Okay, looks like we're getting a go ahead here, so we'll grab a seat. Good afternoon, everyone, and thanks for joining for our next session at the Cantor Global Healthcare Conference. I'm Steve Seedhouse on the biotech team here, and really a privilege to welcome our next participating company, LENZ Therapeutics. I'm joined on stage by CEO Evert Schimmelpennink. Looking forward to the conversation. Thanks so much for joining us at the conference this year. Maybe I'll pass you the mic initially, and I would love if you could give some introductory comments to LENZ, where you guys are at. Obviously, an exciting time upcoming with the launch of VIZZ. Set the stage, and then we'll dive right into Q&A.
Absolutely. Thanks, Steve, and thanks for having us. Great to be here and a great conference, very full busy schedule, which is good. Looking in the room, many of you know the company, but for those that don't, LENZ Therapeutics is a now commercial company that has developed a presbyopia eye drop. Presbyopia is something that's going to happen to all of us. As you age into your mid-40s, you'll start to notice that you're holding your phone further away from your face just to be able to read it. Everything up close starts to become blurry. That's called presbyopia. That's because the lens that's in your eye hardens with age. Because this is inevitable and happens to everyone, obviously this market is huge. There's 128 million presbyopes in the U.S. alone. About a month ago, we got our product FDA- approved, and the product is a presbyopia eye drop.
Think of this as you wake up in the morning, brush your teeth, put your eye drops in, and your near vision is back for the full workday. You're effectively back to the vision that you were used to before you were mid-40s. That seamless distance to near vision is what this eye drop achieves. Super excited to be at this point, obviously. It's always great to get a drug approved. Very grateful for the FDA, and we might talk a little bit more about the label. I'm very excited to be in this time frame now where we have a sales force out. We're starting to detail. There's a lot of enthusiasm for this product in the market. Great time for LENZ, great time, frankly, for consumers that are dealing with presbyopia.
Let's talk about the label then. I mean, what are the key wins from your perspective? Was there anything that you wanted in there that you didn't get in, or are you pretty happy with how it turned out?
Yeah, and I'm very pleased with how it turned out. Some of the key things on the label are obviously that it's a product for VIZZ for the use in presbyopia in adults. It doesn't get broader than that, so very broad label. It very clearly reflected our efficacy, the restoration of near vision for up to 10 hours. Very importantly, the FDA recognized that our MOA is different than Vuity, which was reflected in the label that says that aceclidine active ingredient is pupil- selective and predominantly avoids stimulation of the ciliary body. Those two are very important. That's optometry 101, something that a sales force can talk about and very clearly differentiates the product not only from an efficacy point of view, but also from a potential side effect profile.
It’s been about a month since VIZZ was approved early by the FDA, I should say. Can you just update us on the progress that the company's made in August and is continuing to make now this month to prepare for the launch and ready the product?
Yeah. Surprisingly, we got approved July 31st, early, which, you know, along the whole review period, it was great to work with the FDA, which especially in the current environment meant a lot. It must have not been easy for the agency, people in the agency to show up to work every day, not quite knowing what was going to happen. They stayed very focused on the review of our product. We were always, it felt, top of mind in a very good way. Pleased to see not only the early approval, but the label that we were after. What happened since is that we had to wait until the final label to be able to make that final step in manufacturing. We've been producing bulk products since March or April of the year because this, we believe, is going to be a very large volume product.
Because it is such a large volume, the risk that you would maybe take on an oncology product where you print labels at risk and can do hand packaging is just something that's not feasible for a product of this volume. Once we had the final label end of July, we were able to then start producing all those packaging materials that we're currently packaging. Doing the final packaging on the product, which is why we, and we've been guiding to that for a while now, we're very confident that we'll have samples and products in the market as early as October and full retail and e-pharmacy availability of products at the latest middle of the quarter.
When you say you're on track to have samples on the market by October, are we talking October 1st or is this like Halloween?
That's for me to know and for you to keep guessing.
Fair enough. We'll split the difference, October 15th. I'm just kidding. What are the early expectations you'd like to set for volume, revenue, anything you'd put out there?
Yeah, you're not going to be surprised that we're not guiding on revenue or volume for that matter. We have eight covering analysts that we're very pleased with, and we've worked a lot with all of those analysts. If you look at those models, they're very tight in how they think about the upcoming quarters and next year. Consensus for Q4, which is what we talk about mostly as a sampling quarter, is really, and we'll talk about the commercial strategy in a little bit, but we want to use Q4 really to get that confidence with ECP, so with the eye care professionals, awareness, confidence, and then get them ready to prescribe. That's mostly Q4, which results in a little bit over $1 million in revenue from a consensus point of view. For 2026, there's about $43 million- $44 million in revenue consensus, $125 million in 2027.
That's the revenue side of it. As you think about this launch, and I think that's how a lot of people look at it, obviously Vuity, and many of you know that, launched their product about three years or so ago now. Even though the product failed because frankly it wasn't efficacious, they showed a very strong launch. That's something that from a script volume perspective, to answer that part of your question, a lot of people look at and say, okay, Vuity got up to about 3,000 new scripts a week when they were focused on the ECP marketing, so only focused with their sales force out there in the first quarter. That then doubled to 6,000 scripts a week when they turned on their version of DTC.
A lot of people say that's great, even though your product is so much better than this, you're not at V, so let's assume that you get up to about 2,000 new scripts a week with your sales force and then double that to 4,000 when you put your DTC on. That's when most of how most of the models are, are frankly built, but then with a very different refill rate.
I think you've mentioned just the number of ECPs writing a script and then the number that write multiple scripts will be a couple of key metrics that you're also monitoring. What would be sort of a good start there if you want to put some numbers on it or just speak to it qualitatively?
Yeah. No, so important to emphasize, and we've done it multiple times now, this product's going to get sold in both the e-pharmacy channel as well as the retail channel, and IQVIA will not have insight into the e-pharmacy. That's where we'll push most of the patients or the consumers, but we don't know that mix yet. I know you all will, but we'll keep saying don't look at IQVIA to try to guesstimate what script data is like. We'll help investors to think through that. We'll overcommunicate on that at the right time frame. Early on, we'll start to more talk about the number of ECPs that have written once, the number of ECPs that have written multiple times. Those are some of the early metrics that we'll start to communicate.
We'll start to trend into what's the new script rate that is out there, because that's, I think, the first key one that we all want to see. Ultimately, I think about that more as a Q1, Q2 metric is what's that refill rate, so what's your Rx on scripts. Those are the two key things that I think are going to show success for our product.
Would you guide people to expecting just an update on the launch progress at quarterly updates, or are you going to seek sort of opportunities to be more frequent than that?
Yeah, for at a minimum, of course, during the quarterly updates. During our November call, we'll have samples, we'll have had samples in the market for a little bit, and we'll see what we can say at that moment and whether we can actually make that already factual or a little bit more quantitative. As we all know, there's plenty of conferences in the December, January time frame in between our November and our March call that we may use to provide additional updates.
Okay, and you mentioned a few times, and I think we're all aware in general of the Vuity precedent, but the lack of widespread adoption there suggests there's just millions of presbyopes, right? That this is really the first product launch in principle because they just haven't had experience with Vuity. Is that how you're thinking about it, or do you think you'll actually have to reform opinions of patients and providers that maybe had already formed some view based on an experience with that product?
No, absolutely not. Like I said, Vuity had a great launch, but what that also means is that that's 150,000 patients out of 128 million. That's obviously a super small fraction of the total market out there. Even for those patients, they're clearly interested in a solution that's different than their reading glasses. This is literally a free sample. You can use this for free, try it out, see if you like it. We can pretty much guarantee on the basis of our data that if you're a presbyope and you put this drop in your eye, if you put VIZZ in your eye, you'll be able to read your text message again. Very low barrier to try. The second part of that question is, that's all great, but how about the healthcare group? Have they been burned? That's absolutely not the case.
The first thing that initially our MSLs and now our sales force is talking about is this is not pilocarpine. That's usually the first question that they get. Is this another pilocarpine? The answer is no. We can very clearly point to the difference in MOA. The data is beyond different. We're 3x more efficacious for at least a 3x longer duration, but also a 6x larger population. That's a message that resonates very well. Now with the sales force out there, and we're coming up to probably 10,000 sales calls already in the last three weeks or so, we see this enthusiasm. There's a very large, vast, vast majority of doctors out there that are really looking forward to getting their hands on samples. No, you're not the only one. We have a long list of investors that are asking us about it as well.
People want to get a sample, try this out themselves in their patients, and then are moving into that ready to prescribe group.
I wanted to confirm just quick if you received NCE exclusivity on U.S. approval.
Yeah, no, we expect that that's more of a formality now. This is a new chemical entity for the U.S. It was marketed by Merck, the German Merck, back in the 1970s and 1980s for glaucoma in Europe, never in the U.S. because it's not a good glaucoma product, which actually makes it a great presbyopia product. We expect that the Orange Book will start listing the NCE status sometime this month, which is usually the time frame between approval to the point where you actually see that showing up.
This is sort of one of my simple-minded points of curiosity or questions here. There's no reimbursement or other cost or time burden on the prescriber here because of the cash pay model. Is this process just as simple as they write the script in two seconds as quick as they can sign, and then the e-pharmacy handles the rest? Is the amount of volume that a prescriber is going to have to take on here, if this product takes off the way we expect, going to be like a curve to adapting to that volume, or is it just really straightforward?
No, it's really straightforward for them to write a script, and very few actually still sign. For those that do, we have a script pack, but for most of them, this is an electronic, like any script, and that's literally a couple of seconds. Obviously, this is where the sales force comes in, and that's part of what they're doing now is training not only the doctor, but usually actually the front office staff on this is where you find the products in your EMR. This is where you find the pharmacy in your EMR. This is how you set them as favorites.
That's going to be a very seamless, quick process, and actually ties into what's our, I'm going backwards now, but what's our third pillar in our commercial strategy, which is making sure that there's this seamless journey to the products, seamless journey to first a sample and then your final script.
Okay. Just on the e-pharmacy, as we were sort of snooping around preparing for this and as we're sort of following your launch, at least one source indicated that it was UpScript. Is that the e-pharmacy that you're using?
No, that's absolutely not. That's no secret. We're using UpScript, which is a pharmacy and e-pharmacy dedicated for these self-pay products. They're doing huge volume products. They're doing a lot of insulins. They're very well set up both on the ophthalmology side as well as in the broader side to handle products like these.
Okay. What attracted you to that? Were there other options? Is there anything specific?
Yeah, we looked at all of them, and we preferred working with UpScript because of some of the reasons that I've mentioned there. Their focus is not on reimbursed products, but really in the self-pay. I think of them almost more, and I don't want to sell them short, as a fulfillment center. That's what they're just really, really good at. They get these scripts in and then, you know, within hours sometimes get the product out.
Okay. It looks like Vuity is actually available also from UpScript.
That's correct.
Okay, that's available for $79 cash pay as well.
Yeah.
Is that being replaced by VIZZ or will both be available?
No, both are available. I mean, it's a bit of different products. Now to put it in perspective, I think currently Vuity sells about 1,000 boxes or so or products a month. Very different, different volumes to what we expect.
Is there any risk of just, you know, VIZZ , despite being a better product, if you're driving all kinds of traffic to UpScript and you go on the website and what if the price of Vuity is just dropped to $69 in the next week? Do you see any sort of competitive dynamics there that you would need to account for or prepare for or anticipate?
Yeah. Vuity is abandoned by AbbVie. It's still out there. They're not commercializing it anymore. I don't mean to talk badly about competition, but the product doesn't work. That's very different in a product like this. This is a product where the experience is immediate. The first time point that we've measured in our study is at 30 minutes. These are naive patients, day one, 30 minutes. That's where your endpoint is. This is not a try Vuity for three months and then try to compare it to VIZZ for three months. This is a use Vuity if you ever wanted to compare on Monday and VIZZ on Tuesday and you make up your mind. That's what we like about this product. That's why we're going in so heavy on sampling because we know that the product works.
We want to get it in as many hands as we can to give people the experience and have them then self-select in, which is also why we believe that we will see a very different refill rate. Vuity did not have samples out there, so people bought in on the promise. Again, not to belabor the point there, but we're disappointed with the outcome. We expect that if people try to sample, then buy the product, it means that they've tried it and liked it. You should see a lot more stickiness on our product.
It may be worth just recapping sort of the overall marketing strategy, including the DTC efforts and how broad spectrum that will be. I would imagine through those efforts, a lot of traffic will be driven certainly to the optometrist's office or what have you, but also just directly to VIZZ.com or to UpScript. If I go on VIZZ.com or if I just want this, do I even need to go in for an office visit or can I just navigate through the website, do a virtual telehealth visit or something and just get my hands on a sample without even having to get in the car and go get an eye test?
Remember that this is still a script. You do still need a doctor to write you a script, and this may be a good segue into our commercial strategy. There are three pillars. I hadn't spoken about the third one, but the first one is getting doctors to recommend us. That is, again, because it is a script, the insert or the label recommends an eye exam. It's not obligatory, but it's a good way to get the optometrist, which is mostly optometrists, involved. That's important to us because there are 40 million presbyopes that are organically walking through the doors of an optometrist on an annual basis. We don't have to activate that patient group. They're just sitting there. They're coming in. We want the optometrist to be engaged in that process. That's where sending patients into their offices comes in.
They obviously have an incentive; that patient base becomes wider. They also give you a good eye check, make sure your eye is healthy, and then give you that sample that they can educate you on the product. That's that, doctors to recommend us. If you see what we're doing now, we have our AD sales reps out there, our 10-person inside sales as well. They're really driving awareness at the moment. They're really talking about, this is cycling, it's coming, this is this. As soon as there are samples, we're moving that into confidence building. This is where doctors will have the opportunity to use the product on themselves and their staff, on 10- 20 patients, and moving them from there into being ready to prescribe. That's that, driving awareness and getting doctors to recommend us.
In Q1, we'll do a quarter of that, and in Q1, we'll turn on DTC. If it's the same as Vuity, we're doubling the 40 million into 80 million where we start to push patients into the doctor's office. That's where you would come in and go, I've heard about this. I want to try this. You'll go on to VIZZ.com if that's how you are activated. You'll be able to find your doctor there. You can see which ones will have samples, make an appointment, get your eyes checked, and walk out with your sample.
Are you going to be telling, or is your field force going to be telling the optometrist, keep the patient in the office and have them try the sample in the office right there and talk them through it so before they leave, they already have a sense, okay, like I want to use this, or is it take it home and let us know?
We'll leave that with the doctor. What we've seen is that some of them like to do it that way. Others are, no, here's a sample and they'll coach them through it. This is what you can expect. We'll leave that absolutely with the doctor. The nice thing is that we know that this is a very comfortable, benign product. We're very fine with that strategy.
Okay. One of the other things I noticed in the label is the recommended time at room temperature for the product is 30 days. This seems like it's sort of serendipitously or maybe intentionally like a natural sort of protection against patients. I would imagine there'd be some patients who maybe are going to use this, you know, five days a week when I go to work, but on the weekend or whatever, I'll wear my readers. There could be an incentive or maybe an instinct to sort of ration it. You can't do that, right? If it's out of your fridge and it's just in your, you know, bathroom or something in the morning when you're brushing your teeth, they'd have to throw it out after 30 days.
Was that a coincidence or how does it so perfectly match the shelf life and when you'd want a patient to refill their script are aligned?
We have a phenomenal R&D development team. I don't know that they're that good that they can actually develop a product to have exactly that shelf life. If you think about this, it's refrigerated throughout the chain through wholesale level. When it gets shipped to you, it's shipped at room temperature. You can keep it at room temperature. To be able to get 30 days of room temperature, that's not just for us, it's just general FDA. You need to show twice that amount to be able. In our case, two months, we've shown stability for two months, you'll get 30 days. It's more of a coincidence. It's something that you see a lot with eye drops. You see it obviously with a lot of other products as well, but actually you don't even have that room temperature.
That room temperature piece is important to us because these are single-use blow-fill seal, these little plastic containers. We want people to have a couple of them at their office, a couple of them in the bathroom, a couple of them elsewhere. We were really focused on that. Pleased that we got that, but we weren't focused on exactly 30 days.
That's a good coincidence nonetheless. Is there any risk, do you think, of compounding in this market? Just the cash pay nature, the volume of the market, the sort of likelihood that the DTC, that this would sort of be a viral product. How are you thinking about the evolution of the compounding market and how are you accommodating that risk?
No, it's definitely changed, obviously, with what we saw with the GLP-1s. A couple of reasons why we're not that concerned about it. One, legally you can only compound when products are on shortage. We don't expect this to go on shortage. If this goes on shortage, we have a luxury problem to deal with. We have ample capacity in the chain. Secondly, this is not a GLP-1 that at the time that it was compounded, it was going for, whatever, $1,000 - $1,100 a month. There's less volume to deal with. In our case, this comes in this single dose blow-fill seal, and it's a preservative-free product. You can't compound this into a bottle. From a cost-effective point of view, if you compound, you would go into a monthly volume. You can't do that because this is preservative-free. You can't even use our formulation.
All in all, not too concerned about compounding.
Okay. One thing you mentioned on the approval call that I thought was interesting, caught my ear, was the rarity of receiving FDA approval with a single syllable brand name.
Yeah.
Why'd you mention that? I mean, is that a challenge to negotiate or what are the criteria for that? Actually, just in general, how did you choose the name?
Yeah. No, and we mentioned it because I think it's not only it was a proud moment for us to get that done, but much more importantly, this is something that we developed over two and a half years ago. When we start to think about what do we want this product, this brand to look like, we wanted to make sure that it was not your chemistry book type name that we see with many pharmaceuticals. We really look at this as a lifestyle product, which is what you see in our branding. It's what you see in how we talk about the product, and we wanted the name to reflect that as well. As we started testing names, we looked at hundreds. This was one that immediately stuck with us. As we started to test it, we saw that same name recognition.
You test 20 names over the course of a couple of hours, and at the end of it, you ask the panel, which name do you recollect? This just keeps coming out. Super good name for what we're doing. They make it visible. It's obviously a great slogan there that we can use. Very good there. It is indeed rare to get a single syllable name because you need to show it can look like, sound like, it can be confused with something else. It's very difficult to get a name that actually the FDA approves. Frankly, we got approval for the name already like 14 months ago, at least conditional approval on the final approval of the product.
Interesting. Outside of the U.S., maybe can you just lay out the additional regulatory approvals and timing to be anticipated, and also the overall strategy for commercializing in other regions? I know you have some partnerships, but maybe going forward, what should we expect?
Strategy is very straightforward. We will launch in the U.S. clearly, and we've been focused on that for the last four and a half years since we grew the company or picked up the company. Actually, it was very different. We're licensing the rights. We've done that in a couple of geographies now. We licensed Greater China early because they had to do their own clinical trial. That trial read out over a year ago. Carbon copy data from what we saw in the U.S., great testimony to the product. They submitted to the Chinese FDA a couple of months ago. Think of them as 12 - 18 months or so behind us from a launching perspective. We licensed Southeast Asia, so South Korea and the regions around that more recently. Same with Canada, with [FAIA]. Other regions obviously are highly interesting.
We're not that urgent or we don't feel that urgency to license there. Our own company is extremely well capitalized. It's not that we need the capital from those deals. Frankly, it's our view that as we show success in the U.S., the value of those markets will go up. We have started the regulatory process and the preparation of that in Europe just to make sure that we don't lose time there. That is something that in due course we'll license out.
I have to ask you just because it's a niche that I have to scratch. The business model here is so unique, right? The cash pay model for prescription medicine. We see what's happening in the GLP-1 space. If you guys perfect this and if you get this right and you deliver just this enormous high volume launch and you solidify that business model, are you thinking about LENZ five, ten years from now? Can you replicate this beyond VIZZ ? Are you interested in that or do you want to be a single product company? Help me understand if there's a, you know, a next chapter to this cash pay.
There's always a next chapter. By design, as we've built the company, it's currently a single asset company. We like that everything is focused on this one product. There's not that many, you know, $3+ billion opportunities out there. However, there's always a next. As this grows and as we show success, this can be a great cornerstone. Products in a much larger portfolio. That's where you're going, indeed. Yes, you can look at other ophthalmology assets that fit the mold, that fit maybe the sales force. You can imagine that we've built up this knowledge on how do you build a brand in this market, this pharmaceutical market that's growing very rapidly because it's PBM-insulated, it's IRA-insulated, there's no, you know, most-favored-nation s. It's got a very long tail because it will never genericize in a normal way.
Those are all skills that I think you can apply to different parts of the industry. You might see us going into different tiers.
First and foremost, we'll be tracking the VIZZ launch and looking forward to seeing your success there. I just want to thank you for coming to the conference this year. Thank everyone in the room and on the webcast for listening in, and have a great rest of the day.
Thank you. Thanks, Steve. Thanks, Antoine.