we've got something consumers are definitely going to want.But Canada is not just a revenue play for us. Canada is an incredibly strategic market for us because on the international front, we're able to access other international geographies from the Canadian market, both in terms of finished goods, biomass and extract. And so for us, Canada is a revenue opportunity as well as an export opportunity, and that's in large part why we are entering that country.As we look at the market in Canada as well as the market in Israel, both of those countries appear to be moving towards federally legal THC as well as CBD. And so those are 2 markets where we feel like our portfolio pilot can take root, and we can expand our portfolio to take advantage of a federally permissible environment.And so our portfolio in Canada out of the gate in Q1 will be hemp CBD. It will be -- we will have a good representation, but we won't have a full portfolio. We'll have about 4 to 7 products that we'll have in the marketplace, controlled given the size of the market. But what I'm excited about is the opportunity to expand beyond that and look more broadly into cannabis wellness. And so for us, Canada is a larger pilot of things to come more broadly in the international geographies.

[Operator]

[Operator Instructions] Your next question comes from Derek Dley of Canaccord.

[Pulkit Sabharwal, Associate]

It's actually Pulkit, I'm filling in for Derek, I'm his associate. Just a couple of questions. I was interested in your CapEx initiatives for the upcoming year. I know you already talked about what CapEx looks like after Q2 is rolling off, but something or some color on next year, we really appreciate it.

[Wessel Booysen, Chief Financial Officer]

Sorry, can we just get your name one more time? I thought it was Derek, but you said it's you sitting in for Derek?

[Pulkit Sabharwal, Associate]

That's right, I'm his associate Pulkit.

[Wessel Booysen, Chief Financial Officer]

Yes, very good. Nice to meet you. I think the way you sort of look at CapEx for a year to go is probably start off by saying we finalized and wrapped up the final phase of our new facility, the R&D production facility out in Louisville. And if you look at the year-to-date spend on CapEx, we're sitting on $3.3 million. And so we do expect for the balance of this year, CapEx to be in the range of $7 million to $9 million, which is slightly lower than the previous guidance we gave of $8 million to $10 million.

[Pulkit Sabharwal, Associate]

And just one further question regarding demand. Are you seeing any impact at all from the Delta variant in terms of softness, either for DTC or B2B?

[Adrienne D. Elsner, President, CEO & Director]

I'm sorry, I missed the back half of that. Are we seeing an impact from what?

[Pulkit Sabharwal, Associate]

Any impact in terms of demand softness from either -- from the Delta variant either for DTC or B2B?

[Adrienne D. Elsner, President, CEO & Director]

Yes. So we have an opinion about the Delta variant. And as many of you know, the Delta variant is a loophole that has come into the CBD hemp extract market as a result of the lack of regulation. And so it's a loophole that a number of our competitive peer companies have taken advantage of. The Delta variant, specifically Delta…

[Cory Pala, Director of Investor Relations]

Deanie, sorry to interrupt, just to clarify, he's talking about the COVID virus Delta variant, not Delta-8, which is another very contentious issue. Is that correct?

[Pulkit Sabharwal, Associate]

That's correct, yes, yes. But happy to have a color.

[Adrienne D. Elsner, President, CEO & Director]

Okay. I apologize. We're going back to the pandemic. Okay. I apologize. I went all over the board. So apologies. So in terms of the pandemic. At this point, we obviously are watching it very closely. And we are holding our business and our expectations for the year, consistent with what we were thinking. If something should happen and should there be another lockdown, of course, that's going to change our guidance. At this point, we don't see that happening. And as we look across the country, we're watching the numbers very closely.If it does happen and incredibly unfortunate, if it does, our portfolio is well positioned to take advantage of that opportunity in terms of having a well-developed DTC channel, our direct-to-consumer, 65% of our business during the pandemic last year, our DTC channel jumped up to be as much as 71%-72% of our business in specific quarters. And so again, I think the benefit of Charlotte's Web is we're able to shift our portfolio to be where the consumer is. And should another lock down happen, we will pivot to the channel where we can gain consumers and double down on DTC. So that would be how I would respond to COVID again.

[Operator]

Our next question comes from Michael Lavery of Piper Sandler.

[Michael Scott Lavery, Director & Senior Research Analyst]

Apologies if I might have missed this. I did have to join late. But in the FDA's letter responding to your NDI notification, they called out a couple of things where they've felt like they needed some more information still and didn't have everything they seem to have been looking for. Can you give a sense of how much that suggests maybe their position isn't sort of definitive or conclusive if they were to get, for example, some of the underlying data that forms the basis for the -- I have no idea how you pronounce this, [ Zulinka ] et al 2020 study? Or some of these other things where they look like they've got some sort of voids they want to fill in just the data. Is that potentially something that influences where they may land? Or does this seem like they've got a pretty final position?

[Adrienne D. Elsner, President, CEO & Director]

Thanks for the question, Michael. When you think about the FDA, I'll start with -- we were disappointed and strongly agreed with -- or strongly disagreed with not just the conclusion that they advance, but the reasoning for their conclusion because their letter back to us contained a significant amount of factual inaccuracies. And so the first thing I would tell you to do is, on our website in the IR section, we've posted our response to the FDA, and we laid out an excruciating detail why we think they need to correct the record in terms of what we submitted and what they concluded. Now that said, they drew a conclusion based on 2 examples. One was they can't move forward with an NDI as a dietary supplement because CBD is precluded because it's already a drug. And as you know, 6 months prior to the hemp bill being signed into law December 2018, a drug was approved. It's a CBD isolate. The second reason why they objected to our NDI was that they expressed safety concerns and I think that's the part that we're looking for a correction on, because regarding safety, the conclusion's strong just don't appear to be based on the data we provided in our NDI. So that's what we're trying to get focused on.In terms of what does it mean? I think what you're getting to is the industry has been caught in a little bit of a Catch-22 because the FDA has not been clear about the process by which they want companies to go through to gain regulatory clarity and Congress has been pointing to the FDA to take responsibility for this. And so our decision was full transparency to force the issue to see who has the next decision. And with the FDA objecting to our NDI it becomes very clear that the regulatory process to get established has to start with Congress legislating the FDA to regulate the dietary supplement for CBD and then FDA can regulate within. And so I'm confident there's a way to do this.Over the last 18 months, we've met with the FDA about 8 to 10 different times, and our meetings were very constructive. I've got a great deal of respect for the FDA, but I think they're in a bit of a Catch-22 because they've approved a drug, and they can't seem to move away from that precedent. And so Congress has to act and I think once Congress acts, the FDA can be very clear about the process. The process is scientific. Is intense. There's a ton of data that we've got to do to submit for it. And I feel really good having gone through this, knowing what they're looking for, but now we need Congress to act. And when that happens, I think the category will be able to submit NDIs and the whole thing will begin to open up. Did that answer your question?

[Michael Scott Lavery, Director & Senior Research Analyst]

A bit. I guess, maybe some of what I'm getting at is, which is, I guess, some of -- first of all, how much is the FDA maybe a movable force? I mean it feels like, pick your poison, who would you rather -- I mean, I don't know that Congress is going to cut in there so, I suppose, you never want to give up hope on any option that may exist. But maybe to your point, if you're calling out some ways that there's inconsistencies with the data you provide and what they seem to draw out the conclusions? And you've got a precedent with red yeast rice and monacolin K sort of parallel for full spectrum extract and CBD isolate. I guess, why give up on the FDA? And is that still something you feel like could change? I just know if you watch Congress, it doesn't take long to figure out that they're just as quick to do nothing as is the FDA.

[Adrienne D. Elsner, President, CEO & Director]

Yes, I think that's -- I think it's a fair conclusion. So to be clear, we're not giving up on the FDA. We have every intent to continue to engage with them and work with them. And we've not ever said externally nor internally that we would not be going through the NDI process again going forward. We have every intent to progress the regulatory environment per the regulations that the FDA has laid out. So that will be an active part of how we move our business forward.I think the Congress comment is curious, but I want to just broaden the perspective on this. This is not just a CBD hemp industry challenge. This is a THC sector challenge, because what we're going through with hemp extracts with naturally occurring CBD is exactly what the cannabis industry is going to have to do following us. And so this is not Congress, maybe or maybe not engaging on the hemp CBD industry. This is Congress looking at a category today that is roughly $17 billion to $20 billion in total in the U.S. across 11 states where cannabis is legal and CBD participates.And so some kind of resolution has to be landed for how both of these categories are regulated, and the FDA has to have clarity and perspective about how they want companies to produce safe products for consumers in a way that is holding manufacturers to a very high level of standard. And so we're doing this for ourselves. We're doing this for our category. We're doing this in support of our consumers, but it's the whole sector that is going to put the pressure for Congress to act and push the FDA to move forward, and we will continue to push both fronts.

[Michael Scott Lavery, Director & Senior Research Analyst]

No. And I mean, it's a great point that there's the THC equivalent here, too. That's just maybe a little bit of a time bomb coming.

[Adrienne D. Elsner, President, CEO & Director]

Absolutely.

[Operator]

Cory, there are no further questions at this time. Please proceed.

[Cory Pala, Director of Investor Relations]

Okay. Well, thank you, everyone, for participating in today's call. This is probably the busiest earnings call day we've had with several competing earnings calls happening at the same time. So we really appreciate you making the time and participating. We will look forward to speaking to you again in mid-November following our Q3 2021 results. Thank you, and have a great day.

[Operator]

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.