LENZ Therapeutics, Inc. (LENZ) Earnings Call Transcript & Summary

All right. Good morning, everyone. Thank you very much for coming to the fireside chat today with LENZ. My name is [ Rob Deane ]. I'm a Managing Director in the Investment Banking division. I just had a brief disclaimer that I need to read before we get started here. For important disclosures, please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. And now with that, we have the pleasure of hosting Eef Schimmelpennink, President and CEO of LENZ Therapeutics. We're very delighted to have Eef join us today for our Q&A session to share some insights into LENZ Therapeutics and their recently approved therapy for presbyopia. Maybe with that, Eef, before we get started, can you just tell us a little bit around how LENZ Therapeutics got started for those that may not be familiar with your story?

Absolutely. And first of all, thanks for having us, it would be always great to be here and see so many of you here. The LENZ Therapeutics has been around for a little bit. And like you said, we just got our drug for presbyopia approved a little bit over a month ago, early actually to effect, and I'm sure we're going to talk about that before. But real brief, the history of the company, it's a very smart ophthalmologists about maybe a decade or so ago now. We're looking at the presbyopia landscape, and we're seeing those doughnut-hole shape IOL lenses being brought to development. And they realize that, yes, it's going to work because we know it's basic optics. So if you have a pinhole pupil, you can create that with a lens or like we do with a pharmaceutical, you're going to improve your near vision, but they also realize that, that's pretty invasive to do that with an IOL that you permanently implant and otherwise help the eye. So they set out to achieve the same thing, but then with an eye drop. That thought was, well, if you could do this with an eye drop, that would be phenomenal. It's reversible, noninvasive. Obviously, the better way to do that. The three, let's call it miotics that are known, they were the first to go out with this idea, looked at logically pilocarpine first because that's a product that was first generation glaucoma used in the eye in the U.S. and immediately discarded that because of its side effects. In fact looking at thumbs that the aceclidine, which is our active ingredient was actually brought to market by Merck, the German Merck back in the '70s, '80s, feels pretty much as a glaucoma product for reasons that actually makes it a perfect presbyopia product. So fast forward, that's the asset that I picked up about 4.5 years ago, 5 years ago and that we built LENZ Therapeutics around. And as I said, we're very pleased to have that product approved now.

Great. Thank you for providing some of the context. Can you tell us a little bit about what this is and how it can be -- it can benefit patients with presbyopia. And also maybe starting to dig in a little bit around its differentiation versus other presbyopia therapeutics. I think you mentioned intraocular lenses, but just thinking about the differentiation in the treatment paradigm and the landscape.

Absolutely. So maybe let's start actually by -- and we've used the term presbyopia a few times now. I know that when I was first pitched this idea by the investors that we were putting the Series A together, I literally had to Google what presbyopia was and, oh, that's what I have. So presbyopia is the inevitable loss of near vision that happens when you age. So most of us, as we hit like roughly 45 start to notice that our near vision becomes more and more blurry and we pull a phone away from our faces to still keep it in focus. We're in a darker restaurant. We can't read the menu. You see all the people that put their lights on, on the menu. That's presbyopia. We're never going to market it like that to consumers. I'm sure we're going to talk about the marketing, but just as background, that's it. Because it happens to everyone, that market is obviously huge. It's 128 million presbyopia patients in the U.S. alone, again, effectively everyone over 45. So what you want to do with this eye drop is create a small pinhole pupil, like I've mentioned earlier, and it's very important to get to below 2 millimeters. And that's also where the differentiation comes in because only at a pupil size below 2 millimeters is where you really start to drive that impact on near vision. That's where you really have that increased depth of focus and your near vision comes back. So very important to get to below 2 millimeters. And if you then pull that a little bit further on, what's the ideal target product profile needs to be an eye drop that is once a day. So think of this as you wake up in the morning, brush your teeth, put your eye drop in and you're good to go for the full workday actually the previous speaker used the set it and forget it as well. That's how we talk about it as well. It's a set it and forget it. So it needs to work quickly, but also it needs to work on. So for the full workday, you need to have that benefit of increased near vision. So really bringing that seamless vision back to what it was when you were 30, 35. You wouldn't -- we never thought about the fact that if you want to look at something up close, your lens needs to do something. Very clearly, that's what we achieved with our product. It's been tested logically in very large Phase III trials, and we've seen a near universal effect. 93% of patients get back to at least 20/40 and 20/40 is what ophthalmologists call 20/happy. That's when you can read without reading glasses. So 93% of patients within an hour at that level, 20/40 or better at 10 hours, which is the last time point that we measured, still 7 out of 10 patients at that level. So truly a product that works for almost everyone. We have a very broad inclusion criteria. It's basically an all-comer study. So it works for almost everyone, works rapidly and works long.

Great. Thank you. Now digging into some of the clinical data, obviously, you got to improve, but your data showed really impressive efficacy with over 70% of patients achieving three lines or greater near vision improvement at both 30 minutes and three hours post dose and also 40% still showing this improvement out to 10 hours to your earlier point. Now your Phase III CLARITY trials also showed 95% of participants achieving at least two lines of near vision improvement. So with so many positive aspects of this particular therapeutic, how do you think about what to emphasize in your messaging as you're doing today? Also, can you try to elaborate on the new 20/40 data you recently revealed at launch?

Yes. No, absolutely. Great question. And you heard me go there a little bit just before. So for context, if we talk about three lines, and that's the FDA endpoint. So the FDA endpoint is improvement of at least three lines or more without losing a line in distance vision. And spoiler alert, we don't impact distance vision negatively. We actually had a little bit of improvement in distance vision, so we don't have that issue, but that's the FDA endpoint. Those are the same three lines for those of you in the audience that go to an optometrist that they make you read on those reading charts. So if you can improve three lines, that means that in most instances, you better get back to 20/20, 20/30. So that's the endpoint. Those are the percentages that [ Rob ] you just mentioned. Again, at 30 minutes, we have 71% of patients hitting at least a three-line improvement. And remember, we have patients coming in that were 20/80, 20/100. Basically, that's from side 60 or so that you're reading up close. So very effective. Out of 10 hours, we still have about 40% doing that. Now what we realized that as we started to prepare and talking to and we had our label to our KOLs and our doctors, they all go, that's great, but does this thing work for my patients? And that's why you're no longer talking about three lines or two lines or five, six, seven lines, which we also saw an improvement. They want to know, am I getting my patient to at least 20/40 more than 20/happy that I was talking about. That's new data that we've been sharing since the last couple of weeks, the data that I just referenced that 93% of patients are again, near universal efficacy across a very broad patient group, 93%, 20/40 or better, 70% still at 10 hour. So that's the emphasis that we're changing now, and it's much more of a real-life example or a real-life statistic because it really means that you can read without your reading glasses.

Great. Thank you. Now that this is commercially approved, can you tell us about your commercial strategy? You've mentioned having an 88-person sales force now. How is the sales force being deployed? What are some of the key metrics you're going to be tracking to measure their effectiveness in the initial launch phase?

Yes. Thanks for that question. So if you think about commercial strategy, it's a three-pillar strategy. First one is doctors to recommend us. That's where the sales force comes in, and we'll double-click on that. The second pillar is consumers to request us by name. That's really the DTC consumer campaign that we're starting in Q1, and I'm sure we're going to talk about that as well. And then the third one is making sure that there's a seamless access to our product. So that's very easy access to first a sample that's acting as a bridge to final products and using e-pharmacy or retail pharmacy to have that product show up on the doorstep of our consumers, and again, a very easy way. On the first one and to your question, doctors to recommend us, that's truly indeed the sales force being out there. But before that, we already have the MSL team. So we had 10 people and still have a 10 optometry lab. MSL team that started to have doctor-to-doctor discussions late last year. They already had 4,000, 5,000 discussions with unique doctors. So these are, on average, because we're measuring everything, 23-minute discussions that they have talking about aceclidine because they can do that in a doctor-to-doctor discussion, the importance of being below 2 millimeters and what makes our drug different. Now that we have the product approved, we had about a month or so before our sales force fully in place, trained them up with the label, with the final training and they're out there now. So 88 reps talking to about 13,000 doctors and then as an inside sales force of about 10 people that are expanding that to about 15,000 doctors. So the stages that they're going through are the ones that I'm sure most of you will be familiar with. It's all about awareness now and that awareness has shot up tremendously. So most doctors are aware of this now, even though we've only been out for near three or four weeks, they've already done over 10,000 sales calls. And then moving that doctor in that journey to confidence, and that's where the sample is coming. So we've been guiding or very confident that we'll have samples in the market next month, October. The reps are going to hand deliver those samples to the doctors. They can obviously start using that on themselves on their office staff and on patients. So that's going to give them the confidence in the product, which will then move them to ready to prescribe. What we even see at this moment is that there's a good group of doctors already in that ready to prescribe bucket. There's definitely a group of doctors that look at the data and say, this is phenomenal. I can see how this is different. I want to use it. I'm waiting for samples. There's very few doctors that say, I'm not interested. I think 3%, 4% of doctors that go, you know what, let's take presbyopia eye drop is not something for my practice. So very good foundational interest there already.

Great. Thank you. And your research shows over 60% of the roughly 130 million presbyopes in the U.S. would strongly consider an eye drop solution. And I think -- that seems fairly intuitive. Now how do you think about segmenting this population? And do you have different strategies in place to get in front of these various segments that you might have in mind?

Yes. No, so that really starts to tie into that second pillar, consumers to request us by name. But like you said, there's 128 million presbyopes out here in the U.S. That's a huge target audience. The good thing is that we don't have to teach disease awareness. Again, nobody knows what presbyopia is, but we all know that our vision is getting more and more blurring. But you don't want to put your marketing effort out across or diluted across 128 million presbyopes. Now it works for all of them. So I expect that we'll see in those different groups, people using the product. Across that 128 million, as I think you've mentioned, there's a 60% high interest in the presbyopia eye drug. So if you just blanket, do a survey, that's the number that you get back, which is incredibly high. I've never seen a product that gets that kind of feedback. When we start to segment and say, okay, let's find in those 128 million, the groups that over-index to now think about 90% or more have a high interest to try and use a product like this. There's very clear groups that you see there. The first group and each of those groups is definitely over 10 million in itself. The first group are people that are wearing contact lenses. So they've made a decision usually in their 20s that they want to be glasses free. So they need a distance correction in most cases and have been using contact lenses for that for the better part of their lives, 20, 25 years. So clearly invested paying money to be glasses free. Now they hit 45, 50 and they realized that my near vision is going, there's not a good bifocal contact lens. So that's being pushed out of contact lenses and into wearing either bifocal glasses or reading glasses over the contact lens is clearly something that they don't want. So they're very eager to find a product that allows them to stay in contact lenses, and that's what this eye drop does. It's literally, and we have plenty of contact lens whereas in our study. You put the drop in, in the morning, that wait 10 minutes to put your contact lenses in and now you have that seamless vision again that you were used to. So important group to target, also a very important group for optometrists because this is a group that comes back every year because they use a subscription for the contact lenses. It is a very valuable patient to them. That's the first group. Second group, somewhat similar are people that had LASIK in the past. They put down back in the day, $5,000 or so for eyes. It's a little bit less now. But again, invested in glasses-free life. And they're coming back to the optometrist, 45, ophthalmologists going, my LASIK is wearing off. What they don't realize is it's not the LASIK wearing off, but they're becoming presbyopic. So same issue, same solution. With this eye drop, you can say -- you can just obviously keep the distance vision through your LASIK and then improve your near vision with the eye drop over 10 million people there. And then there's a third group, what we call active aging. These are people that care about their looks. They want to go on with their active lives. Those are people that are maybe using Botox or other ways that care about their aesthetics and don't want to put reading glasses. It's difficult to target or get the number of what the Botox users is in itself. In my experience, I was in San Diego, there's at least 10 million Botox users in California alone. But it's definitely a very large group. So those are the initial groups that we're going after that we can target very, very easily with our DTC campaigns.

Great. Thank you. Now thinking about your commercial strategy now given that the cash pay therapeutic, how do you think about pricing? And are there any dynamics that are unique to cash pay treatments that we should be aware of as you're ramping up commercialization efforts?

Yes. No. So this is indeed a 100% cash pay product, which we like a lot. It makes -- it means that we're insulated from PBMs. There's no negotiations with insurance companies. It's a very fast cycle from sale to your revenue. It also means that you truly have a very healthy revenue stream there, you can control that yourself. There's no erosion on it, if you will. So then it comes down to pricing. And as you would expect, we've done a lot of pricing studies with Kantar and looked at what's the ideal price point for a product like this. And we came out at $79 a month which, by the way, and I know that you asked about VUITY earlier, it's the same price that VUITY priced at. So not only do we have the Kantar studies, we can actually look at VUITY, which is a pilocarpine-based product that AbbVie launched three years ago that, frankly, had a great launch. They very rapidly got up to about 6,000 new scripts per week. They sold to about 150,000 patients at that $79 price point. So very clearly, it's a price point that works. It's a price that people are willing to pay for. We did see a second price opt for them at a slightly lower number, and that's why we also are selling a three-month pack at $198, so $66 per month, that's self-funding. Basically, it's the reduction in shipping fee and distribution fee because we're still obviously just the one shipment that we're passing on to the consumer. So same for us from a bottom line perspective, better for the consumer if they buy at that price. But again, we feel and we've seen it as a price that works. We like the cash pay. The very first scripts are going to be hitting our bottom line. There's nothing that we need to buy down in that.

Thank you. You mentioned VUITY, as you mentioned, strong launch initially and failed to really capture the market. What are some of your key learnings from the VUITY experience? And what can you do or what will you plan on doing differently?

So we learn a lot from VUITY, and it's unique or somewhat unique, I think that you have a product in the market before that but had a great launch, but that didn't fill. So let's talk a little bit about why VUITY really didn't deliver on the promise that was clearly there. We had an internal target of about $150 million for year one. Not surprisingly, the product needs to work, but different than maybe many of the other products that we're used to, where it takes months to whatever C or cholesterol level go down. This is an instant gratification product. This is a product where I promise you that if you put this drop in, you're going to be able to read your text messages again on your phone without your reading glasses within 30 minutes on day one. So I can't mark it through that. I can't tell you or use it for -- if you don't see that, just keep using it for three months and it might improve, that's not how this works. So if you go out with that message, you better deliver that. So VUITY went out with that message, but didn't deliver it. So many people, and I was one of them, went out, bought a bottle of VUITY, they came in a bottle, used it for a couple of days, and we're like disappointed. And that's where the comparison on data comes in. If you look at VUITY, the challenge that they had was because it's a different mechanism, and pilocarpine also stimulates what's called the ciliary body and that drives distance vision impact and other side effects. They couldn't go up to a concentration and actually get the pupil down to below 2 millimeters. So the smallest pupil that VUITY gets to at our 1 is about a 2.3 millimeter pupil. And then very rapidly, it achieves back up to 2 to 3 millimeters. So that effective window they never really get into. And therefore, only one in four patients even noticed an effect. So that was issue one, didn't work for a lot of people. That's why they initially have samples out, but then after a couple of weeks, they literally pull the samples out of the offices because they realize that people sample, they're not going to buy it. So took the samples away. So issue one didn't work for a lot of people. Issue two, if it didn't work, so if you want of those four, then it didn't work long enough. So people felt that, again, it worked for me, but it worked for about 2, 2.5 hours. And that was the average that you were hearing back, and that was what doctors were hearing back. If you now look at the curve on how VUITY launched, again, very strong launch. The first three months when they only were promoting to doctors for the same thing that we're doing in Q4, they got up to about 3,000 new scripts a week, then doctors started to catch on that, well, this doesn't really work. It started to go down, but then they turn on DTC, this is a population that you can activate very easily with DTC. So they turn on DTC at least that version of it, and then it shut back up to about 6,000. But again, nobody refilled. So six months in, they stopped promoting it nine months and they took it out of the back.

Thank you. You mentioned kind of going through kind of the initial launch experience for VUITY. What are some of the key markers of success that you'll be focused on in the first couple of quarters following launch, like, say, early next year?

So actually, let me continue a little bit on the VUITY because the second part of your question was what did we learn from VUITY? And we did learn a lot. VUITY obviously, had a great start despite the fact that they focused on ophthalmology. So their sales force was mostly ophthalmology because it fitted with the rest of that. But what we have is all the data where all the scripts came from 150,000 scripts, almost exclusively 80% came through optometry. So what we're doing differently is that 88-person sales force is calling on optometry 80% of the targets, ophthalmology, 20% of the target. So we obviously have a very -- and we've learned that from VUITY. We've learned that doctors need about a quarter to actually get familiar with the product. So that's a quarter four that we're in or getting into now that we're using to educate the doctor skip and sample skip and their confidence before we turn on DTC in Q4. So those are some of the things that we've learned from VUITY and how that translates into metrics. So a couple of things, and I use every opportunity that I get to emphasize that, and I know that you guys are not going to listen, but don't look at IQVIA for script data. This is going to be a two-channel distribution. e-pharmacy is not being picked up by IQVIA. That's where A part, potentially a significant part of the scripts will flow through. So we've got that channel. We're promoting that. That's the channel where consumers will have the best price. It's also the channel where we'll have most script on our consumers. However, if you prefer to be in line at the CVS for two hours, you can still get it through the retail pharmacy, if that's what you want to do. So IQVIA is only picking up the retail pharmacy and then putting some sort of factor on it to guesstimate what's in the retail channel. So what we'll help you with is appropriately give you insight on what script data really is. I don't expect that we'll do that at our earnings call in November because we're only a couple of weeks into our launch, but other metrics that will be relevant that we'll start to share is what are the amount of doctors that have prescribed, what are the amount of doctors that prescribed multiple times? What's our reach with samples? What are the amount of consumers that have signed up for the vizz.com website. And then we'll start to talk about what's our NRx rate. And then very importantly, and I think that's how most of us, for sure, will judge the success of the launch. What's our refill rate because that's ultimately what we need to start showing is that not only are we pulling patients in, but we're actually keeping them on product.

Yes. So seeing a bunch of investors here. I'm guessing that they'll try to think about benchmarking you against VUITY, but you raised some great points, including how you folks won't be able to really rely on IQVIA data. So how do you think you'll be benchmarked against VUITY? Or is that even a fair comparison given kind of your product profile?

I think it's a great comparison for the launch. So we know that VUITY did well in the launch. So what we see, and we've obviously spoken a lot with our covering analysts. We have eight covering analysts. And if you look at consensus, it's in a very tight band. What most people are doing is saying, great, VUITY got up to 3,000 new scripts early on when they were only promoting two doctors, and that doubled to 6,000 when they started -- when they turn on the DTC. Even though you've got a product that's at least 3x more efficacious, works at least 3x longer, but also for a 6x larger population because VUITY was mostly focused on young emmetropic for people without distance vision correction. Despite all of that, you have an AbbVie. So let's say you get up to 2,000 new scripts a week with your sales force and then 4,000 if you also double that with DTC. So that's, I think, the baseline or I know that's the baseline that most investors and analysts look at for the launch. Then it comes down to refill rates. And that's where, obviously, the two curves need to be very different. So what we know when we ask patients in a study where hundreds of patients obviously in or where you do a general survey with a target profile, people say 80% of the consumers say, I'm going to use this four to seven days a week. So basically, people are saying, I've tried it, it works, why would I not use it every day. So that would be 10 refills a year. What we also know is that, yes, contact lenses, and it compares a little bit like contact lenses because you got that -- you know where it works. You also know at a 95% refill rate, the dry eye products, like 55% refill rate. General medicines at about a 50% refill rate. So it's easy to say I'm going to use it every day. It doesn't know what's happened. So we're literally cutting that those 10 refills. So five refills a year or five fills a year is a 42% refill rate. So that's the second part of the equation that you need to actually start modeling it out. So use VUITY for launch in our mind, we're saying 42% refill rate. If you put all that together, it's a $3 billion market. We're currently getting credit. We're a $1.1 billion, $1.2 billion company. We're currently getting credit for about a $350 million peak revenue. So that's where the upside is.

Thank you. Through your CLARITY trials, what's the most surprising feedback you received from either patients or doctors and their perspectives on this?

So my most favorite one, it's actually on one of our -- on the consumer website on the vizz.com website. Now we have patients in that actually were on the product. So real testimony is unscripted. There's a woman on the called Deanna, who goes, I couldn't believe it actually works. And that's what we've got back quite a few times because it's kind of a miracle that you put a drop in and you can see up close again, especially for those like me that can't do it anymore and you put that product in and you can apparently see again. So that's feedback that is very raw, but that keep coming back from people. We had many doctors tell about their patient experiences where one of the doctors dosed in groups, they have like 10, 12 patients coming in on a Saturday for the first dosing and they would very -- in a very fun way, talk about there's the five patients in the waiting room that are very happy because they're reading the magazines without the reading glasses and then there's the five clumpy people that were on the vehicle. So those are just anecdotal insights. If you look at data, again, it was off the charts on efficacy on near vision. What we also saw is that, and I touched on it very briefly early on, is that we actually improved distance vision as well. So on average, people have about a line or so of distance vision improvement. That's especially impressive if you realize that these people are either 20/20 because of just distance correction that they're wearing or they're on eyes. So it's not that we're putting them in without the contact lenses. They've got the contact lenses in or their normal glasses and they're still improvement distance vision. That's something that we noticed, especially LASIK people actually noticed because then they realized what 20/20 is. They used to have that and now they no longer have it, and maybe 2025, they aged out a little bit. We're giving them that line back to this is what it was like when I just had LASIK.

Thank you. I know we're coming up on time. So maybe talking about your -- digging into your commercial strategy because I'm sure a lot of investors are going to be thinking about how to set expectations around this initial launch and also what some of your readiness that you've already discussed. Now what factors will influence your DTC marketing launch timing? Also, can you tell us what this campaign will entail. And you hit on some of this, but I think it would be good to dig into it a little bit further.

Yes. So from a timing perspective, like I said earlier, we'll turn it on in Q1, just to make sure that doctors have a moment to really get used to the product. So there's 40 million presbyopes that are coming through the doors of optometrists organically every year. So that's a group that they can already treat once we have the product. We know that you can activate the 80 million or so of presbyopes that are not seeing optometrists because they're emmetropic like me and they buy their reading glasses of Amazon. You can activate that group really easily. So there's going to be a big bolus of patients that are coming in, and online once we turn on DTC. What's going to look like is what you expect from a current day commercial campaign. So we'll have a celebrity, very big name, on top of that, that everyone will know. She because this is skewing a little bit on the female side will be the face of the campaign we'll use to really put that messaging out. Then there's a group of influencers below that. And then we know that these patients or consumers, we know exactly where they take or consume their media. This is not surprisingly, still Facebook, Instagram, YouTube, nonlinear TV. So that's where that DTC campaign will go out. And you can start to see a little bit of that, not on the -- we're not pushing it out yet, but if you look at our website, look at our material, we're really going for that lifestyle high-end products. And that's where the name VIZZ, obviously, was chosen with a lot of thought that went into it. We picked that three years ago because we wanted to have a very rememberable consumer-facing name. So very happy that we got that name approved.

Great. Last question. Looking forward, I think we're all very excited to see the initial sales traction and also I'm looking around this room, many people are probably willing to try it. I'm seeing a few wearing glasses in the room. Other than actual dollar figures, revenue numbers, what other KPIs or events should folks be paying attention to and looking for?

Yes. I think it goes back a little bit to what I said earlier. I think the big benchmarks or events that are going to happen over the next months and quarters are really going to be around how many doctors are picking this up, are writing this multiple times. How is this being picked up by the media, we've seen it already. We've not done anything ourselves yet. But when we got approval, this goes around like wildfire. This is something that so many people can identify with. So I think those are the pieces that will really start to show what this launch is all about.

Great. Well, thank you very much for your time today. Perhaps next year's conference, we're going to have some samples here.

It usually the first question I get from investors, did you bring samples?

Yes. All right. Well, thank you very much for your time. Thank you.

Thanks, everyone.